Biosimilars: Global Market, Trends and Competitor Analysis

Table of Contents

1. EXECUTIVE SUMMARY

OVERVIEW

SCOPE AND METHODOLOGY

SIZE AND GROWTH OF THE MARKET

The World Market for Biosimilars

Table 1-1: Global Biosimilar Market Opportunity, 2006-2022 ($ Millions)

Figure 1-1: Global Biosimilar Market Opportunity, 2006-2022 ($ Millions)

Trends Affecting the Market

Market Outlook

2. INTRODUCTION AND OVERVIEW

BIOSIMILARS OVERVIEW

Table 2-1: Scientific Differences of Pharmaceuticals and Biopharmaceuticals

BIOPHARMACEUTICAL INDUSTRY AND APPROVAL PROCESS

GENETIC ENGINEERING

PATENT APPROVAL

REGULATIONS FOR BIOPHARMACEUTICALS

HISTORY OF THE PRESCRIPTION GENERIC PHARMACEUTICALS INDUSTRY

HISTORY OF THE GENERIC APPROVAL PROCESS

REGULATION OF PRESCRIPTION GENERIC PHARMACEUTICALS

BIOPHARMACEUTICALS

Areas of Treatment for Biopharmaceuticals

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 PHARMACEUTICAL REGIONAL ANALYSIS

BIOSIMILAR MARKET BY REGION

Table 5-1: Biosimilar Market Opportunity by Broad Region, 2006-2022 (Europe, United States, Rest of World, Total) ($ Millions)

Figure 5-1: Biosimilar Market Opportunity by Broad Region, 2006-2022 (Europe, United States, Rest of World, Total) ($ Millions)

EUROPE AND BIOSIMILARS

Table 5-2: Biosimilars Approved in EU

Table 5-3: European Market for Biosimilars, 2006-2022 ($ Millions)

Figure 5-2: European Market for Biosimilars, 2006-2022 ($ Millions)

Figure 5-3: European Market for Biosimilars, Market Share by Country, 2017 (Germany, France, UK, Italy Spain, Russia, Rest of Europe)

Germany

Table 5-4: Germany Biosimilar Market, 2017-2022 ($ millions)

France, Italy, Spain and United Kingdom

Table 5-5: France Biosimilar Market, 2017-2022 ($ millions)

Table 5-6: Italy Biosimilar Market, 2017-2022 ($ millions)

Table 5-7: United Kingdom Biosimilar Market, 2017-2022 ($ millions)

Table 5-8: Spain Biosimilar Market, 2017-2022 ($ millions)

Russia

Table 5-9: Russia Biosimilar Market, 2017-2022 ($ millions)

UNITED STATES AND BIOSIMILARS

Table 5-10: Biosimilars Approved in United States

Table 5-11: United States Market for Biosimilars, 2015-2022 ($ Millions)

Figure 5-4: United States Market for Biosimilars, 2015-2022 ($ Millions)

REST OF WORLD AND BIOSIMILARS

Table 5-12: Rest of World Market for Biosimilars, 2006-2022 ($ Millions)

Figure 5-5: Rest of World Market for Biosimilars, 2006-2022 ($ Millions)

Figure 5-6: Rest of World Market for Biosimilars, Market Share by Country, 2017 (Japan, India, China, South Korea, Australia, Brazil, Mexico, Turkey, Iran, Canada, Rest of World)

Japan

Table 5-13: Biosimilars Approved in Japan

Table 5-14: Japan Biosimilar Market, 2017-2022 ($ millions)

India

Table 5-15: Biosimilars Approved in India

Table 5-16: India Biosimilar Market, 2017-2022 ($ millions)

China

Table 5-17: China Biosimilar Market, 2017-2022 ($ millions)

South Korea

Table 5-18: Biosimilars Approved in South Korea

Table 5-19: South Korea Biosimilar Market, 2017-2022 ($ millions)

Australia

Table 5-20: Biosimilars Approved in Australia

Table 5-21: Australia Biosimilar Market, 2017-2022 ($ millions)

Brazil

Table 5-22: Brazil Biosimilar Market, 2017-2022 ($ millions)

Mexico

Table 5-23: Mexico Biosimilar Market, 2017-2022 ($ millions)

Turkey

Table 5-24: Turkey Biosimilar Market, 2017-2022 ($ millions)

Iran

Table 5-25: Iran Biosimilar Market, 2017-2022 ($ millions)

Canada

Table 5-26: Canada Biosimilar Market, 2017-2022 ($ millions)

6. ISSUES AND TRENDS

OVERVIEW

Interchangeability

Patent Issues

Pricing Issues

Table 6-1: Estimated Treatment Cost Per Patient of Selected Biopharmaceuticals (before patent expiration)

Barriers to Entry

Biosimilar Development

Table 6-2: Biosimilars in Development

Provider Education

Innovator Strategies and Challenges

Bulk Suppliers and Contract Manufacturing

Bioequivalence Issues

International Issues

Reimbursement Issues

7. MARKET SUMMARY

TOTAL MARKET SIZE AND FORECAST

Biosimilar Market by Product Type

Table 7-1: Biosimilar Market Value by Product Type (non-glycosylated, glycosylated and peptides/others), 2006 – 2022 ($ millions)

Figure 7-1: Biosimilar Market Value by Product Type (non-glycosylated, glycosylated and peptides/others), 2006 – 2022 ($ millions)

Table 7-2: Biosimilar Recombinant Non-Glycosylated Protein Market, 2017-2022 ($ millions)

Figure 7-2: Recombinant Non-Glycosylated Protein Market: Biosimilar vs. Originator Market Share, 2017 vs. 2022 (%)

Figure 7-3: Insulin Originator Products vs. Biosimilar Products 2006 – 2022

Figure 7-4: Somatropin Originator Products vs. Biosimilar Products 2006 – 2022

Figure 7-5: Filgrastim Originator Products vs. Biosimilar Products 2006 – 2022

Figure 7-6: Interferon Originator Products vs. Biosimilar Products 2006 – 2022

Table 7-3: Biosimilar Recombinant Glycosylated Protein Market, 2017-2022 ($ millions)

Figure 7-7: Recombinant Glycosylated Protein Market: Biosimilar vs. Originator Market Share, 2017 vs. 2022 (%)

Figure 7-8: Erythropoietin Originator Products vs. Biosimilar Products 2006 – 2022

Figure 7-9: Monoclonal Antibodies Originator Products vs. Biosimilar Products 2006 – 2022

Figure 7-10: Monoclonal Antibodies: Biosimilar Product Sales 2017 vs. 2022

Figure 7-11: Follitropin Originator Products vs. Biosimilar Products 2006 – 2022

Table 7-4: Biosimilar Recombinant Peptide and Other Product Market, 2017-2022 ($ millions)

Figure 7-12: Recombinant Peptide and Other Market: Biosimilar vs. Originator Market Share, 2017 vs. 2022 (%)

Figure 7-13: Etanercept Originator Products vs. Biosimilar Products 2006 – 2022

Figure 7-14: Teriparatide Originator Products vs. Biosimilar Products 2006 – 2022

Biosimilar Market by Application

Figure 7-15: Autoimmune Disease Biosimilar Market 2006-2022 ($ Millions)

Figure 7-16: Blood Disorder Biosimilar Market 2006-2022 ($ Millions)

Figure 7-17: Cancer Biosimilar Market 2006-2022 ($ Millions)

Figure 7-18: Growth Hormone Deficiency Biosimilar Market 2006-2022 ($ Millions)

Figure 7-19: Diabetes Biosimilar Market 2006-2022 ($ Millions)

Competitor Analysis

Figure 7-20: Biosimilar Competitor Analysis, 2017 (% Global Market Share)

8. CONCLUSIONS

CONCLUSION 1

CONCLUSION 2

CONCLUSION 3

CONCLUSION 4

CONCLUSION 5

CONCLUSION 6

9. COMPANY PROFILES

3SBIO, INC

Table 9-1: 3SBio Corporate Summary

Company Overview

Company Financials

Table 9-2: 3SBio (2014-2017) ($ millions)

AMEGA BIOTECH

Table 9-3: Amega Biotech Corporate Summary

Company Overview

AMGEN BIOSIMILARS

Table 9-4: Amgen Biosimilars Corporate Summary

Company Overview

Company Financials

Table 9-5: Amgen (2014-2017) ($ millions)

APOTEX, INC.

Table 9-6: Apotex Corporate Summary

Company Overview

AXXO GMBH

Table 9-7: Axxo Corporate Summary

Company Overview

BEIJING FOUR RINGS BIOPHARMACEUTICAL CO LTD.

Table 9-8: Beijing Four Rings Biopharmaceutical Corporate Summary

Company Overview

BIOCAD

Table 9-9: Biocad Corporate Summary

Company Overview

BIOCON LTD

Table 9-10: Biocon Corporate Summary

Company Overview

Company Financials

Table 9-11: Biocon (2014-2017) ($ millions)

BIOGEN INC.

Table 9-12: Biogen Corporate Summary

Company Overview

Company Financials

Table 9-13: Biogen (2014-2017) ($ millions)

BIOGENOMICS LTD.

Table 9-14: BioGenomics Corporate Summary

Company Overview

BIOPARTNERS GMBH

Table 9-15: BioPartners Corporate Summary

Company Overview

BIOSIDUS S.A.

