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.
In the competitive oncology market, Step Pharma differentiates itself by highlighting its novel, "first-in-class" mechanism and excellent safety profile. This strategy attracts interest by focusing on a unique therapeutic opportunity and potential for combination therapies, rather than competing directly on incremental efficacy gains.
InflaRx's strategy targets the C5a pathway, implicated in many inflammatory conditions. By focusing on this single mechanism, their drug could potentially treat a wide range of diseases, from skin conditions to kidney disease, effectively creating a valuable "pipeline in a drug."
Airway selected Bronchopulmonary Dysplasia (BPD) for its lead program due to strong preclinical data, a unique mechanism in infants (arrested lung development), and zero approved treatments. This strategic choice created a clear regulatory path, a strong competitive advantage, and addressed a significant unmet medical need.
To maintain a competitive edge, BridgeBio only pursues programs that are either "first in class" (a novel treatment where none exists) or "best in class" (a demonstrably superior option, like an oral pill versus a daily injection). This strict strategic filter is the core of their entire R&D pipeline selection process.
Unlike ventures in established biological pathways, startups tackling novel biology must first prove a specific drug product can work. The primary question isn't about the platform's potential applications but whether a single, tangible therapeutic is viable. Focusing on a broad platform too early is a mistake.
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.
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.
A key part of Eli Lilly's R&D strategy is tackling large-scale health problems that currently have no treatments and therefore represent a 'zero-dollar market.' This blue-ocean strategy contrasts with competitors who focus on areas with established payment pathways.
The CEO argues that a second entrant in a new drug class can expand the total market, citing historical examples. The goal isn't just to take share from the incumbent (BMS) but to increase diagnosis rates and physician adoption for the entire category, creating a "one plus one equals three" scenario.
Instead of applying AI to optimize existing processes for known targets, Zara strategically focuses its powerful models on historically "undruggable" targets like multi-pass membrane proteins. This approach creates a strong competitive moat and showcases the technology's unique potential.