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Cell and Gene Therapy Market Analysis and Forecast, 2021-2027

The cell and gene therapy market is estimated at $2,599.7 million in 2020. The market is expected to grow at a CAGR of 33.82% during the forecast period from 2021 to 2027.<br>

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Cell and Gene Therapy Market Analysis and Forecast, 2021-2027

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  1. Global Cell and Gene Therapy Market Focus on Product Type, Therapeutic Class, Pipeline, Regional and Country Data (15 Countries) Analysis and Forecast: 2021-2027 February 2021 Table of Content

  2. Global Cell and Gene Therapy Market BIS Research is a leading market intelligence and technology research company. BIS Research publishes in-depth market intelligence reports focusing on market estimations, technology analysis, emerging high-growth applications, deeply segmented granular country-level market data and other important market parameters useful in the strategic decision making for senior management. BIS Research provides multi-client reports, company profiles, databases, and custom research services. Copyright © 2021 BIS Research All Rights Reserved. This document contains highly confidential information and is the sole property of BIS Research. Disclosing, copying, circulating, quoting or otherwise reproducing any or all contents of this document is strictly prohibited. Access to this information is provided exclusively for the benefit of the people or organization concerned. It may not be accessed by or offered whether for sale or otherwise to any third party. All rights reserved at BIS Research 2

  3. Global Cell and Gene Therapy Market T Table of able of C Contents ontents Executive Summary……………………………………………...……………. 23 1. Product Definition .............................................................................................. 31 1.1 Inclusion and Exclusion .............................................................................. 32 2. Research Methodology ...................................................................................... 33 2.1 2.2 2.3 2.4 Primary Data Sources .................................................................................. 34 Secondary Data Sources ............................................................................. 35 Market Estimation Model ............................................................................. 35 Selection Criteria for Company Profiles ..................................................... 38 3. Global Cell and Gene Therapy Market: Global Prospective ............................ 41 3.1 3.2 3.3 Introduction .................................................................................................. 41 Cell and Gene Therapy and Their Clinical Importance ............................. 41 Cell and Gene Therapy Development and Commercialization Landscape .................................................................................................... 42 Global Cell and Gene Therapy Market Size, 2020-2027 ............................. 44 Role of Regulatory Bodies and Consortium in Cell and Gene Therapy ......................................................................................................... 45 Reimbursement and Market Access ........................................................... 45 3.6.1 Reimbursement Scenario of Cell and Gene Therapy Market, by Country ......................................................................................... 45 3.6.1.1 U.S. ..................................................................................................... 45 3.6.1.2 EU 5 .................................................................................................... 46 3.6.1.2.1 France ............................................................................................ 47 3.6.1.2.2 Germany ........................................................................................ 48 3.6.1.2.3 Italy ................................................................................................ 48 3.6.1.2.4 Spain .............................................................................................. 49 3.6.1.2.5 U.K. ................................................................................................ 49 3.7 Key Companies in Cell and Gene Therapy Market and their Contributions ................................................................................................ 50 3.4 3.5 3.6 4. Market Overview ................................................................................................. 51 All rights reserved at BIS Research 3

  4. Global Cell and Gene Therapy Market 4.1 4.2 Cell and Gene Therapy Industry ................................................................. 51 Key Successful Cell and Gene Therapy Commercialization .................... 52 4.2.1 Regional Addressable Market and Growth Potential ..................... 54 4.3 North America .............................................................................................. 55 4.4 Europe ........................................................................................................... 55 4.5 Asia-Pacific ................................................................................................... 56 4.6 Latin America ............................................................................................... 57 4.7 Rest-of-the-World ......................................................................................... 58 5. Impact of COVID-19 Pandemic on Global Cell and Gene Therapy Market..... 59 5.1 5.2 5.3 Disruption of Cell and Gene Therapy Market Due to COVID-19 ............... 59 COVID-19 Affecting Supply Chain of Cell and Gene Therapy Market ...... 61 Interruption in Research and Clinical Development and Commercial Operation ................................................................................. 62 5.3.1 Research and Clinical Development ................................................ 62 5.3.2 Commercial Operation and Access .................................................. 63 5.4 Navigating Crisis Recovery and Looking to the Future ............................ 64 6. Global Cell and Gene Therapy Market: Industry Analysis .............................. 66 6.1 Legal and Regulatory Framework and Requirements............................... 66 6.1.1 Overview of Regulatory Pathway for Cell and Gene Therapy ....... 66 6.1.1.1 Fast Track Designation: ....................................................................... 67 6.1.1.2 Breakthrough Therapy: ........................................................................ 68 6.1.1.3 Accelerated Approval: ......................................................................... 68 6.1.1.4 Priority Review: ................................................................................... 68 6.1.1.5 Regenerative Medicine Advanced Therapy Designation: .................... 68 6.1.2 Expedited Designation Vs. Traditional Approval Timelines: ......... 69 6.1.3 Regulatory Challenges ...................................................................... 69 6.1.4 Successful Regulatory Strategies .................................................... 70 7. Patent Landscape ............................................................................................... 71 8. Cell and Gene Therapy Manufacturing ............................................................. 73 8.1 Viral Vector Manufacturing .......................................................................... 73 All rights reserved at BIS Research 4

