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GENE THERAPY - A GLOBAL MARKET REPORT   

Research Abstract

This report analyzes the Global market for Gene Therapy in US$ Million. Annual estimates and forecasts are provided for the period 2007 through 2015. The report profiles 101 companies including many key and niche players such as AnGes MG, Inc., BioSante Pharmaceuticals, GenVec, Genzyme Corp., 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 mostly extracted from URL research and reported select online sources.

Code : MCP-1127
Price : $4500
Companies : 101
Pages : 447
Date : January 2011
Market Data Tables : 7

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 TABLE OF CONTENTS

  GENE THERAPY (Complete Report) Pages : 447   | $4500
 
  1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS.......13 $295  
   Study Reliability and Reporting Limitations.......1  
   Disclaimers.......2
Data Interpretation & Reporting Level.......2
  
   Quantitative Techniques & Analytics.......3
Product Definitions and Scope of Study.......3
  
  2. MARKET OUTLOOK.......4   
   Gene Therapy – Promising Therapy for Future?.......4
Approved Gene Therapies Fail to Gather Momentum.......4
1$100
   Manufacturers Eye International Markets.......51$100
  3. MARKET DYNAMICS/TRENDS.......67 $950  
   2009 – A Tumultuous Year for Gene Therapy Industry.......6
Hope Floats in Gene Therapy.......6
1$100
   China – First to Approve Gene Therapy Worldwide.......7
The Wait Continues for First Gene Therapy in Major Markets.......7
Table 1: Gene Therapy Clinical Development (2009): Percentage Share Breakdown by Stage (includes corresponding Graph/Chart).......7
1$350
   Cancer Remains the Key Target for Gene Therapy.......8
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).......8
Adenovirus – The Leading Vector Employed in Gene Therapy.......8
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).......8
Efficacy – The Key Challenge for Gene Therapy.......8
1$350
   Gene Therapy Pipeline Strengthens in Asia.......9
Counting on the Success Factors.......9
1$100
   Factors Influencing Gene Therapy Future Development.......10
Human Genome Analysis.......10
Gene Therapy - The Next Generation Cardiovascular Therapy.......10
Public Support for Gene Therapy.......10
RNAi Bodes Bright Prospects.......10
Factors Hampering Market Growth.......10
Stringent Regulatory Laws in US and Europe Prolong Gene Therapy Development.......10
1$100
   Identifying Genetic Fault.......11
Immune Response.......11
Delivering Genetic Materials into Patient Cells.......11
1$100
   Multigene Disorders.......12
Side Effects.......12
Push Towards Germline Gene Transfer.......12
Technical Limitations.......12
1$100
  4. THE GLOBAL LANDSCAPE.......137 $950  
   Alliances and Acquisitions – Strategy for Success.......13
Patent Pooling: Yet Another Obstacle.......13
Commercialization: A Road Uphill.......13
1$100
   Time Line in Gene Therapy Drug Development.......14
Target Diseases and Players Involved.......14
1$100
   Key Players by Application Area.......15
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).......15
1$350
   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).......16
Select Gene Therapy Products in Phase III Development (2010).......16
Select Gene Therapy Products in Phase II Development (2010).......16
1$350
   Select Gene Therapy Products in Phase I and Pre-Clinical Development (2010).......17
Overview of Select Drugs in Pipeline.......17
Allovectin-7® (Vical Inc.).......17
1$100
   Generx (Cardium Therapeutics).......18
Trinam® (Ark Therapeutics).......18
TroVax® (Oxford BioMedica).......18
1$100
   Collategene™ (AnGes MG Inc.).......191$100
  5. REVIEW OF MAJOR MARKETS.......209 $950  
   United States.......20
Regulatory Environment.......20
Food and Drug Administration.......20
FDA Requires Additional Toxicology and Biodistribution Studies.......20
1$100
   IRB and IBC.......21
NIH.......21
1$100
   Europe.......22
Germany and UK- The Hub of European Gene Therapy Market.......22
1$100
   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).......23
Regulatory Environment.......23
Gene Therapy Advisory Committee.......23
1$350
   European Society of Gene and Cell Therapy (ESGCT).......24
Study of Regulatory Environment in Select European Countries.......24
United Kingdom.......24
1$100
   Germany.......25
Italy.......25
Sweden.......25
The Netherlands.......25
Switzerland.......25
Gene Therapy Industry in Europe and the US – A Comparison.......25
