The cell and gene therapy industry analysis by BIS Research projects the market to grow at a significant CAGR of 36.52% during the forecast year 2019-25

1. Global Cell and Gene Therapy Market
Global Cell and Gene
Therapy Market
Focus on Products, Applications,
Regions and Competitive
Landscape: Analysis and
Forecast:2019-2025
July 2019
TOC

2. Global Cell and Gene Therapy Market
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3. Global Cell and Gene Therapy Market
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Table of Contents
1. Research Scope and Methodology..................................................................... 27
1.1 Scope of the Study.......................................................................................... 27
1.2 Research Methodology................................................................................... 28
1.3 Data Sources ................................................................................................... 29
1.4 Assumptions and Limitations........................................................................ 33
1.5 Data and Prediction Modelling....................................................................... 36
2. Global Cell and Gene Therapy Market: Global Prospective.............................. 37
2.1 Introduction ..................................................................................................... 37
2.2 Cell and Gene Therapy and Their Clinical Importance ................................ 37
2.3 Cell and Gene Therapy Development and Commercialization
Landscape ....................................................................................................... 39
2.4 Global Cell and Gene Therapy Market Size, 2018-2025................................ 40
2.5 Role of Regulatory Bodies and Consortium in Cell and Gene
Therapy............................................................................................................ 41
2.6 Reimbursement and Market Access.............................................................. 42
2.7 Key Companies in Cell and Gene Therapy Market and their
Contributions................................................................................................... 44
3. Global Cell and Gene Therapy Market Overview (Addressable Market
Size and Growth Potential), 2018-2025............................................................... 45
3.1 Cell and Gene Therapy Industry .................................................................... 45
3.2 Key Successful Cell and Gene Therapy Commercialization ....................... 46
3.3 Addressable Market and Growth Potential ................................................... 48
3.4 North America ................................................................................................. 49
3.5 Europe.............................................................................................................. 50
3.6 Asia-Pacific...................................................................................................... 50
3.7 Latin America .................................................................................................. 51
3.8 Rest-of-the-World............................................................................................ 52
4. Industry Insights................................................................................................... 53
4.1 Mergers and Acquisitions .............................................................................. 53
4.2 Product Approvals .......................................................................................... 53

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4.3 Partnerships, Collaborations and Joint Ventures ........................................ 54
4.4 Business Expansion Activities and Others .................................................. 55
4.5 Legal Requirements and Regulations ........................................................... 55
4.5.1 Overview of Regulatory Pathway for Cell and Gene Therapy........... 55
4.5.2 FDA Expedited Approval Designations.............................................. 56
4.5.2.1 Fast Track Designation: .................................................................... 56
4.5.2.2 Breakthrough Therapy: ..................................................................... 56
4.5.2.3 Accelerated Approval:....................................................................... 56
4.5.2.4 Priority Review: ................................................................................. 56
4.5.2.5 Regenerative Medicine Advanced Therapy Designation:.................. 57
4.5.3 Expedited Designation Vs. Traditional Approval Timelines: ............ 57
4.5.4 Regulatory Challenges: ....................................................................... 57
4.5.5 Successful Regulatory Strategies....................................................... 58
5. Patent Landscape................................................................................................. 59
6. Cell and Gene Therapy Manufacturing ............................................................... 60
6.1 Viral Vector Manufacturing............................................................................. 60
6.1.1 Upstream Manufacturing ..................................................................... 61
6.1.1.1 Cost Consideration and Timelines .................................................... 61
6.1.1.2 Process Design and Regulatory Burdens ......................................... 62
6.1.1.3 Other Considerations ........................................................................ 62
6.1.1.4 Viral vector Manufacturing ................................................................ 63
6.1.1.4.1 Retrovirus............................................................................. 63
6.1.1.4.2 Lentivirus.............................................................................. 64
6.1.1.4.3 AAV...................................................................................... 64
6.1.1.4.4 Adenovirus ........................................................................... 64
6.1.2 Downstream Manufacturing ................................................................ 65
6.1.2.1 Viral Vector Manufacturing................................................................ 65
6.1.2.1.1 Retrovirus............................................................................. 65
6.1.2.1.2 Lentivirus.............................................................................. 65
6.1.2.1.3 AAV...................................................................................... 66
6.1.2.1.4 Adenovirus ........................................................................... 66

