Biosimilars Market By Molecule Class (Monoclonal Antibodies [Trastuzumab, Bevacizumab, Rituximab, Adalimumab, Others]; Insulin [Glargine, Aspart]; Hematologic [Filgrastim, Pegfilgrastim, Epoetin, Alfa]); By Indication (Oncology, Autoimmune Disorders, Diabetes, Blood Disorders, Ophthalmology, Endocrine and Hematologic Disorders, Others); By Route of Administration (Intravenous, Subcutaneous, Extended Delivery Formats); By End-User (Hospitals & Cancer Centers, Ambulatory Clinics, Specialty Pharmacies, Research Institutes); By Geography, Segment Revenue Estimation, Forecast, 2024–2032.

Biosimilars Market Size & Overview

The Global Biosimilars Market was valued at USD 24.5 billion in 2023 & is projected to reach around USD 74.3 billion by 2030, expanding at a CAGR of 21.1% during the forecast period. The growth is being driven by the rising global demand for cost-effective biologic therapies, patent expirations of blockbuster biologics & the increasing burden of chronic diseases.

 

As of April 2025, a total of 74 biosimilars have received approval from the U.S. FDA. The latest biosimilar to receive approval was ‘Jobevne’ on April 9, 2025. North America, particularly the United States, has taken the lead in biosimilar adoption, with the regional market already exceeding $10 billion in 2024.

 

Biosimilars Market Dynamics:

Market Drivers

• Cost Efficiency of Biosimilars

The significant expense of chronic treatments imposes a heavy strain on the healthcare system. In recent years, growing awareness of the cost-saving potential of biosimilars has led to increased clinical adoption and market availability. In 2023, cost savings from biosimilars surged by over 30%, reaching $12.4 billion. Since their launch, these medications have collectively saved $36 billion. Biosimilars are projected to be as much as 35% cheaper than their branded counterparts, potentially contributing to a $100 billion reduction in U.S. drug costs between 2020 and 2024. Developing and securing approval for a biosimilar is significantly more cost-effective compared to a reference biologic, typically ranging from $100 million to $250 million, whereas creating a new prescription medicine can cost around $2.6 billion.

 

• Patent Expirations of Blockbuster Biologics

Patent protections and litigation are key factors in shaping the timeline for biosimilar market entry under the Biologics Price Competition and Innovation Act (BPCIA). The pharmaceutical market is currently experiencing "Wave 2" of patent expirations. The initial phase (2010–2020) introduced biosimilars for trastuzumab, infliximab, and rituximab, establishing a foundation for biosimilar adoption in autoimmune treatment and oncology segments. This second wave now encompasses the expiration of key monoclonal antibody patents, creating new market entry points for competitors and driving strategic opportunities for cost efficiencies across the healthcare industry. In 2023, Keytruda generated 40% of Merck & Co’s pharmaceutical sales, solidifying its position as the company’s top-performing product. With its patent set to expire in 2028, the market is poised for biosimilar competition. A significant cost-saving potential remains unexploited, with 90% of the 118 biologics set to lose exclusivity over the next decade amounting to a total value of $236 billion.

 

Major Biologics Facing U.S. Patent Expiry (2025–2030)

Reference Product	Molecule Name	Company	Indication Area	Expected LOE (U.S.)	2023 Global Sales (USD Bn)
Cimzia	Certolizumab pegol	UCB	Autoimmune (RA, CD)	2026	$1.8
Simponi / Simponi Aria	Golimumab	Johnson & Johnson	Autoimmune	2027	$2.3
Soliris	Eculizumab	Alexion (AstraZeneca)	Rare Blood Disorders	2025	$4.2
Ultomiris	Ravulizumab	Alexion (AstraZeneca)	PNH, aHUS	2027–2028	$2.0
Ocrevus	Ocrelizumab	Roche	Multiple Sclerosis	2029	$6.3
Dupixent	Dupilumab	Sanofi / Regeneron	Asthma, Dermatitis	2029–2030	$9.4
Tysabri	Natalizumab	Biogen	Multiple Sclerosis	Approved biosimilar	$2.0
Darzalex	Daratumumab	Johnson & Johnson	Oncology – Myeloma	2029	$9.7
Keytruda	Pembrolizumab	Merck	Oncology	2030+ (biologics patents expiring starting 2028)	$25+

