biosimilars market global revenue, trends, growth, share, size and forecast to 2022
TRANSCRIPT
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Biosimilars Market, by Product Type
(Recombinant Glycosylated Proteins,
Recombinant Non-Glycosylated Proteins,
Recombinant Peptides), Application
(Oncology, Blood Disorders, Infectious
Diseases, Autoimmune Diseases, Other
Diseases), and Geography – Global
Opportunity Analysis and Industry
Forecast, 2014-2022.
October 2016
2
1 Table of Contents
1 Introduction .................................................................................................................................. 11
2 Market Overview .......................................................................................................................... 12
2.1 Definitions ............................................................................................................................. 12
2.2 Research Methodology ......................................................................................................... 14
2.3 Market Segmentation ........................................................................................................... 16
2.4 Assumptions .......................................................................................................................... 17
3 Executive Summary ....................................................................................................................... 18
4 Market Dynamics .......................................................................................................................... 22
4.1 Drivers ................................................................................................................................... 22
4.2 Restraints .............................................................................................................................. 24
4.3 Opportunities ........................................................................................................................ 25
4.4 Trends ................................................................................................................................... 25
5 Industry Analysis ........................................................................................................................... 27
5.1 Industry Overview ................................................................................................................. 27
5.2 Regulatory Analysis ............................................................................................................... 28
5.2.1 European Medicines Agency (EMA) .............................................................................. 28
5.2.2 U.S. FDA ......................................................................................................................... 30
5.2.3 India............................................................................................................................... 31
5.2.4 Latin America ................................................................................................................ 34
5.2.5 Other Asia-Pacific Countries ......................................................................................... 35
5.3 Time to Entry Analysis ........................................................................................................... 36
5.4 Pipeline Analysis .................................................................................................................... 37
5.5 Pricing Analysis ...................................................................................................................... 41
5.6 Stakeholders Analysis............................................................................................................ 42
6 Biosimilars Market, by Product Types .......................................................................................... 44
6.1 Market Overview .................................................................................................................. 44
6.2 Market Share Segmentation ................................................................................................. 46
6.3 Revenue Segmentation ......................................................................................................... 47
6.4 Product Types ....................................................................................................................... 48
6.4.1 Recombinant Glycosylated Proteins ............................................................................. 48
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6.4.2 Recombinant Non-Glycosylated Proteins ..................................................................... 50
6.4.3 Recombinant Peptides .................................................................................................. 52
7 Biosimilars Market, by Applications .............................................................................................. 54
7.1 Market Overview .................................................................................................................. 54
7.2 Market Share Segmentation ................................................................................................. 55
7.3 Revenue Segmentation ......................................................................................................... 56
7.4 Applications ........................................................................................................................... 57
7.4.1 Oncology ....................................................................................................................... 57
7.4.2 Blood Disorders ............................................................................................................. 58
7.4.3 Infectious Diseases ........................................................................................................ 59
7.4.4 Autoimmune Diseases .................................................................................................. 60
7.4.5 Other Diseases .............................................................................................................. 61
8 Biosimilars Market, By Regions ..................................................................................................... 62
8.1 Geographic Overview ............................................................................................................ 62
8.2 Market Share Segmentation ................................................................................................. 64
8.3 Revenue Segmentation ......................................................................................................... 66
8.4 Volume Segmentation .......................................................................................................... 68
8.5 North America ....................................................................................................................... 69
8.5.1 By Regions ..................................................................................................................... 70
8.5.1.1 U.S. ............................................................................................................................ 70
8.5.1.2 Canada ...................................................................................................................... 70
8.5.2 By Product Type ............................................................................................................ 70
8.5.3 By Applications .............................................................................................................. 72
8.6 Europe ................................................................................................................................... 73
8.6.1 By Regions ..................................................................................................................... 74
8.6.1.1 Germany .................................................................................................................... 74
8.6.1.2 U.K ............................................................................................................................. 74
8.6.1.3 France ........................................................................................................................ 74
8.6.1.4 Italy ............................................................................................................................ 74
8.6.1.5 Rest of Europe ........................................................................................................... 75
8.6.2 By Product Type ............................................................................................................ 76
8.6.3 By Applications .............................................................................................................. 77
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8.7 Asia-Pacific ............................................................................................................................ 78
8.7.1 By Regions ..................................................................................................................... 78
8.7.1.1 China ......................................................................................................................... 78
8.7.1.2 India........................................................................................................................... 79
8.7.1.3 Russia ........................................................................................................................ 79
8.7.1.4 Australia .................................................................................................................... 79
8.7.1.5 Japan ......................................................................................................................... 80
8.7.1.6 South Korea ............................................................................................................... 80
8.7.1.7 Rest of Asia-Pacific .................................................................................................... 80
8.7.2 By Product Type ............................................................................................................ 81
8.7.3 By Applications .............................................................................................................. 82
8.8 Middle East & Africa ............................................................................................................. 83
8.8.1 By Regions ..................................................................................................................... 84
8.8.1.1 Egypt ......................................................................................................................... 84
8.8.1.2 South Africa ............................................................................................................... 84
8.8.1.3 Nigeria ....................................................................................................................... 84
8.8.1.4 Rest of Middle East & Africa ..................................................................................... 84
8.8.2 By Product Type ............................................................................................................ 85
8.8.3 By Applications .............................................................................................................. 86
8.9 Latin America ........................................................................................................................ 87
8.9.1 By Regions ..................................................................................................................... 88
8.9.1.1 Brazil .......................................................................................................................... 88
8.9.1.2 Argentina ................................................................................................................... 88
8.9.1.3 Columbia ................................................................................................................... 88
8.9.1.4 Mexico ....................................................................................................................... 88
8.9.1.5 Rest of Latin America ................................................................................................ 89
8.9.2 By Product Type ............................................................................................................ 90
8.9.3 By Applications .............................................................................................................. 91
9 Competitive Landscape ................................................................................................................. 92
9.1 Market Share Analysis ........................................................................................................... 92
10 Key Market Players ....................................................................................................................... 93
10.1 Amgen Inc. ............................................................................................................................ 93
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10.1.1 Overview ....................................................................................................................... 93
10.1.2 Key Strategies ................................................................................................................ 93
10.1.3 Recent Developments ................................................................................................... 93
10.2 Astra Zeneca, plc. .................................................................................................................. 94
10.2.1 Overview ....................................................................................................................... 94
10.2.2 Key Strategies ................................................................................................................ 94
10.2.3 Recent Developments ................................................................................................... 94
10.3 Pfizer Inc. ............................................................................................................................... 95
10.3.1 Overview ....................................................................................................................... 95
10.3.2 Key Strategies ................................................................................................................ 95
10.3.3 Recent Developments ................................................................................................... 95
10.4 Biocon Ltd. ............................................................................................................................ 96
10.4.1 Overview ....................................................................................................................... 96
10.4.2 Key Strategies ................................................................................................................ 96
10.4.3 Recent Developments ................................................................................................... 96
