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Blog
Preparing to Launch on Your Own? Consider These Success Factors
Todd Matthews, Senior Director, Corporate Alliances, IQVIA
Mar 15, 2022

Earlier this year, I moderated the workshop, The Decision to Launch on Your Own: Critical Success Factors, as part of Biotech Showcase™. Joining me for the discussion was my IQVIA colleague, Susan Kitlas, as well as Christoph Broja from Gurnet Point Capital and Francesco Lavino from F2G.

We geared our discussion for emerging biopharmaceutical (EBPs) companies with under $200 million in annual R&D spend or less than $500 million in commercial revenue. While some of these companies opt to sell or license their products, our panel focused on those who choose to raise money and build a commercial workforce on their own. This “DIY” group of EBPs represented 40% of all therapies taken to market in 2020.

Panelists emphasized the importance of making the right decision about whether to launch alone. They noted that a therapy with highly targeted provider and patient segments may be a better candidate than a drug that will require engaging with vast swaths of primary care physicians. In the latter case, execution risk can be higher – making it wise to engage a partner rather than fly solo.

Nearly 60% of products fall short of their first-year forecasts, and only 20% of those products recover. What can EBPs do to increase the odds of success? Here are highlights of insights the panelists shared.

Consider the geographical nuances

The go/no-go decision doesn’t have to be monolithic. Different markets around the world may warrant different approaches. For example, an EBP may be positioned to launch alone in the United States but need to work with a third party in European markets due to regulatory environments and/or local languages.

Study the market landscape

How many patients have been diagnosed with the relevant disease or condition? How many are currently being treated? What does the current treatment landscape look like – and how will products in development shape the future landscape? Use those answers to identify unmet needs based on current and/or future products. Then articulate the differentiating benefits of your product. Make sure you develop the right evidence to support those benefits – and can communicate it to all key stakeholders.

Identify patient journeys

In addition to that macro market view, dive into individual patient journeys. Understanding how people are diagnosed and treated is just as important for a commercial model as it is for clinical trial design. The commercialization strategy needs to align to those journeys – being clear about where and when the new treatment fits into the standard of care.

Forecasting? Start at the bottom

Consider the diverse and powerful market dynamics that will influence the success of your product. That includes factors like true demand, market access, payer behavior, and gross-to-net impacts. Understanding those forces is essential to creating a bottoms-up forecast — a highly detailed, payer-by-payer forecast for how you expect your product to perform. This granular approach makes it easier to tackle specific challenges, as well as to adjust as market dynamics shift leading up to your launch.

Put thought leaders under the microscope

18 to 24 months before launch, engage thought leaders as well as any of relevant patient advocacy groups. With thought leaders, think beyond the national names. Local thought leaders are just as critical to inform and engage, as they have significant influence on their local peers and regional payers. They can also make an impact on social media. Getting a locally respected thought leader to adopt the product can lead to as much as a 25% bump in their local area.

Address the shift from R&D to commercial

As you craft your commercial strategy and plan your product launch, stay mindful of the cultural changes this process entails. After all, in most EBPs, teams have devoted years to R&D. Making the pivot to commercialization introduces significant changes. It’s important to establish clear commercial definitions and to communicate frequently as the launch plan takes shape.

Above all, start early!

No matter how you launch – but especially if you’re going to market alone – it’s rarely too early to start planning. The sooner and more thoroughly you prepare, the greater the likelihood of early and continued success.

These are just the highlights of the conversation. If you would like to hear the full discussion, watch the replay. For more information about IQVIA solutions for emerging biopharma companies, visit our website.

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