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