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Biosimilars Market Industry Trends and Global Forecasts to 2035 - Distribution by Drug Class, Therapeutic Area, Type of Manufacturer, Distribution Channel, Geographical Regions and Leading Players- Product Image
Biosimilars Market Industry Trends and Global Forecasts to 2035 - Distribution by Drug Class, Therapeutic Area, Type of Manufacturer, Distribution Channel, Geographical Regions and Leading Players- Product Image
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Biosimilars Market Industry Trends and Global Forecasts to 2035 - Distribution by Drug Class, Therapeutic Area, Type of Manufacturer, Distribution Channel, Geographical Regions and Leading Players

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    Report

  • 319 Pages
  • November 2024
  • Region: Global
  • Roots Analysis
  • ID: 5359104
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The global biosimilars market is valued at USD 24.2 billion in 2024, growing at a CAGR of 16.5% during the forecast period, till 2035.

In recent years, the biologics market has experienced significant growth, owing to its improved effectiveness in managing chronic diseases. However, the high costs associated with biologics pose considerable economic and healthcare challenges.

As the demand for biologics continues to increase, developers are exploring innovative strategies to enhance returns on investment while addressing the need for more affordable alternative biological products that encompass similar safety and efficacy profiles. Amidst patent expirations, shrinking drug pipelines, and pressure to reduce the treatment costs, biosimilars are expected to occupy a significant share within the biopharmaceutical industry.

This trend is further supported by surge in investments and collaborations among biosimilar developers in the past few years. Further, regulatory advancements, such as streamlining approval processes and establishing clearer guidelines for biosimilar development have facilitated the development of biosimilars. Moreover, studies on interchangeability, which assess the feasibility of substituting biosimilars with reference biologics with similar safety or efficacy, have also played a critical role in advancing biosimilar development.

In addition, the rising demand for biosimilars as a cost-effective alternative has promoted the need for increased in-house development and outsourcing operations, thereby creating significant growth opportunities for biosimilar developers.

Key Market Segments

Drug Class

  • Monoclonal Antibodies
  • Proteins
  • Peptides
  • Others

Therapeutic Area

  • Oncological Disorders
  • Autoimmune and Inflammatory Disorders
  • Hematological Disorders
  • Metabolic Disorders
  • Other Disorders

Type of Manufacturer

  • Contract Manufacturers
  • In-house Developers

Distribution Channel

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

Geographical Regions

  • North America (US and Canada)
  • Europe (Germany, UK, France, Spain, Italy, Switzerland, Belgium, Denmark and Rest of Europe)
  • Asia-Pacific (China, India, Japan, South Korea and Australia)
  • Middle East and North Africa (Saudi Arabia, Egypt and UAE)
  • Latin America (Brazil, Mexico and Argentina)

Research Coverage:

  • An overview of the systematic research methodology adopted in this study, which includes research assumptions, forecasting methodologies, primary and secondary research techniques, as well as the various analytical frameworks integrated into the report.
  • A summary of the comprehensive methodologies and frameworks used to forecast and analyze market trends, examining key factors that influence market dynamics while emphasizing the rigorous quality control measures implemented to ensure transparency and credibility in the insights presented throughout the report.
  • A brief overview of the economic factors affecting the biosimilars market, including currency fluctuations, foreign exchange rates, and existing trade barriers. Additionally, it assesses the impact of global recession and inflation on market growth, drawing insights from significant historical events to inform future decision-making.
  • An executive summary of the insights obtained during our research, featuring key takeaways from the current state of the biosimilars industry and its likely evolution in the short to mid-to-long term.
  • A general overview of biosimilars, highlighting the key differences between innovator biologics, biosimilars, and generics. Further, it also provides information on the need for biosimilars, the manufacturing process, development timelines, and future perspectives related to the evolution of the biosimilar industry.
  • A comprehensive evaluation of marketed and clinical-stage biosimilars based on several parameters, including the stage of development (approved, BLA registration, clinical, preclinical and discovery), therapeutic area (autoimmune diseases, bone disorders, cardiovascular disorders, growth disorders, hematological disorders, immunological disorders, infectious diseases, infertility, inflammatory disorders, metabolic disorders, neurological disorders, ocular disorders, oncological disorders, pulmonary disorders, rare diseases and other disorders), drug class (coagulation factors, colony stimulating factors, cytokines, erythropoietin, fusion proteins, growth hormones / factors, immunomodulators, insulin, interferons, monoclonal antibodies, oligonucleotides, recombinant proteins, therapeutic enzymes, vaccines and unspecified). Additionally, it includes detailed analyses of biosimilar developers based on parameters, such as year of establishment, company size, headquarters location, and the most active players (in terms of number of biosimilars developed).

