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Global Biosimilars Market 2018-2024

Global Biosimilars Market 2018-2024

Global Biosimilars Market – Drivers, Restraints, Opportunities, Trends, and Forecasts: 2018–2024

Overview: Biosimilars are the officially approved versions of original biologic drugs, and can be manufactured when the original product's patent expires. Biosimilars are relatively cheaper than their biologic counterparts and hence, users have come to prefer biosimilars over biologics in recent years. Biosimilars have great potential to lower costs improving patient access to life-saving medicines prescription drug costs continue to rise. Over the past two decades, biologics have revolutionized patient management in multiple disease cases, including autoimmune diseases, solid tumors, hematologic malignancies, infectious diseases and hormone deficiencies. According to the estimation of American Cancer Society, around 1,688,780 new cancer cases are expected to be diagnosed and 600,920 are expected to die in 2017. Indian Council for Medical Research estimated around 1.4 million new cancer cases in 2016 and this number is expected to rise to 1.7 million by 2020. According to the estimation of International Diabetes Federation, nearly 82 million people in the SEA region live with diabetes and the figure is expected to rise to 151 million by 2045. India alone accounted for 72 million cases of diabetes in 2017.

Increasing incidences of cancer and chronic diseases, cost effectiveness of biosimilars over biologics, strategic collaborations, promising pipeline of biosimilars with the expiration of biologics patents, and an increased demand for such drugs in the emerging countries are the primary factors driving the biosimilar global market. A complex manufacturing process coupled with high cost of development, and limited obtainability of biosimilar products are responsible for hindering the growth this market to a large extent.

Market Analysis: The “Global Biosimilars Market” is estimated to witness a CAGR of 57.03% during the forecast period 2018–2024. The market is analyzed based on three segments – products, applications, and regions.

Regional Analysis: The regions covered in the report are North America, Europe, Asia Pacific, and Rest of the World (RoW). Europe is set to be the leading region for the biosimilars market growth followed by Asia Pacific, North America and Rest of the World.

Product Analysis: The global Biosimilars market by product is segmented into recombinant glycosylated protein, recombinant non-glycosylated protein, recombinant peptides, and others. Recombinant glycosylated protein, that includes monoclonal antibody and erythropoietin, occupied the largest share in 2017, and is expected to grow at a high CAGR in the coming years due to the following factors: increased patient access to treatment due to its lower cost compared to its corresponding biological drugs, wide therapeutic applications, and many block buster mAbs going off patent in next few years.

Application Analysis: The global biosimilars market by application is segmented into cancer, infectious disease, blood disorders, chronic and immune diseases others. Cancer occupied the largest share in 2017, and blood disorder, chronic and immune disease applications are expected to be fastest growing segment during the forecast period.

Key Players: Pfizer Inc., Novartis AG, Celltrion Healthcare, Dr. Reddy’s Laboratories Limited, Teva Pharmaceuticals Industries, Biocon Ltd, STADA Arzneimittel AG, Mylan N.V., Amgen Inc., Synthon Pharmaceuticals and Samsung Bioepis Co., Ltd are the predominant niche players in this market.

Competitive Analysis: Many top selling biologic drugs are going off-patent in the next five years, paving the way for biosimilar players to gain a strong foothold in the market with their innovative product offerings. The key market players are acquiring other companies to enhance their product portfolio and to strengthen their position in the market. In September 2017, Fresenius Kabi acquired Merck KGaA’s biosimilar business, including the biosimilars development pipeline. Apart from this, the major players are taking advantage of strategic collaborations, agreements and approvals to increase their share in the market. For instance, in February 2018, Mylan N.V. and Revance Therapeutics, Inc. announced a global collaboration and license agreement for the development and commercialization of a proposed biosimilar that is in line with BOTOX, approved as the neuromodulator for the treatment of multiple indications. In November 2017, US drug maker Mylan and India-based Biocon got approval from USFDA for Ogivri, the first biosimilar of Trastuzumab, for the treatment of breast and gastric cancers.

