Biosimilars Market Size, Share, Industry, Forecast and Outlook (2023-2030)

Global Biosimilars Market is segmented By Product (Monoclonal Antibodies,Recombinant Human Growth Hormone (rhGH), Insulin, Anti-coagulants, Erythropoietin, Fusion Proteins, Granulocyte Colony Stimulating Factor, Follitropin), By Technology (Recombinant DNA Technology (rDNA technology), Monoclonal Antibodies (MAb) Technology), By Application (Oncology, Chronic and Immune Diseases, Infectious Diseases, Growth Hormone Deficiency, Blood Disorders) By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies) and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030

Biosimilars Market Overview

The Global Biosimilars Market reached USD 30.1 billion in 2022 and is projected to witness lucrative growth by reaching up to USD 76.7 billion by 2030. The global biosimilars market is expected to exhibit a CAGR of 12.8% during the forecast period 2023-2030. Biosimilars are biological products that closely resemble approved reference biologic goods and don't differ clinically significantly from them.

They are supposed to function like reference products regarding efficacy, safety, and quality. Rheumatology, oncology, hematology, gastroenterology, and endocrinology are all treated with biosimilars.

Biosimilars Market Scope

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Biosimilars Market Dynamics

The rising number of biosimilar drug approvals by the FDA drives the Global Biosimilars Market growth.

A rise in the number of approved biosimilars due to enhanced FDA (U.S. Food and Drug Administration) review procedures and manufacturing and development methods is predicted to fuel market growth for biosimilars. For instance, in March 2022, Amneal Pharmaceuticals, Inc., a pharmaceutical company, announced that the U.S. Food and Drug Administration authorized the Biologics Licence Application (BLA) for filgrastim-ayow, a biosimilar drug to Neupogen.

The product will be made available for purchase under the RELEUKO brand. Additionally, the volume of biosimilar submissions has increased as manufacturers have become more used to the complex regulatory and legal frameworks associated with filing a biosimilar application. 

The time and cost of biosimilar drug development hamper the Global Biosimilars Market growth.

The time and cost for biosimilar drug development is a significant challenge for the Biosimilars market, posing a threat to the industry's growth and profitability. The substantial research expenses of biosimilar medications are a key limitation that delays acceptance rates in poor and impoverished countries. According to recent studies, a biosimilar takes between 7 and 8 years to produce and costs between $100 million and $300 million. Throughout the projected period, high biosimilar medication development costs will continue to impede the market growth.

Biosimilars Market Segment Analysis

The Global Biosimilar Market is segmented based on product, technology, application, distribution channel, and region.

The oncology segment is expected to hold a dominant position in the market over the forecast period.

The oncology segment accounted for the highest market stake, accounting for approximately 30.7% of the biosimilars market in 2022. About one-fourth of the global pharmaceutical market is made up of biologic-based medications, which are used to treat a variety of disorders. Cancer treatment and supportive care improvements have been made due to cancer patients using biologic drugs. 

As per the article published in the Indian Journal of Medical Research in 2022, The number of cancer cases in India in 2022 was calculated using the expected population and the age-specific incidence rate for each individual anatomical site of cancer. 14,61,427 cancer incident cases were found to be the projected number in India for 2022 (the crude rate was 100.4 per 100,000).

Source: DataM Intelligence Analysis (2023)

Global Biosimilars Market Geographical Share

North America holds a dominant position in the global biosimilars market.

North America is estimated to hold around 38.1% of the total market share throughout the forecast period. Owing to the aging population in the region is increasing, advanced healthcare infrastructure, FDA approval for biosimilar drugs, and increasing diseases such as cancer. The government initiatives to support the healthcare system are expected to boost regional growth over the forecast period.

For instance, in January 2023, Amgen, a biopharmaceutical company, launched the autoimmune disease drug Humira in the U.S., giving healthcare professionals and people with conditions like psoriasis, arthritis, and Crohn’s disease a lower-cost option to a treatment now priced at around $90,000 a year. 

Source: DataM Intelligence Analysis (2023)

Biosimilars Market Players

The major global players in the market include Amgen Inc., Teva Pharmaceutical Industries Ltd., Novartis AG, Pfizer Inc., Biocon, Samsung Bioepis, Mylan NV, Celltrion, Biogen, and Intas Pharmaceutical Ltd.

COVID-19 Impact on Biosimilars Market

Russia Ukraine Conflict Analysis

The Russia-Ukraine war may affect the Biosimilars market due to research collaboration and investment and funding being impacted during times of geopolitical instability and economic uncertainty. For the development of biosimilars to advance, international research collaborations and knowledge exchange are essential. 

Research advancement and the dissemination of scientific findings may be hampered or strained by the struggle between institutions, businesses, and researchers in Russia, Ukraine, and other countries.

Artificial Intelligence Analysis:

Artificial intelligence (AI) is increasingly used in the biosimilars market to improve various aspects of the customer experience. Designing biosimilars can be facilitated by AI methods like molecular docking and machine learning. With the help of these techniques, it is possible to anticipate protein structures, molecular interactions, and binding affinities, which facilitates the development of improved biosimilar molecules.

AI systems may analyze enormous datasets, including clinical trial data, patient records, and genetic information to find patterns, forecast treatment outcomes, and optimize dosing plans. This can help prove biosimilarity and assess biosimilars' security and effectiveness.

By Product

• Monoclonal Antibodies
• Recombinant Human Growth Hormone (rhGH)
• Insulin
• Anti-coagulants
• Erythropoietin
• Fusion Proteins
• Granulocyte Colony Stimulating Factor
• Follitropin
• Others

By Technology

• Recombinant DNA Technology (rDNA technology)
• Monoclonal Antibodies (MAb) Technology 

By Application

• Oncology
• Chronic and Immune Diseases
• Infectious Diseases
• Growth Hormone Deficiency
• Blood Disorders
• Others 

By Distribution Channel 

• Hospital Pharmacies 
• Retail Pharmacies
• Online Pharmacies

By Region

• North America
  • The U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • The U.K.
  • France
  • Italy
  • Spain
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
• Middle East and Africa

Key Developments

• In May 2023, Gulf Pharmaceutical Industries PJSC (Julphar), one of the biggest pharmaceutical producers in the Middle East and Africa, announced today that it had entered into a strategic licensing agreement with Sunshine Lake Pharma, a Chinese pharmaceutical firm, to become the first manufacturer of modern Insulin biosimilars in the MENA region.
• In May 2022, Biocon Biologics, and Viatris Inc., introduced Abevmy, a bevacizumab drug in Canada. The Abevmy is a biosimilar to Avastin, developed by Roche and was approved by Health Canada for four oncology indications.

Why Purchase the Report?

• To visualize the Global Biosimilars Market segmentation based on the product, technology, application, distribution channel, and region and understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development. 
• Excel data sheet with numerous data points of biosimilars market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as Excel consisting of key products of all the major players.

The Global Biosimilars Market Report Would Provide Approximately 69 Tables, 70 Figures And 195 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies