Biosimilar Monoclonal Antibody

Global Biosimilar Monoclonal Antibody Market to Reach US$44.5 Billion by 2030

The global market for Biosimilar Monoclonal Antibody estimated at US$14.0 Billion in the year 2024, is expected to reach US$44.5 Billion by 2030, growing at a CAGR of 21.2% over the analysis period 2024-2030. Adalimumab, one of the segments analyzed in the report, is expected to record a 23.7% CAGR and reach US$16.1 Billion by the end of the analysis period. Growth in the Bevacizumab segment is estimated at 18.2% CAGR over the analysis period.

The U.S. Market is Estimated at US$3.7 Billion While China is Forecast to Grow at 19.9% CAGR

The Biosimilar Monoclonal Antibody market in the U.S. is estimated at US$3.7 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$6.8 Billion by the year 2030 trailing a CAGR of 19.9% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 19.7% and 18.0% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 14.3% CAGR.

Global Biosimilar Monoclonal Antibody Market – Key Trends & Drivers Summarized

Why Are Biosimilar Monoclonal Antibodies Becoming Pivotal in Expanding Access to Targeted Biologic Therapies?
Biosimilar monoclonal antibodies (mAbs) are gaining strategic importance in global healthcare systems due to their ability to replicate the efficacy, safety, and clinical performance of originator biologics at significantly lower costs. As biologics become central to the treatment of cancer, autoimmune diseases, and chronic inflammatory conditions, the expiration of patents on blockbuster mAbs has opened the market for biosimilar alternatives—addressing both cost containment imperatives and the need to widen patient access to advanced therapeutics.

Unlike generic small molecules, biosimilar mAbs undergo rigorous analytical characterization and clinical validation to demonstrate high similarity without clinically meaningful differences. Their approval and commercialization are enabling healthcare providers to reduce biologics-related expenditure, expand formulary inclusion, and improve therapy access across public and private settings. In high-burden disease areas like rheumatoid arthritis, breast cancer, and colorectal cancer, biosimilar mAbs are transforming the economics of biologic care.

How Are Regulatory Pathways, Manufacturing Scale, and Clinical Confidence Accelerating Market Uptake?
Streamlined biosimilar regulatory frameworks—such as the EMA’s well-established pathway, the FDA’s 351(k) approval process, and WHO guidance—have matured to support the global rollout of biosimilar mAbs. These frameworks focus on extensive comparability exercises rather than full-scale efficacy trials, enabling faster and cost-efficient development. Regulatory convergence is also facilitating cross-market approvals and accelerating global launch timelines.

Advancements in upstream cell-line engineering, downstream purification processes, and analytical platforms are improving biosimilar manufacturing precision, while reducing development variability and production costs. Simultaneously, post-marketing surveillance data and real-world evidence are reinforcing physician confidence in switching and initiating treatment with biosimilars. Provider education, stakeholder engagement, and payer incentives are also increasing prescriber alignment and institutional adoption across hospitals, oncology centers, and specialty clinics.

Where Is Demand for Biosimilar mAbs Expanding and Which Therapeutic Areas Are Leading Growth?
Europe remains the largest and most mature market for biosimilar monoclonal antibodies, supported by proactive healthcare policy, national biosimilar adoption targets, and tender-based procurement models. North America is witnessing accelerated uptake, particularly following the introduction of biosimilars for trastuzumab, bevacizumab, adalimumab, and rituximab. Asia-Pacific is emerging as a high-growth region with a strong manufacturing base, government-led cost-reduction programs, and rising biologics demand in countries such as India, South Korea, China, and Japan.

Leading therapeutic segments include oncology—particularly breast, lung, and colorectal cancers—where trastuzumab, bevacizumab, and rituximab biosimilars are displacing originator therapies in first- and second-line protocols. In immunology, biosimilars for infliximab, adalimumab, and etanercept are being widely used for rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Hospital-based treatment regimens, specialty pharmacy distribution, and payer-driven substitution policies are key drivers of market volume across these high-cost disease categories.

What Is Fueling the Global Growth of the Biosimilar Monoclonal Antibody Market?
The global growth of the biosimilar mAbs market is being fueled by the dual pressures of biologic drug affordability and therapeutic demand expansion. As healthcare systems seek sustainable models for managing chronic and complex diseases, biosimilars are offering competitive pricing with proven clinical equivalence. Payer incentives, supportive regulation, and improved switching protocols are facilitating institutional acceptance, while originator off-patent expirations continue to unlock new commercial opportunities.

Strategic partnerships, co-development deals, and investment in large-scale biologics manufacturing facilities are supporting supply reliability and product differentiation. Market players are also engaging in targeted physician education, real-world outcome tracking, and multi-channel distribution to accelerate trust and uptake. As biosimilar mAbs become embedded in treatment algorithms and reimbursement schemes, a defining question shapes the next phase: Can the biosimilar industry maintain pricing competitiveness and manufacturing integrity—while scaling global access to high-cost biologic therapies without compromising safety, quality, or clinical outcomes?

SCOPE OF STUDY:

The report analyzes the Biosimilar Monoclonal Antibody market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Type (Adalimumab, Bevacizumab, Infliximab, Rituximab, Trastuzumab, Other Types); Indication (Oncology, Autoimmune Diseases, Other Indications); End-User (Hospitals, Cancer Treatment Centers, Other End-Users)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 43 Featured) -

• Amgen Inc.
• Biocon Biologics Ltd.
• Biogen Inc.
• Boehringer Ingelheim GmbH
• Celltrion Healthcare Co., Ltd.
• Dr. Reddy`s Laboratories Ltd.
• Fresenius Kabi AG
• Henlius Biotech, Inc.
• Merck & Co., Inc.
• Mylan N.V. (now part of Viatris)
• Novartis AG
• Pfizer Inc.
• Samsung Bioepis Co., Ltd.
• Sandoz International GmbH
• Teva Pharmaceutical Industries Ltd.
• Alvotech
• Apobiologix (Apotex Inc.)
• Coherus BioSciences, Inc.
• Formycon AG
• Xbrane Biopharma AB

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

We are diligently following expert opinions of leading Chief Economists (14,949), Think Tanks (62), Trade & Industry bodies (171) worldwide, as they assess impact and address new market realities for their ecosystems. Experts and economists from every major country are tracked for their opinions on tariffs and how they will impact their countries.

We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

To our valued clients, we say, we have your back. We will present a simplified market reassessment by incorporating these changes!

APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

Complimentary Update: Our clients will also receive a complimentary update in July after a final reset is announced between nations. The final updated version incorporates clearly defined Tariff Impact Analyses.

Reciprocal and Bilateral Trade & Tariff Impact Analyses:

USA
CHINA
MEXICO
CANADA
EU
JAPAN
INDIA
176 OTHER COUNTRIES.

Leading Economists - Our knowledge base tracks 14,949 economists including a select group of most influential Chief Economists of nations, think tanks, trade and industry bodies, big enterprises, and domain experts who are sharing views on the fallout of this unprecedented paradigm shift in the global econometric landscape. Most of our 16,491+ reports have incorporated this two-stage release schedule based on milestones.

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