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- 1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
- Study Reliability and Reporting Limitations
- Disclaimers
- Data Interpretation & Reporting Level
- Quantitative Techniques & Analytics
- Product Definitions and Scope of Study
- 2. MARKET OUTLOOK
- Gene Therapy - Promising Therapy for Future?
- Approved Gene Therapies Fail to Gather Momentum
- Manufacturers Eye International Markets
- 3. MARKET DYNAMICS/TRENDS
- 2009 - A Tumultuous Year for Gene Therapy Industry
- Hope Floats in Gene Therapy
- China - First to Approve Gene Therapy Worldwide
- The Wait Continues for First Gene Therapy in Major Markets
- Table 1: Gene Therapy Clinical Development (2009): Percentage Share Breakdown by Stage (includes corresponding Graph/Chart)
- Cancer Remains the Key Target for Gene Therapy
- Table 2: Clinical Development of Gene Therapy by Targeted Indication (2009): Percentage Breakdown of Number of Trials for Cancer Diseases, Cardiovascular Diseases, Infectious Diseases, Monogenic Diseases, Neurological Diseases and Others (includes corresponding Graph/Chart)
- Adenovirus - The Leading Vector Employed in Gene Therapy
- Table 3: Gene Therapy Clinical Development by Vectors Used (2009): Percentage Breakdown of Number of Trials for Adenovirus, Retrovirus, Plasmid DNA, Vaccinia Virus, Lipofection and Others (includes corresponding Graph/Chart)
- Efficacy - The Key Challenge for Gene Therapy
- Gene Therapy Pipeline Strengthens in Asia
- Counting on the Success Factors
- Factors Influencing Gene Therapy Future Development
- Human Genome Analysis
- Gene Therapy - The Next Generation Cardiovascular Therapy
- Public Support for Gene Therapy
- RNAi Bodes Bright Prospects
- Factors Hampering Market Growth
- Stringent Regulatory Laws in US and Europe Prolong 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 for 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
- Table 4: Gene Therapy Clinical Trials Worldwide (2009): Percentage Breakdown by Gene Type Transferred for Antigen, Cytokine, Tumor Suppressor, Growth Factor, Deficiency, Suicide, and Others (includes corresponding Graph/Chart)
- Table 5: Gene Therapy Clinical Trials (2007): Percentage Breakdown by Geographic Region for US, Europe, Canada, Japan and Rest of World (includes corresponding Graph/Chart)
- Select Gene Therapy Products in Phase III Development (2010)
- Select Gene Therapy Products in Phase II Development (2010)
- Select Gene Therapy Products in Phase I and Pre-Clinical Development (2010)
- Overview of Select Drugs in Pipeline
- Allovectin-7® (Vical Inc.)
- Generx (Cardium Therapeutics)
- Trinam® (Ark Therapeutics)
- TroVax® (Oxford BioMedica)
- Collategene™ (AnGes MG Inc.)
- 5. REVIEW OF MAJOR MARKETS
- United States
- Regulatory Environment
- Food and Drug Administration
- FDA Requires Additional Toxicology and Biodistribution Studies
- IRB and IBC
- NIH
- Europe
- Germany and UK- The Hub of European Gene Therapy Market
- Table 6: Gene Therapy Clinical Trials in Europe (2007): Percentage Breakdown of Number of Trials by Country for UK, Germany, Switzerland, France, Belgium, Netherlands and Others (includes corresponding Graph/Chart)
- Regulatory Environment
- Gene Therapy Advisory Committee
- European Society of Gene and Cell Therapy (ESGCT)
- Study of Regulatory Environment in Select European Countries
- United Kingdom
- Germany
- Italy
- Sweden
- The Netherlands
- Switzerland
- Gene Therapy Industry in Europe and the US - A Comparison
- Japan
- Asia-Pacific
- Gene Therapy Industry in Europe and the US - A Comparison
- World's First Gene Therapy Medicine Approved in China
- Prospects for Gendicine
- Competition
- Rest of World
- 6. GENE THERAPY - AN INSIGHT
- Molecular Basics - The Gene
- Genome - The Information Pool
- Functional Cloning
- Random Sequencing
- Positional Cloning
- What is Gene Therapy?
