Medical Affairs has historically been cast as the “supporting act” – credible, trusted, but rarely the star. The function has long been the bedrock of scientific information – a safe pair of hands offering post-launch support and answering queries from healthcare professionals (HCPs). That legacy role no longer fits today’s pharma landscape. More progressive organisations are already rewriting the script, empowering Medical to play a strategic role in shaping launch readiness. The challenge now: can the rest of the industry catch up?
Peer-reviewed literature and industry practice show just how far Medical Affairs has evolved. In many large pharma companies, Medical is moving beyond its old supporting role – integrating data, AI, and predictive modelling to prepare markets, generate real-world evidence, and drive adoption. Momentum is real – but progress is uneven. The next frontier is making it standard everywhere.
Why the old approach no longer fits
Brand lifecycles are already compressed – and macro-economic shifts, organized customers, and scientific complexity are only intensifying the pressure, rendering the traditional, linear approach to drug development and commercialization obsolete. Several forces are converging:
- Shrinking brand lifecycles: The clock is ticking faster. The Inflation Reduction Act (IRA) has introduced a hard new timeline for Medicare price negotiations: just 9 years for small molecules and 13 years for biologics. This effectively pulls forward the economic loss of exclusivity (LOE), even if patent protection lasts longer. Exacerbating this issue, U.S. payers and PBMs are applying tighter controls, including formulary exclusions, step edits, and prior authorization, leading to faster erosion post-launch and shorter revenue peaks. And in areas like immunology and oncology, biosimilar uptake is so much faster than a decade ago, further compressing lifecycles.
- The rise of organized customers: Individual physicians no longer dominate market access. Integrated Delivery Networks (IDNs), payers, and large health systems wield significant power, shaping adoption earlier and with stricter cost controls.
- Increasing scientific complexity: Advanced therapies like gene therapies and personalized medicine demand nuanced evidence earlier. Randomized controlled trials (RCTs) alone aren’t enough. Policy and payer pressures extend the focus to proving value and real-world efficacy for specific regions.
- The importance of pre-launch: Launch is no longer a single moment. Market narratives and formulary decisions often solidify before approval. Brands can no longer wait until approval to shape perception or establish the evidence base. With lifecycles compressed by policy and payer pressure, the early launch years now capture a larger share of total revenue; fast adoption matters more than ever because brands have fewer peak years before price erosion sets in.
These pressures demand a strategic shift – with a repurposed and reinvigorated Medical Affairs function leading the charge.