1$100
   Japan.......26
Asia-Pacific.......26
Gene Therapy Industry in Europe and the US – A Comparison.......26
1$100
   World's First Gene Therapy Medicine Approved in China.......27
Prospects for Gendicine.......27
1$100
   Competition.......28
Rest of World.......28
1$100
  6. GENE THERAPY - AN INSIGHT.......294 $295  
   Molecular Basics – The Gene.......29
Genome – The Information Pool.......29
Functional Cloning.......29
Random Sequencing.......29
1$100
   Positional Cloning.......30
What is Gene Therapy?.......30
A Backdrop.......30
1990 Highlights - The Preliminary Gene Therapy Trial.......30
1995 Highlights.......30
1$100
   2000 Highlights – Clinical Trials Reaches 400-Milestone.......31
2004 Witnesses the First Gene Therapy Drug.......31
Classical Theory of Gene Therapy.......31
Ex-Vivo Approach of Gene Therapy.......31
In-vivo Approach of Gene Therapy.......31
1$100
   Types of Gene Therapy.......32
Monogenic Gene Therapy.......32
Suicide Gene Therapy.......32
Antisense Gene Therapy.......32
Various Approaches.......32
1$100
  7. COMPONENTS OF GENE THERAPY.......335 $395  
   Vector.......33
Delivery Vehicles and Challenges in Use of Viral Vectors.......33
Gene Delivery – Without Virus.......33
1$100
   Non-Viral Products in Pipeline.......34
Well-known Delivery Approaches for Gene Therapy.......34
1$100
   Viral and Non-viral Vectors in Use.......35
Retroviruses.......35
Adenoviruses.......35
Adenoassociated viruses.......35
Herpes simplex viruses.......35
Lentiviruses.......35
1$100
   Liposomes.......36
Viral Vectors by Companies involved.......36
Gene Cassette.......36
Target cells.......36
Stem cells.......36
Differentiated cells.......36
1$100
   The Disc: An Excellent Target for Gene Therapy.......371$100
  8. REVIEW OF VARIOUS APPROACHES.......38   
   Antisense Technology.......38
Catalytic Ribozyme Technology.......38
Triple Helix DNA.......38
2$200
  9. GENE THERAPY FOR DISEASE TREATMENT.......408 $595  
   Gene Therapy for Cancer Treatment.......40
Gene Transfer and Gene Therapeutic Concepts in Cancer.......40
1$100
   Competitive Landscape in Cancer Gene Therapy.......41
Gene Therapy Mechanism in Cancer.......41
1$100
   Advantages Over Chemotherapy.......42
Developments in Cancer Gene Therapy.......42
P53 Gene Therapy – A Novel Approach in Cancer Treatment.......42
1$100
   Gendicine – From Concept to Reality.......43
Vaccines.......43
Gene Therapy for Cardiovascular Disease.......43
1$100
   Cardiovascular Gene Therapy Products under Trial.......44
Gene Therapy for Cystic Fibrosis Disease.......44
1$100
   Gene Therapy for Haemophilia B.......45
Gene Therapy for AIDS/HIV.......45
Gene Therapy for Parkinson’s Disease.......45
The Disease.......45
1$100
   Therapy.......461$100
   Development Pipeline of Gene Therapies in Parkinson’s Disease.......471$100
  10. REGULATORY ENVIRONMENT.......48   
   Gene therapy and Regulatory Environment.......48
Gene Patents - An Overview.......48
1$100
  11. RESEARCH AND DEVELOPMENT.......493 $295  
   Amsterdam Molecular Therapeutics to Develop Gene Therapy for Parkinson's
  Disease.......49
Researchers Develop Synthetic Gene Vectors to Reduce Body Immune Responses.......49
1$100
   Illumina Brings Digital Gene Expression Applications.......50
MolMed Develops Gene Therapy Based Treatment for Skin Cancer.......50
Santaris Pharma Develops New Therapy to Lower Cholesterol Level.......50
Researchers Develop Gene Therapy for Severe Burns.......50
1$100
   AMT Develops (AAV) Vector-Based Gene Therapy.......51
Ark Comes Up with New Gene Therapy Delivery Technology.......51
1$100
  12. RECENT INDUSTRY ACTIVITY.......529 $595  
   Ceregene Initiates Enrolment for Phase IIb Study for CERE-120 in Parkinson’s
  Disease.......52
Oxford BioMedica Releases Phase III Trial Results of TroVax® in Renal Cancer.......52
AnGes To Carry Out Additional Trial for Collategene™.......52
1$100
   Vical Receives Positive Review for Allovectin-7® Phase III Trial.......53
Cardium and bioRASI Ink Master Services Agreement for Generx.......53
Ceregene Commences New Phase I/II Trial for CERE-120 in Parkinson's Disease.......53
GeneVec Discontinues TNFerade Trial in Pancreatic Cancer.......53
1$100
   Transgene Grants Novartis an Option to Acquired License to TG4010.......54
Helmholtz and SIRION Team Up to Develop Gene Therapy for Lymphoid Tumors.......54
1$100
   Targeted Genetics to Merge with Biocontrol.......55
BioSante Merges with Cell Genesys.......55
