When I first worked with a small biotech team preparing to launch its first therapy, the energy in the room was electric. The science was extraordinary, the leadership hungry, and the investors impatient. Yet, amid the whiteboard diagrams of trial designs and regulatory milestones, one crucial question sat unanswered: “How will we get this reimbursed?”
It was not neglect; it was inexperience. Early-stage biotech companies often delay market access until later, after approval, licensing, or funding. It is often mistakenly believed that science leads, and economics comes after. The reality is often harsher. In a world with budget constraints, evidence expectations, and competing priorities, the value narrative determines commercial success long before the first patient receives treatment.
The Early Mistake Most Biotechs Make
Small biotechs face a paradox. They are built on innovation, but implementation often causes them to stumble. With lean teams and limited capital, they prioritise clinical milestones because investors and boards demand visible progress. But payers and health technology assessment (HTA) bodies judge success differently. They ask whether the therapy changes the treatment paradigm, how outcomes compare to existing standards, and whether those outcomes justify the cost.
If that story is not built early, it is nearly impossible to retrofit later. I once saw a biotech complete an elegant Phase II programme with endpoints so novel that no HTA body could translate them into cost-effectiveness terms. They spent the next two years redesigning studies and delaying launch while competitors with more conventional endpoints raced ahead.
Building Access In From the Start
For small biotechs, market access should not be a department; it should be a mindset. The moment you draft your clinical development plan; you are also drafting your future reimbursement dossier. Aligning endpoints with payer expectations, selecting relevant comparators, and gathering real-world data are not extras. They are foundations.
This does not mean hiring a large access team or building a global infrastructure overnight. It means embedding access intelligence into development decisions. Engage payers, patient groups, and clinicians early. Ask what evidence they would need to support reimbursement. Design studies that speak to both regulators and payers. Use modelling to understand what price points could be justified by health outcomes.
When resources are limited, prioritisation matters. A small biotech cannot fight every battle in every market. Identify the first two or three regions that combine regulatory feasibility, pricing potential, and patient access opportunity. Build your launch sequence around these. The rest can follow once data and experience mature.
The Hidden Advantage of Being Small
Ironically, small size can be an advantage. Large pharma companies struggle to move quickly across silos, while biotechs can align science, access, and communication in real time. Decision-making cycles are shorter, risk appetite higher, and storytelling more authentic. Patients, advocacy groups, and even regulators often respond positively to the agility and mission-driven nature of biotechs.
To harness that, leaders must create cross-functional literacy. Scientists need to understand why cost-effectiveness matters. Access specialists must appreciate the nuances of early research. Communication teams must translate data into value stories that resonate with diverse audiences. When everyone understands that market access is the final proof of innovation, the organisation becomes coherent and credible.
Learning From Recent Examples
The lessons of recent years are instructive. Biotechs that incorporated an access strategy early have seen smoother launches and stronger valuations. Those who did not have found themselves forced into desperate partnerships or aggressive price cuts. The rise of patient-centred evidence, adaptive reimbursement models, and outcomes-based contracts is shifting power toward those who can tell a clear, data-driven story of value.
Even major players are adapting. The expansion of access leadership roles — such as Chief Market Access Officers — shows how central this function has become. For smaller firms, the principle is the same: make access a strategic partner, not an afterthought.
The Bottom Line
Science may open the door, but market access determines whether it stays open. For small biotechs, that truth is not a limitation; it is liberation. Once you accept that your product’s value must be proven in economic, clinical, and human terms, you can design your development programme to succeed on all three fronts.
A molecule becomes a medicine only when someone pays for it, and someone receives it. That bridge is built long before the launch.
Key Takeaways
- Market access is not a post-approval activity; it starts at the first design meeting.
- Small biotechs must align clinical evidence with payer expectations early.
- Focus limited resources on priority markets with clear access potential.
- Build internal literacy so science, evidence, and communication align.
- The ability to tell a coherent value story is as critical as the data itself.
Try This
Map your current development programme against payer expectations. For each endpoint, ask: “Would this convince a reimbursement body that our therapy delivers value?” If not, identify one modification or supplementary study that could close that gap. Start there.
Closing Thought
If you are advising or leading a biotech, share this article with your leadership team. Access is not bureaucracy; it is strategy. Those who understand that early will be the ones who turn science into sustainable impact.