  5. Global Cell and Gene Therapy Market Retrovirus .......................................................................................... 73 Lentivirus ........................................................................................... 73 AAV ..................................................................................................... 74 Adenovirus ......................................................................................... 74 Upstream Manufacturing ............................................................................. 77 8.2.1 Cost Consideration and Timelines ................................................... 77 8.2.2 Process Design and Regulatory Burdens ....................................... 78 8.2.3 Other Considerations ........................................................................ 78 8.3 Downstream Manufacturing ........................................................................ 79 8.3.1 Cost Considerations and Timelines ................................................. 79 8.3.2 Challenges in Downstream ............................................................... 80 8.3.3 Scale-Up of Downstream from Research to Clinical Manufacturing .................................................................................... 81 8.4 Non-Viral Vector Manufacturing ................................................................. 82 8.4.1 Non-Viral, Plasmid-Free Manufacturing .......................................... 82 8.4.2 Plasmid ............................................................................................... 82 8.4.3 Naked DNA ......................................................................................... 84 8.4.4 Physical-Mediated Methods ............................................................. 84 8.5 Cell and Gene Therapy Manufacturing Capacity, by Company ............... 85 8.1.1 8.1.2 8.1.3 8.1.4 8.2 9. Global Cell and Gene Therapy Market: Market Dynamics............................... 88 9.1 9.2 Overview ....................................................................................................... 88 Market Drivers .............................................................................................. 89 9.2.1 Increasing Incidences of Cancer and Other Chronic Diseases ............................................................................................. 89 9.2.2 High Number of Rare Diseases Across Globe ................................ 90 9.2.3 Rising Number of Clinical Trials ...................................................... 91 9.2.4 Increasing Funding and Investments in Cell and Gene Therapy Market .................................................................................. 92 9.2.5 Favorable Regulatory Environment for Cell and Gene Therapy Products .............................................................................. 92 9.3 Market Restrains .......................................................................................... 93 9.3.1 Lack of Reliable Vector Production for Cell and Gene Therapy .............................................................................................. 93 All rights reserved at BIS Research 5

  6. Global Cell and Gene Therapy Market 9.3.2 9.3.3 Complex Manufacturing and Distribution Setup ............................ 94 Tedious Process of Therapeutic Commercialization ..................... 95 Market Opportunities ................................................................................... 95 9.4.1 Drug Approvals and Strong Pipeline of Cell and Gene Therapies ........................................................................................... 95 9.4.2 Increasing Number of Mergers and Acquisitions within the Cell and Gene Industry ..................................................................... 96 9.4 10. Global Cell and Gene Therapy Market: Competitive Landscape .................... 98 10.1Key Strategies and Development ............................................................... 99 10.1.1 Product Offerings and Approvals .................................................... 99 10.2Synergistic Activities ................................................................................. 100 10.3Funding and Business Expansions .......................................................... 101 10.4Mergers and Acquisitions ......................................................................... 102 10.5Market Share Analysis ............................................................................... 103 10.6Growth-Share Analysis (by Company), 2020 ........................................... 104 11. Global Cell and Gene Therapy Market (by Product) ...................................... 107 11.1Therapeutic Market .................................................................................... 107 11.1.1 Yescarta ........................................................................................... 108 11.1.2 Provenge .......................................................................................... 109 11.1.3 Luxturna ........................................................................................... 111 11.1.4 Kymriah ............................................................................................ 112 11.1.5 Imlygic .............................................................................................. 113 11.1.6 Gintuit ............................................................................................... 115 11.1.7 MACI ................................................................................................. 115 11.1.8 Gendicine ......................................................................................... 116 11.1.9 Oncorine ........................................................................................... 118 11.1.10 Neovasculgen .................................................................................. 119 11.1.11 Strimvelis ......................................................................................... 120 11.1.12 Invossa ............................................................................................. 121 11.1.13 Zolgensma ....................................................................................... 123 11.1.14 Tecartus ........................................................................................... 124 All rights reserved at BIS Research 6

  7. Global Cell and Gene Therapy Market 11.1.15 11.1.16 11.1.17 11.2Pipeline Analysis ........................................................................................ 129 11.2.1 Phase 1 ............................................................................................. 130 11.2.2 Phase 2 ............................................................................................. 131 11.2.3 Phase 3 ............................................................................................. 132 11.2.3.1SPK-8011 .......................................................................................... 134 11.2.3.2OTL-103 ............................................................................................ 134 11.2.3.3OTL-200 ............................................................................................ 135 11.2.3.4OTL-101 ............................................................................................ 136 11.2.3.5VM202 ............................................................................................... 137 11.2.3.6GS010 ............................................................................................... 138 11.2.3.7bb2121 .............................................................................................. 138 11.2.3.8PTC-AADC ........................................................................................ 139 11.2.4 Pipeline Analysis – CAR-T Focused .............................................. 140 11.2.5 Pipeline Analysis – CAR-NK Focused ........................................... 141 Liso-Cel ............................................................................................ 125 Zynteglo ........................................................................................... 126 Others ............................................................................................... 127 12. Global Cell and Gene Therapy Market (by Therapeutic Class) ..................... 145 12.1Overview ..................................................................................................... 145 12.2Rare Diseases ............................................................................................. 145 12.3Oncology ..................................................................................................... 146 12.4Hematology ................................................................................................. 147 12.5Cardiovascular ........................................................................................... 148 12.6Ophthalmology ........................................................................................... 150 12.7Neurology ................................................................................................... 151 12.8Other Therapeutic Classes ........................................................................ 152 13. Global Cell and Gene Therapy Market (by Region) ....................................... 154 13.1Overview ..................................................................................................... 154 13.2North America ............................................................................................ 155 13.2.1 U.S. ................................................................................................... 157 13.2.1.1Approved Products ............................................................................ 157 All rights reserved at BIS Research 7

  8. Global Cell and Gene Therapy Market 13.2.1.2Competitive Landscape ..................................................................... 158 13.2.1.3Market Size and Forecast .................................................................. 159 13.2.1.4Key Developments ............................................................................ 160 13.2.2 Canada ............................................................................................. 161 13.2.2.1Approved Products ............................................................................ 161 13.2.2.2Market Size and Forecast .................................................................. 162 13.2.2.3Key Developments ............................................................................ 163 13.3Europe ......................................................................................................... 163 13.3.1 Europe Cell and Gene Therapy Market Dynamics ........................ 166 13.3.2 Germany ........................................................................................... 167 13.3.2.1Approved Products ............................................................................ 167 13.3.2.2Market Size and Forecast .................................................................. 168 13.3.2.3Key Developments ............................................................................ 169 13.3.3 France ............................................................................................... 169 13.3.3.1Approved Products ............................................................................ 170 13.3.3.2Market Size and Forecast .................................................................. 170 13.3.3.3Key Developments ............................................................................ 171 13.3.3.4Competitive Landscape ..................................................................... 172 13.3.4 U.K. ................................................................................................... 172 13.3.4.1Approved Products ............................................................................ 173 13.3.4.2Market Size and Forecast .................................................................. 174 13.3.4.3Competitive Landscape ..................................................................... 175 13.3.5 Italy ................................................................................................... 176 13.3.5.1Approved Products ............................................................................ 176 13.3.5.2Market Size and Forecast .................................................................. 177 13.3.5.3Key Developments ............................................................................ 178 13.3.6 Spain ................................................................................................. 178 13.3.6.1Approved Products ............................................................................ 179 13.3.6.2Market Size and Forecast .................................................................. 179 13.3.6.3Key Developments ............................................................................ 180 13.3.6.4Competitive Landscape ..................................................................... 181 13.3.7 The Netherlands .............................................................................. 181 All rights reserved at BIS Research 8

  9. Global Cell and Gene Therapy Market 13.3.7.1Approved Products ............................................................................ 182 13.3.7.2Market Size and Forecast .................................................................. 182 13.3.7.3Key Developments ............................................................................ 184 13.3.7.4Competitive Landscape ..................................................................... 184 13.3.8 Russia ............................................................................................... 184 13.3.8.1Approved Products ............................................................................ 185 13.3.8.2Market Size and Forecast .................................................................. 185 13.3.8.3Competitive Landscape ..................................................................... 186 13.3.9 Rest-of-Europe................................................................................. 186 13.3.9.1Market Size and Forecast .................................................................. 187 13.3.9.2Key Developments ............................................................................ 187 13.4Asia-Pacific (APAC) ................................................................................... 188 13.4.1 Japan ................................................................................................ 189 13.4.1.1Approved Products ............................................................................ 190 13.4.1.2Market Size and Forecast .................................................................. 191 13.4.1.3Key Developments ............................................................................ 192 13.4.1.4Competitive Landscape ..................................................................... 192 13.4.2 China ................................................................................................ 193 13.4.2.1Approved Products ............................................................................ 194 13.4.2.2Market Size and Forecast .................................................................. 194 13.4.2.3Key Developments ............................................................................ 195 13.4.2.4Competitive Landscape ..................................................................... 195 13.4.3 Australia ........................................................................................... 196 13.4.3.1Approved Products ............................................................................ 196 13.4.3.2Market Size and Forecast .................................................................. 197 13.4.3.3Key Developments ............................................................................ 197 13.4.4 South Korea ..................................................................................... 198 13.4.4.1Approved Products ............................................................................ 198 13.4.4.2Market Size and Forecast .................................................................. 200 13.4.4.3Key Developments ............................................................................ 201 13.4.4.4Competitive Landscape ..................................................................... 201 13.4.5 India .................................................................................................. 203 All rights reserved at BIS Research 9

