【レポートの概要(一部)】
1. Report Overview
1.1 Global Stem Cell Technology Market Segmentation
1.2 Top Stem Cell Technology Companies Globally: An Overview
1.3 How This Report Delivers
1.4 Questions Answered by This Analytical Study
1.5 Who is This Report For?
1.6 Methods of Research and Analysis
1.7 Frequently Asked Questions (FAQ)
1.8 Associated Visiongain Reports
1.9 About Visiongain
2. Introduction to the Global Stem Cell Technology and Applications Market 2014 to 2026
2.1 The Stem Cells Technologies and Applications Market in 2015
2.2 Global Stem Cell Technology and Applications Market Forecast 2016-2026
2.3 Fast Growth Due to Therapeutic Potential, Drug Screening and Emerging National Markets
2.4 Drivers and Restraints for the Stem Cell Technology and Applications Market, 2016-2026
3. Leading US Stem Cell Technology Companies
3.1 The Stem Cell Regulatory Environment in the US
3.1.1 Embryonic Stem Cell Research in the US is Still Controversial
3.2 Osiris Therapeutics
3.2.1 Grafix: Additional Clinical Trials to Gain Advantage
3.2.1.1 Is Grafix Really a ‘Stem Cell Product’?
3.2.2 Bio4: Further Rebranding of a Stem Cell Product for Regeneration of Bone Tissue
3.2.3 Cartiform – Launched to Address a Potential $500m Market
3.2.3.1 Partnership with Arthrex for Development of Cartiform and Further Pipeline Expansion
3.2.4 Osiris Therapeutics Stem Cell Revenue Forecast 2015-2026
3.2.5 Osiris Therapeutics: Optimistic Outlook for that Leading Stem Cell Company
3.3 Caladrius Biosciences (formerly Neostem)
3.3.1 Growth Through Acquisitions – Including PCT, Amorcyte, Athelos and California Stem Cell Inc.
3.3.2 Focus Shifted to CLBS12, CLBS10 Is No Longer the Lead Candidates
3.3.3 VSEL Technology: Potential to Treat Ocular Diseases and Chronic Wounds?
3.3.4 Caladrius Biosciences Revenues 2012-2015
3.3.5 Caladrius Biosciences Outlook in Summary: Current Stem Cell Therapy Development is Not Active
3.4 Orthofix
3.4.1 Trinity Evolution and Trinity Elite – Over 135,000 Procedures to Date
3.4.1.1 Positive Results from New Trial in Foot and Ankle Procedures
3.4.1.2 Trinity Elite and Trinity Evolution: Revenue Forecast 2015-2026
3.4.2 Orthofix Outlook in Summary: High Revenues from Trinity Products but Will Have to Demonstrate Efficacy
3.5 NuVasive
3.5.1 Osteocel to Osteocel Plus: Changes and Challenges
3.5.1.1 Osteocel Plus: The Leading Stem Cell Orthobiologic
3.5.1.2 Osteocel Plus: Is it Better than Autograft?
3.5.1.3 Developments at NuVasive: Acquisitions
3.5.1.4 Osteocel Plus: Revenue Forecast 2015-2026
3.5.2 NuVasive Outlook in Summary: Osteocel Plus Revenues Will Continue to Grow, Although will Face Increased Competition in Coming Years
3.6 AlloSource: Non-Profit which Markets AlloStem and Processes Osteocel for NuVasive
3.6.1 AlloStem: Stem Cell Bone Growth Substitute
3.7 RTI Surgical
3.7.1 Map3: RTI Surgical is Competing with Established Players like NuVasive and Orthofix
3.8 Vericel Corporation (formerly Aastrom Biosciences)
3.8.1 Leading Stem Cell Therapy Candidate Ixmyelocel-T
3.8.1.1 Mechanism of Vericel’s Stem Cell Treatment Ixmyelocel-T
3.8.2 Investigation of Ixmyelocel-T: DCM Is its Leading Indication
3.8.3 Vericel Focusing on Dilated Cardiomyopathy (DCM) but CLI Trials Are Discontinued
3.8.4 Acquisition of New Products: Carticel, Epicel and MACI
3.8.5 Vericel Corporation Revenue 2011-2014
3.8.6 Vericel Corporation Outlook in Summary: Expectations All on One Treatment
3.9 U.S. Stem Cell Inc (formerly Bioheart)
3.9.1 MyoCell: Autologous ‘Muscle Stem Cell’ Therapy
3.9.1.1 MyoCell: Undergoing Phase 2/3 MARVEL Trial But Needs Funding
3.9.1.2 MyoCell: MIRROR Phase 3 Development Halted
3.9.2 MyoCell SDF-1: Improved Version of MyoCell
3.9.2.1 MyoCell SDF-1 Phase 1 Trial (REGEN) Trial On Hold Also
3.9.3 Adipocell Halted for CHF, but in Phase 1/2 for CLI with Future Aims to Expand to Rheumatoid Arthritis Treatment
3.9.3.1 Adipocell: DDD, COPD and Dry Macular Degeneration Investigations and Expansion to India for Clinical Trials
3.9.4 Pipeline Development for An As Yet Unnamed Neurological Treatment
3.9.5 U.S. Stem Cell Inc. Revenues 2011-2015
3.9.6 U.S. Stem Cell Inc. Outlook in Summary: Promising Candidates With Halted Development
3.10 Neuralstem
3.10.1 NSI-566 Completed Phase 2 for ALS in Q1 2015 With Further Studies Anticipated in 2016
3.10.2 NSI-566 for Chronic Spinal Cord Injury: Phase 1 Nearing Completion with Phase 1/2 for Acute Spinal Cord Injury Beginning in Korea
