Biosimilars Market Size, Share & Trends Analysis By Product (Recombinant Glycosylated Proteins, Recombinant Non-Glycosylated Proteins), By Application (Rheumatoid Arthritis, Oncology), By Region And Segment Forecasts 2023 - 2030

Report Overview

The global biosimilars market size was valued at USD 21.8 billion in 2022 and is expected to grow at a compound annual growth rate(CAGR) of 15.9% over the forecast period. The cost-effectiveness of biosimilar drugs and the high prevalence of chronic disorders globally are some major factors contributing to market growth. In addition, these drugs are comparatively easy to produce since they require less investment in research and development while providing similar results. This can help in cutting down expenditure on health. Moreover, the reduction in production cost and increasing demand can encourage producers to shift tobiosimilars due to increased profits, which can give a further boost to this market. Biosimilars may contain a bit different substances and combinations of medical ingredients but are considered alike to their reference biologics when it comes to effectiveness and safety.

Several regulations are in place to assess the compatibility and safety of biosimilar drugs. For instance, FDA’s Abbreviated New Drug Application Process requires applicants to scientifically prove that the performance of their product is similar to the reference biologics. It can be demonstrated by proving that their product takes a similar time to reach the bloodstream as the original product. Such regulations can help in building trust in these drugs and expand their market share.Moreover, the increasing prevalence of chronic or non-communicable diseases across the globe is also expected to drive the market. According to a statistic released by the World Health Organization in September 2022, non-communicable diseases, such as cancer, diabetes, and heart diseases, cause 41 million deaths every year out of which 77% of deaths belong to low- and middle-income countries.

However, due to the lack of awareness and high costs, many patients from these countries cannot afford the necessary treatments. Since biosimilars offer similar results and are cheaper than reference biologics, they can be used to increase access to life-saving treatments for patients in these countries and lead to an increase in its customer segment.The regulations with respect to producing biosimilars require about 8 years of exclusivity and the patent expiration of several products further creates an opportunity for the players in the market. An article released in February 2020 by MJH life sciences, The Center for Biosimilars suggests 20 oncology biologics are expected to expire by 2023, which can give a further boost to the market growth during the forecast period.

The U.S. FDA had already approved three cancer-related biosimilars in 2022, which are expected to hit the market in 2023.These growing opportunities in this market are also encouraging key players to increase their investment in the research and development of biosimilars. For instance, according to an article published in Business Today in April 2022, Biocon Biologics had been planning to increase their R&D expenses by 10% to 15% to advance their pipeline of biosimilar molecules. The step is expected to help it strengthen its future position in the market. Currently, there is a boom in the pharmaceutical industry to develop biosimilar medications.

Over 700 clinical trials for biosimilars are being conducted worldwide for different indications including genitourinary, endocrinology, immunology, oncology, and other chronic diseases. The main objective of these trials is to determine the efficacy, similarity, and immunogenicity of a biosimilar drug. For instance, in April 2022, Amgen reported positive outcomes from the phase III study of its biosimilar candidate (abp 654) to Stelara (ustekinumab). Several leading companies, such as Hospira, Celltrion, Pfizer, Inc., Samsung Bioepis, and Biocon, have announced positive outcomes from the clinical trials of their biosimilar candidates. These results have a positive outreach in the market and are expected to boost market growth during the forecast period.

The COVID-19 pandemic had adversely affected the market. The pandemic led to disruptions of supply chains across the world, which restricted the supply of essential ingredients including Active Pharmaceutical Ingredient (API) needed to produce drugs. Many countries including the U.S. depended on China for the supply of these ingredients and it being the center of origin for COVID-19, the country was adversely impacted, which compelled it to block its supply to other countries. According to an article by Lazuline Bio, 70% of pharmaceutical production in India is dependent on China, and India supplies 18% of its total volume of APIs to the U.S. However, the supply chain was highly disrupted owing to the restrictions imposed by the governments of various nations.

Product Insights

On the basis of the product, the market is segmented into recombinant non-glycosylated proteins and glycosylated proteins. The recombinant non-glycosylated proteins segment accounted for the largest revenue share of 54.9% in 2022 owing to the increasing regulatory approvals for biosimilars by various governments. For instance, the U.S. Food and Drug Administration has already approved biosimilars named Yuflyma (adalimumab-aaty) and Idacio (adalimumab-aacf) in May 2023 and December 2022 respectively for the reference product Humira (adalimumab), which is an important drug that facilitates treatment of Rheumatoid Arthritis (RA). Moreover, the increasing prevalence of chronic diseases, such as diabetes can also drive market growth for this segment.

