Global Biosimilar Monoclonal Antibody Market

Biosimilar Monoclonal Antibodies Market Overview

The global biosimilar monoclonal antibodies market was valued at 5 billion in 2021, and it is expected to reach 8 billion with a CAGR of 9.9 % during the forecast period of 2022-2028. The prevalence of chronic disorders is expected to push the biosimilar monoclonal antibodies market. Biosimilar monoclonal antibodies treat chronic diseases such as cancer, autoimmune disease, and rheumatoid arthritis. Biosimilar monoclonal antibodies, like trastuzumab, bevacizumab, and rituximab, are utilized in cancer treatment. Moreover, the incidence of cancer is growing year by year. Therefore, most chronic diseases, including cancer, are expected to drive the biosimilar monoclonal antibodies market.

What is Biosimilar Monoclonal Antibody Market?

Biosimilars are biological creations, such as proteins and antibodies, similar in structure, function, and effectiveness to an FDA-approved biopharmaceutical. They are evolving imperative therapeutics to treat many conditions, including cancer. Biosimilar is also valuable tools for analyzing and assessing the processes and products of biopharmaceuticals as they are more comfortable and less expensive to obtain. Biosimilar antibodies are utilized for many research applications, including flow cytometry, immunofluorescence, and blocking/neutralization assays. Biosimilar monoclonal antibodies are normally used in several bridging assays, including anti-drug antibody (ADA) and pharmacokinetic assays. ADA assays utilize biosimilar monoclonal antibodies to capture and detect anti-drug antibodies.

Growth Drivers

Growing demand for biosimilar Monoclonal Antibody drugs due to their cost-effectiveness

According to the American Journal of Managed Care, biosimilars are priced around 20–30% lower than their parent/branded counterparts. It results in both cost-savings and access to highly effective treatments for patients. Biosimilars have lower R&D costs as approximated to innovator biologics. Lower R&D costs lower the cost for biosimilars. Lower-priced biosimilars also have a low impact on the prices of reference biologics through price competition among manufacturers. This important cost-to-benefit ratio presented by biosimilar drugs is expected to boost their demand in the coming years.

New Research & Collaborations Will Open New Growth Opportunities

The expanded direction of pharmaceutical giants on developing novel biosimilar monoclonal antibodies has paved the path for major research collaborations, which are occurring as key biosimilar monoclonal antibody market trends. Due to the increasing acceptance of these novel drugs, new manufacturers want to enter the positively competitive market, and strategic collaborations can sustain their position.

Opportunities

Patent expiry of blockbuster Biosimilar Monoclonal Antibody and research on new indications

There would be a rise in the patent expiration of several existing biosimilar drugs in the coming decade. It would provide an opportunity for many innovator companies and generic manufacturers to offer tailored services to biosimilars. Again, elements such as the cost-effective nature of biosimilars, increasing acceptance and adoption by various stakeholders with the demand for diversification in technology and business models, and the growing prevalence of chronic conditions are anticipated to drive the global biosimilar monoclonal antibody market.

Restraints

Strict Regulatory Guidelines for Approval Procedure to Hamper Market Growth

Despite favorable results for biosimilar monoclonal antibodies in treating different diseases, the extended and strict regulations for authorization and launch will hinder the biosimilar monoclonal antibodies therapy revenue. Many clinical studies are withdrawn mostly due to failure to meet the stringent regulations and results formulated by the regulatory authorities. In addition to this, the possible side effects of these drugs are other factors restricting the biosimilar monoclonal antibody market growth.

Pre Covid-19 Impact on Global Biosimilar Monoclonal Antibody Market

Before the covid-19 period, the increasing prevalence of chronic conditions such as cancer is one of the primary elements augmenting the growth of the global biosimilar monoclonal antibody market. Chronic diseases pose a major burden across the globe, pushing the governments of different countries to decrease the cost burden about their spread. By the Centers for Disease Control and Prevention, 6 in every ten adults in the US are suffering from a chronic condition, leading to an annual healthcare expenditure of US$ 3.5 trillion. Furthermore, unmet patient needs and enhancing health reimbursement procedures for therapeutic monoclonal antibodies used as a treatment choice for chronic diseases increase the market’s biosimilar monoclonal antibody therapy.

