Contributions of biotechnology industries of India to global bioeconomy: an overview

Abstract

Globally, industrial biotechnology addresses diverse challenges, fostering environmental conservation, sustainable development, economic growth, and innovation. Currently, there are approximately 20,922 biotech companies worldwide, including 6,653 in the US, reflecting significant growth. The global biotech market is valued at $727.1 billion and is projected to expand at a compound annual growth rate of 7.4% by 2025. In India, industrial biotechnology holds promise, with about 3% of the global market share. The country has the highest number of FDA-approved manufacturing facilities outside the US, totaling 665 plants. This growth is driven by government support and a skilled workforce, with a focus on advancements in bioenergy, bio-based materials, and healthcare. Recent years have witnessed a surge in international demand for Indian vaccines and biopharmaceuticals, positioning the country as a leading hub for contract manufacturing and clinical trials. The country’s bioeconomy, valued at $150 billion by 2023, is forecasted to double to $300 billion by 2030. This growth is supported by the government’s BIRAC scheme, which has established 60 successful bio-incubation centers, further promoting innovation and entrepreneurship. India’s bioeconomy basically consists of four segments: BioIndustrial ($72.6 billion, 48.09%), BioAgri ($12.44 billion, 8.24%), BioPharma ($53.8 billion, 35.65%), and BioServices ($12.1 billion, 8.02%), with biotech start-ups reaching 8,531 in 2023. This comprehensive review highlights the significant potential of industrial biotechnology in India by focusing on technological advancements, policy impacts, and market trends. It provides an overview of the current landscape, challenges, and future opportunities, and offers insights to guide strategic initiatives aimed at advancing the sector.

Introduction

Industrial biotechnology, often termed as white biotechnology, involves the use of enzymes and microorganisms to produce essential items. Although the term is relatively modern, its roots have been traced back to thousands of years. For instance, the use of yeast as a biocatalyst in bread-making dates back to approximately 10,000 BC. The application of biotechnology in industrial production holds significant promise for sustainable development (Fig. 1), albeit it is subject to the critical evaluation of economic viability. The practice of fermentation technology, established in the Neolithic age, witnessed the development of various cultures creating beverages and medicines without a scientific understanding until Louis Pasteur’s groundbreaking work in the nineteenth century. Subsequent milestones, such as Alexander Fleming’s discovery of penicillin in 1928, catalyzed the industrial use of fermentation, leading pharmaceutical companies to explore antibiotic discovery. The commercialization of enzyme production, facilitated by Japan’s pioneering work in amino acid fermentation, expanded the scope of the first genetically engineered fermentation product to the market in 1977 (Tiwari et al. 2022). Today, fermentation biotechnology is widely applied in bio-agriculture, probiotics, brewing, biofuel, food, nutraceuticals, and enzyme production, transforming markets toward eco-friendly and innovative solutions. As of 2022, the worldwide industrial biotechnology market has reached a valuation of USD 1023.8 Billion. Projections indicate that this market is anticipated to experience the most substantial Compound Annual Growth Rate (CAGR) of 14% between 2023 and 2032. Forecasts suggest that by 2032, the industrial biotechnology market will be poised to achieve a value of USD 3672.9 Billion (Market.us 2024). India is among the top 12 destinations for industrial biotechnology worldwide and the third largest destination for industrial biotechnology in the Asia–Pacific region. Today, India is poised as one of the leading destinations for bioinnovation and biomanufacturing; hence, it is identified as a sunrise sector and a key part of India’s vision to reach a $5 Tn economy by 2024. India with its established industrial biotechnology stands at the forefront of growth potential across various sectors, contributing significantly to the global biotech industry. With over 2,700 start-ups and 2,500 companies, India aims to have 10,000 start-ups by 2024, showcasing its growing influence (Tiwari et al. 2022). The biopharmaceutical sector dominates revenue, targeting a turnover of $150 billion by 2025 (BIRAC, realizing investment potential for Indian state-specific biotech industries, 2021). India's fermentation industry, valued at $64 billion in 2019, is hovering for growth, aligning with government initiatives. Local demand is driven by initiatives like Atmanirbhar Bharat and Make in India, while the global competitiveness of Indian products has contributed to the rise in international demand for Indian vaccines and biopharmaceuticals. India, exporting vaccines to more than 150 countries, has positioned itself as a prominent hub for contract manufacturing and clinical trials. To manage healthcare expenses, companies are utilizing generics and biosimilars, establishing India as a focal point for providing affordable access to innovative and comprehensive healthcare solutions. India’s share in the global industrial biotechnology industry stands at approximately 3%. India has the highest count of manufacturing facilities approved by the US Food and Drug Administration (FDA) outside the United States, totaling 665 plants, and it contributes to 44% of the worldwide Abbreviated New Drug Applications (ANDA). Additionally, India boasts 1400 manufacturing plants that adhere to the standards set by the World Health Organization (WHO). On a global scale, the fermentation products market, valued at $149.5 billion in 2016, is projected to exceed $205.5 billion by 2023 (Nils-Gerrit Wunsch 2020). With the vision to become a major contributor to global biotech innovation, the Government of India's BIRAC scheme has established 60 successful bio-incubation centers (such as InCeNSE-IISc, AIC-CCMB, NCL-Pune, and BioNEST-BHUetc), fostering innovation and entrepreneurship. As India progresses, it has emerged as a significant player in the global biotechnological industry, with achievements, challenges, and goals shaping its industrial biotechnology trajectory. India’s cabinet approved the BioE3 initiative to strengthen its industrial biotechnology sector, building on achievements such as vaccine development. However, the country has yet to fully capitalize on the broader potential of global industrial biotechnology. The policy targets areas such as bio-based chemicals and climate-resilient agriculture, requiring sustained support and collaboration for success (The Hindu 2024).

Fig. 1.

Overview of key biotechnological techniques across various sectors for sustainable bioeconomy development

This review focuses on India’s industrial biotechnology sector and examines its regulatory framework, research landscape, and sectoral contributions. It explores India’s industrial biotechnology policies; research advancements in bioenergy, bio-based materials, and healthcare; and its leadership in global vaccine production and biopharmaceuticals. The review also highlights India’s market position, government support through initiatives such as BIRAC, and its economic growth, aiming to identify challenges, opportunities, and strategic directions for future sector development.

World perspective of industrial biotechnology vis-a-vis India

Currently, the global biotech market is valued at approximately $727.1 billion. It is projected to grow at a compound annual growth rate (CAGR) of 7.4% by 2025 (Alborno et al. 2022). With around 6,653 biotech companies in the US and 20,922 globally, the industry is anticipated to see further expansion. The global industrial biotechnology-market value is expected to reach $2440.0 billion by 2028. Molecular diagnostics, a crucial sector, are predicted to exceed $25.2 billion by 2025. Artificial intelligence is becoming increasingly integral to the industry, with over 800,000 biotech employees in the US engaged in various sectors. The average biotechnologist earns $80,455 annually, with similar salary averages in Europe and specific figures such as ₹489,595 in India and $41,782 in Singapore. As the industry evolves, the employment rate for biological technicians is expected to increase by 5% from 2019 to 2029 (Omnicoreagency 2024). As of 2024, the global industrial biotechnology sector comprises 12,387 businesses, reflecting a 6.1% increase from the previous year and an average annual growth rate of 6.1% from 2019 to 2024. The industry’s resource utilization is balanced between capital and labor. Notably, the major cost components as a percentage of revenue included wages (26.3%), purchases (25.8%), and Rent and Utilities (0.4%). The market share concentration in the global-biotechnology industry is low, and Merck and Co. Inc. is the largest business in this sector. The global industrial biotechnology business from 2014 to 2024 is illustrated in Fig. 2. While global trends highlight the growing importance of industrial biotechnology in sectors such as biofuels and pharmaceuticals, India has positioned itself as a key player, especially in vaccine and biopharmaceutical production. India has already achieved significant milestones in areas such as vaccine development but has not yet fully tapped into the wider opportunities offered by global industrial biotechnology (The Hindu 2024). Hence, India's Cabinet has recently approved the BioE3 (Biotechnology for Economy, Environment, and Employment) initiative, aimed at strengthening the country's industrial biotechnology manufacturing sector (The Hindu 2024). BioE3 policy focuses on six key sectors: bio-based chemicals, functional foods, precision biotherapeutics, climate-resilient agriculture, carbon capture, and marine/space research. However, realizing its full potential will require sustained financial and infrastructural support from both central and state governments. Although the BioE3 initiative is a promising move, India needs to foster a conducive environment for long-term investments and encourage collaboration between central and state authorities. Without these supportive conditions, the impact of the policy may be limited. For India to reach its full potential in industrial biotechnology, it must make further advancements, positioning itself as a leader in global industrial biotechnology innovations (The Hindu 2024). India ranks among the top 12 biotechnology destinations globally, and is the 3rd largest in the Asia–Pacific region. By 2024, its bioeconomy is valued at USD 130 billion, with industrial biotechnology playing a crucial role in its ambition to become a USD 5 trillion economy. India accounts for 3% of the global market, excelling in biopharmaceuticals, biosimilars, and bio-agriculture. The government has implemented favorable policies such as 100% FDI in greenfield pharma and a National Biotechnology Development Strategy. India is positioned to become a global leader, contributing to vaccine production, agriculture, and environmental solutions, while focusing on innovation, self-reliance, and sustainable development (The Hindu 2024).

Fig. 2.

Illustration of the global-biotechnology industry’s business landscape, showcasing the total number of companies from 2014 to 2024 (Data adapted from: IBIS World 2023)

Industrial biotechnology in healthcare, agriculture, and bioenergy and their market scenario

Industrial biotechnology plays a crucial role across various sectors and contributes to advancements in healthcare, agriculture, and bioenergy. In healthcare, it drives innovations in biopharmaceuticals, vaccines, and diagnostic tools, thereby enhancing disease treatment and prevention. In agriculture, industrial biotechnology improves crop yields, pest resistance, and sustainability, and promotes food security. The bioenergy sector supports the development of renewable energy sources, such as biofuels, reducing reliance on fossil fuels, and addressing climate change. The growth of industrial biotechnology on a global scale plays a pivotal role in addressing various challenges and contributes to sustainable development, economic growth, and innovation. As countries worldwide recognize the potential of industrial biotechnology in diverse industries, a broad perspective emerges, highlighting key trends and opportunities in the field. One of the primary drivers of industrial biotechnology at the global stage is its role in sustainable development. Emphasis on reducing environmental impact, conserving resources, and mitigating climate change has led to increased interest in bioprocessing, biofuels, and green chemistry (Ramchuran et al. 2023).

Countries are leveraging industrial biotechnology to develop eco-friendly alternatives, such as bio-based materials and biofuels, with the objective of reducing the dependence on non-renewable resources and mitigating the environmental impact associated with conventional energy production. Biofuels, derived from renewable biological resources, are increasingly being recognized as viable alternatives to traditional fossil fuels. Globally, countries are investing in research and development to enhance the efficiency and scalability of biofuel production processes. Global efforts to limit the global temperature rise to 2 °C will require annual investments of US$500 billion in renewable energy, with US$25 billion to US$50 billion dedicated to biofuels. The biofuel sector will need US$5 billion to US$10 billion annually for new capacity from 2030 to 2050 (Miftah and Mutta 2024). Liquid biofuels, essential for decarbonizing transportation and addressing energy needs in rural areas, are in increasing demand, driven by factors like EU renewable energy policies and market conditions. In Ethiopia, only 14.25% of energy comes from modern sources, while the rest relies on solid biomass. From 2009 to 2013, Addis Ababa blended 38.54 million liters of ethanol, saving US$30.2 million (Miftah and Mutta 2024). However, ethanol blending ceased in 2017 because of competition from the beverage industry. In Kenya, bioethanol consumption is hindered by high taxes and low awareness; however, incentives can boost its use. In Sudan, Kennana sugar factory produced 50% of the country’s ethanol production in 2020, aiming for 200 million liters by 2020 (Miftah and Mutta 2024). In June 2022, India amended its National Biofuel Policy to reduce petroleum imports. States such as Uttar Pradesh and Tamil Nadu are investing up to INR 75,000 in biofuels. India achieved 10% ethanol blending in 2022 and aims to achieve 20% by 2025–26, boosting farmers and reducing agricultural waste. The MNRE supports rural biomass businesses through initiatives such as biomass banks. India’s biomass market is expected to reach an INR of 32,000 crore by FY2030-31, driven by global investment (Baxi 2023).

In the pharmaceutical and healthcare industries, the global perspective on industrial biotechnology is centered on personalized medicine, advanced therapies, and biopharmaceutical production. Innovations in genetic engineering, bioprocessing, and bioinformatics have paved the way for the development of novel therapies and efficient production of biopharmaceuticals. Ongoing global efforts to combat diseases, including the COVID-19 pandemic, have underscored the importance of biotechnological advancements in vaccine development and therapeutic interventions (Le et al. 2020). The global perspective of industrial biotechnology is characterized by a growing recognition of its transformative potential across various industries. The global landscape of industrial biotechnology is prominently shaped by a cadre of industry leaders, each contributing significantly to the advancement of healthcare and development of innovative therapies. Novo Nordisk A/S, a Danish multinational, was a pioneer in diabetes care and other chronic conditions. Johnson and Johnson, a diversified healthcare giant, has made substantial strides in pharmaceuticals, medical devices, and consumer health. Pfizer Inc., renowned for its groundbreaking contribution to vaccines and pharmaceuticals, continues to be a stalwart in the industrial biotechnology sector. Abbott Laboratories, recognized for its diverse portfolio of diagnostics, medical devices, nutrition, and pharmaceuticals, plays a crucial role in improving global health. AstraZeneca Plc (Merck and Co. Inc., Roche Holding AG, Sanofi S. A., Novartis International AG, and Gilead Sciences Inc. collectively form a formidable cohort of global leaders, contributing to transformative advancements in biopharmaceuticals, research, and healthcare solutions. Their commitment to innovation and scientific excellence positions them at the forefront of the dynamic and ever-evolving fields of industrial biotechnology.

The global pharmaceutical market is projected to reach US$1,155.00bn in 2024, with oncology drugs being the largest segment, valued at US$194.10bn. The sector is expected to grow at a CAGR of 4.71% from 2024 to 2029, reaching US$1,454.00bn by 2029. The United States will generate the highest revenue, US$630.30bn in 2024, thanks to its advanced healthcare infrastructure and strong RandD, maintaining its leadership in pharmaceutical innovation (Statista, Pharmaceuticals–Worldwide, 2024). India is the world’s largest vaccine producer, accounting for 60% of global vaccine production. It supplies 70% of the WHO’s DPT and BCG vaccines, and 90% of the measles vaccine demand. India also leads generic medicines, with a 20% global share, and manufactures 60,000 generic brands. The pharmaceutical sector includes 3,000 companies, over 10,500 facilities, and 500 API manufacturers, contributing to 8% of the global API market. India allows 100% FDI in the brownfield pharmaceutical industry. The pharmaceutical industry's revenue in India totaled INR 4,17,345 crore in 2023–24, marking a 10% increase compared to 2022–23 (Invest India, https://www.investindia.gov.in/sector/pharmaceuticals). Figure 3 shows the contribution of leading biotech companies to the global bioeconomy.

Fig. 3.

Market capitalization of leading global biotech companies, highlighting their financial influence and position within the biotechnology sector (data adapted from: uwex.wisconsin.edu 2021)

The agricultural sector is experiencing a transformative shift, with industrial biotechnology playing a vital role in crop improvement, pest control, and sustainable agricultural practices (Baysal and Baştaş, 2023). Genetically modified organisms (GMOs) and gene editing technologies are employed to improve crop production, augment nutritional content, and develop plants with improved resistance to pests and ailments (Paarlberg et al. 2024). The global perspective of agricultural biotechnology involves balancing the need for increased food production with environmental sustainability and resource conservation. Cross-border collaborations and partnerships are increasingly shaping the global perspective on industrial biotechnology. Countries recognize the importance of sharing knowledge, expertise, and resources to address global challenges. International collaboration facilitates the exchange of scientific advancements, promotes technology transfer, and fosters innovation in industrial biotechnology. Initiatives, such as joint research projects, collaborative networks, and shared infrastructure, have contributed to a more interconnected and globally inclusive biotech landscape. The agriculture market will grow from $13,272.75 billion in 2023 to $14,356.23 billion in 2024, with a CAGR of 8.2%. This growth is driven by population growth, globalization, government policies, crop protection, and climate factors. By 2028, the market is expected to reach $19,286.79 billion, growing at a CAGR of 7.7%, fueled by sustainable practices, genetic engineering, organic farming, and water management. Key trends include precision agriculture, AI integration, digital marketplaces, autonomous equipment, and farm management software adoption (Global Agriculture Market Report 2024). The agriculture market in India is projected to grow from USD 372.94 billion in 2024 to USD 473.72 billion by 2029, with a CAGR of 4.90%. Agriculture remains vital, employing 45% of the workforce and contributing 18% of GDP. India is a major producer of crops, such as rice, wheat, and sugarcane. Technological advancements, government initiatives such as PMKSY and DILRMP, and a focus on sustainable farming are expected to drive growth during the forecast period (Agriculture Industry in India Size and Share Analysis-Growth Trends and Forecasts 2024).

