The primary goal of market access in the biotechnology sector is to ensure the availability of high-quality, therapeutically valuable biotechnology products for patients in need. In this sense, the priority for biotech companies is to plan and execute critical market access activities for successful launch. Navigating the complex landscape of healthcare systems, payer policies and regulatory frameworks is critical to ensuring optimal market access and coverage for biotechnology products. Our agency, Justin Stindt Consultants, specializes in market access in the European and US markets and has helped numerous biotech clients navigate the various activities associated with successful market access.
Market Access for Biotech companies is an essential task from the early stages onwards
Effective market access and pricing assumptions are critical for biotech companies and their investors and partners, having a profound impact on valuations and business development outcomes. This is critical, as biotech companies need big investments pre-revenue with high risks and for this require regular financing rounds or a partner and out-licensing to survive. In order to be successful, companies must develop robust strategies that are aligned with the pricing and reimbursement preferences of US and EU payers in order to achieve a high valuation outcome.
This is why, from discovery to post-approval, biotechs need a tailored Market Access strategy to convince potential investors and partners that the biotech product will not only deliver clinical success but also a robust Payer Value Proposition that will enable reimbursement at a sustainable price.
In the early stages, a focus on high unmet needs, product concepts which are likely to meet acceptance by payers and HTA bodies, and accurate commercial projections are essential. Proof of Concept requires not only clinical trial success but also engagement in health technology assessment scientific advice, identification of payer-relevant endpoints, and formulation of early pricing and market access strategies. Phase III requires finalizing pricing, implementing launch strategies, and engaging in stakeholder management.
Post-approval emphasizes lifecycle profitability in pricing, real-world evidence generation, and strategic lifecycle management, including new indications and competitive positioning. Successfully navigating this complex pathway is critical to sustained market success in the biotech landscape. Even if many biotech companies plan to ultimately outlicense their products or partner with an experienced pharma partner, there are time critical Market Access activities which need to be driven by the biotech company in order to enable the optimal route to Market Access and increase the chances of finding a licensing or pharma partner.
Not all biotechs are the same so a bespoke approach to Market Access is required for each company
While there are some commonalities for biotech companies, it is important to recognize the specificities of the product each biotech company is developing. Biotech manufacturers developing orphan drugs will face different challenges than companies targeting diseases with high incidence and prevalence. ATMPs and cell and gene therapies come with their own set of challenges and often require solutions to move beyond traditional payer paradigms, e.g. a single administration cell and gene therapy with curative potential may represent a significant upfront acquisition cost for payers but deliver lifelong savings compared to chronic therapy. In this context innovative access and contracting solutions can sometimes address these challenges but their design and implementation is a key challenge in itself. Depending on the target indication and market environment, some biotech companies plan to commercialize their developments by themselves, especially in niche indications with a high unmet medical need which may not require a large commercial organization. Other biotech companies may seek to outlicense or partner but even these companies need to run a hybrid approach to progress critical activities until a partner will take over. Market Access activities are critical but a number of them can be outsourced by biotech companies to capable agencies with hands-on experience in supporting lean biotech organizations.
Justin Stindt Consultants is the right agency to support your biotech company with Market Access
Recognizing the critical importance of market access and pricing strategies, Justin Stindt Consultants (JSC) is recognized by biotech companies in all stages of development as consulting firm with professionals having extensive experience in biotech Market Access.
Recognized for its flagship expertise in many domains such as pricing and reimbursement strategies, pricing & reimbursement dossiers, and payer advisory boards, our firm has successfully worked with a diverse group of biotech clients. Operating in major markets including the US and Europe, we provide comprehensive support at every stage of the biotech journey.
Our services include pricing and market access strategies, scientific advice meetings, mock negotiation workshops, and the development of ambitious product concepts. We specialize in indication prioritization and sequencing, providing insight into pricing and reimbursement potential, willingness-to-pay triggers, and market analysis.
We also provide market access training, project management support for local market access deliverables, and evidence generation for successful reimbursement and optimal ROI.
Contact our experts today to customize our services to meet your unique needs and support your biotech endeavors with effective market access strategies.
Some of our Biotech customers
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