Table 9-16: Biosidus Corporate Summary

Company Overview

BIOVIZ TECHNOLOGIES PVT. LTD

Table 9-17: Bioviz Technologies Corporate Summary

Company Overview

BIOXPRESS THERAPEUTICS S.A.

Table 9-18: BioXpress Therapeutics Corporate Summary

Company Overview

BOEHRINGER INGELHEIM GMBH

Table 9-19: Boehringer Ingelheim Corporate Summary

Company Overview

Company Financials

Table 9-20: Boehringer Ingelheim (2014-2017) ($ millions)

CELLTRION, INC.

Table 9-21: Celltrion Corporate Summary

Company Overview

CHEMO GROUP (GRUPO ISUD)

Table 9-22: Chemo Group Corporate Summary

Company Overview

COHERUS BIOSCIENCES, INC

Table 9-23: Coherus Biosciences Corporate Summary

Company Overview

Company Financials

Table 9-24: Coherus (2014-2017) ($ thousands)

DM BIO (DONG-A PHARMACEUTICALS)

Table 9-25: Dong- A Pharmaceuticals Corporate Summary

Company Overview

1. REDDY’S LABORATORIES LIMITED

Table 9-26: Dr Reddy’s Laboratories Corporate Summary

Company Overview

Company Financials

Table 9-27: Dr Reddy’s Laboratories (2014-2017) ($ millions)

GEDEON RICHTER

Table 9-28: Gedeon Richter Corporate Summary

Company Overview

Company Financials

Table 9-29: Gedeon Richter (2014-2017) ($ millions)

HARVEST MOON PHARMACEUTICALS USA, INC.

Table 9-30: Harvest Moon Pharmaceuticals Corporate Summary

Company Overview

HOSPIRA, INC

Table 9-31: Hospira Corporate Summary

Company Overview

INBIOPRO SOLUTIONS PVT LTD

Table 9-32: Inbiopro Solutions Corporate Summary

Company Overview

INTAS PHARMACEUTICALS LTD

Table 9-33: Intas Pharmaceuticals Corporate Summary

Company Overview

Company Financials

Table 9-34: Intas Pharmaceuticals (2014-2017) ($ thousands)

KYOWA HAKKO KIRIN CO, LTD

Table 9-35: Kyowa Hakko Kirin Corporate Summary

Company Overview

Company Financials

Table 9-36: Kyowa Hakko Kirin (2014-2017) ($ billions)

LG CHEM LTD.

Table 9-37: LG Chem Corporate Summary

Company Overview

MERCK & COMPANY

Table 9-38: Merck Corporate Summary

Company Overview

Company Financials

Table 9-39: Merck (2014-2017) ($ millions)

MOMENTA PHARMACEUTICALS INC

Table 9-40: Momenta Pharmaceuticals Corporate Summary

Company Overview

Company Financials

Table 9-41: Momenta (2014-2017) ($ thousands)

MYLAN N.V.

Table 9-42: Mylan Corporate Summary

Company Overview

Company Financials

Table 9-43: Mylan (2014-2017) ($ millions)

PFENEX INC.

Table 9-44: PFEnex Corporate Summary

Company Overview

Company Financials

Table 9-45: PFEnex (2014-2017) ($ thousands)

PFIZER BIOSIMILARS INC.

Table 9-46: Pfizer Biosimilars Corporate Summary

Company Overview

Company Financials

Table 9-47: Pfizer (2014-2017) ($ millions)

RELIANCE GENEMEDIX LIMITED

Table 9-48: Reliance Genemedix Corporate Summary

Company Overview

RELIANCE LIFE SCIENCES

Table 9-49: Reliance Life Sciences Corporate Summary

Company Overview

SAMSUNG BIOEPIS CO LTD

Table 9-50: Samsung Bioepis Corporate Summary

Company Overview

SANDOZ INTERNATIONAL GMBH

Table 9-51: Sandoz International Corporate Summary

Company Overview

Company Financials

Table 9-52: Sandoz (2014-2017) ($ millions)

SCIGEN LTD (BIOTON)

Table 9-53: SciGen Corporate Summary

Company Overview

Company Financials

Table 9-54: SciGen (2014-2017) ($ millions)

STADA ARZNEIMITTEL AG

Table 9-55: Stada Corporate Summary

Company Overview

Company Financials

Table 9-56: Stada (2014-2017) ($ millions)

TEVA PHARMACEUTICAL INDUSTRIES LTD

Table 9-57: Teva Corporate Summary

Company Overview

Company Financials

Table 9-58: Teva (2014-2017) ($ millions)

ZYDUS CADILA HEALTHCARE LTD.

Table 9-59: Zydus Cadila Corporate Summary

Company Overview

Company Financials

Table 9-60: Zydus Cadila (2014-2017) ($ millions)