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MARKET REPORT DETAIL

Opportunities in Human Embryonic Stem Cell (hESC) Products

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Opportunities in Human Embryonic Stem Cell (hESC) Products
Published Date: Aug, 2013
Format: PDF
No of Pages: 133

 
 
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  • Abstract
  • Table of Contents

EXECUTIVE SUMMARY

Human embryonic stem cells (hESCs) are stem cells derived from the inner cell mass of a blastocyst, which is a stage reached four to five days post-fertilization. Human embryonic stem cells are the most pluripotent of all stem cell types and can develop into over 200 different cell types of the human body.

Human embryonic stem cells were first derived from mouse embryos in 1981 by Martin Evans and Matthew Kaufman, and independently by Gail R. Martin. In 1995, the first successful culturing of embryonic stem cells from non-human primates occurred at the University of Wisconsin-Madison. Another breakthrough followed at the University of Wisconsin-Madison in November 1998 when a group led by Dr. James Thomson developed a technique to isolate and grow hESCs derived from human blastocysts. Federal funds to support hESC research became available on August 9, 2001, when President Bush announced his decision regarding federal funding for hESC research.

Because of their plasticity and unlimited capacity for self-renewal, hESCs have been proposed for use in wide range of applications, including toxicology testing, tissue engineering, cellular therapies, and basic stem cell biology research. Of particular interest to the medical community is the potential for use of hESCs to heal tissues with naturally limited capacity for renewal, such as the human heart, liver and brain.

However, human embryonic stem cell research is heavily encumbered by patents held by the University of Wisconsin's Wisconsin Alumni Research Foundation (WARF), which creates significant challenges for companies seeking to develop new products.

This market research report explores the complex IP landscape affecting development of human embryonic stem cell products, providing clear guidance for companies entering or already within the market, from collaborating with WARF to less costly alternatives - such as circumventing the claims, conducting research off-shore, and developing embryonic stem cell products for other species.

Key Findings Include:

Trends for hESC Grants, Scientific Publications, and Patents
Market Size Determination for the hESC Product Market
5-Year Market Size Projections (2013-2017)
Embryonic Stem Cell Patent Restrictions and Strategies to Circumvent Claims
Geographical Breakdown (Leading Countries Conducting hESC Research)
Breakdown of Embryonic Stem Cell Research, by Application and Species
Competitive Analysis of hESC Research Supply Vendors
Overview of Specialty Pharma Companies Developing Embryonic Stem Cell Therapies
Overview of Toxicology Testing Legislation (impacting use of hESC in toxicology applications)
Crucial Trends and Unmet Market Needs
And Much More

TABLE OF CONTENTS

I. BACKGROUND
A. Human Embryonic Stem Cells (hESC)
B. Brief History
C. Use in Treatment of Disease
D. Human Embryonic Stem Cell Line Availability

II. AVAILABLE STEM CELL LINES
A. NIH Registry Approved
B. Sources of Additional Published hESC Lines
C. Sources of Additional Unpublished hESC Lines

III. APPLICATIONS
A. Basic Stem Cell Biology
B. Cellular Therapies
1. Overview
2. Heart Regeneration
3. Pancreatic Islet Cell Replacement
4. Neural Regeneration C. Tissue Engineering
D. Toxicology Testing

IV. APPLICATION PRIORITIES
A. Overall
1. Cell-Based Therapies: Greatest shared priority across research community
a. Beneficial hESC Characteristics
b. hESC Safety Concerns
c. hESC Characterization in Vitro
d. hESC Characterization in Vivo
2. Toxicology Assessment: Another area of huge potential
a. Overview
b. Commercial Interest
B. By Segment
1. Academic
2. Biotech
3. Pharma

V. PATENT ENVIRONMENT
A. Landmark hESC Patents: WARF “Composition of Matter” Patents
1. Background
2. Licensing of WARF Patent Rights
a. Overview of WARF Licensees
b. Recent WARF Licensee: Pfizer, Inc.
3. WARF Patent Exemption: Federal Rights to hESC Research
4. U.S. WARF Patent Challenges
5. Circumventing WARF Patent Rights Using Geographic Limitations
B. Global Stem Cell Patent Landscape
C. U.S. Patents of Importance
1. Geron Corporation Patents
2. Regents of the University of California Patents
3. BresaGen, Inc. Patents
4. Regeneron Pharmaceuticals, Inc.
5. Vanderbuilt University Patents
D. Worldwide Patents of Importance
1. ES Cell International PTE Ltd. Patents (Singapore)
2. DNAVEC Research Inc. Patents (Ibaraki, JP)
3. University of Edinburgh Patents (Edinburgh, GB)
E. Summary of the hESC Intellectual Property Landscape

