Applying traditional, broad primary care launch strategies to highly targeted specialty therapies is a major risk. The complexity of stakeholders and decision-making in areas like oncology means old playbooks can make a company's efforts completely irrelevant.
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Despite sound science, many recent drug launches are failing. The root cause is not the data but an underinvestment in market conditioning. Cautious investors and tighter budgets mean companies are starting their educational and scientific storytelling efforts too late, failing to prepare the market adequately.
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.
Rather than waiting for late-stage development, biotech startups should integrate commercial planning into early trials. This means building in data collection for payers, pricing, and patient access from the start. This "think with the end in mind" approach ensures the company has the right data for pivotal trials and market access.
The company's commercial strategy avoids a blanket approach by segmenting its target audience. It will first focus on 700 cardiologists responsible for 80% of prescriptions, then expand to a secondary tier of 2,000 occasional prescribers, and finally a third tier of 8,000 non-prescribers to ensure both depth and breadth of market penetration.
CRISPR reframes its commercial strategy away from traditional drug launches. By viewing gene editing as a 'molecular surgery,' the company adopts a go-to-market approach similar to medical devices, focusing on paradigm shifts in hospital procedures and physician training.
With over 5,000 oncology drugs in development and a 9-out-of-10 failure rate, the current model of running large, sequential clinical trials is not viable. New diagnostic platforms are essential to select drugs and patient populations more intelligently and much earlier in the process.
The increasing volume of new therapies requires pharma companies to stop treating each launch as a unique event. Instead, they must develop a scalable, repeatable, and excellent launch capability to handle the future pipeline efficiently and consistently.
The fastest, cheapest path to drug approval involves showing a small survival benefit in terminally ill patients. This economic reality disincentivizes the longer, more complex trials required for early-stage treatments that could offer a cure.
When seeking partnerships, biotechs should structure their narrative around three core questions pharma asks: What is the modality? How does the mechanism work? And most importantly, why is this the best differentiated approach to solve a specific clinical challenge and fit into the competitive landscape?
In crowded fields like oncology, most companies flock to a few validated ideas, like kids chasing a soccer ball. Delpha Therapeutics' CEO Kevin Marks argues the real opportunity lies in pioneering novel biology in the wide-open parts of the field, creating a strategic advantage and potential scarcity effect.
