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Market Outlook: Key Drivers, Patent Losses, and Growth Trends
Chapter of the 2025 Global Biosimilars Report
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Increasing research and development (R&D) investments, supportive regulations, strategic partnerships, and upcoming patent expirations for blockbuster biologics are expected to drive significant growth in the biosimilar market, expected to reach $77 billion by 2029 with a compound annual growth rate of 20%. Patent expirations for numerous blockbuster biologics, however, will act as the underlying driver for this expected biosimilar market growth.
This progression of exclusivity losses will lead to an increase in biosimilar approvals and launches across the United States (US) and the European Union (EU). Patent expirations not only influence whether a biosimilar can launch but also how closely the biosimilar manufacturing process can mirror that of the originator. Notably, 15 of the top marketed biologics without approved biosimilars, accounting for about $150 billion in global sales in 2024, are set to lose patent protection by 2033, creating a sizeable market opportunity for biosimilars. These patent expirations will vary in their impact on market growth over the near term, mid-term, and long-term. While patent expirations will certainly drive biosimilar market growth, there will be a slight interval between patent expiration, biosimilar launch, and maximal impact on biosimilar market size. As such, the molecules with the largest originator sales and patent expirations in the near and mid-term are expected to carry the biggest weight in our 2028 biosimilar market size projection. |
Sources: IQVIA; Alira Health analysis. |
This progression of exclusivity losses will lead to an increase in biosimilar approvals and launches across the United States (US) and the European Union (EU). Patent expirations not only influence whether a biosimilar can launch but also how closely the biosimilar manufacturing process can mirror that of the originator. Notably, 15 of the top marketed biologics without approved biosimilars, accounting for about $150 billion in global sales in 2024, are set to lose patent protection by 2033, creating a sizeable market opportunity for biosimilars.
These patent expirations will vary in their impact on market growth over the near term, mid-term, and long-term. While patent expirations will certainly drive biosimilar market growth, there will be a slight interval between patent expiration, biosimilar launch, and maximal impact on biosimilar market size. As such, the molecules with the largest originator sales and patent expirations in the near and mid-term are expected to carry the biggest weight in our 2028 biosimilar market size projection. 
Sources: IQVIA; Alira Health analysis.
In the next three years, two major biologics, Johnson & Johnson ’s Stelara (ustekinumab) and Amgen’s Prolia/Xgeva (denosumab), will see increasing biosimilar competition in the US and the EU markets. Together, they represent a market opportunity of $17 billion based on their 2023 global sales. Stelara is an immunosuppressive drug and has long been a key revenue driver for Johnson & Johnson, totaling just under $11 billion in global sales in 2023. Amgen’s Prolia and Xgeva are different brand names for the same antibody, denosumab. Prolia is approved to treat osteoporosis, while Xgeva is approved for treating bone cancer. In 2023, these two drugs brought over $6 billion in global sales.
In the mid-term, BMS’s Opdivo (nivolumab) and the BMS/Pfizer Eliquis (apixaban) will lose exclusivity, opening another $21 billion slice of the 2023 biologics market to biosimilar competition. Opdivo is an immunotherapy used in oncology and brought in $9 billion in global sales in 2023.
Eliquis, an anticoagulation medicine, yielded $12 billion in global sales in 2023. Patent expiration of these five drugs carry a significant impact for our forecast period through 2028.
Sources: Global Data; Alira Health analysis.
Beyond the projection period, expectations are that the market will continue to grow—particularly in light of the first losses of exclusivity for Ketruyda and Ozempic in 2028 and 2026, respectively. In 2023, these were two of the leading biologics on the market, comprising nearly $40 billion in global sales. Together, the patent expiration of these two drugs will have an outsized impact on the further expansion of the biosimilar market post-2028.
Biosimilar adoption for a given reference product typically builds up in the first year after launch until reaching peak sales. Expecting a similar trend for the upcoming pipeline of biosimilar launches, the greatest impact on the biosimilar market will manifest closer to 2033 and beyond.
Looking at the recent developments in the biosimilar playing field, several notable exits of large pharmaceutical companies will create a vacuum in the market. At the same time, emerging players—particularly companies with a traditional background in generics—are interested in biosimilars. Their expertise in lifecycle management might well position these new generics players to capture a portion of the expected biosimilar market growth.
Because of their lack of experience in biologics manufacturing, generics companies will, however, have to deploy a different business model compared to established pharma players. Whereas pharma companies are often highly integrated and can leverage internal biologics manufacturing capabilities, generics players must foster partnerships with biologics contract development and manufacturing organizations and smaller R&D-focused biotechs.
Only time will tell which of the two business models will ultimately prevail and capture the lion’s share of the expected growth in the biosimilar market.
Building the Biosimilar Business Case
The outlook for the global biosimilar market is quite promising, but this potential can only be realized with careful consideration of the business case around biosimilar development. While all drug developers must consider the manufacturing, regulatory, clinical, and commercial components of a new launch, biosimilar developers have the additional mandate to holistically evaluate all of these elements—and build a clear business case—before development begins.
While patent expiration of originator biologics is a driving factor behind the growing biosimilar market, these expirations not only influence whether a biosimilar can launch but also how closely the biosimilar manufacturing process can mirror that of the originator biologic. The cost structure around biosimilar manufacturing directly ties into the question of biosimilar profitability.
The regulatory and clinical strategy of a biosimilar development program is another core consideration. Extrapolation allows a biosimilar to be approved for an indication held by the originator biologic but where the biosimilar itself has not been directly studied. Consequently, the decision of which indication to pursue in the biosimilar development program requires close analysis around patient population, trial feasibility, the number and types of trials to run, and the market size overall.
To maximize peak volume sales for biosimilars, which are primarily driven by pricing and switching dynamics relative to the originator drug, developers must strategically plan their commercial approach from the early stages of development. A deep understanding of market access, pricing, and competitive positioning is crucial. The market’s response to biosimilar pricing will significantly impact a developer’s positioning among competitors, making it essential for this to be a deliberate and well-informed decision. This strategy will directly affect the long-term sustainability and success of the business case for a biosimilar product.
Biosimilars offer a promising yet complex business opportunity that integrates multiple core elements of drug development. Winning in this space requires a transversal plan that addresses the full biosimilar lifecycle, from development to launch and beyond. A successful approach must seamlessly connect manufacturing, regulatory, clinical, pricing, and other commercial considerations to ensure a competitive edge.