세계의 바이오시밀러 시장(2023-2030년)

Market Overview

The Global Biosimilars Market reached US$ 30.1 billion in 2022 and is projected to witness lucrative growth by reaching up to US$ 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 provide an opportunity to increase patient access to biological therapies by offering more affordable alternatives while maintaining the same therapeutic benefits. They can be essential in enhancing the sustainability of healthcare and broadening the range of available treatments for patients with different illnesses, such as cancer, autoimmune diseases, and chronic inflammatory problems.

Market Dynamics

The growing burden of chronic diseases is boosting the global biosimilars market growth during the forecast period.

Globally, the prevalence of chronic conditions like cancer, autoimmune illnesses, and diabetes is rising. Biosimilars improve patient access to medications that can save their lives by providing economic treatment alternatives for certain ailments. The demand for biosimilars is driven by the rising incidence of chronic diseases.

According to the WHO data report September 2022, the majority of NCD deaths, or 17.9 million people yearly, are caused by cardiovascular illnesses, followed by malignancies (9.3 million), chronic respiratory diseases (4.1 million), and diabetes (2.0 million including renal disease deaths caused by diabetes).

Approval of biosimilar drugs by the FDA provides the Global Biosimilars Market with future growth opportunities.

The Food and Drug Administration approves biosimilar products and offers the regulatory and scientific guidance required to launch safe and efficient biosimilars. The acceptance of biosimilar pharmaceuticals can increase patient access to care by expanding their selection of medications and possibly lowering their expenses. For instance, in September 2022, FDA approved Vegzelma (bevacizumab-add) and Stimufend (pegfilgrastim-FPGA).

COVID-19 Impact Analysis

The COVID-19 pandemic has had a significant impact on the biosimilars market. Biosimilars can enhance access to essential treatments by providing more reasonably priced alternatives. This is especially important when there is a public health emergency since the demand for some biologics can go up. Managing the extra workload and adjusting to remote work arrangements during the pandemic has been difficult for regulatory agencies worldwide. The evaluation and approval of biosimilars may have been delayed due to this.

Russia-Ukraine Conflict Analysis

The impact of the Russia-Ukraine war on the Biosimilars market is complex and multifaceted. Risks in the geopolitical and economic environment of the world can be caused by conflict scenarios. Investors may become less risk-tolerant or divert their attention to other domains, which could influence investments and funding for biosimilar research and development projects worldwide.

Clinical trials for biosimilars involve several nations and sites. Trial completion, data collection, and gaining regulatory permissions are delayed when the conflict interrupts or restricts access to trial locations in Russia or Ukraine.

Segment Analysis

The global biosimilar market is segmented based on product, technology, application, distribution channel, and region.

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

The monoclonal antibodies segment accounted for the highest market stake, accounting for approximately 1/2nd of the Biosimilars market in 2022. The family of biosimilar molecules includes biosimilar monoclonal antibodies (mAbs). Large, complex proteins are typically used to treat conditions like cancer or rheumatoid arthritis. They are employed by the immune system to recognize and destroy invading substances, including bacteria, viruses, and others.

For instance, in September 2022, Biogen Inc., a biotechnology company, declared that the European Medicines Agency had accepted the Marketing Authorization Application for BIIB800, a biosimilar candidate referencing RoACTEMRA (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody.

Geographical Analysis

Increasing collaborations and partnerships among the key players, increasing FDA approvals, and advancement in Biosimilars dominate the North American region.

North America is expected to dominate the Biosimilars market, accounting for around 32.1% of this market. For instance, An expedited FDA approval process for biosimilars is used to increase patient access to high-quality, lower-cost healthcare. In the United States as of January 2022, there were 33 biosimilars that had received FDA approval, 21 of which were currently being sold.

According to the cardinal health report 2022, in cancer, where all three classes of therapeutic oncology biosimilars-namely, rituximab, bevacizumab, and trastuzumab-have topped 60% market share, significant progress has been made in the adoption of biosimilars in the U.S.

Competitive Landscape

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 among others.

Why Purchase the Report?

• To visualize the Global Biosimilar Market segmentation based on the product, technology, application, distribution channel, and region, as well as 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

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Product
• 3.2. Snippet by Technology
• 3.3. Snippet by Application
• 3.4. Snippet by Distribution Channel
• 3.5. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. An increasing number of biosimilar drug approvals by the FDA is boosting the global biosimilar market growth during the forecast period.
  • 4.1.2. Restraints
    • 4.1.2.1. High development costs of the biosimilar drug are hampering the growth of the global biosimilar market in the forecast period.
  • 4.1.3. Opportunity
    • 4.1.3.1. Technological advancements
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's 5 Forces Analysis
• 5.2. Supply Chain Analysis
• 5.3. Unmet Needs
• 5.4. Regulatory Analysis

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID-19
  • 6.1.2. Scenario During COVID-19
  • 6.1.3. Post COVID-19 & Future Scenario
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During the Pandemic
• 6.5. Manufacturers' Strategic Initiatives
• 6.6. Conclusion

7. Russia-Ukraine Conflict Analysis

8. Artificial Intelligence Analysis

9. By Product

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 9.1.2. Market Attractiveness Index, By Product
• 9.2. Monoclonal Antibodies*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Recombinant Human Growth Hormone (rhGH)
• 9.4. Insulin
• 9.5. Anti-coagulants
• 9.6. Erythropoietin
• 9.7. Fusion Proteins
• 9.8. Granulocyte Colony Stimulating Factor
• 9.9. Follitropin
• 9.10. Others

10. By Technology

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
  • 10.1.2. Market Attractiveness Index, By Technology
• 10.2. Recombinant DNA Technology (rDNA technology)*
  • 10.2.1. Introduction
  • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 10.3. Monoclonal Antibodies (MAb) Technology

11. By Application

• 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
• 11.1.2. Market Attractiveness Index, By Application
• 11.2. Oncology*
  • 11.2.1. Introduction
  • 11.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 11.3. Chronic and Immune Diseases
• 11.4. Infectious Diseases
• 11.5. Growth Hormone Deficiency
• 11.6. Blood Disorders
• 11.7. Others

12. By Distribution Channel

• 12.1. Introduction
  • 12.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 12.1.2. Market Attractiveness Index, By Distribution Channel
• 12.2. Hospital Pharmacies*
  • 12.2.1. Introduction
  • 12.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 12.3. Retail Pharmacies
• 12.4. Online Pharmacies

13. By Region

• 13.1. Introduction
  • 13.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 13.1.2. Market Attractiveness Index, By Region
• 13.2. North America
  • 13.2.1. Introduction
  • 13.2.2. Key Region-Specific Dynamics
  • 13.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 13.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
  • 13.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 13.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 13.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 13.2.7.1. The U.S.
    • 13.2.7.2. Canada
    • 13.2.7.3. Mexico
• 13.3. Europe
  • 13.3.1. Introduction
  • 13.3.2. Key Region-Specific Dynamics
  • 13.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 13.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
  • 13.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 13.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 13.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 13.3.7.1. Germany
    • 13.3.7.2. The U.K.
    • 13.3.7.3. France
    • 13.3.7.4. Italy
    • 13.3.7.5. Spain
    • 13.3.7.6. Rest of Europe
• 13.4. South America
  • 13.4.1. Introduction
  • 13.4.2. Key Region-Specific Dynamics
  • 13.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 13.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
  • 13.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 13.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 13.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 13.4.7.1. Brazil
    • 13.4.7.2. Argentina
    • 13.4.7.3. Rest of South America
• 13.5. Asia-Pacific
  • 13.5.1. Introduction
  • 13.5.2. Key Region-Specific Dynamics
  • 13.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 13.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
  • 13.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 13.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 13.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 13.5.7.1. China
    • 13.5.7.2. India
    • 13.5.7.3. Japan
    • 13.5.7.4. Australia
    • 13.5.7.5. Rest of Asia-Pacific
• 13.6. Middle East and Africa
  • 13.6.1. Introduction
  • 13.6.2. Key Region-Specific Dynamics
  • 13.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 13.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
  • 13.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 13.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

14. Competitive Landscape

• 14.1. Competitive Scenario
• 14.2. Product Benchmarking
• 14.3. Company Share Analysis
• 14.4. Key Developments and Strategies

15. Company Profiles

• 15.1. Amgen Inc.*
  • 15.1.1. Company Overview
  • 15.1.2. Product Portfolio and Description
  • 15.1.3. Financial Overview
  • 15.1.4. Key Developments
• 15.2. Teva Pharmaceutical Industries Ltd.
• 15.3. Novartis AG
• 15.4. Pfizer Inc.
• 15.5. Biocon
• 15.6. Samsung Bioepis
• 15.7. Mylan NV
• 15.8. Celltrion
• 15.9. Biogen
• 15.10. Intas Pharmaceutical Ltd

LIST NOT EXHAUSTIVE

16. Appendix

• 16.1. About Us and Services
• 16.2. Contact Us