Andre Moa
13 Feb 2020
3 minute read
One notable characteristic of the launch readiness landscape as we settle into 2020 is the lower volume of innovative drugs entering the marketplace. The record number of approvals granted in 2018 by the two most influential agencies, the US Food and Drug Administration and the European Medicines Agency, did not hold up in 2019.
Year-to-year comparisons can be spurious. New drug approvals from one year to the next are subject to numerous variables. These include internal pressures and resources, the quality and timing of submissions, spill-overs from the previous year, manufacturing or data complications at applicant companies, and one-off upheavals such as the EMA’s transfer from London to Amsterdam.
Nonetheless, the figures do tell a story. The FDA approved 48 new medicines and therapeutic biologics, as well as 21 new biological agents, last year, compared with 59 and 39 respectively in 2018. The EMA’s Committee for Medicinal Products for Human Use issued positive opinions on 41 new medicines, therapeutic biologics and vaccines during 2019, versus a total of 53 in the previous year.
What does this tell us about launch prospects and pharma trends for 2020? For one thing, we should not assume the innovation well is drying up. Rather, the 2019 approvals illustrate the continuing richness of pharmaceutical industry R&D pipelines, their capacity to deliver groundbreaking scientific advances such as gene therapies, and the strong emphasis on specialty, orphan and targeted medicines that continues to unlock unmet needs in key areas such as oncology.
Moreover, the launch management environment has changed irrevocably, with a shift from broad-spectrum, high volume blockbusters to products that start small, then keep building momentum through successive new, precisely segmented indications. This iterative process is what the IQVIA Institute for Data Science, in its Launch Excellence VI white paper, calls “the long launch”.
The transition from volume to value in drug development, and the opportunities opened up by digital transformation, evidence a healthcare environment under constant pressure. Value-based care is now the rallying cry for cost-efficiency, sustainability and better patient outcomes. With many new product launches premium-priced for narrow patient populations, value is also the framework for thorny debates around pharma market access and affordability.
In our Ultimate Guide to Launch Readiness in 2020, we take a detailed look at what this environment means for smart launch strategists and market access in pharma. We consider the resources companies need to optimise in-market potential, and how cutting-edge launch software can help them track and manage global launch challenges in real time, across national and functional boundaries.
Read our updated guide to understand what is happening on the ever more slippery path to a pharmaceutical launch. Then learn how our launch tools can help you not just stay upright but hit the market running.
TRiBECA® Knowledge is a market leader in smart business tools that help pharmaceutical, biotech and medical device companies successfully launch and commercialise products. Our tools enhance visibility and transparency, streamline processes and drive communication and collaboration across brands, management layers, business functions and countries worldwide.