Animal Research at a Crossroads: Strengths, Weaknesses, Opportunities, and Emerging Threats

Abstract

Research involving animals is pivotal to advancing biomedical and veterinary sciences, contributing to discoveries that have saved countless lives and improved global health. However, the field faces increasing scrutiny from ethical, scientific, and societal perspectives. This paper applies a strategic Strengths, Weaknesses, Opportunities, Threats (SWOT) analysis, adapted from traditional business planning, to critically evaluate the current landscape of animal research, offering a balanced perspective on its contributions and challenges. While typically used to assess organizational performance, here the framework is reinterpreted to provide a structured, holistic view of the internal and external factors shaping ethical, scientific, and societal aspects of animal research. Strengths include its foundational role in Nobel Prize-winning discoveries, medical advancements, and therapeutic safety. Key weaknesses, such as public mistrust, ethical concerns, resource limitations, and rigor and reproducibility, are examined. Opportunities lie in the advancement of study refinements, improved methodologies, and fostering stakeholder communication. Threats such as misunderstanding, regulatory complexities, and resource constraints are addressed through strategic recommendations, including investment in Replacement, Reduction, and Refinement (3Rs), effective public engagement, and global harmonization of standards. This paper concludes by presenting an actionable roadmap to ensure the continued ethical and impactful use of animals in research while embracing innovation and maintaining public trust.

Introduction

Research involving animals has been at the forefront of scientific discovery, enabling breakthroughs in understanding disease mechanisms, developing treatments, and ensuring the safety of new drugs and medical devices. It has been integral to the development of vaccines for diseases such as smallpox, polio, and, more recently, COVID-19. Furthermore, animal research has played a key role in advancing therapies for chronic illnesses, including cancer, diabetes, and cardiovascular diseases.¹

Despite these significant contributions, animal research faces increasing scrutiny. Ethical concerns, public skepticism, and the emergence of alternative methodologies have prompted calls for greater refinements and innovation. These dynamics present both challenges and opportunities for the field to evolve in alignment with societal values and scientific advancements.

The Strengths, Weaknesses, Opportunities, and Threats (SWOT) analysis is a widely used strategic planning tool originally developed in the fields of business and management. Traditionally, strengths are defined as internal attributes or resources that an organization does well or that distinguish it from competitors. Weaknesses are internal limitations or areas in need of improvement that hinder performance. Opportunities refer to external conditions that could be leveraged for advantage, while threats are external challenges or risks that could negatively impact success.^2,3

In this article, we adapt the SWOT framework to critically examine the current landscape of animal research. Rather than focusing on organizational strategy, this approach offers a reflective and strategic lens to explore ethical considerations, scientific advancements, regulatory complexities, and societal trends. Here, strengths are framed as the scientific and societal contributions of animal research; weaknesses as internal challenges such as issues with reproducibility and public mistrust; opportunities as advancements in refinement, nonanimal methodologies, and communication; and threats as external pressures including misinformation, regulatory shifts, and resource constraints. This adaptation offers a holistic synthesis of the field, grounded in current evidence, and provides a forward-looking perspective to guide ethical and impactful research. Our goal is to support progress while maintaining public trust and scientific integrity.

Strengths of Research Involving Animals

Over the past century, animal research has played a pivotal role in advancing biomedical science, leading to groundbreaking discoveries that have saved millions of lives. A key strength of this research lies in its dual contributions to both basic and applied science. Basic research, which seeks to understand fundamental biologic processes, has been instrumental in uncovering mechanisms underlying health and disease. The conservation of function across species allows scientists to study complex systems in ways directly relevant to human biology. This foundational knowledge has paved the way for applied research, resulting in life-saving medical interventions. Beyond infectious diseases, animal research has been essential in developing treatments for chronic conditions such as diabetes, heart disease, and cancer, where long-term studies in animal models have provided critical insights into disease progression and management.⁴ Every medical breakthrough available today has relied on insights gained through centuries of basic research with animals. Recognizing the intrinsic value of studying biologic systems is crucial to countering misconceptions that basic research is unnecessary or wasteful. By clearly communicating these connections, we can help the public understand why basic research remains essential for future medical advancements.