- A Backdrop
- 1990 Highlights - The Preliminary Gene Therapy Trial
- 1995 Highlights
- 2000 Highlights - Clinical Trials Reaches 400-Milestone
- 2004 Witnesses the First Gene Therapy Drug
- Classical Theory of Gene Therapy
- Ex-Vivo Approach of Gene Therapy
- In-vivo Approach of Gene Therapy
- Types of Gene Therapy
- Monogenic Gene Therapy
- Suicide Gene Therapy
- Antisense Gene Therapy
- Various Approaches
- 7. COMPONENTS OF GENE THERAPY
- Vector
- Delivery Vehicles and Challenges in Use of Viral Vectors
- Gene Delivery - Without Virus
- Non-Viral Products in Pipeline
- Well-known Delivery Approaches for Gene Therapy
- Viral and Non-viral Vectors in Use
- Retroviruses
- Adenoviruses
- Adenoassociated viruses
- Herpes simplex viruses
- Lentiviruses
- Liposomes
- Viral Vectors by Companies involved
- Gene Cassette
- Target cells
- Stem cells
- Differentiated cells
- The Disc: An Excellent Target for Gene Therapy
- 8. REVIEW OF VARIOUS APPROACHES
- Antisense Technology
- Catalytic Ribozyme Technology
- Triple Helix DNA
- 9. 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
- Development Pipeline of Gene Therapies in Parkinson’s Disease
- 10. REGULATORY ENVIRONMENT
- Gene therapy and Regulatory Environment
- Gene Patents - An Overview
- 11. RESEARCH AND DEVELOPMENT
- Amsterdam Molecular Therapeutics to Develop Gene Therapy for Parkinson's Disease
- Researchers Develop Synthetic Gene Vectors to Reduce Body Immune Responses
- 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
- AMT Develops (AAV) Vector-Based Gene Therapy
- Ark Comes Up with New Gene Therapy Delivery Technology
- 12. RECENT INDUSTRY ACTIVITY
- Ceregene Initiates Enrolment for Phase IIb Study for CERE-120 in Parkinson’s Disease
- Oxford BioMedica Releases Phase III Trial Results of TroVax® in Renal Cancer
- AnGes To Carry Out Additional Trial for Collategene™
- Vical Receives Positive Review for Allovectin-7® Phase III Trial
- Cardium and bioRASI Ink Master Services Agreement for Generx
- Ceregene Commences New Phase I/II Trial for CERE-120 in Parkinson's Disease
- GeneVec Discontinues TNFerade Trial in Pancreatic Cancer
- Transgene Grants Novartis an Option to Acquired License to TG4010
- Helmholtz and SIRION Team Up to Develop Gene Therapy for Lymphoid Tumors
- Targeted Genetics to Merge with Biocontrol
- BioSante Merges with Cell Genesys
- Targeted Genetics Sells Off Gene Therapy IP to Genzyme
- Ark Therapeutics Obtains Clearance for Cerepro for Named Patient Use
- StemCells Acquires Stem Cell Sciences
- FDA Clears Ark Therapeutics to Commence Phase III Clinical Trial of Trinam®
- Introgen Therapeutics Files for Bankruptcy
- Cell Genesys Terminates ITAL-2 Trial of GVAX Vaccine in Advanced Prostate Cancer
- Roche Takes Over Mirus Bio Corp.