  10. Global Cell and Gene Therapy Market 13.4.5.1Approved Products ............................................................................ 203 13.4.5.2Market Size and Forecast .................................................................. 204 13.4.5.3Competitive Landscape ..................................................................... 205 13.4.6 Singapore ......................................................................................... 206 13.4.6.1Approved Products ............................................................................ 206 13.4.6.2Market Size and Forecast .................................................................. 206 13.4.6.3Key Developments ............................................................................ 207 13.4.7 Rest-of-Asia-Pacific ......................................................................... 207 13.4.7.1Market Size and Forecast .................................................................. 207 13.4.7.2Key Developments ............................................................................ 208 13.5Latin America ............................................................................................. 208 13.5.1 Brazil ................................................................................................. 210 13.5.1.1Market Size and Forecast .................................................................. 210 13.5.2 Mexico .............................................................................................. 211 13.5.2.1Market Size and Forecast .................................................................. 212 13.5.3 Rest-of-Latin America (RoLA) ........................................................ 213 13.5.3.1Market Size and Forecast .................................................................. 213 13.6Rest-of-World ............................................................................................. 214 13.6.1 Market Size and Forecast ............................................................... 214 14. Company Profile ............................................................................................... 216 14.1Amgen Inc. .................................................................................................. 216 14.1.1 Company Overview ......................................................................... 216 14.1.2 Role of Amgen Inc. in the Global Cell and Gene Therapy Market ............................................................................................... 216 14.1.3 Financials ......................................................................................... 218 14.1.4 Key Insights About Financial Health of the Company ................. 220 14.1.5 SWOT Analysis ................................................................................ 221 14.2bluebird bio, Inc. ........................................................................................ 222 14.2.1 Company Overview ......................................................................... 222 14.2.2 Role of bluebird bio, Inc. in the Global Cell and Gene Therapy Market ................................................................................ 222 14.2.3 Financials ......................................................................................... 224 All rights reserved at BIS Research 10

  11. Global Cell and Gene Therapy Market Key Insights About Financial Health of the Company ................. 225 SWOT Analysis ................................................................................ 226 14.3Dendreon Pharmaceuticals LLC. .............................................................. 227 14.3.1 Company Overview ......................................................................... 227 14.3.2 Role of Dendreon Pharmaceuticals LLC. in the Global Cell and Gene Therapy Market ............................................................... 227 14.3.3 SWOT Analysis ................................................................................ 229 14.4Castle Creek Pharmaceutical Holdings .................................................... 230 14.4.1 Company Overview ......................................................................... 230 14.4.2 Role of Castle Creek Pharmaceutical Holdings in the Global Cell and Gene Therapy Market ....................................................... 230 14.4.3 SWOT Analysis ................................................................................ 232 14.5Human Stem Cells Institute ....................................................................... 233 14.5.1 Company Overview ......................................................................... 233 14.5.2 Role of Human Stem Global Cell and Gene Therapy Cell Market ............................................................................................... 233 14.5.3 SWOT Analysis ................................................................................ 235 14.6Kite Pharma, Inc. ........................................................................................ 236 14.6.1 Company Overview ......................................................................... 236 14.6.2 Role of Kite Pharma, Inc. in the Global Cell and Gene Therapy Market ................................................................................ 236 14.6.3 Financials ......................................................................................... 239 14.6.4 Key Insights About Financial Health of the Company ................. 240 14.6.5 SWOT Analysis ................................................................................ 241 14.7Kolon TissueGene, Inc. .............................................................................. 242 14.7.1 Company Overview ......................................................................... 242 14.7.2 Role of Kolon TissueGene, Inc. in the Global Cell and Gene Therapy Market ................................................................................ 242 14.7.3 SWOT Analysis ................................................................................ 244 14.8Novartis AG ................................................................................................ 245 14.8.1 Company Overview ......................................................................... 245 14.8.2 Role of Novartis AG in the Global Cell and Gene Therapy Market ............................................................................................... 245 14.2.4 14.2.5 All rights reserved at BIS Research 11

  12. Global Cell and Gene Therapy Market Financials ......................................................................................... 247 Key Insights About Financial Health of the Company ................. 250 SWOT Analysis ................................................................................ 251 14.9Orchard Therapeutics plc. ......................................................................... 252 14.9.1 Company Overview ......................................................................... 252 14.9.2 Role of Orchard Therapeutics plc. in the Global Cell and Gene Therapy Market ...................................................................... 252 14.9.3 Financials ......................................................................................... 254 14.9.4 SWOT Analysis ................................................................................ 255 14.10Organogenesis Holdings Inc. .................................................................... 256 14.10.1 Company Overview ......................................................................... 256 14.10.2 Role of Organogenesis Holdings Inc. in the Global Cell and Gene Therapy Market ...................................................................... 256 14.10.3 Financials ......................................................................................... 257 14.10.4 Key Insights About Financial Health of the Company ................. 258 14.10.5 SWOT Analysis ................................................................................ 259 14.11Pfizer, Inc. ................................................................................................... 260 14.11.1 Company Overview ......................................................................... 260 14.11.2 Role of Pfizer, Inc. in the Global Cell and Gene Therapy Market ............................................................................................... 260 14.11.3 Financials ......................................................................................... 262 14.11.4 Key Insights About Financial Health of the Company ................. 264 14.11.5 SWOT Analysis ................................................................................ 265 14.12RENOVA THERAPEUTICS ......................................................................... 266 14.12.1 Company Overview ......................................................................... 266 14.12.2 Role of RENOVA THERAPEUTICS in the Global Cell and Gene Therapy Market ...................................................................... 266 14.12.3 SWOT Analysis ................................................................................ 268 14.13Shanghai Sunway Biotech Co., Ltd., ........................................................ 269 14.13.1 Company Overview ......................................................................... 269 14.13.2 Role of Shanghai Sunway Biotech Co., Ltd., in the Global Cell and Gene Therapy Market ....................................................... 269 14.13.3 SWOT Analysis ................................................................................ 270 14.8.3 14.8.4 14.8.5 All rights reserved at BIS Research 12