3.10.3 NSI-566 for Ischaemic Stroke: Phase 1/2 Trials Underway in China
3.10.4 Neuralstem: Preclinical Investigation for 11 Other Indications and NSI-189 in Phase 2 Trials
3.10.5 Neuralstem Revenues 2011-2014
3.10.6 Neuralstem Outlook in Summary: Aiming to Treat a Wide Range of Conditions – Potential Revenues are Huge
3.11 Astellas/Ocata Therapeutics (formerly Advanced Cell Technology)
3.11.1 Broad Intellectual Property Portfolio and Funding Issues Solved
3.11.2 MA09-hRPE in Two Phase 1/2 Trials for Stargardt’s Macular Degeneration
3.11.2.1 Possible Early Signals of Efficacy
3.11.3 MA09-hRPE: Phase 2 in Dry Age Related Macular Degeneration and Phase 1/2 for Myopic Macular Degeneration
3.11.4 Ocata Therapeutics Revenues, 2011-2014
3.11.5 Astellas/Ocata Therapeutics Outlook in Summary: Strengthened Through its Parent Company
3.12 Athersys
3.12.1 Leading Product: MultiStem Demonstrates Positive Results in Phase 2 Trials for Ischaemic Stroke
3.12.2 MultiStem Is Also In Development for Other Indications Although Not All Have Been Successful
3.12.3 Plans for MultiStem to Enter the Japanese Market
3.12.4 Athersys Revenues
3.12.5 Athersys Outlook in Summary: Strong Potential of MultiStem
3.13 Cord Blood Stem Cells Approvals: Procedures to Products
3.13.1 Hemacord by New York Blood Center
3.13.2 HPC, Cord Blood by ClinImmune and University of Colorado Cord Blood Bank
3.13.3 Ducord by Duke University School of Medicine
3.13.4 Allocord by SSM Cardinal Glennon Children’s Medical Center
3.13.5 HPC, Cord Blood BLA 125432 by LifeSouth Community Blood Centers
3.13.6 HPC Cord Blood by Bloodworks Northwest
4. Leading Asia-Pacific Stem Cell Technology Companies
4.1 South Korea: Moving Rapidly to Commercialisation for MSC Therapies – but is it Exercising Enough Caution?
4.2 India: An Emerging Stem Cell Industry
4.3 Japan: Has Been Less Active than other Asian Countries in hESC Research But Has Implemented a New Pathway to Encourage Growth
4.4 China: Taking Measures to Tighten Up Liberal Stem Cell Research Laws
4.5 Australia Unrestrictive Regulatory Environment
4.6 Mesoblast Ltd: Australian Company with Extensive Product Pipeline
4.6.1 Mesoblast’s Strategic Partnering and Acquisitions
4.6.2 Mesoblast’s Broad Pipeline: MSC-100-IV Is the Lead Candidate
4.6.3 MSC-100-IV (formerly Prochymal): World’s First Approved Stem Cell Drug Outside of South Korea- Currently Has Limited Market Access
4.6.3.1 Mesoblast Also Evaluating MSC-100-IV for Treatment of Crohn’s Disease
4.6.3.2 MSC-100-IV: Revenue Forecast, 2016-2026
4.6.4 Mesoblast Evaluating MPCs for Treatment of Diabetes in Phase 2
4.6.5 Mesoblast Evaluating MPCs for Treatment of Rheumatoid Arthritis in Phase 2
4.6.6 MPC-150-IM in Phase 3 for Chronic Heart Failure
4.6.7 Phase 2 Trial of MPCs in Acute Myocardial Infarction with MPC-25-IC
4.6.8 Phase 3 Trials of MPCs in Intervertebral Disc Repair and Spinal Fusion
4.6.9 Trials Involving Umbilical Cord Blood Cells Expanded with MPCs in Haematological Malignancies
4.6.10 Phase 2 in Wet AMD, Preclinical in Neurology
4.6.11 Mesoblast Revenue 2012-2015
4.6.12 Mesoblast Outlook in Summary: Large and Diversified Development Pipeline Supports a Leading Company
4.7 Reliance Life Sciences
4.7.1 CardioRel – Available in the Indian Market Only
4.7.1.1 CardioRel: Revenue Forecast 2015-2026
4.7.2 ReliNethra- The First Stem Cell Therapy in India