Covid-19 Impact on Global Biosimilar Monoclonal Antibody Market

During the covid-19 period, in the pandemic era, nearly 88% of the cancer care centers encountered challenges in providing usual cancer care for many causes, including preventative measures, absence of personal protection equipment, and staff deficiency, as per the research article issued in the JCO Global Oncology 2020. Further, this influence was more prominent in low-income countries. Therefore, COVID-19 is anticipated to hinder cancer patients’ number of cancer therapies, indirectly impacting the examined segment. The key participants in the biosimilar monoclonal antibodies therapeutics market shared a decline in the sales growth for their products. Amid the pandemic, the top-selling medicine in the market, Humira, noticed a favorable growth of 4% compared to the year 2019.

Post Covid-19 Impact on Global Biosimilar Monoclonal Antibody Market

After the covid-19 outbreak, many of the current best-selling drugs are set to fail their patent protection in the coming years. It is creating new opportunities for biosimilar drugs. After the pandemic, patents of nearly 20 oncology biologics will expire, which could guide more biosimilars in oncology specialization. Currently available biosimilars are utilized to treat many conditions and disorders, including cancer, rheumatoid arthritis, infectious disorders, psoriasis, anemia, kidney failure, type 1 and type 2 diabetes, post-menopausal osteoporosis, and expansion hormone disorders, which shows the growth in the biosimilar monoclonal antibody market.

By Type Segmental Analysis

Based on type, the global biosimilar monoclonal antibody market is segmented into Synthetic Chemicals, Biopharmaceuticals and others. Biopharmaceutical has share largest share in the global biosimilar monoclonal antibody market. Biopharmaceuticals Like generic drugs, biosimilars are interpretations of drugs that offer patients a more accessible treatment choice once their production is generally less expensive. It may be connected to a shortened clinical trial program and conceivably to applying more advanced and efficient technologies during the downstream and upstream processes.

By Application Segmental Analysis

Based on application, the global biosimilar monoclonal antibody market is segmented into Chronic & Autoimmune Disease, Oncology and others. The prevalence of chronic & autoimmune diseases is expected to drive the biosimilar monoclonal antibodies market. Biosimilar monoclonal antibodies treat chronic diseases such as cancer, autoimmune disease, and rheumatoid arthritis. Biosimilars of monoclonal antibodies like trastuzumab, bevacizumab, and rituximab are utilized in cancer treatment. Moreover, the incidence of cancer is growing year by year. Therefore, most chronic & autoimmune diseases, including cancer, are expected to drive the biosimilar monoclonal antibodies market.

By Regional Segmental Analysis

The global biosimilar monoclonal antibody market is segmented into North America, Europe, Asia-Pacific, South America and The Middle East & Africa. Europe region has accounted for the largest share of the biosimilars market, followed by the Asia Pacific & North America. Evolution in these markets is primarily pushed by several aspects, such as the forthcoming patent expiry of biologic products and the availability of new biosimilar, the rising incidence of chronic diseases, the emergence of new participants and early entry into the market.

Competitors Analysis

The companies include Biocon, Accord Healthcare, AET Biotech, Amgen, Celltrion, Reddy’s Laboratories, Hospira, 3SBio, Allergan, Alvartis Pharma and other prominent players in the global biosimilar monoclonal antibody market. Key Stakeholders

• Market research and consulting firms
• Industry associations
• Biosimilar Monoclonal Antibody Firms
• Local Governments
• Regulatory bodies
• Suppliers
• Retailers

Recent Developments

• In July 2021, Biocon Ltd., in collaboration with Viatris, Inc., received FDA support for the first convertible biosimilar SEMGLEE (insulin glargine-yfgn injection) to cure diabetes.
• In April 2021, Novartis AG partnership and agreement with Bio-Thera Solutions (China) to commercialize BAT1706 (proposed bevacizumab biosimilar by Bio-Thera Solutions) in the US and Europe, Canada, and other international markets.
• October 2018 – Amgen declared the launch of Amgevita, a biosimilar of adalimumab in Europe.
• October 2018 – In October 2018, Biogen declared the launch of Imraldi, an adalimumab biosimilar,

Scope of the Report

Report Attribute	Details
Revenue in 2021	USD 5 Billion
The revenue forecast in 2028	USD 8 Billion
Growth Rate	CAGR of 9.9% from 2022 to 2028.
Historical data	2017 – 2020
Base Year	2021
Forecast period	2022 – 2028
Region covered	North America, Europe, Asia-Pacific, South America, and Middle East & Africa
Key companies Profiled	The companies include Biocon, Accord Healthcare, AET Biotech, Amgen, Celltrion, Reddy’s Laboratories, Hospira, 3SBio, Allergan, and Alvartis Pharma Trend key players.

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