VI. HISTORICAL AND FUTURE GROWTH PROJECTIONS
A. Scientific Publication Analysis
1. Historical Analysis (Trailing 10 Years)
2. Future Growth Predictions (5-Year Forecasts)
3. Breakdown of ESC Research by Species
B. Grant Analysis
C. Patent Analysis
1. All Fields
2. Abstract Only
D. Market Size Quantification
E. Key Research Applications
1. Size of Market Segments
2. Trend Data
F. Geographical Breakdown (Leading Countries Conducting hESC Research)

VII. hESC PRODUCT COMPETITORS
A. Cellartis AB
1. Human embryonic stem cell lines
2. Monoclonal Antibodies for hESC Research
3. Differentiated Cell Products
4. Associated hESC products
B. Vitrolife
C. Tataa Biocenter
D. Invitrogen
1. hESC Culture Media & Reagents
2. hESC-qualified Basement Membrane Extract
3. hESC cDNA Libraries
4. hESC Reporter Cells
5. hESC PCR Kits
6. hESC Stem Cell Antibodies
7. hESC Stem Cell Growth Factors
E. Stem Cell Technologies
1. hESC Culture Media & Reagents
2. hESC Primary & Secondary Antibodies
F. BD Biosciences
G. Chemicon
1. hESC Culture Media and Reagents
2. hESC Lines
3. hESC Kits
4. hESC Antibodies
H. R&D Systems
I. SA Biosciences
J. Thermo Scientific
K. Australian Stem Cell Centre

VIII. SPECIALTY PHARMACEUTICAL COMPANIES DEVELOPING hESC THERAPIES
A. Geron
B. Novocell
C. Cell Cure Neurosciences Ltd
D. Cell Dynamics International
E. Advanced Cell Technology

IX. FEATURED LABS (POTENTIAL CUSTOMERS)
A. Academic Labs
B. Private Labs
C. Government Labs
D. International Labs

X. TOXICOLOGY TESTING LEGISLATION
A. European Union to Ban Animal-Testing for Cosmetic Development in 2009
B. Responses to the European Ban on Animal Testing for Cosmetic Development
1. Overview
2. Skin Irritation
3. Eye Irritation
4. Skin Sensitisation
5. Mutagenicity/Genotoxicity
6. Reproductive Toxicity
C. EU Legislation Regarding Animal-Based Testing for Drug Discovery

XI. PRODUCT DEVELOPMENT GUIDANCE
A. Product Categories
1. hESCs
2. hESC Derivative Cells
3. hESC Reporter Cells
4. hESC Antibodies
5. hESC Characterization & PCR Kits
6. hESC Qualified BME
7. hESC cDNA Libraries
8. hESC Growth Factors
9. hESC Media and Culture Reagents
B. Product Ideas & Suggestions
1. Areas of Underdeveloped Competition
2. Mouse ESC Products
3. iPS Cells Products
4. Non-animal-derived Culture Reagents for hESCs
5. Strategic Collaborations
6. Products for generating Pure ESC populations
7. hESC Toxicity Assay Kit

XII. EVENTS OF INTEREST
A. Adult Stem Cell Therapy & Regenerative Medicine
B. 2013 Society for Hematology and Stem Cells, 42nd Annual Scientific Meeting
C. Stem Cells in Translation
D. Life Cycle of Stem Cell Therapies
E. Stem Cells in Science and Medicine
F. 8th Annual Translational Stem Cell Research Conference
G. Shanghai International Symposium on Cancer Stem Cells
H. Stem Cell Congress 2013
I. 1st Annual Conference of the German Stem Cell Network (GSCN)
J. Stem Cell Society Singapore (SCSS) Symposium 2013
K. Cell Symposia: Using Stem Cells to Model and Treat Human Disease
L. World Stem Cell Summit 2013
M. Stem Cells and Reprogramming

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