4.7.3 ReliNethra C and A Possible Neurological Disorder Treatment, NeuroRel
4.7.4 Cord Blood Repository for Stem Cell Storage
4.7.5 Reliance Life Sciences Outlook in Summary: More Diversification is Needed
4.8 Anterogen
4.8.1 Cupistem is the World’s First Approved Stem Cell Product Derived From Adipose Tissue
4.8.2 Queencell and Adipocell: Stromal Vascular Fraction Containing Autologous MSCs and Depressed Scar Treatment
4.8.3 Anterogen’s Expanding Pipeline
4.8.4 Anterogen Outlook in Summary: A Strong Player in the Korean Market
4.9 Pharmicell
4.9.1 Hearticellgram-AMI is One of the First Approved Cardiovascular Stem Cell Treatments
4.9.1.1 Hearticellgram-AMI May Not Be Easily Approved Outside of South Korea
4.9.1.2 Hearticellgram-AMI Revenue Forecast 2015-2026
4.9.2 Cerecellgram Has Reached Phase 3 For the Treatment of Strokes and Phase 2/3 For Spinal Cord Injuries
4.9.3 Immunocellgram for Cancers and Lungcellgram for Pulmonary Fibrosis Are Both In Preclinical Development
4.9.4 Other Phase 1 Treatments for Erectile Dysfunction and Multiple System Atrophy
4.9.5 Livercellgram for Hepatic Failure Treatment Has Completed Phase 2
4.9.6 Pharmicell Outlook in Summary: Quick to Market With a Large Pipeline But May Have Difficulty With Regional Expansion
4.10 MEDIPOST
4.10.1 Cartistem is the World’s First Approved Allogeneic Stem Cell Drug Treatment
4.10.2 Cartistem’s Development: Phase 3 Updates and Expansion
4.10.3 Cartistem Revenue Forecast 2015-2026
4.10.4 Neurostem Has Reached Phase 1/2a
4.10.5 Pneumostem and Promostem: Lung Disease Stem Cell Treatment and Haematopoietic Transplantation Therapy
4.10.6 MEDIPOST Outlook in Summary: One Stem Cell Therapy Launched, Plans to Expand, and the Largest Cord Blood Repository in South Korea
4.11 Stempeutics
4.11.1 Stempeucel Has Reached Phase 2 For Various Indications
4.11.2 Stempeucel for Various Other Indications
4.11.3 Alliance with Cipla
4.11.4 Developments at Stempeutics: Patent Approvals and Developments in the European Marketplace
4.11.5 Stempeutics Outlook in Summary: Using Stempeucel to Treat a Range of Disorders
5. Leading European Stem Cell Technology Companies
5.1 Regulation in Europe
5.2 UK Leads in European Stem Cell R&D
5.3 TiGenix: Proprietary Technology Platform and Three Stem Cell Products in Development
5.3.1 ChondroCelect Already on the Market
5.3.2 eASC Technology Platform
5.3.3 Favourable Data Released for Cx601’s European Phase 3 Trial
5.3.3.1 The Road to Approval for Cx601 in Europe and the US
5.3.3.2 Cx601: TiGenix Partners with Lonza and Plans to Launch in the US and Europe
5.3.4 Cx611: Phase 2 for Rheumatoid Arthritis Delayed and Phase 1/2 for Severe Sepsis Planned
5.3.5 Cx621 – Positive Results from Phase 1 But Development is Halted
5.3.6 TiGenix Outlook in Summary: Cx601 Reaching End of Development and Represents the Company’s Greatest Strength
5.4 Celyad (formerly Cardio3 BioSciences)
5.4.1 Celyad’s Proprietary Cardiopoiesis Technology Platform – Can be Applied to Various Stem Cell Sources
5.4.2 C-Cure: Stem Cell Therapy for the Treatment of Heart Failure
5.4.2.1 C-Cure: Two Phase 3 Trials Underway
5.4.3 New Agreements: Possible Extension of C-Cure Into the Asian Market and Customised Automated Manufacturing
5.4.4 Celyad Outlook in Summary: Targeting a Therapeutic Area with High Unmet Need
5.5 Apceth