10.5 Novartis International AG ..................................................................................................... 97
10.5.1 Overview ....................................................................................................................... 97
10.5.2 Key Strategies ................................................................................................................ 97
10.5.3 Recent Developments ................................................................................................... 97
10.6 STADA Arzneimittel AG ......................................................................................................... 98
10.6.1 Overview ....................................................................................................................... 98
10.6.2 Key Strategies ................................................................................................................ 98
10.6.3 Recent Developments ................................................................................................... 98
10.7 Teva Pharmaceuticals Industries Ltd. ................................................................................... 99
10.7.1 Overview ....................................................................................................................... 99
10.7.2 Key Strategies ................................................................................................................ 99
10.7.3 Recent Developments ................................................................................................... 99
11 Last Word: Scalar 360 Degree Market Perspective .................................................................... 100
12 Appendix ..................................................................................................................................... 101
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2 List of Tables
Table 1. Research Methodology ..................................................................................................... 14
Table 2. Assumptions ...................................................................................................................... 17
Table 3. Global Biosimilars Market Size (US$ billion), (2016-2022) ............................................... 19
Table 4. Global Biosimilars Volume (million units), (2014-2022) ................................................... 21
Table 5. EMA Approved Biosimilars ................................................................................................ 28
Table 6. U.S. FDA Approved Biosimilars ......................................................................................... 30
Table 7. Approved Biosimilars in India ........................................................................................... 31
Table 8. Biosimilars Approved, Marketed in Latin America ........................................................... 34
Table 9. Biosimilars Approved, Marketed in Australia ................................................................... 35
Table 10. Time to Entry Analysis ( Generics Vs. Biologics Vs. Biosimilars) ....................................... 36
Table 11. Time to Market Entry for Biosimilars from EMA’s approval ............................................. 36
Table 12. Top Selling Biologic Products to Lose Patent in the Coming Years (Sales in US$ billion) . 37
Table 13. Companies with Largest Number of Biosimilars in Pipeline (2015) .................................. 39
Table 14. Top Biosimilars in Phase 3 Stage of the Development ..................................................... 40
Table 15. Development & Investment Costs (Generics Vs. Biologics Vs. Biosimilars) ...................... 41
Table 16. Pricing of Top Biosimilars Products with Average Market Price (2015) ........................... 41
Table 17. Impact of the Growth of Biosimilars Market on Stakeholders ......................................... 42
Table 18. Global Biosimilars Market Size (US$ billion), By Product Types (2014-2022) ................... 47
Table 19. Global Recombinant Glycosylated Proteins Biosimilars Market Size (US$ billion), By
Regions (2014-2022) ............................................................................................................................. 49
Table 20. Global Recombinant Non-Glycosylated Proteins Biosimilars Market Size (US$ billion), By
Regions (2014-2022) ............................................................................................................................. 51
Table 21. Global Recombinant Peptides Biosimilars Market Size (US$ billion), By Regions (2014-
2022) ........................................................................................................................................... 53
Table 22. Global Biosimilars Market Size (US$ billion), By Applications (2014-2022) ...................... 56
Table 23. Global Biosimilars Market for Oncology; Market Size (US$ billion) (2014-2022) ............. 57
Table 24. Global Biosimilars Market for Blood Disorders; Market Size (US$ billion) (2014-2022) .. 58
Table 25. Global Biosimilars Market for Infectious Diseases; Market Size (US$ billion) (2014-2022) .
..........................................................................................................................................59
Table 26. Global Biosimilars Market for Autoimmune Diseases; Market Size (US$ billion) (2014-
2022) ........................................................................................................................................... 60
Table 27. Global Biosimilars Market for Other Diseases; Market Size (US$ billion) (2014-2022) .... 61
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Table 28. Biosimilars Market Prospects, by Geography (2016-2022) .............................................. 63
Table 29. Global Biosimilars Market Size (US$ billion), By Regions (2014-2022) ............................. 66
Table 30. Global Biosimilars Market; Market Size, By Major Countries (2014-2022) ...................... 67
Table 31. Global Biosimilars Volume (million units), (2014-2022) ................................................... 68
Table 32. Biosimilars Market in North America; Market Size (US$ billion) (2014-2022) ................. 69
Table 33. Biosimilars Market in U.S; Market Size (US$ billion), (2014-2022) ................................... 70
Table 34. Biosimilars Market in Canada; Market Size (US$ billion), (2014-2022) ............................ 70
Table 35. Biosimilars Market in North America; Market Size (US$ billion), By Product Type (2014-
2022) ........................................................................................................................................... 71
Table 36. Biosimilars Market in North America; Market Size (US$ billion), By Applications (2014-
2022) ........................................................................................................................................... 72
Table 37. Biosimilars Market in Europe; Market Size (US$ billion) .................................................. 73
Table 38. Biosimilars Market in Germany; Market Size (US$ billion), (2014-2022) ......................... 74
Table 39. Biosimilars Market in U.K.; Market Size (US$ billion), (2014 -2022) ................................. 74
Table 40. Biosimilars Market in France; Market Size (US$ billion), (2014-2022) ............................. 74
Table 41. Biosimilars Market in Italy; Market Size (US$ billion), (2014-2022) ................................. 74
Table 42. Biosimilars Market in Rest of Europe; Market Size (US$ billion), (2014-2022) ................ 75
Table 43. Biosimilars Market in Europe; Market Size (US$ billion), By Product Type (2014-2022) .....
