The global biosimilars market was valued at USD 20.44 billion in 2022 and is expected to grow significantly, reaching USD 23.96 billion in 2023 and projected to surge to USD 73.03 billion by 2030. This reflects an impressive compound annual growth rate (CAGR) of 17.3% during the forecast period. In 2022, Europe led the global biosimilars market, accounting for a dominant share of 50.44%.
Biosimilars are safe, effective, and highly similar alternatives to approved biologic drugs. Unlike generic drugs—which are identical copies of chemically synthesized drugs—biosimilars are modeled after complex biological drugs, which are large protein molecules derived from living cells through intricate manufacturing processes. While biosimilars are not identical to their reference biologics, they closely match in terms of safety, purity, and efficacy. Once the patent on a reference biologic expires, biosimilars are eligible to enter the market. Regulatory approval for biosimilars is granted only after rigorous evaluation demonstrates their similarity and performance compared to the original biologic. Compared to the approval process for original biologics, biosimilars benefit from a more streamlined regulatory pathway.
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Global Biosimilars Market – Key Takeaways
Market Size & Forecast
The global biosimilars market was valued at USD 20.44 billion in 2022 and grew to USD 23.96 billion in 2023.
It is projected to reach USD 73.03 billion by 2030, expanding at a robust CAGR of 17.3% from 2023 to 2030.
Growth is driven by rising healthcare cost pressures, increasing chronic disease prevalence, and the patent expiration of major biologic drugs.
Market Share
Europe led the global biosimilars market in 2022 with a 44% share, supported by:
A well-established regulatory environment.
Patent cliffs for high-value biologics.
Strong adoption of cost-saving measures across public health systems.
The European Medicines Agency (EMA)’s proactive stance, with 86 biosimilar approvals since 2006, solidifying the region’s leadership.
Monoclonal antibodies represented the largest product segment in 2022 due to:
Broad therapeutic use in cancer, autoimmune disorders, and chronic diseases.
High regulatory approval rates and expanding development pipelines.
Strong revenue contributions and long-term growth potential.
Key Country Highlights
Japan:
The biosimilars market is gaining momentum through strategic licensing and commercialization agreements.
Deals like Biocon’s partnership with Yoshindo for ustekinumab and denosumab are enhancing local biosimilar access.
Demand is driven by a rising elderly population and the growing burden of chronic conditions, necessitating affordable treatment options.
United States:
As of September 2023, the FDA had approved 43 biosimilars, with momentum increasing post-pandemic.
Key approvals of interchangeable biosimilars such as Abrilada (Pfizer) and Cyltezo (Boehringer Ingelheim) are reshaping the competitive landscape.
Emphasis on expanding access, lowering drug prices, and supporting substitution policies is boosting biosimilar adoption.
China:
A dynamic domestic pipeline is emerging, led by players like Shanghai Henlius.
Government-backed policies to reduce healthcare costs and promote generic drug use are accelerating biosimilar development.
Local production capabilities are expanding to meet rising demand for affordable biologics.
Europe:
The region continues to dominate due to:
Favorable interchangeability guidance from the EMA.
A high number of approved biosimilars across multiple therapeutic areas.
Payers’ growing preference for biosimilars amid budget constraints.
Patent expiries of major biologics like Humira and Stelara, opening doors for broader competition and price reduction.
Market Segmentation
By Product Type: Monoclonal antibodies, erythropoietin, granulocyte colony-stimulating factors, insulin, and other biologic drugs form major segments of the biosimilars market.
By Application: Oncology, autoimmune diseases, diabetes, renal disorders, and infectious diseases are the key therapeutic areas driving biosimilars market demand.
By End User: Hospitals, specialty clinics, and retail pharmacies represent the primary end-user segments in the biosimilars market.
By Distribution Channel: Hospital pharmacies, retail pharmacies, and online pharmacies contribute to diverse supply channels for the biosimilars market.
List Of Key Companies Profiled:
Celltrion Inc. (South Korea)
Pfizer Inc. (U.S.)
Novartis AG (Switzerland)
Amgen Inc. (U.S.)
Biocon (India)
Biogen (U.S.)
Coherus BioSciences (U.S.)
Samsung Bioepis (South Korea)
Shanghai Henlius Biotech, Inc. (China)
Biosimilars Market Growth:
The Biosimilars Market is experiencing strong growth due to the rising prevalence of chronic diseases such as cancer, autoimmune disorders, and diabetes, where biologic therapies play a critical role. The high cost of original biologics has created a significant opportunity for biosimilars to enter the market and offer more affordable treatment options. Government initiatives to reduce healthcare costs, combined with an aging population and growing demand for accessible healthcare, are expected to drive sustained growth in the biosimilars sector over the coming years.
Restraining Factors:
Despite its growth potential, the Biosimilars Market faces several restraining factors. Stringent regulatory requirements, high development costs, and complex manufacturing processes can pose barriers to entry for new players. Additionally, patent litigation and market exclusivity for original biologics can delay the launch of biosimilars. Concerns regarding interchangeability, safety, and efficacy among healthcare providers and patients may also hinder market adoption. Furthermore, limited awareness in emerging markets and resistance from originator biologic manufacturers can slow market expansion.
Regional Analysis:
Regionally, Europe holds a dominant position in the Biosimilars Market, thanks to supportive regulatory frameworks and early adoption of biosimilar products. North America, particularly the United States, is rapidly catching up as the FDA continues to streamline approval pathways and biosimilars gain broader acceptance. The Asia Pacific region is poised for significant growth, fueled by rising healthcare demands, government support, and a large patient population. Latin America and the Middle East & Africa are also emerging markets, though they face challenges such as regulatory complexity and limited infrastructure.
Key Industry Developments:
October 2023: Pfizer’s Abrilada (adalimumab-afzb) received approval from the U.S. FDA as the second interchangeable biosimilar to Humira. The FDA grants interchangeable status only to biosimilars that meet additional data requirements, demonstrating that patients switching between the reference biologic and the biosimilar experience the same clinical outcomes as those consistently treated with the original product.
July 2023: Boehringer Ingelheim introduced Cyltezo (adalimumab-adbm), the first interchangeable branded biosimilar to Humira, in the U.S. market. The launch of Cyltezo supports the broader objective of enhancing treatment accessibility and affordability for patients across the country.