  • Detailed profiles of prominent companies in North America, Europe, Asia-Pacific, and the rest of the world. Each profile includes an overview of the company (year of establishment, headquarters location, employee count, leadership team, business segments), financial information (if available), biosimilar pipeline details, recent developments and future outlook.
  • A brief overview of the regulatory guidelines established by regulatory bodies across different regions, such as North America, Europe, and Asia-Pacific. It also presents details on regulatory approval pathways issued by authorities in these regions.
  • An analysis of the factors contributing to the high pricing of novel biologics, including factors influencing biosimilar pricing. This section also presents a price comparison between various biosimilars and their reference biologics.
  • A case study focused on the growing global biosimilars market and associated opportunities for biologics CMOs and CDMOs. It discusses the need for outsourcing manufacturing operations for biosimilar drugs and examines the impact of biosimilars on the global contract manufacturing market, along with the associated challenges and future perspectives.
  • An in-depth analysis of factors impacting the growth of the biosimilars industry. This includes information on key drivers, potential restraints, emerging opportunities, and existing challenges within the sector.
  • A detailed estimation of the current market size and future growth potential within the biosimilars market over the next decade. Based on various parameters and validations from reliable secondary and primary sources, we’ve provided informed estimates on market evolution till 2035. The report also features the likely distribution of the current and forecasted opportunities along with three forecast scenarios, namely conservative, base, and optimistic, representing different growth trajectories.

  • A detailed estimation of the current market size and future opportunities in the biosimilars market across various drug classes, such as monoclonal antibodies, proteins, peptides, and others.
  • A detailed projection of current market size and future opportunities in the biosimilar market across different therapeutic areas, including oncological disorders, autoimmune and inflammatory disorders, hematological disorders, metabolic disorders, and others.
  • A detailed projection of current market size and future opportunities in the biosimilars market across different types of manufacturers, such as contract manufacturers and in-house developers.
  • A detailed projection of the current market size and future opportunities in the biosimilars market across different distribution channels, such as hospital pharmacies, retail pharmacies and online pharmacies.
  • A detailed projection of current market size and future opportunities in the biosimilars market across different geographical regions such as North America, Europe, Asia-Pacific, Middle East and North Africa (MENA), and Latin America.
  • Detailed information on leading players engaged in the development of biosimilars.

Complimentary Excel Data Packs

  • Market Landscape
  • Market Forecast and Opportunity Analysis

Key Benefits of Buying this Report

  • The report offers valuable insights into revenue estimation for both the overall market and its sub-segments, in order to empower market leaders and newcomers with critical information requisite for establishing their footprint in the industry.
  • Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
  • The report provides stakeholders with an overview of the global biosimilars market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.

Table of Contents

1. PREFACE
1.1. Introduction
1.2. Market Share Insights
1.3. Key Market Insights
1.4. Report Coverage
1.5. Key Questions Answered
1.6. Chapter Outlines

2. RESEARCH METHODOLOGY
2.1. Chapter Overview
2.2. Research Assumptions
2.2.1. Market Landscape and Market Trends
2.2.2. Market Forecast and Opportunity Analysis
2.2.3. Comparative Analysis
2.3. Database Building
2.3.1. Data Collection
2.3.2. Data Validation
2.3.3. Data Analysis

2.4. Project Methodology
2.4.1. Secondary Research
2.4.1.1. Annual Reports
2.4.1.2. Academic Research Papers
2.4.1.3. Company Websites
2.4.1.4. Investor Presentations
2.4.1.5. Regulatory Filings
2.4.1.6. White Papers
2.4.1.7. Industry Publications
2.4.1.8. Conferences and Seminars
2.4.1.9. Government Portals
2.4.1.10. Media and Press Releases
2.4.1.11. Newsletters
2.4.1.12. Industry Databases
2.4.1.13. Roots Proprietary Databases
2.4.1.14. Paid Databases and Sources
2.4.1.15. Social Media Portals
2.4.1.16. Other Secondary Sources

2.4.2. Primary Research
2.4.2.1. Types of Primary Research
2.4.2.1.1. Qualitative Research
2.4.2.1.2. Quantitative Research
2.4.2.1.3. Hybrid Approach

2.4.2.2. Advantages of Primary Research

2.4.2.3. Techniques for Primary Research
2.4.2.3.1. Interviews
2.4.2.3.2. Surveys
2.4.2.3.3. Focus Groups
2.4.2.3.4. Observational Research
2.4.2.3.5. Social Media Interactions
2.4.2.4. Key Opinion Leaders Considered in Primary Research
2.4.2.4.1. Company Executives (CXOs)
2.4.2.4.2. Board of Directors
2.4.2.4.3. Company Presidents and Vice Presidents
2.4.2.4.4. Research and Development Heads
2.4.2.4.5. Technical Experts
2.4.2.4.6. Subject Matter Experts
2.4.2.4.7. Scientists
2.4.2.4.8. Doctors and Other Healthcare Providers

