Biosimilars: Global Market, Trends and Competitor Analysis

 
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Published Nov 14, 2017 | 214 Pages | Pub ID: KLI15532315

Biosimilars: Global Market, Trends and Competitor Analysis

Worldwide interest in biosimilars is gaining momentum. These close models of significant and profitable biopharmaceuticals are expected to have a dramatic market impact. Some of the biggest-selling biological drugs developed during the first phase of the biotechnology revolution in the 1980s, including human growth hormone (hGH) and insulin, have lost patent protection.
  • Who’s Set to Win as Biosimilars Reach Markets?
  • What Companies May Face Threats?
  • Are Reports of Market Effects Hype or Reality?
  • What are the Best Disease Categories?
  • What Will the Opportunity Be in the Next Ten Years?
This Kalorama Information report, Biosimilars: Global Market, Trends, and Competitor Analysis, addresses these points and more. The report is a detailed analysis both of the market for biosimilars and for the market effects on pharmaceutical markets. Kalorama Information last visited this topic in 2013, but since that time there has been increasing worldwide involvement in the development of the biosimilar arena.

Biosimilar Market by Region

The global market for biosimilar products has grown, adding to the growing strategies of cost savings and improved health outcomes. Despite the benefits, both economical and to patient health, the market was initially slow to develop and has thus far only reached a fraction of its potential. Biosimilars: Global Market, Trends, and Competitor Analysis provides the complete world and regional picture of the follow-on biologics market, now one of the hottest segments in the pharmaceutical industry, including information on the following market segments:
  • Global Biosimilar Market Opportunity, 2006-2022
  • Biosimilar Market Opportunity by Broad Region, 2006-2022 (Europe, United States, Rest of World, Total)
  • Biosimilars Approved in United States
  • United States Market for Biosimilars, 2015-2022
  • Biosimilars Approved in EU
  • European Market for Biosimilars, 2006-2022
  • European Market for Biosimilars, Market Share by Country, 2017 (Germany, France, UK, Italy Spain, Russia, Rest of Europe)
  • Germany Biosimilar Market, 2017-2022
  • France Biosimilar Market, 2017-2022
  • Italy Biosimilar Market, 2017-2022
  • United Kingdom Biosimilar Market, 2017-2022
  • Spain Biosimilar Market, 2017-2022
  • Russia Biosimilar Market, 2017-2022
  • 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)
  • Rest of World Market for Biosimilars, 2006-2022
  • Biosimilars Approved in Japan
  • Japan Biosimilar Market, 2017-2022
  • Biosimilars Approved in India
  • India Biosimilar Market, 2017-2022
  • China Biosimilar Market, 2017-2022
  • Biosimilars Approved in South Korea
  • South Korea Biosimilar Market, 2017-2022
  • Biosimilars Approved in Australia
  • Australia Biosimilar Market, 2017-2022
  • Brazil Biosimilar Market, 2017-2022
  • Mexico Biosimilar Market, 2017-2022
  • Turkey Biosimilar Market, 2017-2022
  • Iran Biosimilar Market, 2017-2022
  • Canada Biosimilar Market, 2017-2022

Biosimilar Market by Application

Insulin, blood products and monoclonal antibodies are expected to show the most potential for generic equivalent products. Generic versions are available in several world markets for epoetin alfa, rituximab, insulin, and other products. As we move through the forecast period, biosimilars in cancer treatment are expected to show favorable results. Although revenues for biosimilars remain small due to the regulatory restrictions in most lucrative markets, such as the United States, there are a number of products, which entered recently or will enter the market in the coming years, further expanding revenues for the biosimilar market. The report looks at the market by application, including the following:
  • Autoimmune Disease Biosimilar Market 2006-2022
  • Blood Disorder Biosimilar Market 2006-2022
  • Cancer Biosimilar Market 2006-2022
  • Growth Hormone Deficiency Biosimilar Market 2006-2022
  • Diabetes Biosimilar Market 2006-2022