Benefits: The report provides complete details about various types of biosimilars in various applications and regions. With that, key stakeholders will get clarity about the major trends, drivers, investments, vertical players’ initiatives, government initiatives toward the product adoption in the upcoming years along with the details of commercial products available in the market. Moreover, the report provides details about the major challenges that are going to impact the market growth. Additionally, the report gives complete details about the most promising business opportunities to key stakeholders to expand their business and capture the revenue in the specific verticals to analyze before investing or expanding the business in this market.

Key Stakeholders:


1 INDUSTRY OUTLOOK
1.1 Industry overview
1.2 Industry Trends
2 Report Outline
2.1 Report Scope
2.2 Report Summary
2.3 Research Methodology
2.4 Report Assumptions
3 Market Snapshot
3.1 Market Definition – Infoholic Research
3.2 Segmented Addressable Market (SAM)
3.3 Trends of the biosimilars market
3.4 Related Markets
3.4.1 Over the counter drugs
3.4.2 Orphan drugs
3.4.3 Human Insulin
4 Market Outlook
4.1 Biosimilar products approved in US
4.2 Biosimilar products approved in Europe
4.3 Biologics patent expiration in US and Europe (2010-2020)
4.4 Market segmentation
4.5 PEST Analysis
4.6 Porter 5(Five) Forces
5 Market Characteristics
5.1 DRO – Global Biosimilars Market Dynamics
5.1.1 Drivers
5.1.1.1 Increasing incidence of disease
5.1.1.2 Cost-effectiveness of biosimilars than biologics
5.1.1.3 Strategic collaboration to develop new biosimilar drugs
5.1.2 Opportunities
5.1.2.1 Promising pipeline of biosimilars
5.1.2.2 Opportunities in emerging market
5.1.3 Restraints
5.1.3.1 Limited obtainability of biosimilar products
5.1.3.2 Difficult manufacturing process and high development cost
6 Product: Market Size and Analysis
6.1 Overview
6.2 Recombinant glycosylated proteins
6.2.1 Monoclonal antibody
6.2.2 Erythropoietin
6.3 Recombinant non-glycosylated proteins
6.3.1 Recombinant human growth hormone
6.3.2 Granulocyte colony stimulating factor
6.3.3 Insulin
6.3.4 Interferon
6.4 Recombinant peptides and others
7 Application: Market Size and Analysis
7.1 Overview
7.2 Cancer
7.3 Blood disorders
7.4 Chronic and immune disease
7.5 Infectious disease
7.6 Others
8 Regions: Market Size and Analysis
8.1 Overview
8.2 North America
8.2.1 US
8.2.2 Canada
8.3 Europe
8.3.1 UK
8.3.2 Germany
8.3.3 France
8.3.4 Spain
8.4 Asia Pacific
8.4.1 India
8.4.2 China
8.4.3 Japan
8.5 Rest of the World
9 Competitive Landscape
9.1 Overview
10 Vendor Profiles
10.1 Pfizer, Inc.,
10.1.1 Overview
10.1.2 Business Units
10.1.3 Geographic Presence
10.1.4 Business Focus
10.1.5 SWOT Analysis
10.1.6 Business Strategies
10.2 Novartis AG
10.2.1 Overview
10.2.2 Business Units
10.2.3 Geographic Revenue
10.2.4 Business Focus
10.2.5 SWOT Analysis
10.2.6 Business Strategies
10.3 Celltrion Healthcare
10.3.1 Overview
10.3.2 Business Focus
10.3.3 SWOT Analysis
10.3.4 Business Strategy
10.4 Dr. Reddy’s Laboratories Limited
10.4.1 Overview
10.4.2 Business Unit
10.4.3 Geographic Presence
10.4.4 Business Focus
10.4.5 SWOT Analysis
10.4.6 Business Strategy
10.5 Biocon Ltd
10.5.1 Overview
10.5.2 Business Unit
10.5.3 Geographic Presence
10.5.4 Business focus
10.5.5 SWOT analysis
10.5.6 Business Strategy
10.6 Teva Pharmaceutical Industries Ltd.
10.6.1 Overview
10.6.2 Business Unit
10.6.3 Geographic Presence
10.6.4 Business focus
10.6.5 SWOT analysis
10.6.6 Business Strategy
10.7 STADA Arzneimittel AG
10.7.1 Overview
10.7.2 Business Unit
10.7.3 Geographic Presence
10.7.4 Business focus
10.7.5 SWOT analysis
10.7.6 Business Strategy
11 Companies to Watch For
11.1 Amgen Inc.
11.1.1 Overview
11.2 Mylan N.V.
11.2.1 Overview
11.2.2 MYLAN N.V.: Recent Developments
11.3 Synthon Pharmaceuticals Inc.,
11.3.1 Overview
11.3.2 Synthon Pharmaceuticals Inc.: Recent Developments
11.4 Samsung Bioepis Co., Ltd.
11.4.1 Overview
11.4.2 SAMSUNG BIOEPIS CO., LTD: Recent Developments
12 Annexure
12.1 Abbreviations
TABLES
TABLE 1 GLOBAL BIOSIMILARS MARKET REVENUE BY REGIONS, 2017–2024 ($MILLION) 50
TABLE 1 GLOBAL BIOSIMILARS MARKET BY VENDOR RANKING, 2017 61
TABLE 2 OTHER PROMINENT VENDORS OF BIOSIMILARS MARKET 62
TABLE 3 PFIZER, INC.: OFFERINGS 63
TABLE 4 PFIZER, INC.: RECENT DEVELOPMENTS 64
TABLE 5 NOVARTIS AG: PRODUCT OFFERINGS 69
TABLE 6 NOVARTIS AG: RECENT DEVELOPMENTS 69
TABLE 7 NOVARTIS AG: OVERVIEW SNAPSHOT 71
TABLE 8 CELLTRION HEALTHCARE: OFFERINGS 76
TABLE 9 CELLTRION HEALTHCARE: RECENT DEVELOPMENTS 76
TABLE 10 DR, REDDY’S LABORATORIES LIMITED: PRODUCT OFFERINGS 81
TABLE 11 DR. REDDY’S LABORATORIES LIMITED: RECENT DEVELOPMENTS 82
TABLE 12 BIOCON LTD: PRODUCT OFFERINGS 89
TABLE 13 BIOCON LTD: RECENT DEVELOPMENTS 90
TABLE 14 TEVA PHARMACEUTICAL INDUSTRIES LTD: PRODUCT OFFERINGS 95
TABLE 15 TEVA PHARMACEUTICAL INDUSTRIES LTD: RECENT DEVELOPMENTS 95
TABLE 16 STADA ARZNEIMITTEL AG: PRODUCT OFFERINGS 100
TABLE 17 STADA ARZNEIMITTEL AG: RECENT DEVELOPMENTS 101
TABLE 18 AMGEN INC.: SNAPSHOT 106
TABLE 19 AMGEN INC.: RECENT DEVELOPMENTS 106
TABLE 20 MYLAN N.V.: SNAPSHOT 110
TABLE 21 SYNTHON PHARMACEUTICALS: SNAPSHOT 111
TABLE 22 SAMSUNG BIOEPIS CO., LTD: SNAPSHOT 112
CHARTS
CHART 1 RESEARCH METHODOLOGY OF GLOBAL BIOSIMILARS MARKET 13
CHART 2 GLOBAL BIOSIMILARS MARKET REVENUE, 2017–2024 ($MILLION) 16
CHART 3 NUMBER OF BIOSIMILARS APPROVED FROM 2006-2017 27
CHART 4 SEGMENTATION OF GLOBAL BIOSIMILARS MARKET 29
CHART 5 PEST ANALYSIS OF GLOBAL BIOSIMILARS MARKET 29
CHART 6 PORTER 5 FORCES ON GLOBAL BIOSIMILARS MARKET 30
CHART 7 DRO – IMPACT ANALYSIS OF GLOBAL BIOSIMILARS MARKET 36
CHART 8 KEY STAKEHOLDERS 37
CHART 9 GLOBAL BIOSIMILARS MARKET BY PRODUCT SEGMENTATION, 2017 (%) 39
CHART 10 GLOBAL RECOMBINANT GLYCOSYLATED PROTEIN MARKET FORECAST, 2017–2024 ($MILLION) 40
CHART 11 GLOBAL RECOMBINANT GLYCOSYLATED PROTEIN MARKET BY TYPE SEGMENTATION, 2017 (%) 40
CHART 12 GLOBAL RECOMBINANT NON-GLYCOSYLATED PROTEIN MARKET FORECAST, 2017–2024 ($MILLION) 42
CHART 13 GLOBAL RECOMBINANT NON-GLYCOSYLATED PROTEIN MARKET BY TYPE SEGMENTATION, 2017 (%) 43
CHART 14 GLOBAL RECOMBINANT PEPTIDE AND OTHERS MARKET FORECAST, 2017–2024 ($MILLION) 45
CHART 15 GLOBAL BIOSIMILARS MARKET BY APPLICATION SEGMENTATION, 2017 (%) 46
CHART 16 GLOBAL BIOSIMILARS MARKET BY GEOGRAPHICAL SEGMENTATION, 2017 (%) 51
CHART 17 BIOSIMILARS MARKET REVENUE IN NORTH AMERICA, 2017–2024 ($MILLION) 52
CHART 18 BIOSIMILARS MARKET REVENUE IN EUROPE, 2017–2024 ($MILLION) 54
CHART 19 BIOSIMILARS MARKET REVENUE IN ASIA PACIFIC, 2017–2024 ($MILLION) 57
CHART 20 BIOSIMILARS MARKET REVENUE IN REST OF THE WORLD, 2017–2024 ($MILLION) 60
CHART 21 PFIZER, INC.: OVERVIEW SNAPSHOT 66
CHART 22 PFIZER INC.: BUSINESS UNITS 67
CHART 23 PFIZER INC.: GEOGRAPHIC PRESENCE 68
CHART 24 PFIZER INC: SWOT ANALYSIS 69
CHART 25 NOVARTIS AG: BUSINESS UNITS 73
CHART 26 NOVARTIS AG: GEOGRAPHIC REVENUE 74
CHART 27 NOVARTIS AG: SWOT ANALYSIS 75
CHART 28 CELLTRION HEALTHCARE: OVERVIEW SNAPSHOT 78
CHART 29 CELLTRION HEALTHCARE: BUSINESS SEGMENTS 79
CHART 30 CELLTRION HEALTHCARE: SWOT ANALYSIS 81
CHART 31 DR. REDDY’S LABORATORY LIMITED: OVERVIEW SNAPSHOT 86
CHART 32 DR. REDDY’S LABORATORY LIMITED: BUSINESS UNITS 87
CHART 33 DR. REDDY’S LABORATORY LIMITED: GEOGRAPHICAL PRESENCE 87
CHART 34 DR. REDDY’S LABORATORY LIMITED: SWOT ANALYSIS 89
CHART 35 BIOCON LTD: OVERVIEW SNAPSHOT 92
CHART 36 BIOCON LTD: BUSINESS UNITS 93
CHART 37 BIOCON LTD: GEOGRAPHICAL PRESENCE 93
CHART 38 BIOCON LTD: SWOT ANALYSIS 94
CHART 39 TEVA PHARMACEUTICAL INDUSTRIES LTD: OVERVIEW SNAPSHOT 97
CHART 40 TEVA PHARMACEUTICAL INDUSTRIES LTD: BUSINESS UNITS 98
CHART 41 TEVA PHARMACEUTICAL INDUSTRIES LTD: GEOGRAPHICAL PRESENCE 99
CHART 42 TEVA PHARMACEUTICAL INDUSTRIES LTD: SWOT ANALYSIS 100
CHART 43 STADA ARZNEIMITTEL AG: OVERVIEW SNAPSHOT 102
CHART 44 STADA ARZNEIMITTEL AG: BUSINESS UNITS 103
CHART 45 STADA ARZNEIMITTEL AG: GEOGRAPHICAL PRESENCE 104
CHART 46 STADA ARZNEIMITTEL AG: SWOT ANALYSIS 105

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