$35+ Bn Biosimilars (mAbs, GCSF, Insulin, Anticoagulant, rhGH, Teriparatide, GLP-1) Markets - Global Forecast to 2035 - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Biosimilars Market by Drug Class (mAbs (Adalimumab, Infliximab, Rituximab, Trastuzumab), GCSF, Insulin, Anticoagulant, rhGH, Teriparatide, GLP-1), Indication (Oncology, Autoimmune, Diabetes, Obesity), Competitive Landscape, Region - Global Forecast to 2035" report has been added to ResearchAndMarkets.com's offering.

The global biosimilars market is projected to reach USD 72.29 billion by 2035 from USD 35.04 billion in 2025, at a CAGR of 7.5%

The report will help market leaders and new entrants by providing them with the closest approximations of the revenue numbers for the overall biosimilars market and its subsegments. It will also help stakeholders better understand the competitive landscape and gain more insights to better position their businesses and make suitable go-to-market strategies. This report will enable stakeholders to understand the market's pulse and provide them with information on the key market drivers, restraints, opportunities, and challenges.

The expansion of the biosimilars market has been predominantly fueled by heightened awareness and education regarding the safety, efficacy, and interchangeability of biosimilar products. Additionally, favorable insurance coverage and reimbursement structures implemented by both public and private payers have played a crucial role in this growth, alongside an increasing demand for cost-effective biologic therapies.

Nonetheless, the market faces challenges from escalating complexities in the manufacturing processes and intensifying competition, leading to significant pricing pressures that may hinder further growth.

The monoclonal antibodies segment is expected to grow at the highest CAGR during the study period.

Monoclonal antibodies (mAbs) such as infliximab, rituximab, adalimumab, trastuzumab, pembrolizumab, dupilumab, Ustekinumab, Risankizumab, and others are primarily utilized for the treatment of autoimmune disorders, various cancers, chronic illnesses, and select infectious diseases. The anticipated rise in patient demographics, coupled with increasing adoption rates and the impending patent expirations of several key biologics, is projected to drive demand in the mAb sector.

These therapeutics are extensively employed in managing chronic and life-threatening conditions, notably cancer, rheumatoid arthritis, psoriasis, and inflammatory bowel disease, which are experiencing heightened global prevalence due to an aging populace and lifestyle-related risk factors. The emergence of biosimilars for these mAbs offers an opportunity to mitigate healthcare expenditures and improve access to essential therapies.

With over 10-15 leading mAbs facing patent expirations within the next decade, competition is poised to intensify, piquing the interest of pharmaceutical companies in the mAb market. The affordability and extensive applicability of mAb biosimilars, particularly in oncology and autoimmune therapies, are likely to significantly contribute to future market growth.

The US is expected to grow at the highest CAGR in the global biosimilars market from 2025 to 2035.

The United States is projected to experience the highest compound annual growth rate (CAGR) in the global biosimilars market between 2025 and 2035. This rapid growth is largely driven by the expiration of patents on several blockbuster biologics and the increasingly favorable regulatory environment established by the Biologics Price Competition and Innovation Act (BPCIA). Over the next decade, the US is expected to see biosimilar entries for major biologics such as Keytruda (pembrolizumab), Stelara (ustekinumab), and Eylea (aflibercept), which are all multi-billion-dollar products. These launches will significantly expand the addressable market for biosimilars, particularly in oncology, immunology, and ophthalmology.

Additionally, the growing payer and provider acceptance of biosimilars in the US healthcare system is accelerating uptake. For instance, biosimilars of adalimumab (Humira), the highest-selling biologic in the US for over a decade, began launching in 2023 with multiple entrants such as Amgen, Boehringer Ingelheim, and Sandoz.

Early signs show that competitive pricing is starting to drive formulary access and payer adoption. Moreover, legislative and policy efforts, including Medicare reforms and price transparency regulations, are expected to further incentivize biosimilar use, leading to cost savings and greater market penetration. As more biosimilars gain interchangeable status, market dynamics are likely to mirror those seen in generics, thus supporting sustained growth in the US biosimilars sector over the next decade.

Key Attributes:

Market Dynamics

Drivers

• Rising Global Demand for Affordable Alternatives to Expensive Biologic Therapies
• Increasing Number of Biosimilar Launches and Approvals
• Impending and Ongoing Patent Expiry of Blockbuster Biologics
• Entry of Emerging Players with Cost-Efficient Manufacturing Capabilities

Restraints

• Manufacturing Complexities and High Cost of Biosimilars
• Intense Competition and Pricing Pressure Among Market Players

Opportunities

• Launch of Glp-1 Biosimilars
• Increasing Strategic Partnerships and Collaborations Among Biosimilar Manufacturers
• Growing Focus on Advanced R&D Operating Models

Challenges

• Increased Market Competition Between Biosimilar Manufacturers and Originator Biologic Companies

Technology Analysis

Key Technologies

• Advanced Bioprocessing & Manufacturing Technologies
• Analytical & Characterization Techniques

Complementary Technologies

• Ai & Ml
• Lab Automation & Robotics

Adjacent Technologies

• Microbial Fermentation
• D Bioprinting & High-Density Cell Culture
• Trends/Disruptions Impacting Customers' Businesses

Value Chain Analysis

Ecosystem Analysis

• Role in Ecosystem
• Patent Analysis
• List of Key Patents

Pipeline Analysis

• Biosimilar Products in Clinical Pipeline
• List of Key Biologics to Go Off-Patent

Companies Featured

• Sandoz Group Ag
• Pfizer Inc.
• Amgen Inc.
• Celltrion Inc.
• Biocon
• Dr. Reddy's Laboratories Ltd.
• Eli Lilly and Company
• Teva Pharmaceutical Industries Ltd.
• Fresenius Kabi Ag
• Stada Arzneimittel Ag
• Boehringer Ingelheim International GmbH
• Samsung Biologics
• Amneal Pharmaceuticals LLC
• Coherus Biosciences
• Bio Thera Solutions
• Aprogen
• Shanghai Henlinus Biotech, Inc.
• Alvotech
• Amega Biotech
• Biocad
• Probiomed S.A. De C.V.
• Fujifilm Kyowa Kirin Biologics Co. Ltd.
• Polpharma Biologics Group
• Neuclone
• Xentria
• Yl Biologics
• Kashiv Biosciences, LLC
• Nanogen Pharmaceutical Biotechnology Jsc
• Synermore Biologics (Suzhou) Co. Ltd.
• Curateq Biologics Pvt. Ltd.

For more information about this report visit https://www.researchandmarkets.com/r/o8xspv

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