Global Biosimilars Market

Biosimilars Market Size, Share, Growth Analysis, By Indication Type(Auto-Immune Diseases, Blood Disorder, Diabetes, Oncology), By Product(Human Growth Hormone, Erythropoietin, Monoclonal Antibodies, Insulin), By Region - Industry Forecast 2024-2031


Report ID: SQMIG35H2167 | Region: Global | Published Date: June, 2024
Pages: 165 |Tables: 70 |Figures: 75

Biosimilars Market Insights

Biosimilars Market size was valued at USD 15.6 billion in 2019 and is poised to grow from USD 19.27 billion in 2023 to USD 128.76 billion by 2031, growing at a CAGR of 23.5% in the forecast period (2024-2031).

A biopharmaceutical product that is highly comparable to a standard biologics medication is referred to as a biosimilar, also known as just a biologic. Its complicated molecular system is built by living things or cells. Firms focus on regulating body authorization to launch the manufacturing of biosimilars when the patents on a biologic medication fall. A biological medication must be demonstrated to be identical in regards to quality, safety, and efficiency in order to be labeled as a biosimilar. Biosimilars are much more costly than generic medicines because their development needs greater rd spending and is much more complicated.

Several causes, including the patent expirations of popular biological therapies, decreased pricing, the increased frequency of chronic illnesses, and cost-cutting efforts by government agencies and 3rd party suppliers, are now driving this industry.

US Biosimilars Market is poised to grow at a sustainable CAGR for the next forecast year.

Market Snapshot - 2024-2031

Global Market Size

USD 15.6 billion

Largest Segment

Oncology

Fastest Growth

Oncology

Growth Rate

23.5% CAGR

Global Biosimilars Market ($ Bn)
Country Share for North America Region (%)

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Biosimilars Market Segmental Analysis

The Global Biosimilars Market segmentation is based on indication type, product type, and region. Based on indication the Biosimilars Market is segmented into auto-immune diseases, blood disorders, diabetes, oncology, growth deficiency, and female infertility. Based on product the Biosimilars Market is segmented into human growth hormone, erythropoietin, monoclonal antibodies, insulin, interferon, colony-stimulating factors, and others. Based on region the Global Biosimilars market is segmented into North America, Europe, Asia-Pacific, Latin America, and MEA.

Biosimilars Market Analysis by Indication

The increased prevalence of cancers globally is the main reason propelling the rise of the studied market over the projected period, and the oncology sector is anticipated to hold the largest share in the biosimilars market. The growth of the examined market is also anticipated to be fueled by key competitors' expanding oncology-focused r&d. initiatives as well as an increase in FDA certifications.

Biosimilars Market Analysis by Product

Due to numerous United States FDA approvals and launches, monoclonal antibodies had the highest share of the Global biosimilars market share in 2021. Additionally, over the projection timeframe, the sector's entire growth is being fueled by the patent expirations of numerous reference biologics and significant R&D expenditures made by market participants.

Global Biosimilars Market Size by Indication (%), 2019 (%)

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Biosimilars Market Regional Insights

In 2021, the North American region held the largest market share of the Global Biosimilars Market. Over the course of the forthcoming years, North America is predicted to experience a substantial rate in the biosimilars market. The high prevalence of chronic illnesses, such as cancer, as well as the significant investments in r&d by the leading companies, are the main factors propelling the expansion of the area's market under study. Numerous significant market competitors, including Novartis, Pfizer Inc., Biogen, Coherus Biosciences Inc., and some others, are based in North America. The market expansion in the area is accelerated by the expanding product portfolio and new product releases.

Global Biosimilars Market By Region, 2024-2031
  • Largest
  • Fastest

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Biosimilars Market Dynamics

Biosimilars Market Driver

  • Rising demand for biosimilars due to their affordability is to boost the market.

