The biosimilar monoclonal antibody market was valued for $8.72 billion in 2022 and is estimated to reach $64.69 billion by 2032, exhibiting a CAGR of 22.2% from 2023 to 2032. Biosimilar monoclonal antibodies are biologic treatments that closely resemble established reference monoclonal antibodies, commonly referred to as originator or innovator monoclonal antibodies. These similarities encompass aspects such as structure, function, effectiveness, safety, and quality. Monoclonal antibodies (mAbs) are large proteins produced in living cells and are designed to target specific molecules or cells in the body involved in disease processes. Biosimilar monoclonal antibodies find application in a range of therapeutic areas, including oncology, immunology, and infectious diseases. Biosimilar monoclonal antibodies are produced by different manufacturers other than the originator product but demonstrate no clinically meaningful differences from the reference product. They undergo rigorous analytical and clinical testing to establish their similarity with reference biosimilars and demonstrate safety and efficacy.
The major factors driving the growth of biosimilar monoclonal antibody market are increasing demand for biosimilar mAbs, supportive regulatory environment, and increase in patent expirations of blockbuster monoclonal antibodies. Monoclonal antibodies and similar biologic medications have emerged as essential choices for addressing a variety of persistent and intricate health conditions, including cancer, autoimmune disorders, and inflammatory issues. Rise in prevalence of these diseases, coupled with the increasing aging population, has led to a higher demand for biologics, including biosimilar mAbs. In addition, biosimilar mAbs are generally more cost-effective than their originator counterparts. As the innovative monoclonal antibodies are highly costly, healthcare providers and payers are increasingly seeking cost-saving options without compromising on therapeutic efficacy. Biosimilars offer a more affordable treatment option, which can lead to increase in adoption in both, developed and developing markets.
Furthermore, due to patent expirations and advancements in biotechnological research, manufacturers of biosimilars have had the opportunity to investigate fresh therapeutic applications for their offerings. This widens the potential applications of biosimilar mAbs. Furthermore, increase in the number of biosimilar manufacturers and their willingness to invest in R&D and production capabilities have intensified competition in the biosimilar mAbs market, which contributes to lowering prices and enhancing overall market penetration. Moreover, regulatory agencies in many countries, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established clear guidelines for the approval of biosimilar products. These guidelines provide a transparent pathway for development, testing, and approval of biosimilar mAbs, which boosts the confidence of manufacturers entering the market.
The biosimilar monoclonal antibody market is segmented on the type, indication, end user and region. On the basis of type, the market is categorized into adalimumab, bevacizumab, infliximab, rituximab, trastuzumab, and others. On the basis of indication, the market is classified into oncology, autoimmune diseases, and others. On the basis of end user, the market is segmented into hospitals, cancer treatment centers and others. Region-wise, the market is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and rest of Europe), Asia-Pacific (Japan, China, Australia, India, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and rest of LAMEA).
Major key players that operate in the global biosimilar monoclonal antibody market are Novartis AG, Pfizer Inc., Amgen Inc., Coherus BioSciences, Inc., Teva Pharmaceutical Industries Limited, Shanghai Henlius Biotech, Inc., BIOCAD, Biogen, Biocon, and Celltrion Healthcare Co., Ltd. The key players have adopted strategies such as collaboration, product launch, agreement, clinical trial approval, acquisition, and product approval to expand their product portfolio.
The major factors driving the growth of biosimilar monoclonal antibody market are increasing demand for biosimilar mAbs, supportive regulatory environment, and increase in patent expirations of blockbuster monoclonal antibodies. Monoclonal antibodies and similar biologic medications have emerged as essential choices for addressing a variety of persistent and intricate health conditions, including cancer, autoimmune disorders, and inflammatory issues. Rise in prevalence of these diseases, coupled with the increasing aging population, has led to a higher demand for biologics, including biosimilar mAbs. In addition, biosimilar mAbs are generally more cost-effective than their originator counterparts. As the innovative monoclonal antibodies are highly costly, healthcare providers and payers are increasingly seeking cost-saving options without compromising on therapeutic efficacy. Biosimilars offer a more affordable treatment option, which can lead to increase in adoption in both, developed and developing markets.
Furthermore, due to patent expirations and advancements in biotechnological research, manufacturers of biosimilars have had the opportunity to investigate fresh therapeutic applications for their offerings. This widens the potential applications of biosimilar mAbs. Furthermore, increase in the number of biosimilar manufacturers and their willingness to invest in R&D and production capabilities have intensified competition in the biosimilar mAbs market, which contributes to lowering prices and enhancing overall market penetration. Moreover, regulatory agencies in many countries, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established clear guidelines for the approval of biosimilar products. These guidelines provide a transparent pathway for development, testing, and approval of biosimilar mAbs, which boosts the confidence of manufacturers entering the market.
The biosimilar monoclonal antibody market is segmented on the type, indication, end user and region. On the basis of type, the market is categorized into adalimumab, bevacizumab, infliximab, rituximab, trastuzumab, and others. On the basis of indication, the market is classified into oncology, autoimmune diseases, and others. On the basis of end user, the market is segmented into hospitals, cancer treatment centers and others. Region-wise, the market is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and rest of Europe), Asia-Pacific (Japan, China, Australia, India, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and rest of LAMEA).
Major key players that operate in the global biosimilar monoclonal antibody market are Novartis AG, Pfizer Inc., Amgen Inc., Coherus BioSciences, Inc., Teva Pharmaceutical Industries Limited, Shanghai Henlius Biotech, Inc., BIOCAD, Biogen, Biocon, and Celltrion Healthcare Co., Ltd. The key players have adopted strategies such as collaboration, product launch, agreement, clinical trial approval, acquisition, and product approval to expand their product portfolio.
Key Benefits for Stakeholders
- This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the biosimilar monoclonal antibody market analysis from 2022 to 2032 to identify the prevailing biosimilar monoclonal antibody market opportunities.
- The market research is offered along with information related to key drivers, restraints, and opportunities.
- Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
- In-depth analysis of the biosimilar monoclonal antibody market segmentation assists to determine the prevailing market opportunities.
- Major countries in each region are mapped according to their revenue contribution to the global market.
- Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
- The report includes the analysis of the regional as well as global biosimilar monoclonal antibody market trends, key players, market segments, application areas, and market growth strategies.
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Key Market Segments
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
- Mexico
- Europe
- Germany
- France
- UK
- Italy
- Spain
- Rest of Europe
- Asia-Pacific
- Japan
- China
- India
- Australia
- South Korea
- Rest of Asia-Pacific
- LAMEA
- Brazil
- Saudi Arabia
- South Africa
- Rest of LAMEA
Key Market Players
- Amgen Inc.
- Novartis AG
- Teva Pharmaceutical Industries Limited
- Shanghai Henlius Biotech, Inc.
- BIOCAD
- Celltrion Healthcare Co., Ltd.
- Biocon
- Coherus BioSciences, Inc.
- Pfizer Inc.
- Biogen
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Table of Contents
CHAPTER 1: INTRODUCTION
CHAPTER 2: EXECUTIVE SUMMARY
CHAPTER 3: MARKET OVERVIEW
CHAPTER 4: BIOSIMILAR MONOCLONAL ANTIBODY MARKET, BY TYPE
CHAPTER 5: BIOSIMILAR MONOCLONAL ANTIBODY MARKET, BY INDICATION
CHAPTER 6: BIOSIMILAR MONOCLONAL ANTIBODY MARKET, BY END USER
CHAPTER 7: BIOSIMILAR MONOCLONAL ANTIBODY MARKET, BY REGION
CHAPTER 8: COMPETITIVE LANDSCAPE
CHAPTER 9: COMPANY PROFILES
List of Tables
List of Figures
Executive Summary
According to this report, the biosimilar monoclonal antibody market was valued at $8.7 billion in 2022, and is estimated to reach $64.7 billion by 2032, growing at a CAGR of 22.2% from 2023 to 2032.The Biosimilar Monoclonal Antibody Market is likely to experience a significant growth rate of 22.2% from 2023-2032 owing to increasing demand for novel therapeutics from pharmaceutical sector
A biosimilar monoclonal antibody is a highly similar version of a reference monoclonal antibody drug that has demonstrated comparable efficacy, safety and quality. Developed through advanced biotechnology, biosimilar mAbs offer cost-effective alternatives to the original reference product, expanding patient access to essential treatments while maintaining regulatory standards. Key factors driving the growth of the biosimilar monoclonal antibody market are rising prevalence of chronic disorders, rise in regulatory approvals and increasing adoption of biosimilars. The rising prevalence of chronic diseases such as cancer, autoimmune disorders and inflammatory conditions, has driven the demand for effective therapeutic options. Biosimilar monoclonal antibodies have emerged as viable alternatives to reference biologics, addressing unmet medical needs and providing physicians with additional treatment choices. Thus, as the global prevalence of chronic diseases continues to increase, the market for biosimilar monoclonal antibodies is expected to witness sustained growth.
In addition, biosimilar offer significant cost savings as compared to reference biologics, thereby driving the market growth. Biologic therapies are often associated with high costs, limiting patient access. Biosimilars offer a cost-effective alternative, allowing healthcare systems to allocate resources more efficiently and expand patient access to life-saving treatments. This cost advantage enhances the adoption of biosimilar monoclonal antibodies, particularly in regions with budget constraints. Further, in both developed and developing countries, there is a growing demand for affordable biologic therapies. Biosimilar monoclonal antibodies offer a treatment option to bridge the gap between the high cost of biologics and patients need for accessible treatment options. This demand-driven market dynamic propels the development and commercialization of biosimilars, fostering competition and promoting equitable healthcare access.
Furthermore, physician and patient acceptance is crucial for the success of biosimilar monoclonal antibodies. Healthcare professionals are increasingly open to prescribing biosimilars owing to robust clinical data demonstrating their therapeutic equivalence. Patient advocacy groups and educational initiatives have also played a role in dispelling misconceptions about biosimilars, building trust and encouraging patients to opt for these more affordable treatment options, thus propelling the market growth. Moreover, regulatory agencies, such as the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have played a pivotal role in fostering the growth of the biosimilar monoclonal antibody market. Evolving guidelines and regulatory pathways have facilitated streamlined approval processes for biosimilars, reducing the barriers to entry for manufacturers. For instance, in December 2020, Amgen announced that the U. S. Food and Drug Administration (FDA) approved RIABNI (rituximab-arrx), a biosimilar to Rituxan (rituximab), for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis), and Microscopic Polyangiitis (MPA). This environment encourages competition, leading to increased availability and affordability of biosimilar monoclonal antibodies.
Emerging markets present a significant growth opportunity for biosimilar monoclonal antibodies. These regions often struggle to provide access to high-cost biologic therapies. Biosimilars offer a solution by providing affordable treatment options, addressing unmet medical needs, and improving healthcare access. The strategic entry into these markets further contributes to the expansion of the biosimilar monoclonal antibody market.
Further, rise in the number of clinical studies for development of biosimilar is expected to fuel the market growth. For instance, in January 2021, Shanghai Henlius Biotech, Inc., announced that the filing of clinical trial for HLX04-O, a recombinant anti-VEGF humanized monoclonal antibody ophthalmic injection, for the treatment of wet age-related macular degeneration (wAMD) has been approved by the Therapeutic Goods Administration, Australia. Thus, such approvals for clinical studies are expected to propel the market expansion.
The biosimilar monoclonal antibody market is segmented on the type, indication, end user and region. On the basis of type, the market is categorized into adalimumab, bevacizumab, infliximab, rituximab, trastuzumab, and others. On the basis of indication, the market is classified into oncology, autoimmune diseases, and others. On the basis of end user, the market is segmented into hospitals, cancer treatment centers and others. Region-wise, the market is analyzed across North America (the U. S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and rest of Europe), Asia-Pacific (Japan, China, Australia, India, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and rest of LAMEA). The key players profiled in the study include Novartis AG, Pfizer Inc., Amgen Inc., Coherus BioSciences, Inc., Teva Pharmaceutical Industries Limited, Shanghai Henlius Biotech, Inc., BIOCAD, Biogen, Biocon, and Celltrion Healthcare Co., Ltd. The key players have adopted strategies such as collaboration, product launch, agreement, clinical trial approval, acquisition, and product approval to expand their product portfolio.
Key Market Insights
On the basis of type, the adalimumab segment dominated the market in terms of revenue in 2022, and is expected to witness highest CAGR during the forecast period.On the basis of indication, the oncology segment dominated the market in terms of revenue in 2022.
Based on the end user, the hospitals segment dominated the market in terms of revenue in 2022.
Region-wise, North America generated the largest revenue in 2022. However, Asia-Pacific is anticipated to grow at the highest CAGR during the forecast period.
Companies Mentioned
- Amgen Inc.
- Novartis AG
- Teva Pharmaceutical Industries Limited
- Shanghai Henlius Biotech, Inc.
- BIOCAD
- Celltrion Healthcare Co., Ltd.
- Biocon
- Coherus BioSciences, Inc.
- Pfizer Inc.
- Biogen
Methodology
The analyst offers exhaustive research and analysis based on a wide variety of factual inputs, which largely include interviews with industry participants, reliable statistics, and regional intelligence. The in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. The primary research efforts include reaching out participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions.
They are also in professional corporate relations with various companies that allow them greater flexibility for reaching out to industry participants and commentators for interviews and discussions.
They also refer to a broad array of industry sources for their secondary research, which typically include; however, not limited to:
- Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
- Scientific and technical writings for product information and related preemptions
- Regional government and statistical databases for macro analysis
- Authentic news articles and other related releases for market evaluation
- Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecast
Furthermore, the accuracy of the data will be analyzed and validated by conducting additional primaries with various industry experts and KOLs. They also provide robust post-sales support to clients.
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