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Global Orphan Drugs Market Trends and Drivers, Restraints, and Opportunities 2017-2023

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Global Orphan Drugs Market Trends and Drivers, Restraints, and Opportunities 2017-2023


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Global Orphan Drugs Market Trends and Drivers, Restraints, and Opportunities 2017-2023

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Global Orphan Drugs Market Trends and Drivers, Restraints, and Opportunities 2017-2023



Executive Summary

Orphan Drugs Market-Global Drivers, Restraints, Opportunities, Trends, and Forecasts: 2017-2023

Overview: Orphan diseases or rare diseases rarely occur among the people, which is nearly 7 out of 10,000 individuals. Around 5,000 to 8,000 rare diseases have been recognized and the origin of approximately 80% of these diseases is from the genes. Regardless of the alleged huge number of individuals being affected by rare life-threatening conditions, the disease burden estimates of the public health are unreliable. About 50% of the orphan genetic ailments are in kids' with 30% of them cannot live for more than 5 years.

New-born screening, legislation, and construction of national strategies are the major activities being carried out in the orphan drugs market. Legislation has helped in driving the development of more orphan drugs. For instance, the US congress passed Orphan Drug Act in 1983, and it was mainly intended to encourage development of new drugs for rare diseases. Currently, numerous legislation and strategies are developed to facilitate research of orphan drugs globally in more than 35 countries.

Cancer, metabolic diseases, blood diseases, immunologic disease, and neurologic diseases are the types of diseases that are addressed with orphan drugs. Cystic fibrosis, glioma, pancreatic cancer, acute myeloid leukemia, multiple myeloma, renal cell carcinoma, ovarian cancer and Duchenne muscular dystrophy are some of the common indications among the various disease types.

Market Analysis: The Global Orphan Drugs Market is estimated to witness a CAGR of 11.9% during the forecast period 2017-2023. The market is analyzed based on three segments, namely types, applications, and regions.

Regional Analysis: The regions covered in the report are North America, Europe, Asia Pacific, and Rest of the World (RoW). North America is the leading region for the orphan drugs market growth followed by Europe. Asia Pacific and RoW are set to be the emerging regions. India, China, and Japan are set to be the most attractive destinations due to the large untapped market.

Types Analysis: The global orphan drugs market by products is segmented into biologics and non-biologics. Biologics orphan drugs is the largest segment in the market with a market share of more than 60% in 2016. It is expected to grow at a double-digit CAGR in the market. However, non-biologic orphan drugs are still expected to hold more than quarter of the market share by 2023. The market is also witnessing various mergers, acquisitions, and collaborations among the top players, which is defining the future of the global orphan drugs market.

Key Players: Novartis AG, F. Hoffmann-La Roche Ltd, Celgene, Bristol-Myers Squibb Company, Shire pharmaceuticals, Pfizer, Sonafi, and Bayer Healthcare are the key players in the market. These top ten players occupy nearly 50% of the orphan drugs market.

Competitive Analysis: Currently, large pharmaceutical companies are extremely active in the orphan drugs market. Merger and acquisition is the major trend in the market. For instance, around 40% of the biotechnology companies are acquired between the year 2008-2012, and they have an orphan drug in development. Novartis, GSK, Roche, and Pfizer are the largest orphan drug companies. Pfizer, Gilead, Roche, Shire, BMY, and Celgene are leading orphan drug acquirers. Around 50% of the top 20 orphan drugs were either acquired or in-licensed by large pharmaceutical companies.

Benefits: The report provides complete details about the usage and adoption rate of orphan drugs during the forecast period and among the regions. With that, key stakeholders can know about the major trends, drivers, investments, vertical player's initiatives, government initiatives toward the orphan drugs adoption in the upcoming years along with the details of commercial drugs 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 key 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 Industry Outlook 10