In comparison to original biologics, the development costs of biosimilars are cheaper. The price of biosimilars is reduced by lower R&D expenses. Due to supplier pricing rivalry, less expensive biosimilars frequently cause reference biologics to cost less. In the upcoming years, demand for biosimilar medications is anticipated to rise due to its notable cost-to-benefit proportion.

  • Increasing incidence of chronic illness to drive market growth.

The incidence of chronic illness is increasing, which is boosting the world market. Due to their affordability, biosimilar medications are gaining popularity on a global scale. The requirement for biosimilars, particularly for expensive patented pharmaceuticals, is estimated to rise during the projection period caused by an increase in cancer victims, chronic illness cases, and the aging population.

Biosimilars Market Restraint

  • Complexities in the development of biosimilars

It takes enormous financial outlays, technological know-how, experience with clinical trials, research criteria, and quality control systems to produce biosimilars because it is such a difficult and expensive process. Contrary to the manufacturing of generic drugs, makers of biosimilars are obligated to make comparable investments in clinical studies and post-approval safety monitoring systems.

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Biosimilars Market Competitive Landscape

Companies in the global biosimilar market could contribute money to mergers and acquisitions, product launches, changes in technology, and R&D projects. Major corporations may also spend money on new product development and marketing in the next few years. The market's greatest share belonged to Amgen Inc. It created a market for the breakthrough medicine "Mvasi," and the increased countrywide prescription rate is the primary driver of the firm's supremacy in 2021.

Biosimilars Market Top Players Company Profiles

  • Pfizer Inc.
  • Novartis AG
  • Teva Pharmaceutical Industries Ltd.
  • Samsung Bioepis
  • Sandoz International GmbH (a subsidiary of Novartis AG)
  • Amgen Inc.
  • Biocon Limited
  • Mylan N.V.
  • Dr. Reddy's Laboratories Ltd.
  • Fresenius Kabi AG
  • Celltrion Inc.
  • Apotex Inc.
  • STADA Arzneimittel AG
  • Hospira (a subsidiary of Pfizer Inc.)
  • Lupin Limited
  • Glenmark Pharmaceuticals Ltd.
  • Merck & Co., Inc.
  • Biogen Inc.
  • Sanofi S.A.
  • AbbVie Inc.

Biosimilars Market Recent Development

  • In February 2022, Biocon Biologics has agreed to acquire Viatris' biosimilars business, a global franchise focused on oncology, immunology, and endocrinology, with the goal of strengthening its position through its portfolio and future pipeline biosimilar drugs.
  • In December 2021, for the treatment of plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis, Coherus Biosciences, Inc. 's YUSIMRY, a biosimilar to Humira (adalimumab), has been given U.S. FDA approval.
  • In November 2021, to aid in the management of hyperglycemia in adult and pediatric patients with type 1 diabetes as well as individuals with type 2 diabetes, Viatris Inc. and Biocon Biologics Ltd. introduced the interchangeable biosimilar SEMGLEE.

Biosimilars Key Market Trends

  • As long as patients are the primary beneficiaries, reduced biosimilar costs will exert a significant influence on global biosimilar demand. The latest fad among the producers situated in developing biosimilar markets is the innovation's cost reduction with significant reductions. This will continue to be a common tendency over the course of the projection period, ultimately fueling the expansion of the worldwide biosimilars market. Additionally, producers of biosimilars are probably going to experiment with new production volumes or sizes. During the projected period, biosimilar manufacturers may benefit from the ability to create value by producing many biosimilar pharmaceuticals at the same site.

Biosimilars Market SkyQuest Analysis

SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Co-relates, and Analyses the Data collected by means of Primary Exploratory Research backed by the robust Secondary Desk research.

According to our analysis, the Oncology sector dominated the Global Biosimilars market in 2021 owing to the high incidence of cancers worldwide. In 2021, Monoclonal antibodies dominated the Global biosimilars market share due to the rise in the number of various U.S. FDA certificates and new product launches. In 2021, North America is to be the fastest-growing market over the forecast period.