2.4.2.5. Ethics and Integrity
2.4.2.5.1. Research Ethics
2.4.2.5.2. Data Integrity

2.4.3. Analytical Tools and Databases

3. MARKET DYNAMICS
3.1. Chapter Overview
3.2. Forecast Methodology
3.2.1. Top-down Approach
3.2.2. Bottom-up Approach
3.2.3. Hybrid Approach
3.3. Market Assessment Framework
3.3.1. Total Addressable Market (TAM)
3.3.2. Serviceable Addressable Market (SAM)
3.3.3. Serviceable Obtainable Market (SOM)
3.3.4. Currently Acquired Market (CAM)

3.4. Forecasting Tools and Techniques
3.4.1. Qualitative Forecasting
3.4.2. Correlation
3.4.3. Regression
3.4.4. Extrapolation
3.4.5. Convergence
3.4.6. Sensitivity Analysis
3.4.7. Scenario Planning
3.4.8. Data Visualization
3.4.9. Time Series Analysis
3.4.10. Forecast Error Analysis

3.5. Key Considerations
3.5.1. Demographics
3.5.2. Government Regulations
3.5.3. Reimbursement Scenarios
3.5.4. Market Access
3.5.5. Supply Chain
3.5.6. Industry Consolidation
3.5.7. Pandemic / Unforeseen Disruptions Impact

3.6. Key Market Segmentation
3.7. Robust Quality Control
3.8. Limitations

4. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS
4.1. Chapter Overview
4.2. Market Dynamics
4.2.1. Time Period
4.2.1.1. Historical Trends
4.2.1.2. Current and Future Estimates
4.2.2. Currency Coverage and Foreign Exchange Rate
4.2.2.1. Major Currencies Affecting the Market
4.2.2.2. Factors Affecting Currency Fluctuations and Foreign Exchange Rates
4.2.2.3. Impact of Foreign Exchange Rate Volatility on the Market
4.2.2.4. Strategies for Mitigating Foreign Exchange Risk

4.2.3. Trade Policies
4.2.3.1. Impact of Trade Barriers on the Market
4.2.3.2. Strategies for Mitigating the Risks Associated with Trade Barriers

4.2.4. Recession
4.2.4.1. Historical Analysis of Past Recessions and Lessons Learnt
4.2.4.2. Assessment of Current Economic Conditions and Potential Impact on the Market

4.2.5. Inflation
4.2.5.1. Measurement and Analysis of Inflationary Pressures in the Economy
4.2.5.2. Potential Impact of Inflation on the Market Evolution

5. EXECUTIVE SUMMARY
6. INTRODUCTION
6.1. Chapter Overview
6.2. Overview of Biologics
6.3. Overview of Biosimilars and Biobetters
6.4. Difference between Innovator Biologics, Biosimilars and Generics
6.5. Advantages of Biosimilars
6.6. Manufacturing of Biosimilars
6.7. Development Timeline of Biosimilars
6.8. Future Perspectives

7. MARKET LANDSCAPE
7.1. Chapter Overview
7.2. Biosimilars: Developers Landscape
7.2.1. Analysis by Year of Establishment
7.2.2. Analysis by Company Size
7.2.3. Analysis by Location of Headquarters
7.3. Biosimilars: Overall Market Landscape
7.3.1. Analysis by Stage of Development
7.3.2. Analysis by Therapeutic Area
7.3.3. Analysis by Drug Class

8. COMPANY PROFILES: BIOSIMILAR DEVELOPERS BASED IN NORTH AMERICA
8.1. Chapter Overview
8.2. Amgen
8.2.1. Company Overview
8.2.2. Financial Information
8.2.3. Biosimilar Pipeline
8.2.4. Recent Developments and Future Outlook
8.3. Coherus BioSciences
8.3.1. Company Overview
8.3.2. Financial Information
8.3.3. Biosimilar Pipeline
8.3.4. Recent Developments and Future Outlook

8.4. Eli Lilly
8.4.1. Company Overview
8.4.2. Financial Information
8.4.3. Biosimilar Pipeline
8.4.4. Recent Developments and Future Outlook

8.5. Pfizer
8.5.1. Company Overview
8.5.2. Financial Information
8.5.3. Biosimilar Pipeline
8.5.4. Recent Developments and Future Outlook

9. COMPANY PROFILES: BIOSIMILAR DEVELOPERS BASED IN EUROPE
9.1 Chapter Overview
9.2. BIOCAD
9.2.1. Company Overview
9.2.2. Biosimilar Pipeline
9.2.3. Recent Developments and Future Outlook
9.3. Fresenius Kabi
9.3.1. Company Overview
9.3.2. Financial Information
9.3.3. Biosimilar Pipeline
9.3.4. Recent Developments and Future Outlook

9.4. Sandoz
9.4.1. Company Overview
9.4.2. Financial Information
9.4.3. Biosimilar Pipeline
9.4.4. Recent Developments and Future Outlook

9.5. STADA
9.5.1. Company Overview
9.5.2. Financial Information
9.5.3. Biosimilar Pipeline
9.5.4. Recent Developments and Future Outlook

10. COMPANY PROFILES: BIOSIMILAR DEVELOPERS BASED IN ASIA-PACIFIC AND REST OF THE WORLD
10.1 Chapter Overview
10.2. Biocon
10.2.1. Company Overview
10.2.2. Financial Information
10.2.3. Biosimilar Pipeline
10.2.4. Recent Developments and Future Outlook
10.3. Dr. Reddy’s Laboratories
10.3.1. Company Overview
10.3.2. Financial Information
10.3.3. Biosimilar Pipeline
10.3.4. Recent Developments and Future Outlook

10.4. Celltrion
10.4.1. Company Overview
10.4.2. Financial Information
10.4.3. Biosimilar Pipeline
10.4.4. Recent Developments and Future Outlook

10.5. Intas Pharmaceuticals
10.5.1. Company Overview
10.5.2. Biosimilar Pipeline
10.5.3. Recent Developments and Future Outlook

10.6. Teva Pharmaceuticals
10.6.1. Company Overview
10.6.2. Financial Information
10.6.3. Biosimilar Pipeline
10.6.4. Recent Developments and Future Outlook

11. REGULATORY LANDSCAPE
11.1. Chapter Overview
11.2. Regulatory Guidelines for Biosimilars in North America
11.2.1. Regulatory Guidelines for Biosimilars in the US
11.2.1.1. Overview
11.2.1.2. Regulatory Landscape in the US
11.2.1.3. Regulatory Approval Pathway
11.3. Regulatory Guidelines for Biosimilars in Europe
11.3.1. Overview
11.3.2. Regulatory Landscape in Europe
11.3.3. Regulatory Approval Pathway

11.4. Regulatory Guidelines for Biosimilars in Asia-Pacific
11.4.1. Regulatory Guidelines for Biosimilars in China
11.4.1.1. Overview
11.4.1.2. Regulatory Landscape in China
11.4.1.3. Regulatory Approval Pathway

11.4.2. Regulatory Guidelines for Biosimilars in Japan
11.4.2.1. Overview
11.4.2.2. Regulatory Landscape in Japan
11.4.2.3. Regulatory Approval Pathway

11.4.3. Regulatory Guidelines for Biosimilars in Australia
11.4.3.1. Overview
11.4.3.2. Regulatory Landscape in Australia
11.4.3.3. Regulatory Approval Pathway

11.5. Future Perspectives

12. COST PRICE ANALYSIS
12.1. Chapter Overview
12.2. Factors Contributing to High Price of Novel Biologics
12.3. Pricing of Biosimilars
12.3.1. Price Comparison of Different Biosimilars with its Reference Biologic
12.4. Concluding Remarks

13. CASE STUDY: OUTSOURCING OF BIOSIMILARS
13.1. Chapter Overview
13.2. Need for Outsourcing Manufacturing Operations
13.3. Impact of Biosimilars on the Global Contract Manufacturing Market
13.3.1. Biosimilars: Historical Trend of FDA Approvals

13.4. Biosimilars Contract Manufacturing Service Providers
13.5. Challenges Associated with Outsourcing of Biosimilar Manufacturing Operations
13.6. Future Perspectives

14. MARKET IMPACT ANALYSIS
14.1. Chapter Overview
14.2. Market Drivers
14.3. Market Restraints
14.4. Market Opportunities
14.5. Market Challenges
14.6. Conclusion

15. GLOBAL BIOSIMILARS MARKET
15.1. Chapter Overview
15.2. Key Assumptions and Methodology
15.3. Global Biosimilars Market, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
15.3.1. Scenario Analysis
15.3.1.1. Conservative Scenario
15.3.1.2. Optimistic Scenario

15.4. Key Market Segmentations

16. BIOSIMILARS MARKET, BY DRUG CLASS
16.1. Chapter Overview
16.2. Key Assumptions and Methodology
16.3. Biosimilars Market: Distribution by Drug Class, 2019, 2024 and 2035
16.3.1. Biosimilars Market for Monoclonal Antibodies, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
16.3.2. Biosimilars Market for Proteins, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
16.3.3. Biosimilars Market for Peptides, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
16.3.4. Biosimilars Market for Others, Historical Trends (since 2019) and Forecasted Estimates (till 2035)

16.4. Data Triangulation and Validation

17. BIOSIMILARS MARKET, BY THERAPEUTIC AREAS
17.1. Chapter Overview
17.2. Key Assumptions and Methodology
17.3. Biosimilars Market: Distribution by Therapeutic Areas, 2019, 2024 and 2035
17.3.1. Biosimilars Market for Oncological Disorders, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
17.3.2. Biosimilars Market for Autoimmune and Inflammatory Disorders, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
17.3.3. Biosimilars Market for Hematological Disorders, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
17.3.4. Biosimilars Market for Metabolic Disorders, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
17.3.5. Biosimilars Market for Other Disorders, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
17.4. Data Triangulation and Validation

18. BIOSIMILARS MARKET, BY TYPE OF MANUFACTURER
18.1. Chapter Overview
18.2. Key Assumptions and Methodology
18.3. Biosimilars Market: Distribution by Type of Manufacturers, 2019, 2024 and 2035
18.3.1. Biosimilars Market for Contract Manufacturers, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
18.3.2. Biosimilars Market for In-house Developers, Historical Trends (since 2019) and Forecasted Estimates (till 2035)

18.4. Data Triangulation and Validation

19. BIOSIMILARS MARKET, BY DISTRIBUTION CHANNELS
19.1. Chapter Overview
19.2. Key Assumptions and Methodology
19.3. Biosimilars Market: Distribution by Distribution Channels, 2019, 2024 and 2035
19.3.1. Biosimilars Market for Hospital Pharmacies, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
19.3.2. Biosimilars Market for Retail Pharmacies, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
19.3.3. Biosimilars Market for Online Pharmacies, Historical Trends (since 2019) and Forecasted Estimates (till 2035)

19.4. Data Triangulation and Validation

20. BIOSIMILARS MARKET, BY GEOGRAPHICAL REGIONS
20.1. Chapter Overview
20.2. Key Assumptions and Methodology
20.3. Biosimilars Market: Distribution by Geographical Regions, 2019, 2024 and 2035
20.3.1. Biosimilars Market in North America, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.1.1. Biosimilars Market in the US, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.1.2. Biosimilars Market in Canada, Historical Trends (since 2019) and Forecasted Estimates (till 2035)

20.3.2. Biosimilars Market in Europe, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.2.1. Biosimilars Market in Germany, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.2.2. Biosimilars Market in the UK, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.2.3. Biosimilars Market in France, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.2.4. Biosimilars Market in Spain, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.2.5. Biosimilars Market in Italy, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.2.6. Biosimilars Market in Switzerland, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.2.7. Biosimilars Market in Belgium, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.2.8. Biosimilars Market in Denmark, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.2.9. Biosimilars Market in Rest of Europe, Historical Trends (since 2019) and Forecasted Estimates (till 2035)

20.3.3. Biosimilars Market in Asia-Pacific, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.3.1. Biosimilars Market in China, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.3.2. Biosimilars Market in India, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.3.3. Biosimilars Market in Japan, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.3.4. Biosimilars Market in South Korea, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.3.5. Biosimilars Market in Australia, Historical Trends (since 2019) and Forecasted Estimates (till 2035)

20.3.4. Biosimilars Market in Middle East and North Africa, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.4.1. Biosimilars Market in Saudi Arabia, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.4.2. Biosimilars Market in Egypt, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.4.3. Biosimilars Market in UAE, Historical Trends (since 2019) and Forecasted Estimates (till 2035)

20.3.5. Biosimilars Market in Latin America, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.5.1. Biosimilars Market in Brazil, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.5.2. Biosimilars Market in Mexico, Historical Trends (since 2019) and Forecasted Estimates (till 2035)
20.3.5.3. Biosimilars Market in Argentina, Historical Trends (since 2019) and Forecasted Estimates (till 2035)

