This report provides a comprehensive analysis of the Global Biologics and Biosimilars Market, including historical market sizes from 2019 to 2022 and forecasts for 2024 to 2031. The market is estimated to be valued at USD 23,960 Million in 2023 and is projected to grow to approximately USD 73,030 Million by 2031, reflecting a compound annual growth rate (CAGR) of 17.3% during the forecast period. This growth underscores the increasing demand for advanced data management solutions and highlights the importance of technological innovations in the sector.
The global biologics and biosimilars market is experiencing significant growth driven by the increasing prevalence of chronic diseases and the rising demand for advanced therapeutic options. Biologics, which are complex molecules derived from living organisms, play a crucial role in treating conditions such as cancer, autoimmune disorders, and rare diseases, offering targeted and effective treatments. The introduction of biosimilars, which are highly similar versions of existing biologics, is enhancing market accessibility by providing more affordable alternatives, thereby expanding patient reach and reducing healthcare costs. Advances in biotechnology and manufacturing processes are facilitating the development and production of these therapies, while supportive regulatory frameworks are encouraging innovation and market entry. Additionally, the growing emphasis on personalized medicine and the integration of digital technologies are further propelling the market forward. However, the industry faces challenges including stringent regulatory requirements, high development costs, and complex manufacturing processes that can impede market growth. Intellectual property issues and market competition also pose significant hurdles for biosimilar manufacturers. Regional dynamics reveal that North America and Europe remain dominant markets due to their advanced healthcare infrastructure and high adoption rates, while emerging markets in Asia and Latin America are rapidly expanding as they improve their healthcare systems and increase investment in biotechnology. Collaboration between pharmaceutical companies, research institutions, and healthcare providers is fostering innovation and accelerating the development of new biologic and biosimilar therapies. As the market continues to evolve, the focus on sustainability, quality, and accessibility remains paramount, ensuring that biologics and biosimilars contribute effectively to global healthcare advancements.
For the geography segment, regional supply, demand, major players, and price are presented from 2019 to 2031. This report covers the following regions:
North America
Asia-Pacific
Europe
Middle East and Africa
South America
Segments-
By Product Type:
Biologics
Biosimilars
Others
In terms of product type, the market is divided into biologics and biosimilars. Biologics encompass monoclonal antibodies, vaccines, and recombinant proteins, which are extensively used in treating various diseases such as cancer and autoimmune disorders. Biosimilars, on the other hand, are characterized by their similarity to already approved biologics and provide cost-effective treatment alternatives, thus expanding patient access to these therapies.
By Source:
Human-Derived
Animal-Derived
Microbial-Derived
Plant-Derived
Others
This segmentation includes products derived from various origins, such as human, animal, and microorganisms. Human-derived biologics, including monoclonal antibodies and therapeutic proteins, dominate the market due to their specificity and efficacy in treating diseases. Animal-derived products, such as vaccines and insulin, are also significant, though their use is often limited by regulatory and ethical concerns. Microorganism-derived biologics, including recombinant proteins produced in bacteria or yeast, are gaining traction due to advancements in genetic engineering, enabling the mass production of therapeutic agents. Biosimilars in this segment are increasingly being developed to mimic human-derived biologics, offering more cost-effective treatment options.
By Manufacturing Process:
Recombinant DNA Technology
Monoclonal Antibody Production
Cell Culture Techniques
Others
This segmentation encompasses various methodologies used in the production of biologics and biosimilars, including fermentation, cell culture, and purification techniques. Fermentation processes, primarily used for microorganisms, involve growing bacteria or yeast to produce therapeutic proteins on a large scale. Cell culture processes, which utilize mammalian or insect cells, are essential for producing more complex biologics like monoclonal antibodies, ensuring proper post-translational modifications. Purification processes are critical to isolate and refine the final product, guaranteeing its safety and efficacy. The increasing focus on automation and advanced bioprocessing technologies is enhancing the efficiency and yield of manufacturing processes, driving the growth of the biologics and biosimilars market. Together, these segments highlight the diverse landscape of biologics and biosimilars, reflecting the ongoing innovations and demand for targeted therapies in modern healthcare.
