THE GLOBAL MARKET FOR STEM CELLS

Transcription

1 THE GLOBAL MARKET FOR STEM CELLS BIO035F May 2016 Paul Evers Project Analyst ISBN: BCC Research 49 Walnut Park, Building 2 Wellesley, MA USA (toll-free within the USA), or (+1) information@bccresearch.com

2 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY GOALS AND OBJECTIVES 2 REASONS FOR DOING THE STUDY 2 SCOPE OF REPORT 2 MARKET ANALYSES AND FORECASTS 2 METHODOLOGY 3 INTENDED AUDIENCE 3 INFORMATION SOURCES 3 ANALYST'S CREDENTIALS 3 RELATED BCC RESEARCH REPORTS 3 BCC RESEARCH WEBSITE 3 DISCLAIMER 4 CHAPTER 2 SUMMARY 6 DEFINITIONS 6 APPLICATIONS 6 RESEARCH AND COMMERCIALIZATION 6 FUNDING 7 MARKET 7 SUMMARY TABLE GLOBAL STEM CELL MARKET BY REGION, THROUGH 2021 ($ SUMMARY FIGURE GLOBAL STEM CELL MARKET BY REGION, ($ 8 8 CHAPTER 3 OVERVIEW 10 CELLS 10 STEM CELLS 10 FIGURE 1 EARLY DEVELOPMENT OF EMBRYO 10 INDUCED PLURIPOTENT STEM CELLS 13 Mesenchymal Stem Cells 14 hpscs 14 THE CANCER PROBLEM 15 CANCER STEM CELLS-A WIDER 15 CHAPTER 4 STEM CELL RESEARCH 19 HISTORY 19 EMBRYONIC STEM CELLS 20 Growth and Identification of ESCs 20 Stimulating ESCs to Differentiate 21 NEW CELL LINE 21 ADULT STEM CELLS 22 Mesenchymal Stem Cells (MSCs) 22 Hematopoietic Stem Cells (HSCs) 23 Neural Stem Cells (NSCs) 23 Endothelial Progenitor Cells (EPCs) 23 Epithelial Stem Cells (ESCs) 23

3 Very Small Embryonic-Like Cells (VSELs) 23 CORD BLOOD STEM CELLS 23 INDUCED PLURIPOTENT STEM CELLS (IPSCS) 24 Nuclear Reprogramming 25 CELL-BASED THERAPEUTICS 25 EMBRYONIC-DERIVED STEM CELLS 25 ADULT/PROGENITOR-DERIVED STEM CELLS 26 ENGINEERED SCS FOR TRANSPLANTATION 26 THERAPEUTIC STEM CELL BANKING 27 STEM CELL-BASED BIOMEDICAL RESEARCH 28 REGULATION OF STEM CELL RESEARCH 32 NATIONAL REGULATORY MEASURES 32 Australia 32 Brazil 33 Canada 33 China 33 France 34 Germany 35 India 35 Ireland 35 Israel 36 Italy 36 Japan 36 South Korea 36 Spain 37 Sweden 37 United Kingdom 37 United States 37 California 38 Massachusetts 38 Michigan 38 New Jersey 38 New York 38 FDA Approach 38 EUROPEAN UNION 39 PRACTICALITIES OF STEM CELL RESEARCH AND PRODUCTION 39 STEM CELL PRODUCTION 39 STEM CELL ACQUISITION 40 Characterization and Expansion 40 Maintenance and Storage 41 STEM CELL PRODUCTION ECONOMICS 42 Customized Therapy 42 Banks 43 NOVEL STEM CELL PRODUCTION DEVELOPMENTS 44 ISOLATION AND ENGINEERING 44 Adult Stem Cells 44 Embryonic Stem Cells 45

4 Induced Pluripotent Stem Cells 47 STEM CELL BANKING 48 ISCBI PROJECT 48 TABLE 1 COUNTRIES ENGAGED IN THE ISCBI PROGRAM 49 FUTURE PERSPECTIVE: THE RISE OF THE ORGANOIDS 50 CHAPTER 5 STEM CELL APPLICATIONS 52 REGENERATIVE MEDICINE 52 CURRENT APPLICATIONS OF STEM CELL THERAPY 55 CANCER 55 Hematopoiesis (Blood Cell Formation) 55 AMYOTROPHIC LATERAL SCLEROSIS 56 PARKINSON'S DISEASE 57 SPINAL CORD INJURY 59 ALZHEIMER'S DISEASE 60 STROKE 61 HEART DISEASE 63 Doubts Expressed 66 PERIPHERAL ARTERIAL DISEASE 66 TYPE 1 DIABETES 68 ORTHOPEDIC REPAIR 70 LIVER FAILURE 70 GRAFT-VERSUS-HOST DISEASE 71 LUNG DISEASE 72 STATUS OF STEM CELL CLINICAL TRIALS 73 Prochymal-stem Cell Therapy 73 Prochymal-Crohn's Disease and Gastrointestinal Injury from Radiation Mesenchymal Precursor Cell (MPC) Product-Stem Cell Therapy (Orphan Drug) MyoCell-Stem Cell Therapy 74 ixmyelocel-t-stem Cell Therapy (Fast Track) 74 StemEx (carlecortemcel-l)-stem Cell Therapy (Orphan Drug) (Fast Track) GSK Stem Cell Therapy 75 Adult Autologous Stem Cell Therapy (Renew)-Stem Cell Therapy CHAPTER 6 STEM CELL PATENTS 78 GENERAL BACKGROUND ON PATENTS 78 STEM CELL PATENTS 79 PATENTABILITY OF STEM CELL LINES 79 INDIVIDUAL COUNTRY POLICIES 80 UNITED STATES 80 CANADA 80 EPC 80 UNITED KINGDOM 80 GERMANY 81 JAPAN 81

5 CHINA 81 ips Cells 81 TABLE 2 IPS-RELATED PATENTS (YAMANAKA, 2011) 82 TABLE 3 CLASSIFICATION OF STEM CELL PATENTS 83 CHAPTER 7 STEM CELL MARKETS 85 MARKETS FOR STEM CELLS 85 MARKET DRIVERS 85 Healthcare 85 TABLE 4 HEALTHCARE SYSTEMS OF DIFFERENT COUNTRIES 87 Market Restraints 88 Biotechnology 89 Pharmaceutical 90 MARKET OPPORTUNITIES BY THERAPEUTIC CLASS 91 CANCER 91 Other Cancers 91 CARDIOVASCULAR DISEASE 92 Myocardial Infarction 93 TABLE 5 EXAMPLES OF COMPANIES DEVELOPING STEM CELL THERAPIES FOR CVD 94 CENTRAL NERVOUS SYSTEM DISEASE 95 Spinal Cord Injury (SCI) 95 TABLE 6 STATISTICS FOR SCI IN THE U.S., Neurodegenerative Diseases 97 TABLE 7 NEURODEGENERATIVE DISEASES WORLDWIDE, DIABETES MELLITUS 98 TABLE 8 STATISTICS FOR DIABETES IN THE U.S., TABLE 9 GLOBAL MARKET FOR DIABETES MELLITUS TREATMENTS AND DEVICES, THROUGH 2021 ($ BILLIONS) SKELETAL SYSTEM 100 GLOBAL MARKET ESTIMATES AND FORECASTS 101 TABLE 10 GLOBAL STEM CELL MARKET BY REGION, THROUGH 2021 ($ 101 REGIONAL AND NATIONAL MARKET ANALYSIS 101 AMERICAS 101 TABLE 11 AMERICAS STEM CELL MARKET BY COUNTRY, THROUGH 2021 ($ U.S. 102 TABLE 12 POTENTIAL U.S. PATIENT POPULATIONS FOR CELL-BASED THERAPIES 102 TABLE 13 U.S. STEM CELL THERAPY MARKET, THROUGH 2021 ($ 103 TABLE 14 U.S. STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 15 U.S. STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ Canada 104 TABLE 16 CANADA STEM CELL THERAPY MARKET, THROUGH 2021 ($ 105 TABLE 17 CANADA STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 18 CANADA STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ Brazil

6 TABLE 19 BRAZIL STEM CELL THERAPY MARKET, THROUGH 2021 ($ 107 TABLE 20 BRAZIL STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 21 BRAZIL STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ Mexico 108 TABLE 22 MEXICO STEM CELL THERAPY MARKET, THROUGH 2021 ($ 108 TABLE 23 MEXICO STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ EUROPE 109 TABLE 24 EUROPE STEM CELL MARKET BY COUNTRY, THROUGH 2021 ($ 109 Market Opportunities by Disease Category 110 TABLE 25 STATISTICS FOR CVD IN EUROPE, TABLE 26 RATE OF DEATH FROM HEART DISEASE IN DIFFERENT EUROPEAN COUNTRIES, 2012 (NO. OF DEATHS PER 100,000 CASES) TABLE 27 STATISTICS FOR CNS DISORDERS AND INJURIES IN EUROPE, TABLE 28 STATISTICS FOR SCI AND PARKINSON'S DISEASE IN DIFFERENT EUROPEAN COUNTRIES, 2011 TABLE 29 PREVALENCE OF DIABETIC PATIENTS IN DIFFERENT EUROPEAN COUNTRIES, 2013 France 112 TABLE 30 FRANCE STEM CELL THERAPY MARKET, THROUGH 2021 ($ 112 TABLE 31 FRANCE STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 32 FRANCE STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ Germany 113 TABLE 33 GERMANY STEM CELL THERAPY MARKET, THROUGH 2021 ($ 114 TABLE 34 GERMANY STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 35 GERMANY STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ Italy 114 TABLE 36 ITALY STEM CELL THERAPY MARKET, THROUGH 2021 ($ 115 TABLE 37 ITALY STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 38 ITALY STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ Spain 116 TABLE 39 SPAIN STEM CELL THERAPY MARKET, THROUGH 2021 ($ 117 TABLE 40 SPAIN STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 41 SPAIN STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ United Kingdom 118 TABLE 42 U.K. STEM CELL THERAPY MARKET, THROUGH 2021 ($ 119 TABLE 43 U.K. STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 44 U.K. STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($

7 ASIA 119 Market Opportunities by Disease Category 119 TABLE 45 STATISTICS FOR CVD IN DIFFERENT REGIONS OF THE WORLD, TABLE 46 EXAMPLES OF STEM CELL POLICIES IN ASIAN COUNTRIES 120 TABLE 47 ASIA STEM CELL MARKET BY COUNTRY, THROUGH 2021 ($ 121 Japan 121 TABLE 48 JAPAN STEM CELL THERAPY MARKET, THROUGH 2021 ($ 123 TABLE 49 JAPAN STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 50 JAPAN STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ China 123 TABLE 51 CHINA STEM CELL THERAPY MARKET, THROUGH 2021 ($ 127 TABLE 52 CHINA STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 53 CHINA STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ India 128 TABLE 54 POTENTIAL CANDIDATES FOR STEM CELL THERAPY IN INDIA 129 TABLE 55 INDIA STEM CELL THERAPY MARKET, THROUGH 2021 ($ 129 TABLE 56 INDIA STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 57 INDIA STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ REST OF WORLD TABLE 58 REST OF WORLD STEM CELL MARKET BY SEGMENT, THROUGH 2021 ($ CHAPTER 8 COMPANY PROFILES 132 3DMATRIX 133 ALDAGEN INC. 133 ANGIOBLAST SYSTEMS 135 ARTERIOCYTE 136 ATHERSYS INC. 136 BEIKE BIOTECHNOLOGY CO. LTD. 137 BIOTIME INC. 138 BRAINSTORM CELL THERAPEUTICS INC. 139 CALADRIUS BIOSCIENCES INC. 140 CAPRICOR INC. 141 CELLERANT THERAPEUTICS INC. 142 CELLERIX SA 143 CELLULAR DYNAMICS INTERNATIONAL 144 CELYAD 145 CLONTECH 145 CYTORI THERAPEUTICS INC. 146 EPISTEM LTD. 148 GAMIDA CELL LTD. 148 GLOBALSTEM 149 HYBRID ORGAN GMBH 150

8 INTELLICELL BIOSCIENCES INC. 151 INTERNATIONAL STEM CELL CORP. 151 JUVENTAS THERAPEUTICS INC. 153 MESOBLAST LTD. 153 NEURALSTEM 155 NEUROGENERATION 156 OCATA 156 OSIRIS THERAPEUTICS INC. 157 PRIMEGEN BIOTECH LLC 158 RENEURON GROUP 158 RHINOCYTE INC. 160 STEM CELLS INC. 160 STEMCELL TECHNOLOGIES SARL 161 STEM CELL THERAPEUTICS CORP. 162 STEMEDICA CELL TECHNOLOGIES INC. 163 STEMINA BIOMARKER DISCOVERY INC. 164 STEMPEUTICS RESEARCH PVT. LTD. 165 TIGENIX NV 166 U.S. STEM CELL 167 VERASTEM INC. 168 VERICEL 169 VERISTEM TECHNOLOGIES 169 VIACYTE 170 VITRO DIAGNOSTICS INC. 171 WICELL RESEARCH INSTITUTE 172 XPAND BIOTECHNOLOGY BV 173 CHAPTER 9 GLOSSARY 175 CHAPTER 10 SIGNIFICANT STEM CELL RESEARCH PATENTS 182 TABLE 59 SIGNIFICANT STEM CELL RESEARCH PATENTS 182

