1 Table of Contents

EXECUTIVE SUMMARY

INTRODUCTION

• 2.1 Defining Biosimilars
• 2.2 Comparative Analysis: Biosimilars vs Generics
• 2.3 Biobetters
• 2.4 Why Biosimilars? SWOT Analysis

KEY DRIVERS

• 3.1 Constrained Payer Environment
• 3.2 Cost-effectiveness
• 3.3 Patent expiration

KEY BARRIERS

• 4.1 Development complexities and cost
• 4.2 Strategies from originators
• 4.3 Interchangeability and substitution concerns

BIOSIMILARS IN MATURE MARKETS

• 5.1 Biosimilar Approval Pathways Across Key Mature Markets
• 5.2 Biosimilars in EU
  • 5.2.1 Developments in the EU Biosimilar Landscape: Gainsharing
• 5.3 Biosimilars in the US
  • 5.3.1 Developments in the US Biosimilar Landscape: Reimbursement
  • 5.3.2 Developments in the US Biosimilar Landscape: Rebate
• 5.4 Biosimilars in Japan

BIOSIMILARS IN EMERGING MARKET

• 6.1 Biosimilar Approval Pathways Across Key Emerging Markets
• 6.2 Biosimilars in South Korea
• 6.3 Biosimilars in China
  • 6.3.1 Developments in the Chinese Biosimilar Landscape: Reforms
  • 6.3.2 Developments in the Chinese Biosimilar Landscape: Investments
• 6.4 Biosimilars in Brazil
• 6.5 Biosimilars in India
• 6.6 Strategies for Biosimilars Manufacturers in Emerging Markets

GLOBAL BIOSIMILAR PIPELINE ANALYSIS

• 7.1 Global Biosimilar Pipeline by Stage of Development
• 7.2 Global Biosimilar Pipeline by Therapy Area
• 7.3 Global Biosimilar Pipeline by Indication: Top 10 targeted indications
• 7.4 Global Biosimilar Pipeline by Molecule: Top 10 targeted biosimilars
• 7.5 Most Active Manufacturers in the Global Biosimilar Pipeline: Product Volume by Stage of Development
• 7.6 Most Active Manufacturers in the Global Biosimilar Pipeline: Product Volume by Molecule
• 7.7 Most Active Manufacturers in the Global Biosimilar Late Stage Pipeline

GLOBAL BIOSIMILAR MARKET AND PRODUCT SALES FORECAST

• 8.1 Global Rituximab Biosimilar Market Forecast 2017 - 2024
• 8.2 Rituximab Biosimilar Market: ABP 798 Global Sales Forecast 2017 - 2024
• 8.3 Global Infliximab Biosimilar Market Forecast 2017 - 2024
• 8.4 Infliximab Biosimilar Market: Inflectra Global Sales Forecast 2017 - 2024
• 8.5 Global Trastuzumab Biosimilar Market Forecast 2017 - 2024
• 8.6 Trastuzumab Biosimilar Market: Kanjinti Global Sales Forecast 2017 - 2024
• 8.7 Global Bevacizumab Biosimilar Market Forecast 2017 - 2024
• 8.8 Bevacizumab Biosimilar Market: Mvasi Global Sales Forecast 2017 - 2024
• 8.9 Global Adalimumab Biosimilar Market Forecast 2017 - 2024
• 8.10 Adalimumab Biosimilar Market: Global Imraldi Sales Forecast 2017 - 2024
• 8.11 Insulin Glargine Biosimilar Market: Basaglar Global Sales Forecast 2017 - 2024
• 8.12 Etanercept Biosimilar Market: Benepali Global Sales Forecast 2017 - 2024

STRATEGIC ALLIANCES

• 9.1 Global Biosimilar Partnership Deals by Region and Value
• 9.2 Global Biosimilars Partnership Deals by Year
• 9.3 Global Biosimilar Licensing Deals by Region and Value
• 9.4 Global Biosimilar Licensing Deals by Year
• 9.5 Top 10 Targeted Biosimilars in Strategic Alliances
• 9.6 Most Active Companies in Strategic Alliances

COMPANY PROFILE

• 10.1 Sandoz
• 10.2 Pfizer
• 10.3 Celltrion
• 10.4 Samsung Bioepis
• 10.5 Amgen
• 10.6 Biocon
• 10.7 Dr. Reddy's Laboratories

BIBLIOGRAPHY

Disclaimer

Global Biosimilars Market - Increasingly Lucrative Market Fueled by Constrained Payer Environment and Patent Expiries for Best-Selling Biologics

Summary

GBI Research’s latest report: “Biosimilars” provides an in-depth assessment of the current developments and trends in the global biosimilars market. This report also assesses the state of the biosimilar R&D and commercial landscape through multilevel analytics that include data split by therapy area, stage of development, molecule, and company. Global revenue forecasts to 2024 for biosimilars with strong market potential, both in development and in the market, are provided.

Data analyses from our study shows that there will be enormous commercial opportunities for biosimilar manufacturers over the coming years, given the number of high-revenue-generating biologics that will go off patent in the next five years, and promising revenue forecasts for biosimilars in late-stage development.

Information leveraged from our robust industry-leading database highlights a diverse number of biosimilars in the pipeline for a wide range of therapy areas, with several of these in the later stages of development. Government support for biosimilars is increasing in key mature and emerging markets, given the cost-saving opportunities that these products represent for national healthcare budgets.

Our study details current biosimilar regulatory frameworks and guidelines implemented in the US, Europe, Japan, China, South Korea, India and Brazil, and recent developments in the landscape within these markets. GBI Research conducted extensive research efforts in order to provide a comprehensive view of the global biosimilar market. This new report adds to our unique portfolio of trusted industry analyses that enable our clients to assess the most promising commercial areas in the market and exploit key business opportunities.

Scope

- How does the global biosimilar pipeline look like in 2018?
- What is the distribution of pipeline biosimilars by stage of development?
- Which are the therapy areas set to benefit the most from biosimilar drugs in development?
- Which biosimilars are commonly targeted in the pipeline?
- How many companies are currently involved in biosimilar drug development? Which are the most active in the pipeline?
- What is the size of the global biosimilar market?
- How much revenue will promising biosimilar drugs in the market, and in development, record to 2024?
- What are the key factors driving growth in the global biosimilars market?
- What are the factors restraining the growth of global biosimilar market?
- How does legislation regarding biosimilar interchangeability differ among key geographical markets?
- How will legal or political changes in the landscape affect the biosimilar market?
- What are the key differences in biosimilar regulatory pathways between US, Europe, Japan, South Korea, China, Brazil, and India?
- What are the regulatory evidence requirements in each country?

Reasons to buy

- Develop an overview of the current biosimilar landscape in key markets
- Learn how regulatory or legal changes will affect the market
- Identify market prospects