Key Players
Amgen
Roche
AbbVie
Bristol-Myers Squibb
Sandoz
Pfizer
Mylan (now part of Viatris)
Samsung Bioepis
Celltrion
Teva Pharmaceutical Industries
For the competitor segment, the report includes global key players and some small players. The information for each competitor includes:
Company Profile
Main Business Information
Financial Analysis
Market Share
Please ask for sample pages for the full company list
Base Year: 2023
Historical Data: from 2019 to 2022
Forecast Data: from 2024 to 2031
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TABLE OF CONTENTS
Market Taxonomy
1. Executive Summary
1.1. Market Overview
1.2. Market Analysis and Recommendations
1.3. RA Analysis and Recommendations
2. Market Introduction
2.1. Market Definition
3. Market Background
3.1. Market Overview
3.1.1. Global Biologics and Biosimilars MarketOutlook
3.1.2. Global Biologics and Biosimilars MarketOverview
3.2. Macro-Economic Overview
3.2.1. GDP Growth
3.2.2. Retail Industry Growth
3.3. Pricing Analysis
3.4. Challenges related to the adoption of Global Biologics and Biosimilars Market
3.5. Regulations of Global Biologics and Biosimilars Market
3.6. Forecast Factors: Relevance and Impact
3.7. Market Dynamics
3.7.1. Drivers
3.7.2. Restraints
3.7.3. Opportunity
3.7.4. Trends
3.7.5. SWOT Analysis
4. Market Forecast
4.1. Market Value Projections
4.2. Market Size Projections
4.3. Y-o-Y Projections
4.4. Absolute Opportunity Analysis
5. Global Global Biologics and Biosimilars Market Analysis By Product Type
5.1. Introduction
5.1.1. Market Value Share Analysis By Product Type
5.1.2. Y-o-Y Growth Analysis By Product Type
5.2. Historical Market Size (USD Mn) Analysis 2018-2022 By Product Type
5.3. Market Attractiveness Analysis By Product Type
6. Global Global Biologics and Biosimilars Market Analysis By Source
6.1. Introduction
6.1.1. Market Value Share Analysis By Source
6.1.2. Y-o-Y Growth Analysis By Source
6.2. Historical Market Size (USD Mn) Analysis 2018-2022 By Source
6.3. Market Attractiveness Analysis By Source
7. Market Structure Analysis
7.1. Market Analysis by Tier of Companies
7.2. Market Concentration
8. Competition Analysis
8.1. Competition Dashboard
8.2. Company Profiles (15 Companies)
8.2.1 Amgen
8.2.1.1. Overview
8.2.1.2. Product Type Portfolio
8.2.1.3. Financial Overview
8.2.2. Roche
8.2.2.1. Overview
8.2.2.2. Product Type Portfolio
8.2.2.3. Financial Overview
8.2.3. AbbVie
8.2.3.1. Overview
8.2.3.2. Product Type Portfolio
8.2.3.3. Financial Overview
8.2.4. Bristol-Myers Squibb
8.2.4.1. Overview
8.2.4.2. Product Type Portfolio
8.2.4.3. Financial Overview
8.2.5. Sandoz
8.2.5.1. Overview
8.2.5.2. Product Type Portfolio
8.2.5.3. Financial Overview
8.2.6. Pfizer
8.2.6.1. Overview
8.2.6.2. Product Type Portfolio
8.2.6.3. Financial Overview
8.2.7. Mylan (now part of Viatris)
8.2.7.1. Overview
8.2.7.2. Product Type Portfolio
8.2.7.3. Financial Overview
8.2.8. Samsung Bioepis
8.2.8.1. Overview
8.2.8.2. Product Type Portfolio
8.2.8.3. Financial Overview
8.2.9. Celltrion
8.2.9.1. Overview
8.2.8.2. Product Type Portfolio
8.2.9.3. Financial Overview
8.2.10. Teva Pharmaceutical Industries
8.2.10.1. Overview
8.2.10.2. Product Type Portfolio
8.2.10.3. Financial Overview
8.2.11. Company11
8.2.11.1. Overview
8.2.11.2. Product Type Portfolio
8.2.11.3. Financial Overview
8.2.12. Company12
8.2.12.1. Overview
8.2.12.2. Product Type Portfolio
8.2.12.3. Financial Overview
8.2.13. Company13
8.2.13.1. Overview
8.2.13.2. Product Type Portfolio
8.2.13.3. Financial Overview
8.2.14. Company14
8.2.14.1. Overview
8.2.14.2. Product Type Portfolio
8.2.14.3. Financial Overview
8.2.15. Company15
8.2.15.1. Overview
8.2.15.2. Product Type Portfolio
8.2.15.3. Financial Overview
