Biosimilars Market to Reach More than US$ 85 Bn by 2031

Biosimilars Market Outlook 2031

• The global biosimilars market was valued at US$ 20.4 Bn in 2021

• The global market is expected to advance at a CAGR of 15.5% from 2022 to 2031

• The global biosimilars market is anticipated to reach more than US$ 85 Bn by the end of 2031

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Overview of Biosimilars Market

Biosimilar can be defined as a biologic medical product, which is considered very similar to an already-approved biologic. These biosimilars are approved based on their efficacy, quality, safety, and the standards of pharmaceutical quality that apply to all biologic medicines.

Biosimilars are generic versions of biologics that have passed their patent expiration date. The global biosimilars market is expected to be driven by patent expiration of well-known biologics. Increase in approval and sales of biosimilars has led to a significant decline in sales of biologics that had a steady or growing demand.

The burden of chronic diseases has been rising across the globe. Increase in prevalence of chronic diseases can be largely ascribed to the aging population and changing lifestyle of the people. Diabetes, hypertension, stroke, respiratory diseases, oral diseases, obesity, arthritis, and cancer are some of the common chronic diseases. On the other hand, biosimilar monoclonal antibodies are being extensively used in the treatment of rheumatoid arthritis and cancer.

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Approvals of biosimilars have been increasing globally owing to changing regulations and rise in pressure on healthcare systems to facilitate treatment for all patients. Biosimilars or copy biologics are being increasingly adopted by physicians, authorities, and patients, owing to the much-needed improvements in the access to therapeutically viable options for the treatment of various diseases. Companies are increasing the production of biosimilar medicines, oncology biosimilars, and Remicade biosimilars to broaden their revenue streams.

High Prevalence of Chronic Diseases and Rise in Number of Cancer Patients to Boost Biosimilars Market

Rise in prevalence of chronic diseases is augmenting the global market. Biosimilar drugs are becoming increasingly popular across the world because of their cost-effectiveness. Increase in cancer patients and chronic disease cases; and growth in geriatric population are projected to fuel the demand for biosimilars during the forecast period.

Over half of the population of the U.S. is likely to suffer from at least one chronic disease during their lifetime. According to the WHO, chronic disease prevalence is expected to rise by 57% by 2020. Rapid population growth in emerging markets is expected to drive the prevalence of chronic diseases.

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Cancer is the second leading cause of death globally, with over 70% of deaths occurring in low- and middle-income countries. The incidence of cancer increases with age, most likely due to the rise in risk of specific cancers as people get older.

Growth in pipeline of biosimilar drugs for the treatment of chronic diseases is projected to propel the global biosimilars market in the next few years. ABRILADA, a biosimilar to Humira, was approved by the U.S. Food and Drug Administration (FDA) in November 2019 for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, and plaque psoriasis.
Changing Government Regulations to Augment Demand for Recombinant Non-glycosylated Protein Products

In terms of product, the recombinant non-glycosylated proteins segment held a relatively large market share in 2021. The segment has been split into insulin, granulocyte colony stimulating factor, recombinant human growth factor, and interferons.

Recombinant non-glycosylation involves the production of active substances in bacteria, which results in non-glycosylation, allowing the active substance to remain biologically active. Growth of the segment can be attributed to the rise in the prevalence of chronic diseases, which require recombinant non-glycosylated proteins biosimilars for treatment. Additionally, changing regulations and increase in focus of governments on the approval of biosimilars are anticipated to drive the recombinant non-glycosylated proteins segment during the forecast period.

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Advancements in Biomedical Technology to Drive Oncology Treatments

Based on indication, the oncology segment held large revenue share of the global biosimilars market in 2021. Growth in prevalence of cancer and increase in the number of ongoing studies in the biosimilars filed across the world are likely to augment the segment during the forecast period.
Biologics are a broad category of products that include blood and blood components, vaccines, hormones, and allergens (anti-allergy medications). Monoclonal antibodies are important biologics; these are used to treat a range of diseases, including breast cancer, lymphoma, rheumatoid arthritis, psoriasis, ulcerative colitis, and Crohn's disease.

Advancements in biomedical technology have resulted in an increase in commercialization of biologics in the last few decades. This has improved cancer care. Cancer treatment is expensive; therefore, development of a biosimilar product with comparable clinical efficacy has led to lower healthcare costs and improved access to care. Hence, the oncology segment is expected to account for significant share of the market during the forecast period.

Regional Outlook of Global Biosimilars Market

Europe held more than 45% share of the global biosimilars market in 2021. It is projected to be a highly lucrative region of the global market, with high market attractiveness index, during the forecast period.

The biosimilars market in Europe is the largest in the world, accounting for roughly 60% of the global biosimilars market and growing steadily year after year. As of October 2019, 54 biosimilars of 15 originator biological medicines were approved for marketing in Europe. Countries in Europe provide valuable examples of different approaches to biosimilars policy, led by their large biosimilars markets and diverse healthcare systems.

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Biosimilars sales reflect Europe's legislative and regulatory leadership in the market. The biosimilars markets in the region is more mature than that in the U.S. However, opportunities for biosimilars companies in Europe are limited due to lower overall spending on biologicals.

Europe has set the standard, approving more treatments than any other continent. Currently, biosimilars account for 10% of the total biologics market in the region, with a majority (7%) occurring in the past five years. The percentage is significantly higher in terms of volume, reflecting the steadily increasing level of revenue savings as a result of the rise in biosimilars competition and penetration. More than 60 biosimilars have been approved for use in the European Union (EU) to date, with several more being evaluated. Therefore, the biosimilars market in Europe is expected to grow at a significant pace during the forecast period.

Analysis of Key Players in Biosimilars Market

The global biosimilars market is consolidated, with a small number of leading players accounting for a relatively large share. Most of the companies are making significant investments in research & development activities. Diversification of product portfolio and mergers & acquisitions are important strategies adopted by key players in the global biosimilars market. Pfizer, Inc., Intas Pharmaceuticals Ltd., Biocon, Dr. Reddy's Laboratories Ltd., Teva Pharmaceutical Industries Ltd., Sandoz International GmbH (A Novartis Division), Celltrion, Inc., Amgen, Inc., STADA Arzneimittel AG, and Apotex, Inc. are the prominent players operating in the global biosimilars market.

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