5. Global Cell and Gene Therapy Market
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6.1.2.2 Cost Considerations and Timelines................................................... 66
6.1.2.3 Challenges in Downstream ............................................................... 67
6.1.2.4 Scale-up of Downstream from Research to Clinical
Manufacturing................................................................................ 68
6.2 Non-Viral Vector Manufacturing .................................................................... 69
6.2.1 Non-Viral, Plasmid-Free Manufacturing ............................................. 69
6.2.2 Plasmid.................................................................................................. 70
6.2.3 Naked DNA............................................................................................ 70
6.2.4 Physical-Mediated Methods ................................................................ 70
6.3 Cell and Gene Therapy Manufacturing Capacity, by Company .................. 71
7. Market Dynamics .................................................................................................. 74
7.1 Impact Analysis............................................................................................... 74
7.2 Market Drivers ................................................................................................. 75
7.2.1 Increasing Prevalence of Cancer and Chronic Diseases.................. 75
7.2.2 Rising Number of Clinical Trials ......................................................... 76
7.2.3 Steady Investment and Consolidation in the Cell and Gene
Therapy Market..................................................................................... 77
7.2.4 Favorable Regulatory Environment .................................................... 78
7.3 Market Restraints ............................................................................................ 80
7.3.1 Lack of Reliable Vector Production for Cell and Gene Therapy....... 80
7.4 Opportunities................................................................................................... 81
7.4.1 Drug Approvals and Strong Pipeline of Cell and Gene
Therapies .............................................................................................. 81
7.5 Market Challenges .......................................................................................... 81
7.5.1 High Cost of Therapy ........................................................................... 81
7.5.2 Lack of Therapy Specific Assays........................................................ 82
8. Global Cell and Gene Therapy Market (by Product) .......................................... 83
8.1 Therapeutic Market ......................................................................................... 83
8.1.1 Yescarta ................................................................................................ 84
8.1.2 Provenge ............................................................................................... 85
8.1.3 Luxturna ................................................................................................ 86
8.1.4 Kymriah ................................................................................................. 87

6. Global Cell and Gene Therapy Market
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8.1.5 Imlygic................................................................................................... 89
8.1.6 Gintuit.................................................................................................... 90
8.1.7 MACI ...................................................................................................... 90
8.1.8 Laviv ...................................................................................................... 91
8.1.9 Gendicine.............................................................................................. 92
8.1.10 Oncorine................................................................................................ 93
8.1.11 Neovasculgen ....................................................................................... 94
8.1.12 Strimvelis .............................................................................................. 95
8.1.13 Invossa.................................................................................................. 96
8.1.14 Others.................................................................................................... 98
8.2 Pipeline Analysis............................................................................................. 99
8.2.1 Phase 1................................................................................................ 101
8.2.2 Phase 2................................................................................................ 102
8.2.3 Phase 3................................................................................................ 103
8.2.4 Phase 4................................................................................................ 105
9. Global Cell and Gene Therapy Market (by Therapeutic Class)....................... 106
9.1 Rare Diseases................................................................................................ 106
9.2 Oncology........................................................................................................ 107
9.3 Hematology.................................................................................................... 108
9.4 Cardiovascular .............................................................................................. 109
9.5 Ophthalmology.............................................................................................. 110
9.6 Neurology ...................................................................................................... 112
9.7 Other Therapeutic Classes........................................................................... 113
10. Global Cell and Gene Therapy Market (by Region), 2018-2025 ($Million)...... 115
10.1 Overview ........................................................................................................ 115
10.2 North America ............................................................................................... 116
10.2.1 U.S. ...................................................................................................... 118
10.2.1.1 Approved Products ...................................................................... 118
10.2.1.2 Market Size and Forecast............................................................ 119
10.2.1.3 Key Developments....................................................................... 120
10.2.1.4 Competitive landscape................................................................. 121
10.2.2 Canada ................................................................................................ 122