Biosimilar Market by Product Type

The world market for biosimilars has historically been fueled primarily by the demand for bioequivalent versions of blood products erythropoietin and G-CSF. A focus for biosimilar production in the United States and key markets in Europe is hGH. Another area showing great promise is the monoclonal antibody segment, which includes several autoimmune and oncology products. Biosimilars: Global Market, Trends, and Competitor Analysis breaks down the biosimilars market by product type, including the following segments:
  • Biosimilar Market Value by Product Type (non-glycosylated, glycosylated and peptides/others), 2006 - 2022
  • Biosimilar Recombinant Non-Glycosylated Protein Market, 2017-2022
  • Recombinant Non-Glycosylated Protein Market: Biosimilar vs. Originator Market Share, 2017 vs. 2022 (%)
  • Insulin Originator Products vs. Biosimilar Products 2006 - 2022
  • Somatropin Originator Products vs. Biosimilar Products 2006 - 2022
  • Filgrastim Originator Products vs. Biosimilar Products 2006 - 2022
  • Interferon Originator Products vs. Biosimilar Products 2006 - 2022
  • Biosimilar Recombinant Glycosylated Protein Market, 2017-2022
  • Recombinant Glycosylated Protein Market: Biosimilar vs. Originator Market Share, 2017 vs. 2022 (%)
  • Erythropoietin Originator Products vs. Biosimilar Products 2006 - 2022
  • Monoclonal Antibodies Originator Products vs. Biosimilar Products 2006 - 2022
  • Monoclonal Antibodies: Biosimilar Product Sales 2017 vs. 2022
  • Follitropin Originator Products vs. Biosimilar Products 2006 - 2022
  • Biosimilar Recombinant Peptide and Other Product Market, 2017-2022
  • Recombinant Peptide and Other Market: Biosimilar vs. Originator Market Share, 2017 vs. 2022 (%)
  • Etanercept Originator Products vs. Biosimilar Products 2006 - 2022
  • Teriparatide Originator Products vs. Biosimilar Products 2006 - 2022

Biosimilar Market Issues and Trends

The issues and trends surrounding the prescription biosimilar pharmaceutical market are staggering and in some cases seemingly insurmountable. But as the pharmaceutical industry has experienced in the past, the generics industry is tough, resilient and determined, managing to overcome obstacles and prevail. The report discusses many of the market issues that will need to be addressed moving forward, including:
  • Interchangeability
  • Patent Issues
  • Pricing Issues

Biosimilar Market Competitor Analysis

Biosimilars: Global Market, Trends, and Competitor Analysis provides a complete competitor analysis for 2017, by percentage of global market share. There is a smaller group of companies engaging in the development and commercialization of biosimilar products than is normally seen in the mainstream generic industry. This is due to significant barriers to entry into the market, though current trends in biotechnology are bringing new opportunities for the biosimilars industries in the future. The companies participating in this unique market, which require a combination of biopharmaceutical knowledge and manufacturing expertise, are profiled in the report, including:
  • 3SBio, Inc.
  • Amega Biotech
  • Amgen Biosimilars
  • Apotex, Inc.
  • Axxo GmbH
  • Beijing Four Rings Biopharmaceutical Co Ltd.
  • Biocad
  • Biocon Ltd
  • Biogen Inc.
  • BioGenomics Ltd.
  • BioPartners GmbH
  • Biosidus S.A.
  • Bioviz Technologies Pvt. Ltd
  • BioXpress Therapeutics S.A.
  • Boehringer Ingelheim GmbH
  • Celltrion, Inc.
  • Chemo Group (Grupo Isud)
  • Coherus BioSciences, Inc.
  • DM Bio (Dong-A Pharmaceuticals)
  • Dr Reddy’s Laboratories Limited
  • Gedeon Richter
  • Harvest Moon Pharmaceuticals USA, Inc.
  • Hospira, Inc.
  • Inbiopro Solutions Pvt Ltd
  • Intas Pharmaceuticals Ltd
  • Kyowa Hakko Kirin Co, Ltd
  • LG Chem Ltd.
  • Merck & Company
  • Momenta Pharmaceuticals, Inc.
  • Mylan N.V.
  • PFEnex Inc.
  • Pfizer Biosimilars Inc.
  • Reliance GeneMedix Limited
  • Reliance Life Sciences
  • Samsung Bioepis Co Ltd
  • Sandoz International GmbH
  • SciGen Ltd (Bioton)
  • Stada Arzneimittel AG
  • Teva Pharmaceutical Industries Ltd
  • Zydus Cadila Healthcare Ltd.

Market Conclusions

The report draws six main market conclusions that involve patent protection, pricing, market participants, emerging markets, evolving market strategies and education.
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
DR. 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)

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