Biotech Market Entry

When biotech companies approach the final stages of clinical development, they face a range of strategic options regarding product commercialization.

While all biotech executives have an intuitive strategic bias on how to go to market, it is important to run an objective assessment from a financial, strategic and operational perspective. This will drive internal alignment and lay the foundation for successful execution.

Regardless of the final strategic decision, it pays off to understand the commercialization requirements in a given territory. This is certainly needed in a “go-direct” scenario to properly size the organization and plan investments. But also in a “licensing” strategy, knowing what it takes to commercialize provides significant leverage in BD discussions.

More and more companies look for alternatives to the traditional “go direct vs. licensing” trade-off. This is especially true for ex-US market strategies. We encourage companies to evaluate innovative hybrid models against their specific corporate priorities and needs.

Successful biotech organizations understand that there are significant opportunities even outside the US and major EU markets. “ROW” markets such as Israel, Saudi Arabia, and others can represent early revenue opportunities leveraging US approval and pricing.

Projects in This Space

For the past 15 years we have worked with emerging biotechs in the US and Europe on their market entry strategy. Our biotech clients span a broad range of disease areas with a particular focus on rare disease and specialty care indications. We support our clients across the full market entry planning process.

01. Market Assessment

  • Clinical landscape
  • Pricing and access strategy
  • Market prioritization
  • Launch sequence
  • Revenue forecasting

02. Commercialization Strategy

  • Assessment of different options (go-direct vs. licensing vs. hybrid models)
  • Organization design
  • Launch budget creation
  • Financial valuation

03. Operational Planning and Execution

  • Tactical launch planning
  • Operational support on topics such as supply chain planning, HTA dossier development, early access strategy, etc.

Case Studies

Ex-US Commercialization Strategy in Oncology+

A US biotech developing a breast cancer product required support to define and execute its ex-US commercialization strategy. The company sought an innovative way to go-direct while minimizing risk and simultaneously optimizing flexibility and profitability.

Bionest identified gaps in the client’s EU opportunity assessment and conducted the necessary research to refine revenue expectations. We then worked with the client to build a detailed deployment strategy. In order to meet the client’s strategic priorities, we leveraged a highly outsourced / virtual structure – i.e., without making actual hires in Europe. Bionest defined the optimal organization infrastructure and key launch activities (including supply chain set-up), which fed into a detailed launch budget.

This project culminated in an optimal, yet realistic, tactical plan for EU commercialization. Bionest continued to provide operational support on defined workstreams to ensure launch excellence.

Ex-US Go-to-Market Strategy for a Gene Therapy Company +

Bionest recently worked with a US biotech developing a gene therapy. The company wanted to understand how to approach ex-US markets.

We conducted a thorough market assessment of Europe and Japan with a major focus on pricing and access. The resulting revenue forecast laid the foundation for an evaluation of go-direct vs. licensing strategies. We defined the required organizational set-up for going direct in each market and compared this vs. deal term scenarios.

Together with our client we presented the findings to the BoD. The company decided for a go-direct strategy in Europe and a licensing approach in Japan. Bionest subsequently continued working with the client on developing detailed operational plans for the European launch.

Launch Readiness Strategy for an Innovative Biotech+

Bionest worked with a US biotech that was pursuing a dual licensing and go-direct strategy in Europe. The company wanted to make sure that if they didn’t receive a favorable licensing offer, they would be ready to launch on their own.

Bionest provided a team of former EU biotech executives that led the launch preparations for the client and coordinated a variety of external parties across key functions such as regulatory, market access, supply chain, medical and commercial.

Bionest’s coordination of launch efforts created significant bandwidth for the US team and provided much needed EU-specific expertise to a US-focused organization.