Market Access Is the New Commercial Strategy: Why EU/UK Biotech Leaders Need HTA Fluency to Unlock Adoption, Not Just Sales Capability

In 2025, the traditional playbook for biotech commercialisation in Europe is being rewritten. The era of sales-led growth - built on field force expansion, key opinion leader engagement, and promotional spend  -  is giving way to an access-led model. In markets like the UK, France, and Germany, where health technology assessment (HTA) agencies such as NICE, HAS, and IQWiG effectively decide what gets used and funded, market access fluency has become the defining commercial skill.

For biotech leaders, success is no longer about how well a product can be sold, but how convincingly its value can be demonstrated. The gatekeepers of adoption have changed, and with them, the very nature of commercial strategy.

 

From Selling to Securing Access

In the past, biotech companies entering Europe often borrowed strategies from traditional pharma: build a strong sales team, engage clinicians, and grow market share through visibility and relationships. While this approach worked when prescribing power sat primarily with physicians, the modern European market operates under very different dynamics.

Today, even a therapy with exceptional clinical promise can fail to reach patients if it cannot pass the scrutiny of HTA bodies. Agencies such as NICE in the UK, HAS in France, and IQWiG in Germany do not evaluate products on marketing strength  -  they assess them on cost-effectiveness, real-world outcomes, and budget impact.

That means commercial success now depends less on persuasion and more on evidence. It demands early, strategic engagement with payers and regulators, a deep understanding of HTA methodologies, and the ability to articulate product value in health-economic terms that align with national priorities.

Sales capability still matters, but it has become a downstream function. The real commercial battle is fought - and often won  -  at the reimbursement stage.

 

The Rise of the Access-Led Commercial Model

Access-led growth redefines what it means to “go to market.” Rather than focusing solely on promotional reach, biotech companies must build cross-functional strategies that integrate regulatory affairs, health economics, medical affairs, and commercial operations.

This approach starts long before launch. Market access teams are now involved at the earliest stages of clinical development, shaping trial endpoints to align with HTA expectations and national value frameworks. For example, a pivotal Phase III study designed purely for regulatory approval may not satisfy the evidence requirements for NICE or HAS reimbursement. Including real-world comparators, patient-reported outcomes, or health economic endpoints early can make the difference between conditional access and outright rejection.

An access-led model also requires sophisticated stakeholder engagement. Payers, policymakers, and HTA assessors must be treated as strategic partners rather than post-launch obstacles. The ability to anticipate their needs, align data strategies, and communicate value narratives that go beyond efficacy is now a core leadership skill in European biotech.

 

Why HTA Fluency Is the New Commercial Language

Health technology assessment used to be the domain of specialists  -  a technical function tucked within market access or health economics teams. In 2025, that separation no longer works. For biotech leaders, fluency in HTA principles has become essential to commercial leadership.

HTA fluency means more than understanding the mechanics of cost-effectiveness modelling. It requires the ability to interpret how national agencies define “value”  -  and how those definitions differ between markets. For instance:

• NICE (UK) emphasises cost per QALY (quality-adjusted life year) and uses stringent thresholds that can make innovative but expensive therapies difficult to justify without clear long-term savings or quality-of-life improvements.
• HAS (France) evaluates added clinical benefit (ASMR rating) alongside economic impact, influencing not only reimbursement but pricing negotiations.
• IQWiG (Germany) focuses on comparative effectiveness, requiring robust head-to-head evidence against standard of care.

Understanding these nuances allows biotech leaders to tailor development, data collection, and communication strategies for each market. It transforms HTA engagement from a reactive process into a proactive competitive advantage.

 

Early Access, Evidence, and Economics

The European regulatory ecosystem is increasingly flexible -  conditional approvals, early access schemes, and adaptive pathways are becoming more common. But flexibility does not guarantee access.

Biotech firms often secure EMA approval with limited datasets, only to face resistance from HTA bodies demanding additional evidence. The result is a familiar bottleneck: approved therapies that cannot be reimbursed and therefore cannot reach patients.

Companies that anticipate this gap by building health-economic evidence early can shorten time to market access dramatically. Integrating real-world data, health outcomes modelling, and patient advocacy input from the start ensures that value arguments are not retrofitted post-approval.

This early investment pays off in both speed and sustainability. Therapies that enter markets with well-structured HTA dossiers and clear payer narratives tend to achieve faster reimbursement, fewer pricing delays, and more durable access positions.

 

Redefining Commercial Leadership

The shift from sales-led to access-led growth requires a new kind of leadership. Commercial success now demands cross-disciplinary literacy - the ability to navigate science, regulation, economics, and policy simultaneously.

Modern biotech leaders must:

• Think beyond the sale. The real customer is not just the prescriber, but the payer, policymaker, and health system stakeholder who determines adoption.
• Speak the language of value. Leaders need to articulate therapeutic benefit in economic and societal terms, not just clinical ones.
• Integrate functions. Market access, medical, regulatory, and commercial teams must operate as one unit, aligned by shared goals and unified data strategy.
• Champion evidence. Decision-making must be driven by real-world outcomes and cost-effectiveness insights, not traditional brand metrics.

This evolution demands a shift in recruitment priorities as well. European biotech firms are increasingly seeking commercial leaders with backgrounds in health economics, policy engagement, or regulatory strategy - professionals who can bridge science and system.

 

The New Commercial Toolkit

To thrive in this environment, companies are retooling their commercial operations around three core capabilities:

1. Evidence generation as a commercial function. Data generation is no longer a purely scientific exercise; it is a strategic commercial investment. Companies that can produce compelling health economic and real-world evidence are best positioned to negotiate with HTA bodies.
2. Policy intelligence. Continuous monitoring of HTA guidelines, reimbursement criteria, and evolving payer expectations allows firms to anticipate shifts rather than react to them.
3. Collaborative access strategy. Engaging patient groups, clinicians, and policymakers early builds legitimacy and shapes evidence narratives that resonate across stakeholders.

By embedding these capabilities, biotech firms can move from being price-takers to value-setters in highly scrutinised reimbursement environments.

 

From Sales Growth to Access Leadership

The distinction between selling and securing access may seem subtle, but in practice it redefines the entire trajectory of a biotech’s success. A product that cannot secure HTA approval remains commercially invisible, no matter how strong its science or sales effort. Conversely, a product that demonstrates meaningful, cost-effective outcomes can achieve rapid uptake and sustained market presence, even in resource-constrained systems.

Access is now strategy. And those who master it will shape not only the fortunes of their companies but the future of healthcare delivery across Europe.

 

Conclusion

For EU and UK biotech leaders, fluency in health technology assessment is no longer optional - it is essential. As reimbursement gatekeepers like NICE, HAS, and IQWiG set the terms of market entry, commercial success depends on understanding their frameworks and aligning innovation with system value.

In 2025 and beyond, the winning biotech firms will not be those that outspend competitors on sales, but those that outthink them on access. Because in today’s Europe, the path to commercial success runs not through the sales force, but through the health system itself.