With regard to the prospects and growth of global industrial biotechnology, many challenges have been faced through a global lens. These include ethical considerations, regulatory frameworks, and public acceptance across countries, posing challenges to the harmonization of standards and practices. The responsible and ethical use of biotechnology, including addressing concerns related to genetically modified organisms and ensuring equitable distribution of benefits, remains a topic of global discussion.

Historical perspective of industrial biotechnology

The history of biotechnology is marked by groundbreaking discoveries and advancements that have shaped modern science, beginning with early observations of living cells, culminating in the development of vaccines and molecular biology techniques. In 1663, Robert Hooke first observed living cells using a simple microscope, marking the beginning of the classical era of biotechnology. van Leeuwenhoek identified protozoa and bacteria in 1677. Giacomo Pylarini discovered the vaccination procedure in 1701 (Belongia and Naleway 2003), leading to Jenner’s development of the first smallpox vaccine in 1798. The nineteenth century, known as the “milestone era,” saw significant advancements. In 1802, the term “biology” was coined, and in 1809, Nicolas Appert invented the term heat sterilization of food. Henri Dutrochet identified living cells as tissue-building blocks in 1824. Jöns Jacob Berzelius coined “protein” in 1838. In 1862, Louis Pasteur discovered fermentation and pasteurization, Charles Darwin proposed natural selection in 1859, and Gregor Mendel uncovered inheritance laws in 1863. Miescher identified DNA in 1869, and Flemming discovered mitosis in 1870 (Paweletz 2001). In 1881, Pasteur developed vaccines against cholera and anthrax. The first rabies vaccine was developed in 1885 by Louis Pasteur and Emile Roux (Smith 2012). In 1907, Thomas Hunt Morgan proposed the mutation theory, which laid the foundation for understanding heredity (Kenney and Borisy 2009). Two years later, in 1909, Wilhelm Johannsen introduced the terms ‘gene’ gene ‘genotype’ to describe genetic composition, while ‘phenotype’ referred to observable traits (Roll-Hansen 2014). In 1911, Morgan mapped the chromosome locations in fruit flies (Másová 2008). In 1918, Evans and Swezy identified that human genetic material consists of 48 chromosomes in diploid cells (Evans and Swezy 1928). Throughout history, humans have exploited controlled microbial fermentation to produce fermented foods and beverages. In 1919, the production of citric acid by Aspergillus niger introduced aerobic fermentation (Wells and Herrick 1938). In 1928, Griffith demonstrated the ‘transforming principle’ by converting rough-type bacteria into smooth-type strains (Singh et al. 2023). Beadle and Tatum proposed the ‘One gene, one enzyme’ theory in 1941, based on their work with the mold Neurospora crassa (Griffiths et al. 2000). The production of citric acid by Aspergillus niger in 1919 facilitated industrial-scale aerobic production of penicillin during World War 2, paving the way for the establishment of processes for various antibiotics in the post-war period. After that, Barbara McClintock discovered ‘jumping genes’ and demonstrated the concept of ‘transposable elements’ in 1947 (Ravindran 2012). The advent of modern industrial biotechnology, originating in the mid-twentieth century, signified a pivotal era of scientific advancement and innovation (Table 1). In 1950, Erwin Chargaff formulated ‘Chargaff’s rules’ describing the proportions of adenine, guanine, cytosine, and thymine in DNA (Manchester 2008). The foundational breakthrough occurred in 1953 with the discovery of the double helix structure of DNA by James Watson and Francis Crick, providing a blueprint for understanding genetic information, and researchers were awarded the Nobel Prize in Physiology in 1962 (Sulek 1969). Subsequently, Crick and Gamov introduced the ‘Central Dogma’ in 1957, outlining how proteins are expressed from DNA through mRNA (Crick 1970). François Jacob and Jacques Monod documented gene-based regulation in 1959, coining the terms ‘operon’ and ‘repressor’ (Lodish 2008). In 1966, Nirenberg, Matthaei, and Ochoa deciphered the genetic code and identified codons encoding amino acids (Baldwin 2008). Duesberg and Vogt identified the first viral oncogene in 1970 to study human cancer (Vogt 2010). Nathan Ames developed the Ames test in 1973 to study DNA damage and identify cancer-causing chemicals (Griffiths et al. 2000).The discovery of the DNA structure laid the groundwork for the expansion of the field, as scientists unraveled the complexities of molecular biology. The advent of recombinant DNA technology in the 1970s allowed the manipulation of genetic material, opening unprecedented possibilities for gene cloning and the development of genetically modified organisms. The synthesis of insulin in bacteria in 1978 marked a significant milestone, highlighting the practical applications of biotechnological advancements in medicine. Subsequent decades witnessed exponential growth in biotechnological research and applications across diverse sectors, such as agriculture, healthcare, and environmental science, propelling humanity into a new age of scientific possibilities. The inception of the industrial biotechnology sector can be traced back to the 1970s, primarily grounded in the novel recombinant DNA technique disclosed in 1973 by Stanley Cohen from Stanford University and Herbert Boyer from the University of California, San Francisco. Recombinant DNA involves crafting proteins such as human insulin and various therapies within cultured cells under precise manufacturing conditions (Bera 2009). Boyer and venture capitalist Robert Swanson played fundamental roles in establishing Genentech in 1976, currently the largest biotechnology industry in terms of market capitalization. Commercial ventures swiftly capitalized on Boyer and Cohen's rDNA technology despite controversy and public fear of cloning. Recognizing the potential of using bacteria with human genetic information, scientists have aimed to mimic the body's natural defenses and address birth disorders. By 1977, even before Genentech had its own facilities, Boyer and Itakura had successfully expressed the mammalian protein somatostatin in bacteria, a virtually identical match to the natural hormone (Riggs et al. 2018). In 1978, Boyer and Itakura developed a plasmid for human insulin, facing competition from various rivals, including start-ups backed by pharmaceutical companies. Eli Lilly and Company partnered with Genentech for the production process of humulin, becoming the first industrial biotechnology product approved by the FDA in 1982 (Kinch 2015). Through the creation of rDNA technology, Boyer and Cohen initiated the industrial biotechnology sector, catalyzing the development of significant applications, notably within Genentech, for various medical purposes. Genomic data have enabled the development of mathematical models describing metabolism, initially for Escherichia coli and later for Saccharomyces cerevisiae. Genome-scale metabolic stoichiometric models (GEMs) have evolved from descriptive functions to predictive tools that incorporate additional data and constraints (Pereira et al. 2016). Simultaneously, genetic and genomic engineering methods have led to metabolic engineering and synthetic biology. Synthetic Biology focuses on designing genetic components and building genetic circuits to model biological systems, whereas Metabolic Engineering optimizes cellular processes to produce the desired compounds efficiently. It utilizes databases and libraries to maximize production rates, manage conditions, and inhibitors to maintain growth, with metabolic flux manipulation as a key strategy for achieving these objectives (García-Granados et al. 2019). These combined approaches have led to the creation of cell factories that produce a wide array of valuable substances including chemicals, solvents, monomers, pharmaceuticals, nutraceuticals, and antibiotics (Pereira et al. 2016).

Table 1.

