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Biosimilars Market 2025: Market Size, Growth Drivers, and Regional Dynamics
Chapter of the 2025 Global Biosimilars Report
11 minute read
Due to differences in the legal framework, the biosimilar market evolved in the EU earlier than in the US. However, the US market closed this gap in recent years with a high number of biosimilar approvals. The global biosimilar market grew from $12.5 billion in 2019 to $26.7 billion in 2023.
In 2004, with Directive 2004/27/EC, the European Union (EU) finalized the first dedicated regulatory pathway for biosimilars in the world. The global biosimilar market began to take shape in 2006 when European Medicines Agency (EMA) approved the first biosimilar, Omnitrope® (somatropin), setting a milestone for biosimilar regulations and approvals worldwide.
Over the past decade, the biosimilar market has experienced significant growth, driven by the patent expirations of blockbuster biologics like Humira® (adalimumab) and Herceptin® (trastuzumab) and increasing demand for affordable biologic treatments. As of July 2025, the Food and Drug Administration (FDA) has approved 72 biosimilars, while the EMA has authorized 119 biosimilars (excluding withdrawn products). Momentum accelerated in 2024, with the FDA granting 18 approvals and the EMA approving a record 28 biosimilars. The trend remains strong in 2025, with the FDA approving nine biosimilars so far and the EMA issuing 21 biosimilar authorizations or positive Committee for Medicinal Products for Human Use opinions through mid-2025.
In 2009, the United States (US) Biologics Price Competition and Innovation Act (BPCIA) established a legal framework for biosimilar approval in the US. The US market saw its first biosimilar approval in 2015 with Zarxio® (filgrastim), paving the way for more competition and encouraging further developments in the biosimilar sector.
This article provides an in-depth analysis of the global biosimilars market, including its size, growth drivers, and evolving regional dynamics. It also explores how policy, regulation, and competition are shaping the trajectory of biosimilar adoption across key markets and therapeutic areas.
Sources: Global Data; Alira Health analysis.
Market Sizing and Development
In 2020, the global biosimilar market totaled $17.8 billion with Europe leading at $8.9 billion, capturing 55% of the overall market. At $7.1 billion, the US held 40% of the global biosimilar market in 2020, with the rest of the world, including significant markets like Canada, China, and Japan, totaling $1.8 billion or 8% of the total market. With a CAGR of 14%, the global biosimilar market increased to $30.3 billion in 2024, with each region showing a strong expansion in absolute sales from the 2020 baseline.
Sources: IQVIA; Alira Health analysis.
Key Geographies Driving Market Growth
By market size, Europe and the US dominate the biosimilar market with a combined global market share in excess of 80%. With the establishment of a biosimilar-friendly regulatory framework and other initiatives like the US Inflation Reduction Act (IRA) and interchangeability guidelines in the US and the EU, both regions have seen significant growth in recent years.
United States
The passage of the BPCIA in 2009 was a pivotal moment in formalizing the path forward for biosimilar approvals in the US. Since then, biosimilar approvals and uptake have significantly increased.
By 2023, there were 45 approved biosimilars in the market. Since 2023, an additional 27 biosimilars were approved (through September 2025), bringing the total to 72 FDA-approved biosimilars.
Additionally, the IRA created an incentive for biosimilar use. Because they are biologics, biosimilars often fall under the Medicare Part B reimbursement framework, which covers drugs that are administered in a doctor’s office or in an outpatient setting. The reimbursement price under Medicare Part B is set at the average sale price (ASP) of the biosimilar plus a fixed percentage of the ASP of the originator. Beginning in October 2022, under the new Medicare Part B guidance, biosimilars can receive an 8% add-on payment rate if a biosimilar’s ASP is lower than the originator product. This new add-on rate, which replaces the previous 6% add-on, creates a bigger financial incentive for providers to use the less expensive biosimilar, as they can still receive a margin based on the higher priced originator product.
Sources: “Biosimilar Product Information”; Alira Health analysis
The US has a unique path for biosimilar market growth and capture due to the introduction of interchangeability with the 2009 BPCIA. Under these guidelines, a biosimilar could attain the interchangeability designation with the submission of additional data from a switching study. Once interchangeable status is granted, a pharmacist can substitute a biosimilar for a reference product in the pharmacy without prescriber intervention. This goes beyond the more traditional practice of switching, where healthcare providers prescribe the biosimilar directly. Interchangeability is governed by the FDA, and of the 58 biosimilars currently approved by the FDA, six have attained interchangeability status. The first interchangeable biosimilar designation was granted in 2021.
In 2024, the FDA published updated draft guidance that would make it easier for biosimilars to achieve the interchangeability designation. Under the proposed new rules, biosimilar developers will be able to demonstrate that a biosimilar is interchangeable with the reference product by simply providing a statement based on comparative analytical and clinical data in the drug’s original Biologics License Application. This update removes the mandate for a dedicated switching study, lowering the barrier for biosimilar market competition.
Entry into the US market is often complicated by patent disputes between originators and biosimilar developers. The “patent dance” is a litigation process, mandated by the BPCIA, and involves a series of information exchanges between the biosimilar applicant and the reference product sponsor to identify and potentially resolve patent disputes before the biosimilar is marketed.
The European Union
As the first region to establish a regulatory framework for biosimilar approval, Europe has played a pioneering role in the global biosimilar market. From 2020 through 2024, the market grew with a CAGR of 13% up to $14.6 billion, buoyed by the EMA’s positive view on biosimilars and active track record of reviewing and approving this class of medications.
The biosimilar approvals landscape in the EU is quite diverse and comprises 25 originator drugs. Again, Humira (adalimumab) faces the most biosimilar competition, with 10 approved biosimilars in the EU (excluding withdrawn products) accounting for 11% of all approvals. However, this landscape is expected to change significantly with more loss of exclusivity by the end of the decade.
The EMA and the country-specific regulatory bodies emphasize that biosimilars approved in the EU are interchangeable from a scientific viewpoint. In practice, this means that a biosimilar can be used instead of its reference product, or vice versa. Each EU country decides which biologics—including biosimilars—are available for prescribing within its own borders, and they also decide whether automatic substitution of biosimilars is allowed at the pharmacy level. Of note, a biosimilar can also be used in place of another biosimilar of the same reference product. This positive regulatory and practical stance towards biosimilars maintains the EU’s position as an attractive market for biosimilar developers.
Sources: “Biosimilars approved in Europe;” Alira Health analysis
Rest of the World
For many regions outside of the US and the EU, regulatory approvals from the FDA or the EMA often serve as a key input for local submission. Across the globe, local regulatory bodies and health systems are driven to biosimilar adoption by a common motivation: broadening access to effective medications and controlling healthcare costs.
Canada
With a strong, high-growth biologics market, Canada represents a significant emerging opportunity for biosimilars. In 2024, Canada captured 12% of the North American biosimilar market, up from 4% in 2020.
Compared to the US and the EU, challenges like brand loyalty to originator biologics and switching caution from healthcare providers have slowed the uptake of biosimilars in Canada. Recognizing a place for biosimilars in expanding access and controlling healthcare costs, the Canadian government has implemented policies aimed at promoting biosimilar use.
| Under the Biosimilars Initiative, now implemented in 12 out of 13 provinces and territories, patients with public PharmaCare health coverage must transition to an approved biosimilar of originator biologics, barring no medical exception. This policy aims to provide safe and effective biologic treatments at a lower government cost, but it also creates an attractive, relatively secure market for biosimilar developers. A key factor to maximizing opportunity under the Biosimilars Initiative is the timing of regulatory approvals to ensure a “first-to-market” or early market position; once a patient has switched from the reference product to a biosimilar, there is no further mandate to switch to another. | 
Sources: IQVIA; Alira Health analysis. |
Under the Biosimilars Initiative, now implemented in 12 out of 13 provinces and territories, patients with public PharmaCare health coverage must transition to an approved biosimilar of originator biologics, barring no medical exception. This policy aims to provide safe and effective biologic treatments at a lower government cost, but it also creates an attractive, relatively secure market for biosimilar developers. A key factor to maximizing opportunity under the Biosimilars Initiative is the timing of regulatory approvals to ensure a “first-to-market” or early market position; once a patient has switched from the reference product to a biosimilar, there is no further mandate to switch to another.
