Regenerative Medicine Market : Current Analysis and Forecast (2020-2026): Emphasis on Product Type (Cell Therapy, Gene Therapy, Tissue Engineering, Small Molecule and Biologics), Material Type (Synthetic Materials, Biologically Derived Materials, Genetically Engineered Materials, Other (Pharmaceuticals)), Application (Cardiovascular, Oncology, Dermatology, Musculoskeletal, Wound Healing, Ophthalmology, Neurology, Others) and Region/Country
- UNI4065912
- 345 Pages
- March 2020
- Pharmaceuticals
“Cell therapy regenerative medicine dominated the market, with a 60% share in 2019”
Based on product type, the global regenerative medicine market is bifurcated into Cell therapy, gene therapy, tissue engineering and small molecule and biologics. The market of the Cell therapy segment was expected to grow tremendously and is projected to dominate the market in 2026 due to the technological advancements coupled with increasing utilization of cell therapy as a treatment to several conditions. Tissue Engineering segment is expected to generate revenue of US$ 52.2 billion by 2026. However, the Gene Therapy segment is expected to witness the highest CAGR growth of 33.9% during the forecast period 2020-2026.
“Biologically Derived Materials dominated the material type segment, generating revenue of US$ 16.59 billion in 2019”
Based on material type the global Regenerative Medicine market is segmented into synthetic materials, biologically derived materials, genetically engineered materials and others (pharmaceuticals). The Biologically Derived Materials occupied the largest share and is expected to maintain its dominance throughout the forecast period 2020-2026 owing to the increased usage and advancements in biologically derived materials. Synthetic Materials segment is expected to generate revenue of US$ 57.51 billion by 2026. Genetically Engineered Materials segment is expected to witness the highest CAGR growth of 33.9% during the forecast period.
“In 2019, Regenerative medicine was majorly used for the treatment of Oncology disorder”
Cardiovascular, Oncology, Dermatology, Musculoskeletal, Immunology and Inflammation, Ophthalmology, Neurology, Others are the major application of Regenerative medicine. The application of regenerative medicine for the treatment of Oncology disorder generated revenue of US$ 15.50 billion in 2019. However, the application of regenerative medicine for the treatment of Neurology disorder is expected to witness the highest CAGR growth of 33.0% during the forecast period. Musculoskeletal segment is expected to generate revenue of US$ 12.50 billion by 2026.
“North America dominates the global Regenerative Medicine market”
For better understanding of the overall adoption rate of regenerative medicine in major markets, detailed country-level analysis has been conducted for major regions/countries including North America (US, Canada, Rest of North America), Europe (UK, Germany, France, Spain, Italy, Rest of Europe), Asia-Pacific (China, India, Japan, Australia and South Korea, Rest of Asia-Pacific), and the Rest of the World (Brazil, South Africa and others). Based on the estimation, North America dominated the global Regenerative Medicine Market, generating revenue of US$ 12.10 billion in 2019. The increasing demand for regenerative medicine in the treatment of chronic diseases, cancer, and enhancement in nanotechnologies would drive the market for regenerative medicine in the North American region.
Competitive Landscape-Top Market Players
Some of the major players profiled in the study includes Athersys, Inc., Corline Biomedical AB, Mesoblast, Nuvasive, Inc., Cook Biotech, Integra LifeSciences Corporation, Organogenesis, Osiris Therapeutics, Inc., Stryker Corporation, U.S. Stem Cell, Inc., Spark Therapeutics, Pfizer, REGENXBIO, Abbott Laboratories, Roche, Sarepta Therapeutics, Gilead Sciences. Several M&A’s along with partnerships have been undertaken by these players to facilitate costumers with hi-tech and innovative products.
Reasons to buy:
• Current and future market size from 2019 to 2026 in terms of value (US$)
• Combined analysis of deep dive secondary research and input from primary research through Key Opinion Leaders of the industry
• Country-level details of the overall adoption of the regenerative medicine market
• A quick review of overall industry performance at a glance
• In-depth analysis of key industry players
• A detailed analysis of regulatory framework, drivers, restraints, key trends and opportunities prevailing in the industry
• Examination of industry attractiveness with the help of Porter’s Five Forces analysis and start-ups
• The study comprehensively covers the market across different segments and sub-segments of the technology
• Region/country Covered: North America (US, Canada, Rest of North America), Europe (UK, Germany, France, Spain, Italy, Rest of Europe), Asia-Pacific (China, India, Japan, Australia and South Korea, Rest of Asia-Pacific), and the Rest of the World (Brazil, South Africa and others)
Customization Options:
UMI understands that you may have your own business need, hence we also provide fully customized solutions to clients. The Global Regenerative Medicine Market can be customized to the country level or any other market segment.
