Instead of a broad launch targeting primary care, Madrigal focused its specialty sales force on the 315,000 patients already diagnosed with moderate-to-severe MASH. This disciplined approach of targeting a specific, existing patient population allowed for efficient market penetration and rapid success.

Causeway Therapeutics strategically targets a market with no existing FDA-approved drugs. By focusing on conditions like tennis elbow, where the standard of care is limited, they are creating a new therapeutic category rather than competing in a crowded space, giving them a unique market position.

To enter the competitive ulcerative colitis market, MRM Health is positioning its drug in an underserved population: mild-to-moderate UC patients who have failed conventional treatments but are hesitant to move to aggressive, immunosuppressive advanced therapies. This creates a valuable intermediate step-up option for physicians and patients.

Instead of directly competing with dominant anti-CD20 therapies, Immunic strategically targets patients who need to switch due to side effects like infection risk. This go-to-market strategy carves out a valuable niche as a safer, long-term oral alternative without needing to prove superior efficacy upfront.

Instead of competing directly with an established drug, companies can target a non-overlapping, genetically defined patient population. Idea Biosciences' drug for uveal melanoma is for HLA A2-negative patients, while the approved drug KimTrac is for HLA A2-positive patients. This strategy allows for market entry without a head-to-head battle.

Protagonist believes its oral IL-23 blocker will not just compete with existing injectables but will capture a new market. They target the over 50% of eligible patients who currently take no therapy due to a dislike of injections or the safety profiles of other oral options, thereby expanding the total addressable market.

Successful drug launches require nailing three fundamentals. Common failures include: misjudging the patient population (epidemiology), failing to secure reimbursement and patient access, and lacking clear differentiation against the established "gold standard" treatment in physicians' minds.

While the FDA's primary endpoint for gout drugs is a simple biomarker (uric acid levels), Crystallis designed its Phase 3 trials around harder clinical endpoints like flare reduction. This forward-thinking strategy aims to generate data needed to convince payers of the drug's value, ensuring market access post-approval.

Beyond converting patients from existing injectable therapies, the company's core growth strategy for its oral IL-23 drug is to capture the 50%+ of eligible patients who currently refuse treatment altogether because they dislike injections. This transforms the strategy from market share capture to market creation.