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Gene Therapy

Abstract

Description

This report analyzes the Global market for Gene Therapy in US$ Million. Annual estimates and forecasts are provided for the period 2009 through 2017. The report profiles 98 companies including many key and niche players such as AnGes MG, Inc., BioSante Pharmaceuticals, GenVec, Oxford BioMedica, Shenzhen SiBiono GeneTech Co., Ltd., Transgene, and Vical Inc. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

  • Study Reliability and Reporting Limitations
  • Disclaimers
  • Data Interpretation & Reporting Level
    • Quantitative Techniques & Analytics
  • Product Definitions and Scope of Study

II. EXECUTIVE SUMMARY

1. MARKET OUTLOOK

  • Gene Therapy - Promising Therapy for Future
  • Approved Gene Therapies Fail to Gather Momentum
  • Manufacturers Eye International Markets

2. 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

3. 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.)

4. REVIEW OF MAJOR MARKETS

  • The 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

5. 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

6. 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

7. REVIEW OF VARIOUS APPROACHES

  • Antisense Technology
  • Catalytic Ribozyme Technology
  • Triple Helix DNA

8. 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

9. REGULATORY ENVIRONMENT

  • Gene therapy and Regulatory Environment
  • Gene Patents - An Overview

10. 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

11. RECENT INDUSTRY ACTIVITY

  • Sanofi-Aventis Snaps Up Genzyme Corp.
  • 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®

12. STRATEGIC CORPORATE DEVELOPMENTS - A HISTORIC PERSPECTIVE BUILDER

  • 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
  • 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

13. FOCUS ON SELECT GLOBAL PLAYERS

  • AnGes MG, Inc. (Japan)
  • BioSante Pharmaceuticals (US)
  • GenVec (US)
  • Oxford BioMedica (UK)
  • Shenzhen SiBiono GeneTech Co., Ltd (China)
  • Transgene (France)
  • Vical, Inc. (US)

14. GLOBAL MARKET PERSPECTIVE

    • Table 7: World Current & Future Market Analysis for Gene Therapy - Annual Sales Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart)

III. COMPETITIVE LANDSCAPE

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