Sources: IQVIA; Alira Health analysis.
Asian-Pacific (APAC)
The biosimilar market in the APAC region has experienced rapid growth since 2020. Much of this expansion is driven by the opportunity to save on healthcare spending and expand access to otherwise prohibitively expensive originator biologics.
Sources: IQVIA; Alira Health analysis.
China
In February 2015, the National Medical Products Administration, China’s FDA equivalent, released the “Technical Guideline for the Research, Development and Evaluation of Biosimilars.” This guidance formalized the Chinese regulatory framework for biosimilars and established a clear protocol for both local and foreign biologics manufacturers to follow.
Since then, China’s biosimilar market has emerged as one of the most rapidly growing segments within the biosimilar space. From 2020 revenue of $209 million to $1.6 billion in 2024, the market has seen unparalleled growth with a CAGR of 50%. Like most markets, this growth in biosimilar sales is driven by the country’s increasing demand for affordable biologics and the Chinese government’s goal to address the healthcare needs of an expanding and aging population. China’s biosimilar market is dominated by domestic pharmaceutical companies. Innovent Biologics, Henlius Biotech, and Shanghai Fosun Pharma are the market leaders, but international collaborations are becoming increasingly common. Western biosimilar players often partner with Chinese firms to navigate the regulatory landscape and gain market access, leveraging local expertise in production and distribution. |
Sources: IQVIA; Alira Health analysis. |
Since then, China’s biosimilar market has emerged as one of the most rapidly growing segments within the biosimilar space. From 2020 revenue of $209 million to $1.6 billion in 2024, the market has seen unparalleled growth with a CAGR of 50%. Like most markets, this growth in biosimilar sales is driven by the country’s increasing demand for affordable biologics and the Chinese government’s goal to address the healthcare needs of an expanding and aging population.
China’s biosimilar market is dominated by domestic pharmaceutical companies. Innovent Biologics, Henlius Biotech, and Shanghai Fosun Pharma are the market leaders, but international collaborations are becoming increasingly common. Western biosimilar players often partner with Chinese firms to navigate the regulatory landscape and gain market access, leveraging local expertise in production and distribution. 
Sources: IQVIA; Alira Health analysis.
Japan
In 2024, Japan captured 23% of the APAC biosimilar market, after China’s 68%. While it is the second biggest player in the region, Japan’s approach to biosimilars sets it apart. The concept of “biosames” has emerged in Japan; upon loss of exclusivity, pharmaceutical companies launch biologics that are identical to originator biologics but simply marketed under a different brand name. While it is too soon to know if this approach will stifle biosimilar market competition, it does achieve the goal of quickly bringing biologics to market.
Biosimilar Emerging Markets
The Latin-American (LATAM) biosimilar market was valued at $44 million in 2020 and increased to $167 million in 2024, reflecting a CAGR of 40% from 2020 to 2024. The countries with the most approved biosimilars are Brazil, Mexico, Argentina, Chile, and Ecuador.
In the MEA region, uptake of biosimilars has lagged behind the rest of the world, but as local health systems begin to champion initiatives around broader medication access and lower healthcare costs, biosimilars will play a meaningful role in achieving those goals. Furthermore, local governments have identified biosimilars as an opportunity to boost gross domestic product and create jobs by offering incentives for contract development and manufacturing organizations and other biosimilar players to localize parts of the complex biologics global supply chain to the region.
While official biosimilar-specific regulatory guidance in the MEA is currently limited, recent World Health Organization guideline revisions have aimed to streamline the approval process for biosimilars in the region. The past five years have seen progressive expansion of the Middle Eastern and African market from a $74 million value in 2020 to $336 million in 2024, reflecting a CAGR of 46% during that time.
