Supporting rare disease market entry: Building a European market access strategy

Working for a  commercial stage biopharmaceutical company  to support the development of its strategy for a rare and complex disease area with limited awareness and highly fragmented care pathways across Europe.

The client needed to:

• Build a clear picture of the patient journey and treatment landscape across key European markets
• Understand diagnostic challenges, referral patterns, and delays to treatment
• Identify drivers and barriers to diagnosis, treatment initiation, and ongoing management
• Inform market entry and commercial strategy in a rare disease context with small patient populations

Given the rarity of the condition and variability between healthcare systems, a multi-market, insight-led approach was critical to inform decision-making.

Bryter designed and delivered a multi country research programme across Europe, combining qualitative depth with strategic analysis to provide a holistic view of the market.

1. Mapping the Patient and Treatment Journey

• Explore the end-to-end journey from early symptoms through diagnosis and ongoing management
• Identify key pain points, delays, and unmet needs at each stage

2. Stakeholder-Centric Insight

• Engage a range of stakeholders, including:
  • Specialist clinicians
  • Multidisciplinary care teams
• Capture perspectives on:
  • Diagnosis and referral patterns
  • Treatment decision-making
  • Perceptions of emerging therapies

3. Cross Market Comparison

• Assess differences across European markets in:
  • Healthcare system structure and access pathways
  • Diagnosis rates and disease awareness
  • Treatment availability and reimbursement considerations

4. Commercial and Strategic Framing

• Synthesise insights into clear implications for market entry strategy
• Identified opportunities to:
  • Improve diagnosis and patient identification
  • Optimise engagement with key stakeholders
  • Tailor market-specific strategies

This approach ensured that insights were not only descriptive, but directly aligned to commercial decision-making.

The programme delivered a comprehensive understanding of the disease and treatment landscape across Europe, enabling the client to refine its launch and growth strategy through:

• Clear mapping of patient journeys and unmet needs
• Identification of key barriers to diagnosis and treatment access
• Insight into cross-market variation, enabling prioritisation and localisation
• Strategic guidance on how to engage clinicians and support earlier diagnosis

The research resulted in: 

 More effective market entry planning across European markets