Global Biosimilars Market 2018-2024

  • Product Code:
  • Published Date:
    Mar 2019
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  • Category:
    Healthcare & Pharmaceuticals
  • Publisher:
    Infoholic Research
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:

Table of Contents
1.1 Industry overview 9
1.2 Industry Trends 10
2 Report Outline 11
2.1 Report Scope 11
2.2 Report Summary 11
2.3 Research Methodology 12
2.4 Report Assumptions 12
3 Market Snapshot 14
3.1 Market Definition – Infoholic Research 14
3.2 Segmented Addressable Market (SAM) 14
3.3 Trends of the biosimilars market 14
3.4 Related Markets 16
3.4.1 Over the counter drugs 16
3.4.2 Orphan drugs 17
3.4.3 Human Insulin 18
4 Market Outlook 19
4.1 Biosimilar products approved in US 19
4.2 Biosimilar products approved in Europe 21
4.3 Biologics patent expiration in US and Europe (2010-2020) 27
4.4 Market segmentation 28
4.5 PEST Analysis 28
4.6 Porter 5(Five) Forces 29
5 Market Characteristics 31
5.1 DRO – Global Biosimilars Market Dynamics 31
5.1.1 Drivers 31 Increasing incidence of disease 31 Cost-effectiveness of biosimilars than biologics 32 Strategic collaboration to develop new biosimilar drugs 33
5.1.2 Opportunities 33 Promising pipeline of biosimilars 33 Opportunities in emerging market 34
5.1.3 Restraints 34 Limited obtainability of biosimilar products 34 Difficult manufacturing process and high development cost 35
6 Product: Market Size and Analysis 38
6.1 Overview 38
6.2 Recombinant glycosylated proteins 38
6.2.1 Monoclonal antibody 40
6.2.2 Erythropoietin 41
6.3 Recombinant non-glycosylated proteins 41
6.3.1 Recombinant human growth hormone 43
6.3.2 Granulocyte colony stimulating factor 43
6.3.3 Insulin 43
6.3.4 Interferon 44
6.4 Recombinant peptides and others 44
7 Application: Market Size and Analysis 45
7.1 Overview 45
7.2 Cancer 45
7.3 Blood disorders 46
7.4 Chronic and immune disease 47
7.5 Infectious disease 48
7.6 Others 49
8 Regions: Market Size and Analysis 50
8.1 Overview 50
8.2 North America 51
8.2.1 US 52
8.2.2 Canada 53
8.3 Europe 53
8.3.1 UK 54
8.3.2 Germany 55
8.3.3 France 55
8.3.4 Spain 55
8.4 Asia Pacific 56
8.4.1 India 57
8.4.2 China 57
8.4.3 Japan 58
8.5 Rest of the World 58
9 Competitive Landscape 60
9.1 Overview 60
10 Vendor Profiles 63
10.1 Pfizer, Inc., 63
10.1.1 Overview 63
10.1.2 Business Units 66
10.1.3 Geographic Presence 67
10.1.4 Business Focus 67
10.1.5 SWOT Analysis 68
10.1.6 Business Strategies 68
10.2 Novartis AG 69
10.2.1 Overview 69
10.2.2 Business Units 72
10.2.3 Geographic Revenue 73
10.2.4 Business Focus 74
10.2.5 SWOT Analysis 74
10.2.6 Business Strategies 75
10.3 Celltrion Healthcare 76
10.3.1 Overview 76
10.3.2 Business Focus 79
10.3.3 SWOT Analysis 80
10.3.4 Business Strategy 80
10.4 Dr. Reddy’s Laboratories Limited 81
10.4.1 Overview 81
10.4.2 Business Unit 86
10.4.3 Geographic Presence 86
10.4.4 Business Focus 87
10.4.5 SWOT Analysis 88
10.4.6 Business Strategy 88
10.5 Biocon Ltd 89
10.5.1 Overview 89
10.5.2 Business Unit 92
10.5.3 Geographic Presence 92
10.5.4 Business focus 93
10.5.5 SWOT analysis 93
10.5.6 Business Strategy 94
10.6 Teva Pharmaceutical Industries Ltd. 95
10.6.1 Overview 95
10.6.2 Business Unit 97
10.6.3 Geographic Presence 98
10.6.4 Business focus 99
10.6.5 SWOT analysis 99
10.6.6 Business Strategy 100
10.7 STADA Arzneimittel AG 100
10.7.1 Overview 100
10.7.2 Business Unit 102
10.7.3 Geographic Presence 103
10.7.4 Business focus 104
10.7.5 SWOT analysis 104
10.7.6 Business Strategy 105
11 Companies to Watch For 106
11.1 Amgen Inc. 106
11.1.1 Overview 106
11.2 Mylan N.V. 109
11.2.1 Overview 109
11.2.2 MYLAN N.V.: Recent Developments 110
11.3 Synthon Pharmaceuticals Inc., 111
11.3.1 Overview 111
11.3.2 Synthon Pharmaceuticals Inc.: Recent Developments 111
11.4 Samsung Bioepis Co., Ltd. 112
11.4.1 Overview 112
11.4.2 SAMSUNG BIOEPIS CO., LTD: Recent Developments 113
12 Annexure 115
12.1 Abbreviations 115

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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
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