7. Global Cell and Gene Therapy Market
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10.2.2.1 Approved Products ...................................................................... 122
10.2.2.2 Market Size and Forecast............................................................ 122
10.2.2.3 Key Developments....................................................................... 124
10.2.2.4 Competitive landscape................................................................. 124
10.3 Europe............................................................................................................ 124
10.3.1 Germany.............................................................................................. 127
10.3.1.1 Approved Products ...................................................................... 128
10.3.1.2 Market Size and Forecast............................................................ 128
10.3.1.3 Key Developments....................................................................... 129
10.3.1.4 Competitive landscape................................................................. 130
10.3.2 France.................................................................................................. 130
10.3.2.1 Approved Products ...................................................................... 131
10.3.2.2 Market Size and Forecast............................................................ 131
10.3.2.3 Key Developments....................................................................... 132
10.3.2.4 Competitive landscape................................................................. 132
10.3.3 U.K. ...................................................................................................... 133
10.3.3.1 Approved Products ...................................................................... 133
10.3.3.2 Market Size and Forecast............................................................ 134
10.3.3.3 Competitive landscape................................................................. 135
10.3.4 Italy ...................................................................................................... 135
10.3.4.1 Approved Products ...................................................................... 136
10.3.4.2 Market Size and Forecast............................................................ 136
10.3.4.3 Key Developments....................................................................... 137
10.3.5 Spain.................................................................................................... 137
10.3.5.1 Approved Products ...................................................................... 138
10.3.5.2 Market Size and Forecast............................................................ 138
10.3.5.3 Key Developments....................................................................... 139
10.3.5.4 Competitive landscape................................................................. 139
10.3.6 The Netherlands ................................................................................. 140
10.3.6.1 Approved Products ...................................................................... 140
10.3.6.2 Market Size and Forecast............................................................ 140
10.3.6.3 Key Developments....................................................................... 141
10.3.6.4 Competitive landscape................................................................. 142

8. Global Cell and Gene Therapy Market
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10.3.7 Russia.................................................................................................. 142
10.3.7.1 Approved Products ...................................................................... 143
10.3.7.2 Market Size and Forecast............................................................ 143
10.3.7.3 Competitive landscape................................................................. 144
10.3.8 Rest-of-Europe.................................................................................... 144
10.3.8.1 Market Size and Forecast............................................................ 145
10.3.8.2 Key Developments....................................................................... 145
10.4 Asia-Pacific.................................................................................................... 145
10.4.1 Japan................................................................................................... 147
10.4.1.1 Approved Products ...................................................................... 147
10.4.1.2 Market Size and Forecast............................................................ 148
10.4.1.3 Key Developments....................................................................... 149
10.4.1.4 Competitive landscape................................................................. 149
10.4.1.5 China150
10.4.1.6 Approved Products ...................................................................... 150
10.4.1.7 Market Size and Forecast............................................................ 151
10.4.1.8 Key Developments....................................................................... 152
10.4.1.9 Competitive landscape................................................................. 152
10.4.2 Australia.............................................................................................. 153
10.4.2.1 Approved Products ...................................................................... 153
10.4.2.2 Market Size and Forecast............................................................ 153
10.4.2.3 Key Developments....................................................................... 154
10.4.3 South Korea ........................................................................................ 155
10.4.3.1 Approved Products ...................................................................... 155
10.4.3.2 Market Size and Forecast............................................................ 157
10.4.3.3 Key Developments....................................................................... 157
10.4.3.4 Competitive landscape................................................................. 158
10.4.4 India..................................................................................................... 159
10.4.4.1 Approved Products ...................................................................... 160
10.4.4.2 Market Size and Forecast............................................................ 160
10.4.4.3 Competitive landscape................................................................. 161
10.4.5 Singapore............................................................................................ 162
10.4.5.1 Approved Products ...................................................................... 162

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10.4.5.2 Market Size and Forecast............................................................ 162
10.4.5.3 Key Developments....................................................................... 163
10.4.6 Rest-of-Asia-Pacific............................................................................ 163
10.4.6.1 Market Size and Forecast............................................................ 163
10.4.6.2 Key Developments....................................................................... 164
10.5 Latin America ................................................................................................ 164
10.5.1 Brazil.................................................................................................... 166
10.5.1.1 Market Size and Forecast............................................................ 166
10.5.2 Mexico ................................................................................................. 167
10.5.2.1 Market Size and Forecast............................................................ 168
10.5.3 Rest-of-Latin America ........................................................................ 169
10.5.3.1 Market Size and Forecast............................................................ 169
10.6 Rest-of-World ................................................................................................ 170
10.6.1.1 Market Size and Forecast............................................................ 170
11. Competitive Landscape ..................................................................................... 172
11.1 Market Share Analysis.................................................................................. 172
11.2 Growth Share Analysis................................................................................. 173
12. Company Profiles ............................................................................................... 175
12.1 Overview ........................................................................................................ 175
12.2 Amgen Inc...................................................................................................... 176
12.2.1 Company Overview ............................................................................ 176
12.2.2 Role of Amgen Inc. in the Global Cell and Gene Therapy
Market.................................................................................................. 176
12.2.3 Financials............................................................................................ 178
12.2.4 Key Insights about Financial Health of the Company..................... 180
12.2.5 SWOT Analysis................................................................................... 181
12.3 bluebird bio, Inc. ........................................................................................... 182
12.3.1 Company Overview ............................................................................ 182
12.3.2 Role of bluebird bio, Inc. in the Global Cell and Gene Therapy
Market.................................................................................................. 182
12.3.3 Financials............................................................................................ 184
12.3.4 Key Insights about Financial Health of the Company ..................... 185

