Gene Therapy - Worldwide Market Challenges & Opportunities

1.METHODOLOGY
Study Reliability and Reporting Limitations
Disclaimers
Quantitative Techniques & Reporting Level
2.MARKET DYNAMICS
Future – On a Promising Note
Market Predictions Thrive On
China – First to Hit the Market
Counting on the Success Factors
Global Market Analysis
3.KEY ISSUES/TRENDS
Factors Influencing Gene Therapy Future Development
Human Genome Analysis
Gene Therapy - The Next Generation Cardiovascular Therapy
Public Support for Gene Therapy
RNAi Bode Bright Prospects
Factors Hampering Market Growth
Stringent Regulatory Laws in US and Europe Prolongs Gene Therapy Development
Identifying Genetic Fault
Immune Response
Delivering Genetic Materials into Patient Cells
Multigene Disorders
Side Effects
Push Towards Germline Gene Transfer
Technical Limitations
4.THE GLOBAL LANDSCAPE
Alliances and Acquisitions – Strategy to Success
Patent Pooling: Yet Another Obstacle
Commercialization: A Road Uphill
Time Line in Gene Therapy Drug Development
Target Diseases and Players Involved
Key Players by Application Area
Various Gene Therapy Products Under Development (2007)
Gene Therapy Industry in Europe and the US – A Comparison
5.REVIEW OF MAJOR MARKETS
United States
Regulatory Environment
Food and Drug Administration
FDA Requires Additional Toxicology and Biodistribution Studies
CBER
IRB and IBC
NIH
Europe
Germany and UK- The Hub of European Gene Therapy Market
Regulatory Environment
Gene Therapy Advisory Committee
European Society of Gene and Cell Therapy (ESGCT)
Study of Regulatory Environment in Select European Countries
United Kingdom
Medicines and Healthcare Products Regulatory Agency
Germany
Italy
Sweden
The Netherlands
Switzerland
Japan
Asia-Pacific
World's First Gene Therapy Medicine Approved in China
Prospects for Gendicine
Competition
Gene Therapy Formulations under Clinical Trials by Select Company in China
Rest of World
6.PRODUCT FACTS
Vector
Gene Cassette
Target cells
7.GENE THERAPY FOR DISEASE TREATMENT
Gene Therapy for Cancer Treatment
Gene Transfer and Gene Therapeutic Concepts in Cancer
Competitive Landscape in Cancer Gene Therapy
Gene Therapy Mechanism in Cancer
Advantages Over Chemotherapy
Developments in Cancer Gene Therapy
P53 Gene Therapy – A Novel Approach in Cancer Treatment
Gendicine – From Concept to Reality
Vaccines
Gene Therapy for Cardiovascular Disease
Cardiovascular Gene Therapy Products under Trial
Gene Therapy for Cystic Fibrosis Disease
Gene Therapy for Haemophilia B
Gene Therapy for AIDS/HIV
Gene Therapy for Parkinson’s Disease
The Disease
Therapy
8.REGULATORY ENVIRONMENT
Gene therapy and Regulatory Environment
Gene Patents - An Overview
9.CORPORATE DEVELOPMENTS
International Consolidated to Acquire China Gene
Ark Therapeutics to Acquire Lymphatix
Oxford BioMedica Obtains Rights for RNAi Technology
Gene Bridges Inks Licensing Agreement with Genencor
AMT Enters into R&D Agreement with NIH
VGX Inks Supply Agreement with a U.K. Consortium
Researchers Develop Synthetic Gene Vectors to Reduce Body Immune Responses
Cardium Therapeutics Receives Fast Track Designation for Generx™
Oxford Biomedica’s ProSavin Enters Phase I/II Trial
Lentigen Acquires Gene Delivery Technology from Cell Genesys
VIRxSYS Acquires SMaRT™ RNA Technology
Gene Logic Divests Genomics Assets
Genzyme Inks Agreement with Ceregene
Silence Therapeutics Extends Agreement with Quark
Benda Inks HIV Vaccine Joint Venture with DNAVEC
Research Dynamics Bags Contract for Multicenter Clinical Study
Thermo Fischer Collaborates with Lentigen to Develop Gene- Silencing Technology
Fovea Enters into Collaboration with GENZYME Corporation
Oxford BioMedica Inks Licensing Agreement with Children’s Hospital
Sigma and Oxford Sign Joint License Agreement for LentiVector Technology
Benda Attains Additional Stake in SiBiono
Oxford BioMedica Acquires Oxxon
Oxford BioMedica and Sanofi-Aventis Agrees to Co-Develop and Market TroVax
Illumina Completes Acquisition of Solexa
Illumina Brings Digital Gene Expression Applications
MolMed Develops Gene Therapy Based Treatment for Skin Cancer
Santaris Pharma Develops New Therapy to Lower Cholesterol Level
Researchers Develop Gene Therapy for Severe Burns
10.MAJOR PLAYERS
AnGes MG, Inc. (Japan)
Cell Genesys (US)
GenVec (US)
Genzyme Corporation (US)
Introgen Therapeutics, Inc. (US)
Oxford BioMedica (UK)
Shenzhen SiBiono GeneTech Co., Ltd (China)
Targeted Genetics Corp. (US)
Transgene (France)
Urigen Pharmaceuticals, Inc. (US)
Vical, Inc. (US)
Exhibits
Table 1: Global Gene Therapy Market for the Period 2007-2015 (Sales in US$ Million)
Table 2: Percentage Breakdown of Gene Therapy Clinical Trails by Disease/Application Area in the World -
Table 3: Percentage Breakdown of Gene Therapy Clinical Trials by Gene Type Transferred in the World -
Table 4: Percentage Breakdown of Gene Therapy Clinical Trials by Vector Type in the World -
Table 5: Gene Therapy Clinical Trials by Develpment Phase in the World -
Table 6: Percentage Breakdown of Gene Therapy Clinical Trials by Geographic Region -
Table 7: Percentage Breakdown Gene Therapy Clinical Trials by Country in Europe -
Companies Profiled