5.5.1 Proprietary Technology Platform Delivers Therapeutic Genes Directly to the Target
5.5.2 Agenmestencel-T for the Treatment of GI-tract Adenocarcinoma
5.5.3 Alecmestencel-T for the Treatment of PAOD/CLI
5.5.4 Alecmestencel-L for the Treatment of GvHD
5.5.5 Technology Licensing Agreement With Cynata Therapeutics
5.5.6 Apceth Outlook in Summary: A Variety of Industry Firsts and Positive Outlook, Although Pipeline is in Early Stages
5.6 ReNeuron
5.6.1 CTX Neural Cell Line: Provides Technical and Competitive Advantages
5.6.1.1 CTX for Stroke: Promising Results Lead to Next Stage
5.6.1.2 CTX for Stroke: Phase 2 Study Developments and a Long-Term Observational Study
5.6.1.3 CTX for Critical Limb Ischaemia: Phase 1 Will be Completed This Year
5.6.2 hRPCs for the Treatment of Retinitis Pigmentosa Has Reached Phase 1/2 and is ReNeuron’s First US Clinical Trial
5.6.3 Exosome Technology Platform in Preclinical Trials with Potential in Oncology Treatment
5.6.4 Non-therapeutic Products: ReNcell VM and ReNcell CX, Licensed to Merck Millipore
5.6.5 Recent Developments in the Company: Investment and Collaboration
5.6.6 ReNeuron Revenue, 2012-2015
5.6.7 ReNeuron Outlook in Summary: Underlying Platform a Major Strength and Source of Competitive Advantage
6. Leading Israeli Stem Cell Technology Companies
6.1 Israel: A Strong Presence in Stem Cell Research
6.2 Gamida Cell
6.2.1 Novartis Not to Buy Gamida Cell and Invests Further Instead
6.2.2 NAM Technology Platform
6.2.3 Copper Chelator Based Technology
6.2.4 StemEx: Halted Development
6.2.5 NiCord – Aiming for a “Paradigm Shift” in Treatment Practice, Receives Orphan Drug Designation
6.2.6 CordIn: New Product in the Pipeline
6.2.7 Gamida Cell Outlook in Summary: Strong Support and Potential
6.3 Cell Cure Neurosciences
6.3.1 Technological Platform to Produce Retinal Pigmented Epithelial Cells for the Treatment of AMD
6.3.2 OpRegen and OpRegen Plus: Product Candidates for Dry AMD
6.3.3 Exclusive Licence Agreement with Teva for OpRegen and Possibly OpRegen Plus
6.3.4 Cell Cure Neurosciences Outlook in Summary: Focusing on Only Retinal Therapies with a Small Pipeline
6.4 Pluristem Therapeutics
6.4.1 PLX Cells: Secretes Therapeutic Proteins in Damaged Tissues
6.4.2 PLX-PAD is in Phase 2 for Intermittent Claudication and Prepares to Initiate Phase 2 for CLI With Further Expansions Planned
6.4.3 PLX-PAD for Injured Gluteal Muscle in Phase 1/2 and for PAH in Phase 1
6.4.4 PLX-R18 for ARS in Preclinical Development
6.4.5 Agreements and Partnerships: Change for Pluristem
6.4.6 Pluristem Therapeutics Revenue, 2012-2015
6.4.7 Pluristem Therapeutics Outlook in Summary: Proprietary Technology and PLX-PAD for Multiple Indications
6.5 BrainStorm Cell Therapeutics
6.5.1 A Proprietary Therapeutic Platform: NurOwn
6.5.2 NurOwn Has Progressed to Phase 2
6.5.3 BrainStorm Outlook in Summary: Financial Support and Manufacturing Optimisation Should Help Develop a Promising Therapy
7. Qualitative Analysis of the Stem Cell Technologies Market, 2016-2026
7.1 SWOT Analysis of the Stem Cell Technologies Market
7.2 Strengths
7.2.1 Recent Approvals of Stem Cell Therapies
7.2.2 Relaxation of Regulatory Barriers
7.2.3 Huge Number of Ongoing Clinical Trials – Should Lead to a Barrage of Approvals over the Coming Years
7.2.4 HSCT is Already an Established Procedure
7.3 Weaknesses