........................................................................................................................................... 76
Table 44. Biosimilars Market in Europe; Market Size (US$ billion), By Applications (2014-2022) ... 77
Table 45. Biosimilars Market in Asia-Pacific; Market Size (US$ billion) ............................................ 78
Table 46. Biosimilars Market in China; Market Size (US$ billion), (2014-2022) ............................... 78
Table 47. Biosimilars Market in India; Market Size (US$ billion), (2014-2022) ................................ 79
Table 48. Biosimilars Market in Russia; Market Size (US$ billion), (2014-2022) .............................. 79
Table 49. Biosimilars Market in Australia; Market Size (US$ billion), (2014-2022) .......................... 79
Table 50. Biosimilars Market in Japan; Market Size (US$ billion), (2014-2022) ............................... 80
Table 51. Biosimilars Market in South Korea; Market Size (US$ billion), (2014-2022) .................... 80
Table 52. Biosimilars Market in Rest of Asia-Pacific; Market Size (US$ billion), (2014-2022) .......... 80
Table 53. Biosimilars Market in Asia-Pacific; Market Size (US$ billion), By Product Type (2014-
2022) ........................................................................................................................................... 81
Table 54. Biosimilars Market in Asia-Pacific; Market Size (US$ billion), By Applications (2014-2022)
..........................................................................................................................................82
Table 55. Biosimilars Market in Middle East & Africa; Market Size (US$ billion) ............................. 83
Table 56. Biosimilars Market in Egypt; Market Size (US$ billion), (2014-2022) ............................... 84
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Table 57. Biosimilars Market in South Africa; Market Size (US$ billion), (2014-2022) .................... 84
Table 58. Biosimilars Market in Nigeria; Market Size (US$ billion), (2014-2022) ............................. 84
Table 59. Biosimilars Market in Rest of Middle East & Africa; Market Size (US$ billion), (2014-2022)
........................................................................................................................................... 84
Table 60. Biosimilars Market in Middle East & Africa; Market Size (US$ billion), By Product Type
(2014-2022). .......................................................................................................................................... 85
Table 61. Biosimilars Market in Middle East & Africa; Market Size (US$ billion), By Applications
(2014-2022). .......................................................................................................................................... 86
Table 62. Biosimilars Market in Latin America; Market Size (US$ billion) ........................................ 87
Table 63. Biosimilars Market in Brazil; Market Size (US$ billion), (2014-2022) ............................... 88
Table 64. Biosimilars Market in Argentina; Market Size (US$ billion), (2014-2022) ........................ 88
Table 65. Biosimilars Market in Columbia; Market Size (US$ billion), (2014-2022) ......................... 88
Table 66. Biosimilars Market in Mexico; Market Size (US$ billion), (2014-2022) ............................ 88
Table 67. Biosimilars Market in Rest of Latin America; Market Size (US$ billion), (2014-2022) ...... 89
Table 68. Biosimilars Market in Latin America; Market Size (US$ billion), By Product Type (2014-
2022) ........................................................................................................................................... 90
Table 69. Biosimilars Market in Latin America; Market Size (US$ billion), By Applications (2014-
2022) ........................................................................................................................................... 91
Table 70. Acronyms ........................................................................................................................ 101
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3 List of Figures
Figure 1. Research Methodology ..................................................................................................... 15
Figure 2. Global Biosimilars Market Share(%), By Geography (2015 & 2022) ................................. 20
Figure 3. Global Biosimilars Market Share(%), By Product Type (2015 & 2022) ............................. 20
Figure 4. Global Biosimilars Market Share(%), By Applications (2015 & 2022) ............................... 21
Figure 5. Biosimilars Timeline .......................................................................................................... 27
Figure 6. Market Attractiveness for Biosimilars Set up ................................................................... 27
Figure 7. Number of Biological Products going Off Patent by 2022 In U.S ...................................... 37
Figure 8. Estimated Sales of Biological Products going Off Patent by 2022 In U.S (In Billion) ......... 38
Figure 9. Biosimilars by Stage of Development (2016) .................................................................... 38
Figure 10. Number of Biosimilar Companies By Geography (2016) .............................................. 40
Figure 11. Global Biosimilars Market: Prescriber Acceptance Vs. Patient Acceptance, By
Geography (2015) ................................................................................................................................. 43
Figure 12. Market Attractiveness for different Biosimilars Product Segments ............................. 44
Figure 13. Global Biosimilars Market By Product Segments: Market Size Vs. Market Penetration
(2015).............. ...................................................................................................................................... 45
Figure 14. Global Biosimilars Market Share(%), By Product Type (2015 & 2022) ......................... 46
Figure 15. Global Biosimilars Market Size (US$ billion), By Product Types (2014-2022) ............... 47
Figure 16. Global Recombinant Glycosylated Proteins Biosimilars Market Size (US$ billion), By
Regions (2015 & 2022) .......................................................................................................................... 48