9 LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL STEM CELL MARKET BY REGION, THROUGH 2021 ($ TABLE 1 COUNTRIES ENGAGED IN THE ISCBI PROGRAM 49 TABLE 2 IPS-RELATED PATENTS (YAMANAKA, 2011) 82 TABLE 3 CLASSIFICATION OF STEM CELL PATENTS 83 TABLE 4 HEALTHCARE SYSTEMS OF DIFFERENT COUNTRIES 87 TABLE 5 EXAMPLES OF COMPANIES DEVELOPING STEM CELL THERAPIES FOR CVD 94 TABLE 6 STATISTICS FOR SCI IN THE U.S., TABLE 7 NEURODEGENERATIVE DISEASES WORLDWIDE, TABLE 8 STATISTICS FOR DIABETES IN THE U.S., TABLE 9 GLOBAL MARKET FOR DIABETES MELLITUS TREATMENTS AND DEVICES, THROUGH 2021 ($ BILLIONS) TABLE 10 GLOBAL STEM CELL MARKET BY REGION, THROUGH 2021 ($ 101 TABLE 11 AMERICAS STEM CELL MARKET BY COUNTRY, THROUGH 2021 ($ 101 TABLE 12 POTENTIAL U.S. PATIENT POPULATIONS FOR CELL-BASED THERAPIES 102 TABLE 13 U.S. STEM CELL THERAPY MARKET, THROUGH 2021 ($ 103 TABLE 14 U.S. STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 15 U.S. STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ TABLE 16 CANADA STEM CELL THERAPY MARKET, THROUGH 2021 ($ 105 TABLE 17 CANADA STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 18 CANADA STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ TABLE 19 BRAZIL STEM CELL THERAPY MARKET, THROUGH 2021 ($ 107 TABLE 20 BRAZIL STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 21 BRAZIL STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ TABLE 22 MEXICO STEM CELL THERAPY MARKET, THROUGH 2021 ($ 108 TABLE 23 MEXICO STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ TABLE 24 EUROPE STEM CELL MARKET BY COUNTRY, THROUGH 2021 ($ 109 TABLE 25 STATISTICS FOR CVD IN EUROPE, TABLE 26 RATE OF DEATH FROM HEART DISEASE IN DIFFERENT EUROPEAN COUNTRIES, 2012 (NO. OF DEATHS PER 100,000 CASES) TABLE 27 STATISTICS FOR CNS DISORDERS AND INJURIES IN EUROPE, TABLE 28 STATISTICS FOR SCI AND PARKINSON'S DISEASE IN DIFFERENT EUROPEAN COUNTRIES, 2011 TABLE 29 PREVALENCE OF DIABETIC PATIENTS IN DIFFERENT EUROPEAN COUNTRIES, 2013 TABLE 30 FRANCE STEM CELL THERAPY MARKET, THROUGH 2021 ($ 112 TABLE 31 FRANCE STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 32 FRANCE STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ TABLE 33 GERMANY STEM CELL THERAPY MARKET, THROUGH 2021 ($

10 TABLE HEADING TABLE 34 GERMANY STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 35 GERMANY STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ TABLE 36 ITALY STEM CELL THERAPY MARKET, THROUGH 2021 ($ 115 TABLE 37 ITALY STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 38 ITALY STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ TABLE 39 SPAIN STEM CELL THERAPY MARKET, THROUGH 2021 ($ 117 TABLE 40 SPAIN STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 41 SPAIN STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ TABLE 42 U.K. STEM CELL THERAPY MARKET, THROUGH 2021 ($ 119 TABLE 43 U.K. STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 44 U.K. STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ TABLE 45 STATISTICS FOR CVD IN DIFFERENT REGIONS OF THE WORLD, TABLE 46 EXAMPLES OF STEM CELL POLICIES IN ASIAN COUNTRIES 120 TABLE 47 ASIA STEM CELL MARKET BY COUNTRY, THROUGH 2021 ($ 121 TABLE 48 JAPAN STEM CELL THERAPY MARKET, THROUGH 2021 ($ 123 TABLE 49 JAPAN STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 50 JAPAN STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ TABLE 51 CHINA STEM CELL THERAPY MARKET, THROUGH 2021 ($ 127 TABLE 52 CHINA STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 53 CHINA STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ TABLE 54 POTENTIAL CANDIDATES FOR STEM CELL THERAPY IN INDIA 129 TABLE 55 INDIA STEM CELL THERAPY MARKET, THROUGH 2021 ($ 129 TABLE 56 INDIA STEM CELL RESEARCH AND SERVICES MARKET, THROUGH 2021 ($ TABLE 57 INDIA STEM CELL CORD BLOOD SERVICES MARKET, THROUGH 2021 ($ TABLE 58 REST OF WORLD STEM CELL MARKET BY SEGMENT, THROUGH 2021 ($ TABLE 59 SIGNIFICANT STEM CELL RESEARCH PATENTS

11 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL STEM CELL MARKET BY REGION, ($ 8 FIGURE 1 EARLY DEVELOPMENT OF EMBRYO 10