- FDA Declines Accepting Approval Application for Advexin
- Transgene's TG4010 Therapeutic Vaccine Meets Primary Endpoint in NSCLC
- Ark Therapeutics Obtains SPA for Phase III Study of Trinam® from FDA
- International Consolidated Acquires China Gene
- Ark Therapeutics Acquires 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
- 13. CORPORATE ACTIVITY IN THE RECENT PAST - A PERSPECTIVE BUILDER
- 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
- RheoGene Plans Merger with Intrexon
- Covalon Acquires Gene Therapy Technology from Perfusion
- Inovio Takes Over DNA Expression and Delivery Assets of Valentis
- Mologen Inks Agreement with ONCO
- Aida Acquires Controlling Stake in Qiaer
- Neurologix Inks Licensing Agreement with Diamyd Medical’s Subsidiary
- Takara Inks Collaboration Agreement with Chinese Center for Disease Control
- JDRF Collaborates with Genzyme Corp and AGTC
- Galapagos Collaborates with Arthrogen
- Genzyme Acquires Avigen’s Gene Therapy Assets
- Diamyd Acquires Nurel
- Oxford BioMedica Accords with Sigma-Alrdrich
- Oxford BioMedica Inks Licensing Agreement with Pfizer
- genOway Acquires IngenKO Pty Ltd
- Crucell Strikes a Deal with Two Asian Firms
- Corautus’ VEGF-2 Gene Therapy Gains Recognition from US FDA
- ViroMed Ceases Development of Gene Therapy
- Corautus Genetics Pacts with CSEMC
- Takara Bio Collaborates with Mie University
- Celladon Accords with V-Kardia
- Genzyme Acquires Ilex Oncology
- Genzyme and AGTC Form Collaboration
- Sanofi-Synthelabo Merges with Aventis
- Guidant Forms Collaboration with Columbia and Stony Brook
- Louisiana and Bionomics Team-Up
- Avigen Receives FDA Clearance to Commence Phase I/II Clinical Trial of Av201
- Oxford BioMedica and Viragen Enters into Licensing Agreement
- Oxford BioMedica Signs Licensing Agreement with Merck
- Avigen Starts Gene Therapy Trial for Parkinson’s Disease
- Oxford BioMedica Acquires Chiron Patents
- UA duo Establishes Gene-therapy Firm
- SiBiono Commences Construction of Gene Therapy Facility
- Avigen Receives FDA Approval for Clinical Trial of AV201
- UK GTAC Approves Clinical Trial
- CYGEE Bags patent Approval for Novel Gene Therapy Technology
- Mirus Bio Receives $1.26 million SBIR Grant
- CEGE Trials Novel Gene Therapy
- Avigen Suspends Haemophilia Gene Therapy Trials
- Oxford BioMedica and RPR Enters into Licensing Agreement
- Schering AG Acquires Collateral Therapeutics
- MolMed SpA Buys Rights to RectroNectin
- Avigen Receives US FDA Approval
- Targeted Genetics Receives Patents
- Enzo Biochem Conducts Phase I Studies Related to HIV Treatment
- Eurogene Acquires Oy Quattrogene
- Cardion AG Acquires Tolerance Pharmaceuticals
- Aventis Restructures Gene-Therapy Alliance with Introgen
- Boehringer Ingelheim Austria GmbH Inks Agreement with BIA Separations
- Cell Genesys Establishes New Subsidiary
- Chiron Divests Gene Therapy Manufacturing Facility
- ViroMed Conducts Clinical Trials on Gene Therapy Drug
- EG009 Gene Therapy Doubles Survival Rate of Malignant Glioma Patients in Phase I/II Clinical Trials
- Genteric Receives Patent for Insulin Gene Pill System
- Bayer Corp. Receives Marketing and Distribution Rights to Coagulin-B
- Avigen Receives Patent for Parkinson’s Disease Gene Therapy
- Aventis Acquires License form Electrofect
- DeveloGen Acquires Hepavec
- Targeted Genetics Acquires Genovo Inc
- GenStar Acquires Allegro Inc
- Argonex and Rohm & Haas Company Enter into a Joint Venture
- Nexell Therapeutics and Takara Shuzo Join Forces
- BTG International Inks Licensing Agreement with Avigen
- Oxford BioMedica Awarded US Patents Concerning Retroviral and Lentiviral Systems
- Genteric Receives Gene Therapy Patent
- GenVec Granted Broad Gene Therapy Patent
- 14. FOCUS ON SELECT GLOBAL PLAYERS
- AnGes MG, Inc. (Japan)
- BioSante Pharmaceuticals (US)
- GenVec (US)
- Genzyme Corp. (US)
- Oxford BioMedica (UK)
- Shenzhen SiBiono GeneTech Co., Ltd (China)
- Transgene (France)
- Vical, Inc. (US)
- 15. GLOBAL MARKET PERSPECTIVE
- Table 7: World Current & Future Market Analysis for Gene Therapy - Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart)
- COMPETITIVE LANDSCAPE
- Total Companies Profiled: 100 (including Divisions/Subsidiaries - 105) Region/Country Players
- The United States 64
- Canada 2
- Japan 2
- Europe
- France
- Germany
- The United Kingdom
- Italy
- Rest of Europe 9
- Asia-Pacific (Excluding Japan) 6
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