7.3.1 Phase 3 Trials Comprise Only a Small Fraction of Present Studies
7.3.2 Regulatory and Reimbursement Concerns
7.3.3 Uncertain Mechanism of Action in Stem Cell Therapies
7.4 Opportunities
7.4.1 Unmet Clinical Needs
7.4.2 Interactions with Related Technologies
7.4.3 Non-Therapeutic Uses: Cord Blood Banking and Cell-Based Assays
7.5 Threats
7.5.1 Financial Risks
7.5.2 Pipeline Failure
7.5.3 Long-term Safety Concerns
7.6 STEP Analysis of the Stem Cell Technologies Market
7.7 Social Factors
7.7.1 Increasing Burden of Disease
7.7.2 Biological Insurance through Stem Cell Banking
7.7.3 Stem Cell Tourism: Opportunities and Threats to the Market
7.7.4 The Overall Pharmaceutical Market Trend Towards Specialised Treatments Will Support Stem Cell Therapy Progress
7.7.5 Trends Towards Emerging Markets and Partnerships Lead to More Complex Business Models
7.8 Technological Factors
7.8.1 Increasing Research Output
7.8.2 IPSC Breakthroughs
7.8.3 Greater Understanding of Stem Cell Differentiation
7.8.4 Biomaterials, Bioprinting, and Other Developments
7.8.5 CRISPR: A Breakthrough in Genome Editing
7.8.6 Technology Will Drive a Trend Towards Collaboration to Access Novel Platforms
7.9 Economic Factors
7.9.1 Grey Market for Stem Cell Therapies
7.9.2 Broad Changes in Healthcare Markets
7.9.3 New Business Models Need to Be Developed
7.9.4 Shift to the Emerging Marketplace
7.10 Political Factors
7.10.1 Controversies and Ethical Objections over Embryonic Stem Cell Research
7.10.2 Strong Support from Some Governments
7.10.3 Pressure to Deregulate the Stem Cell Therapies Market
7.10.4 Restrictive Governmental Policies Due to Economic Recovery Strategies
8. Research Interviews
8.1 Interview with Dr Silviu Itescu, MBBS, FRACP, CEO and Managing Director, Mesoblast Ltd, (ASX:MSB; Nasdaq:MESO), Australia
8.1.1 Mesoblast: An Overview
8.1.2 A Leader in the Stem Cell Technologies Market
8.1.3 Mesoblast’s Most Advanced Stem Cell Product
8.1.4 Mesoblast’s Biggest Strengths
8.1.5 Challenges of the Stem Cell Technologies Market
8.1.6 Future Areas of Focus in the Stem Cell Technology Market
8.1.7 Comparing The Global Stem Cell Technology Market
8.2 Interview with Dr Yael Margolin, PhD, President and CEO, Gamida Cell
8.2.1 An Overview of Gamida Cell and Stem Cells Transplantation
8.2.2 The Advantages of Gamida Cell’s Leading Product
8.2.3 Expanding on Gamida Cell’s Stem Cell Product Portfolio
8.2.4 Dealing With the Difficulties of Bringing a Stem Cell Product to Market
8.2.5 Important Trends and Areas to Focus on in Bringing a Stem Cell Product Through Development
8.2.6 Gamida Cell’s Biggest Strength
8.2.7 NiCord’s Clinical Development
8.2.8 Future Aims in the Stem Cell Technology Market
9. Conclusions
9.1 The US Leads the Field for Stem Cell Research
9.2 Market Remains Under Capitalised and Investment and Partnering is Essential
9.3 The Industry Continues to Innovate New Discoveries
9.4 Industry has Many Barriers to Overcome
9.5 Competition Will Increase from 2016 to 2026
9.6 The Future of the Stem Cells Technologies Market
【レポート販売概要】
■ タイトル:世界のトップ幹細胞企業分析:アメリカ、ヨーロッパ、イスラエル、アジア■ 英文:Pharma Leader Series: Top Stem Cell Companies Report 2016-2026 : Market Analysis and Leading Players in the United States, Europe, Israel and Asia
■ 発行日:2016年4月
■ 調査会社:visiongain
■ 商品コード:VGAIN6041541
■ 調査対象地域:グローバル
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