Northbrook, IL 60062 -- (SBWIRE) -- 08/15/2023 -- The report "Biosimilars Market by Drug Class (Drug Class (Monoclonal Antibodies (Adalimumab, Infliximab, Rituximab, Trastuzumab), Insulin, Erythropoietin, Anticoagulants. rhGH), Indication, Region – Global Forecast to 2028", size is projected to reach 66.9 billion by 2028 from 29.4 in 2023, at a CAGR of 17.8% during the forecast period. Major factors driving the market growth at significant CAGR are rising incidence of chronic diseases and increasing demand of biosimilars. Furthermore, increased number of approvals and investment in research and development of biosimilars is likely to upsurge the market growth in coming years.

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Key Market Players:

Some of the prominent players in the biosimilars market are Novartis AG (Switzerland), Pfizer, Inc. (US), Dr. Reddy's Laboratories Ltd. (India), Amgen, Inc. (US), Eli Lilly and Company (US), and among others.

DRIVER: Launch of novel biosimilars

Various key market players operating in the market have a strong emphasis on the development of biosimilars. As of December 2022, FDA has approved 40 biosimilars, and 25 have launched in the US. During the COVID-19 pandemic, FDA approvals slowed significantly; however, approvals rebounded in 2022, with seven new biosimilar approvals. All seven biosimilars approved in 2022 referenced products with previously approved biosimilars; no biosimilars were approved in 2022 referencing new reference products. 2022 also registered four new product launches, including the first two Lucentis (ranibizumab) biosimilars. Additionally, in 2022, FDA designated two new interchangeable biosimilars: Rezvoglar (referencing Lantus (insulin glargine)) and Cimerli (referencing Lucentis (ranibizumab)). Although there was an overall decline in approvals during the 2020 to 2021 timeframe, the number of development programs participating in the FDA's Biosimilar Development Program has continued to rise. As of April 2023, there are around 60-70 biosimilars under pipeline studies. (Clinical.gov); half of them will be launched in three to four years. Growing approvals of biosimilars will ensure access to a greater pool of therapeutics and drive market growth.

RESTRAINT: Complexities in Manufacturing

Developing biosimilars is a highly complex and costly process that requires significant investments, technical capabilities, clinical trial expertise, scientific standards, and quality systems. Unlike the development of generic medicines, biosimilar manufacturers must invest in clinical trials and post-approval safety monitoring programs similar to that of the original innovator companies. Developing a biosimilar is a complex process. Biosimilars, like all biologics, are produced through an intricate, multistep process using living cells. However, the cell line and manufacturing process of the reference product are proprietary and belong to the original manufacturer.

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Monoclonal Antibodies accounted for the largest share of the drug class segment in the biosimilars market in 2022.

Based on the drug class, the biosimilars market is segmented into monoclonal antibodies, insulin, granulocyte colony-stimulating factor, erythropoietin, recombinant human growth hormone, etanercept, follitropin, teriparatide, interferons, anticoagulants and other drug class. The monoclonal antibodies product segment accounted for the largest share. It is expected to dominate the market throughout the forecast period. Declining of the monoclonal antibodies biosimilars owing to increased competition is likely to have positive impact on the market growth. Rising prevalence of cancer is also one of the major factor increasing demand of mabs is boosting growth of the segment.

The oncology segment accounted for the largest share of the indication segment in the biosimilars market in 2022.

Based on the indication, the biosimilars market is segmented into oncology, inflammatory and autoimmune diseases; chronic diseases, blood disorders; growth hormone deficiency; infectious diseases and other indications. Oncology accounted for the largest share of the market in 2022. Rising incidence of cancer coupled with increased demand for the cost effective biosimilars is driving the segmental growth. Furthermore, increased research and huge number of products under clinical trials is further expected to project growth at faster pace.

Asia Pacific is likely to grow at the highest growth rate during the forecast period.

Based on the region, the global biosimilars market is segmented into North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. Europe is the largest regional segment followed by Asia Pacific. The Asia Pacific region is estimated to grow at the highest CAGR in the biosimilars market during the forecast period. The emergence of new players the market, increased approvals for biosimilars in the region and loss of patent exclusitivity are some of the major factors propelling the market in Asia Pacific region.

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