Sources: IQVIA; Alira Health analysis.
Market Development by Therapeutic Area
The therapeutic areas of oncology and immunology have driven and continue to drive the development of biosimilars. Complementary to the increasing medical need, a strong driver is the expiration of patent protection for blockbuster drugs, primarily antibodies. As a result, the development pipeline shows a shift in therapeutic areas with an increased focus on oncology, musculoskeletal diseases, and ophthalmology.
Five key therapeutic areas drove the biosimilar market in recent years: oncology, immunology, gastroenterology, endocrine and metabolic, and cardiovascular. While the distribution of the biosimilar market share changed during this period, each therapeutic area saw growth in absolute market size from 2020 to 2024, a trend that is expected to continue.
Sources: IQVIA; Alira Health analysis.
Of the top biosimilar therapeutic areas, oncology and immunology are the clear leaders, mirroring the research and development pipeline of originator biologics. In oncology, for example, the last fifteen years brought novel biologics to market, like Keytruda® and Opdivo®, that transformed patient care. As these drugs begin to reach loss of exclusivity, market opportunity emerges for biosimilars, explaining the growth seen in the oncology biosimilars space from 2020 to 2024, with an increase in value from $2 billion to $8.3 billion during that time.
Analysis of the marketed biosimilars in 2024 further demonstrates the leading position of the oncology and immunology therapeutic areas. Of the nine biosimilars that captured the top 80% of the global market, three were immunology drugs, four were oncology drugs, and one can be prescribed in both therapeutic areas.
The top three molecules with approved biosimilars in 2024, adalimumab, infliximab, and bevacizumab, together captured 45% of the market, up from 24% in 2020. The increase in sales of these three molecules is a key driver of the growth observed in the biosimilars market.
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Sources: IQVIA; Alira Health analysis. | |
Market Trends, Drivers, and Restraints
The market for biosimilars is expected to grow significantly, driven by the increasing prevalence of chronic diseases, the consequent financial burden on healthcare systems, and the expiration of patents for top-selling blockbuster biologics. However, this growth could be impeded by challenges such as costly patent litigation and the need to build greater confidence among healthcare providers and patients to ensure market adoption.
Drivers in Biosimilar Markets
Increasing medical need and cost savings: The rising prevalence of chronic and other diseases is driving the demand for cost-effective biologic treatments. Biosimilars offer a more affordable alternative to originator biologics, providing significant cost-saving opportunities for health systems.
Expiration of patents for blockbuster biologics: The expiration of patents for major biologics opens up the market for biosimilar competition. This creates a substantial revenue potential in the biosimilar market, as new biosimilar products can enter and capture market share previously held by the original biologics.
Growing acceptance and confidence: The awareness and confidence of healthcare providers and patients towards biosimilars is gradually increasing. As companies market more biosimilars and demonstrate their efficacy and safety, trust in these products grows, encouraging wider adoption across all stakeholders.
Restraints in Biosimilar Markets
Competition and pricing pressure: The biosimilar market, especially for blockbuster drugs, is highly competitive. Companies are under pressure to complete crucial clinical trials successfully and capture market share quickly. This intense competition could lead to aggressive pricing strategies, which may impact profitability.
Patent litigation: A biosimilar applicant can either launch the drug at risk or attempt to resolve patent rights in advance. Patent litigation in the US is a significant risk factor that can be both costly and time-consuming, delaying the market entry of biosimilars. Originator companies often initiate these legal disputes to protect their market share and can hinder the timely availability of biosimilar alternatives.
Adoption hesitation: Despite the large market potential, the adoption of biosimilars is influenced by factors beyond pricing. Trust and confidence in biosimilars among healthcare providers and patients, the willingness of physicians to prescribe them, and the coverage decisions of payers all play crucial roles in determining the success of biosimilar products in the market.
Source: Global Data; Alira Health analysis.
Note: Data includes biosimilars in clinical trials (Phase I – III) and pre-registration stage.