1.1 Market Definition 24
1.2 Objective of the Study 24
1.3 Limitation 24
1.4 Stakeholders 25
1.5 Currency used in the Report 25
1.6 Scope of the Global Regenerative Medicine Market Study 25
2. RESEARCH METHODOLOGY OR ASSUMPTION 26
2.1 Research Methodology for Global Regenerative Medicine Market Study 26
2.1.1 Main objective of the Global Regenerative Medicine Market Study 27
3. INDUSTRY PERFORMANCE 28
4. EXECUTIVE SUMMARY 29
4.1 Key Facts on Cancer and Cardiovascular Diseases (CVDs), Global 30
5. MARKET OVERVIEW 32
5.1 Market Introduction 32
5.1.1 Cord Blood and Regenerative Medicine 32
5.2 Market Drivers 33
5.2.1 Growing Prevalence of Genetic Disorders and Chronic Diseases 33
5.2.2 Rising Pipeline of the Regenerative Medicine Products 36
5.2.3 The transformative potential of CAR T 38
5.2.3.1 Adoption of traditional healthcare settings to administer CARTs 40
5.2.3.2 Enabling rapid innovation of cell therapy with solid tumors 41
5.2.4 Technological Advancements in Regenerative Medicine 41
5.3 Market Challenges 45
5.3.1 High Cost Associated with Regenerative Medicines 45
5.3.2 Ethical Issues related to the use of Stem Cell & Regenerative Medicines 47
5.4 Market Opportunities 49
5.4.1 Increasing Number of Products in the Pipeline 49
5.4.2 Rising Number of Organ Transplantation 50
6. REIMBURSEMENT POLICY 52
6.1 General Overview 52
6.1.1 Reimbursement in Japan and the European Union 52
6.1.2 Reimbursement in the United Kingdom 52
6.1.3 Reimbursement in the United States 53
6.1.3.1 Establish cost-effectiveness 54
6.1.3.2 Explore innovative payment plans with payers 54
6.1.3.3 Engage providers and coordinate care 55
6.1.3.4 Offer patient assistance programs to address unique circumstances 55
6.1.3.5 Utilize alternative distribution channels 55
7. LEGAL & REGULATORY FRAMEWORK 57
7.1 General Overview 57
7.2 FDA’s Framework for Regenerative Medicine 64
7.3 Europe 67
7.4 Regenerative Medicine Product in Japan Under Pharmaceuticals and Medical Devices Act (PMD ACT) 67
7.4.1 The basic structure of NHI Pricing in Japan 68
7.5 Regulation of Regenerative Medicine in India 71
8. DEMAND AND SUPPLY SIDE ANALYSIS 73
8.1 Demand Side Analysis 73
8.2 Supply Side Analysis 75
8.2.1 Select Significant Clinical & Data Events: Q3 2019 77
8.2.1.1 Gene Therapy & Genome Editing Programs 77
8.2.1.2 Cell-Based Immuno-Oncology Programs 78
8.2.1.3 Cell Therapy Programs 79
8.2.2 Top Partnerships under Regenerative Medicine 84
8.2.3 Top Mergers & Acquisitions under Regenerative Medicine 90
8.2.4 Top Business Expansion & Investment under Regenerative Medicine 94
9. VALUE CHAIN ANALYSIS 96
9.1 Value Chain Analysis 96
10. MARKET INSIGHTS BY PRODUCT 98
10.1 General Overview 98
10.1.1 Cell Therapy 99
10.1.2 Gene Therapy 100
10.1.3 Tissue Engineering 102
10.1.4 Small Molecule and Biologics 107
11. REGENERATIVE MEDICINE MARKET INSIGHTS, BY MATERIAL TYPE 115
11.1 General Overview 115
11.1.1 Synthetic Materials 117
11.1.2 Biologically Derived Materials 118
11.1.3 Genetically Engineered Materials 120
11.1.4 Others (Pharmaceuticals) 121
12. REGENERATIVE MEDICINE MARKET INSIGHTS, BY APPLICATION 123
12.1 General Overview 123
12.1.1 Cardiovascular 124
12.1.2 Oncology 127
12.1.3 Dermatology 132
12.1.4 Musculoskeletal 134
12.1.5 Immunology and Inflammation 137
12.1.6 Ophthalmology 140
12.1.7 Neurology 142
12.1.8 Others 144
13. MARKET INSIGHTS BY REGION 146
13.1 General Overview 146
13.2 North America Regenerative Medicine Market (2019-2026) 147
13.2.1 North America Regenerative Medicine Market by Product 148
13.2.2 North America Regenerative Medicine Market by Material Type 149
13.2.3 North America Regenerative Medicine Market by Application 149
13.2.4 North America Regenerative Medicine Market by Country 150
13.2.4.1 US Regenerative Medicine Market (2019-2026) 150
13.2.4.2 US Healthcare Expenditure 152
13.2.4.2.1 Health Spending by Type of Service or Product 152
