Diseases like Ebola and malaria, which primarily affect poor countries, lack market incentives for vaccine R&D. The Ebola vaccine only progressed because it was briefly on a U.S. bioterrorism list created after 9/11, highlighting how market failures require creative, sometimes accidental, incentives to overcome.
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Breakthrough drugs aren't always driven by novel biological targets. Major successes like Humira or GLP-1s often succeeded through a superior modality (a humanized antibody) or a contrarian bet on a market (obesity). This shows that business and technical execution can be more critical than being the first to discover a biological mechanism.
By leveraging bulk purchasing, Gavi vaccinates children in developing countries for just $24 (compared to $1,300 in the US). This small investment saves one life for every 50-60 children vaccinated, yielding a cost-benefit ratio unmatched in healthcare or philanthropy.
While the FDA is often blamed for high trial costs, a major culprit is the consolidated Clinical Research Organization (CRO) market. These entrenched players lack incentives to adopt modern, cost-saving technologies, creating a structural bottleneck that prevents regulatory modernization from translating into cheaper and faster trials.
A significant portion of biotech's high costs stems from its "artisanal" nature, where each company develops bespoke digital workflows and data structures. This inefficiency arises because startups are often structured for acquisition after a single clinical success, not for long-term, scalable operations.
Unlike a drug that can be synthesized to a chemical standard, most vaccines are living biological products. This means the entire manufacturing process must be perfectly managed and cannot be altered without re-validation. This biological complexity makes production far more difficult and expensive than typical pharmaceuticals.
Regulating technology based on anticipating *potential* future harms, rather than known ones, is a dangerous path. This 'precautionary principle,' common in Europe, stifles breakthrough innovation. If applied historically, it would have blocked transformative technologies like the automobile or even nuclear power, which has a better safety record than oil.
The Orphan Drug Act successfully incentivized R&D for rare diseases. A similar policy framework is needed for common, age-related diseases. Despite their massive potential markets, these indications suffer from extremely high failure rates and costs. A new incentive structure could de-risk development and align commercial goals with the enormous societal need for longevity.
A massive disconnect exists where scientific breakthroughs are accelerating, yet the biotech market is in a downturn, with many companies trading below cash. This paradox highlights structural and economic failures within the industry, rather than a lack of scientific progress. The core question is why the business is collapsing while the technology is exploding.
Selling low-cost vaccines to organizations like Gavi isn't just charity for pharmaceutical companies. It creates massive economies of scale, lowering the cost of goods for their high-margin primary markets and increasing overall net profit, creating a powerful win-win incentive structure.
Unlike traditional UN agencies, Gavi operates as a public-private alliance. Its key innovation is not just fundraising but acting as a market-shaper. By guaranteeing consistent, large-scale purchases, Gavi gives private manufacturers the predictability needed to invest in capacity, ultimately lowering costs and ensuring supply security.