Figure 17. Global Recombinant Non-Glycosylated Proteins Biosimilars Market Size (US$ billion),
By Regions (2015 & 2022) ..................................................................................................................... 50
Figure 18. Global Recombinant Peptides Biosimilars Market Size (US$ billion), By Regions (2015
& 2022) ....................................................................................................................................... 52
Figure 19. Global Biosimilars Market Size (US$ billion), By Applications (2015) ........................... 54
Figure 20. Global Biosimilars Market Share (%), By Applications (2015 & 2022) .......................... 55
Figure 21. Global Biosimilars Market Size (US$ billion), By Applications (2015 vs. 2022) ............. 56
Figure 22. Global Biosimilars Market for Oncology; Market Size (US$ billion) (2015 & 2022) ..... 57
Figure 23. Global Biosimilars Market for Blood Disorders; Market Size (US$ billion) (2015 &
2022) ....................................................................................................................................... 58
Figure 24. Global Biosimilars Market for Infectious Diseases; Market Size (US$ billion) (2015 &
2022) ....................................................................................................................................... 59
Figure 25. Global Biosimilars Market for Autoimmune Diseases; Market Size (US$ billion) (2015
& 2022) ....................................................................................................................................... 60
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Figure 26. Global Biosimilars Market for Other Diseases; Market Size (US$ billion) (2015 & 2022)
....................................................................................................................................... 61
Figure 27. Global Biosimilars Market Share (%), By Major Regions (2015 & 2022)....................... 64
Figure 28. Top 5 Countries, By Market Share (%) (2015) ............................................................... 65
Figure 29. Top 5 Countries, By Market Share (%) (2022) ............................................................... 65
Figure 30. Biosimilars Market in North America; Snapshot (2015) ............................................... 69
Figure 31. Biosimilars Market in North America; Market Size (US$ billion) (2014-2022) ............. 69
Figure 32. Biosimilars Market in North America; Market Size (US$ billion), By Product Type
(2014-2022) ....................................................................................................................................... 70
Figure 33. Biosimilars Market in North America; Market Size (US$ billion), By Applications (2016
vs. 2022) ....................................................................................................................................... 72
Figure 34. Biosimilars Market in Europe; Snapshot (2015) ........................................................... 73
Figure 35. Biosimilars Market in Europe; Market Size (US$ billion) (2014-2022) .......................... 73
Figure 36. Biosimilars Market in Europe; Market Size (US$ billion), By Product Type (2014-2022) .
....................................................................................................................................... 76
Figure 37. Biosimilars Market in Europe; Market Size (US$ billion), By Applications (2016 vs.
2022) ....................................................................................................................................... 77
Figure 38. Biosimilars Market in Asia-Pacific; Snapshot (2015) ..................................................... 78
Figure 39. Biosimilars Market in Asia-Pacific; Market Size (US$ billion) (2014-2022) ................... 78
Figure 40. Biosimilars Market in Asia-Pacific; Market Size (US$ billion), By Product Type (2014-
2022) ....................................................................................................................................... 81
Figure 41. Biosimilars Market in Asia-Pacific; Market Size (US$ billion), By Applications (2016 vs.
2022) ....................................................................................................................................... 82
Figure 42. Biosimilars Market in Middle East & Africa; Snapshot (2015) ...................................... 83
Figure 43. Biosimilars Market in Middle East & Africa; Market Size (US$ billion) (2014-2022) .... 83
Figure 44. Biosimilars Market in Middle East & Africa; Market Size (US$ billion), By Product
Segments (2014-2022) .......................................................................................................................... 85
Figure 45. Biosimilars Market in Middle East & Africa; Market Size (US$ billion), By Applications
(2016 vs. 2022) ...................................................................................................................................... 86
Figure 46. Biosimilars Market in Middle Latin America; Snapshot (2015) ..................................... 87
Figure 47. Biosimilars Market in Latin America; Market Size (US$ billion) (2014-2022) ............... 87
Figure 48. Biosimilars Market in Latin America; Market Size (US$ billion), By Product Type (2014-
2022) ....................................................................................................................................... 90
Figure 49. Biosimilars Market in Latin America; Market Size (US$ billion), By Applications (2016
vs. 2022) ....................................................................................................................................... 91
Figure 50. Market Share (%) of Major Players (2015) .................................................................... 92
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2 Market Overview
2.1 Definitions
Global biosimilars market is defined as the market size and market share estimation
of the various segments of the biosimilars market, capturing ongoing drivers, trends,
challenges of the market, industry analysis involving the regulatory analysis and
studying about the major participants and players in biosimilars market environment.