10. Global Cell and Gene Therapy Market
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12.3.5 SWOT Analysis................................................................................... 186
12.4 Dendreon Pharmaceuticals LLC.................................................................. 187
12.4.1 Company Overview ............................................................................ 187
12.4.2 Role of Dendreon Pharmaceuticals LLC. in the Global Cell and
Gene Therapy Market ......................................................................... 187
12.4.3 SWOT Analysis................................................................................... 188
12.5 Fibrocell Science, Inc.................................................................................... 189
12.5.1 Company Overview ............................................................................ 189
12.5.2 Role of Fibrocell Science, Inc. in the Global Cell and Gene
Therapy Market................................................................................... 189
12.5.3 Key Insights about Financial Health of the Company ..................... 191
12.5.4 SWOT Analysis................................................................................... 192
12.6 Human Stem Cells Institute.......................................................................... 193
12.6.1 Company Overview ............................................................................ 193
12.6.2 Role of Human Stem Global Cell and Gene Therapy Cell
Market.................................................................................................. 193
12.6.3 SWOT Analysis................................................................................... 195
12.7 Kite Pharma, Inc. ........................................................................................... 196
12.7.1 Company Overview ............................................................................ 196
12.7.2 Role of Kite Pharma, Inc. in the Global Cell and Gene Therapy
Market.................................................................................................. 196
12.7.3 Financials............................................................................................ 198
12.7.4 Key Insights about Financial Health of the Company ..................... 199
12.7.5 SWOT Analysis................................................................................... 200
12.8 Kolon TissueGene, Inc.................................................................................. 201
12.8.1 Company Overview ............................................................................ 201
12.8.2 Role of Kolon TissueGene, Inc. in the Global Cell and Gene
Therapy Market................................................................................... 201
12.8.3 SWOT Analysis................................................................................... 202
12.9 Novartis AG ................................................................................................... 203
12.9.1 Company Overview ............................................................................ 203
12.9.2 Role of Novartis AG in the Global Cell and Gene Therapy
Market.................................................................................................. 203
12.9.3 Financials............................................................................................ 205

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12.9.4 SWOT Analysis................................................................................... 207
12.10 Orchard Therapeutics plc............................................................................. 208
12.10.1 Company Overview ............................................................................ 208
12.10.2 Role of Orchard Therapeutics plc. in the Global Cell and Gene
Therapy Market................................................................................... 208
12.10.3 Financials............................................................................................ 210
12.10.4 SWOT Analysis................................................................................... 211
12.11 Organogenesis Holdings Inc........................................................................ 212
12.11.1 Company Overview ............................................................................ 212
12.11.2 Role of Organogenesis Holdings Inc. in the Global Cell and
Gene Therapy Market ......................................................................... 212
12.11.3 SWOT Analysis................................................................................... 213
12.12 Pfizer, Inc. ...................................................................................................... 214
12.12.1 Company Overview ............................................................................ 214
12.12.2 Role of Pfizer, Inc. in the Global Cell and Gene Therapy Market.... 214
12.12.3 Financials............................................................................................ 215
12.12.4 Key Insights about Financial Health of the Company..................... 217
12.12.5 SWOT Analysis................................................................................... 218
12.13 RENOVA THERAPEUTICS............................................................................ 219
12.13.1 Company Overview ............................................................................ 219
12.13.2 Role of RENOVA THERAPEUTICS in the Global Cell and Gene
Therapy Market................................................................................... 219
12.13.3 SWOT Analysis................................................................................... 221
12.14 Shanghai Sunway Biotech Co., Ltd., ........................................................... 222
12.14.1 Company Overview ............................................................................ 222
12.14.2 Role of Shanghai Sunway Biotech Co., Ltd., in the Global Cell
and Gene Therapy Market.................................................................. 222
12.14.3 SWOT Analysis................................................................................... 223
12.15 Sibiono GeneTech Co. Ltd., ......................................................................... 224
12.15.1 Company Overview ............................................................................ 224
12.15.2 Role of Sibiono GeneTech Co. Ltd., in the Global Cell and
Gene Therapy...................................................................................... 224
12.15.3 SWOT Analysis................................................................................... 225
12.16 Spark Therapeutics, Inc................................................................................ 226

