“We don’t need to worry about Market Access, once we find a partner, they’ll take care of it.”
It is one of the most common statements we hear from early and mid-stage biotech companies. And it is one of the costliest misconceptions in the industry.
While it is true that a licensing or pharma partner will eventually own the commercial Market Access execution, early neglect of market access and pricing and reimbursement strategy can seriously undermine your asset’s value, and in some cases, cost you the deal entirely.
Why This Misconception Exists
The logic seems reasonable on the surface. Biotech companies are laser-focused on clinical development, financing rounds, and scientific milestones. Market Access can feel like a “late-stage commercial problem”, the kind of challenge a big pharma partner with a full Market Access team is better equipped to handle.
But this thinking fundamentally misunderstands both the timeline of Market Access and the expectations of potential partners. From our experience, Market Access and reimbursement risk is among the top reasons biotech licensing deals are discounted or abandoned at the due diligence stage.
What Partners Actually Expect
When a pharma or large biotech company evaluates your asset for licensing or acquisition, Market Access readiness is central to how they value the deal.
Sophisticated partners will assess:
- Price potential and reimbursement probability across key markets (US, EU5), including sensitivity to payer archetypes and budget impact
- Strength of your payer value proposition: does the clinical evidence being generated align with what payers need to grant reimbursement at a sustainable price?
- HTA readiness: have you engaged with bodies such as NICE (UK), G-BA (Germany), HAS (France), AIFA (Italy), or AEMPS (Spain) for early scientific advice?
- Competitive positioning from a payer perspective: not just clinical differentiation, but evidence of superiority over existing standard of care
If these questions have not been addressed, a partner is likely either to discount the asset value or walk away. As one JSC client, the CEO of a pre-clinical stage biotech, noted: the Market Access analysis JSC delivered was used directly in investor and partner discussions to demonstrate price and reimbursement potential, forming a credible commercial narrative well before Phase I.
Market Access Is Not a Hand-Off, It Is a Handshake
Even if your end goal is to out-license, there are critical Market Access activities that only you, as the originating biotech, can and must drive during development. These cannot wait for a partner, because by the time a partner arrives, the key decisions have already been baked into your clinical program.
Evidence generation is the clearest and most irreversible example. Payers and HTA bodies require specific types of clinical evidence: active comparators against the standard of care, patient-reported outcomes, health-related quality of life data, and robust long-term follow-up. These cannot be retrofitted after the fact.
The following real-world scenario illustrates what happens when a biotech reaches the partnering stage without having addressed these questions early enough.
📄 Real-World Case Study: The Hidden Price of a Placebo-Controlled Trial
The Asset: A promising new medicine with a novel mechanism of action (MoA) targeting a serious disease with several therapeutic alternatives. KOL support. Strong efficacy signal in early trials.
The Clinical Program Design: A Phase III placebo-controlled trial in a non-orphan indication where multiple generic alternatives already exist and are widely used as standard of care. The comparator chosen: placebo.
What the Payers Saw Market by Market:
- France & Germany (value-based markets): Both HAS (France) and G-BA (Germany) assess added clinical benefit against the appropriate comparator, which is the existing standard of care, not placebo. A placebo-controlled trial, regardless of how impressive the vs-placebo results are, is evaluated as providing no demonstrated added benefit over the actual alternatives available to patients. The consequence: pricing at parity with generics or, in the worst case, at a discount.
- Italy & Spain (budget-sensitive markets): In markets where budget impact drives access decisions, payers must justify spending significantly more on a new therapy when low-cost generic alternatives exist and there is no head-to-head evidence of superiority. The answer is almost always restricted access or price negotiation to generic-equivalent levels.
- UK, Nordics (cost-effectiveness driven markets): NICE/HTA endorsement driven by health economic analysis based on submission of a cost-effectiveness/cost-utility model. Without evidence of superiority over low cost generics, virtually impossible to demonstrate cost-effectiveness at a sustainable price.
The Result: Price potential was severely constrained across all major European markets. Revenue projections had to be revised downward. Negotiations with potential licensing partners became significantly more difficult, with partners either requesting major deal-value concessions or withdrawing from discussions entirely.
⚠️ The comparator decision was made during protocol design years before any partner engagement. By the time anyone raised the payer question, it was too late to change the trial.
This is not an isolated case. The European Medicines Agency’s own guidance emphasizes that HTA bodies increasingly expect clinical trial designs to reflect real-world comparators, a principle reinforced under the EU Joint Clinical Assessment framework that came into effect in 2025. Designing trials for regulatory approval alone, without payer alignment, is a structural risk that biotechs continue to underestimate.
The Hybrid Approach: What Lean Biotechs Should Actually Do
We are not suggesting that every biotech needs to build an in-house Market Access team. A lean, outsourced approach can cover the essential bases at each stage without the overhead of a full commercial function.
At minimum, a biotech aiming to out-license should have the following in place:
Early stage (pre-clinical to Phase I): Directional pricing and reimbursement assessment to understand price potential across geographies; identification of payer-relevant endpoints and appropriate comparators to inform trial design; early engagement with HTA bodies for scientific advice where timelines allow.
Mid-stage (Phase II/III): Formal HTA scientific advice in key markets (EMA, NICE, G-BA, HAS); a payer value proposition that translates clinical data into a compelling reimbursement narrative; analogue research and price benchmarking against comparable approved therapies.
Pre-partnering: A fully documented Market Access package for due diligence; scenario modelling for price and revenue projections across geographies; health economic modelling to support cost-effectiveness arguments where relevant.
These represent the materials a partnering team will request during due diligence, and the absence of any one of them introduces friction and value uncertainty into the negotiation.
The Real Risk: Leaving Value on the Table
The biotech companies that secure the best deal terms are not those with the most promising science alone, they are the ones who can demonstrate that their science will translate into a reimbursed, commercially viable product.
Market Access insight shapes your clinical strategy, investor narrative, target product profile, and negotiating position. Starting late means you have already locked in decisions that may limit your options.
A partner will handle Market Access execution but not Market Access strategy. That starts with you, much earlier than you think.
Bottom Line
If your biotech has not yet engaged with pricing, reimbursement, and payer strategy, now is the right time to start regardless of where you are in the development cycle. The decisions you make today about trial design, comparators, endpoints, and indications will directly determine the commercial value of your asset and the terms you can negotiate with a future partner.
Ready to Understand the Market Access Potential of Your Asset?
Justin Stindt Consultants specializes in Market Access strategy for biotech companies across all stages, from pre-clinical through to launch. Our team provides tailored pricing and reimbursement assessments, HTA engagement support, payer value propositions, and due diligence packages that help biotechs maximize asset value and secure the right partnerships.
Contact our experts at jstindt.com/contact-us for a tailored consultation.
