The U.S. market's high prices create the large profit pool necessary to fund risky drug development. If the U.S. adopted price negotiation like other countries, the global incentive for pharmaceutical innovation would shrink, resulting in fewer new drugs being developed worldwide.

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.

The weight-loss drug market is a duopoly, not a monopoly, because companies cannot patent the underlying biological mechanism (mimicking GLP-1). Instead, Novo Nordisk and Eli Lilly patented distinct molecules that achieve a similar outcome, allowing both to compete directly.

Adderall's success proves a core chemical patent isn't essential for market dominance. A strong brand that becomes synonymous with a condition, combined with secondary patents on novel delivery mechanisms (like Adderall XR's capsule), can create a durable, highly profitable business moat.

While patents are important, a pharmaceutical giant's most durable competitive advantage is its ability to navigate complex global regulatory systems. This 'regulatory know-how' is a massive barrier to entry that startups cannot easily replicate, forcing them into acquisition by incumbents.

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.

Investing in clinical studies is not just for product validation; it's a powerful marketing strategy. It allows you to make scientifically-backed claims in ads that competitors cannot legally replicate, creating a significant and sustainable competitive advantage.

Developing an antibiotic is costly, but its use is short-term and new drugs are held in reserve, making them unprofitable. This market failure, not a lack of scientific capability, has caused pharmaceutical companies to exit the space, creating a worsening global health crisis.

An FDA-style regulatory model would force AI companies to make a quantitative safety case for their models before deployment. This shifts the burden of proof from regulators to creators, creating powerful financial incentives for labs to invest heavily in safety research, much like pharmaceutical companies invest in clinical trials.