12. Global Cell and Gene Therapy Market
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12.16.1 Company Overview ............................................................................ 226
12.16.2 Role of Spark Therapeutics, Inc. in the Global Cell and Gene
Test Market ......................................................................................... 226
12.16.3 Financials............................................................................................ 228
12.16.4 Key Insights about Financial Health of the Company ..................... 229
12.16.5 SWOT Analysis................................................................................... 230
12.17 Vericel Corporation....................................................................................... 231
12.17.1 Company Overview ............................................................................ 231
12.17.2 Role of Vericel Corporation in the Global Cell and Gene
Therapy Market................................................................................... 231
12.17.3 Financials............................................................................................ 233
12.17.4 Key Insights About Financial Health of the Company .................... 235
12.17.5 SWOT Analysis................................................................................... 236
12.18 ViroMed Co., Ltd............................................................................................ 237
12.18.1 Company Overview ............................................................................ 237
12.18.2 Role of ViroMed Co., Ltd. in the Global Cell and Gene Therapy
Market.................................................................................................. 237
12.18.3 Financials............................................................................................ 239
12.18.4 SWOT Analysis................................................................................... 240

13. Global Cell and Gene Therapy Market
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List of Figures
Figure 1: Impact of Market Drivers and Market Challenges on the Global Cell and Gene Therapy
Market.......................................................................................................................................... 21
Figure 2: Global Cell and Gene Therapy Market Snapshot................................................................... 22
Figure 3: Dominant Segments of the Global Cell and Gene Therapy Market, 2019 and 2025............ 23
Figure 4: Global Cell and Gene Therapy Market (by Approved Product), 2019 and 2025................... 24
Figure 5: Global Cell and Gene Therapy Market (by Therapeutic Class), 2019 and 2025 .................. 25
Figure 6: Global Cell and Gene Therapy Market (by Region), 2019 and 2025 .................................... 26
Figure 1.1: Global Cell and Gene Therapy Market Segmentation ........................................................ 27
Figure 1.2: Global Cell and Gene Therapy Market Research Methodology ......................................... 28
Figure 1.3: Global Cell and Gene Therapy Market Research Methodology Approach ........................ 28
Figure 1.4: Primary Research ................................................................................................................. 29
Figure 1.5: Secondary Research ............................................................................................................ 30
Figure 1.6: Data Triangulation................................................................................................................. 31
Figure 1.7: Bottom-Up Approach (Segment-Wise Analysis) ................................................................. 32
Figure 1.8: Top-Down Approach (Segment-Wise Analysis).................................................................. 33
Figure 1.9: Assumptions and Limitations................................................................................................ 35
Figure 1.10: Considered Factors for Data Prediction and Modelling..................................................... 36
Figure 2.1: Clinical Trials by Therapeutic Category, Cell and Gene Therapy, 2018............................. 38
Figure 2.2: Global Cell and Gene Therapy Market Size, 2018-2025 .................................................... 40
Figure 3.1: Addressable Market Size of Commercialized Products, 2018............................................ 47
Figure 3.2: Addressable Market Size of Commercialized Products, 2025............................................ 48
Figure 3.3: North America Cell and Gene Therapy Addressable Market, 2018 and 2025................... 49
Figure 3.4: Europe Cell and Gene Therapy Addressable Market, 2018 and 2025............................... 50
Figure 3.5: Asia-Pacific Cell and Gene Therapy Addressable Market, 2018 and 2025 ....................... 51
Figure 3.6: Latin America Cell and Gene Therapy Addressable Market 2019 and 2025..................... 52
Figure 4.1: Product Approvals Share (by Company), January 2016 – April 2019................................ 54
Figure 4.2: Synergistic Activities Share (by Company), January 2016 – April 2019............................. 55
Figure 5.1: Share of Patents (by Ownership), 2016-2019 ..................................................................... 59
Figure 7.1: Number of Active and Completed Clinical Trials for Cell and Gene Therapy, by Start
Date (2014-2018)........................................................................................................................ 76

