Biosimilars Market

SKU: DMPH466 | Last Updated On: Sep 16 2022 | Available Formats

> Biosimilars Market Expected to reach a high CAGR of 9.60% By 2029: DataM Intelligence

Biosimilars Market is segmented by Therapy Type (Recombinant Non-Glycosylated Proteins (Human growth hormone, Granulocyte colony-stimulating factor, Interferons, Insulin), Recombinant Glycosylated Proteins (Erythropoietin, Monoclonal antibodies, Follitropin)), By Application (Oncology, Blood Disorders, Growth Hormonal Deficiency, Chronic and Autoimmune Disorders, Others), By End User (Hospitals, Retail Pharmacies), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2022-2029.


Market Overview

[150 Pages Report] The Biosimilars Market size was valued at USD 12,915.10 million in 2021 and is estimated to reach at a compound annual growth rate CAGR of 9.60% over the forecast period 2022 to 2029.

Biosimilars Market - Strategic Insights



Market CAGR


Segments Covered

By Therapy Type, By Application, By End User and By Region

Report Insights Covered

Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and acquisitions, New Product Launches, Growth Strategies, Revenue Analysis, and Other key insights.

Fastest Growing Region

Asia Pacific

Largest Market Share 

North America

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Biosimilar drugs are highly identical to approved biological 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 are expected to further fuel market expansion soon. As per a recent article, biosimilars are estimated to play a significant role in enhancing the public health issue by addressing customer needs. The potential savings from the use of biosimilars is estimated to be around over USD 100 billion by the year 2021. An increase in demand for biosimilar drugs to reduce healthcare costs will be one of the major market boosting factors. In 2021,  According to a recent report, more than 40 biosimilars are under development, including approximately 20 biosimilars ready to be released into the market, and a significant number of biosimilars are in the pipeline.

Market Dynamics:

An increasing number of biosimilar drug approvals by the FDA

An increase in the number of approved biosimilars due to greater clarity in the U.S. Food and Drug Administration (FDA) review process other than the manufacturing and development process are expected to drive biosimilars market growth. For instance, in July 2018, the U.S. FDA introduced a Biosimilars Action Plan to encourage the development of biosimilars. This approval process encourages applicants to resolve patent disputes before launching biosimilars. Moreover, the number of filed biosimilars applications has increased as manufacturers have become more comfortable with the complex regulatory and litigation schemes associated with filing a biosimilar application. For instance, according to the biosimilars update report by Amgen in 2019, As of January 2019, the US Food and Drug Administration (FDA) approved 17 biosimilars, out of which 7 products launched in 4 therapeutic areas.

However, the high development cost of the biosimilar drug will be one of the major reasons impeding the adoption rates in underdeveloped and few developing countries. As per recent research, it takes around 7 to 8 years and costs around USD 100 million to USD 250 million to develop a biosimilar. High costs related to biosimilar drugs development will continue to hinder market growth over the forecast timeframe.

Moreover, several manufacturing challenges for biosimilars that primarily arise due to biologics being far more structurally complex and more difficult to characterize, produce, and reproduce than most small-molecule drugs are also expected to restrain the market growth. A small variation in the manufacturing process can potentially alter the medicine’s safety and efficacy.

Market Segmentation:

The monoclonal antibodies segment is predicted to hold a prominent share in the global market of biosimilars

The global biosimilars market has been segmented by product type into monoclonal antibodies, recombinant human growth hormone (rhgh), insulin, anti-coagulants, erythropoietin, fusion proteins, granulocyte colony-stimulating factor, and follitropin among others. The monoclonal antibodies segment is expected to hold the highest market share in the year 2019. Increasing usage of biosimilar monoclonal antibodies that are cost-effective and increasing number of product launches is expected to drive the market for monoclonal antibodies. For instance, in April 2020, Roche developed a serology test to detect antibodies in individuals who have been exposed to COVID-19. In April 2020, Lilly partnered with the National Institutes of Allergy and Infectious Diseases (NIAID) to study baricitinib as part of NIAID’s Adaptive COVID-19 treatment clinical trial. NIAID, part of the National Institutes of Health (NIH), and Lilly progressed LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), to Phase 2 testing in pneumonia patients hospitalized with COVID-19.

Moreover, the oncology segment dominated the global market for biosimilars in terms of revenue in 2019. This is due to the high prevalence of cancer including lung, liver, colorectal, stomach, breast, and blood cancer.

Geographical Penetration:

North America is expected to dominate the biosimilars market

By geography, North America is expected to dominate the global biosimilars market in the year 2019, growing with a CAGR of xx% during the forecast period. U.S. dominated the North American Biosimilars market and was valued at USD XX million in the year 2019. U.S. accounted for the highest market revenue share of XX% in the year 2019. There have been numerous licensing transactions and joint ventures in this industry which has improved the accessibility of the marketed biosimilars in the U.S. Owing to the higher ability to provide higher returns than for small molecules or generic drugs, the industry is drawing interest in a wide spectrum of pharmaceutical companies. For instance, Amgen Inc. is fostering its product pipeline to become a powerhouse in the U.S. biosimilars market. The company has invested about USD 200 million in each of its 10 programs.

Competitive Landscape:

The global biosimilars market is highly fragmented. There is massive competition in the biosimilar market. With the presence of many domestic and also international market players. Most of the market players are adopting various growth strategies such as acquisitions, partnerships, new product launches to survive in the market. For instance, in 2018 Mylan NV  launched Hulio, a biosimilar to AbbVie's Humira (adalimumab).

COVID-19 Impact: COVID has positively impacted the biosimilars market

The spread of COVID-19 across the globe has positively impacted the biosimilars market as many clinical trials were being conducted. In April 2020, Lilly partnered with the National Institutes of Allergy and Infectious Diseases (NIAID) to study baricitinib as part of NIAID’s Adaptive COVID-19 treatment clinical trial. NIAID, part of the National Institutes of Health (NIH), and Lilly progressed LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), to Phase 2 testing in pneumonia patients hospitalized with COVID-19. The Pfizer initiative, the COVID-19 Therapeutics Accelerator, will assess, identity, and scale-up treatments to make products available and affordable for vulnerable communities. It will screen thousands of safety-related compounds and consider new investigational compounds and monoclonal antibodies. 

Recent Developments:

  • In March 2020, Pfizer Inc. and Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for tanezumab 2.5 mg which is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF) inhibitors.
  • In 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.), a human monoclonal antibody, for the treatment of metastatic Merkel cell carcinoma (MCC), a rare disease.

Trending Topics

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What is the Biosimilars Market growth?

The market is growing at a CAGR of 9.60%

What is Biosimilars Market size in 2021?

The Biosimilars Market size was valued at USD 12,915.10 million in 2021

Who are the key players in Biosimilars Market?

Amgen Inc, Teva Pharmaceutical Industries Ltd, Novartis AG, Pfizer Inc, Biocon, Samsung Bioepis, Mylan NV, Celltrion, Biogen, Intas Pharmaceutical Ltd.

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