Biosimilar Monoclonal Antibodies Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Infliximab, Rituximab, Abciximab, Trastuzumab, Adalimumab, Bevacizumab, Others), By Application (Oncology, Chronic & Autoimmune Diseases, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 5.66 Billion
CAGR (2026-2031)	12.61%
Fastest Growing Segment	Oncology
Largest Market	North America
Market Size (2031)	USD 11.54 Billion

Market Overview

The Global Biosimilar Monoclonal Antibodies Market will grow from USD 5.66 Billion in 2025 to USD 11.54 Billion by 2031 at a 12.61% CAGR. Biosimilar monoclonal antibodies are biologic therapeutic agents designed to be highly similar to approved reference products regarding safety, purity, and potency, serving as cost-effective alternatives for treating chronic conditions such as cancer and autoimmune diseases. The market’s expansion is fundamentally underpinned by the expiration of patents for blockbuster biologics and the urgent global necessity to optimize healthcare expenditures. According to the Association for Accessible Medicines, in its 2025 report, biosimilar medicines generated $20.2 billion in savings for the U.S. healthcare system and patients in 2024 alone, highlighting the substantial economic impact of these therapies.

However, market proliferation faces a significant challenge in the form of complex market access barriers and exclusionary contracting practices. Originator companies frequently utilize rebate walls and patent thickets to delay the commercial entry or formulary adoption of these lower-cost alternatives. This restricted market access impedes the speed at which biosimilar monoclonal antibodies can capture market share, potentially stalling the broader financial relief they offer to healthcare systems.

Key Market Drivers

Supportive regulatory frameworks and abbreviated approval pathways are acting as a primary catalyst for the Global Biosimilar Monoclonal Antibodies Market, fundamentally reducing the barriers to entry for competitors. Regulatory agencies have established clear, streamlined guidelines that allow manufacturers to leverage comparative data, thereby decreasing the time and capital investment required to bring these complex biologics to commercialization. This pro-competitive environment has encouraged a surge in pipeline activity, ensuring a steady influx of therapeutic options that challenge originator dominance. According to Cardinal Health, March 2025, in the '10 years of biosimilars' report, these optimized regulatory mechanisms have successfully facilitated the approval of 70 new biosimilars over the past decade, significantly broadening the availability of treatment options for patients and providers.

Concurrently, the market is being propelled by the growing acceptance of biosimilars among physicians and patients, which is overcoming historical hesitation regarding safety and efficacy. As real-world evidence mounts and educational initiatives take hold, clinical confidence in these agents has matched that of reference biologics, leading to robust adoption rates across major therapeutic areas. This shift from skepticism to reliance is driving substantial volume growth, validating the role of biosimilars as essential components of modern medical practice. According to the Association for Accessible Medicines, September 2025, in the '2025 U.S. Generic & Biosimilar Medicines Savings Report', the industry reached a milestone of 3.3 billion days of patient therapy delivered to date, reflecting deep market penetration. The same report noted that biosimilars have generated $56.2 billion in cumulative savings since their inception, underscoring the enduring economic value driven by this increased acceptance.

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Key Market Challenges

Complex market access barriers and exclusionary contracting practices are significantly hampering the growth of the Global Biosimilar Monoclonal Antibodies Market by restricting commercial entry and uptake. Originator companies frequently implement rebate walls, a strategy where they withhold widely utilized volume-based discounts unless a payer grants their reference product exclusive or preferred status on a formulary. This financial structure incentivizes healthcare systems to favor higher-priced reference biologics over more affordable biosimilar alternatives, thereby preventing new monoclonal antibody therapies from capturing meaningful market share despite their cost advantages.

These obstructionist tactics not only limit current adoption but also create a high-risk environment that discourages manufacturers from investing in future pipeline development. The long-term impact of these barriers is quantitatively evident in the shrinking number of programs for upcoming off-patent products. According to the Biosimilars Council, in 2025, although 118 biologics are projected to lose patent exclusivity over the next decade, only 12 molecules currently have corresponding biosimilars in development. This substantial gap in the development pipeline illustrates how restricted market access is effectively stalling the broader expansion of the sector.

Key Market Trends

Manufacturers are strategically pursuing interchangeability designations to dismantle the market access barriers that have historically insulated originator biologics from competition. This regulatory classification is pivotal because it enables pharmacy-level substitution without the intervention of the prescribing healthcare provider, allowing biosimilar developers to bypass exclusionary contracting practices and rebate walls implemented by reference product manufacturers. By securing this status, companies can compete more aggressively on price and secure preferred formulary positions, effectively commoditizing the market and accelerating volume uptake. The significance of this trend is highlighted by the high regulatory hurdles involved; according to Cardinal Health, February 2024, in the '2024 Biosimilars Report', only 9 biosimilars had successfully received interchangeability status in the U.S. market as of early 2024, underscoring the exclusivity and strategic value of this designation in driving market penetration.