14. Global Cell and Gene Therapy Market
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Figure 8.1: Global Cell and Gene Therapy Market, by Therapeutic Drugs, 2018-2025....................... 83
Figure 8.2: Global Revenue for Yescarta, 2018-2025 ........................................................................... 84
Figure 8.3: Global Revenue for Provenge, 2018-2025.......................................................................... 85
Figure 8.4: Global Revenue for Luxturna, 2018-2025............................................................................ 86
Figure 8.5: Global Revenue for Kymriah, 2018-2025 ............................................................................ 88
Figure 8.6: Global Revenue for Imlygic, 2018-2025............................................................................... 89
Figure 8.7: Global Revenue for MACI, 2018-2025................................................................................. 90
Figure 8.8: Global Revenue for Gendicine, 2018-2025 ......................................................................... 92
Figure 8.9: Global Revenue for Oncorine, 2018-2025........................................................................... 93
Figure 8.10: Global Revenue for Neovasculogen, 2018-2025 .............................................................. 94
Figure 8.11: Global Revenue for Strimvelis, 2018-2025........................................................................ 95
Figure 8.12: Global Revenue for Invossa, 2018-2025 ........................................................................... 97
Figure 8.13: Global Revenue for Other Drugs, 2018-2025.................................................................... 98
Figure 8.14: Cell and Gene Therapy Medicines in Development by Disease, 2018 .......................... 100
Figure 8.15: Cell and Gene Therapy: Breakdown of Pipeline, 2017 ................................................... 101
Figure 8.16: Number of Phase 1 Clinical Trials for Cell and Gene Therapy, 2014-2018 ................... 102
Figure 8.17: Number of Phase 2 Clinical Trials for Cell and Gene Therapy, 2014-2018 ................... 103
Figure 8.18: Global Cell and Gene Therapy Market, By Late Phase, 2018-2025 .............................. 103
Figure 9.1: Global Cell and Gene Therapy Market, By Rare Diseases, 2018-2025........................... 106
Figure 9.2: Global Cell and Gene Therapy Market, By Oncology, 2018-2025 ................................... 107
Figure 9.3: Global Cell and Gene Therapy Market, By Hematology, 2018-2025 ............................... 108
Figure 9.4: Global Cell and Gene Therapy Market, By Cardiovascular Disease, 2018-2025............ 109
Figure 9.5: Global Cell and Gene Therapy Market, By Ophthalmology, 2018-2025 .......................... 111
Figure 9.6: Global Cell and Gene Therapy Market, By Neurology, 2018-2025 .................................. 112
Figure 9.7: Global Cell and Gene Therapy Market, By Other Therapeutic Class, 2018-2025........... 113
Figure 10.1: Global Cell and Gene Therapy Market (by Region), 2019 and 2025 ............................. 115
Figure 10.2: North America Cell and Gene Therapy Market, 2018-2025 ........................................... 116
Figure 10.3: North America-Market Dynamics ..................................................................................... 117
Figure 10.4: U.S. Cell and Gene Therapy Market, 2018-2025............................................................ 119
Figure 10.5: Projections of the Older Adult Population in the U.S.: 2020 to 2060 (Million) ................ 120
Figure 10.6: Canada Cell and Gene Therapy Market, 2018-2025...................................................... 123
Figure 10.7: Europe Cell and Gene Therapy Market, 2018-2025 ....................................................... 125

15. Global Cell and Gene Therapy Market
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Figure 10.8: Europe-Market Dynamics................................................................................................. 127
Figure 10.9: Germany Cell and Gene Therapy Market, 2018-2025.................................................... 129
Figure 10.10: France Cell and Gene Therapy Market, 2018-2025...................................................... 131
Figure 10.11: The U.K. Cell and Gene Therapy Market, 2018-2025 .................................................. 134
Figure 10.12: Italy Cell and Gene Therapy Market, 2018-2025 .......................................................... 136
Figure 10.13: Spain Cell and Gene Therapy Market, 2018-2025........................................................ 138
Figure 10.14: The Netherlands Cell and Gene Therapy Market, 2018-2025...................................... 141
Figure 10.15: Russia Cell and Gene Therapy Market, 2018-2025...................................................... 143
Figure 10.16: Rest-of-Europe Cell and Gene Therapy Market, 2018-2025........................................ 145
Figure 10.17: Europe Cell and Gene Therapy Market, 2018-2025..................................................... 146
Figure 10.18: Asia-Pacific Market Dynamics........................................................................................ 146
Figure 10.19: Japan Cell and Gene Therapy Market, 2018-2025....................................................... 148
Figure 10.20: China Cell and Gene Therapy Market, 2018-2025 ....................................................... 151
Figure 10.21: Australia Cell and Gene Therapy Market, 2018-2025................................................... 154
Figure 10.22: S. Korea Cell and Gene Therapy Market, 2018-2025................................................... 157
Figure 10.23: India Cell and Gene Therapy Market, 2018-2025......................................................... 160
Figure 10.24: Singapore Cell and Gene Therapy Market, 2018-2025 ................................................ 162
Figure 10.25: Rest-of-Asia-Pacific Cell and Gene Therapy Market, 2018-2025................................. 164
Figure 10.26: Latin America Cell and Gene Therapy Market, 2018-2025 .......................................... 165
Figure 10.27: Latin America: Market Dynamics ................................................................................... 166
Figure 10.28: Brazil Cell and Gene Therapy Market, 2018-2025........................................................ 167
Figure 10.29: Mexico Cell and Gene Therapy Market, 2018-2025 ..................................................... 168
Figure 10.30: Rest-of-Latin America Cell and Gene Therapy Market, 2018-2025 ............................. 169
Figure 10.31: Rest-of-World Cell and Gene Therapy Market, 2018-2025 .......................................... 171
Figure 11.1: Market Share Analysis for the Global Cell and Gene Therapy Market, 2018 ................ 172
Figure 11.2: Growth Share Matrix for Global Cell and Gene Therapy Market (by Company),
2018........................................................................................................................................... 173
Figure 12.1: Total Number of Companies Profiled............................................................................... 175
Figure 12.2: Amgen Inc.: Overall Product Portfolio.............................................................................. 176
Figure 12.3: Amgen Inc.: Pipeline Product Portfolio ............................................................................ 177
Figure 12.4: Amgen Inc.: Overall Financials, 2016-2018..................................................................... 178
Figure 12.5: Amgen Inc.: Revenue (by Region), 2016-2018............................................................... 179

16. Global Cell and Gene Therapy Market
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Figure 12.6: Amgen Inc.: R&D Expenditure, 2016-2018 ..................................................................... 180
Figure 12.7: Amgen Inc.: SWOT Analysis............................................................................................ 181
Figure 12.8: Pipeline Product Portfolio: bluebird bio, Inc. .................................................................... 183
Figure 12.9: bluebird bio, Inc.: Overall Financials, 2016-2018 ............................................................ 184
Figure 12.10: bluebird bio, Inc.: R&D Expenditure, 2016-2018........................................................... 185
Figure 12.11: bluebird bio, Inc.: SWOT Analysis.................................................................................. 186
Figure 12.12: Dendreon Pharmaceuticals LLC: Product Portfolio....................................................... 188
Figure 12.13: Dendreon Pharmaceuticals LLC.: SWOT Analysis....................................................... 188
Figure 12.14: Fibrocell Science, Inc.: Overall Product Portfolio .......................................................... 190
Figure 12.15: Fibrocell Science, Inc.: Pipeline Product Portfolio ......................................................... 190
Figure 12.16: Fibrocell Science, Inc.: R&D Expenditure, 2016-2018.................................................. 191
Figure 12.17: Fibrocell Science, Inc.: SWOT Analysis ........................................................................ 192
Figure 12.18: Human Stem Cell Institute: Overall Product Portfolio.................................................... 194
Figure 12.19: Human Stem Cell Institute: SWOT Analysis.................................................................. 195
Figure 12.20: Kite Pharma, Inc.: Overall Product Portfolio .................................................................. 197
Figure 12.21: Kite Pharma, Inc.: Pipeline Product Portfolio................................................................. 197
Figure 12.22: Kite Pharma, Inc.: Overall Financials, 2016-2018......................................................... 198
Figure 12.23: Kite Pharma, Inc.: R&D Expenditure, 2016-2018.......................................................... 199
Figure 12.24: Kite Pharma, Inc.: SWOT Analysis ................................................................................ 200
Figure 12.25: Kolon TissueGene, Inc.: Pipeline Product Portfolio....................................................... 202
Figure 12.26: Kolon TissueGene, Inc.: SWOT Analysis ...................................................................... 202
Figure 12.27: Novartis AG: Overall Product Portfolio........................................................................... 204
Figure 12.28: Novartis AG: Pipeline Product Portfolio ......................................................................... 204
Figure 12.29: Novartis AG: Overall Financials, 2016-2018 ................................................................. 205
Figure 12.30: Novartis AG: Revenue (by Business Segment), 2016-2018......................................... 206
Figure 12.31: Novartis AG: SWOT Analysis......................................................................................... 207
Figure 12.32: Orchard Therapeutics plc.: Pipeline Product Portfolio................................................... 209
Figure 12.33: Orchard Therapeutics plc.: Overall Financials, 2016-2018........................................... 210
Figure 12.34: Orchard Therapeutics plc: SWOT Analysis................................................................... 211
Figure 12.35: Organogenesis Holdings Inc.: Overall Product Portfolio............................................... 213
Figure 12.36: Organogenesis Holdings Inc.: SWOT Analysis............................................................. 213
Figure 12.37: Pfizer, Inc.: Pipeline Product Portfolio............................................................................ 215

