Monoclonal Antibodies (mAbs) Biosimilars Market - Global Industry Research Analysis

Monoclonal antibodies (mAbs) Biosimilars Market Insights

According to Market Research Store, the global monoclonal antibodies (mAbs) biosimilars market size was valued at around USD 10.62 billion in 2023 and is estimated to reach USD 64.07 billion by 2032, to register a CAGR of approximately 22.1% in terms of revenue during the forecast period 2024-2032.

The monoclonal antibodies (mAbs) biosimilars report provides a comprehensive analysis of the market, including its size, share, growth trends, revenue details, and other crucial information regarding the target market. It also covers the drivers, restraints, opportunities, and challenges till 2032.

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Global Monoclonal Antibodies (mAbs) Biosimilars Market: Overview

The Monoclonal Antibodies (mAbs) Biosimilars Market focuses on biologic drugs that are highly similar to approved monoclonal antibody therapies, offering comparable efficacy and safety at a lower cost. These biosimilars are used in treating cancer, autoimmune disorders, infectious diseases, and chronic conditions such as rheumatoid arthritis and psoriasis. They are developed to provide cost-effective alternatives to expensive branded monoclonal antibody therapies while maintaining therapeutic equivalence.

Market growth is driven by the rising prevalence of chronic diseases, increasing healthcare cost pressures, and patent expirations of major monoclonal antibody drugs. Regulatory support for biosimilar approvals and growing physician acceptance have further accelerated market expansion. Advancements in biopharmaceutical manufacturing and the development of next-generation biosimilars with improved formulations are also contributing to increased adoption.

Key Highlights

• The monoclonal antibodies (mAbs) biosimilars market is anticipated to grow at a CAGR of 22.1% during the forecast period.
• The global monoclonal antibodies (mAbs) biosimilars market was estimated to be worth approximately USD 10.62 billion in 2023 and is projected to reach a value of USD 64.07 billion by 2032.
• The growth of the monoclonal antibodies (mAbs) biosimilars market is being driven by several factors, including the increasing cost of biologics, the expiration of patents on many blockbuster mAbs, and the growing demand for more affordable healthcare options.
• Based on the type, the adalimumab segment is growing at a high rate and is projected to dominate the market.
• On the basis of indication, the oncology segment is projected to swipe the largest market share.
• In terms of end-user, the hospitals segment is expected to dominate the market.
• By region, North America is expected to dominate the global market during the forecast period.

Monoclonal Antibodies (mAbs) Biosimilars Market: Dynamics

Key Drivers

• Cost Reduction: Biosimilars offer a significant cost reduction compared to their originator biologics. This cost-effectiveness is a major driver, as it can help reduce healthcare expenditures and improve access to life-saving therapies.
• Increased Access to Medicines: Biosimilars can increase access to vital medications for patients, particularly in developing countries where the high cost of originator biologics can be a major barrier.
• Patent Expiry of Originator Biologics: The expiration of patents on many blockbuster biologic drugs has paved the way for the development and commercialization of biosimilars.
• Growing Global Healthcare Expenditure: The increasing global healthcare expenditure and the rising prevalence of chronic diseases are driving the demand for cost-effective treatment options, including biosimilars.

Restraints

• Complex Regulatory Approval Process: The development and approval of biosimilars require rigorous scientific and regulatory processes, which can be time-consuming and expensive.
• Biosimilarity Assessment Challenges: Demonstrating biosimilarity to the originator product can be complex and challenging, requiring extensive analytical and clinical data.
• Physician and Patient Acceptance: Overcoming physician and patient concerns regarding the safety and efficacy of biosimilars compared to the originator products.
• Intellectual Property Disputes: Potential for intellectual property disputes between originator companies and biosimilar manufacturers.

