2024 BioPharma Trends (Part 1): The weather, and these topics, are heating up...

As we move deeper into 2024, several key trends are shaping the landscape. At Sigla Sciences, here are our reflections on what to watch as the year continues to unfold:

???? Biosimilar Adoption Acceleration — where do PBMs end up? PBM strategies on biosimilars are evolving and shaking up the market. We’ll see continued biosimilars adoption on formularies through 2024. The focus is now on how these products transition through vertically integrated systems. However, watch for potential regulatory scrutiny as the DOJ probes PBM practices on a national scale.

?? The IRA’s Ongoing Impact — when do we think about Part B??What about Medicare Part B? While the industry continues adjusting to the Inflation Reduction Act with a focus on Medicare Part D into 2026, the implications for Part B by 2028 are looming. This fall's strategic planning should incorporate these timelines, potentially prompting shifts in pipeline strategies sooner rather than later.

?? Big Oncology News from Little Biotechs — are you ASCO ready? With ASCO 2024 just around the corner and the recent release of abstracts, anticipation is building that several smaller biotech firms will unveil groundbreaking results. Get ready for a barrage of exciting data in complex disease areas. Key updates to watch include advancements in Antibody-Drug Conjugates (ADCs), Tumor Infiltrating Lymphocytes (TILs), T Cell Receptors (TCRs), next-generation Selective Estrogen Receptor Degraders (SERDs), and a wealth of emerging biomarkers. Prepare your cheat sheets — this year’s ASCO is set to be an acronym-filled adventure in oncology innovation!

?? Launch Dynamics & Accelerated Approvals — are companies ready? More biotechs are focused on rare and orphan diseases, gaining accelerated approval timelines at the FDA for their therapies even when complex ATMPs / cell & gene therapies. For patients, this is great news. For earlier-stage biotechs taking their first product to market, this is both exhilarating and terrifying; many have just a skeleton crew working on go-to-market and market access in Phase II, although Phase II could be the registrational trial! Plan early, plan often, and engage experts would be our advice. Everyone is launching into an environment of increased payer scrutiny, highly competitive markets, persisting high capital costs, and pressure for even more comprehensive value/HEOR and patient tolerability evidence dossiers. Challenges abound!

?? Obesity, Diabetes, Cardiovascular — where to invest? The GLP-1 class has taken the market by storm. How many chronic disease areas can we connect into obesity and pre-diabetes where they may have clinical benefit? Does the market fully understand the risks? What can we learn from the success stories of patient engagement and digital marketing here? And what does it mean for diabetes and cardiovascular drugs that may see lighter demand down the line? The GLP-1 trend continues to evolve and highlights the complexities of this large market against a backdrop of managing promotions, payer relationships, and patient demand.

?? These insights are just a glimpse into the complexities and opportunities within the biopharma sector this year. Stay tuned as we continue to analyze these trends and provide strategic guidance to navigate this ever-evolving landscape.

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