Chronology of modern industrial biotechnology development

Year	Event description	References
1953	Watson and Crick proposed a revolutionary model outlining the structure of DNA, paving the way for profound advancements in genetic research	Ruse and Ruse 1981
1971	A genetically engineered Pseudomonas putida, “superbug,” was developed to efficiently degrade hydrocarbons in oil spills using plasmid transfer	Pandey and Arora 2020
1973	Stanley Cohen and Herbert Boyer refined techniques for manipulating DNA, enabling its precise editing and replication within bacterial cells	Wright 1986
1975	The technique for generating monoclonal antibodies was developed by Köhler and César Milstein	Milstein 1980
1978	The year saw the emergence of DNA sequencing and cloning techniques in genetic engineering, highlighted by the synthesis of human insulin	Rosenberg et al. 1995
1982	Humulin, the first biotech drug approved by the FDA, is a genetically engineered human insulin produced by bacteria for diabetes treatment	Kinch 2015
1983	PCR was invented by American biochemist Kary Mullis
1990	The first federally approved gene therapy was successfully administered to a young girl with an immune disorder	Walters and Palmer 1997
1994	The US-FDA approves the "Flavr Savr" tomato as the first genetically modified food	Sharma et al. 2022
1999	Recognizing the potential of bio-based products and bioenergy, President Clinton signed an Executive Order 13,134 to promote their development and utilization	Hoskinson and Hess 2004
2000	Har Gobind Khorana was the first to synthesize DNA in a test tube, and Sir Ian Wilmut achieved the cloning of an adult sheep named ‘Dolly.’	Verma et al., 2011; Singh et al., 2023
2003	The Human Genome Project, which mapped the locations and sequences of genes on all 46 human chromosomes, was successfully completed	Chial, 2008; Singh et al., 2023
2008	Venter replicated the genetic makeup of bacteria entirely using laboratory chemicals	Verma et al., 2011; Singh et al., 2023
2019	CRISPR technology was first introduced as a method for editing human genes to potentially treat cancer patients	Gupta and Rajpal, 2012; Singh et al., 2023
2020	“Trojan horse” a designer-nanoparticle was discovered to remove atherosclerotic plaque A CRISPR-based strategy, PAC-MAN (Prophylactic Antiviral Crispr in huMAN cells) was developed to find and destroy viruses in vitro Artificial intelligence demonstrated an AI algorithm-based approach for protein folding Construction of a human thymus using stem cells and bioengineered scaffold	Abbott et al. 2020
2021	Lipid nanoparticles were discovered to deliver CRISPR genome editing into the livers of mice for reducing LDL cholesterol levels Development of engineered monoclonal antibodies based female contraception	Qiu et al. 2021
2022	The world’s smallest remote-controlled walking robot is demonstrated for clearing blocked arteries	Han et al. 2022
2023	Bioengineered cornea derived from pig’s skin is shown to reinstate visualization in blind people Ants had been used as biosensors to detect cancer via urine	Rafat et al. 2023
2024	Rice grains are shown to serve as scaffolds for cultured animal cells Beta-lactoglobulin, produced through precision fermentation, is introduced as an alternative to whey protein, coinciding with the expansion of the emerging animal-free dairy sector	Woodford 2024; Park et al. 2024; Lyubomirova 2024

Indian scientists have made significant historical contributions to early biotechnological advancements (Table 2). Sir Jagadish Chandra Bose invented Crescograph to measure plant growth. Dr. Veena Parnaik has advanced the understanding of nuclear lamins in stem cell differentiation. Dr. Venkatraman Ramakrishnan contributed to the ribosome structure and protein synthesis. Dr. Har Gobind Khorana pioneered studies on genetic coding. Dr. Janaki Ammal worked in plant breeding and Prof. Ananda Mohan Chakrabarty engineered Pseudomonas putida for oil degradation. Dr. G.N. Ramachandran discovered a Ramachandran plot for protein structure assessment. The cumulative impact of these historical initiatives has positioned India as a formidable player in the global industrial biotechnology sector with a robust foundation for industrial biotechnological advancements. Navigating through historical evolution reveals India's journey in industrial biotechnology, characterized by a commitment to scientific excellence, strategic foresight, and a relentless pursuit of innovation. This historical perspective sets the stage for understanding the complexities of India's current industrial biotechnological landscape.

Table 2.

India’s historical contributions to early biotechnological advancements

Indian scientist	Contribution	References
Jagadish Chandra Bose	Invented Crescograph to measure plant growth in 1928	Mukherjee and Sen 2007
Veena Parnaik	Dr. Parnaik has advanced our understanding of nuclear lamins in embryonic development, showing that human lamin A/C is essential for proper development, as its depletion disrupts stem cell differentiation	Sehgal et al. 2013
Venkatraman Ramakrishnan	In 1999, Ramakrishnan's lab published a 5.5 Å resolution structure of the 30S subunit, followed by its complete molecular structure in 2000, including complexes with antibiotics. His subsequent studies provided insights into protein synthesis fidelity. In 2007, his lab determined the ribosome's atomic structure with tRNA and mRNA. Since 2013, he has focused on eukaryotic and mitochondrial translation using Cryo-EM. Ramakrishnan is also known for his work on histone and chromatin structure	Fernández et al. 2013
Har Gobind Khorana	A Nobel Prize-winning biochemist who studied the genetic code and protein synthesis. His work established the foundation for modern biotechnology and genetics	Bansal 2024
Janaki Ammal	Worked on plant breeding, cytogenetics, and phytogeography	Janaki-Ammal 1940
Ananda Mohan Chakrabarty	He is best known for genetically engineering a bacterium, Pseudomonas putida, to degrade oil, which led to the first patent granted for a genetically modified organism in the U.S	Pandey and Arora 2020
Dr. G.N. Ramachandran	Discovered the Ramachandran plot to visualize the allowed and disallowed regions of protein backbone dihedral angles (φ, ψ). It helps to assess protein structure quality, predict secondary structure, and detect steric clashes or folding issues. It is essential in protein structure validation, modeling, and refining for accurate 3D conformations	Subramanian 2001

Extent of bio-industrialization in India

The extent of bio-industrialization in India has been steadily growing, reflecting the country's commitment to harnessing industrial biotechnology for economic and sustainable development. The Indian biotechnology industry has made significant strides in areas, such as pharmaceuticals, agriculture, healthcare, and environmental management. Government initiatives, research institutions, and private enterprises play pivotal roles in nurturing innovation and technological advancement. The key areas of focus include the development of biopharmaceuticals, genetically modified crops, and industrial enzymes.

In the Agriculture sector, India has approved the commercial use of BG-1 and BG-2 GM cotton, while Bollgard II Roundup Ready Flex (BG-2 RRF) approval is still pending. GM crops have modified DNA, often by introducing genes from different species, to enhance the desired traits. Bt cotton, Bt brinjal, and DMH-11 mustard are examples of GM crops in India. The Genetic Engineering Appraisal Committee (GEAC) oversees approvals, and violations can result in fines or imprisonment (Mukherjee 2022). The FMC Corporation introduced three new crop-protection solutions for Indian farmers. Velzo^® fungicide will help combat oomycete diseases such as downny mildew in grapes and late blight in potatoes and tomatoes. Vayobel^® herbicide, a pre-emergent solution, aids rice farmers in weed control. Ambriva^® herbicide, powered by Isoflex^® active, tackles resistant Phalaris minor weeds, offering wheat farmers in the Indo-Gangetic plains a new tool for resistance management (FMC 2024). India is a major agricultural exporter, with exports valued at US$ 15.76 billion from April to July 2024. In 2023–24, exports totaled US$ 48.15 billion, down from US$ 52.5 billion in 2022–23. In 2021–22, exports reached US$ 50.2 billion, a 20% increase from the previous year. Key exports include agri and allied products (US$ 37.3 billion), rice (US$ 11.14 billion), and coffee (12.3% growth). Marine products exported US$ 8.07 billion, benefiting coastal farmers (IBEF, Agriculture and Food Industry and Exports, 2024).

In the biopharma sector, Gennova BioPharma introduced pegaspargase (pediatric pack size) in 2024 for the treatment of acute lymphoblastic leukemia in children. In 2023, Lupin launched Vilfuro-G for COPD management. Glenmark Pharma introduced a Teneligliptin + Dapagliflozin + Metformin triple-drug FDC for type 2 diabetes, and ICPA released mucofibro softgel capsules for oral lesion healing. Entod Beauty London launched Eyecirque Advance for under-eye dark circles, whereas Glenmark introduced Akynzeo I.V. for chemotherapy-induced nausea and Sacubitril + Valsartan Tablets. Entod Pharma unveiled a nanotology-based ocular aesthetic range, and BDR Pharma launched generic apalutamide for prostate cancer. Takeda introduced cinryze to treat hereditary angioedema. In 2022, Anglo French Drugs launched the LYBER Range; Eli Lilly introduced Ramiven for high-risk early breast cancer; ICPA Health launched a Heximetro antiseptic gel; and Glenmark released lobeglitazone for type 2 diabetes. Bayer launched Verquvo for cardiovascular disease, whereas BDR Pharma partnered with Varenyam Healthcare to launch Sugmadex. Takeda also introduced Adynovate for hemophilia, Vicks launched Tulsi Cough Drops, and Bayer relaunched canesten antifungal (Pharmabiz.com, 2024, accessed from https://www.pharmabiz.com/ArticleList.aspx?sid=13). India plays a crucial role in the global pharmaceutical and vaccine industries and is the largest supplier of generic medicines. It accounts for 20% of the global supply volume and provides 60% of the world’s vaccines. Ranked third in volume and fourteenth in value, the key sectors include OTC medicines, generics, APIs, vaccines, biosimilars, and CRM. India leads the supply of vaccines such as DPT, BCG, and Measles and has the most US FDA-approved plants outside USA. Known for its affordable, high-quality products, India is called the “Pharmacy of the World.” In FY23, the industry had a turnover of US$ 49.78 billion, with exports making up 75%. Pharmaceutical product exports totaled US$ 27.8 billion in FY24 (IBEF, Pharmaceutical Exports from India, 2024). India has a 5.92% share of the global pharmaceutical market. In 2021–22, it exported pharmaceutical products worth US$ 24.62 billion, stable compared to the previous year. Despite global supply chain disruptions, exports grew 18% YoY in 2020–21 to US$ 24.4 billion. In March 2022, exports rose from 23% to US$ 2.4 billion. The US, UK, South Africa, Russia, and Nigeria are major export destinations. India is the largest vaccine exporter, supplying 65–70% of WHO’s vaccine needs. From April to September 2022, drug and pharmaceutical exports totaled US$ 12.7 billion (Government of India, Department of Commerce, Ministry of Commerce and Industry).

