This blog is Part 2 of our ‘Asembia 2025 series’ and features original insights inspired by sessions we attended at Asembia's AXS25 Summit. You can continue exploring this series by reading Part 1 and Part 3.
Patient access to essential medications has become increasingly complex, with new challenges emerging that fundamentally reshape how pharmaceutical companies approach market entry and sustainability. Recent industry insights reveal a landscape where traditional pathways to patient care are being redrawn by policy changes, market dynamics, and technological innovations.
The Access Dilemma: New Barriers on the Rise
The most striking development in patient access is the proliferation of "new-to-market blocks" affecting approximately half of U.S. covered lives. Unlike the traditional approach where FDA-approved drugs enjoyed broader initial coverage, payers now implement automatic non-coverage until their own review processes are complete. This shift creates significant hurdles for manufacturers at launch, exactly when building awareness and adoption is most critical.
"The proliferation of new-to-market blocks affecting half of U.S. covered lives represents a fundamental shift in patient access strategy. At ConnectiveRx, we're seeing pharmaceutical companies adapt by implementing more sophisticated access and affordability solutions earlier in the product lifecycle to overcome these barriers and ensure patients can access the treatments they need."
- Chris Dowd, ConnectiveRx, SVP, Market Development
Both pharmacy and medical benefit products face increasingly restrictive environments:
- Pharmacy benefits: Higher rebating requirements, elevated out-of-pocket costs, and tighter distribution controls
- Medical benefits: Increased co-insurance requirements, expanded step therapy protocols, and reduced plan inclusion
The Inflation Reduction Act: Dividing Industry Opinion
The IRA's impact on drug pricing has created a fascinating divide among industry experts:
- 50% expect higher launch prices as manufacturers front-load costs
- 40% anticipate the intended effect of lower prices
- 10% predict minimal impact
Beyond pricing, the IRA is reshaping investment strategies, with three-quarters of companies reducing investment in therapeutic areas with high Medicare enrollment. The legislation also includes provisions for CMS price negotiations and CPI penalties, fundamentally altering how companies approach pricing strategies.
Biosimilars: Slow Progress, Major Opportunities
The biosimilar market presents a study in contrasts. Originator biologics maintained over 50% market share in 2024—significantly higher than typical small molecule scenarios. Yet the future looks promising, with 88 biologics losing exclusivity in the next five years, representing over $100 billion in potential market value.
Some blockbuster drugs are approaching patent cliffs and are creating substantial biosimilar opportunities, despite ongoing challenges including:
- Pricing pressures and rebating expectations
- Payer access restrictions
- Provider prescribing hesitations
- Patient affordability concerns
Vertical Integration: Tighter Control, Greater Complexity
The consolidation of payers and providers has introduced new layers of complexity. This vertical integration enables:
- Stricter formulary management
- Enhanced step therapy requirements
- Greater adoption of interchangeable biosimilars
- More sophisticated enforcement mechanisms
A staggering 77% of industry stakeholders report tight management of biologics classes, with expectations of further tightening as biosimilar competition increases.
Strategic Evolution: Earlier Planning, Smarter Technology
Companies are adapting by starting market access planning during Phase 2/3 trials rather than waiting for later stages. This earlier approach reflects the recognition that commercial viability must be evaluated sooner in our increasingly restrictive environment.
Perhaps most notably, AI adoption is accelerating dramatically:
- 78% of companies currently use AI
- 99% expect to use AI within 2-3 years
- Primary applications include pricing modeling, content development, and competitive intelligence
"The acceleration of AI adoption in pharmaceutical market access is transformative. At ConnectiveRx, we're leveraging these technologies to enhance program management, prevent fraud, improve operational efficiency, and deliver better outcomes for clients.”
- Chris Dowd, ConnectiveRx, SVP, Market Development
The Path Forward
As the pharmaceutical industry navigates these complex dynamics, success requires a multifaceted approach:
- Early engagement with market access planning
- Strategic use of technology to model complex scenarios
- Flexible pricing strategies that account for policy uncertainties
- Proactive relationship building with evolving provider networks
The current landscape demands that manufacturers move beyond traditional launch strategies to embrace sophisticated, data-driven approaches that anticipate barriers rather than simply react to them. Those who master this evolution will be best positioned to ensure their innovations reach the patients who need them most.