13.2.4.2.2 Health Spending by Major Sources of Funds 153
13.2.4.2.3 Facts on Heart Disease in the US 153
13.2.4.2.4 Facts on Coronary Heart Disease (CHD) in the US 154
13.2.4.2.5 Facts on Stroke in the US 154
13.2.4.2.6 US Regenerative Medicine Market by Product 155
13.2.4.2.7 US Regenerative Medicine Market by Material Type 156
13.2.4.2.8 US Regenerative Medicine Market by Application 156
13.2.4.3 Canada Regenerative Medicine Market (2019-2026) 157
13.2.4.3.1 Facts on Heart Disease in Canada 159
13.2.4.3.2 Canada Regenerative Medicine Market by Product 160
13.2.4.3.3 Canada Regenerative Medicine Market by Material Type 161
13.2.4.3.4 Canada Regenerative Medicine Market by Application 161
13.2.4.4 Rest of North America Regenerative Medicine Devices Market (2019-2026) 162
13.2.4.4.1 Rest of NA Regenerative Medicine Market by Product 162
13.2.4.4.2 Rest of NA Regenerative Medicine Market by Material Type 163
13.2.4.4.3 Rest of NA Regenerative Medicine Market by Application 163
13.3 Europe Regenerative Medicine Market 164
13.3.1 Facts on Cardiovascular Disease in Europe 166
13.3.2 Europe Regenerative Medicine Market by Product 167
13.3.3 Europe Regenerative Medicine Market by Material Type 168
13.3.4 Europe Regenerative Medicine Market by Application 168
13.3.5 Europe Regenerative Medicine Market by Country 169
13.3.5.1 Germany Regenerative Medicine Market (2019-2026) 169
13.3.5.1.1 Germany Regenerative Medicine Market by Product 171
13.3.5.1.2 Germany Regenerative Medicine Market by Material Type 171
13.3.5.1.3 Germany Regenerative Medicine Market by Application 172
13.3.5.2 United Kingdom Regenerative Medicine Market 172
13.3.5.2.1 United Kingdom Healthcare Expenditure 174
13.3.5.2.2 UK Regenerative Medicine Market by Product 176
13.3.5.2.3 UK Regenerative Medicine Market by Material Type 177
13.3.5.2.4 UK Regenerative Medicine Market by Application 177
13.3.5.3 France Regenerative Medicine Market (2019-2026) 178
13.3.5.3.1 France Regenerative Medicine Market by Product 179
13.3.5.3.2 France Regenerative Medicine Market by Material Type 180
13.3.5.3.3 France Regenerative Medicine Market by Application 180
13.3.5.4 Italy Regenerative Medicine Market 181
13.3.5.4.1 Key Facts of Healthcare Spending - Italy in 2018, by Region 182
13.3.5.4.2 Italy Regenerative Medicine Market by Product 184
13.3.5.4.3 Italy Regenerative Medicine Market by Material Type 184
13.3.5.4.4 Italy Regenerative Medicine Market by Application 185
13.3.5.5 Spain Regenerative Medicine Market 185
13.3.5.5.1 Spain Healthcare Expenditure Statistics 187
13.3.5.5.2 Spain Regenerative Medicine Market by Product 188
13.3.5.5.3 Spain Regenerative Medicine Market by Material Type 188
13.3.5.5.4 Spain Regenerative Medicine Market by Application 189
13.3.5.6 Rest of Europe Regenerative Medicine Market (2019-2026) 189
13.3.5.6.1 Rest of Europe Regenerative Medicine Market by Product 191
13.3.5.6.2 Rest of Europe Regenerative Medicine Market by Material Type 191
13.3.5.6.3 Rest of Europe Regenerative Medicine Market by Application 192
13.4 Asia Pacific Regenerative Medicine Market 192
13.4.1 Asia-Pacific Regenerative Medicine Market by Product 193
13.4.2 Asia-Pacific Regenerative Medicine Market by Material Type 194
13.4.3 Asia-Pacific Regenerative Medicine Market by Application 194
13.4.4 Asia-Pacific Regenerative Medicine Market by Country 195
13.4.4.1 China Regenerative Medicine Market (2019-2026) 195
13.4.4.1.1 China Regenerative Medicine Market by Product 198
13.4.4.1.2 China Regenerative Medicine Market by Material Type 199
13.4.4.1.3 China Regenerative Medicine Market by Application 199
13.4.4.2 Japan Regenerative Medicine Market 200
13.4.4.2.1 Japan Regenerative Medicine Market by Product 202
13.4.4.2.2 Japan Regenerative Medicine Market by Material Type 203
13.4.4.2.3 Japan Regenerative Medicine Market by Application 203
