Emerging Biopharma Launches: Strategizing in Today’s Global Market
A look at the current landscape and how young companies can set the stage for product launch.
When it comes to emerging biotechnology or biopharmaceutical organizations, the typical product launch strategies for novel and promising medicines won’t necessarily work. New technologies come with new challenges, and companies working in this space need to be aware of these challenges ahead of time. This is especially true for those smaller entities hoping to expand to a global launch for their product.
John Arena is interim president of global pharma services at Cencora, managing a team that offers a broad range of solutions to biopharma companies of all sizes—from startups to large pharma—to support market-entry success and patient access worldwide.
Historically, emerging biopharma companies would be looking to get acquired by a larger company, who would then handle the commercialization of their product. In fact, back in 2001, emerging biopharma companies were responsible for only 34% of the molecules in the R&D pipeline1 without a larger firm involved. However, recent trends show that more emerging biopharma companies are bringing their products to market directly.
“We track the trends in the market, one of which is biopharma funding,” Arena tells Pharm Exec. “Post-COVID, there was a decline in biopharma funding, but that has not only stabilized, we’re also seeing funding in this area pick up and definitely return to growth.”
Emerging biopharma companies appear to be responsible for driving the growth, as they account for 70% of the clinical-stage industry pipeline,2 while 60% of their assets are unpartnered, according to recent research. But these organizations also face unique challenges in moving their products from drug discovery and development through to commercialization.
“Oftentimes, these companies have more limited resources and less organizational experience managing the commercialization of a product, but we’ve seen that, when flanked by the right partner, they can go to market on their own,” says Arena. “They’ve got to be very intentional in how they manage their resourcing to do that.”
Arena pointed to the cell and gene therapy (CGT) space as an example of the growing biopharma market, citing the record-breaking nine CGTs approved by the FDA in 2024, including Mesoblast’s Ryoncil. Cencora, a partner, is providing integrated support3–including cryogenic storage and transportation and patient services–to aid in the commercial launch of Ryoncil in the US.
“It’s such an exciting area of science, and it really speaks to true innovation, which is just great for patients worldwide,” says Arena. “We believe that the next five years has significant promise for growth in that overall market—as evidenced by the nearly 2,000 CGT trials underway globally and the increasing number of regulatory approvals. We continue to invest in solutions that enable us to deliver enhanced support across the product lifecycle to help developers navigate the unique challenges, including those related to patient access, logistics, and market access.”
One of the biggest issues that emerging companies are facing when it comes to strategizing is the ever-evolving regulatory landscape globally, including policy and legislative uncertainty in the US. Meanwhile, in Europe, life sciences organizations are adapting to the EU’s new Health Technology Assessment regulation, including the Joint Clinical Assessment process.
“This question comes up all the time,” says Arena when asked about the regulatory landscape, “and the complexities of bringing these drugs to market continue to mount. Early-stage planning and cross-functional collaboration is paramount to effectively navigate and stay ahead of the constantly changing regulatory requirements.”
Of course, the regulatory climate in the US isn’t the only thing companies need to consider. For emerging biotechs preparing to launch their first or second product, developing a global launch sequencing strategy early in the process is essential—as is understanding the varying regulatory processes and requirements across global markets.
“One common misperception is that you can leverage the same go-to-market strategy used for the US to support your European launches,” notes Arena. “That’s just not the case. The regulatory standards are different, down even to the country level. You really need a go-to-market strategy that’s tailored to each country’s requirements. Companies need to understand compliance, supply chain, and regulatory and quality standards, as well as the factors that influence pricing, market access, and reimbursement in each market. You must deploy a level of local market expertise to tailor your strategy and investment to make sure you’re set up for commercial success.”
Despite the changing political landscape, the US still has many advantages for emerging biotech. It remains many companies’ top choice for their initial launches, and their launch strategies are generally still tailored for a US entrance. In fact, 34 of the 50 novel drugs approved by the FDA in 2024 were cleared in the US before any other country.4
“Bringing a product from clinical through commercialization stages while considering global market expansion is an inherently complex process. The earlier a company can start planning–with an eye toward future markets–the greater likelihood of market expansion success,” Arena tells Pharm Exec. “Companies need to understand the interdependencies throughout the planning process–including coordination-related commercialization planning, regulatory filing, and market access—as any missteps along the way can delay product launch and impact success. Our goal is to simplify the process and provide our partners with the support they need to accelerate speed-to-market.”
References
1. Emerging Biopharma’s Contribution to Innovation. IQVIA. June 13, 2022. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/emerging-biopharma-contribution-to-innovation
2. Biopharma M&A: Outlook for 2025. IQVIA blog. January 27, 2025. https://www.iqvia.com/locations/emea/blogs/2025/01/biopharma-m-and-a-outlook-for-2025
3. Ryoncil Commercial Launch Update and Product Pipeline. Mesoblast press release. January 30, 2025. https://investorsmedia.mesoblast.com/static-files/f5e08d4a-20c0-4b7b-a71f-20822e1903cc
4. New Drug Therapy Approvals 2024. FDA. https://www.fda.gov/media/184967/download?attachmen4t4
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