According to the International Diabetes Federation’s Atlas 2021, 537 million adults across the world were living with diabetes, whereas as per the facts released by the American Heart Association, the age-adjusted prevalence rate for cardiovascular disease was 7354.1 per 100,000 people in 2020. The recombinant glycosylated proteins segment is expected to grow at the fastest CAGR of 14.9% over the forecast period. Biologics, such as erythropoietin (EPO), Humira, and Neulasta, have been beneficial in the treatment of chronic disease and with their patent expiration, many players are competing to enter the biosimilars market, which can significantly drive market growth with improved access to treatments. Moreover, technological advancements in the recombinant glycosylated proteins segment have also led to the emergence of several therapies, such as modified proteins and soluble receptors, that can further add to the growth of this segment.

Application Insights

On the basis of applications, the market has been segmented into oncology, chronic and autoimmune disorders, rheumatoid arthritis, growth hormonal deficiency blood disorders, and chronic and autoimmune disorders. The chronic and autoimmune disorders segment accounted for the largest revenue share of around 21.6% in 2022 due to the increasing prevalence of and awareness regarding autoimmune diseases. As per the National Institute of Environmental Health Sciences, approximately 24 million people in the U.S. are inflicted by autoimmune diseases. The oncology application segment is estimated to grow at the fastest CAGR of 17.0% over the forecast period.

The increasing number of cancer cases worldwide is expected to be the major driver for market growth. According to the statistics released by the World Cancer Research Fund International, nearly 18.1 million people were suffering from cancer in 2020. The development of biosimilars for the treatment of cancer can provide cost-effective treatment options for patients in low- and middle-income countries where the death rates for cancer patients are higher. Increasing accessibility to affordable treatment can further boost the market.

Regional Insights

North America dominated the market with the largest revenue share of 40.4% in 2022 owing to a strong regulatory framework for biosimilars and the presence of major players in the region. Moreover, the region has relatively easy access to biosimilars. According to the U.S. Generic Biosimilars Saving Report 2021, 31 biosimilars had been approved and 20 have been launched in the U.S., which has resulted in an increment of nearly 10 million days of therapy. The 20 biosimilars launched in the U.S. are priced 30% lesser than the biologics and have resulted in lowering the cost for both biosimilars and biologics. This cost reduction is expected to provide a further boost for biosimilars in this region.

Asia Pacific is expected to grow at the fastest CAGR of 18.4% over the forecast period. The presence of key players, such as Dr. Reddy’s Laboratories, Biocon, Pfizer Inc., and Celltrion, has helped in the development and commercialization of biosimilars in this region. For instance, in August 2019, Dr. Reddy’s Laboratories launched a biosimilar of Roche’s Avastin in India, which facilitates the treatment of various types of cancers. Similar developments in the market coupled with increased health expenditure are expected to propel the growth of biosimilars in this region. According to the World Bank data retrieved in April 2023, health expenditure in China as a percentage of GDP has increased from 4.98% in 2015 to 5.59% in 2020.

Key Companies & Market Share Insights

The market is highly competitive, with the presence of a large number of global and local players. Since biosimilars help in the reduction of costs and lead to increased profit margins, it has encouraged new players to enter the market. Several players are focusing on seeking regulatory approvals, launching new products, increasing spending on research and development, and regional expansion to strengthen their position in the market. For instance, in January 2020, Pfizer Inc. launched a biosimilar for Roche cancer drug Rituxan (rituximab) in Japan. Rituxan is the first biosimilar launched by Pfizer Inc. in Japan, which has helped the company to enter the Japanese market and the cost for Rituxan will be 24% lower than its reference biologics resulting in increased profit margin. Such opportunities are expected to further boost the market growth. Some of the prominent players in the global biosimilars market include:

• Amgen Inc.

• F Hoffman-La Roche Ltd.

• Sandoz International GmbH

• Dr. Reddy’s Laboratories Ltd.

• Teva Pharmaceutical Industries Ltd.

• Pfizer Inc.

• Samsung Biopis

• Biocon

• Viatris Inc.

• Celltrion Healthcare Co.,Ltd.

• AbbVie Inc.

Biosimilars Market Report Scope

Global Biosimilars Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2018 to 2030. For this report, Grand View Research has segmented the biosimilars market based on product, application, and region:

• Product Outlook (Revenue in USD Billion, 2018 - 2030)

  • Recombinant Non-glycosylated Proteins

  • Recombinant Glycosylated Proteins

• Application Outlook (Revenue in USD Billion, 2018 - 2030)

  • Oncology

  • Blood Disorders

  • Growth Hormonal Deficiency

  • Rheumatoid Arthritis

  • Chronic and Autoimmune Disorders

  • Others

• Regional Outlook (Revenue in USD Billion, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Sweden

    • Norway

    • Denmark

  • Asia Pacific

    • China

    • Japan

    • India

    • Australia

    • Thailand

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa

    • Saudi Arabia

    • South Africa

    • UAE

    • Kuwait