Opportunities

• Expanding Therapeutic Areas: Expanding the availability of biosimilars to a wider range of therapeutic areas, including oncology, immunology, and ophthalmology.
• Developing Next-Generation Biosimilars: Developing next-generation biosimilars with improved efficacy, safety, and delivery mechanisms.
• Focus on Emerging Markets: Expanding the availability of biosimilars in emerging markets to improve access to affordable medications.
• Developing Innovative Manufacturing Technologies: Developing innovative manufacturing technologies to improve the efficiency and cost-effectiveness of biosimilar production.

Challenges

• Maintaining Therapeutic Equivalence: Ensuring the therapeutic equivalence of biosimilars to their originator products while maintaining high levels of safety and efficacy.
• Addressing Patient Concerns: Addressing patient concerns and building trust in the safety and efficacy of biosimilars.
• Staying Competitive: Remaining competitive in a dynamic market with increasing competition from other biosimilar manufacturers.
• Meeting Evolving Regulatory Requirements: Keeping pace with evolving regulatory requirements and ensuring compliance with global regulatory standards.

Monoclonal antibodies (mAbs) Biosimilars Market: Report Scope

Monoclonal Antibodies (mAbs) Biosimilars Market: Segmentation Insights

The global monoclonal antibodies (mAbs) biosimilars market is divided by type, indication, end-user and region.

Segmentation Insights by Type

Based on type, the global monoclonal antibodies (mAbs) biosimilars market is divided into adalimumab, bevacizumab, infliximab, rituximab, trastuzumab, and others.

Adalimumab dominates the Monoclonal Antibodies (mAbs) Biosimilars Market due to its widespread use in treating autoimmune disorders, including rheumatoid arthritis, psoriasis, and Crohn’s disease. The rising demand for cost-effective alternatives to branded biologics has driven the growth of Adalimumab biosimilars.

Bevacizumab holds a significant share, primarily used in oncology for treating various cancers, including colorectal and lung cancer. Its biosimilars are gaining traction due to increasing cancer prevalence and regulatory approvals.

Infliximab is another key segment, widely used in inflammatory diseases like Crohn’s disease and ulcerative colitis. Its biosimilars offer an affordable alternative to the reference biologic, driving their adoption.

Rituximab remains essential in treating blood cancers and autoimmune diseases. The growing acceptance of biosimilars in oncology and hematology has fueled the expansion of this segment.

Trastuzumab is a major player in the market, primarily used for HER2-positive breast cancer treatment. The increasing demand for biosimilars in oncology is driving the growth of Trastuzumab biosimilars, making it a crucial segment in the market.

Segmentation Insights by Indication

On the basis of indication, the global monoclonal antibodies (mAbs) biosimilars market is bifurcated into oncology, autoimmune diseases, and others.

Oncology dominates the Monoclonal Antibodies (mAbs) Biosimilars Market due to the high prevalence of cancer and the increasing demand for cost-effective biologic treatments. Biosimilars of Bevacizumab, Rituximab, and Trastuzumab are widely used in oncology, particularly for treating colorectal cancer, non-Hodgkin’s lymphoma, and HER2-positive breast cancer. The rising adoption of biosimilars in cancer treatment and regulatory approvals are driving growth in this segment.

Autoimmune Diseases hold a significant share in the market, primarily driven by biosimilars of Adalimumab and Infliximab, which are extensively used in treating rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis. The increasing patient population suffering from autoimmune conditions and the cost advantage of biosimilars compared to branded biologics are fueling the expansion of this segment.

Segmentation Insights by End-User

On the basis of end user, the global monoclonal antibodies (mAbs) biosimilars market is bifurcated into hospitals, cancer treatment centers, and others.

Hospitals dominate the Monoclonal Antibodies (mAbs) Biosimilars Market due to the high volume of biologic drug administrations, particularly for cancer and autoimmune diseases. Hospitals have well-established oncology and immunology departments, making them primary centers for administering biosimilars such as Bevacizumab, Rituximab, and Trastuzumab for cancer treatment, as well as Adalimumab and Infliximab for autoimmune disorders. The increasing adoption of cost-effective biosimilars in hospital settings, driven by regulatory approvals and reimbursement policies, further strengthens this segment’s growth.