  13. Global Cell and Gene Therapy Market 14.14Sibiono GeneTech Co. Ltd., ...................................................................... 271 14.14.1 Company Overview ......................................................................... 271 14.14.2 Role of Sibiono GeneTech Co. Ltd., in the Global Cell and Gene Therapy .................................................................................. 271 14.14.3 SWOT Analysis ................................................................................ 272 14.15Spark Therapeutics, Inc. ............................................................................ 273 14.15.1 Company Overview ......................................................................... 273 14.15.2 Role of Spark Therapeutics, Inc. in the Global Cell and Gene Test Market ...................................................................................... 273 14.15.3 Financials ......................................................................................... 275 14.15.4 Key Insights About Financial Health of the Company ................. 276 14.15.5 SWOT Analysis ................................................................................ 277 14.16Vericel Corporation .................................................................................... 278 14.16.1 Company Overview ......................................................................... 278 14.16.2 Role of Vericel Corporation in the Global Cell and Gene Therapy Market ................................................................................ 278 14.16.3 Financials ......................................................................................... 279 14.16.4 Key Insights About Financial Health of the Company ................. 281 14.16.5 SWOT Analysis ................................................................................ 282 All rights reserved at BIS Research 13

  14. Global Cell and Gene Therapy Market List of Tables List of Tables Table 3.1: Approved Gene Therapies Worldwide ............................................................................... 43 Table 3.2: Key Companies in Cell and Gene Therapy Market, 2020 ................................................. 50 Table 4.1: Key Products of Cell and Gene Therapy Market ............................................................... 52 Table 8.1: Key Viral Vectors ................................................................................................................. 75 Table 8.2: Cell and Gene Therapy Manufacturing Capacity (by Company) ...................................... 85 Table 9.1: Number of Clinical Trials for Cell and Gene Therapy, 2020 .............................................. 91 Table 11.1: List of key Cell/Gene Therapy Products with Marketing Authorization (MA) ................ 128 Table 11.2: Key Cell and Gene Therapy Drugs in Phase 3, 2020 ................................................... 133 Table 11.3: Pipeline for NK-Focused Therapies ............................................................................... 142 Table 12.1: List of Cell and Gene Therapy Products with Marketing Authorization in the European Union by EMA ....................................................................................................... 164 All rights reserved at BIS Research 14

  15. Global Cell and Gene Therapy Market List of List of Figures Figures Figure 1: Cell and Gene Therapy Funding (2019 and 2020-H1) ........................................................ 24 Figure 2: Global Cell and Gene Therapy Market, 2020-2027 ............................................................. 25 Figure 3: Market Drivers, Opportunities, and Restraints ..................................................................... 26 Figure 4: Share of Key Developments and Strategies, January 2016-January 2021 ....................... 27 Figure 5: Global Cell and Gene Therapy Market Share (Product Type), 2020-2027 ........................ 28 Figure 6: Global Cell and Gene Therapy Market Share (by Therapeutic Class), 2020-2027 ........... 29 Figure 7: Global Cell and Gene Therapy Market (by Region) ............................................................ 30 Figure 1.1: Definitions of Cell and Gene Therapies ............................................................................ 31 Figure 2.1: Global Cell and Gene Therapy Market Research Methodology ...................................... 33 Figure 2.2: Primary Research Methodology ........................................................................................ 34 Figure 2.3: Global Cell and Gene Therapy Market Research Methodology Approach ..................... 36 Figure 2.4: Total Number of Companies Profiled ................................................................................ 39 Figure 3.1: Clinical Trials by Therapeutic Category, Regenerative Medicines and Advanced Therapies, 2020 ....................................................................................................................... 42 Figure 3.2: Global Cell and Gene Therapy Market Size, 2020-2027 ................................................. 44 Figure 3.3: Factors Involved in Payer Decision Flow, Process Considerations and Stakeholder Drivers in Reimbursement in U.S. ...................................................................... 46 Figure 3.4: Emerging Payment Models for Cell and Gene Therapies in Europe ............................... 47 Figure 4.1: Addressable Market Size of Commercialized Products, 2020 ......................................... 53 Figure 4.2: Global Cell and Gene Therapy Market, 2020-2027.......................................................... 54 Figure 4.3: North America Cell and Gene Therapy Addressable Market, 2020 Vs 2027 .................. 55 Figure 4.4: Europe Cell and Gene Therapy Addressable Market, 2020 Vs 2027 ............................. 56 Figure 4.5: Asia-Pacific Cell and Gene Therapy Addressable Market, 2020 Vs 2027 ...................... 57 Figure 4.6: Latin America Cell and Gene Therapy Addressable Market 2020 Vs 2027 .................... 58 Figure 5.1: Number of Cancer Cases Diagnosed in the Netherlands (January 3, 2020, to April 12, 2020) .......................................................................................................................... 60 Figure 5.2: Pre-COVID-19 and Post-COVID-19 Scenario of Global Cell and Gene Therapy Market, 2020-2025 ................................................................................................................... 61 Figure 5.3: Areas of Disruption in Clinical Development ..................................................................... 63 Figure 5.4: Measure to Navigate Crisis Recovery ............................................................................... 65 All rights reserved at BIS Research 15

