By Fran DeGrazio, executive editor
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Looking out across the ocean of trends in healthcare needs and advancements, as well as the drivers for them, I see seven strong currents on the near horizon that should draw sustained focus from biopharmaceutical companies and their commercial partners in 2025 and beyond. Each of these key influences on attention and effort will bring challenges, to be sure. Nevertheless, given the goal of reaching patients effectively while achieving market success, the benefits outweigh the risks in every case. For each of the seven waves to ride, I offer here some directional guidance for drug and biological product developers and deliverers:
Wave #1: The Need To Heed Health Policy
Health policy, which encompasses the broad set of decisions, plans, and actions underpinning societal goals for effective and efficient healthcare, will become increasingly important. Central to that increased focus on health policy is the concept of Health Technology Assessment (HTA) — a multidisciplinary approach to evaluating new technologies in terms of clinical effectiveness, safety, and cost. More so than ever before, HTAs will be leveraged to inform or respond to health policy decisions. Biopharma sponsor companies, in particular, will need to apply them to drug and biologics product development, including delivery device and system development, with greater diligence and intention.
Take, for example, cost effectiveness, a key consideration of an HTA. Consider such scenarios as the delivery of a drug product via an on-body device, either by way of adding the device to the drug product or by way of developing the drug and device as a combination product. On the way to commercialization, justifying cost in relation to need and effectiveness will be critical to general acceptance in the marketplace from a health policy perspective.
Even more prone to scrutiny around cost justification are new and emerging ATMPs (advanced therapy medicinal products), which reflect a growing desire for more personalized approaches to treatment. The corresponding growth in the cell and gene therapy market is unmistakable: In 2024 the FDA approved 20 gene therapies. Also on the rise are Instances of CAR-T (Chimeric Antigen Receptor T-Cell) therapies for treating certain cancers and of stem-cell transplantation for treating blood disorders. Across the landscape of ATMP development, a significant and representative example of addressing a wider swath of heretofore unmet needs is the FDA’s approval in 2024 of the first genome-edited, hematopoietic stem cell-based gene therapy for sickle cell anemia patients older than 12.
To make these life-changing and lifesaving technologies more universally available without breaking the bank of cost, so to speak, there will need to be continued innovation, not only from a therapeutic standpoint but also in the consideration of effective and efficient processes, delivery approaches, and supply chains.
Given that biopharma companies may need to address input emerging from HTAs, they should infuse such thinking into their organizations, starting with early stage, cross-functional discussions of potential technologies to be employed in product development and, ultimately, delivery. Thinking about potential HTA-uncovered risk early helps provide sufficient time for identifying — and perhaps avoiding — the need for mitigation.
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Looking out across the ocean of trends in healthcare needs and advancements, as well as the drivers for them, I see seven strong currents on the near horizon that should draw sustained focus from biopharmaceutical companies and their commercial partners in 2025 and beyond. Each of these key influences on attention and effort will bring challenges, to be sure. Nevertheless, given the goal of reaching patients effectively while achieving market success, the benefits outweigh the risks in every case. For each of the seven waves to ride, I offer here some directional guidance for drug and biological product developers and deliverers: