Cover Image
Market Research Report

Biosimilars: Global Market, Trends and Competitor Analysis

Published by Kalorama Information Product code 96359
Published Content info 214 Pages
Delivery time: 1-2 business days
Price
Back to Top
Biosimilars: Global Market, Trends and Competitor Analysis
Published: November 14, 2017 Content info: 214 Pages
Description

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

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

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.

Table of Contents
Product Code: KLI15532315

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
  • 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)
Back to Top