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Opportunities for Economic Advancement

The High Cost of Drug Development

By mandating a move away from experiments on animals and toward advanced scientific methods, the U.S. has the opportunity to advance biomedical research, rapidly expand job growth in science and technology, and reduce healthcare costs. In a paper titled “Animal testing and its alternatives—the most important omics is economics,” researchers report that “an economy of alternative approaches has developed that is outperforming traditional animal testing.”1

Non-Animal Biomedical Research Methods

A variety of human cell-based and tissue methods, advanced computer models, and other technologies can be used for basic, translational, and preclinical biomedical research. Here are just a few of the exciting examples.

  • Organs-on-chips
    include human cells that mimic the structure and function of human organs and replicate human physiology and drug responses more accurately than experiments on animals.
  • Three-dimensional human cell–derived models
    such as organoids, replicate self-organized human tissues in a complex structure that recapitulates the function of human organs and tissues.
  • Sophisticated computer models
    can simulate human biology and the progression of disease, accurately predicting how new drugs will react in the human body and aiding in biomarker identification and treatment.
  • Non-invasive human imaging
    with human volunteers allows researchers to better understand the human brain and other organs, even down to the level of a single neuron.
  • “Omics” studies,
    including genomics, proteomics, and more, give insight into the complex molecular mechanisms that underpin human biology and direct the form and function of human cells and cellular processes.

In the current system, bringing a new drug to market may cost more than $1 billion and takes an average of 14 years.2 The high costs of research and development (R&D) may be shifted to patients in the form of increasingly unmanageable price tags for prescription drugs,3 even though the development of those drugs was likely already subsidized by public funding, meaning patients are essentially “paying twice” for access to lifesaving medications.4

During a 2017 conference, then–U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb lamented the high cost of drug development and its impact on both patients and the U.S. economy. He discussed the importance of reducing R&D costs “to make sure we’re providing an efficient path for the translation of cutting-edge science into practical treatments that are going to benefit patients” and “because the rising cost of drug development is unsustainable.” He stated, “[u]nless we find ways to modernize how we approach our work, and make more efficient use of our resources, then we’re going to get fewer medicines, and higher costs,” adding, “[a]t a time when people are rightly worried about the rising prices of drugs, and the impact on patient access, we also need to be thinking about these factors that contribute to the high cost of making new medicines.”5

One factor contributing to the high cost of R&D is the substantial risk associated with developing a product that fails to result in a marketable drug because it does not succeed in human clinical trials. Ninety-five percent of drugs that test safe and effective in animals fail in human trials,6 most because they are either not safe or not effective.789 There are also instances in which drugs that make it to market are recalled due to adverse effects or safety concerns that were not detected in animal tests.10 Failure during the clinical trial phases of drug development is the biggest driver of R&D costs,11 highlighting the urgent need for better predictive models.12

Conversely, drugs that could be effective in humans may never enter clinical trials because they were ineffective or unsafe in animals. Scientists advocating for the use of human-based models during research and drug testing made the following observation:

[P]otentially effective drug candidates never enter clinical trials owing to negative preclinical tests given that most animal models poorly resemble human conditions and thus have low predictive values. The discrepancies derive from different anatomical layouts and biological barriers, divergent receptor expression and immune responses, host specificities of microorganisms, and distinct pathomechanisms.13

With the use of human-relevant technology in place of expensive, time-consuming, and inaccurate experiments on animals, the cost of drug discovery has the potential to decrease dramatically. Experts have estimated that the use of organs-on-chips—just one type of non-animal model—could reduce R&D costs by 10% to 26%, resulting in savings of up to $706 million. By reducing both the expense and time it takes to get effective therapies to market, manufacturers will be able to pass these savings on to patients.14

“Drugs showing safety and efficacy in preclinical animal models may show very different pharmacological properties when administered to humans.”15

