Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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SEARCH JOBSImmunology is the second largest therapy area by value and forecast to reach $156 billion globally by the end of 2023, at ex-manufacturer prices. Over the past 5 years, immunology enjoyed stellar growth at 15% CAGR, or over 3 times the rate of the overall pharmaceutical market. It has given rise to numerous blockbuster brands which harnessed the potential of multi-indicationality (a ‘pipeline in a product’), most notably AbbVie’s Humira, which generated over $20 billion in annual, global revenue at list price.
However, overall immunology growth is expected to slow down dramatically over the next 5 years to 4-6% CAGR (2022-2027), as the underlying business fundamentals are disrupted while innovators will have to navigate a much harsher competitive environment (see Figure 1).
Within immunology, it is important to note the starkly different growth prospects of the underlying autoimmune vs. inflammation market. Future growth of the larger ($132 billion in 2022), more mature autoimmune market is forecast at ~4% CAGR (2022-2027), while the smaller ($18 billion in 2022), less developed inflammation market is expected to grow at 3-4 times that rate, i.e., 12-15% CAGR, over the same time period.
Autoimmune: From hyper-growth to growth pocketsLong-dominating, first-generation innovation in the autoimmune market is maturing, as major flagship brands are facing LoE. Especially the entry of biosimilars of leading brands Humira, in the U.S., and Stelara will introduce low(er) cost options for two backbone mechanisms of action, anti-TNF and IL-12/23, across major autoimmune indications, including RA, IBD, PsO, PsA. Those biosimilars will exert downward price pressure beyond the originators to erode top-line market growth and will have profound implications for sequencing of therapy options, as payers seek to push biosimilars for first-line use, thus relegating newer, innovative therapies to later lines.
At the same time, all major autoimmune indications face extensive crowding as the next wave of innovation is jostling for position, with intensifying inter- and intra-class competition as therapy options proliferate. For example,
Such abundance of choice gives payers more leverage to extract value, as illustrated, for example, in the widening gross-to-net gap in the U.S. In 2022, average off-invoice concession by manufacturers exceeded 50% in immunology for the first time ever.
Innovators will need to carefully carve out their place in increasingly complex treatment algorithms, with high-stakes head-to-head data becoming critical to demonstrate superiority vs. leading competitors and/or the SoC to convince payers and HCPs, combined with RWE to pin-point patient segments of high unmet need who benefit the most from a given therapy.
Furthermore, the autoimmune market continues to be fiercely competitive, with total promotional investment exceeding $3 billion p.a. globally in each of the past 5 years, while in the U.S. market leading autoimmune brands consistently feature among the top 10 spenders on TV advertising and other direct to consumer (DTC) activities. Consequently, playing in the autoimmune market and rising above that noise level comes at a heavy cost to innovators.
Autoimmune innovators therefore face an unforgiving environment – squeezed between new low-cost options and a crowded innovation frontier. Such opportunity fragmentation also spells the likely end of the possibility of any future $10 billion+ autoimmune mega-blockbuster.
As white space in major autoimmune indications is disappearing, it is not surprising that innovators are increasingly looking elsewhere for new opportunities:
Two key trends are shaping the emerging innovation landscape and future competitive dynamics in immunology:
While more information is needed to understand the wider applicability of such biomarker-based approach, especially its feasibility in routine clinical practice, above examples may signal the arrival of precision medicine in immunology.
These innovation trends are also reflected in recent high-profile immunology deals:
The immunology market of the past is a foreign country, as new business realities take hold. Innovators must therefore move with the times to find success in a dramatically altered, much harsher and unforgiving environment.
Specifically, winning in crowded immunology indications requires:
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