Biosimilar Monoclonal Antibodies Global Market Report 2020-30: COVID-19 Growth and Change

December 2020 •
200 pages •
Report ID: 5995085 •
Format: PDF

Summary
Table of contents

Major players in the biosimilar monoclonal antibodies market are Pfizer, Novartis, Allergan, Coherus BioSciences, Biocon, Amgen, Boehringer Ingelheim, Celltrion, BioXpress Therapeutics, and Intas Pharmaceuticals Limited.

The global biosimilar monoclonal antibodies market is expected to decline from $3.21 billion in 2019 to $3.04 billion in 2020 at a compound annual growth rate (CAGR) of -5.18%. The decline is mainly due to the COVID-19 outbreak that has led to restrictive containment measures involving social distancing, remote working, and the closure of industries and other commercial activities resulting in operational challenges. The entire supply chain has been disrupted, impacting the market negatively. The market is then expected to recover and reach $7.18 billion in 2023 at a CAGR of 33.13%.

The biosimilar monoclonal antibodies market consists of sales of biosimilar monoclonal antibodies and related services by entities (organizations, sole traders and partnerships) that produce biosimilar monoclonal antibodies, which are used to treat patients with chronic diseases such as cancer, rheumatoid arthritis, and autoimmune disease. Biosimilar monoclonal antibodies are highly similar to actual monoclonal antibodies in terms of pharmaceutical quality, safety, and efficacy, and are used to boost immunity by identifying and neutralizing foreign bodies. The market consists of revenue generated by the biosimilar monoclonal antibodies companies by the sales of these products.

In May 2020, AbbVie, a US-based biopharmaceutical company, has acquired Allergan for an amount of $63 million. This transaction expands and diversifies AbbVie’s revenue base and supports in maintaining its leadership positions in biosimilar monoclonal antibodies. Allergan is an Ireland-based pharmaceutical company that manufactures, develops, and markets drugs, biosimilars, medical devices, eye care, and others.

The biosimilar monoclonal antibodies market covered in this report is segmented by type into synthetic chemicals; biopharmaceuticals; others and by application into chronic & autoimmune diseases; oncology; others.

Stringent regulations imposed on approvals of biosimilars is anticipated to hinder the growth of the biosimilar monoclonal antibodies market. The governments of different regions impose different rules regarding the production and use of biosimilars. Further, issues such as patent infringement or agreement issues restrict the manufacturers of biosimilars from commercializing the government-approved biosimilars. The US Food and Drug Administration requires a double regulatory approval for biosimilars, restricting the use of biosimilars as an interchangeable drug to biologics, whereas, in Europe, the European Medicines Agency (EMA) approves biosimilars as interchangeable products for biologics. In February 2019, out of the total 17 approved biosimilars, only 7 biosimilars including 4 originating biologics could enter the US commercial market. The strict government policies for approval of these drugs negatively impact manufacturers in the biosimilar monoclonal antibodies market.

The prevalence of chronic diseases is expected to drive the biosimilar monoclonal antibodies market. Biosimilar monoclonal antibodies are used to treat chronic diseases such as cancer, autoimmune disease, and rheumatoid arthritis. In cancer treatment, biosimilars of monoclonal antibodies such as trastuzumab, bevacizumab, and rituximab are used. Moreover, the incidence of cancer is increasing year by year. According to the American cancer society (ACS), in 2020, about 1.8 million new cancer cases are expected in the United States. Therefore, the prevalence of chronic diseases including cancer is expected to drive the biosimilar monoclonal antibodies market.

The focus areas for many companies in the biosimilar monoclonal antibodies market has shifted to mergers and acquisitions to acquire more production capabilities. Large prime manufactures are forming joint ventures or buying small or midsized companies to acquire new capabilities, or to gain access to new markets. In February 2017, Aurobindo Pharma Limited announced that it had acquired four cell culture-derived biosimilar products from TL Biopharmaceutical AG of Switzerland. As part of the agreement, TL will supply all the developmental data for four molecules and Aurobindo and/or its affiliates will develop, commercialize and market these products globally. Out of the four biosimilars acquired, three of them are monoclonal antibodies in oncology. In another instance, in May 2020, AbbVie, a US-based biopharmaceutical company, announced its decision to acquire Allergan for an amount of $63 million. This transaction expands and diversifies AbbVie’s revenue base and supports in maintaining its leadership positions in biosimilar monoclonal antibodies.

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