India produces industrially important enzymes. Fermbox Bio has launched EN3ZYME, an innovative enzyme cocktail that improves the efficiency and cost-effectiveness of converting pretreated agri-residues into fermentable cellulosic sugars. These sugars enable the production of second-generation ethanol and serve as a carbon source for the precise fermentation of bio-ingredients and biomaterials, thereby promoting a circular economy (Business Standard 2024). In December 2019, EW Nutrition launched Axxess XY, a novel thermostable xylanase enzyme that offers high performance to feed producers (The Times of India 2020).

India’s bio-industrialization has been significantly shaped by key government initiatives and policies, such as Make in India and the Biotechnology Industry Research Assistance Council (BIRAC). Make in India, launched in 2014, aims to boost manufacturing across sectors, including biotechnology, by promoting innovation, improving infrastructure, and encouraging foreign investments. It has fostered the growth of biopharma and industrial biotechnology, improving the country’s global competitiveness. BIRAC, under the Department of Biotechnology, supports biotech innovation through grants and funding to start-ups and SMEs, stimulating the research, development, and commercialization of biotech products. Additionally, India’s National Biopharma Mission and Atmanirbhar Bharat initiative aims to make the country self-reliant in critical biotech sectors, such as vaccines and biosimilars. The National Biopharma Mission (NBM), an industry-academia collaborative mission, aimed to accelerate biopharmaceutical development in India. It includes the Innovation in India (i3) program, which promotes entrepreneurship and indigenous manufacturing. Approved in 2017 with a budget of Rs. 1500 crore, the mission is co-funded by 50% by a World Bank loan and managed by a dedicated Program Management Unit (PMU) at BIRAC (Ministry of Science and Technology, 2020). Leading private companies, such as Biocon, Cipla, and Wockhardt, have been instrumental in this growth, while collaborations with public entities and international partners, such as the Serum Institute of India, have strengthened India's position in global biotech markets (Panda et al. 2023).

The expansion of bio-industrialization has not only contributed to the nation's economic growth, but has also addressed critical challenges, such as food security, healthcare, and environmental sustainability. Ongoing research efforts and strategic collaborations are expected to drive further growth in India's bioindustrial sector in the coming years. Despite India’s progress in biotechnology, obstacles, such as regulatory hurdles, limited research funding, and infrastructure challenges, continue to impede rapid growth. However, emerging trends such as expansion into bio-based materials, advanced therapies, and personalized medicine offer promising opportunities for innovation, paving the way for significant advancements in the sector. The current percentage share of the industrial biotechnology segment is shown in Fig. 4.The BioIndustrial segment, which makes up nearly half of India's BioEconomy, is valued at $72.6 billion. Its prominence stems from the increasing use of bio-based solutions in areas, such as biofuels, chemicals, bioplastics, and enzymatic applications across various industries (BIRAC, India Bioeconomy report 2024). This segment plays a key role in India’s sustainability and green technology efforts. The BioAgri segment, worth $12.44 billion, contributes 8.24% to the BioEconomy and focuses on agricultural biotechnology, enhancing productivity and resilience through genetically modified crops like Bt Cotton and precision farming. Billion, valued at $53.8 billion and accounting for 35.65% of the BioEconomy, is central to India’s healthcare innovation. It covers pharmaceuticals, medical devices, diagnostics, and biologics, underscoring India's growing leadership in affordable biopharmaceuticals. Additionally, the BioServices segment, valued at $12.1 billion, includes contract research, clinical trials, bioinformatics, biotech software, and bioeducation, highlighting India’s emergence as a global hub for research and development services, offering cost-effective solutions in drug discovery and data management (BIRAC, India Bioeconomy report 2024). By understanding sectoral performance, stakeholders can target initiatives to enhance the impact of industrial biotechnology on India’s self-sufficiency, sustainability, and global competitiveness.

Fig. 4.

Current market share of various industrial biotechnology segments in India: BioIndustrial ($72.6 billion), BioAgri ($12.44 billion), BioPharma ($53.8 billion), and BioServices ($12.1 billion) (data adapted from: BIRAC, India Bioeconomy report 2024)

Leading biotechnology companies in India

The leading biotechnology companies in India highlight the nation's growth in the biotech sector, showcasing their contributions to healthcare, agriculture, and industrial innovations. This helps investors, researchers, and policymakers to identify key players, foster collaborations, and track advancements. It also emphasizes India's potential in global-biotechnology markets, attracting both domestic and international partnerships and investments to drive economic growth. India hosts several prominent biotech industries that significantly contribute to the global industrial biotechnology market (Table 3). Companies can be grouped according to their core expertise. Vaccine producers include the Serum Institute of India, Bharat Biotech, Panacea Biotec Ltd., GlaxoSmithKline Pharmaceuticals, Bharat Serums and Vaccines Ltd., Shantha Biotech, and Wockhardt Ltd., all of which play significant roles in global immunization efforts. Biopharmaceutical innovators, such as Biocon Ltd., Dr. Reddy Laboratories Ltd., and Sun Pharma Advanced Research Company, focus on advancing treatments in areas, such as oncology, immunology, and neurodegeneration. Finally, Novozymes South Asia, Syngene International Ltd., and SIRO Clinpharm contribute to industrial biosolutions, contract research, and clinical operations, supporting the pharmaceutical industry with sustainable solutions and drug development services. The Serum Institute of India, the world’s largest vaccine manufacturer, generates Rs. 25,000 crores in revenue and supports global immunization efforts. Panacea Biotec Ltd. focuses on gastrointestinal, nephrology, and oncology, earning a Rs. 149.02 crore. GlaxoSmithKline Pharmaceuticals, with Rs. 3216 crores, specializes in vaccines and antibiotics. Bharat Serums and Vaccines Ltd. generates Rs. 1240 crores, offering vaccines and critical care. Biocon Ltd., earning a Rs. 3620 core, focuses on oncology and diabetes. Other key players include Novozymes South Asia (Rs. 500 + crore), Wockhardt Ltd. (Rs. 2840 crore), and Dr. Reddy Laboratories Ltd. (Rs. 24,500 crore), which contribute significantly to global healthcare and biosolutions. Not only vaccines, the Serum Institute of India also produces rdESAT-6 and rCFP-10 (Cy-Tb) injections for the Mantoux Test, ONCO-BCG (BCG LIVE) for Uro-Oncology; Tetanus Antitoxin and Anti-rabies serum. In addition to vaccines, Panacea Biotec Ltd also produces Sitcom tablets for Hemorrhoids/Piles, Livoluk Fibre for Constipation; DapaBest, Glizid for diabetes; Cilamin, Livoluk for GI disorders; Evergraf, Fosbait for Nephrological disorders; Azafab, Bemustin for oncology; Toff-DC for cough and cold. The products of Bharat Biotech consist of vaccines, including ROTAVAC, TypbarTCV, Biopolio, Comvac, JENVAC, and COVAXIN. In addition to vaccines, the company also produces therapeutics such as SLVRGEN^® and Biogit^®. Likewise, Biocon also produces biosimilar products, including Glargine (Basalog^®) and Disposable Pen (BASALOG One^®), GLARICON, GLARZIA, TRASTUZUMAB, PEGFILGRASTIM, and BEVACIZUMAB.