Concurrent with regulatory strategies, the market is witnessing a decisive shift towards subcutaneous administration and the development of self-injection devices, moving therapy delivery from clinical settings to the patient's home. This trend represents a transition towards "biobetters," where manufacturers reformulate intravenous monoclonal antibodies into subcutaneous versions to offer superior convenience, reduced systemic healthcare costs, and improved patient adherence. This differentiation strategy allows biosimilar firms to capture market share not just through price attrition, but by offering tangible value-added improvements over the standard of care. The commercial impact of this shift is evident in recent payer dynamics; according to Celltrion, August 2024, in a corporate press release, the company’s newly launched subcutaneous infliximab formulation, Zymfentra, secured 75% coverage across the U.S. insurance market within just five months of its launch, demonstrating the robust demand for these patient-centric delivery innovations.

Segmental Insights

The Oncology segment constitutes the fastest-growing category within the Global Biosimilar Monoclonal Antibodies Market, driven by the rising global prevalence of cancer and the critical need for cost-effective therapies. This rapid expansion is primarily fueled by the recent patent expirations of blockbuster reference biologics, which allow pharmaceutical manufacturers to introduce affordable biosimilar alternatives. Furthermore, regulatory bodies such as the U.S. Food and Drug Administration and the European Medicines Agency have established streamlined approval pathways to facilitate market entry. Consequently, healthcare systems are increasingly adopting oncology biosimilars to manage rising expenditures while ensuring broader patient access to essential treatments.

Regional Insights

North America maintains a dominant position in the Global Biosimilar Monoclonal Antibodies Market, driven primarily by the patent expiration of blockbuster biologics and a favorable regulatory framework. The U.S. Food and Drug Administration has established clear guidelines that streamline the approval process, encouraging market entry for manufacturers. Additionally, high healthcare expenditure and a concerted effort to reduce prescription drug costs accelerate the adoption of these therapies. The strong presence of major pharmaceutical companies investing in diverse development pipelines further consolidates the region's leadership in this sector.

Recent Developments

• In December 2025, Amneal Pharmaceuticals received U.S. FDA approval for two denosumab biosimilars, serving as affordable alternatives to the reference products Prolia and Xgeva. These products were developed through a strategic collaboration with mAbxience, leveraging the partner's expertise in the development and manufacturing of monoclonal antibodies. The approval covered therapeutic indications for osteoporosis and the prevention of skeletal-related events in patients with multiple myeloma and solid tumor metastases. This partnership successfully navigated the regulatory pathway, culminating in a commercial launch plan intended to broaden patient access to essential bone-health treatments in the United States.
• In May 2024, Celltrion received marketing authorization from the European Commission for Omlyclo, a biosimilar to Xolair (omalizumab). This approval established the product as the first omalizumab biosimilar in Europe, indicated for the treatment of severe allergic asthma and chronic spontaneous urticaria. The authorization followed a positive recommendation from the Committee for Medicinal Products for Human Use, which reviewed extensive analytical and clinical data confirming biosimilarity to the reference product. This strategic achievement allowed the company to strengthen its presence in the European immunology market, providing healthcare systems with a cost-effective option for managing severe allergic conditions through high-quality monoclonal antibody therapy.
• In March 2024, Sandoz obtained FDA approval for two denosumab biosimilars, Jubbonti and Wyost, referencing the biologic products Prolia and Xgeva respectively. These monoclonal antibodies were approved to treat conditions such as osteoporosis in postmenopausal women and to prevent skeletal-related events in patients with bone metastases. Notably, these products were also granted interchangeable status, which streamlines the substitution process for patients and pharmacists. This development marked a key expansion of the company's immunology and oncology portfolio in the United States, utilizing a comprehensive data package to demonstrate that the biosimilars matched the reference medicines in efficacy and safety.
• In February 2024, Alvotech received U.S. FDA approval for Simlandi, a high-concentration, citrate-free biosimilar to Humira (adalimumab). This approval was particularly significant as it marked the first high-concentration formulation of the drug to be granted interchangeable status, allowing for pharmacy-level substitution without the intervention of a prescriber. The product, designed for patients with various inflammatory conditions, entered a competitive market sector dominated by the reference biologic. This regulatory milestone underscored the company's commitment to expanding patient access to affordable biologic therapies and highlighted its manufacturing capabilities in delivering complex biosimilar monoclonal antibodies to the U.S. market.

Key Market Players

• Abbott Laboratories
• Pfizer Inc.
• Novartis AG
• AbbVie, Inc.
• Coherus Oncology, Inc
• Biocon Limited
• Allergan plc.
• Accord Healthcare limited.
• Amgen inc.
• Dr. Reddy’s Laboratory Limited

By Product	By Application	By Region
Infliximab Rituximab Abciximab Trastuzumab Adalimumab Bevacizumab Others	Oncology Chronic & Autoimmune Diseases Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Biosimilar Monoclonal Antibodies Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Biosimilar Monoclonal Antibodies Market, By Product:

• Infliximab
• Rituximab
• Abciximab
• Trastuzumab
• Adalimumab
• Bevacizumab
• Others

• Biosimilar Monoclonal Antibodies Market, By Application:

• Oncology
• Chronic & Autoimmune Diseases
• Others

• Biosimilar Monoclonal Antibodies Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE