Biosimilar Market Trends, 2019

Table of Contents

1. Executive Summary
Overview
Scope and Methodology
Size and Growth of the Market

• The Global Market for Biosimilars
  • Table 1-1: Global Biosimilar Market Opportunity, 2019-2024 ($ Millions)
  • Figure 1-1: Global Biosimilar Market Opportunity, 2019-2024 ($ Millions)
• Trends Affecting the Market
• Market Outlook

2. Introduction and Overview
Biosimilars Overview

• Table 2-1: Scientific Differences of Pharmaceuticals and Biopharmaceuticals

What’s Been Going On in the Market?

• Europe
• US
• Rest of World

Industry Leaders

3. Biosimilar Pharmaceuticals for Expired Biologic Patents

• Table 3-1: Select Marketed Biologics with Expired Patents

4. Biosimilar Pharmaceuticals for Future Expired Biologic Patents

• Table 4-1: Select Marketed Biologics with Active Patents

5. Biosimilar Market Activity
Market Summary

• Table 5-1: Global Biosimilar Market Opportunity by Region, 2019-2024 ($ Millions) (European Union, United States, Rest of World, Global Biosimilar Market)

• Figure 5-1: Global Biosimilar Market Growth by Region, 2019-2024 (%) (European Union, United States, Rest of World)

Development Overview

• Table 5-2: Biosimilar Approval by Product and Region (Biologic, Product/Innovator, United States, European Union, Japan, Canada, China, South Korea, Australia)

• Figure 5-2: Biosimilar Approvals by Region (United States, European Union, Japan, Canada, China, South Korea, Australia)

• Competitor Analysis
  • Figure 5-3: Biosimilar Competitor Analysis, Estimated 2019 (% Global Market Share)

  Europe and Biosimilars

  • Table 5-3: Biosimilars Approved in EU (Biosimilar Name, Manufacturer, Reference Drug, Approval Date)
  • Figure 5-4: Biosimilar Competitor Activity: European Union (Number of Approvals by Biologic)
• European Union Biosimilar Market Overview
  • Table 5-4: European Union Biosimilar Market, 2019-2024 ($ millions)
  • Figure 5-5: European Union Biosimilar Market, 2019-2024 ($ millions)

  United States and Biosimilars

  • Table 5-5: Biosimilars Approved in United States (Biosimilar Name, Manufacturer, Reference Drug, Approval Date)
  • Figure 5-6: Biosimilar Competitor Activity: United States (Number of Approvals by Biologic)
• United States Biosimilar Market Overview
  • Table 5-6: United States Biosimilar Market, 2019-2024 ($ millions)
  • Figure 5-7: United States Biosimilar Market, 2019-2024 ($ millions)

  Rest of World and Biosimilars

• Rest of World Biosimilar Market Overview
  • Table 5-7: Rest of World Biosimilar Market, 2019-2024 ($ millions)
  • Figure 5-8: Rest of World Biosimilar Market, 2019-2024 ($ millions)
• Japan
  • Table 5-8: Biosimilars Approved in Japan (Biosimilar Name, Manufacturer, Reference Drug, Approval Date)
  • Figure 5-9: Biosimilar Competitor Activity: Japan (Number of Approvals by Biologic)
• India
  • Table 5-9: Selected Biosimilars Approved in India (Biosimilar Name, Manufacturer, Reference Drug, Approval Date)
• China
  • Figure 5-10: Biosimilar Competitor Activity: China (Number of Approvals by Biologic)
• South Korea
  • Table 5-10: Biosimilars Approved in South Korea (Biosimilar Name, Manufacturer, Reference Drug, Approval Date)
  • Figure 5-11: Biosimilar Competitor Activity: South Korea (Number of Approvals by Biologic)
• Australia
  • Table 5-11: Biosimilars Approved in Australia (Biosimilar Name, Manufacturer, Reference Drug, Approval Date)
  • Figure 5-12: Biosimilar Competitor Activity: Australia (Number of Approvals by Biologic)

6. Legislative and Patent Issues
Overview

• EU Guidelines
• US Guidelines
• Interchangeability
• Patent and Patent Dance Issues
  • Table 6-1: Selected Patent Litigation Activity (Innovator, Biosimilar Company, Product, Status)

7. Other Industry Issues and Trends
Provider Education
Switching Concerns
Innovator Strategies and Challenges
Reimbursement Issues
Biosimilar Naming and Labeling