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.

Ipsen's billion-dollar drug Somatoline is maintaining strong sales despite facing generic competition since 2021. The drug is extremely difficult to manufacture, which has prevented generic players from ramping up production. This "manufacturing moat" serves as a powerful, often overlooked, defense against revenue erosion after a patent cliff.

China’s biotech rise is fueled by its 'first to file' patent system. Companies feed newly published patents into computers to design trivially different but functionally identical molecules, effectively creating a 'shadow generic industry' that undermines IP.

Drug developers often operate under a hyper-conservative perception of FDA requirements, avoiding novel approaches even when regulators might encourage them. This anticipatory compliance, driven by risk aversion, becomes a greater constraint than the regulations themselves, slowing down innovation and increasing costs.

Large pharmaceutical companies face losing up to 50% of their revenues by 2030 due to the largest patent expiration wave in history. To survive, they will be forced to acquire innovation from the biotechnology sector, fueling a sustained M&A cycle for years to come.

The emergence of low-cost, compounded versions of GLP-1 drugs from telehealth companies like Hims is creating significant pricing pressure on market leaders Novo Nordisk and Eli Lilly. This dynamic has pushed the pharma giants toward direct-to-consumer models with lower prices to compete.

To commercialize a simple mixture, the company built an IP portfolio around the timing, delivery, and indications for GIK. Crucially, they secured a 'trifecta' of FDA support: Special Protocol Assessment, Breakthrough Designation, and a Biologic License Application, which grants 12 years of market exclusivity, creating a strong competitive barrier without a traditional drug patent.

The FDA quickly rebuked Hims & Hers for its mass-market compounded obesity drug. This move defends intellectual property and reinforces that compounding pharmacies are for niche medical needs, not for producing illegal, mass-market copycats of branded drugs.

MFN's pressure on global pricing will change how innovation is valued. Truly disruptive drugs may command higher prices ex-US, while incremental "me-too" drugs in crowded classes will not. This will force pharma companies to shift R&D investment away from iterative improvements and toward therapies with radical treatment-disrupting potential.