13.4.4.3 India Regenerative Medicine Market 204
13.4.4.3.1 Current Trends in Regenerative Medicine in India 204
13.4.4.3.2 India Regenerative Medicine Market by Product 206
13.4.4.3.3 India Regenerative Medicine Market by Material Type 207
13.4.4.3.4 India Regenerative Medicine Market by Application 207
13.4.4.4 Australia Regenerative Medicine Market (2019-2026) 208
13.4.4.4.1 Australia Regenerative Medicine Market by Product 210
13.4.4.4.2 Australia Regenerative Medicine Market by Material Type 211
13.4.4.4.3 Australia Regenerative Medicine Market by Application 211
13.4.4.5 South Korea Regenerative Medicine Market 212
13.4.4.5.1 South Korea Regenerative Medicine Market by Product 212
13.4.4.5.2 South Korea Regenerative Medicine Market by Material Type 213
13.4.4.5.3 South Korea Regenerative Medicine Market by Application 213
13.4.4.6 Rest of Asia-Pacific Regenerative Medicine Market (2019-2026) 214
13.4.4.6.1 Rest of APAC Regenerative Medicine Market by Product 215
13.4.4.6.2 Rest of APAC Regenerative Medicine Market by Material Type 215
13.4.4.6.3 Rest of APAC Regenerative Medicine Market by Application 216
13.5 Rest of World Regenerative Medicine Market (2019-2026) 216
13.5.1 Rest of World Regenerative Medicine Market by Product 217
13.5.2 Rest of World Regenerative Medicine Market by Material Type 218
13.5.3 Rest of World Regenerative Medicine Market by Application 218
13.5.4 Rest of World Regenerative Medicine Market by Country 219
13.5.4.1 Brazil Regenerative Medicine Market (2019-2026) 219
13.5.4.1.1 Brazil Regenerative Medicine Market by Product 222
13.5.4.1.2 Brazil Regenerative Medicine Market by Material Type 222
13.5.4.1.3 Brazil Regenerative Medicine Market by Application 223
13.5.4.2 South Africa Regenerative Medicine Market (2019-2026) 223
13.5.4.2.1 South Africa Regenerative Medicine Market by Product 224
13.5.4.2.2 South Africa Regenerative Medicine Market by Material Type 225
13.5.4.2.3 South Africa Regenerative Medicine Market by Application 225
13.5.4.3 Other RoW Countries Regenerative Medicine Market (2019-2026) 226
13.5.4.3.1 Other RoW Regenerative Medicine Market by Product 226
13.5.4.3.2 Other RoW Regenerative Medicine Market by Material Type 227
13.5.4.3.3 Other RoW Regenerative Medicine Market by Application 227
14. COMPETITIVE SCENARIO 228
14.1 Porter’s Five forces analysis 228
14.1.1 Bargaining power of the Supplier 228
14.1.2 Bargaining power of Buyer 228
14.1.3 Industry Rivalry 229
14.1.4 Availability of Substitute 229
14.1.5 Threat of New Entrants 229
14.2 Market Share Analysis, by Company 2019 229
14.2.1 Market Share of Key Players in Regenerative Medicine, 2019 230
15. TOP COMPANY PROFILES 232
15.1 Athersys, Inc 232
15.1.1 Key Facts 232
15.1.2 Business Description 233
15.1.3 Key Product/Services Offerings 233
15.1.4 Growth Strategy 233
15.1.5 SWOT Analysis 234
15.1.6 Key Financials 235
15.1.6.1 Revenue Split 236
15.1.7 Recent Developments 236
15.1.7.1 Partnerships 236
15.1.7.2 Business Expansions and Investment 237
15.2 Corline Biomedical AB 238
15.2.1 Key Facts 238
15.2.2 Business Description 239
15.2.3 Key Product/Services Offerings 239
15.2.4 Growth Strategy 239
15.2.5 SWOT Analysis 240
15.2.6 Key Financials 241
15.2.6.1 Revenue Split 242
15.2.7 Recent Developments 242
15.2.7.1 Partnerships 242
15.3 Mesoblast 243
15.3.1 Key Facts 243
15.3.2 Major Shareholders 243
15.3.3 Business Description 244
15.3.4 Key Product/Services Offerings 244
15.3.5 Growth Strategy 244
15.3.6 SWOT Analysis 245
15.3.7 Key Financials 246
15.3.8 Recent Developments 247
15.3.8.1 Partnerships 247
15.3.8.2 Business Expansions and Investment 247
15.4 NuVasive, Inc. 248
15.4.1 Key Facts 248
15.4.2 Business Description 248
15.4.3 Key Product/Services Offerings 249
15.4.4 Growth Strategy 249
15.4.5 SWOT Analysis 251
15.4.6 Key Financials 252
15.4.6.1 Revenue Split, by Region and Segment 253
15.4.7 Recent Developments 253
15.4.7.1 Product Launches 253
15.4.7.2 Business Expansions and Investment 254
15.4.7.3 Merger and Acquisition 254
15.5 Cook Biotech 255
15.5.1 Key Facts 255
15.5.2 Business Description 255
15.5.3 Key Product/Services Offerings 255
15.5.4 Growth Strategy 256
15.5.5 SWOT Analysis 256
15.5.6 Recent Developments 257
15.5.6.1 Partnerships 257
15.5.6.2 Mergers and Acquisitions 257
15.6 Integra LifeSciences 258
15.6.1 Key Facts 258
15.6.2 Major Shareholders 258
15.6.3 Business Description 259
15.6.4 Key Product/Services Offerings 259
15.6.5 Growth Strategy 260
15.6.6 SWOT Analysis 261
15.6.7 Key Financials 262
15.6.7.1 Revenue Split 263
15.6.8 Recent Developments 264
15.6.8.1 Product Launches 264
15.6.8.2 Partnerships 265
15.6.8.3 Mergers and Acquisitions 265
15.7 Organogenesis 267
15.7.1 Key Facts 267
15.7.2 Business Description 267
15.7.3 Key Product/Services Offerings 268
15.7.4 Growth Strategy 268
15.7.5 SWOT Analysis 270
15.7.6 Key Financials 271
15.7.7 Recent Developments 272
15.7.7.1 Product Launches 272
15.7.7.2 Mergers and Acquisitions 273
15.8 Osiris Therapeutics, Inc 274
15.8.1 Osiris Therapeutics, Inc Key Facts 274
15.8.2 Business Description 274
15.8.3 Key Product/Services Offerings 274
15.8.4 Growth Strategy 275
15.8.5 SWOT Analysis 276
15.8.6 Key Financials 277
15.8.6.1 Revenue Split 278
15.8.7 Recent Developments 278
15.8.7.1 Product Launches 278
15.8.7.2 Mergers and Acquisitions 279
15.9 Stryker Corporation 280
15.9.1 Key Facts 280
15.9.2 Business Description 280
15.9.3 Key Product/Services Offerings 281
15.9.4 Growth Strategy 281
15.9.5 SWOT Analysis 282
15.9.6 Key Financials 283
15.9.6.1 Revenue Split 284
15.9.7 Recent Developments 284
15.9.7.1 Merger and Acquisition 284
15.10 U.S. Stem Cell Inc. 286
15.10.1 Key Facts 286
15.10.2 Business Description 286
15.10.3 Key Product/Services Offerings 286
15.10.4 Growth Strategy 286
15.10.5 SWOT Analysis 287
15.10.6 Key Financials 288
15.10.7 Recent Developments 289
15.10.7.1 Business Expansion 289
15.11 Spark Therapeutics, Inc. 290
15.11.1 Key Facts 290
15.11.2 Business Description 290
15.11.3 Product Segmentation 290
15.11.4 Growth Strategy 291
15.11.5 SWOT Analysis 292
15.11.6 Key Financials 293
15.11.6.1 Revenue Split, by Region and Segment 294
15.11.7 Recent Developments 294
15.11.7.1 Product Launches 294
15.11.7.2 Partnerships 294
15.11.7.3 Mergers and Acquisitions 295
15.12 Pfizer 296
15.12.1 Key Facts 296
15.12.2 Business Description 297
15.12.3 Key Product/Services Offerings 297
15.12.4 Growth Strategy 298
15.12.5 SWOT Analysis 299
15.12.6 Key Financials 300
15.12.6.1 Revenue Split 301
15.12.7 Recent Developments 301
15.12.7.1 Product Launches 301
15.12.7.2 Partnerships 302
15.12.7.3 Mergers and Acquisitions 302
15.13 REGENXBIO Inc. 303
15.13.1 Key Facts 303
15.13.2 Ownership Structure 303
15.13.3 Business Description 304
15.13.4 Key Product/Services Offerings 304
15.13.5 Growth Strategy 304
15.13.6 SWOT Analysis 306
15.13.7 Key Financials 307
15.13.8 Recent Developments 308
15.13.8.1 Partnerships 308
15.13.8.2 Business Expansions and Investment 308
15.13.8.3 Mergers and Acquisitions 309
15.14 Abbott Laboratories 310
15.14.1 Key Facts 310
15.14.2 Business Description 310
15.14.3 Key Product/Services Offerings 311
15.14.1 SWOT Analysis 312
15.14.2 Key Financials 313
15.14.2.1 Revenue Split 314
15.14.3 Recent Developments 314
15.14.3.1 Product Launches 314
15.14.3.2 Partnership 315
15.14.3.3 Merger and Acquisition 315
15.15 Roche Holding AG 316
15.15.1 Key Facts 316
15.15.2 Business Description 316
15.15.3 Key Product/Services Offerings 317
15.15.4 SWOT Analysis 318
15.15.5 Key Financials 319
15.15.5.1 Revenue Split 320
15.15.6 Recent Developments 320
15.15.6.1 Product Launches 320
15.15.6.2 Partnerships 323
15.15.6.3 Mergers and Acquisitions 324
15.16 Sarepta Therapeutics 325
15.16.1 Key Facts 325