Job and Economic Growth in the Technology Sector

The market for human cell–based in vitro technology for biomedical research and testing is growing rapidly. According to market research firm DataM Intelligence, “The Global Organ-On Chip Market reached USD 107.5 million in 2022 and is expected to reach USD 796.7 million by 2031 and is expected to grow with a CAGR [compound annual growth rate] of 29.6% during the forecast period 2024–2031.”16 A similar CAGR of 26.5% is predicted for three-dimensional cell cultures, which are expected to reach $14.8 billion by 2028.17 The markets for induced pluripotent stem cells, 3D bioprinting, and cell-based assays are also expected to continue thriving.181920

Contract research organizations that focus heavily on breeding and supplying animals, on the other hand, are not faring as well. In late 2024, Charles River Laboratories, which was under federal investigation for possible violations of monkey-importation laws, reported a 3.2% decline in revenue in Q2, prompting the company to lay off approximately 600 employees.21 Inotiv (previously Envigo), another animal supplier that had recently settled a criminal investigation regarding the abuse of dogs it bred for experimentation, reported a 32.8% drop in Q3 2024 revenue, with a consolidated net loss of $26.1 million,22 and has noted that its financial losses have been due to a decrease in its sales of primates.23

Transitioning away from animal experimentation and testing can open new opportunities to retrain laboratory staff, including experimenters, animal technicians and caretakers, animal welfare officers, and breeders in skills that will better equip them for stable and fulfilling careers in growing industries. Building new infrastructure around human-relevant research will fill the gaps left by failing animal breeders and suppliers, creating a wealth of job opportunities that are free from the mental24252627 and physical282930 risks associated with working in facilities with sick, stressed, and captive animals.

Ethical new technology will streamline drug development, making the process safer, cheaper, and more effective. Expanding these techniques allows for the creation of interdisciplinary research teams that will be fundamental in furthering translational science and creating personalized disease models for precision medicine.

Human Biology–Based Methods Outperform Animal Tests

iStock.com/Natali_Mis

Select cases can demonstrate how research tools based in human biology are better than experiments on animals for predicting outcomes in humans. Here are just a few examples, including several showing how the use of these tools could have prevented morbidity and mortality in humans.

  • A human liver–on-a-chip developed by Emulate Inc. in Boston “was able to correctly identify 87% of the tested drugs that caused drug-induced liver injury in patients despite passing animal testing evaluations. These drugs that initially passed animal testing evaluations ultimately caused nearly 250 deaths and 10 liver transplants.”31 In September 2024, the FDA Center for Drug Evaluation and Research accepted this liver chip into its Innovative Science and Technology Approaches for New Drugs Pilot Program, which will allow developers to use the technology to screen new drugs for their potential to cause drug-induced liver injury in humans, one of the leading reasons drugs fail in clinical trials.32 Troglitazone had been withdrawn from the market due to severe and fatal liver toxicity that killed at least 63 people. The newer in vitro tests predicted this potential hazard, while the preclinical animal studies had not. One author of the study commented, “[p]atients need safer affordable medicines delivered in their lifetime. The pharmaceutical industry is in crisis, with empty pipelines and skyrocketing costs. Focusing on human biology is the route to developing safer medicines faster and with lower total development costs.”33
  • Working from a large chemical database, a computer algorithm was able to predict the human toxicity of a new chemical better than animal tests.34 In an interview on the paper, one author noted, “[t]hese results are a real eye-opener—they suggest that we can replace many animal tests with computer-based prediction and get more reliable results.”35
  • Emulate and Janssen Pharmaceuticals have demonstrated how a blood vessel–on-a-chip was able to predict a human thrombosis caused by an antibody therapy. This therapy had previously been determined to be safe following preclinical animal tests, but clinical trials had to be stopped after humans given the drug developed blood clots.36
  • Computational models representing human heart cells predict human cardiotoxicity, which can produce dangerous arrythmias, more accurately than animal tests.37 Models like these are critical for “improving drug safety, thereby lowering the risk for patients during clinical trials; and speeding up the development of medicines for patients in urgent need of healthcare.”38
References
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  2. National Center for Advancing Translational Sciences. New Therapeutic Uses. April 19, 2024. Accessed September 25, 2024. https://ncats.nih.gov/research/research-activities/ntu ↩︎
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