Label – and label extension – strategy is starting to shift from a broader and broader focus to a very specific one

Pharmaceutical leaders and innovators are looking to identify indications for drugs that let them get treatment to the right patient, and only the right patient, in order to ultimately become the preferred approved treatment for that subsegment across a multi-payer environment.

The new path to market share is hyper-targeting, even with what would have once been mass-market drugs. Today, drug, device and digital therapeutics makers don’t want to try to own an entire category – an impossible dream in any but the rarest of rare diseases. Instead, they want 100% of the patients in a particular population. Clinical and commercial teams are asking Where can it make the most meaningful difference? instead of Where can this treatment make any kind of impact?

This shift is happening both because markets are getting more crowded and research methodologies are becoming more sophisticated. These more-personalised labels are enabled by testing against now well-known levers of scientific discovery, like biomarkers and co-morbidities, and increasingly against new ones, like behaviour that can be tracked with diaries and wearables, and demographic subsegments.

Supporting and accelerating this shift is critical for companies because, in a future where rebates are increasingly constrained, market specificity will be the most critical lever of payer choice. The goal will be to be the one drug that is proven in a specific outcome for a specific population. The value is set on that unique – and niche – difference. In 2019, look for early leaders to subsegment indications both by true differentiators and by investments in subset research that competitors just haven’t analysed yet.

From: This is the best drug

To: This is the best drug for you

As categories become more crowded, innovators will increasingly look for advantages by understanding where their drugs have the most impact vs. trying to win on rebates and discounts. They’ll stop fighting for a small piece of the big pie and start carving out high shares of very specific niches.

Search for the right patient is one of ten trends outlined in the Syneos Health 2019 Health Trend Ten which outlines critical shifts that will change how we test and commercialise novel new therapies and innovations in the years ahead. The report looks beyond numbers and statistics, turning the uncertainties our industry faces into informative trends, relevant questions and actionable insights. Download the eBook to read all ten trends and gain access to ten worksheets that provide clear takeaways and edifying interactive experiences at trends.health.

The creation of the Health Trend Ten was led by Leigh Householder, with contributions from a team of 200+ clinical and commercial minds across the company.