 

Market Opportunities

With biologics accounting for nearly 40% of global pharmaceutical spending, the introduction of biosimilars offers a strategic opportunity to lower treatment costs while expanding patient access. As part of the Biosimilar User Fee Act reauthorization commitment for fiscal years 2023–2027, the FDA plans to introduce a pilot regulatory science program focused on improving the development of interchangeable products & optimizing the development process of biosimilar products. The increasing availability of interchangeable biosimilars, particularly in the U.S. & Europe is expected to accelerate substitution & prescription flexibility. Enhancing market dynamics through initiatives such as provider education, patient awareness campaigns, and financial incentives similar to those in the Oncology Care Model has the potential to accelerate biosimilar adoption.

 

Market Restraints

Development cost of biosimilars can range from USD 100 Mn - USD 300 Mn per product, significantly higher than traditional generics. This poses a barrier for smaller players & limits the number of competitors in certain therapeutic classes. Between 2025 and 2034, patent protection will expire for 16 complex biologics, yet no biosimilars are currently in development for these treatments. Despite their substantial costs, the combination of a relatively small market and significant development hurdles discourages competition. Although regulatory bodies like the FDA & EMA have introduced clear approval pathways, prescribers in regions with limited biosimilar exposure may hesitate to switch from reference biologics. According to surveys conducted across Europe & the U.S., nearly 30–40% of physicians remain cautious about automatic substitution or switching patients who are stable on original biologics. Legal & patent-related hurdles often involving “patent thickets” & strategic litigation by originator companies can delay biosimilar market entry even after regulatory approval.

 

Biosimilars Market Recent Developments:

• On April 16, 2025, China's Chime Biologics entered a strategic partnership with Polpharma Biologics, a European biosimilars specialist, to facilitate the comprehensive development and manufacturing of a biosimilar product for the global market. However, the companies have not revealed details regarding the specific therapy or target indication.

• On February 6, 2025, Dr. Reddy’s Laboratories SA revealed a license agreement with Shanghai Henlius Biotech, Inc. to support the development and commercialization of HLX15 (daratumumab), Henlius’s biosimilar candidate to Janssen’s Darzalex® and Darzalex Faspro®.

• On January 19, 2025, Tanvex BioPharma, Inc., a CDMO specializing in biologics and biosimilar products, announced the successful completion of its acquisition of Bora Biologics Co., Ltd., a subsidiary of Bora Pharmaceuticals. As a result, Tanvex’s CDMO services will now operate under the Bora Biologics name while remaining under Tanvex's ownership.

 

Recent FDA Approvals in 2025: Strengthening the Competitive Landscape

The first quarter of 2025 has already seen a surge in biosimilar activity with multiple high-impact approvals. Notably:

• Jobevne (bevacizumab-nwgd), a biosimilar to Avastin, was approved on April 9, 2025, targeting various cancers, including metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and ovarian cancer

• Bomyntra and Conexxence (denosumab-bnht) were approved in March 2025 as biosimilars to Xgeva and Prolia, expanding competition in the bone health segment.

• Omlyclo (omalizumab-igec), a biosimilar to Xolair, received FDA clearance in March 2025, targeting allergic asthma and chronic idiopathic urticaria.

• Osenvelt and Stoboclo (denosumab-bmwo), biosimilars to Prolia, were approved in February 2025, adding further pressure in the osteoporosis space.

• Merilog (insulin aspart-szjj), referencing NovoLog, was approved in February 2025, signaling continued expansion in diabetes care.

 

Biosimilars Market Trends

 

Biosimilars Market Segmentation: A Comprehensive Overview

By Molecule Class:

• Monoclonal Antibodies
  • Trastuzumab
  •  Bevacizumab
  •  Rituximab,
  • Adalimumab
  • Others
• Insulin
  • Glargine
  • Aspart
• Hematologic
  • Filgrastim
  • Pegfilgrastim
  • Epoetin
  • Alfa

 

Biosimilars Market Segmentation: A Comprehensive Overview

By Molecule Class:

• Monoclonal Antibodies

  • Trastuzumab

  •  Bevacizumab

  •  Rituximab,

  • Adalimumab

  • Others

• Insulin

  • Glargine

  • Aspart

• Hematologic

  • Filgrastim

  • Pegfilgrastim

  • Epoetin

  • Alfa

 