15.16.2 Business Description 325
15.16.3 Key Product/Services Offerings 325
15.16.4 Growth Strategy 326
15.16.5 SWOT Analysis 326
15.16.6 Key Financials 327
15.16.6.1 Revenue Split 328
15.16.7 Recent Developments 328
15.16.7.1 Partnerships 328
15.17 Gilead Sciences, Inc. 330
15.17.1 Key Facts 330
15.17.2 Business Description 330
15.17.3 Key Product/Services Offerings 331
15.17.4 Growth Strategy 331
15.17.5 SWOT Analysis 332
15.17.6 Key Financials 333
15.17.6.1 Revenue Split, by Region and Segment 334
15.17.7 Recent Developments 334
15.17.7.1 Product Launches 334
15.17.7.2 Partnerships 335
15.17.7.3 Business Expansions and Investment 337
15.17.7.4 Mergers and Acquisitions 338
TABLE 2 Number of cumulative treated patients by disease group, 2018-2030 38
TABLE 3 Regenerative Medicine FDA-Approved Products 43
TABLE 4 Addressable Global Patient Population, by Therapeutic Need, and Mode of Therapy, Population 44
TABLE 5 Addressable Global Patient Population, by Therapeutic Need, and Mode of Therapy, Population 47
TABLE 6 Gene Therapy (in vivo), Number of Assets 50
TABLE 7 Publications on reimbursement/risk-sharing, link with Orphan Drugs 53
TABLE 8 Related to reimbursement of regenerative medicine-based products per country 53
TABLE 9 Priority Review Designation 57
TABLE 10 Orphan Drug Designation 58
TABLE 11 Conditional Approval 59
TABLE 12 Marketing authorization under exceptional circumstances 60
TABLE 13 Marketing authorization under exceptional circumstances 60
TABLE 14 Regulatory Framework Parameters 65
TABLE 15 Structural Versus Non-structural Cells, Tissues 65
TABLE 16 Selected Allogeneic Stem Cell Therapies 66
TABLE 17 GMP Manufacturing Cost and Scale-Up Analysis for Cell-Based Therapies 69
TABLE 18 GMP Manufacturing Cost and Scale-Up Analysis for Cell-Based Therapies 70
TABLE 19 Top Product Launches under Regenerative Medicine 79
TABLE 20 Top Partnerships under Regenerative Medicine 84
TABLE 21 Top Mergers & Acquisitions under Regenerative Medicine 90
TABLE 22 Top Business Expansion & Investment under Regenerative Medicine 94
TABLE 23 FDA Approved Cellular and Gene Therapy Products 101
TABLE 24 List of most commercially available bone tissue-engineered products along with their description 104
TABLE 25 US FDA 510(k) medical devices approved for bone applications between 2011 and 2015 105
TABLE 26 US FDA 510(k) cleared allograft-based medical devices approved between 2011 and 2015 105
TABLE 27 Small molecules regulating the maintenance and proliferation of PSCs 108
TABLE 28 CDER approvals in 2018 110
TABLE 29 Selected Potential Approvals for New Drugs in 2019 113
TABLE 30 Synthesis of synthetic materials for tissue engineering applications using Adipose stem cells (ASCs) 117
TABLE 31 Maximum range of porosity and mechanical strength attained for composite bone scaffolds using protein and polysaccharide biomaterials 119
TABLE 32 Molecules attached to monomeric elastin-like recombinamers and their mechanism of action 120
TABLE 33 Global Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 124
TABLE 34 Exemplar injectable biomaterials used for the in vivo delivery of pro-angiogenic growth factors in animal models of MI 126
TABLE 35 Some of the commercially available skin substitutes that have been successfully used in clinical practice 133
TABLE 36 Overview of Epidemiology and Treatment Options for Musculoskeletal Diseases 135
TABLE 37 Advantages of Gingival Mesenchymal Stem Cells (GMSCs) obtained from current studies in the treatment of Immunological Diseases 138
TABLE 38 List of studies in which the therapeutic potential of administration of GMSCs for the treatment of immunological diseases was obtained 138
TABLE 39 Use of Stem Cells in Ophthalmologic and Oculoplastic Surgery 140
TABLE 40 Programs with products granted Regenerative Medicine Advanced Therapy (RMAT) designation between December 2016 and October 2018 144