1.1 Industry Overview 10

1.2 Industry Trends 10

2 Report Outline 12

2.1 Report Scope 12

2.2 Report Summary 12

2.3 Research Methodology 13

2.4 Report Assumptions 13

3 Market Snapshot 15

3.1 Market Definition-Infoholic Research 15

3.2 Segmented Addressable Market (SAM) 15

3.2.1 Advantages of Development of Orphan Drug 16

3.2.2 Trends of orphan drug market 16

3.3 Related Addressable Markets (RAM) 17

3.3.1 Oncology (Cancer) Drugs 17

3.3.2 Active pharmaceutical ingredients (APIs) 18

3.3.3 Over the counter drugs (OTC) 18

4 Market Outlook 20

4.1 Overview 20

4.2 Regulatory Framework for orphan drugs 20

4.3 Funding Scenario for orphan drugs 22

4.4 Market Segmentation 23

4.5 Porter 5(Five) Forces 24

4.6 PEST Analysis 25

5 Market Characteristics 26

5.1 Market Dynamics 26

5.1.1 Drivers 26

5.1.1.1 Conducive government legislation 26

5.1.1.2 Marketing exclusivity for orphan drugs 26

5.1.1.3 Growing unmet need for treatment of orphan diseases 27

5.1.2 Opportunities 27

5.1.2.1 Growing Novel indications for known orphan drugs 27

5.1.2.2 Untapped emerging market 27

5.1.3 Restraints 27

5.1.3.1 High cost of treatment 27

5.1.3.2 Lack of Adequate patients for clinical trials 28

5.1.4 DRO-Impact Analysis 28

5.1.5 Key Stakeholders 29

6 Drug Details: Market Size and Analysis 30

6.1 Overview 30

7 Types: Market Size and Analysis 46

7.1 Overview 46

7.1.1 Biologics 46

7.1.2 Non-Biologics 47

8 Application: Market Size and Analysis 50

8.1 Overview 50

8.1.1 Oncology 50

8.1.2 Metabolic Diseases 51

8.1.3 Hematology 52

8.1.4 Infectious Diseases 53

8.1.5 Neurology 53

8.1.6 Others 54

9 Pipeline Molecules: Market Size and Analysis 55

9.1 Overview 55

10 Regions: Market Size and Analysis 71

10.1 Overview 71

10.2 North America 72

10.2.1 Overview 72

10.2.2 US 72

10.2.3 Canada 73

10.3 Europe 74

10.3.1 Overview 74

10.3.1.1 UK 75

10.3.1.2 Germany 75

10.3.1.3 France 75

10.4 APAC 75

10.4.1 Overview 75

10.4.1.1 India 77

10.4.1.2 Japan 78

10.4.1.3 China 78

10.5 Rest of the World 79

10.5.1 Overview 79

10.5.1.1 Brazil 80

10.5.1.2 Mexico 80

10.5.1.3 Africa 80

10.5.1.4 Middle East 80

11 Competitive Landscape 81

12 Vendor Profiles 83

12.1 Novartis AG 83

12.1.1 Overview 83

12.1.2 Business Unit 86

12.1.3 Geographic Presence 87

12.1.4 Business Focus 88

12.1.5 SWOT Analysis 88

12.1.6 Business Strategy 89

12.2 F.Hoffmann-La Roche Ltd 90

12.2.1 Overview 90

12.2.2 Business Unit 94

12.2.3 Geographic Presence 95

12.2.4 Business Focus 95

12.2.5 SWOT Analysis 96

12.2.6 Business Strategy 96

12.3 Celgene Corporation 97

12.3.1 Overview 97

12.3.2 Geographic Presence 99

12.3.3 Business Focus 99

12.3.4 SWOT Analysis 99

12.3.5 Business Strategy 100

12.4 Bristol-Myers Squibb 101

12.4.1 Overview 101

12.4.2 Geographic Presence 105

12.4.3 Business Focus 105

12.4.4 SWOT Analysis 105

12.4.5 Business Strategy 106

12.5 Shire PLC 107

12.5.1 Overview 107

12.5.2 Business Unit 110

12.5.3 Geographic Presence 112

12.5.4 Business Focus 112

12.5.5 SWOT Analysis 113

12.5.6 Business Strategy 113

13 Companies to Watch For 114

13.1 Pfizer Inc., 114

13.1.1 Overview 114

13.1.2 Highlights 115

13.2 Sanofi 116

13.2.1 Overview 116

13.3 Bayer AG 117

13.3.1 Overview 117

13.4 Alexion Pharmaceutical Inc. 118

13.4.1 Overview 118

13.5 Biogen Pharmaceuticals. 119

13.5.1 Overview 119

13.6 Eli Lilly and Company. 121

13.6.1 Overview 121

13.7 Amgen Inc. 122

13.7.1 Overview 122

Annexure 125

Abbreviations 125

To know more information on Purchase by Section, please send a mail to sales@kenresearch.com

Charts

CHART 1 PEST ANALYSIS OF ORPHAN DRUGS MARKET 11

CHART 2 RESEARCH METHODOLOGY OF GLOBAL ORPHAN DRUGS MARKET 13

CHART 3 GLOBAL ORPHAN DRUGS MARKET REVENUE, 2016-2023 (USD BILLION) 16

CHART 4 SEGMENTATION OF GLOBAL ORPHAN DRUGS MARKET 21

CHART 5 PORTER 5 FORCES OF ORPHAN DRUGS MARKET 21

CHART 6 MARKET DYNAMICS-DRO ANALYSIS 22

CHART 7 DRO-IMPACT ANALYSIS OF GLOBAL ORPHAN DRUGS MARKET 25

CHART 8 KEY STAKEHOLDERS OF GLOBAL ORPHAN DRUGS MARKET 25

CHART 9 ORPHAN DRUGS MARKET REVENUE BY TYPES SEGMENTATION, 2016 VS. 2023 (USD BILLION) 42

CHART 10 BIOLOGICS ORPHAN DRUGS MARKET REVENUE BY TYPES SEGMENTATION, 2016-2023 (USD BILLION) 43

CHART 11 NON-BIOLOGICS ORPHAN DRUGS MARKET REVENUE BY TYPES SEGMENTATION, 2016-2023 (USD BILLION) 44

CHART 12 ORPHAN DRUGS MARKET SHARE BY APPLICATION SEGMENTATION, 2016 (%) 45

CHART 13 HEMATOLOGY MARKET SHARE, 2016 47

CHART 14 ORPHAN DRUG THERAPEUTIC AREA IN PIPELINE, 2016 49

CHART 15 ORPHAN DRUGS IN PIPELINE, 2016 50

CHART 16 ORPHAN DRUGS MARKET SHARE BY REGIONAL SEGMENTATION, 2016 VS. 2023 (%) 64

CHART 17 ORPHAN DRUGS MARKET REVENUE IN NORTH AMERICA, 2016-2023 (USD BILLION) 65

CHART 18 ORPHAN DRUGS MARKET REVENUE IN EUROPE, 2016-2023 (USD BILLION) 68

CHART 19 ORPHAN DRUGS MARKET REVENUE IN APAC, 2016-2023 (USD BILLION) 70

CHART 20 ORPHAN DRUGS MARKET REVENUE IN REST OF THE WORLD, 2016-2023 (USD BILLION) 72

CHART 21 ORPHAN DRUGS MARKET SHARE, 2016 75

CHART 22 NOVARTIS AG: OVERVIEW SNAPSHOT 77

CHART 23 NOVARTIS AG: BUSINESS UNITS 78

CHART 24 NOVARTIS AG: GEOGRAPHIC REVENUE 79

CHART 25 NOVARTIS AG: SWOT ANALYSIS 80

CHART 26 F. HOFFMANN-LA ROCHE LTD.: OVERVIEW SNAPSHOT 84

CHART 27 F. HOFFMANN-LA ROCHE LTD.: BUSINESS UNITS 84

CHART 28 F. HOFFMANN-LA ROCHE LTD.: GEOGRAPHIC REVENUE 85

CHART 29 F. HOFFMANN-LA ROCHE LTD.: SWOT ANALYSIS 86

CHART 30 CELGENE CORPORATION: OVERVIEW SNAPSHOT 88

CHART 31 CELGENE CORPORATION: GEOGRAPHIC REVENUE 89

CHART 32 CELGENE CORPORATION: SWOT ANALYSIS 90

CHART 33 BRISTOL-MYERS SQUIBB: OVERVIEW SNAPSHOT 93

CHART 34 BRISTOL-MYERS SQUIBB: BUSINESS SEGMENTS 94

CHART 35 BRISTOL-MYERS SQUIBB: GEOGRAPHIC REVENUE 96

CHART 36 BRISTOL-MYERS SQUIBB: SWOT ANALYSIS 96

CHART 37 SHIRE PLC: OVERVIEW SNAPSHOT 100

CHART 38 SHIRE PLC: BUSINESS UNITS 101

CHART 39 SHIRE PLC: GEOGRAPHIC REVENUE 102

CHART 40 SHIRE PLC: SWOT ANALYSIS 102

Tables

TABLE 1 REGULATORY FRAMEWORK FOR ORPHAN DRUGS 18

TABLE 2 FUNDED PROJECTS OF 2017 20

TABLE 3 LIST OF ORPHAN DRUGS APPROVED IN THE MARKET 26

TABLE 4 MARKET REVENUE OF TOP 15 DRUGS, 2016 AND 2023 (USD BILLION) 44

TABLE 5 MOLECULES IN DEVELOPMENT (2015) 46

TABLE 6 AUTOIMMUNE DISEASES MOLECULES 50

TABLE 7 BLOOD DISORDER MOLECULES 52

TABLE 8 RARE CANCER MOLECULES 52

TABLE 9 BLOOD CANCER MOLECULES 55

TABLE 10 CARDIOVASCULAR DISORDERS MOLECULES 56

TABLE 11 DIGESTIVE DISORDERS MOLECULES 57

TABLE 12 EYE DISORDERS MOLECULES 57

TABLE 13 GENETIC DISORDERS MOLECULES 57

TABLE 14 GROWTH DISORDERS MOLECULES 60

TABLE 15 INFECTIOUS DISORDERS MOLECULES 60

TABLE 16 NEUROLOGIC DISORDERS MOLECULES 61

TABLE 17 RESPIRATORY DISORDERS MOLECULES 62

TABLE 18 TRANSPLANTATION MOLECULES 62

TABLE 19 OTHER DISORDERS MOLECULES IN THE PIPELINE 63

TABLE 20 ORPHAN DRUGS MARKET REVENUE BY REGIONS, 2016-2023 (USD BILLION) 65

TABLE 21 TOP 5 ORPHAN DRUGS IN THE US MARKET 66

TABLE 22 REGULATORY AUTHORITIES IN ASIA PACIFIC 69

TABLE 23 NOVARTIS AG: OFFERINGS 76

TABLE 24 NOVARTIS AG: RECENT DEVELOPMENTS 76

TABLE 25 F. HOFFMANN-LA ROCHE LTD.: OFFERINGS 82

TABLE 26 F. HOFFMANN-LA ROCHE LTD.: RECENT DEVELOPMENTS 82

TABLE 27 CELGENE CORPORATION: OFFERINGS 88

TABLE 28 CELGENE CORPORATION: RECENT DEVELOPMENTS 88

TABLE 29 BRISTOL-MYERS SQUIBB: OFFERINGS 92

TABLE 30 BRISTOL-MYERS SQUIBB: RECENT DEVELOPMENTS 92

TABLE 31 SHIRE PLC: OFFERINGS 98

TABLE 32 SHIRE PLC: RECENT DEVELOPMENTS 98

TABLE 33 PFIZER: RECENT DEVELOPMENTS 104

TABLE 34 SANOFI: RECENT DEVELOPMENTS 106

TABLE 35 BAYER AG: RECENT DEVELOPMENTS 107

TABLE 36 ALEXION PHARMACEUTICAL, INC.: RECENT DEVELOPMENTS 108

TABLE 37 BIOGEN PHARMACEUTICALS: RECENT DEVELOPMENTS 109

TABLE 38 ELI LILLY AND COMPANY: RECENT DEVELOPMENTS 110

TABLE 39 AMGEN INC.: RECENT DEVELOPMENTS 111

Novartis AG, F. Hoffmann-La Roche Ltd, Celgene, Bristol-Myers Squibb Company, Shire pharmaceuticals, Pfizer, Sonafi, and Bayer Healthcare


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