20.4. Market Movement Analysis
20.5. Penetration-Growth (P-G) Matrix
20.6. Data Triangulation and Validation

21. BIOSIMILARS MARKET, BY LEADING PLAYERS
21.1. Chapter Overview
21.2. Key Assumptions and Methodology

22. CONCLUDING REMARKSAPPENDIX I: TABULATED DATAAPPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS
LIST OF FIGURES
Figure 2.1 Research Methodology: Project Methodology
Figure 2.2 Research Methodology: Data Sources for Secondary Research
Figure 3.1 Market Dynamics: Forecast Methodology
Figure 3.2 Market Dynamics: Key Market Segmentation
Figure 3.3 Market Dynamics: Robust Quality Control
Figure 4.1 Lessons Learnt from Past Recessions
Figure 5.1 Executive Summary: Market Landscape
Figure 5.2 Executive Summary: Market Forecast and Opportunity Analysis
Figure 6.1 Number of Biologics Approved by the USFDA, 2015-2023
Figure 6.2 Need for Biosimilars
Figure 6.3 Steps Involved in Upstream Processing
Figure 6.4 Steps Involved in Downstream Processing
Figure 6.5 Reference Biologic and Biosimilar Development Timeline
Figure 7.1. Biosimilar Developers: Distribution by Year of Establishment
Figure 7.2 Biosimilar Developers: Distribution by Company Size
Figure 7.3 Biosimilar Developers: Distribution by Location of Headquarters (Region)
Figure 7.4 Biosimilar Developers: Distribution by Location of Headquarters (Country)
Figure 7.5 Biosimilars: Distribution by Stage of Development
Figure 7.6 Biosimilars: Distribution by Therapeutic Area
Figure 7.7 Biosimilars: Distribution by Drug Class
Figure 8.1 Amgen: Consolidated Financial Details (USD Billion)
Figure 8.2 Coherus BioSciences: Consolidated Financial Details (USD Million)
Figure 8.3 Eli Lilly: Consolidated Financial Details (USD Billion)
Figure 8.4 Pfizer: Business Segment-wise Revenues and Consolidated Financial Details (USD Million)
Figure 9.1 Fresenius Kabi: Business Segment-wise Revenues and Consolidated Financial Details (EUR Million)
Figure 9.2 Sandoz: Consolidated Financial Details (USD Million)
Figure 9.3 STADA: Business Segment-wise Revenues and Consolidated Financial Details (EUR Million)
Figure 10.1 Biocon: Business Segment-wise Revenues and Consolidated Financial Details (INR Billion)
Figure 10.2 Dr. Reddy’s Laboratories: Business Segment-wise Revenues and Consolidated Financial Details (INR Billion)
Figure 10.3 Celltrion: Consolidated Financial Details (KRW Billion)
Figure 10.4 Teva Pharmaceuticals: Consolidated Financial Details (USD Billion)
Figure 11.1 Regulatory Approval Pathways for Biologics and Biosimilars in the US
Figure 11.2 Comparability Study Steps for Biosimilar Development in Europe
Figure 11.3 Guidelines and Approval Pathway for Biosimilar Development in China
Figure 11.4 Guidelines for Approval of Biosimilars in Australia
Figure 12.1 Potential Cost Saving Projections
Figure 13.1 Need for Outsourcing Biosimilar Manufacturing Operations
Figure 13.2 Biosimilars: Historical Trend of FDA Approvals, 2015-2024
Figure 13.3 Challenges Associated with Outsourcing Biosimilar Manufacturing Operations
Figure 15.1 Global Biosimilars Market, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 15.2 Global Biosimilars Market, Forecasted Estimates (till 2035): Conservative Scenario (USD Billion)
Figure 15.3 Global Biosimilars Market, Forecasted Estimates (till 2035): Optimistic Scenario (USD Billion)
Figure 16.1 Biosimilars Market: Distribution by Drug Class, 2019, 2024 and 2035
Figure 16.2 Biosimilars Market for Monoclonal Antibodies, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 16.3 Biosimilars Market for Proteins, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 16.4 Biosimilars Market for Peptides, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 16.5 Biosimilars Market for Others, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 17.1 Biosimilars Market: Distribution by Therapeutic Area, 2019, 2024 and 2035
Figure 17.2 Biosimilars Market for Oncological Disorders, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 17.3 Biosimilars Market for Autoimmune and Inflammatory Disorders, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 17.4 Biosimilars Market for Hematological Disorders, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 17.5 Biosimilars Market for Metabolic Disorders, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 17.6 Biosimilars Market for Other Disorders, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 18.1 Biosimilars Market: Distribution by Type of Manufacturer, 2019, 2024 and 2035
Figure 18.2 Biosimilars Market for Contract Manufacturers, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 18.3 Biosimilars Market for In-house Developers, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 19.1 Biosimilars Market: Distribution by Distribution Channel, 2019, 2024 and 2035
Figure 19.2 Biosimilars Market for Hospital Pharmacies, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 19.3 Biosimilars Market for Retail Pharmacies, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 19.4 Biosimilars Market for Online Pharmacies, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.1 Biosimilars Market: Distribution by Geographical Regions, 2019, 2024 and 2035
Figure 20.2 Biosimilars Market in North America, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.3 Biosimilars Market in the US, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.4 Biosimilars Market in Canada, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.5 Biosimilars Market in Europe, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.6 Biosimilars Market in Germany, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.7 Biosimilars Market in the UK, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.8 Biosimilars Market in France, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.9 Biosimilars Market in Spain, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.10 Biosimilars Market in Italy, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.11 Biosimilars Market in Switzerland, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.12 Biosimilars Market in Belgium, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.13 Biosimilars Market in Denmark, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.14 Biosimilars Market in Rest of Europe, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.15 Biosimilars Market in Asia-Pacific, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.16 Biosimilars Market in China, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.17 Biosimilars Market in India, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.18 Biosimilars Market in Japan, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.19 Biosimilars Market in South Korea, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.20 Biosimilars Market in Australia, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.21 Biosimilars Market in Middle East and North Africa, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.22 Biosimilars Market in Saudi Arabia, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.23 Biosimilars Market in Egypt, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.24 Biosimilars Market in UAE, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.25 Biosimilars Market in Latin America, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.26 Biosimilars Market in Brazil, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.27 Biosimilars Market in Mexico, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.28 Biosimilars Market in Argentina, Historical Trends (since 2019) and Forecasted Estimates (till 2035) (USD Billion)
Figure 20.29 Market Movement Analysis
Figure 20.30 Penetration-Growth (P-G) Matrix
Figure 22.1 Concluding Remarks: Market Landscape
Figure 22.2 Concluding Remarks: Market Forecast and Opportunity Analysis