TABLE 41 North America Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 149
TABLE 42 Leading Sites of New Cancer Cases and Deaths – 2020 Estimates 151
TABLE 43 US Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 156
TABLE 44 Collaborative Networks and Infrastructure Supporting Regenerative Medicine in Canada 157
TABLE 45 Canada Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 161
TABLE 46 Rest of NA Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 163
TABLE 47 Regenerative Medicine Products approved in Europe 165
TABLE 48 Europe Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 168
TABLE 49 Europe Regenerative Medicine Market Size, by Country, 2019-26 (US$ Bn) 169
TABLE 50 Germany Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 172
TABLE 51 Therapeutic Developments - UK 173
TABLE 52 UK Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 177
TABLE 53 France - Government Health Expenditure 178
TABLE 54 France Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 180
TABLE 55 Italy Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 185
TABLE 56 Spain Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 189
TABLE 57 Rest of Europe Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 192
TABLE 58 Asia-Pacific Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 194
TABLE 59 Asia-Pacific Regenerative Medicine Market Size, by Country, 2019-26 (US$ Bn) 195
TABLE 60 Main Stem Cell Research Institutes in China 196
TABLE 61 Stem Cells Products Approved for Clinic Pre-Clinic Trial by the SFDA 197
TABLE 62 China Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 199
TABLE 63 Japan Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 203
TABLE 64 India Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 207
TABLE 65 Australian Regenerative Medicine Sector Vision and Priority Action Areas 208
TABLE 66 Assessment of the Australian Regenerative Medicine Sector 209
TABLE 67 Australia Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 211
TABLE 68 South Korea Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 213
TABLE 69 Rest of APAC Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 216
TABLE 70 Rest of World Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 218
TABLE 71 Examples of Brazilian Regenerative Medicine Firms 219
TABLE 72 mHealth benefits in 2017 - Brazil 220
TABLE 73 Number of people with the four heart conditions in Brazil, 2015 221
TABLE 74 Brazil Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 223
TABLE 75 South Africa Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 225
TABLE 76 Other RoW Regenerative Medicine Market Size, by Application, 2019-26 (US$ Bn) 227
TABLE 77 Athersys, Inc Key Facts 232
TABLE 78 Athersys, Inc Ownership Structure 232
TABLE 79 Product segmentation of Athersys, Inc 233
TABLE 80 Athersys, Inc Growth Strategy 233
TABLE 81 Athersys, Inc Partnerships 236
TABLE 82 Athersys, Inc Business Expansions, Investment and Divestitures 237
TABLE 83 Corline Biomedical AB Key Facts 238
TABLE 84 Corline Biomedical AB Ownership Structure 238
TABLE 85 Product segmentation of Corline Biomedical AB 239
TABLE 86 Corline Biomedical AB Growth Strategy 239
TABLE 87 Corline Biomedical AB Partnerships 242
TABLE 88 Mesoblast Key Facts 243
TABLE 89 Mesoblast Key Facts 243
TABLE 90 Product segmentation of Mesoblast 244
TABLE 91 Mesoblast Growth Strategy 244
TABLE 92 Mesoblast Partnerships 247
TABLE 93 Mesoblast Business Expansions, Investment and Divestitures 247
TABLE 94 NuVasive, Inc. Key Facts 248
TABLE 95 NuVasive, Inc. Ownership Structure 248
TABLE 96 Product Segmentation of NuVasive 249
TABLE 97 NuVasive Growth Strategy 249
TABLE 98 NuVasive Inc., Product Launches 253
TABLE 99 NuVasive Inc. Business Expansions, Investment and Divestitures 254
TABLE 100 NuVasive Inc. Merger and Acquisition 254
TABLE 101 Cook Biotech Key Facts 255
