For many, a drug’s price seems to mirror the immense difficulty of creating life-saving therapies. Yet a closer look at the drug development landscape reveals a more nuanced picture—one where complex processes, regulatory frameworks, and layered profit incentives often play a significant role. Understanding these factors is essential to re-imagine how we approach affordability and accessibility.
The R&D Reality
Drug development is undeniably resource-intensive. Companies frequently cite the billions spent on research and development to justify high prices, and indeed, the process involves significant risk. On average, only about 12% of drugs entering clinical trials ultimately receive FDA approval [1]. The need to absorb the costs of failed candidates is one of the main cited factors for the high price tags of successful drugs.
However, early-stage research often relies on public grants or academic institutions. In the United States, for example, nearly 60% of basic biomedical research funding came from public sources in the 2010s [2]. Despite a reducing share of funding the grant dollars from the National Institute of Health (NIH) and others still drive innovation. Once promising discoveries move to private industry, additional costs related to market preparation, regulatory compliance, and commercialization add more layers of expense on top of the necessity to drive shareholder value. While tools like AI-driven drug discovery and high-throughput screening have made R&D more efficient, these advancements often reduce timelines but fail to lower costs for patients [3].
Moreover, strategies like “evergreening,” where companies make minor modifications to extend patent protections, limit the development of more cost-competitive alternatives [4]. These practices reveal a fundamental disconnect between innovation and accessibility in a system that should theoretically be designed to provide both to the ultimate benefactor of the research: patients.
Manufacturing Challenges
Drugs that survive the rigorous development pipeline face another challenge: manufacturing. Biologics, such as monoclonal antibodies or cell therapies, require highly specialized production considerations. Unlike small-molecule drugs, which are synthesized through chemical reactions, biologics are currently cultivated in living cells—a process that can at times be as much of an art as it is a science.
Scaling up production adds complexity and cost to any drug development effort. Large-scale bioreactors used for biologics manufacturing must not only be built, commissioned, and maintained, but they must meet stringent quality standards for every batch while minimizing risks like contamination. A single large-scale production can incur a huge cost despite the increase in production titers and efficiency of downstream processing [5]. The substantial up-front investment makes the risk of batch failure an eye-watering proposition even for large companies. Moreover, conventional stainless steel bioreactor systems often require extensive cleaning and validation between batches, adding time and expense to production that is only economically justified if used almost continuously through its lifecycle.
Innovations like single-use systems and modular facilities offer potential solutions by streamlining processes and reducing contamination risks. However, these systems demand significant upfront investment and require a cultural shift in manufacturing practices, which can be slow to adopt in a highly regulated industry [6]. For smaller organizations, these barriers can be insurmountable without collaborative infrastructure or other mechanisms to gain access to production early in the drug development process. This may necessitate late-stage process changes which further delay development and increase costs to re-optimize the production platform and conduct comparability studies.
The Role of Regulation
Robust regulatory oversight helps ensure that drugs are safe, effective, and of high quality. However, compliance with global regulations is costly and time-consuming, particularly for smaller companies. The process of obtaining FDA approval alone involves an average timeline of 8–12 years and significantly contributes to the up to $2.6 billion required to bring a new drug to market [7]. Beyond the initial approval, facilities must meet ongoing GMP standards, which include frequent inspections, extensive record-keeping, and constant process validation.
Recent efforts by regulatory agencies aim to streamline the drug approval process and reduce associated costs without compromising safety and efficacy. Initiatives such as the FDA’s Breakthrough Therapy designation and Accelerated Approval pathway help expedite the review of innovative treatments, particularly for unmet medical needs. Additionally, regulatory authorities have been exploring the use of real-world evidence and advanced analytics to support drug approvals, potentially reducing the reliance on lengthy and expensive clinical trials.