The 'Global Biosimilars Market – Market Size and Forecast (2014–2022)' report
includes market size and forecast estimates for the period 2014 to 2022. The scope
of this report is regulatory analysis with respect of geographies for biosimilars,
pipeline analysis, different product types for biosimilars and its applications in
oncology, blood disorders, infectious diseases, autoimmune diseases, and others.
The report has 2014 as the historical year, 2015 as the base year and years 2016 to
2022 as forecast years.
This report defines the Biosimilars as–
Biosimilars are the biologic pharmaceutical drugs which are similar to the reference
biologic products. These drugs are an interchangeable biological product that
contains synthetically developed protein molecules. When the patent of brand drug is
expired, pharmaceutical companies are planning to develop off-patent biologics i.e.
biosimilars that offer similar biological activity.
Recombinant Glycosylated Proteins Product Type as–
Biosimilars obtained from Erythropoietin(EPO), Urokinase, Glucocerebrosidase,
Monoclonal antibodies, Chimaeric Antibodies, Humanized / cdr-grafted / reshaped
antibodies, Human antibodies and fusion protein, Follitropin, Thyrotropin,
Becaplermin, Granulocyte-macrophage-CSF (GM-CSF), Recombinant Human
DNASE (RHDNASE), Factor VIIA, Activated protein-c, and tissue plasminogen
activator.
Recombinant Non-Glycosylated Proteins Product Type as–
Biosimilars obtained from Insulin, Interferons; alfa, beta-1a, gamma, human growth
hormone (HGH), Lepirudin, Interleukin-11, Anakinra, Interleukin-2 (Il-2), and
Granulocyte colony-stimulating factor (G-CSF).
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Recombinant Peptides Product Type as–
Biosimilars obtained from Cyclosporine, Calcitonin, Bivalirudin, Enfuvirtide,
Glucagon, Eptifibatide, Octreotide, Desmopressin, LH-RH (Leuprolide), Nesiritide,
and Teriparatide.
Other Diseases Application Segment as–
Biosimilars for disease such as Gaucher Disease, Fertility Disorders, Skin Ulcers,
Osteoporosis, Systemic Sepsis, Hypoglycemia, and Congestive Heart Failure.
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2.2 Research Methodology
The market study of biosimilars market incorporates prolonged two-way approaches,
secondary and primary research to collect the information commercially and study
the market. The data collection part was focused, and related to capturing the whole
market from various perspective. Data collected from multiple sources was logically
linked and analyzed by our analysts.
Secondary Data
Secondary data gathering procedure, with subsequent references such as company
websites, journals, magazines, directories, databases such as Bloomberg, Hoovers,
Factiva, company annual reports, press releases, white papers, and government
publishing sources also have been taken into consideration. Data from these
sources have been used to obtain industry analysis, company profiles and other key
areas such as market drivers, opportunities, and trends from biosimilars market
perspective.
Table 1. Research Methodology
Report Parameter Secondary Source
Market Size, Share, Revenue Company Annual Reports, SEC Filings, Financials,
Press Releases, Directories, Journals.
Industry Analysis Company websites, Market journals, White
papers, Magazines, other market studies.
Competitive Landscape Company Annual Reports, Financials, Press
Releases, Investors Relations, Directories,
Journals.
Primary Data
Primary data is the most important data in the research study. Primary data has
been considered and linked to the report to make the study more crisp and
informative. Structured interviews with industry specialists, VPs, CEOs, directors,
technology consultants were taken to collect the key primary data. The primary data
was focused on both, the demand and supply side of the market. Market Engineering
was carried out from the data, and excessive analysis has been done on it. Primary
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data was also considered extensively in validating the secondary content. Market
engineering process involved both top-down and bottom-up approach to estimate the
market size and market forecast and segment the market into more sub-segments.
Market size estimation
Both, top-down and bottom-up approaches were used to estimate the size of the
global biosimilars market.
Figure 1. Research Methodology
Global
Market
Size
Market-specific Revenues of Key Market
Players
Revenues of Key Market Players
Global Market
Size
Segment-specific Market Size
Regional
Market
Size
Bottom-up
Top-down
Economic Indicators
Scalar Market Research has conducted a comprehensive study of the global
economic conditions and economic indicators to evaluate their impact on the current
market conditions and forecast the market scenarios.