Report Metric Details
Market size value in 2019 USD 15.6 billion
Market size value in 2031 USD 128.76 billion
Growth Rate 23.5%
Base year 2023
Forecast period 2024-2031
Forecast Unit (Value) USD Billion
Segments covered
  • Indication Type
    • Auto-Immune Diseases, Blood Disorder, Diabetes, Oncology, Growth Deficiency, Female Infertility
  • Product
    • Human Growth Hormone, Erythropoietin, Monoclonal Antibodies, Insulin, Interferon, Colony Stimulating Factors, Others
Regions covered North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA)
Companies covered
  • Pfizer Inc.
  • Novartis AG
  • Teva Pharmaceutical Industries Ltd.
  • Samsung Bioepis
  • Sandoz International GmbH (a subsidiary of Novartis AG)
  • Amgen Inc.
  • Biocon Limited
  • Mylan N.V.
  • Dr. Reddy's Laboratories Ltd.
  • Fresenius Kabi AG
  • Celltrion Inc.
  • Apotex Inc.
  • STADA Arzneimittel AG
  • Hospira (a subsidiary of Pfizer Inc.)
  • Lupin Limited
  • Glenmark Pharmaceuticals Ltd.
  • Merck & Co., Inc.
  • Biogen Inc.
  • Sanofi S.A.
  • AbbVie Inc.
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Table Of Content

Executive Summary

Market overview

  • Exhibit: Executive Summary – Chart on Market Overview
  • Exhibit: Executive Summary – Data Table on Market Overview
  • Exhibit: Executive Summary – Chart on Biosimilars Market Characteristics
  • Exhibit: Executive Summary – Chart on Market by Geography
  • Exhibit: Executive Summary – Chart on Market Segmentation
  • Exhibit: Executive Summary – Chart on Incremental Growth
  • Exhibit: Executive Summary – Data Table on Incremental Growth
  • Exhibit: Executive Summary – Chart on Vendor Market Positioning

Parent Market Analysis

Market overview

Market size

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • SWOT Analysis

KEY MARKET INSIGHTS

  • Technology Analysis
    • (Exhibit: Data Table: Name of technology and details)
  • Pricing Analysis
    • (Exhibit: Data Table: Name of technology and pricing details)
  • Supply Chain Analysis
    • (Exhibit: Detailed Supply Chain Presentation)
  • Value Chain Analysis
    • (Exhibit: Detailed Value Chain Presentation)
  • Ecosystem Of the Market
    • Exhibit: Parent Market Ecosystem Market Analysis
    • Exhibit: Market Characteristics of Parent Market
  • IP Analysis
    • (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
  • Trade Analysis
    • (Exhibit: Data Table: Import and Export data details)
  • Startup Analysis
    • (Exhibit: Data Table: Emerging startups details)
  • Raw Material Analysis
    • (Exhibit: Data Table: Mapping of key raw materials)
  • Innovation Matrix
    • (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
  • Pipeline product Analysis
    • (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
  • Macroeconomic Indicators

COVID IMPACT

  • Introduction
  • Impact On Economy—scenario Assessment
    • Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
  • Revised Market Size
    • Exhibit: Data Table on Biosimilars Market size and forecast 2021-2027 ($ million)
  • Impact Of COVID On Key Segments
    • Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
  • COVID Strategies By Company
    • Exhibit: Analysis on key strategies adopted by companies

MARKET DYNAMICS & OUTLOOK

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • Regulatory Landscape
    • Exhibit: Data Table on regulation from different region
  • SWOT Analysis
  • Porters Analysis
    • Competitive rivalry
      • Exhibit: Competitive rivalry Impact of key factors, 2021
    • Threat of substitute products
      • Exhibit: Threat of Substitute Products Impact of key factors, 2021
    • Bargaining power of buyers
      • Exhibit: buyers bargaining power Impact of key factors, 2021
    • Threat of new entrants
      • Exhibit: Threat of new entrants Impact of key factors, 2021
    • Bargaining power of suppliers
      • Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
  • Skyquest special insights on future disruptions
    • Political Impact
    • Economic impact
    • Social Impact
    • Technical Impact
    • Environmental Impact
    • Legal Impact

