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.

The FDA incentivizes animal drug development by granting years of market exclusivity to companies that prove a generic human drug works for a novel use in animals. This avoids the "aspirin problem" in human medicine, where no one will fund trials for off-patent drugs because they can't be profitably marketed.

Suppliers label products 'for research use only' to legally ship them for non-human applications. This allows consumers, framed as amateur scientists, to purchase substances for personal use, bypassing FDA approval for human consumption and creating a thriving gray market.

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.

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.

In the absence of formal regulation, peptide users have created a decentralized trust system. They import substances from gray-market Chinese suppliers and then pay independent US or European labs to verify purity, creating a crowdsourced quality control process.

The FDA defines a peptide as an amino acid chain of 40 or less. Blockbuster drugs like Ozempic and Mounjaro are all exactly 39 amino acids long. This perfect fit suggests potential regulatory shaping or clever drug design to fit an advantageous classification.