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Tips for Successful Market Entry for Small and Mid-Size Pharma Companies

By Ryan Witherington and Olga Yaremchuk

In our collective experience working with dozens of clients, we’ve found that smaller pharma companies and biotechs wrestle with many common challenges, regardless of their therapeutic area. From limited budgets to a late start on market access activities, we see the same roadblocks time and again.

Here are four tips for smaller manufacturers on how you might approach the journey to commercialization—and come out ahead, despite the obstacles.

1. Get an early start on commercialization

Small-sized pharma companies do not usually begin market access activities until a few months before FDA approval. As leaders build out their team, immediate needs often take precedence over what seems like the far horizon of market access. As a result, companies are often behind the eight ball for the entire commercialization process.

For smaller companies, it is especially important to start market access planning as early as possible, ideally by phase I or II. While big pharma can sometimes afford to play catch up if they get behind, your company cannot. When your product is in development, you should go ahead and conduct market research to better understand the therapeutic landscape and how your product will be received.

A simulated P&T session can help you understand how your therapy might fare in an actual P&T committee review. By understanding how payers assess and compare clinical data and value propositions for established brands in your space, you can get a head start on developing a strong, persuasive target product profile. For example, your company might realize that there are critical gaps in your existing real-world evidence, which might lead you to expand your data collection in phase III.

When your product is in Phase I or II, consider conducting an analysis of a historical, analogous market access scenario to help you better anticipate the policies payers might apply to your therapy. By choosing a market access analog that is comparable to your drug in at least one arena—such as the disease area, competitive landscape, or market entry timing—you can better predict payer behavior and likely restrictions. Modeling your therapy’s market entry scenario can help you set timing expectations and establish a well-received price point.

2. Prioritize patient identification and HCP targeting

Small biopharma companies are more prevalent in the rare disease space. These manufacturers face their own set of unique challenges, most notably patient identification. If only 10,000 patients across the U.S. are diagnosed with a particular rare disease every year, which geographies and health plans are likely to have the highest concentration of patients?

Real-world datasets, especially claims and lab data, can help manufacturers answer these questions and find the right physicians, specialists, and plans to focus on. Early identification of the HCPs most likely to prescribe your therapy will help you develop effective messaging and target key opinion leaders. Companies with limited means can choose the most useful dataset for them, depending on disease progression and the ideal timeline for their particular therapy. For example, normalized lab data can help you find an addressable future market by identifying target patients on competitor therapies.

Rare disease manufacturers also need to think more about payer coverage than they tend to. Many assume that all rare disease therapies are likely to be covered without restrictions, because the condition is so rare that payers will not need to control access. However, as explained in an earlier post, payers may place restrictions on even the first commercialized treatment for a rare disease indication, often due to a lack of longitudinal patient data.

Being prepared for the payer response to your therapy is essential, as these insights can help you collect the data you need for a convincing case.

3. Hyper-focus your promotional strategy

Smaller pharma and biopharma companies usually lack an extensive sales force. In some cases, they depend entirely on medical science liaisons (MSL) to drive utilization. Generally speaking, their promotional strategy rarely involves casting a wide net to reel in as many HCPs as possible, although this can differ based on the indication and competitive scenario.

Before you go to market, your company should invest in a quick knowledge download like our HCP Targeting Report, which helps you identify where your patients are diagnosed, how they’re covered, and the net-new NPIs who are most likely to prescribe your therapy. Even for smaller pharma companies with limited resources, data like this is easily affordable and immensely useful in planning your physician engagement strategy.

Understanding providers’ testing patterns, prescribing preferences, and the variable criteria for treatment success is also crucial. Using claims and lab data, your company can follow the patient journey to pinpoint where existing therapies have failed—and surface valuable opportunities with a given subpopulation. This is especially useful for manufacturers of second- and third-line therapies.

Once you’re ready to launch, real-time alerts from lab test results can help your MSLs or sales reps promote your therapy to a provider who is in the process of diagnosing and treating a target patient. This information is especially useful for rare disease manufacturers, as you can leverage this clinical trigger to educate a provider about your new treatment before they’ve made a prescribing decision.

4. Invest in a data partnership

At small and mid-market pharma companies, everybody is wearing multiple hats. There might be one market access team member, one data analytics expert, and one branding lead. With so much to be done by so few people, burnout is common. Typically, many of these folks came from much larger and more well-funded pharma companies, which can engender frustration with the continual resource constraints of a smaller company.

When your team members are accustomed to having more resources at their disposal, there can also be internal resistance toward exploring more creative ways of sourcing the information you need.

Most small pharma companies assume that they can’t afford much market access data. At most, they might buy a one-time cut of market access data in a flat file, which becomes immediately outdated as soon as it’s purchased. After using this data for one or two queries, they’re back to the starting block.

While it may seem self-serving, our last piece of advice is to partner with a data vendor. Even with a limited budget, you can still purchase essential data and market insights—not to mention consultative expertise—from a larger vendor. Look for a vendor whose broad portfolio and efficiencies of scale mean they have a more competitive, à la carte pricing strategy.

At MMIT, we specialize in supporting pharma companies of all sizes throughout the commercialization journey, from pre-launch market research to HCP engagement and post-market research. With the right market access strategies in place, your team will be well positioned for your launch and ready to meet your first-year sales goals.

For assistance with strategic planning and forecasting, learn more about our Custom Market Research. Get qualitative feedback on your therapy through a simulated P&T session with our P&T Perspectives, and accurately predict payer uptake with our Strategic Launch Report.

0 Comments Commercial Strategy |
© 2024 MMIT
Ryan Witherington

Ryan Witherington

Ryan Witherington is a solution consultant at MMIT.

Olga Yaremchuk

Olga Yaremchuk is a senior solutions consultant at MMIT.

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