TABLE 102 Product segmentation of Cook Biotech 255
TABLE 103 Cook Biotech Growth Strategy 256
TABLE 104 Cook Biotech Partnerships 257
TABLE 105 Cook Biotech Industries Mergers and Acquisitions 257
TABLE 106 Integra LifeSciences Key Facts 258
TABLE 107 Integra LifeSciences Major Shareholders 258
TABLE 108 Product Segmentation of Integra LifeSciences 259
TABLE 109 Integra LifeSciences Growth Strategy 260
TABLE 110 Integra LifeSciences Product Launches 264
TABLE 111 Integra LifeSciences Partnerships 265
TABLE 112 Integra LifeSciences Mergers and Acquisitions 265
TABLE 113 Organogenesis Key Facts 267
TABLE 114 Organogenesis Ownership Structure 267
TABLE 115 Product Segmentation of Organogenesis 268
TABLE 116 Organogenesis Growth Strategy 268
TABLE 117 Organogenesis Product Launches 272
TABLE 118 Organogenesis Mergers and Acquisitions 273
TABLE 119 Osiris Therapeutics, Inc Key Facts 274
TABLE 120 Product segmentation of Osiris Therapeutics 274
TABLE 121 Osiris Therapeutics Growth Strategy 275
TABLE 122 Osiris Therapeutics Product Launches 278
TABLE 123 Osiris Therapeutics Merger and Acquisition 279
TABLE 124 Stryker Corporation Key Facts 280
TABLE 125 Stryker Corporation Ownership Structure 280
TABLE 126 Product segmentation of Stryker Corporation 281
TABLE 127 Stryker Corporation Growth Strategy 281
TABLE 128 Stryker Corporation, Merger and Acquisition 284
TABLE 129 U.S. Stem Cell Inc., Key Facts 286
TABLE 130 Product segmentation of Sony Corporation 286
TABLE 131 U.S. Stem Cell Inc., Growth Strategy 286
TABLE 132 U.S. Stem Cell Clinic, Business Expansion 289
TABLE 133 Spark Therapeutics, Inc. Key Facts 290
TABLE 134 Product Segmentation of Spark Therapeutics, Inc. 290
TABLE 135 Spark Therapeutics, Inc. Growth Strategy 291
TABLE 136 Spark Therapeutics, Inc., Product Launches 294
TABLE 137 Spark Therapeutics, Inc., Partnerships 294
TABLE 138 Spark Therapeutics, Inc. Mergers and Acquisitions 295
TABLE 139 Pfizer Key Facts 296
TABLE 140 Pfizer Ownership Structure 296
TABLE 141 Product segmentation of Pfizer Inc. 297
TABLE 142 Pfizer Inc. Growth Strategy 298
TABLE 143 Pfizer Inc., Product Launches 301
TABLE 144 Pfizer Inc., Partnerships 302
TABLE 145 Pfizer Inc., Mergers and Acquisitions 302
TABLE 146 REGENXBIO Inc. Key Facts 303
TABLE 147 REGENXBIO Inc. Ownership Structure 303
TABLE 148 REGENXBIO Inc., Product/Services Offerings 304
TABLE 149 REGENXBIO Inc. Growth Strategy 304
TABLE 150 REGENXBIO Inc. Partnerships 308
TABLE 151 REGENXBIO Inc. Business Expansions, Investment and Divestitures 308
TABLE 152 REGENXBIO Inc. Mergers and Acquisitions 309
TABLE 153 Abbott Laboratories Key Facts 310
TABLE 154 Product segmentation of Abbott Laboratories 311
TABLE 155 Abbott laboratories Growth Strategy 311
TABLE 156 Abbott Laboratories, Inc. Product Launches 314
TABLE 157 Abbott Laboratories, Inc. Partnership 315
TABLE 158 Abbott Laboratories, Inc. Merger and Acquisition 315
TABLE 159 Roche Key Facts 316
TABLE 160 Product segmentation of Roche 317
TABLE 161 Roche Growth Strategy 317
TABLE 162 Roche Product Launches 320
TABLE 163 Roche Partnerships 323
TABLE 164 Roche Mergers and Acquisitions 324
TABLE 165 Sarepta Therapeutics Key Facts 325
TABLE 166 Product segmentation of Sarepta Therapeutics 325
TABLE 167 Sarepta Therapeutics, Growth Strategy 326
TABLE 168 Sarepta Therapeutics. Partnerships 328
TABLE 169 Gilead Sciences, Inc. Key Facts 330
TABLE 170 Gilead Sciences, Inc., Ownership Structure 330
TABLE 171 Product segmentation of Gilead Sciences, Inc. 331
TABLE 172 Gilead Sciences, Inc. Growth Strategy 331
TABLE 173 Gilead Sciences, Inc. Product Launches 334
TABLE 174 Gilead Sciences, Inc. Partnerships 335
TABLE 175 Gilead Sciences, Inc. Business Expansions, Investment and Divestitures 337
TABLE 176 Gilead Sciences, Inc. Mergers and Acquisitions 338
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