Cancer Treatment Centers also hold a significant share, as these specialized facilities focus on targeted monoclonal antibody therapies. Cancer treatment centers frequently administer biosimilars for various malignancies, including breast cancer, colorectal cancer, and lymphoma, benefiting from the affordability and accessibility of biosimilars. The rising prevalence of cancer and the increasing reliance on biosimilars to lower treatment costs are key factors driving demand in this segment.

Monoclonal Antibodies (mAbs) Biosimilars Market: Regional Insights

• North America is expected to dominates the global market

North America holds a dominant position in the monoclonal antibodies biosimilars market, primarily driven by the United States. The presence of key biopharmaceutical companies, a well-established regulatory framework by the FDA, and growing healthcare expenditures support market growth. The rising demand for affordable biologics due to the high cost of branded mAbs is also fueling biosimilar adoption. Canada is also expanding its biosimilar usage through government policies promoting cost savings in healthcare.

Europe is a major market for mAbs biosimilars, led by Germany, the UK, and France. The European Medicines Agency (EMA) has been at the forefront of biosimilar approvals, creating a favorable regulatory environment. High acceptance among healthcare providers, well-developed reimbursement policies, and the push for cost-effective biologics in public healthcare systems drive market expansion. The region has witnessed the successful launch of several mAbs biosimilars, contributing to increased competition and reduced treatment costs.

Asia-Pacific region is experiencing rapid growth in the mAbs biosimilars market, with China, Japan, and India being key contributors. Governments in these countries are actively promoting biosimilar development to improve access to biologic therapies. China’s expanding biopharmaceutical sector and India’s strong biosimilar manufacturing capabilities make them significant players. Japan’s regulatory framework for biosimilars, along with its aging population and high incidence of chronic diseases, further boosts market growth.

Latin America is an emerging market for monoclonal antibody biosimilars, with Brazil, Mexico, and Argentina leading in adoption. The rising burden of cancer and autoimmune diseases, coupled with increasing healthcare expenditures, is driving demand. Government initiatives to expand access to affordable biologics are supporting market growth, though regulatory challenges and slower adoption in some countries pose hurdles.

Middle East and Africa region is gradually adopting biosimilar mAbs, particularly in the UAE, Saudi Arabia, and South Africa. Rising healthcare investments, expanding pharmaceutical industries, and the increasing prevalence of chronic diseases are key drivers. However, market growth is slower in some parts of Africa due to limited healthcare infrastructure and affordability concerns.

Monoclonal Antibodies (mAbs) Biosimilars Market: Competitive Landscape

The report provides an in-depth analysis of companies operating in the monoclonal antibodies (mAbs) biosimilars market, including their geographic presence, business strategies, product offerings, market share, and recent developments. This analysis helps to understand market competition.

Some of the major players in the global monoclonal antibodies (mAbs) biosimilars market include:

• Amgen
• Amneal Pharmaceuticals
• Biocon
• Biogen
• Boehringer Ingelheim
• Celltrion
• Erythropoietin
• Fresenius Kabi
• Granulocyte- Colony Stimulating Factor
• Human Growth Hormone
• Insulin
• Interferon
• Merck
• Monoclonal Antibody
• Mylan
• Novartis
• Pfizer
• Roche
• Samsung Bioepis
• Sandoz
• Teva Pharmaceutical Industries

The global monoclonal antibodies (mAbs) biosimilars market is segmented as follows:

By Type

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

By Indication

• Oncology
• Autoimmune Diseases
• Others

By End-User

• Hospitals
• Cancer Treatment Centers
• Others

By Region

• North America
  • U.S.
  • Canada
• Europe
  • U.K.
  • France
  • Germany
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Rest of Latin America
• The Middle East and Africa
  • GCC Countries
  • South Africa
  • Rest of Middle East Africa

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