LIST OF TABLES
Table 6.1 Difference between Reference Biologics, Biosimilars and Generics
Table 6.2 Steps Involved in Manufacturing of Biosimilars
Table 7.1 Biosimilar Developers: Information on Year of Establishment, Company Size and Location of Headquarters
Table 7.2 Biosimilars: Information on Developer, Stage of Development, Reference Biologic and Generic Name
Table 7.3 Biosimilars: Information on Developer and Therapeutic Area
Table 7.4 Biosimilars: Information on Developer and Drug Class
Table 8.1 Biosimilar Developers in North America: List of Companies Profiled
Table 8.2 Amgen: Company Overview
Table 8.3 Amgen: Biosimilar Pipeline
Table 8.4 Amgen: Recent Developments and Future Outlook
Table 8.5 Coherus BioSciences: Company Overview
Table 8.6 Coherus BioSciences: Biosimilar Pipeline
Table 8.7 Coherus BioSciences: Recent Developments and Future Outlook
Table 8.8 Eli Lilly: Company Overview
Table 8.9 Eli Lilly: Biosimilar Pipeline
Table 8.10 Eli Lilly: Recent Developments and Future Outlook
Table 8.11 Pfizer: Company Overview
Table 8.12 Pfizer: Biosimilar Pipeline
Table 8.13 Pfizer: Recent Developments and Future Outlook
Table 9.1 Biosimilar Developers in Europe: List of Companies Profiled
Table 9.2 BIOCAD: Company Overview
Table 9.3 BIOCAD: Biosimilar Pipeline
Table 9.4 BIOCAD: Recent Developments and Future Outlook
Table 9.5 Fresenius Kabi: Company Overview
Table 9.6 Fresenius Kabi: Biosimilar Pipeline
Table 9.7 Fresenius Kabi: Recent Developments and Future Outlook
Table 9.8 Sandoz: Company Overview
Table 9.9 Sandoz: Biosimilar Pipeline
Table 9.10 Sandoz: Recent Developments and Future Outlook
Table 9.11 STADA: Company Overview
Table 9.12 STADA: Biosimilar Pipeline
Table 9.13 STADA: Recent Developments and Future Outlook
Table 10.1 Biosimilar Developers in Asia-Pacific and Rest of the World: List of Companies Profiled
Table 10.2 Biocon: Company Overview
Table 10.3 Biocon: Biosimilar Pipeline
Table 10.4 Biocon: Recent Developments and Future Outlook
Table 10.5 Dr. Reddy’s Laboratories: Company Overview
Table 10.6 Dr. Reddy’s Laboratories: Biosimilar Pipeline
Table 10.7 Dr. Reddy’s Laboratories: Recent Developments and Future Outlook
Table 10.8 Celltrion: Company Overview
Table 10.9 Celltrion: Biosimilar Pipeline
Table 10.10 Celltrion: Recent Developments and Future Outlook
Table 10.11 Intas Pharmaceuticals: Company Overview
Table 10.12 Intas Pharmaceuticals: Biosimilar Pipeline
Table 10.13 Intas Pharmaceuticals: Recent Developments and Future Outlook
Table 10.14 Teva Pharmaceuticals: Company Overview
Table 10.15 Teva Pharmaceuticals: Biosimilar Pipeline
Table 10.16 Teva Pharmaceuticals: Recent Developments and Future Outlook
Table 12.1 Price Comparison of Different Biosimilars with their Reference Biologics
Table 13.1 List of Biosimilars Contract Manufacturing Service Providers
Table 21.1 Leading Industry Players: Based on the Company Size and Number of Approved Biosimilars
Table 23.1 Biosimilar Developers: Distribution by Year of Establishment
Table 23.2 Biosimilar Developers: Distribution by Company Size
Table 23.3 Biosimilar Developers: Distribution by Location of Headquarters (Region)
Table 23.4 Biosimilar Developers: Distribution by Location of Headquarters (Country)
Table 23.5 Biosimilars: Distribution by Stage of Development
Table 23.6 Biosimilars: Distribution by Therapeutic Area
Table 23.7 Biosimilars: Distribution by Drug Class
Table 23.8 Amgen: Consolidated Financial Details (USD Billion)
Table 23.9 Coherus BioSciences: Consolidated Financial Details (USD Million)
Table 23.10 Eli Lilly: Consolidated Financial Details (USD Billion)
Table 23.11 Pfizer: Business Segment-wise Revenues and Consolidated Financial Details (USD Million)
Table 23.12 Fresenius Kabi: Business Segment-wise Revenues and Consolidated Financial Details (EUR Million)
Table 23.13 Sandoz: Consolidated Financial Details (USD Million)
Table 23.14 STADA: Business Segment-wise Revenues and Consolidated Financial Details (EUR Million)
Table 23.15 Biocon: Business Segment-wise Revenues and Consolidated Financial Details (INR Billion)
Table 23.16 Dr. Reddy’s Laboratories: Business Segment-wise Revenues and Consolidated Financial Details (INR Billion)
Table 23.17 Celltrion: Consolidated Financial Details (KRW Billion)
Table 23.18 Teva Pharmaceuticals: Consolidated Financial Details (USD Billion)
Table 23.19 Global Biosimilars Market, Historical Trends (since 2019) and Forecasted Estimates (till 2035), (USD Billion)
Table 23.20 Global Biosimilars Market, Forecasted Estimates (till 2035): Conservative Scenario (USD Billion)
Table 23.21 Global Biosimilars Market, Forecasted Estimates (till 2035): Optimistic Scenario (USD Billion)
Table 23.22 Biosimilars Market: Distribution by Drug Class, 2019, 2024 and 2035
Table 23.23 Biosimilars Market for Monoclonal Antibodies, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.24 Biosimilars Market for Proteins, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.25 Biosimilars Market for Peptides, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.26 Biosimilars Market for Others, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.27 Biosimilars Market: Distribution by Therapeutic Area, 2019, 2024 and 2035
Table 23.28 Biosimilars Market for Oncological Disorders, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.29 Biosimilars Market for Autoimmune and Inflammatory Disorders, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.30 Biosimilars Market for Hematological Disorders, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios(USD Billion)
Table 23.31 Biosimilars Market for Metabolic Disorders, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.32 Biosimilars Market for Other Disorders, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.33 Biosimilars Market: Distribution by Type of Manufacturer, 2019, 2024 and 2035
Table 23.34 Biosimilars Market for Contract Manufacturers, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.35 Biosimilars Market for In-house Developers, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.36 Biosimilars Market: Distribution by Distribution Channel, 2019, 2024 and 2035
Table 23.37 Biosimilars Market for Hospital Pharmacies, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.38 Biosimilars Market for Retail Pharmacies, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.39 Biosimilars Market for Online Pharmacies, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.40 Biosimilars Market: Distribution by Geographical Regions, 2019, 2024 and 2035
Table 23.41 Biosimilars Market in North America, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.42 Biosimilars Market in the US, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.43 Biosimilars Market in Canada, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.44 Biosimilars Market in Europe, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.45 Biosimilars Market in Germany, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.46 Biosimilars Market in the UK, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.47 Biosimilars Market in France, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.48 Biosimilars Market in Spain, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.49 Biosimilars Market in Italy, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.50 Biosimilars Market in Switzerland, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.51 Biosimilars Market in Belgium, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.52 Biosimilars Market in Denmark, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.53 Biosimilars Market in Rest of Europe, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.54 Biosimilars Market in Asia-Pacific, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.55 Biosimilars Market in China, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.56 Biosimilars Market in India, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.57 Biosimilars Market in Japan, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.58 Biosimilars Market in South Korea, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.59 Biosimilars Market in Australia, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.60 Biosimilars Market in Middle East and North Africa, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.61 Biosimilars Market in Saudi Arabia, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.62 Biosimilars Market in Egypt, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.63 Biosimilars Market in UAE, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.64 Biosimilars Market in Latin America, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.65 Biosimilars Market in Brazil, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.66 Biosimilars Market in Mexico, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)
Table 23.67 Biosimilars Market in Argentina, Historical Trends (since 2019) and Forecasted Estimates (till 2035), Conservative, Base and Optimistic Scenarios (USD Billion)

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Amgen
  • BIOCAD
  • Biocon
  • Celltrion
  • Coherus BioSciences
  • Reddy’s Laboratories
  • Eli Lilly
  • Fresenius Kabi
  • Intas Pharmaceuticals
  • Pfizer
  • Sandoz
  • STADA
  • Teva Pharmaceuticals

Methodology

 

 

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