  16. Global Cell and Gene Therapy Market Figure 6.1: Expedited Approval Designations for Cell and Gene Therapies ...................................... 67 Figure 7.1: Number of Patents (by Year), 2016-2020 ......................................................................... 71 Figure 7.2: Share of Patents (by Country), 2016-2021 ....................................................................... 72 Figure 8.1: Steps Involved in Bioprocessing ....................................................................................... 76 Figure 8.2: Typical Production Methods of Viral Vectors .................................................................... 76 Figure 8.3: Typical Production Method of Plasmid Vectors ................................................................ 83 Figure 9.1: Impact Analysis of Market Dynamics ................................................................................ 88 Figure 9.2: Rising Incidences of Cancer (2015 and 2018) ................................................................. 89 Figure 9.3: Prevalence of Rare Diseases ............................................................................................ 90 Figure 9.4: Deal Value of Mergers and Acquisitions (2016-2019) ...................................................... 97 Figure 10.1: Share of Key Developments and Strategies, January 2016- January 2021 ................. 99 Figure 10.2: Share of Product Offerings and Approvals, January 2016-January 2021 ................... 100 Figure 10.3: Share of Synergistic Activities, January 2016-January 2021 ....................................... 101 Figure 10.4: Share of Funding and Expansions, January 2016-January 2021 ................................ 102 Figure 10.5: Share of Mergers and Acquisitions, January 2016-January 2021 ............................... 103 Figure 10.6: Market Share Analysis: Global Cell and Gene Therapy Market, 2020 ........................ 104 Figure 10.7: Growth-Share Matrix for Global Cell and Gene Therapy Market (by Company), 2020 .............................................................................................................. 105 Figure 11.1: Global Cell and Gene Therapy Market (by Therapeutic Drugs), 2020-2027............... 107 Figure 11.2: Global Revenue for Yescarta, 2020-2027 .................................................................... 108 Figure 11.3: Global Revenue for Provenge, 2020-2027 ................................................................... 110 Figure 11.4: Global Revenue for Luxturna, 2020-2027..................................................................... 111 Figure 11.5: Global Revenue for Kymriah, 2020-2027 ..................................................................... 112 Figure 11.6: Global Revenue for Imlygic, 2020-2027 ....................................................................... 114 Figure 11.7: Global Revenue for MACI, 2020-2027 .......................................................................... 115 Figure 11.8: Global Revenue for Gendicine, 2020-2027 .................................................................. 117 Figure 11.9: Global Revenue for Oncorine, 2020-2027 .................................................................... 118 Figure 11.10: Global Revenue for Neovasculogen, 2020-2027 ....................................................... 119 Figure 11.11: Global Revenue for Strimvelis, 2020-2027 ................................................................. 120 Figure 11.12: Global Revenue for Invossa, 2020-2027 .................................................................... 122 Figure 11.13: Global Revenue for Zolgensma, 2020-2027 .............................................................. 123 Figure 11.14: Global Revenue for Tecartus, 2020-2027 .................................................................. 124 All rights reserved at BIS Research 16