The long history of medical progress highlights the essential role of animal models in translating scientific discoveries into real world treatments. Critical treatments such as insulin for diabetes, chemotherapy for cancer, and medications for cardiovascular disease emerged from experiments conducted with animals. In addition, advances in surgical techniques, organ transplantation, and neurologic treatments have all been guided by animal research, enabling lifesaving medical progress.⁴ These achievements underscore the irreplaceable role of animal models in understanding complex biologic systems, testing innovative therapies, and addressing both acute and chronic health challenges.

Animal research is also central to drug development and safety testing. Before new treatments or medical devices are approved for human use, they must undergo rigorous preclinical testing, often involving animal models. In the United States, the Food Drug and Cosmetic Act (FDCA) authorizes the FDA to oversee and regulate the production, sale, and distribution of food, drugs, medical devices, and cosmetics. The FDCA intends to protect the public from adulterated and misbranded products manufactured and sold in the United States. Safety is a priority and animal model use has been traditionally essential to meet that requirement. The FDA has also been a pioneer in incorporating new approach methodologies, which include nonanimal-based methods, into the regulatory framework to complement traditional testing.⁵ Without such testing, the safety of new drugs or medical devices could not be reliably ensured.

A further strength of animal research is its contributions to Nobel Prize-winning discoveries. Of the 229 Nobel Prizes awarded in Physiology or Medicine, approximately 192 have involved animal models, highlighting their indispensable role in advancing both fundamental and applied biomedical science.⁶ Discoveries made possible through the use of vertebrate species include the development of insulin therapy for diabetes (1923, dogs), the understanding of the poliovirus and the creation of the polio vaccine (1954, monkeys), organ transplantation and immune response (1990, mice), and the role of Helicobacter pylori in peptic ulcer disease (2005, gerbils and pigs). More recently, the 2020 prize recognized the discovery of the hepatitis C virus, where chimpanzees were essential for isolating the virus and developing diagnostic tests and treatments. These examples underscore the essential contributions of vertebrate animal models in landmark scientific achievements that have transformed human health.⁷

Other strengths include the development of a strong grounding in animal welfare and science, training, and education programs up to and including veterinary board specialists and enhanced IACUC member training and professional society certifications. In addition, animal research has significantly advanced veterinary science. Vaccines, surgical techniques, and treatments developed for companion animals, livestock, and wildlife have improved the health and welfare of countless animals globally. This has contributed to our understanding of One Health and conservation efforts and assisted in maintaining and supporting endangered species. Closer to home for many of us, research involving dogs led to the development of the canine parvovirus vaccine, saving millions of pets worldwide.⁸

Weaknesses of Research Involving Animals

While animal research has clear strengths, it also faces significant weaknesses that challenge its ethical and scientific standing. One of the most prominent issues remains public mistrust. Many people are unaware of the rigorous ethical frameworks and regulations that govern animal research. As a result, there is skepticism about its necessity and ethicality. Historical reluctance to advocate clearly by some organizations that support and or conduct research using animal models including patient advocacy groups exists. Misrepresentation from groups critical of animal research and media outlets often exacerbates this mistrust, painting a negative picture of animal research without acknowledging its benefits.⁹

Another complicating factor is the need to balance the use of animal, human, and nonanimal models in research, as each plays a critical role in advancing scientific understanding. It is important to note that all have limitations that are to be considered before application. While these models are necessary and provide valuable insights, biologic differences between animals and humans mean that results do not always translate effectively. For instance, treatments that are effective in preclinical studies may fail during human clinical trials due to differences in metabolism, physiology, and genetics.¹⁰ This limitation highlights the importance of integrating complementary methods, such as advanced in vitro systems and computational approaches, to improve predictive accuracy and translational success. In addition, challenges related to rigor and reproducibility in both animal and nonanimal research further obscure translational outcomes. Inconsistent methodologies, insufficient sample sizes, and lack of standardized practices can undermine the reliability of findings, emphasizing the need for robust experimental designs and transparent reporting practices.¹¹

Noncompliance with animal welfare regulations and policies continues to be a significant concern. While the majority of researchers adhere to ethical standards, instances of mistreatment, inadequate care, or failure to follow protocols can undermine the credibility of the entire field. Such lapses not only present the potential for animal harm but may also erode public confidence and invite regulatory scrutiny.

Animal research is also resource intensive, requiring significant financial investment, specialized facilities, and highly trained personnel. These demands can limit the scope of studies, particularly in resource-constrained environments. Smaller institutions and developing nations often struggle to meet these requirements creating disparities in research opportunities and outcome quality. Global inconsistencies in ethical and regulatory standards further complicate international collaborations and raise concerns about ethical outsourcing of research.^12,13

Opportunities in Research Involving Animals

The Replacement, Reduction, and Refinement (3Rs) framework provides a foundation for enhancing both the ethical and scientific dimensions of animal research.^14,15 Despite numerous challenges, ample opportunities to improve the use of animals in research exist. The principle of Reduction emphasizes the potential to minimize the use of animals through improved study design and the optimization of experimental protocols. Advances in statistical modeling, computational tools, and data analysis techniques enable researchers to achieve robust results with fewer animals, ensuring that resources are used efficiently while maintaining scientific rigor.

The Replacement of animal models with innovative nonanimal methodologies is another significant opportunity. Technologies such as organ-on-a-chip systems, advanced computational models, and stem cell-based platforms are rapidly gaining traction. These methods offer ethical and scientifically robust alternatives that reduce the reliance on animals while providing highly predictive results. For example, organ-on-a-chip technology enables researchers to study human organ systems in vitro, replicating physiologic responses more accurately than in-vitro cell cultures and complementary to some animal models.¹⁶ It should be noted it is more accurate for some specific questions related to human organ systems and may not be suitable for studying whole-body systems or complex interactions that require a complete living organism. Collaboration between researchers using animal models and those developing nonanimal methodologies offers the potential for hybrid approaches that combine the strengths of both. These collaborations can accelerate the development of alternatives while ensuring that animal models are available where necessary.

Refinement of experimental procedures is equally important. Enhancing animal welfare through improved housing conditions, pain management, and less invasive techniques can reduce potential pain and/or distress and improve the reliability of research outcomes. Noninvasive imaging technologies, such as MRI, CT, PET, and fluorescence imaging, are becoming increasingly accessible and can replace more invasive approaches. As noted by Rinwa and colleagues,¹⁷ implementing refinement principles not only improves the well-being of rodents used in research but also enhances the quality and reproducibility of scientific outcomes.

Building on the 3Rs, a Culture of Care is essential for fostering ethical and high-quality research. This culture is supported by 4 key pillars: quality science, animal welfare, human welfare, and communication. High-quality science is directly linked to ethical research practices, which include prioritizing both animal welfare and the well-being of researchers and caregivers. Ensuring human welfare mitigates compassion fatigue and fosters a supportive research environment. Strong communication promotes transparency, collaboration, and accountability.¹⁸

A Culture of Challenge complements this by driving progress through critical thinking, innovation, accountability, and ethical advancement. Encouraging researchers to question established practices, explore new methodologies, and uphold high ethical standards ensures that research remains both scientifically rigorous and ethically sound. By fostering a mindset of continuous improvement, the integration of a Culture of Care and Challenge strengthens the practical application of the 3Rs, promoting more ethical and effective research.¹⁸ Improving openness and communication represents a major opportunity for fostering public trust. Outreach initiatives that explain the necessity, benefits, and ethical considerations of animal research can bridge the gap between researchers and the public. Transparent reporting of research outcomes, ethical reviews, and compliance measures can further demystify the field and demonstrate its commitment to accountability.⁴ To address such issues, NIH emphasizes the importance of openness and prompt correction of any noncompliance. Self-reporting and oversight are crucial in strengthening public trust and ensuring that potential animal welfare concerns are thoroughly evaluated and addressed.¹⁹ For example, the University of Washington announced 4 noncompliant items identified during a recent USDA inspection of its animal facilities, underscoring the importance of strict adherence to established guidelines. Openly addressing such noncompliance and implementing corrective actions are critical to ensuring accountability, maintaining trust, and demonstrating a commitment to the highest standards of animal welfare.²⁰

Threats to Research Involving Animals

The field of animal research faces several significant threats, chief among them being the spread of misleading information. Groups critical of research with animals and sensationalized media portrayals often present distorted narratives about the ethical and scientific aspects of animal research. This misrepresentation undermines public understanding and support, creating obstacles for researchers seeking funding or regulatory approval.

