Strong product pipeline and increasing investments for the development of biosimilars expected to elevate biosimilars market growth

Biosimilars Market by Product (Recombinant Glycosylated Proteins, Recombinant Peptides and Recombinant Non-Glycosylated Proteins), Disease Indication (Infectious Diseases, Oncology, Autoimmune Diseases, Growth Hormone Deficiency and Blood Disorders) Manufacturing Type (In-House Manufacturing and Contract Manufacturing) – Global Outlook & Forecast 2022-2030

According to the deep-dive market assessment study conducted by Growth+ Reports, the global biosimilars market was pegged at ~US$ 15.1 billion in 2021. The market is expected to witness a CAGR of ~21.5% from 2022 to 2030. The oncology segment held the largest market share due to rising incidence of cancers that have led to increasing R&D activities for developing cancer treatments. Cost of cancer treatment is not affordable for everyone and rapidly becoming challenging. The advent of oncology biosimilars are helping minimize the economic burden associated with cancer treatment. The global biosimilars market is mainly driven by their cost-effectiveness, new product launches, strong product pipeline, increasing investments for the development of biosimilars, and increasing partnerships among companies for development of biosimilars. However, higher costs for the development and stringent regulatory policies for approval of biosimilars are likely to restrain the market to a certain extent.

Biosimilars market has been segmented into recombinant glycosylated proteins, recombinant peptides, and recombinant non-glycosylated proteins. Recombinant glycosylated proteins segment is further categorized into monoclonal antibodies, follitropin, and erythropoietin. Similarly, recombinant peptide is categorized into calcitonin and glucagon. The recombinant non-glycosylated proteins segment is categorized into human growth hormone, insulin, interferons, and granulocyte colony-stimulating factor.

Geographically, the global biosimilars market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World (RoW). Europe dominated the biosimilars market followed by Asia Pacific. The large share of Europe in the global market can be attributed to several factors such as rising incidences of infectious diseases, rising geriatric population and presence of prominent players in this region. Moreover, biosimilars have been approved in Europe since 2006, long before FDA gave a nod for biosimilars in the U.S. According to a report published by

the European Medicine Agency, over the past 10 years, the EU has approved the highest number of biosimilars worldwide, amassing considerable evidence of their use and safety

Biosimilars have the ability to precisely target signaling pathways and cells and in turn help in revolutionizing the battle against various disease areas, such as cancer, blood-related disorders, autoimmune diseases, among others. For instance, Truxima, a biosimilar to rituximab is used for treating non-Hodgkin's lymphoma. Similarly, in Sept 2017, the FDA approved bevacizumab-awwb (Mvasi), the first biosimilar that can be used to treat colorectal, lung, brain, kidney, and cervical cancers.

The cost-saving potential of biosimilars is a major factor propelling the growth of the biosimilars market. According to RAND Corporation, biosimilars are expected to reduce direct spending on biologic drugs by US$ 54 billion from 2017 to 2026, or about 3% of total estimated biologic spending over the same period. Nevertheless, the cost savings potential of these drugs might vary across biological classes. Increasing use and growing demand for biologics coupled with increasing need for savings and efficiencies within the health care systems are factors expected to fuel the market growth during the forecast period.

Increasing R&D activities in pharmaceutical companies has resulted in robust product pipeline. Newer product launches by key players as well as increasing investments for the development of biosimilars have also played a pivotal role in propelling the biosimilars market. For instance, in August 2020, Samsung Biologics, a major shareholder in biosimilar manufacturer Samsung Bioepis announced their intent to invest around US$ 2 billion in its new manufacturing plant and bio complex. Samsung also claimed that the new plant will be the world’s largest biosimilar manufacturing facility.

Varying regulatory frameworks in different regions as well as higher costs required during the development process of biosimilars are some of the factors hindering the market growth. Development of biosimilars takes longer time as compared to development of other biological drugs. This is another factor that is likely to restrict the market growth to a certain extent.

Regionally, Europe held the largest market share in 2021. The growth of biosimilars market in this region can be attributed to factors such as increasing prevalence of infectious diseases and rising demand for biosimilars owing to its cost-effectiveness. Robust product pipeline and increasing product launches by players in the region are some of the other factors that are likely to boost the biosimilars market.

Some of the prominent players operating in the global biosimilars market are Pfizer Inc., Sandoz International GmbH, Amgen Inc., Samsung Biologics., Biocon, Teva Pharmaceutical Industries Ltd., Eli Lilly and Company, Celltrion Healthcare Co.,Ltd., Mylan N.V., STADA Arzneimittel AG, among others.

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