  17. Global Cell and Gene Therapy Market Figure 11.15: Global Revenue for Other Drugs, 2020-2027 ............................................................. 126 Figure 11.16: Global Revenue for Zynteglo, 2020-2027 ................................................................... 127 Figure 11.17: Global Revenue for Other Drugs, 2020-2027 ............................................................. 127 Figure 11.18: Cell and Gene Therapy Medicines in Development by Disease, 2018 ..................... 129 Figure 11.19: Number of Phase 1 Clinical Trials for Cell and Gene Therapy, 2018-2020 .............. 131 Figure 11.20: Number of Phase 2 Clinical Trials for Cell and Gene Therapy, 2018-2020 .............. 132 Figure 11.21: Global Cell and Gene Therapy Market, by Late Phase, 2021-2027 .......................... 132 Figure 11.22: Global Revenue for SPK-8011, 2021-2027 ................................................................ 134 Figure 11.23: Global Revenue for OTL-103, 2021-2027 .................................................................. 135 Figure 11.24: Global Revenue for OTL-200, 2021-2027 .................................................................. 136 Figure 11.25: Global Revenue for OTL-101, 2021-2027 .................................................................. 137 Figure 11.26: Global Revenue for VM 202, 2021-2027 .................................................................... 137 Figure 11.27: Global Revenue for GS010, 2021-2027 ..................................................................... 138 Figure 11.28: Global Revenue for bb2121, 2021-2027 .................................................................... 139 Figure 11.29: Global Revenue for PTC-AADC, 2021-2027 .............................................................. 140 Figure 11.30: Pipeline For CAR-T Therapies (2020) ........................................................................ 141 Figure 12.1: Global Cell and Gene Therapy Market (Rare Diseases), 2020-2027 .......................... 145 Figure 12.2: Global Cell and Gene Therapy Market (Oncology), 2020-2027 .................................. 146 Figure 12.3: Global Cell and Gene Therapy Market (Hematology), 2020-2027 .............................. 147 Figure 12.4: Global Cell and Gene Therapy Market (Cardiovascular Disease), 2020-2027 ........... 149 Figure 12.5: Global Cell and Gene Therapy Market (Ophthalmology), 2020-2027 ......................... 150 Figure 12.6: Global Cell and Gene Therapy Market (Neurology), 2020-2027 ................................. 151 Figure 12.7: Global Cell and Gene Therapy Market (Other Therapeutic Class), 2020-2027 .......... 153 Figure 12.8: Global Cell and Gene Therapy Market (by Region) ..................................................... 154 Figure 12.9: North America Global Cell and Gene Therapy Market, 2020-2027 ............................. 156 Figure 12.10: North America: Market Dynamics ............................................................................... 156 Figure 12.11: U.S. Cell and Gene Therapy Market, 2020-2027 ....................................................... 160 Figure 12.12: Canada Cell and Gene Therapy Market, 2020-2027 ................................................. 162 Figure 12.13: Europe Cell and Gene Therapy Market, 2020-2027 .................................................. 163 Figure 12.14: Europe: Market Dynamics ........................................................................................... 166 Figure 12.15: Germany Cell and Gene Therapy Market, 2020-2027 ............................................... 168 Figure 12.16: France Cell and Gene Therapy Market, 2020-2027................................................... 171 All rights reserved at BIS Research 17

  18. Global Cell and Gene Therapy Market Figure 12.17: U.K. Cell and Gene Therapy Market, 2020-2027 ....................................................... 174 Figure 12.18: Italy Cell and Gene Therapy Market, 2020-2027 ....................................................... 177 Figure 12.19: Spain Cell and Gene Therapy Market, 2020-2027 ..................................................... 180 Figure 12.20 Netherlands Cell and Gene Therapy Market, 2020-2027 ........................................... 183 Figure 12.21: Russia Cell and Gene Therapy Market, 2020-2027 ................................................... 185 Figure 12.22: Rest-of-Europe Cell and Gene Therapy Market, 2020-2027 ..................................... 187 Figure 12.23: Asia-Pacific Cell and Gene Therapy Market, 2020-2027 ........................................... 188 Figure 12.24: Asia-Pacific Market Dynamics ..................................................................................... 189 Figure 12.25: Japan Cell and Gene Therapy Market, 2020-2027 .................................................... 191 Figure 12.26: China Cell and Gene Therapy Market, 2020-2027 .................................................... 194 Figure 12.27: Australia Cell and Gene Therapy Market, 2020-2027 ................................................ 197 Figure 12.28: South Korea Cell and Gene Therapy Market, 2020-2027 ......................................... 200 Figure 12.29: India Cell and Gene Therapy Market, 2020-2027 ...................................................... 204 Figure 12.30: Singapore Cell and Gene Therapy Market, 2020-2027 ............................................. 206 Figure 12.31: Rest-of-Asia-Pacific Cell and Gene Therapy Market, 2020-2027 .............................. 208 Figure 12.32: Latin America Cell and Gene Therapy Market, 2020-2027 ....................................... 209 Figure 12.33: Latin America: Market Dynamics ................................................................................ 210 Figure 12.34: Brazil Cell and Gene Therapy Market, 2020-2027 ..................................................... 211 Figure 12.35: Mexico Cell and Gene Therapy Market, 2020-2027 .................................................. 212 Figure 12.36: Rest-of-Latin America Cell and Gene Therapy Market, 2020-2027 .......................... 213 Figure 12.37: Rest-of-World Cell and Gene Therapy Market, 2020-2027 ....................................... 215 Figure 13.1: Amgen Inc.: Overall Product Portfolio ........................................................................... 217 Figure 13.2: Amgen Inc.: Pipeline Product Portfolio ......................................................................... 217 Figure 13.3: Amgen Inc.: Overall Financials, 2017-2019 .................................................................. 218 Figure 13.4: Amgen Inc.: Revenue (by Region), 2017-2019 ............................................................ 219 Figure 13.5: Amgen Inc.: R&D Expenditure, 2017-2019 .................................................................. 220 Figure 13.6: Amgen Inc.: SWOT Analysis ......................................................................................... 221 Figure 13.7: Pipeline Product Portfolio: bluebird bio, Inc. ................................................................. 223 Figure 13.8: bluebird bio, Inc.: Overall Financials, 2017-2019 ......................................................... 224 Figure 13.9: bluebird bio, Inc.: R&D Expenditure, 2017-2019 .......................................................... 225 Figure 13.10: bluebird bio, Inc.: SWOT Analysis............................................................................... 226 Figure 13.11: Dendreon Pharmaceuticals LLC: Product Portfolio .................................................... 228 All rights reserved at BIS Research 18