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2.3 Market Segmentation
Biosimilars Market
ProductApplications Region
• Recombinant Glycosylated Proteins
• Recombinant Non-Glycosylated Proteins
• Recombinant Peptides
• Oncology
• Blood Disorders
• Infectious Diseases
•Autoimmune Diseases
•Others
• North America
• Europe
• Asia-Pacific
• Middle East and Africa
• Latin America
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3 Executive Summary
Biosimilars are the biologics pharmaceutical drugs which are similar to the reference
biologic products. These drugs are an interchangeable biological product that
contains synthetically developed protein molecules. When the patent of branded
drug is expired, pharmaceutical companies are planning to develop off-patent
biologics i.e. biosimilars that offer similar biological activity. In short, biosimilars are
analogs of generic biologics which are previously available as patented
pharmaceutical drugs.
The biosimilars market offers many growth opportunities and driving factors as
compared to the restraining factors. It is stated by various research scientists that
development of biosimilars will drastically reduce the price of pharmaceutical drugs.
Thus, large number of key companies such as Hospira, Inc., Teva Pharmaceutical,
Amgen, and others are in constant efforts to develop biosimilar. For which, these
companies are rigorously increasing their research and development expenses on
clinical trials to introduce novel biosimilars which would ultimately drive the market
growth. For example, Amgen, Inc. have strong research pipeline (phase III molecule)
for the biosimilar products such as ABP 501, ABP 980 and ABP 215. Furthermore,
demand for biosimilars is also expected to increase due to the rise in the incidence
of diseases such as cancer, cardiovascular problem, and others. For these diseases,
biosimilars have proven a promising option for the disease diagnosis and mitigation.
Other factors such as rising number of off-patented drugs, positive result of many
biosimilar clinical trials and others drive the market growth to a great extent.
However, a strict regulatory framework for the biosimilar manufacturers to develop
these products restricts companies to invest in this market, leading to hampering the
market growth during the future period.
The major revenue opportunities are expected to come from application sectors such
as Oncology, Blood Disorders, Infectious Diseases, and Autoimmune Diseases.
Whereas oncology disorders will account for 59.07% of the total revenue generated
by 2022, blood disorders and autoimmune diseases will demand a great potential
towards biosimilars market. Recombinant glycosylated proteins will continue to
dominate in the biosimilars market while biosimilars from recombinant non-
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Figure 2. Global Biosimilars Market Share (%), By Geography (2015 & 2022)
5%
44%
25%
22%
4%30%
36%
18%
12%
4%
North America
Europe
Asia-Pacif ic
Latin America
Middle East & Africa
Source: Scalar Market Research Analysis
Inside circle shows the market share for the year 2015 & outside circle shows market share
for the year 2022.
Figure 3. Global Biosimilars Market Share(%), By Product Type (2015 & 2022)
36%
58%
6%
36%
60%
4%
Recombinant Non-Glycosylated Proteins
Recombinant Glycosylated Proteins
Recombinant Peptides
Source: Scalar Market Research Analysis
Inside circle shows the market share for the year 2015 & outside circle shows market share
for the year 2022.
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5 Industry Analysis
5.1 Industry Overview
Figure 5. Biosimilars Timeline
EMA publishes draft guidelines for marketing and approval of biosimilars
Final Guidelines for approval by EMA
EMA approves1st BiosimilarOmnitrope
Obamacare clears path for FDA on approval of biosimilars
Japan & Canada Adopts EMA Guidelines
FDA approves first biosimilar Zarxio
FDA issues draft guidelines
2001 2005 2006 2009 2010 2012 2015
Source: Scalar Market Research Analysis
Figure 6. Market Attractiveness for Biosimilars Set-up
Parameter Regulated Markets Semi-Regulated
Markets
Non-Regulated
Markets
●=Favorable ◑=Less Favorable ◔=Not Favorable
Source: Scalar Market Research Analysis
SAMPLE
44
6 Biosimilars Market, by Product Types
6.1 Market Overview
The product segments of the biosimilars market included in this report are
Recombinant Glycosylated Proteins, Recombinant Non-Glycosylated Proteins, and
Recombinant Peptides. Recombinant Glycosylated Proteins continues to be the
largest product type in 2015, while Recombinant Non-Glycosylated Proteins is
expected to possess great potential during the forecast period.
The Recombinant Glycosylated Proteins includes the biosimilars of erythropoietin,
monoclonal antibodies (mAbs), follitropin etc.
The Recombinant Non-Glycosylated Proteins includes the biosimilars of G-CSF,
Interferons, Human Growth Hormone (HGH), Insulin, Filgrastim, Somatropin, etc.
The Recombinant peptides include the biosimilars of glucagon, calcitonin, etc.
Figure 12. Market Attractiveness for different Biosimilars Product Segments
Characteristics Recombinant
Glycosylated
Proteins
Recombinant Non-
Glycosylated
Proteins
Recombinant
Peptides
Market Size
Growth Rate
Overall Attractiveness
●=Significantly Attractive ◑=Attractive ◔=Less Attractive
SAMPLE
45
Figure 13. Global Biosimilars Market By Product Segments: Market Size vs. Market
Penetration (2015)
Market Penetration
Ma
rke
t Siz
e
High
Hig
h
Recombinant Non-Glycosylated
Proteins
Recombinant Peptides
Recombinant Glycosylated
Proteins
Source: Scalar Market Research Analysis
SAMPLE
47
6.3 Revenue Segmentation
Figure 15. Global Biosimilars Market Size (US$ billion), By Product Types (2014-2022)
0.7
2
1.1
0
1.6
7
2.5
4
3.8
7
5.9
0 9.0
1 13
.77
21
.06
1.1
4
1.7
5
2.6
8
4.1
2 6.3
2 9.7
1
14
.93
22
.97
35
.37
0.1
2
0.1
7
0.2
5
0.3
6
0.5
1
0.7
3
1.0
4
1.4
6
2.0
5
2014 2015 2016 2017 2018 2019 2020 2021 2022
Recombinant Non-Glycosylated Proteins Recombinant Glycosylated Proteins Recombinant Peptides
Source: Scalar Market Research Analysis
Table 18. Global Biosimilars Market Size (US$ billion), By Product Types (2014 –
2022)
Product Type 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR (2016-2022)
Recombinant Non-Glycosylated Proteins
Recombinant Glycosylated Proteins
Recombinant Peptides
TOTAL 52.77%
Source: Scalar Market Research Analysis
Biosimilars from recombinant glycosylated proteins accounts for the largest product
segment of the biosimilars market in 2015. This market segment is expected to grow
at a CAGR of XX% from US$ XX billion in 2015 to US$ XX billion in 2022.
SAMPLE
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7 Biosimilars Market, by Applications
7.1 Market Overview
Figure 19. Global Biosimilars Market Size (US$ billion), By Applications (2015)
USD3.02
Billion
Source: Scalar Market Research Analysis
The application segments of the biosimilars market included in this report are
oncology diseases, autoimmune diseases, blood disorders, infectious diseases, and
other diseases. Oncology was the largest application segment in 2015, and it’s also
expected to be the fastest growing application segment in the forecast period. The
rise in the aging population, increasing cancer patients, and rise of hospital acquired
infection patients globally are factors responsible for the growth of this application
segment.
Oncology| US$ XX Billion
Autoimmune Diseases |US$ XX Billion
Blood Disorders |US$ XX Billion
Infectious Diseases |US$ XX Billion
Others |US$ XX Billion
SAMPLE
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8 Biosimilars Market, By Regions
8.1 Geographic Overview
The regional segments of the biosimilars market included in this report are North
America (NA), Europe (EU), Asia-Pacific (APAC), Latin America (LA), and Middle
East & Africa (MEA). Europe was the largest regional segment in 2015, while North
America and Asia-Pacific are expected to be the fastest growing regional segments
in the forecast period.
SAMPLE
63
Table 28. Biosimilars Market Prospects, by Geography (2016-2022)
Geography Growth Prospects Indicators
North America
Europe
Asia-Pacific
Latin America
Middle East &
Africa
Source: Scalar Market Research Analysis
SAMPLE
92
9 Competitive Landscape
9.1 Market Share Analysis
Figure 50. Market Share (%) of Major Players (2015)
47%
16%
17%
4%
6%
11%Sandoz AG
Teva Pharmaceuticals
Hospira (Pfizer)
Biocon
Stada Arzneimettel
Others
Source: Scalar Market Research Analysis
.
SAMPLE
101
12 Appendix
Table 70. Acronyms
CAGR Compounded Annual Growth Rate
NA North America
EU Europe
APAC Asia-Pacific
MEA Middle East & Africa
LA Latin America
NR Not Reported
R&D Research & Development
PCS Pieces
G-CSF Granulocyte Colony Stimulating Factor
EMA European Medicines Agency
SAMPLE