By Indication:

• Oncology

• Autoimmune Disorders

• Diabetes

• Blood Disorders

• Opthalmology

• Endocrine and Hematologic Disorders

• Others

 

By Route of Administration:

• Intravenous

• Subcutaneous

• Extended Delivery Formats

 

By End-User:

• Hospitals & Cancer Centers

• Ambulatory Clinics

• Specialty Pharmacies

• Research Institutes

 

By Region:

• North America

• Europe

• Asia Pacific

• Latin America

• Middle East & Africa

 

Segmentation Analysis – Biosimilars Market

By Molecule Class:

Monoclonal Antibodies hold the largest market share at 42%, driven by their widespread use in oncology & autoimmune therapies, as well as multiple high-revenue biologics losing exclusivity. In Europe, eight bevacizumab biosimilars, six trastuzumab biosimilars and five rituximab biosimilars are available as anti-cancer drugs. In 2020, Pfizer became the first company to launch three monoclonal antibody (mAb) biosimilar treatments for oncology (ZIRABEV™, RUXIENCE™ & TRAZIMERA™) to the U.S. market.

Insulin is the fastest-growing product segment, projected to expand at a CAGR of around 22.3%. As diabetes continues to rise in emerging countries like India, the need for affordable biosimilar insulin alternatives is becoming increasingly urgent. Interchangeable biosimilar insulin glargine provides a viable solution for accessing high-quality biologic therapy, which might otherwise be out of reach due to its high cost. The growth is supported by increasing diabetes prevalence and cost-driven adoption of biosimilar insulin products across emerging markets.

 

By Indication:

Oncology dominates with an estimated 25% market share, as biosimilars for cancer therapies gain rapid traction due to high treatment costs and strong clinical evidence. Many blockbuster biologics used in oncology (like Herceptin, Avastin, and Rituxan) have lost or are losing patent protection in major markets like the US and Europe. As of April 2025, there are 25 FDA approved oncology biosimilars which include bevacizumab, trastuzumab, rituximab and others.

Autoimmune Diseases represent the fastest-growing segment, expected to grow at a CAGR of over 21.5%, fueled by rising incidence of conditions like rheumatoid arthritis and Crohn’s disease, alongside expanding biosimilar availability in this space.

 

 

 

 

Regional Analysis – Biosimilars Market

The biosimilars market is expanding rapidly across all major regions, but adoption rates, regulatory environments, and therapeutic focus vary significantly. North America, particularly the United States, has taken the lead in biosimilar adoption, with the regional market already exceeding $10 billion in 2024. The United States is currently the largest biosimilars market projected to surpass $31 billion by 2030. This dominance is underpinned by the following key statistics:

• High-cost biologic usage base - Biologics account for ~46% of drug spending in the U.S.

• Massive savings potential - Biosimilars projected to save the U.S. healthcare system $180–250B over 10 years

• Rapid product approvals - 45 biosimilars approved by the FDA as of early 2024; 38 launched

• Aggressive 2023 launches - 8 adalimumab biosimilars entered U.S. market in one year

• Improving interchangeability - Products like Cyltezo (adalimumab) and Rezvoglar (insulin glargine) now interchangeable

 

 

Biosimilars Market: Competitive Landscape

The biosimilar market is set to evolve into three distinct categories- emerging, established and smaller players. Leading companies like Samsung Bioepis, Sandoz and Amgen are expanding their portfolios with biosimilars targeting high-value drugs such as Opdivo & Keytruda. Meanwhile, emerging players like Biocad, Mabxience (Insud Pharma), Innovent Biologics & Luye Pharm are making strides with late-stage biosimilars for oncology indications. Additionally, smaller firms like Shanghai Henlius Biotech & Prestige Biopharma are entering the market, focusing on less competitive segments. To navigate this shifting landscape, manufacturers of reference product must assess incoming biosimilar competition, strategize launches for next-generation and monitor patent dynamics.

 

Key Players in the Biosimilars Market

• Novartis AG (Sandoz)

• Pfizer Inc.

• Amgen Inc.

• Samsung Bioepis

• Celltrion Healthcare

• Biocon Biologics

• Viatris Inc. (formerly Mylan)

• Coherus BioSciences, Inc.

• Teva Pharmaceutical Industries Ltd.

• Alvotech