Biopharma companies need more than just strong clinical data to succeed; they need a well-planned biopharma market access strategy. With pricing pressures, evolving payer expectations, and global regulatory hurdles, market access has become one of the most critical elements of a successful product launch.
Unfortunately, many companies delay access planning until late-stage development. By then, it’s often too late to align your product’s value story with what payers need to see.
So, what does a strong biopharma market access strategy look like? And when should you start building it?
Step 1: Begin Early- Preclinical to Phase 1
The foundation of a successful biopharma market access strategy starts early in development. You may not have robust clinical data yet, but now is the time to align your product profile with what future stakeholders will care about.
Key Actions:
- Conduct current and what future landscape assessments might be to identify access barriers, competitor strategies, and payer requirements.
- Begin outlining a target product profile (TPP) that integrates access-related considerations like route of administration, distribution channels, quality of life improvements, or caregiver burden.
- Explore pricing analogs to understand early expectations for market positioning.
An early access mindset informs smarter clinical and commercial decisions.
Step 2: Generate Evidence- Phase 2
During Phase 2, you can start generating the data needed to support a credible and differentiated value story.
Key Actions:
- Refine your value proposition using early clinical and market insights.
- Define your HEOR (health economics and outcomes research) plan to support future payer engagement.
- Convene payer advisory boards and include provider/patient insights where possible.
- Identify any real-world evidence gaps that should be addressed before launch.
Step 3: Operationalize- Phase 3 to Pre-Launch
With pivotal data in hand, your biopharma market access strategy should evolve from planning to execution.
Key Actions:
- Build essential access tools: Global Value Dossier (GVD), budget impact model, and cost-effectiveness models.
- Finalize global pricing strategy and country-specific HTA submission timelines.
- Develop a clear payer engagement / Value Proposition plan and integrate access with your broader launch strategy.
This is when market access becomes the bridge between clinical promise and commercial reality.
Step 4: Execute and Adapt- Launch and Beyond
Market access is never one-and-done. After launching, your strategy should evolve alongside new data, changing market conditions, and competitor activity.
Key Actions:
- Track formulary decisions and real-world adoption.
- Update your value story as new evidence becomes available (e.g., post-marketing studies, label expansions).
- Continue proactive stakeholder engagement to support access and maintain formulary positioning.
- Respond quickly to policy changes, biosimilar competition, or updated payer criteria.
Ready for a conversation about market access strategy?
Danforth Advisors now offers dedicated Market Access & Value support as part of our strategic advisory services for life science companies.
Having partnered with 1,500+ life science firms, our team brings decades of experience guiding biopharma companies through every phase of the access journey, from early planning and payer insights to evidence generation, HTA submissions, and launch support. Connect with our team today.