Broader societal trends of declining trust in science pose another serious threat. Public skepticism of scientific institutions, practices, and even results has grown in recent years, fueled by misleading information and polarized debates on controversial topics. This mistrust can influence funding decisions, regulatory policies, and public opinion, all of which are critical to the sustainability of animal research.⁴

As noted in the weakness section above noncompliance with ethical standards and regulatory frameworks remains a persistent risk. Isolated incidents of noncompliance can have far-reaching consequences, damaging the credibility of individual researchers, institutions, and the broader research community. Regulatory penalties, public backlash, and reduced funding are just some of the repercussions of ethical lapses.

On-going and newer constraints on the cost of conducting animal research, combined with limited funding for the 3Rs and related initiatives, restrict the ability to innovate and conduct large-scale studies. This issue disproportionately affects smaller institutions and developing nations, where financial and infrastructural resources are often scarce.¹⁵

The complexity of international regulations adds to these challenges. Differences in ethical and regulatory standards across countries make it difficult to harmonize practices and collaborate effectively. Navigating these regulatory landscapes can slow progress, increase administrative burdens, and raise concerns about ethical inconsistencies.¹²

Strategic Implications

The SWOT analysis highlights the need for strategic interventions to address the challenges and opportunities in animal research (Figure 1). Leveraging the strengths of animal research, such as its contributions to medical advancements, can bolster public and political support. Addressing weaknesses, including public mistrust and the reliance on animal models as a primary approach, requires proactive efforts to invest in and integrate innovative alternatives. Opportunities such as the refinement of methods, reduction of animal use, and replacement with nonanimal technologies must be prioritized. Mitigating threats like misrepresentation, regulatory complexity, and resource constraints demands coordinated action at institutional, national, and international levels.

Figure 1.

Illustration of the 4 quadrants of a Strengths, Weaknesses, Opportunities, and Threats (SWOT) analysis, as outlined in the text. The analysis emphasizes leveraging strengths and opportunities to address weaknesses and mitigate threats, fostering a robust foundation for scientific progress. The framework highlights the importance of both animal and nonanimal models in advancing biomedical research, while focusing on the ethical, rigorous, and innovative approaches necessary for sustainable and impactful science.

Action Plan

To ensure the ethical and impactful use of animals in research, a comprehensive action plan is essential for the scientific community that relies on animals to support biomedical advances (Figure 2). Strategies to address weaknesses and mitigate threats should include clarifying the role of animals, while ensuring the optimization of the 3Rs. Emphasizing a Culture of Care ensures that ethical considerations remain at the forefront, while fostering a Culture of Challenge holds researchers accountable for evaluating what is working and what can be improved.^18,21

Figure 2.

Summary of the key points of an action plan for ethical and impactful research going forward.

Investments in the 3Rs should be expanded, with increased funding for developing complementary nonanimal methodologies, refining existing practices, and optimizing study designs to reduce reliance on animal models. Ongoing and additional commitments to animal welfare and science specific to species used for research including ongoing fiscal support for training programs are essential. Efforts to engage the public must be prioritized, focusing on clear and accurate communication about the contributions of animal research and the ongoing efforts for continuous improvement. Educational outreach and accessible reporting can address misrepresentation and help repair and build public trust. These efforts should include the use of multimedia formats including social media and future sharing formats in the future.

Global collaboration is also a key component of the action plan. Aligning international standards and sharing best practices will promote consistent ethical and scientific quality worldwide. Encouraging partnerships between researchers using animal models and those advancing alternative methods will drive innovation and facilitate the integration of nonanimal approaches, ultimately enhancing the impact and sustainability of research.

Conclusion

The value of a SWOT analysis lies in its holistic approach, recognizing strengths and weaknesses while defining a path forward. Animal research remains a cornerstone of scientific progress, driving discoveries that have transformed medicine and improved lives. However, its continued success depends on addressing ethical concerns, fostering innovation, and strengthening public understanding. By prioritizing the 3Rs, the scientific community can ensure that animal research continues to evolve to meet societal and scientific demands.

Building public trust requires clear and accurate communication about the benefits of animal research and the ongoing efforts to maximize animal welfare and thereby scientific quality. Collaborative efforts, including global harmonization of standards and partnerships between researchers using animal models and those advancing nonanimal methods, are critical to driving innovation. Through strategic action, the adoption of a Culture of Care, and a commitment to ethical leadership, the field can maintain its essential role in scientific discovery while meeting the highest ethical standards.

Conflict of Interest

The authors have no conflicts of interest to declare.

Funding

This work was internally funded by support from the University of Washington and the University of Pittsburgh.