Biosimilars Market Size, Share & Trends Analysis Report By Product, By Application (Oncology, Growth Hormone, Blood Disorders, Chronic & Autoimmune Disorders), By Region, And Segment Forecasts, 2020 - 2025

Report Overview

The global biosimilars market size was valued at USD 4.36 billion in 2019. It is anticipated to exhibit a CAGR of 34.2% during 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.

Biosimilar drugs are highly identical to approved biologic drugs. They possess similar medical properties in terms of potency, safety, and efficacy to original biologic products. High prevalence of chronic diseases such as diabetes, cancer, growth hormone deficiency, and anemia is expected to further fuel market expansion in the near future.

As stated by the National Cancer Institute (NCI), an estimated 1,735,350 new cases of cancer are likely to be diagnosed in the U.S. in 2018, and 609,640 people will die from the disease. In 2012, there were around 14 million new cancer cases and about 8.2 million cancer-related deaths worldwide. Thus, there is a high demand for cost-effective biosimilars for the treatment of such chronic disorders, which, in turn, is expected to boost the market growth.

Total healthcare costs have increased due to high-prices patented pharmaceutical drugs, especially biologics. Governments of several countries are emphasizing on cost-effective drug synthesis. The U.S. is known as the country with the highest health expenditure. It has recently put emphasis on cutting healthcare expenditures. Similarly, price regulation in Japan and reduced health budget in India, have raised cost containment demands. This brings into the light the need for developing new, improved, efficient, and affordable therapeutics. Thus, efforts to bring down healthcare expenditures are projected to boost the market for biosimilars.

Stringent government regulations for the development and production of biosimilars could hinder biosimilars market growth. Specific guidelines are provided by various regulatory authorities to maintain the safety profile and effectiveness of proposed drugs. Different regulatory bodies including European Medicines Agency, U.S. Food and Drug Administration (FDA), and China Food and Drug Administration have diverse regulations for drug approvals. The presence of different regulations make biosimilar drug approval process highly tedious and time-consuming.

Biosimilars Market Trends

Phenomenal rise in R&D activities by major pharmaceutical and healthcare companies to develop biosimilar versions of biologics have been witnessed in the recent past. Focusing on R&D is an essential strategy to drive long-term growth. Several pharmaceutical and biotech companies are focusing on M&A, partnerships, and collaborations to gain leadership in terms of consumer retention and to expand their existing product portfolios. For instance, in January 2021, Biogen and Samsung Biologics entered into a strategic partnership by forming Samsung Bioepis which has launched several biosimilars of infliximab, etanercept, adalimumab, and trastuzumab in Europe.

Rapid growth of the biotechnology industry has created the demand for safe and cost-effective medicines to curtail the existing healthcare expenditure. Biosimilars have proven to be less expensive than originators drugs due to cost-effective manufacturing processes. Various studies indicate the fact that biosimilars, which are derivatives of living organisms fit the cost-effectiveness ratio. Biosimilars have been proven to be of slightly lower or almost equal effectivity in comparison to their respective reference biopharmaceuticals and are available at a competitive cost. This is attributed to the rising demand for biosimilars worldwide.

Biological drugs are facing patent expiration in the near future and are subject to face competition from biosimilars. For instance, the patents of a blockbuster biologic Avastin expired in July 2019 in the US and will expire in January 2022 in Europe. Also, FDA has approved several biosimilars including Cyltezo, Amjevita, and Hyrimoz for AbbVie’s Humira, and these biosimilars are expected to be launched by 2023. The patent and Intellectual Property Rights (IPR) expirations of these biological drugs are presenting huge opportunities for biosimilar manufacturers to tap this 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.

In contrast to chemical medicines, biosimilar drugs are produced from living organisms by using biotechnology methods that include the usage of sophisticated methods of cell culture and purification technologies. The time taken to develop biosimilar ranges between seven to eight years and costs around USD 100 million to USD 250 million in the US and Europe. Biosimilars are large molecule sizes and have complex structures. They are manufactured using an inimitable line of living cells, which makes it difficult to produce an identical copy. Compared to chemical medicines that have simpler structures and are manufactured using a predictable chemical process, biosimilars involve more complexities in their manufacturing process incurring high costs. Thus, the high manufacturing cost and complexities act as major restraints for the development of biosimilars.

Availability of substitute products including biobetters and non-original biologics is expected to hinder the market growth. Biobetters are recombinant protein drugs and belong to the same class as that of the biologics but are not identical in nature. Non-original biologics are identical to innovator drugs but lack a dedicated regulatory pathway. Biosimilars are facing excessive competition from them, mostly because biosimilars have regulatory policies governing their use. Many countries, such as China and the U.S., lack a consistent regulatory pathway for biobetters and non-original biologics, which makes it an opportunistic market in the respective countries. Biosimilar manufacturing includes a number of complexities compared to the ease of manufacturing biobetters and non-original biologics. Thus, the rising acceptance of non-original biologics and bio-betters is likely to hinder the biosimilar market.

Product Insights

Recombinant non-glycosylated proteins include human growth hormone, granulocyte colony-stimulating factor, interferons, and insulin. In 2016, recombinant non-glycosylated proteins was the largest revenue-generating segment due to increased regulatory approvals. For instance, in November 2016, the European Medicines Agency approved three drugs: Lusduna (insulin glargine biosimilar) and Movymia and Terrosa (teriparatide biosimilar).

In addition, increasing incidence of chronic diseases such as diabetes, cancer, arthritis, Alzheimer’s disease, chronic kidney disease, and chronic pain is expected to boost the market growth. According to the Centers for Disease Control and Prevention (CDC), in 2016, around 29.0 million individuals in the U.S. were suffering from diabetes. As stated by the Canadian Diabetes Association, the prevalence of diabetes is growing in Canada and it is projected to reach around 5.0 million by 2025.

