Published: 30 Nov 2021 | Report Code: 10248259 | Pages: 116
North America biosimilars market is expected to grow by 25.1% annually in the forecast period and reach $27.57 billion by 2030 driven by the affordability of biosimilar-based treatment, rising incidence of chronic diseases due to aging populations, patent expirations of many blockbuster drugs, and better healthcare provisions. Highlighted with 29 tables and 54 figures, this 116-page report “North America Biosimilars Market 2020-2030 by Product Type (Non-glycosylated, Glycosylated), Indication (Cancer, Autoimmune Disease, Blood Disorder, Diabetes), Manufacturing (Contract, Inhouse), End User (Hospitals and Clinics, Research Institutes), and Country: Trend Forecast and Growth Opportunity” is based on a comprehensive research of the entire North America biosimilars market and all its sub-segments through extensively detailed classifications. Profound analysis and assessment are generated from premium primary and secondary information sources with inputs derived from industry professionals across the value chain. The report is based on studies on 2017-2019 and provides estimate for 2020 and forecast from 2021 till 2030 with 2019 as the base year (Year 2020 is not appropriate for research base due to the outbreak of COVID-19). In-depth qualitative analyses include identification and investigation of the following aspects: • Market Structure • Growth Drivers • Restraints and Challenges • Emerging Product Trends & Market Opportunities • Porter’s Fiver Forces The trend and outlook of North America market is forecast in optimistic, balanced, and conservative view by taking into account of COVID-19. The balanced (most likely) projection is used to quantify North America biosimilars market in every aspect of the classification from perspectives of Product Type, Indication, Manufacturing, End User, and Country. Based on Product Type, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2019-2030 included in each section. • Recombinant Non-glycosylated Biosimilars o Insulin o Recombinant Human Growth Hormone (rHGH) o Granulocyte Colony Stimulating Factor o Interferon • Recombinant Glycosylated Biosimilars o Monoclonal Antibodies (mAb) o Erythropoietin (EPO) o Follicle Stimulating Hormone • Recombinant Peptides and Others o Tumor Necrosis Factor (TNF)-Inhibitor o Parathyroid Hormone o Enzymes, Immunomodulators, GnRH Analogs and Others Based on Indication, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2019-2030 included in each section. • Cancer • Autoimmune Disease • Blood Disorder • Diabetes • Growth Hormone Deficiency • Infectious Diseases • Other Indications Based on Manufacturing, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2019-2030 included in each section. • Contract Manufacturing • Inhouse Manufacturing Based on End User, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2019-2030 included in each section. • Hospitals and Clinics • Research Institutes • Other End Users Geographically, the following national/local markets are fully investigated: • U.S. • Canada • Mexico For each key country, detailed analysis and data for annual revenue ($ mn) are available for 2019-2030. The breakdown of key national markets by Product Type, Indication, and End User over the forecast years are also included. The report also covers current competitive scenario and the predicted trend; and profiles key vendors including market leaders and important emerging players. Key Players (this may not be a complete list and extra companies can be added upon request): AMEGA Biotech S.A. Apotex Inc. Biocon Ltd Biogen Inc. Boehringer Ingelheim Celltrion, Inc. Dr. Reddy’s Laboratories Ltd. Eli Lilly and Company Intas Pharmaceuticals Ltd. LG Chem, Ltd. Merck and Co. Inc. Mylan N.V. Pfizer Inc. Samsung Biologics Co., Ltd. Sandoz International GmbH STADA Arzneimittel AG Teva Pharmaceutical Industries Ltd. (Please note: The report will be updated before delivery so that the latest historical year is the base year and the forecast covers at least 5 years over the base year.)
Table Of Contents:
1 Introduction 7 1.1 Industry Definition and Research Scope 7 1.1.1 Industry Definition 7 1.1.2 Research Scope 8 1.2 Research Methodology 11 1.2.1 Overview of Market Research Methodology 11 1.2.2 Market Assumption 12 1.2.3 Secondary Data 12 1.2.4 Primary Data 12 1.2.5 Data Filtration and Model Design 13 1.2.6 Market Size/Share Estimation 14 1.2.7 Research Limitations 15 1.3 Executive Summary 16 2 Market Overview and Dynamics 18 2.1 Market Size and Forecast 18 2.1.1 Impact of COVID-19 on World Economy 21 2.1.2 Impact of COVID-19 on the Market 24 2.2 Major Growth Drivers 26 2.3 Market Restraints and Challenges 31 2.4 Emerging Opportunities and Market Trends 34 2.5 Porter’s Fiver Forces Analysis 38 3 Segmentation of North America Market by Product Type 42 3.1 Market Overview by Product Type 42 3.2 Recombinant Non-glycosylated Biosimilars 44 3.2.1 Insulin 46 3.2.2 Recombinant Human Growth Hormone (rHGH) 47 3.2.3 Granulocyte Colony Stimulating Factor 48 3.2.4 Interferon 49 3.3 Recombinant Glycosylated Biosimilars 50 3.3.1 Monoclonal Antibodies (mAb) 51 3.3.2 Erythropoietin (EPO) 52 3.3.3 Follicle Stimulating Hormone 53 3.4 Recombinant Peptides and Others 54 3.4.1 Tumor Necrosis Factor (TNF)-Inhibitor 55 3.4.2 Parathyroid Hormone 56 3.4.3 Enzymes, Immunomodulators, GnRH Analogs and Others 57 4 Segmentation of North America Market by Indication 58 4.1 Market Overview by Indication 58 4.2 Cancer 60 4.3 Autoimmune Disease 61 4.4 Blood Disorder 62 4.5 Diabetes 63 4.6 Growth Hormone Deficiency 64 4.7 Infectious Diseases 65 4.8 Other Indications 66 5 Segmentation of North America Market by Manufacturing 67 5.1 Market Overview by Manufacturing 67 5.2 Contract Manufacturing 69 5.3 Inhouse Manufacturing 70 6 Segmentation of North America Market by End User 71 6.1 Market Overview by End User 71 6.2 Hospitals and Clinics 73 6.3 Research Institutes 74 6.4 Other End Users 75 7 North America Market 2019-2030 by Country 76 7.1 Overview of North America Market 76 7.2 U.S. 79 7.3 Canada 89 7.4 Mexico 91 8 Competitive Landscape 93 8.1 Overview of Key Vendors 93 8.2 New Product Launch, Partnership, Investment, and M&A 97 8.3 Company Profiles 98 AMEGA Biotech S.A. 98 Apotex Inc. 100 Biocon Ltd 101 Biogen Inc. 102 Boehringer Ingelheim 103 Celltrion, Inc. 104 Dr. Reddy’s Laboratories Ltd. 105 Eli Lilly and Company 106 Intas Pharmaceuticals Ltd. 107 LG Chem, Ltd. 108 Merck and Co. Inc. 109 Mylan N.V. 110 Pfizer Inc. 111 Samsung Biologics Co., Ltd. 112 Sandoz International GmbH 113 STADA Arzneimittel AG 114 Teva Pharmaceutical Industries Ltd. 115 RELATED REPORTS 116
List Of Tables: Table 1. Snapshot of North America Biosimilars Market in Balanced Perspective, 2019-2030 17 Table 2. Growth Rate of World GDP, 2020-2022 22 Table 3. World Health Spending by Region, $ bn, 2013-2020 30 Table 4. Main Product Trends and Market Opportunities in North America Biosimilars Market 34 Table 5. North America Biosimilars Market by Product Type, 2019-2030, $ mn 42 Table 6. North America Biosimilars Market: Recombinant Non-glycosylated Biosimilars by Product, 2019-2030, $ mn 45 Table 7. North America Biosimilars Market: Recombinant Glycosylated Biosimilars by Product, 2019-2030, $ mn 50 Table 8. North America Biosimilars Market: Recombinant Peptides and Others by Product, 2019-2030, $ mn 54 Table 9. North America Biosimilars Market by Indication, 2019-2030, $ mn 58 Table 10. North America Biosimilars Market by Manufacturing, 2019-2030, $ mn 67 Table 11. North America Biosimilars Market by End User, 2019-2030, $ mn 71 Table 12. North America Biosimilars Market by Country, 2019-2030, $ mn 77 Table 13. U.S. Biosimilars Market by Product Type, 2019-2030, $ mn 82 Table 14. U.S. Biosimilars Market by Indication, 2019-2030, $ mn 82 Table 15. U.S. Biosimilars Market by End User, 2019-2030, $ mn 82 Table 16. FDA Approved Biosimilars in U.S., 2015-2020 83 Table 17. U.S. Select Pending Biosimilar BLAs as of December 2020 87 Table 18. U.S. Biosimilar Market Share (market share data through July 2020) 88 Table 19. Canada Biosimilars Market by Product Type, 2019-2030, $ mn 90 Table 20. Canada Biosimilars Market by Indication, 2019-2030, $ mn 90 Table 21. Canada Biosimilars Market by End User, 2019-2030, $ mn 90 Table 22. Mexico Biosimilars Market by Product Type, 2019-2030, $ mn 92 Table 23. Mexico Biosimilars Market by Indication, 2019-2030, $ mn 92 Table 24. Mexico Biosimilars Market by End User, 2019-2030, $ mn 92 Table 25. Breakdown of World Market by Key Vendor, 2020, % 95 Table 26. AMEGA Biotech S.A.: Company Snapshot 98 Table 27. AMEGA Biotech S.A.: Business Segmentation 98 Table 28. AMEGA Biotech S.A.: Product Portfolio 99 Table 29. AMEGA Biotech S.A.: Revenue, 2018-2020, $ mn 99
List Of Figures: Figure 1. Research Method Flow Chart 11 Figure 2. Bottom-up Approach and Top-down Approach for Market Estimation 14 Figure 3. North America Market Forecast in Optimistic, Conservative and Balanced Perspectives, 2019-2030 16 Figure 4. North America Biosimilars Market, 2019-2030, $ mn 18 Figure 5. EMA and FDA Biosimilar Approvals, 2015 - 2019 19 Figure 6. EMA-approved Biosimilars Distribution by Reference Product and Therapeutic Area 19 Figure 7. FDA-approved Biosimilars Distribution by Reference Product and Therapeutic Area 20 Figure 8. Impact of COVID-19 on Business 24 Figure 9. Primary Drivers and Impact Factors of North America Biosimilars Market 26 Figure 10. Worldwide Geriatric Population (60 years and above) by Regions, 2015 & 2030, million 29 Figure 11. World Population 65 and Over, % of Total Population, 1950-2060 29 Figure 12. Primary Restraints and Impact Factors of North America Biosimilars Market 31 Figure 13. Investment Opportunity Analysis 35 Figure 14. Porter’s Fiver Forces Analysis of North America Biosimilars Market 38 Figure 15. Breakdown of North America Biosimilars Market by Product Type, 2019-2030, % of Revenue 43 Figure 16. North America Addressable Market Cap in 2021-2030 by Product Type, Value ($ mn) and Share (%) 43 Figure 17. North America Biosimilars Market by Product Type: Recombinant Non-glycosylated Biosimilars, 2019-2030, $ mn 44 Figure 18. North America Biosimilars Market by Recombinant Non-glycosylated Biosimilars: Insulin, 2019-2030, $ mn 46 Figure 19. North America Biosimilars Market by Recombinant Non-glycosylated Biosimilars: Recombinant Human Growth Hormone (rHGH), 2019-2030, $ mn 47 Figure 20. North America Biosimilars Market by Recombinant Non-glycosylated Biosimilars: Granulocyte Colony Stimulating Factor, 2019-2030, $ mn 48 Figure 21. North America Biosimilars Market by Recombinant Non-glycosylated Biosimilars: Interferon, 2019-2030, $ mn 49 Figure 22. North America Biosimilars Market by Product Type: Recombinant Glycosylated Biosimilars, 2019-2030, $ mn 50 Figure 23. North America Biosimilars Market by Recombinant Glycosylated Biosimilars: Monoclonal Antibodies (mAb), 2019-2030, $ mn 51 Figure 24. North America Biosimilars Market by Recombinant Glycosylated Biosimilars: Erythropoietin (EPO), 2019-2030, $ mn 52 Figure 25. North America Biosimilars Market by Recombinant Glycosylated Biosimilars: Follicle Stimulating Hormone, 2019-2030, $ mn 53 Figure 26. North America Biosimilars Market by Product Type: Recombinant Peptides and Others, 2019-2030, $ mn 54 Figure 27. North America Biosimilars Market by Recombinant Peptides and Others: Tumor Necrosis Factor (TNF)-Inhibitor, 2019-2030, $ mn 55 Figure 28. North America Biosimilars Market by Recombinant Peptides and Others: Parathyroid Hormone, 2019-2030, $ mn 56 Figure 29. North America Biosimilars Market by Recombinant Peptides and Others: Enzymes, Immunomodulators, GnRH Analogs and Others, 2019-2030, $ mn 57 Figure 30. Breakdown of North America Biosimilars Market by Indication, 2019-2030, % of Sales Revenue 59 Figure 31. North America Addressable Market Cap in 2021-2030 by Indication, Value ($ mn) and Share (%) 59 Figure 32. North America Biosimilars Market by Indication: Cancer, 2019-2030, $ mn 60 Figure 33. North America Biosimilars Market by Indication: Autoimmune Disease, 2019-2030, $ mn 61 Figure 34. North America Biosimilars Market by Indication: Blood Disorder, 2019-2030, $ mn 62 Figure 35. North America Biosimilars Market by Indication: Diabetes, 2019-2030, $ mn 63 Figure 36. North America Biosimilars Market by Indication: Growth Hormone Deficiency, 2019-2030, $ mn 64 Figure 37. North America Biosimilars Market by Indication: Infectious Diseases, 2019-2030, $ mn 65 Figure 38. North America Biosimilars Market by Indication: Other Indications, 2019-2030, $ mn 66 Figure 39. Breakdown of North America Biosimilars Market by Manufacturing, 2019-2030, % of Sales Revenue 68 Figure 40. North America Addressable Market Cap in 2021-2030 by Manufacturing, Value ($ mn) and Share (%) 68 Figure 41. North America Biosimilars Market by Manufacturing: Contract Manufacturing, 2019-2030, $ mn 69 Figure 42. North America Biosimilars Market by Manufacturing: Inhouse Manufacturing, 2019-2030, $ mn 70 Figure 43. Breakdown of North America Biosimilars Market by End User, 2019-2030, % of Revenue 72 Figure 44. North America Addressable Market Cap in 2021-2030 by End User, Value ($ mn) and Share (%) 72 Figure 45. North America Biosimilars Market by End User: Hospitals and Clinics, 2019-2030, $ mn 73 Figure 46. North America Biosimilars Market by End User: Research Institutes, 2019-2030, $ mn 74 Figure 47. North America Biosimilars Market by End User: Other End Users, 2019-2030, $ mn 75 Figure 48. Breakdown of North America Biosimilars Market by Country, 2019 and 2030, % of Revenue 77 Figure 49. Contribution to North America 2021-2030 Cumulative Market by Country, Value ($ mn) and Share (%) 78 Figure 50. U.S. Biosimilars Market, 2019-2030, $ mn 80 Figure 51. Biosimilar Approvals and Launches in U.S., 2015-2020 80 Figure 52. Canada Biosimilars Market, 2019-2030, $ mn 89 Figure 53. Biosimilars Market in Mexico, 2019-2030, $ mn 91 Figure 54. Growth Stage of North America Biosimilars Industry over the Forecast Period 93
Key Players (this may not be a complete list and extra companies can be added upon request): AMEGA Biotech S.A. Apotex Inc. Biocon Ltd Biogen Inc. Boehringer Ingelheim Celltrion, Inc. Dr. Reddy’s Laboratories Ltd. Eli Lilly and Company Intas Pharmaceuticals Ltd. LG Chem, Ltd. Merck and Co. Inc. Mylan N.V. Pfizer Inc. Samsung Biologics Co., Ltd. Sandoz International GmbH STADA Arzneimittel AG Teva Pharmaceutical Industries Ltd. (Please note: The report will be updated before delivery so that the latest historical year is the base year and the forecast covers at least 5 years over the base year.)