Table of Contents
- 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
- 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
- BIOSIMILAR PHARMACEUTICALS FOR EXPIRED BIOLOGIC PATENTS
Table 3-1: Select Marketed Biologics with Expired Patents
- BIOSIMILAR PHARMACEUTICALS FOR FUTURE EXPIRED BIOLOGIC PATENTS
Table 4-1: Select Marketed Biologics with Active Patents
- 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)
- 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
- 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)
- CONCLUSIONS
CONCLUSION 1
CONCLUSION 2
CONCLUSION 3
CONCLUSION 4
CONCLUSION 5
CONCLUSION 6
- 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
- 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)