The recombinant glycosylated proteins segment is expected to witness lucrative CAGR during the study period. Patent cliff of biologics products including erythropoietin and monoclonal antibodies is anticipated to propel this growth. For instance, Roche’s Actemra/RoActemra (tocilizumab) was approved by the European Medicines Agency in January 2009 and by the U.S. FDA in January 2010. Patents of these drugs expired in the U.S. in December 2015 and it will expire in Europe in April 2017.

European countries including Germany, U.K., and France have the most favorable market conditions for biosimilars. Demand for biosimilars is high in European countries as compared to other regions owing to the availability of a well-developed regulatory framework coupled with the presence of a large number of biopharmaceutical companies. These companies focus on price competition and innovative product development to command market dominance.

Application Insights

The oncology segment dominated the global market for biosimilars in terms of revenue in 2016. This is due to the high prevalence of cancer including lung, liver, colorectal, stomach, breast, and blood cancer. According to the World Health Organization (WHO), cancer is the second leading cause of deaths around the world. It was accountable for around 8.8 million deaths in 2015.

The death rate due to cancer is high in low- and middle-income countries with about 70% deaths caused by cancer. The high cost of cancer drugs and treatment and the unavailability of advanced healthcare facilities are some of the major factors responsible for the high mortality rate. Therefore, there is an increasing demand for low-cost therapeutic drugs that are highly effective and less expensive.

The blood disorders segment is projected to grow at a lucrative rate during the forecast period. Factors such as the positive outcome of the ongoing biosimilars clinical trials and prevalence of anemia, hemophilia, and blood clots among other blood disorders are expected to propel growth in the near future. Thus, there is a rising demand for innovative therapeutic products at low cost which is expected to drive growth.

Germany, U.K., China, and India are projected to account for the largest share in the market for biosimilars. The favorable regulatory environment, government support, and increasing prominence to cut down healthcare expenditures in these countries are some of the key reasons for high product adoption in these regions. In addition, biopharmaceutical companies are focusing on new product development and its launch to cater to the unmet needs of patients, which is expected to positively impact market growth.

Regional Insights

Europe held the largest market share in terms of revenue in 2021 due to the presence of a well-defined regulatory framework for biosimilars and major biopharmaceutical companies such as Johnson & Johnson, Novartis, AstraZeneca, Pfizer, Merck, Sanofi, and GlaxoSmithKline. Furthermore, well-developed healthcare infrastructure and a growing number of product launches have fueled the regional market growth.

The U.S has been a late entrant in the biosimilars market and has yet to reach its full potential. It presents ample commercialization prospects and is believed to provide a multitude of opportunities for biosimilars manufacturers. A large number of market players have emerged in the recent years in the U.S., such as Amgen, Inc., Merck & Co., Inc., and Mylan Pharmaceuticals, Inc. among others.

The U.S. accounted for the largest revenue share in the North American market owing to the growing number of product approvals, rising demand for biosimilars, and regional presence of leading players in the market. For instance, in May 2022, Amneal Pharmaceuticals received the Biologics License Application (BLA) by the U.S. FDA for its FYLNETRA (pegfilgrastim-pbbk), a biosimilar drug to Neulasta. Also, in December 2021, Coherus BioSciences received the FDA approval for its YUSIMRY (adalimumab-aqvh), a biosimilar drug of HUMIRA. Thus, the rising product approvals are expected to drive the demand for biosimilars in the U.S.  

Indian biosimilars market is expected to grow at a lucrative CAGR during the forecast period owing to the high demand for cost-effective drugs, presence of contract manufacturing organizations, and favorable government regulations. As of January 2022, around 127 biosimilars were approved in India, boosted by the strong R&D and manufacturing capabilities of leading Indian companies such as Biocon, Zydus Cadila, Reliance Life Sciences, Intas, Dr.Reddys, Sun Pharma, and Lupin.

Key Companies & Market Share Insights

The market is fragmented with the presence of many medium- and large-scale manufacturers. Several big companies in the sector include Amgen Inc.; F. Hoffmann-La Roche Ltd.; Sandoz International GmbH; Dr. Reddy’s Laboratories Ltd.; Teva Pharmaceutical Industries Ltd.; Pfizer Inc.; Samsung Bioepis; Biocon; and Mylan N.V.

Leading players are involved in collaborations, new drug developments, mergers and acquisitions, and regional expansions to strengthen their market positions. New drug launches and collaborations help companies to gain maximum revenue share and expand regional presence and existing product portfolio. For instance, in October 2016, Teva Pharmaceutical Industries Ltd. and Celltrion Healthcare entered into a strategic partnership to commercialize CT-P10 and CT-P6 (Celltrion’s monoclonal antibodies biosimilar candidates) in U.S. and Canada.

Biosimilars Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global biosimilars market report on the basis of product, application, and region:

• Product Outlook (Revenue, USD Million, 2014 - 2025)

  • Recombinant Non-Glycosylated Proteins

    • Human Growth Hormones

    • Granulocyte Colony-Stimulating Factor (G-CSF)

    • Interferons

    • Insulin

  • Recombinant Glycosylated Proteins

    • Erythropoietin

    • Monoclonal Antibodies

    • Follitropin

• Application Outlook (Revenue, USD Million, 2014 - 2025)

  • Oncology

  • Blood Disorders

  • Growth Hormonal Deficiency

  • Chronic and Autoimmune Disorders

  • Others

• Regional Outlook (Revenue, USD Million, 2014 - 2025)

  • North America

    • The U.S.

    • Canada

  • Europe

    • Germany

    • The U.K.

  • Asia Pacific

    • China

    • India

  • RoW