17. Global Cell and Gene Therapy Market
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Figure 12.38: Pfizer, Inc.: Overall Financials, 2016-2018.................................................................... 215
Figure 12.39: Pfizer, Inc.: Revenue (by Region), 2016-2018 .............................................................. 216
Figure 12.40: Pfizer, Inc.: R&D Expenditure, 2016-2018..................................................................... 217
Figure 12.41: Pfizer, Inc.: SWOT Analysis ........................................................................................... 218
Figure 12.42: RENOVA THERAPEUTICS: Pipeline Product Portfolio ............................................... 220
Figure 12.43: RENOVA THERAPEUTICS: SWOT Analysis............................................................... 221
Figure 12.44: Product Portfolio: Shanghai Sunway Biotech Co., Ltd.,................................................ 223
Figure 12.45: Shanghai Sunway Biotech Co., Ltd.: SWOT Analysis .................................................. 223
Figure 12.46: Sibiono GeneTech Co. Ltd.: Overall Product Portfolio.................................................. 225
Figure 12.47: Sibiono GeneTech Co. Ltd.: SWOT Analysis................................................................ 225
Figure 12.48: Spark Therapeutics, Inc.: Overall Product Portfolio ...................................................... 227
Figure 12.49: Spark Therapeutics, Inc.: Pipeline Product Portfolio..................................................... 227
Figure 12.50: Spark Therapeutics, Inc.: Overall Financials, 2015-2017 ............................................. 228
Figure 12.51: Spark Therapeutics, Inc.: R&D Expenditure, 2015-2017.............................................. 229
Figure 12.52: Spark Therapeutics, Inc.: SWOT Analysis..................................................................... 230
Figure 12.53: Vericel Corporation: Overall Product Portfolio............................................................... 232
Figure 12.54: Vericel Corporation: Pipeline Product Portfolio.............................................................. 232
Figure 12.55: Vericel Corporation: Overall Financials, 2016-2018...................................................... 233
Figure 12.56: Vericel Corporation: Revenue (by Product), 2016-2018............................................... 234
Figure 12.57: Vericel Corporation: R&D Expenditure (2016-2018)..................................................... 235
Figure 12.58: Vericel Corporation: SWOT Analysis............................................................................. 236
Figure 12.59: ViroMed Co., Ltd.: Pipeline Product Portfolio ................................................................ 238
Figure 12.60: ViroMed Co: Overall Financials, 2016-2018.................................................................. 239
Figure 12.61: ViroMed Co., Ltd.: SWOT Analysis................................................................................ 240

18. Global Cell and Gene Therapy Market
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List of Tables
Table 2.1: Approved gene therapies worldwide, October 2018............................................................. 40
Table 2.2: Product Class Inclusions in EU and US Regulatory Pathway.............................................. 42
Table 2.3: Key Market Access Landscape (9 Countries), January 2019 .............................................. 43
Table 2.4: Key Companies in Cell and Gene Therapy Market, 2018.................................................... 44
Table 3.1: Key Products of Cell and Gene Therapy Market .................................................................. 46
Table 6.1: Key Viral Vectors.................................................................................................................... 60
Table 6.2: Cell and Gene Therapy Manufacturing Capacity, by Company........................................... 72
Table 7.1: Impact Analysis ...................................................................................................................... 74
Table 7.2: Key Cell and Gene Therapies with FDA Expedited Review................................................. 79
Table 8.1: List of key Cell/Gene Therapy Products with Marketing Authorization (MA) ....................... 99
Table 8.2: Key Cell and Gene Therapy Drugs in Phase 3, 2018 ........................................................ 104
Table 9.1: List of Cell and Gene Therapy Medicines in Development (As of November 2018)........ 114
Table 10.1: List of Cell and Gene Therapy Products with Marketing Authorization in the
European Union by EMA .......................................................................................................... 125
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