In the case of biosimilars, specific programs have been implemented to lower barriers to market entry. The FDA’s Biosimilar Action Plan, for example, focuses on improving the efficiency of biosimilar development and review processes while providing clearer guidelines for manufacturers. These measures aim to foster competition, increase the availability of biosimilars, and ultimately reduce the cost of biologic therapies for patients and healthcare systems
Despite these efforts, many older drugs—such as insulin—continue to command high prices. This is partly due to limited competition and fragmented supply chains, as well as regulatory hurdles that make it difficult for biosimilars or generics to enter the market [8] [9]. These challenges highlight the need for reform to ensure both safety and accessibility.
Moving Forward
Closing the gap between drug prices and scientific costs calls for systemic change. While there is no single solution, targeted efforts in three areas could have a transformative impact:
- Revolutionizing Manufacturing
Expanding the use of scalable, modular GMP facilities can democratize access to high-quality biomanufacturing. Flexible systems—such as those designed for “biomanufacturing on demand”—allow smaller organizations to produce therapeutics at a fraction of the cost, empowering innovation beyond the largest players [10]. - Streamlining Collaboration
Strengthening public-private partnerships and embracing open science can reduce redundancies in early-stage research. For example, initiatives like the NIH’s “All of Us” program demonstrate how shared data and resources can accelerate innovation [11]. By pooling expertise, companies and institutions can focus on discovery rather than duplicating efforts. - Rewarding Efficiency
Incentivizing cost-effective production methods through regulatory reform can ensure affordability. Programs that fast-track biosimilars and generics have already shown promise in reducing costs while maintaining quality standards [9].
Conclusion
Scientific breakthroughs should be celebrated for their potential to improve lives—not solely for the profits they generate. By addressing the complex challenges in R&D, manufacturing, and regulation, we can create a system where the benefits of innovation are accessible to all.
When a transformative new therapy emerges, the question should not be whether we can afford it, but how we can ensure it reaches those who need it most. With intentional collaboration and a commitment to continuous improvement, we can pave the way for a brighter, more equitable future in healthcare.
Stay Curious!
References
- Congressional Budget Office (CBO). (2021). Research and development in the pharmaceutical industry. https://www.cbo.gov/publication/57126
- National Center for Science and Engineering Statistics (NCSES). (2024). Analysis of Federal Funding for Research and Development in 2022: Basic Research. National Science Foundation. https://ncses.nsf.gov/pubs/nsf24332
- Chisowa, T., & Colluru, V. (2025). Nature and AI in drug discovery: a solution to high costs. World Economic Forum. https://www.weforum.org/stories/2025/01/turning-to-nature-and-ai-in-drug-discovery/
- Gaudry, K. Evergreening: a common practice to protect new drugs. Nat Biotechnol 29, 876–878 (2011). https://doi.org/10.1038/nbt.1993
- Shukla, A. A., & Thömmes, J. (2010). Biopharmaceutical manufacturing: Historical and future trends in titers, yields, and efficiency. BioProcessing Journal, 8(4), 8–20.
- Harrison, C. (2023). Embracing single-use innovations in a post-COVID era. Pharmaceutical Manufacturing. https://www.pharmamanufacturing.com/production/unit-operations/article/55136462/embracing-single-use-innovations-in-a-post-covid-era
- Wouters, O. J., McKee, M., & Luyten, J. (2020). Estimated research and development investment needed to bring a new medicine to market, 2009-2018. JAMA, 323(9), 844–853. doi:10.1001/jama.2020.1166.
- Cefalu, W. T., et al. (2018). Insulin Access and Affordability Working Group: Conclusions and Recommendations. Diabetes Care, 41(6), 1299–1311. doi:10.2337/dci18-0019. https://diabetesjournals.org/care/article/41/6/1299/36487/Insulin-Access-and-Affordability-Working-Group
- Blackstone, E. A., & Fuhr, J. P. (2013). The economics of biosimilars. American Health & Drug Benefits, 6(8), 469–478.
- Pardee, K., et al. (2016). Portable, on-demand biomolecular manufacturing. Cell, 167(1), 248–259.e12. doi:10.1016/j.cell.2016.09.013. Retrieved from https://doi.org/10.1016/j.cell.2016.09.013
- NIH “All of Us” Research Program: https://allofus.nih.gov.
