Human Embryonic Stem Cell (hESC) Research - Global Strategic Business Report

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW
Stem Cells Research: A Sunrise Sector in Biotechnology Arena
Human Embryonic Stem Cells
An Introduction
Embryonic Stem Cells
Sources and Cell Culture
Comparison on Adult and Embryonic Stem Cells
Advantages and Drawbacks of Various Stem Cells
Human Embryonic Stem Cells
The Market Perspective
Timeline for Embryonic Stem Cell Research Activities: Major Events from 1963 through 2014
Issues Hindering Development of hESC Research
Consideration of Best Translational Pathways Pivotal in Ensuring Growth Of hESCs
Ethical Issues and Technical Hurdles Bog Down hESC Research
Teratomas
No Longer an Impediment to Stem Cell Therapy Development
Human Embryonic and Induced Pluripotent Stem Cell Research Trends
Human Embryonic Stem Cell Research: Key Statistical Highlights
Table 1: Worldwide Publication of Hesc research Papers (2007-2013) (includes corresponding Graph/Chart)
Table 2: Average Citations per hESC Paper (includes corresponding Graph/Chart)
Table 3: Average Citations per hiPSC Paper (includes corresponding Graph/Chart)
Research Topics on hESC and hiPSC by Number of Papers Published: 2011-2013
Haploid Human Embryonic Stem Cell Line: The New Frontier
Human Induced Pluripotent Stem Cells Remains Best Alternative for hESC

2. REGULATORY LANDSCAPE
Overview
Human Embryonic Stem Cell Regulations in Select Countries Worldwide
Intellectual Property: WARF Sword Hangs Over New Patents
WARF Fails to Gain Patents in Europe
Diversity in Patent Regimes Pose Tremendous Challenges
International Divide on Patenting Dents hESC Research

3. HESC APPLICATION AND CLINICAL TRIALS
Drug Testing
Clinical Applications
hESC-derived Cardiomyocytes Helps in Better Identification of Cardiotoxicity
hESC-derived Cardiomyocytes Provides Physiological Relevant Model For Testing Drug Toxicity
Human Pluripotent Stem Cells Hold Immense Potential in Treating Lung Diseases
Liver Cells Derived from hESC Shows Potential Benefits in Enabling Drug Development and Modeling Liver Diseases
Researchers Succeed in Creating Human Kidney from hESCs
hESC offers Hope for Patients with Spinal Cord Injury
hESC to Enable Better treatment of Neurodegenerative Disorders
Amyotrophic Lateral Sclerosis (ALS)
Huntington disease
Parkinson Disease
hESC Derivatives Showing Way Forward for Eye-related Disorders
Age-related Macular Degeneration (AMD)
Stargardt Disease
Myopic Macular Degeneration
Human Embryonic Stem Cells Provide New Options in Fight against Diabetes
Type I Diabetes Mellitus
Type II Diabetes Mellitus
Human Stem Cells Pioneering Heart Disease Treatment
hESC Opens Up New Vistas for Dental Treatment

4. COMPETITIVE LANDSCAPE
Overview
Select Global Players Involved in Developing hESC and iPSC- based Drugs and Products
Astellas Institute of Regenerative Medicine (US)
Asterias Biotherapeutics, Inc. (US)
BD Biosciences (US)
Cell Cure Neurosciences Ltd. (Israel)
Cellular Dynamics International (US)
GE Healthcare (UK)
MilliporeSigma (US)
PerkinElmer, Inc. (US)
Reliance Life Sciences Ltd. (India)
Research & Diagnostics Systems, Inc. (US)
SABiosciences Corp. (US)
STEMCELL Technologies, Inc. (Canada)
Stemina Biomarker Discovery, Inc. (US)
Takara Bio, Inc. (Japan)
TATAA Biocenter AB (Sweden)
Thermo Fisher Scientific, Inc. (US)
UK Stem Cell Bank (UK)
ViaCyte, Inc. (US)
Vitrolife AB (Sweden)