Market Size by Region

  • Chart on Market share by geography 2021-2027 (%)
  • Data Table on Market share by geography 2021-2027(%)
  • North America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • USA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Canada
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Europe
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Germany
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Spain
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • France
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • UK
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Europe
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Asia Pacific
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • China
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • India
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Japan
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Korea
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Asia Pacific
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Latin America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Brazil
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of South America
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Middle East & Africa (MEA)
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • GCC Countries
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Africa
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of MEA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)

KEY COMPANY PROFILES

  • Competitive Landscape
    • Total number of companies covered
      • Exhibit: companies covered in the report, 2021
    • Top companies market positioning
      • Exhibit: company positioning matrix, 2021
    • Top companies market Share
      • Exhibit: Pie chart analysis on company market share, 2021(%)

Methodology

For the Biosimilars Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:

1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.

2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Biosimilars Market.

3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.

4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.

Analyst Support

Customization Options

With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Biosimilars Market:

Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.

Regional Analysis: Further analysis of the Biosimilars Market for additional countries.

Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.

Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.

Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.

Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.

Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.

Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.

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FAQs

Biosimilars Market size was valued at USD 15.6 billion in 2019 and is poised to grow from USD 19.27 billion in 2023 to USD 128.76 billion by 2031, growing at a CAGR of 23.5% in the forecast period (2024-2031).

Companies in the global biosimilar market could contribute money to mergers and acquisitions, product launches, changes in technology, and R&D projects. Major corporations may also spend money on new product development and marketing in the next few years. The market's greatest share belonged to Amgen Inc. It created a market for the breakthrough medicine "Mvasi," and the increased countrywide prescription rate is the primary driver of the firm's supremacy in 2021. 'Pfizer Inc.', 'Novartis AG', 'Teva Pharmaceutical Industries Ltd.', 'Samsung Bioepis', 'Sandoz International GmbH (a subsidiary of Novartis AG)', 'Amgen Inc.', 'Biocon Limited', 'Mylan N.V.', 'Dr. Reddy's Laboratories Ltd.', 'Fresenius Kabi AG', 'Celltrion Inc.', 'Apotex Inc.', 'STADA Arzneimittel AG', 'Hospira (a subsidiary of Pfizer Inc.)', 'Lupin Limited', 'Glenmark Pharmaceuticals Ltd.', 'Merck & Co., Inc.', 'Biogen Inc.', 'Sanofi S.A.', 'AbbVie Inc.'

Rising demand for biosimilars due to their affordability is to boost the market.

As long as patients are the primary beneficiaries, reduced biosimilar costs will exert a significant influence on global biosimilar demand. The latest fad among the producers situated in developing biosimilar markets is the innovation's cost reduction with significant reductions. This will continue to be a common tendency over the course of the projection period, ultimately fueling the expansion of the worldwide biosimilars market. Additionally, producers of biosimilars are probably going to experiment with new production volumes or sizes. During the projected period, biosimilar manufacturers may benefit from the ability to create value by producing many biosimilar pharmaceuticals at the same site.

In 2021, the North American region held the largest market share of the Global Biosimilars Market. Over the course of the forthcoming years, North America is predicted to experience a substantial rate in the biosimilars market. The high prevalence of chronic illnesses, such as cancer, as well as the significant investments in r&d by the leading companies, are the main factors propelling the expansion of the area's market under study. Numerous significant market competitors, including Novartis, Pfizer Inc., Biogen, Coherus Biosciences Inc., and some others, are based in North America. The market expansion in the area is accelerated by the expanding product portfolio and new product releases.

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Global Biosimilars Market

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