Table 3.

Compilation of top players in the biotech industry in India

Name of the biotech industries	Year of establishment	Services	Market capitalization (INR)	Revenue (INR)/annum
Serum Institute of India	1966	Bacterial vaccines, Viral vaccines, Influenza vaccine, Polysaccharide Conjugate Vaccines, Recombinant Products	1.92 lakh Cr	25,000 Cr
Panacea Biotec Ltd	1984	Drugs for Hemorrhoids, Constipation, Diabetes, Gastro-intestinal disorders, Nephrological disorders, Oncology, Orthopedics, Cough and cold, Fever, and Pain. Also manufacture Vaccines and Adjuvants	1,039 Cr	149.02Cr
GlaxoSmithKline Pharmaceuticals	1924	Vaccines, Specialty and General Medicines	36,298.63 Cr	3216 Cr
Bharat Serums and Vaccines Limited	1971	Different bio pharmaceutical		1240 Cr in fiscal 2022
Biocon Ltd	1978	Drugs for diabetes, oncology, and immunology	33,598 Cr	3620 Cr
Novozymes South Asia	1998	Agricultural and industrial biosolutions		Over 500 Cr in financial year 2022
Wockhardt Ltd	1967	Biopharmaceuticals, nutrition products, vaccines, active pharmaceutical ingredients	6640 Cr	2840 Cr
Dr. Reddy Laboratories Ltd	1984	Drugs for gastroenterology, cardiovascular diseases, diabetology, oncology, dermatology	96,078 Cr	24500Cr
Sun Pharma Advanced Research Company	2006	Drugs for Neuro Degeneration, Oncology, Ophthalmology, Dermatology,	12,881 Cr	21.18 Cr
Syngene International Ltd	1993	Contract research, development and manufacturing organization	28,553 Cr	910.1 Cr
SIRO Clinpharm	1996	Clinical operations, data services, data analytics, and medical writing	NA	241.72 Cr
Shantha Biotech	1993	Drugs and pediatric combination vaccines	NA	NA
Bharat Biotech	1996	Vaccines for Rotavirus, and other viral diseases like Chikungunya, Zika, Japanese Encephalitis		₹8,148 crore in financial year 2022

NA Not available

Emerging start-ups in India

Biotechnology start-ups in India play a major role in driving innovation, economic growth, and addressing societal challenges. India's biotech start-up sector has experienced significant growth, with a sharp rise over the past three years. From 2021 to 2023, the number of biotech start-ups has grown by 59%, from 5,365 to 8,531. This growth has been part of a steady upward trend since 2016, particularly after 2020 (BIRAC, India Bioeconomy Report 2024). Table 4 illustrates the key biotechnology start-ups in India, along with their areas of focus and notable contributions. These start-ups play a crucial role in advancing the country's scientific and technological landscape, particularly in healthcare, agriculture, and environmental sustainability. They act as catalysts for translating scientific discoveries into practical applications, bridging the gap between academia and the industry. Biotechnology start-ups also provide ample job opportunities, attract skilled professionals, and foster a culture of entrepreneurship. At the 3rd Global Bio-India event in New Delhi on December 4th 2023, the Union Minister of State (Independent Charge) Science and Technology unveiled the India Bioeconomy Report 2023 by the Association of Industrial Biotechnology Led Enterprises. According to the India Bioeconomy Report 2023, India's bioeconomy will grow by 29% in 2022, reaching $137.24 billion. The bioindustrial sector contributed 59% of this total, while the biopharmaceutical sector accounted for 49%. Projections suggest that by 2025, India will have approximately 13,470 biotechnology start-ups, with this number expected to grow to 35,000 by 2030, highlighting the accelerating pace of entrepreneurial activity in the sector. In 2022, Maharashtra, Karnataka, and Telangana led dynamic development in the entrepreneurial landscape, with 1,391 start-ups registered, marking a significant 23% increase from the previous year. The year also witnessed a notable 19% increase in private equity and venture capital investments in the biotech industry, reaching a record-breaking $938.8 million. The dynamic and agile nature of start-ups allows them to explore unconventional ideas and rapidly adapt to evolving technologies, making them crucial players in biotechnological advancement and global competitiveness.

Table 4.

Overview of emerging start-ups shaping the industrial biotechnology sector in India

Name of the start-up	Location	Services
Pandorum Technologies	Bangalore, Karnataka	Utilizing cutting-edge 3D printing technology, the company endeavors to fabricate human liver tissue capable of serving as a viable substitute in cases of liver transplantation or failure
XCode Life Sciences	Chennai, Tamil Nadu	Dedicated to advancing personalized genomics, the company offers reliable testing kits designed to deliver valuable genomic insights, aimed at enhancing human health and overall well-being
Oncostem Diagnostics	Bangalore, Karnataka	The company pioneers predictive and prognostic tests tailored to discern patterns indicative of cancer recurrence risk, striving to enhance early detection and treatment outcomes
Zumutor Biologics	Bangalore, Karnataka	With a focus on precision medicine, the company aims to deliver targeted NK cell therapies, leveraging the power of the immune system to combat various diseases. Through the creation of expansive human antibody libraries, the company seeks to unearth novel immunotherapies and monoclonal antibodies, with the goal of revolutionizing treatment options for diverse ailments
Sea6 Energy	Bangalore, Karnataka	By harnessing the potential of seaweed, the company is dedicated to producing ethanol and transforming it into a range of sustainable products, including biofuel, plant growth stimulants, and animal feed ingredients
Vyome Therapeutics	New Delhi, Delhi	Dedicated to combatting inflammatory diseases, the company develops innovative medicines and treatments featuring locally active therapeutics, aiming to alleviate symptoms and improve patient outcomes
GANIT Labs	Bangalore, Karnataka	Leveraging genomic sequencing technologies, the company explores and interprets data from diverse organisms, unraveling insights into genetic markers associated with metabolic disorders, cancer, and rare diseases
MedGenome	Bangalore, Karnataka	Operating a robust genomics diagnostics and research platform, the company seeks to unravel the genetic underpinnings of various diseases, facilitating early diagnosis and targeted treatment strategies
Mapmygenome	Hyderabad, Andhra Pradesh	Specializing in molecular diagnostics services, the company offers comprehensive testing solutions to aid in disease detection, prognosis, and treatment planning
Farcast Biosciences	Bangalore, Karnataka	Employing an innovative platform, the company focuses on preserving the tumor microenvironment, fostering a deeper understanding of cancer progression and treatment responses
Bugworks Research	Bangalore, Karnataka	Dedicated to addressing the global challenge of antimicrobial resistance (AMR), the company pioneers the development of novel antibiotic drugs, aiming to combat resistant pathogens and safeguard public health
Bharat Biotech	Telangana, Hyderabad	Advancing the frontier of industrial biotechnology, the company develops biotherapeutics and vaccines, with the aim of tackling a broad spectrum of diseases and improving global healthcare outcomes

Impact of biotechnological industries on Indian bioeconomy

The utilization of biotechnological products and processes has led to improved living conditions, enhanced healthcare, increased agricultural output, and the creation of employment opportunities. India is recognized as one of the top 12 global biotech destinations, ranking third in Asia (Department of Biotechnology, Ministry of Science and Technology, Government of India 2021). The country's biotech industry is poised for substantial growth, driven by rising economic prosperity, a growing focus on health, and a population exceeding 1 billion. The current estimated value of the industry is USD 63 billion for FY2019-20, and it is anticipated to reach USD 150 billion by FY25.

Industry size and growth projections

The Indian biotech sector includes over 3500 start-ups, with an expected increase of 10,000 by 2024–25. India’s biotechnology industry spans five primary segments: biopharmaceuticals, bio-services, agricultural biotechnology (bio-agri), industrial biotechnology, and bioinformatics. Each of these sectors plays a crucial role in advancing bioeconomy. The percentage share of the biotechnology sectors is distributed as Diagnostics/Medical Devices, with the largest share at 25.6%, followed by vaccine at 17.8%, and BioIT/Healthcare Research at 15%. Other segments included BT Cotton (14.4%), biologics/therapeutics (10.7%, COVID Bioeconomy (7.8%), enzymes (3.7%), biofuels (3.6%), and Biofertilizers/Biopesticides at 1.4% (https://www.niir.org/blog/indias-biotechnology-sector/). Incomes from diverse biotechnological enterprises are shown in Fig. 5. According to the India Bioeconomy Report 2023 by BIRAC, various sectors within India’s bioeconomy demonstrate significant profitability, with the bioethanol sector emerging as the leader, contributing $73 million daily. Following closely are the biotherapeutics sector, generating $46 million daily, and the vaccine bioeconomy contributes $38 million daily. The bio-agri bioeconomy also plays a significant role, contributing $28 million per day, while the diagnostics sector generates $30 million daily. The enzymes bioeconomy, primarily focused on poultry and aqua, accounts for $48.22 million daily, highlighting the diverse and substantial impact of these segments on India’s growing bioeconomy. Currently, the growth of the industrial biotechnology industry in India is primarily driven by vaccines and recombinant therapeutics. India’s bioeconomy has shown consistent growth, driven by advances in biotechnology, RandD, and sustainable practices (Fig. 6).

Fig. 5.

Income generated from different biotechnological enterprises in India, reflecting its financial contribution to the bioeconomy (data adapted from: BIRAC, India Bioeconomy report 2023)

Fig. 6.

Growth pattern of India’s bioeconomy from 2011 to 2023, along with projections for its expected growth by 2030 (BIRAC, India Bioeconomy Report, 2021, 2022, 2023, 2024)

Government initiatives and funding schemes

The expansion of India’s bioeconomy is supported by various government initiatives and funding schemes designed to foster growth and innovation. The expansion of India’s biotechnology sector is driven by both domestic and international demands. Domestically, initiatives such as Aatmanirbhar Bharat and Make in India have spurred growth, whereas global competitiveness has boosted the export of vaccines and biopharmaceuticals. The Department of Biotechnology has funded 51 biotech-KISAN hubs, which connect farmers, particularly women, with scientists and institutions, providing valuable information on soil health, irrigation, and new agricultural technologies. Additionally, the Union Budget 2023 introduced plans to establish 500 ‘waste to wealth’ plants under the GOBARdhan (Galvanizing Organic Bio-Agro Resources Dhan) scheme, which includes 200 compressed biogas plants, with a total investment of INR 10,000 crore. The GOBARdhan initiative, led by the Government of India, aims to convert organic waste into biogas, CBG, and Bio-CNG, thereby promoting a circular economy. It includes various schemes for fostering sustainable growth, clean energy, and rural employment. GOBARdhan contributes to India’s climate goals, enhances sanitation, and improves health, especially for women, while supporting the country’s Sustainable Development Goals, such as clean energy, good health, and climate action. These initiatives promoted a circular economy while strengthening India’s position in the global economy.

Export figures and global competitiveness

India has become a prominent player in the global bioeconomy driven by its competitiveness in the export of vaccines and biopharmaceuticals. It is a major exporter of vaccines to over 150 countries and serves as a key destination for contract manufacturing and clinical trials. This strong global presence highlights India’s ability to produce high-quality cost-effective products. The demand for Indian vaccines and biosimilars abroad is a testament to a country’s competitiveness in the biotechnology sector, reinforcing its position as a leading player in the global bioeconomy. India’s growing exports have been fueled by continuous advancements in industrial biotechnology, research, and development.

Specific contributions to the GDP and sectoral investments

India’s bioeconomy has made significant contributions to the national GDP and continues to attract substantial sectoral investments. In 2019, the bioeconomy accounted for $62.5 billion, or approximately 2.2% of India’s GDP of $2.8 trillion. By 2020, the bioeconomy’s contribution increased to 2.7%, amounting to $259.3 billion in a $2.6 trillion economy, reflecting 22% growth (Fig. 7). This growth is driven by expanding sectors, such as agriculture, healthcare, and industrial biotechnology. Between 2018 and 2022, the life sciences sector in India saw 22 mergers and acquisitions valued at $4.6 billion, indicating a strong influx of investments. India currently holds a 3% share of the global-biotechnology industry, a figure that reflects the country’s growing prominence in the global biotech market and has the fifth-largest area of organic agricultural land, positioning it as a major player in the global bioeconomy.

Fig. 7.

Impact of bioeconomy on India’s national GDP from 2015 to 2021, along with projections for growth by 2030(BIRAC, India Bioeconomy Report, 2021, 2022)

Gaps in Indian industrial biotechnology

Indian industrial biotechnology has witnessed substantial growth in recent years; however, several gaps persist, hindering its optimal development and global competitiveness. These gaps span various aspects of research, infrastructure, policy, and commercialization. Identifying and addressing these challenges are crucial for the sustainable advancement of the industrial biotechnology sector in India. One significant gap lies in the research and development domain. Although India has made notable strides in biotechnological research, there is a need for increased investment and collaboration between academia and industry. Connecting research institutions to industrial applications is essential for translating innovative ideas into practical solutions. A lack of funding, limited interdisciplinary research, and inadequate technology transfer mechanisms often impede the seamless transition of discoveries from laboratories to industrial settings. Infrastructure remains a key area where gaps persist. Access to state-of-the-art facilities and cutting-edge technologies is crucial to fostering innovation in industrial biotechnology. Small- and medium-sized enterprises (SMEs) in India often face challenges due to limited access to high-tech laboratories, production facilities, and pilot-scale bioreactors, which hinders their ability to scale up and compete on a global level. Strengthening research infrastructure through public–private partnerships and government initiatives can help address this gap, facilitating the development of advanced biotechnological products and processes. Policy frameworks play a pivotal role in shaping the industrial biotechnology trajectory. There is a pressing need for comprehensive policies that incentivize RandD and streamline regulatory pathways. For instance, a more transparent approval process akin to those in leading biotech nations, such as the US and Germany, could accelerate product development and market entry. Ambiguous regulatory pathways, lengthy approval processes, and inconsistent policies can create uncertainties for businesses and discourage investment in the sector (Gadzanku et al. 2021). A more robust and transparent regulatory environment is essential for fostering innovation and attracting both domestic and foreign investments. The commercialization of biotechnological products faces challenges in India, particularly in terms of market access and awareness. Many innovative biotech products face difficulties in reaching the market due to a lack of comprehensive market research, distribution challenges, and limited consumer awareness of the benefits of biotechnological innovations. Developing effective marketing strategies, improving market intelligence, and facilitating collaboration between industry players can help bridge this gap and enhance the commercialization prospects of biotechnological innovations. Human capital is a critical factor in the success of any industry, and the industrial biotechnology sector is no exception. India requires a skilled workforce with expertise in various biotechnological disciplines. The current education system often emphasizes theoretical knowledge of practical training. There is a need for more hands-on opportunities, industry internships, and collaboration with biotech companies to ensure that graduates are job ready. Collaborative efforts between academia and industry can help design curricula that align with the evolving needs of the biotech sector, ensuring that graduates are well equipped to contribute effectively to industrial biotechnology. Another notable gap is the limited focus on sustainable and green industrial biotechnology practices (Luthra et al. 2015). As the world faces environmental challenges, there is an increasing demand for eco-friendly biotechnological solutions. India has the potential to become a global leader in green biotechnology by prioritizing research in areas such as sustainable bioprocessing, bio-based waste utilization, and the production of environmentally friendly bioplastics and biofuels. Integrating sustainability into industrial biotechnology practices can address environmental concerns and open new avenues for growth and collaboration. While India has made significant strides in industrial biotechnology, addressing the existing gaps is crucial for sustained growth and competitiveness at the global stage. A concerted effort involving the government, academia, and industry is needed to invest in research, enhance infrastructure, streamline policies, facilitate commercialization, develop a skilled workforce, and promote sustainable practices. Closing these gaps will not only propel the Indian biotech industry forward, but also contribute to addressing global challenges through innovative biotechnological solutions.