5. REGIONAL MARKET OVERVIEW
The United States
Market Overview
Funding in Human Embryonic Stem Cell Research Showing Steady Increase
Table 4: NIH Funding for hESC Research: FY2014
FY2016E (includes corresponding Graph/Chart)
Table 5: Stem Cell Research Funding by NIH: Funding of Select Stem Cells Segments for FY2014
FY2016E (includes corresponding Graph/Chart)
Stem Cell Research, including hESC, Attract State Funding
Policy Framework Structure on hESC Research in the US
Scientific Advice
Clinical Research
Legislative Position of Select US States Human Stem Cell Regulation
A Brief Overview on Major Regulations for hESC in the US
Ethical Issues Marr hESC Research Market
Role of National Academies in Human Embryonic Stem Cell Research in US
Embryonic Stem Cell Research Oversight Committees
Opposition Continues in Certain States; Oklahoma Vetoes hESC Research in the State
Previous Anti-hESC Research Policy Puts the US at a Disadvantage
Wisconsin Alumni Research Foundation: An Enduring but Controversial Legacy
The Consumer Watchdog versus WARF Case
Timeline of Consumer Watchdog versus Wisconsin Alumni Research Foundation Case
Impact of WARF versus Consumer Watchdog case on the hESC market
Major Clinical Trials Being Undertaken in hESC Research Space
A Glance on Select hESC Clinical Trials Underway in the US
Europe
Market Overview
Overview of Legislations on hESC in Europe
hESC Research Legislation in Select EU Countries
Policy Framework Overview
Clinical Research
Major Regulations Covering hESC Market on Pan-European Scale
A Glance over Key EU Regulations Governing Human Stem Cell Research
Major Differences between EU and the US Legislations
Europe Readies €80-Billion War Chest for Research Purposes
Patent Laws in EU Covering hESCs
European Court of Justice’s Clarity on Patents to Boost European hESC Research
EC’s Stand on hESC Research to Aid Further Infusion of Funding
Rest of World
Asia-Pacific
Overview
hESC Research in Select Regional Markets
China
Chinese hESC Industry in Rapid Development Mode
Stem Cell Tourism Powering Chinese hESC Research Market
Liberal Chinese Cultural Ethos Power hESC Research
Government Funding
A Major Source in Chinese hESC Research Market
Moral, Political and Material Risks Mar Chinese hESC Research Market
Public acceptability and Moral Standards Govern Chinese Patent Law
Despite flaws, Ethical Guidelines Enables Rapid Development of hESC Research Market
India
Regenerative Medicine and Stem Cell Biology Gaining Ground in India
India Streamlines Stem Cell Research Industry
Brief Overview on Major Research Undertakings in Stem Cell Research
Korea
Stem Cell Research Resumes at a Gradual Pace in Korea Following Years of Hiatus
Brazil
Brazilian hESC Research Market- An Overview
Timeline of Major Historical Events in Brazilian Stem Cell Research
The MiHeart Study Project
A Case of Successful Initiative
Role of Media in Brazilian Stem Cell Therapy Research Field

6. RECENT INDUSTRY ACTIVITY
DSMB Grants Approval for Cell Cure Neurosciences’ Second Cohort OpRegen® Clinical Trial
Thermo Fisher Takes Over MTI-GlobalStem
Astellas Pharma Acquires Ocata Therapeutics
Nutech Mediworld Develops HESC therapy for Type-II Diabetes
FDA Grants Fast-Tracks Designation for Cell Cure Neurosciences’ OpRegen®
Takara Bio Completes Acquisition of Cellectis AB

7. GLOBAL MARKET PERSPECTIVE
Table 6: World Recent Past, Current & Future Analysis for Human Embryonic Stem Cell Research
Analyzed with Annual Investment Figures in US$ Million for Years 2014 through 2022 (includes corresponding Graph/Chart)

III. COMPETITIVE LANDSCAPE

Total Companies Profiled: 25 (including Divisions/Subsidiaries 28)

• The United States (16)
• Canada (1)
• Japan (2)
• Europe (7)
  • The United Kingdom (3)
  • Rest of Europe (4)
• Asia-Pacific (Excluding Japan) (1)
• Middle East (1)