Biosimilar Monoclonal Antibodies Market Size, Share, Forecast To 2033

(MENAFN- Straits Research) Introduction

Biosimilar monoclonal antibodies (mAbs) are biologic drugs designed to be highly similar to already approved reference monoclonal antibodies, with no clinically meaningful differences in safety, purity, or effectiveness. Produced using living cells, these antibodies are crucial in treating conditions such as cancer, autoimmune diseases, and inflammatory disorders. Rigorous testing ensures biosimilars match the efficacy of original biologics, offering a cost-effective alternative that enhances patient access to essential treatments.

Market Dynamics Expanding biosimilar approvals & reimbursement policies drive the global market

Regulatory agencies like the FDA (U.S.), EMA (Europe), and PMDA (Japan) are streamlining the approval processes for biosimilar monoclonal antibodies, enabling faster market entry. Therefore, governments and insurance providers are enhancing reimbursement policies to expand patient access and deliver cost savings.

• For instance, in January 2023, the U.S. Medicare program increased reimbursement incentives for biosimilars through the Inflation Reduction Act, offering an 8% add-on payment compared to reference biologics to drive provider adoption.

These efforts are significantly boosting biosimilar uptake, making treatments more affordable, and improving access to critical therapies for patients worldwide.

Partnerships & collaborations for market expansion create tremendous opportunities

Strategic partnerships between biopharmaceutical companies, contract manufacturing organizations (CMOs), and healthcare providers are pivotal in driving the global biosimilar monoclonal antibodies market. These collaborations enable cost-sharing in research and development, simplify regulatory approval processes, and strengthen distribution networks, helping to overcome financial and technical challenges.

Moreover, joint ventures between global and regional players facilitate entry into emerging markets, where biosimilars offer cost-effective alternatives to high-priced biologics. In 2022, Biocon Biologics and Viatris formed a strategic alliance, broadening their biosimilar portfolio with Trastuzumab, Bevacizumab, and Insulin Glargine. This expanded their presence, particularly in the U.S. and Europe, improving access to affordable biologic treatments.

Such collaborations present substantial opportunities for market expansion by accelerating biosimilar adoption, enhancing production capabilities, and broadening their footprint.

Regional Analysis

North America leads the global biosimilar monoclonal antibodies market , supported by a favorable regulatory environment, substantial healthcare expenditure, and rapid adoption of biosimilars. The FDA's Biologics Price Competition and Innovation Act (BPCIA) has simplified the approval process, facilitating quicker market entry. Robust reimbursement policies, government incentives, and insurer backing have further encouraged healthcare providers to adopt biosimilars more widely. Moreover, the presence of major industry players like Amgen Inc., Pfizer Inc., and Mylan N.V. bolsters regional market growth.

Key Highlights

• The global biosimilar monoclonal antibodies market size was valued at USD 14.92 billion in 2024 and is projected to grow from USD 21.14 billion in 2025 to reach USD 70.92 billion by 2033, exhibiting a CAGR of 16.3% during the forecast period (2025-2033).
• Based on type, the global market is segmented into adalimumab, bevacizumab, infliximab, rituximab, trastuzumab, and others. The adalimumab segment is the largest revenue contributor to the market.
• Based on indication, the global biosimilar monoclonal antibodies market is segmented into oncology, autoimmune diseases, and others. The oncology segment is the largest revenue contributor to the market.
• Based on the distribution channel, the global market is segmented into hospital pharmacies, drug stores & retail pharmacies, and others. The dental clinics segment is the largest revenue contributor to the market.
• North America is the highest shareholder in the global market.

Competitive Players

Roche Holding AG

Novartis AG

Pfizer Inc.

Samsung Bioepis

Amgen Inc.

Viatris Inc.

Teva Pharmaceutical Industries Ltd.

Biogen Inc.

Celltrion Inc.

Sandoz AG

Boehringer Ingelheim International GmbH

Merck KGaA

Amneal Pharmaceuticals Inc.

Biocon

Recent Developments

• In July 2024, Amneal Pharmaceuticals, Inc. announced the addition of omalizumab, a biosimilar referencing XOLAIR, to its biosimilar pipeline. XOLAIR is widely used for treating allergic asthma and chronic idiopathic urticaria. This expansion reinforces Amneal's commitment to developing cost-effective biologic alternatives, increasing patient access to advanced allergy and asthma treatments.

Segmentation

By Type

Adalimumab

Bevacizumab

Infliximab

Rituximab

Trastuzumab

Others

By Indication 

Oncology

Autoimmune Diseases

Others

By Distribution Channel 

Hospital Pharmacies

Drug Stores & Retail Pharmacies

Others

By Regions

North America

Europe

Asia-Pacific

Central & South America

The Middle East and Africa

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