Challenges faced by biotech industries in India

Biotech firms secure patents for their products, gain a competitive edge, and allow cost recovery from extensive research and development (RandD) expenses. However, significant risk factors must be considered. While the global biotech industry faces RandD phases that can cost up to a billion dollars, in India, the costs may be lower due to a less-expensive labor force, but the risk remains the same, with the potential for no viable products emerging after years of research. While the FDA approval process poses a significant challenge for global biotech firms in India, the Central Drugs Standard Control Organization (CDSCO) approval process also presents challenges, including lengthy timelines, regulatory ambiguity, and evolving standards that can hinder the speed of market entry for biotech products (Darrow et al. 2020). With substantial failure, valuation becomes challenging, contributing to stock market volatility. In an initial report, the BIO industry group, along with analysts from BioMedTracker and Amplion, examined 7,455 drug development programs progressing through clinical phases from 2006 to 2015 (Mullard 2016). Multiple reports have indicated a recent decline in the success rates of drug development projects, with academic drug discovery and development facing similar challenges. According to the Biotechnology Innovation Organization (BIO), the success rates were 63% in Phase I, 31% in Phase II, 58% in Phase III, and 85% in NDA/BLA (Takebe et al. 2018). Mullard (2016) reported that the BIO industry group, alongside BioMedTracker and Amplion analysts, examined 7,455 drug development programs from 2006 to 2015. The success rates were similarly reported as 63% in Phase I, 31% in Phase II, 58% in Phase III, and 85% during the regulatory review process, leading to an overall success rate of 9.6% (63% × 31% × 58% × 85% = 9.6%). When broken down by therapeutic area, hematology projects had a success rate of 26%, while oncology projects had a success rate of only 5%. Drugs for rare non-cancerous diseases performed better, with a 25% success rate, and projects involving biomarkers had a 26% success rate (Mullard 2016). At this juncture, a substantial amount of financial resources and time are dedicated to research and development (RandD). Even after a successful product launch, biotech firms in India face challenges, such as market reception issues, litigation risks, and competition from generic manufacturers, especially in the case of biopharmaceuticals, where patent challenges including compulsory licensing are a growing concern. The contentious issue of escalating healthcare costs, particularly drug prices, remains a focal point. In India, the ethical dilemma of affordability is more pronounced, as biotech treatments, which can cost up to $20,000 annually, are out of reach. This creates challenges for both government and private insurers in balancing patient access to cutting-edge treatments with financial sustainability. This raises questions about cost sharing, potential patient non-adherence, and clashes between profit motives and patient welfare. Employers and insurers must balance actuarial concerns with patients’ healthcare needs. Advances in decoding the human genome have raised concerns about patient privacy. As genetic information becomes more accessible, dilemmas arise regarding the right to access such information and its impact on employment, mortgages, and insurance. Questions have emerged about the ethical implications of sharing confidential genetic information, especially when linked to expensive biotech treatments. The evolving field of industrial biotechnology focuses on enhancing food production, particularly in developing nations. Genetically modified (GM) crops, produced by splicing genes, offer benefits such as pesticide resistance and increased yields. However, directing biotech potential to benefit farmers in less-developed countries (LDCs) is crucial. Over 88% of certain crops in the U.S. are genetically modified, highlighting the industry's impact on agriculture. Rapid advancements in industrial biotechnology pose challenges owing to the mismatch between technological development and regulatory adaptation. In India, societal concerns related to biotechnology include the environmental risks associated with GMOs, such as unintended crossbreeding and ecological disruption, along with safety concerns around laboratory practices. Additionally, public resistance to GM crops and fears of bioterrorism continue to fuel debates, especially among rural communities and activists. The evolving nature of regulations for patenting genetic innovations and new drug development adds to the complexity. Beyond these points, the biotech sector faces challenges comparable to those of the pharmaceutical industry, such as loss of patents, high RandD costs, low productivity, and the need for mergers and acquisitions (MandA) to fortify pipelines. Some firms adopt the fully integrated pharmaceutical companies (FIPCO) model through MandA strategies to enhance long-term viability. In India, the adoption of the FIPCO model through MandA is less widespread than in global markets. However, few leading players are moving in this direction, potentially strengthening their RandD pipelines and market reach. Examples of Indian biotech firms that adopt such models can help clarify how this strategy plays out locally.

Future road map of industrial biotechnology

Industrial biotechnology is an advanced technology that focuses on resource conservation, pollution prevention, and lowering production costs. Referred to as the third wave in the biotechnology domain, industrial biotechnology is revolutionizing manufacturing processes while addressing environmental concerns. It involves the utilization of enzymes and microorganisms to create a variety of bio-based products in sectors, such as chemicals, paper, textiles, food ingredients, and pharmaceuticals. Unlike other biotechnologies in the medical and agricultural sectors, industrial biotechnology is distinct in its effectiveness in reducing costs and developing environmentally friendly products, providing a competitive advantage in the market.

Industrial biotechnology offers vast potential in several critical areas. Key aspects include the reduction of petrochemical dependence, waste management, and production of sustainable products. Below are some key areas in which industrial biotechnology has a significant impact:

• The potential to reduce petrochemical demand by 20–80% using feedstock as an alternative.

• The ability to replace up to 80% of plastics in waste streams through biotechnology using bioremediation microorganisms.

• Simplification of vitamin B2 production through biotechnological processes.

• Biomass generated in manufacturing through industrial biotechnology can be used as feedstock for other products or to enhance the cost efficiency.

• Industrial biotechnology is highly effective in establishing sustainable economic systems.

• With India’s focus on sustainable agriculture, waste management, and growing demand for green technologies, industrial biotechnology is well positioned to play a crucial role in transitioning the country toward a bio-based economy. The anticipated shift toward a bio-based economy is expected to have profound implications for India's agricultural, energy, and healthcare sectors. With a focus on bioprocesses that use renewable biological resources, India can reduce its reliance on fossil fuels, improve agricultural practices, and offer sustainable healthcare solutions.

The future of industrial biotechnology is paved with the significance of diverse products, each playing a crucial role in shaping sustainable and innovative solutions (Fig. 8). Organic acids and polymers hold promise as environmentally friendly alternatives to traditional materials, contributing to a greener future. Amino acids are essential building blocks for proteins and offer opportunities for efficient and sustainable production processes in the context of industrial biotechnology. Alcohol is a versatile biofuel and presents a cleaner energy option. Nutraceuticals and vitamins cater to the growing demand for functional and health-promoting additives, aligning with an increasing focus on well-being. Biopharmaceuticals revolutionize medicine by harnessing biological processes for therapeutic purposes and ensuring precision and efficacy. Antibiotics, a cornerstone of healthcare, are evolving through biotechnological advancements to address emerging challenges in drug resistance. Enzymes not only drive efficiency in industrial processes, but also contribute to sustainability by reducing energy consumption, minimizing waste, and enabling the recycling of materials, thus lowering the environmental footprint of industries. Finally, bioenergy and biofuels offer renewable alternatives to conventional energy sources, promising a sustainable and eco-friendly energy landscape. Together, these products represent the forefront of industrial biotechnology, driving advancements toward a future characterized by resource efficiency, environmental consciousness, and improved human well-being. The future of biotechnology, driven by genetic recombination and splicing, holds transformative potential across multiple sectors. In medicine, the continued advancement of recombinant DNA technology using organisms such as Tetrahymena thermophila and Saccharomyces cerevisiae will enable the development of personalized therapies, more effective vaccines, and treatments for genetic disorders (Dede and Arslanyolu 2023, Kjeldsen et al. 2023). In agriculture, genetically modified crops are another outcome of genetic recombinations. Through the insertion of genes that confer traits, such as resistance to pests or tolerance to specific environmental conditions, scientists have developed crops with improved yields and resilience. In industry, the production of enzymes for various processes is a significant application of recombinant products. Microorganisms can be genetically engineered to express enzymes that are valuable in industrial processes such as the production of biofuels or the breakdown of waste materials. In India, although recombinant DNA technologies hold promise for enhancing agricultural productivity and developing new medicines, they also raise significant ethical concerns, particularly in terms of food security and the environmental impact of genetically modified crops. Addressing these concerns through clear regulations will be the key to realizing the benefits of recombinant products. A balance between the benefits and potential risks associated with genetic engineering is crucial as the development and application of recombination products continue to advance.

Fig. 8.

Outline of the future roadmap for industrial biotechnology in India, highlighting key strategies, milestones, and projected advancements for growth and innovation

Conclusion

India’s industrial biotechnology sector exhibits dynamic interplay between challenges and opportunities. The entrepreneurial spirit fosters research and technological breakthroughs, and promising transformative solutions. However, continued growth relies on strengthening policy frameworks, upgrading infrastructure, and fostering a skilled workforce. Despite these challenges, this comprehensive review emphasizes the nation’s immense potential, supported by government initiatives, such as Atmanirbhar Bharat and Make in India, which encourage self-reliance and innovation. With harmonious collaboration among government, academia, and industry players, as well as between established companies and emerging ventures, India is poised to propel its industrial biotechnology sector toward a future where sustainable practices and innovation lead, positioning India as a global leader in green biotechnology and affordable healthcare solutions. Future research should focus on expanding biotech start-ups, promoting sustainable bio-based products, increasing investment in RandD, advancing renewable energy solutions, boosting agricultural productivity, and promoting global collaboration for innovation and sustainability.

Data availability

Data sharing is not applicable to this article, as no datasets were generated or analyzed during the current study.

Declarations

Conflict of interest

The authors have no conflict of interests to disclose.