9. Global Global Biologics and Biosimilars Market Analysis By Region
9.1. Introduction
9.1.1. Market Value Share Analysis By Region
9.1.2. Y-o-Y Growth Analysis By Region
9.2. Historical Market Size (USD Mn) Analysis 2018-2022 By Region
9.2.1. North America
9.2.2. Middle East and Africa
9.2.3. South America
9.2.4. Asia-Pacific
9.2.5. Others
9.3. Current Market Size (USD Mn) Forecast 2023-2030 By Region
9.3.1. North America
9.3.2. Middle East and Africa
9.3.3. South America
9.3.4. Asia-Pacific
9.3.5. Others
9.4. Market Attractiveness Analysis By Region
10. North America Global Biologics and Biosimilars MarketAnalysis
10.1. Introduction
10.2. Historical Market Size (USD Mn) Analysis 2018-2022 By Country
10.2.1. U.S.
10.2.2. Canada
10.2.3. Mexico
10.2.4. Rest of North America
10.3. Current Market Size (USD Mn) Forecast 2023-2030 By Country
10.3.1. U.S.
10.3.2. Canada
10.3.3. Mexico
10.3.4. Rest of North America
10.4. Historical Market Size (USD Mn) Analysis 2018-2022 By Product Type
10.5. Current Market Size (USD Mn) Forecast 2023-2030 By Product Type
10.6. Historical Market Size (USD Mn) Analysis 2018-2022 By Source
10.7. Current Market Size (USD Mn) Forecast 2023-2030 By Source
11. South America Global Biologics and Biosimilars Market Analysis
11.1. Introduction
11.2. Regional Pricing Analysis
11.3. Historical Market Size (USD Mn) Analysis 2018-2022 By Country
11.3.1. Brazil
11.3.2. Argentina
11.3.3. Rest of South America
11.4. Current Market Size (USD Mn) Forecast 2023-2030 By Country
11.4.1. Brazil
11.4.2. Argentina
11.4.3. Rest of South America
11.5. Historical Market Size (USD Mn) Analysis 2018-2022 By Product Type
11.6. Current Market Size (USD Mn) Forecast 2023-2030 By Product Type
11.7. Historical Market Size (USD Mn) Analysis 2018-2022 By Source
11.8. Current Market Size (USD Mn) Forecast 2023-2030 By Source
12. Europe Global Biologics and Biosimilars MarketAnalysis
12.1. Introduction
12.2. Regional Pricing Analysis
12.3. Historical Market Size (USD Mn) Analysis 2018-2022 By Country
12.3.1. Germany
12.3.2. Italy
12.3.3. France
12.3.4. Spain
12.3.5. U.K.
12.3.6. Rest of Europe
12.4. Current Market Size (USD Mn) Forecast 2023-2030 By Country
12.4.1. Germany
12.4.2. Italy
12.4.3. France
12.4.4. Spain
12.4.5. U.K.
12.4.6. Rest of Europe
12.5. Historical Market Size (USD Mn) Analysis 2018-2022 By Product Type
12.6. Current Market Size (USD Mn) Forecast 2023-2030 By Product Type
12.7. Historical Market Size (USD Mn) Analysis 2018-2022 By Source
12.8. Current Market Size (USD Mn) Forecast 2023-2030 By Source
13. Middle East and Africa Global Biologics and Biosimilars Market Analysis
13.1. Introduction
13.2. Regional Pricing Analysis
13.3. Historical Market Size (USD Mn) Analysis 2018-2022 By Country
13.3.1. Saudi Arabia
13.3.2. U.A.E.
13.3.3. South Africa
13.3.4. Turkey
13.3.5. Rest of Middle East and Africa
13.4. Current Market Size (USD Mn) Forecast 2023-2030 By Country
13.4.1. Saudi Arabia
13.4.2. U.A.E.
13.4.3. South Africa
13.4.4. Turkey
13.4.5. Rest of Middle East and Africa
14. Asia-Pacific Global Biologics and Biosimilars Market Analysis
14.1. Introduction
14.2. Regional Pricing Analysis
14.3. Historical Market Size (USD Mn) Analysis 2018-2022 By Country
14.3.1. China
14.3.2. India
14.3.3. Japan
14.3.4. South Korea
14.3.5. Singapore
14.3.6. Australia and New Zealand
14.3.7. Rest of Asia-Pacific
14.4. Current Market Size (USD Mn) Forecast 2023-2030 By Country
14.4.1. China
14.4.2. India
14.4.3. Japan
14.4.4. South Korea
14.4.5. Singapore
14.4.6. Australia and New Zealand
14.4.7. Rest of Asia-Pacific
i. Research Methodology
ii. Assumptions & Acronyms
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