  19. Global Cell and Gene Therapy Market Figure 13.12: Dendreon Pharmaceuticals LLC.: SWOT Analysis .................................................... 229 Figure 13.13: Castle Creek Pharmaceutical Holdings: Overall Product Portfolio ............................ 231 Figure 13.14: Castle Creek Pharmaceutical Holdings : Pipeline Product Portfolio .......................... 231 Figure 13.15: Castle Creek Pharmaceutical: SWOT Analysis .......................................................... 232 Figure 13.16: Human Stem Cell Institute: Overall Product Portfolio................................................. 234 Figure 13.17: Human Stem Cell Institute: SWOT Analysis ............................................................... 235 Figure 13.18: Kite Pharma, Inc.: Overall Product Portfolio ............................................................... 237 Figure 13.19: Kite Pharma, Inc.: Pipeline Product Portfolio .............................................................. 238 Figure 13.20: Kite Pharma, Inc.: Overall Financials, 2016-2018 ...................................................... 239 Figure 13.21: Kite Pharma, Inc.: R&D Expenditure, 2016-2018 ....................................................... 240 Figure 13.22: Kite Pharma, Inc.: SWOT Analysis ............................................................................. 241 Figure 13.23: Kolon TissueGene, Inc.: Pipeline Product Portfolio .................................................... 243 Figure 13.24: Kolon TissueGene, Inc.: SWOT Analysis ................................................................... 244 Figure 13.25: Novartis AG: Overall Product Portfolio ........................................................................ 246 Figure 13.26: Novartis AG: Pipeline Product Portfolio ...................................................................... 246 Figure 13.27: Novartis AG: Overall Financials, 2017-2019 .............................................................. 247 Figure 13.28: Novartis AG: Revenue (by Business Segment), 2017-2019...................................... 248 Figure 13.29: Novartis AG: Net Revenue (by Region), 2017-2019 .................................................. 249 Figure 13.30: Novartis AG: R& D Expense, 2017-2019 ................................................................... 250 Figure 13.31: Novartis AG: SWOT Analysis ...................................................................................... 251 Figure 13.32: Orchard Therapeutics plc.: Pipeline Product Portfolio ............................................... 253 Figure 13.33: Orchard Therapeutics plc.: Overall Financials, 2017-2019 ........................................ 254 Figure 13.34: Orchard Therapeutics plc: SWOT Analysis ................................................................ 255 Figure 13.35: Organogenesis Holdings Inc.: Overall Product Portfolio ............................................ 257 Figure 13.36: Organogenesis Holdings Inc.: Overall Financials, 2017-2019 ................................... 257 Figure 13.37: Organogenesis Holdings Inc.: R&D Expenditure, 2017-2019 ................................... 258 Figure 13.38: Organogenesis Holdings Inc.: SWOT Analysis .......................................................... 259 Figure 13.39: Pfizer, Inc.: Overall Product Portfolio .......................................................................... 261 Figure 13.40: Pfizer, Inc.: Pipeline Product Portfolio ......................................................................... 261 Figure 13.41: Pfizer, Inc.: Overall Financials, 2017-2019 ................................................................. 262 Figure 13.42: Pfizer, Inc.: Revenue (by Region), 2017-2019 ........................................................... 263 Figure 13.43: Pfizer, Inc.: R&D Expenditure, 2017-2019 .................................................................. 264 All rights reserved at BIS Research 19

  20. Global Cell and Gene Therapy Market Figure 13.44: Pfizer, Inc.: SWOT Analysis ........................................................................................ 265 Figure 13.45: RENOVA THERAPEUTICS: Pipeline Product Portfolio ............................................ 267 Figure 13.46: RENOVA THERAPEUTICS: SWOT Analysis ............................................................ 268 Figure 13.47: Product Portfolio: Shanghai Sunway Biotech Co., Ltd., ............................................. 270 Figure 13.48: Shanghai Sunway Biotech Co., Ltd.: SWOT Analysis ............................................... 270 Figure 13.49: Sibiono GeneTech Co. Ltd.: Overall Product Portfolio ............................................... 272 Figure 13.50: Sibiono GeneTech Co. Ltd.: SWOT Analysis ............................................................. 272 Figure 13.51: Spark Therapeutics, Inc.: Overall Product Portfolio ................................................... 274 Figure 13.52: Spark Therapeutics, Inc.: Pipeline Product Portfolio .................................................. 274 Figure 13.53: Spark Therapeutics, Inc.: Overall Financials, 2017-2019 .......................................... 275 Figure 13.54: Spark Therapeutics, Inc.: R&D Expenditure, 2017-2019 ........................................... 276 Figure 13.55: Spark Therapeutics, Inc.: SWOT Analysis ................................................................. 277 Figure 13.56: Vericel Corporation: Overall Product Portfolio ............................................................ 279 Figure 13.57: Vericel Corporation: Overall Financials, 2017-2019 ................................................... 279 Figure 13.58: Vericel Corporation: Revenue (by Product), 2017-2019 ............................................ 280 Figure 13.59: Vericel Corporation: R&D Expenditure (2017-2019) .................................................. 281 Figure 13.60: Vericel Corporation: SWOT Analysis .......................................................................... 282 All rights reserved at BIS Research 20

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