Targeted Genetics Sells Off Gene Therapy IP to Genzyme.......55
Ark Therapeutics Obtains Clearance for Cerepro for Named Patient Use.......55
1$100
   StemCells Acquires Stem Cell Sciences.......56
FDA Clears Ark Therapeutics to Commence Phase III Clinical Trial of Trinam®.......56
Introgen Therapeutics Files for Bankruptcy.......56
1$100
   Cell Genesys Terminates ITAL-2 Trial of GVAX Vaccine in Advanced Prostate
  Cancer.......57
Roche Takes Over Mirus Bio Corp........57
FDA Declines Accepting Approval Application for Advexin.......57
1$100
   Transgene's TG4010 Therapeutic Vaccine Meets Primary Endpoint in NSCLC.......58
Ark Therapeutics Obtains SPA for Phase III Study of Trinam® from FDA.......58
International Consolidated Acquires China Gene.......58
Ark Therapeutics Acquires Lymphatix.......58
1$100
   Oxford BioMedica Obtains Rights for RNAi Technology.......59
Gene Bridges Inks Licensing Agreement with Genencor.......59
AMT Enters into R&D Agreement with NIH.......59
1$100
   VGX Inks Supply Agreement with a U.K. Consortium.......601$100
  13. CORPORATE ACTIVITY IN THE RECENT PAST – A PERSPECTIVE BUILDER.......6117 $950  
   Cardium Therapeutics Receives Fast Track Designation for Generx™.......61
Oxford Biomedica’s ProSavin Enters Phase I/II Trial.......61
Lentigen Acquires Gene Delivery Technology from Cell Genesys.......61
VIRxSYS Acquires SMaRT™ RNA Technology.......61
1$100
   Gene Logic Divests Genomics Assets.......62
Genzyme Inks Agreement with Ceregene.......62
Silence Therapeutics Extends Agreement with Quark.......62
Benda Inks HIV Vaccine Joint Venture with DNAVEC.......62
Research Dynamics Bags Contract for Multicenter Clinical Study.......62
1$100
   Thermo Fischer Collaborates with Lentigen to Develop Gene-Silencing Technology.......63
Fovea Enters into Collaboration with GENZYME Corporation.......63
Oxford BioMedica Inks Licensing Agreement with Children’s Hospital.......63
Sigma and Oxford Sign Joint License Agreement for LentiVector Technology.......63
1$100
   Benda Attains Additional Stake in SiBiono.......64
Oxford BioMedica Acquires Oxxon.......64
Oxford BioMedica and Sanofi-Aventis Agrees to Co-Develop and Market TroVax.......64
Illumina Completes Acquisition of Solexa.......64
1$100
   RheoGene Plans Merger with Intrexon.......65
Covalon Acquires Gene Therapy Technology from Perfusion.......65
Inovio Takes Over DNA Expression and Delivery Assets of Valentis.......65
Mologen Inks Agreement with ONCO.......65
1$100
   Aida Acquires Controlling Stake in Qiaer.......66
Neurologix Inks Licensing Agreement with Diamyd Medical’s Subsidiary.......66
Takara Inks Collaboration Agreement with Chinese Center for Disease Control.......66
JDRF Collaborates with Genzyme Corp and AGTC.......66
1$100
   Galapagos Collaborates with Arthrogen.......67
Genzyme Acquires Avigen’s Gene Therapy Assets.......67
Diamyd Acquires Nurel.......67
Oxford BioMedica Accords with Sigma-Alrdrich.......67
1$100
   Oxford BioMedica Inks Licensing Agreement with Pfizer.......68
genOway Acquires IngenKO Pty Ltd.......68
Crucell Strikes a Deal with Two Asian Firms.......68
Corautus’ VEGF-2 Gene Therapy Gains Recognition from US FDA.......68
ViroMed Ceases Development of Gene Therapy.......68
Corautus Genetics Pacts with CSEMC.......68
1$100
   Takara Bio Collaborates with Mie University.......69
Celladon Accords with V-Kardia.......69
Genzyme Acquires Ilex Oncology.......69
Genzyme and AGTC Form Collaboration.......69
Sanofi-Synthelabo Merges with Aventis.......69
1$100
   Guidant Forms Collaboration with Columbia and Stony Brook.......70
Louisiana and Bionomics Team-Up.......70
Avigen Receives FDA Clearance to Commence Phase I/II Clinical Trial of Av201.......70
Oxford BioMedica and Viragen Enters into Licensing Agreement.......70
Oxford BioMedica Signs Licensing Agreement with Merck.......70
Avigen Starts Gene Therapy Trial for Parkinson’s Disease.......70
1$100
   Oxford BioMedica Acquires Chiron Patents.......71
UA duo Establishes Gene-therapy Firm.......71
SiBiono Commences Construction of Gene Therapy Facility.......71
Avigen Receives FDA Approval for Clinical Trial of AV201.......71
UK GTAC Approves Clinical Trial.......71
1$100
   CYGEE Bags patent Approval for Novel Gene Therapy Technology.......72
Mirus Bio Receives $1.26 million SBIR Grant.......72
CEGE Trials Novel Gene Therapy.......72
Avigen Suspends Haemophilia Gene Therapy Trials.......72
Oxford BioMedica and RPR Enters into Licensing Agreement.......72
Schering AG Acquires Collateral Therapeutics.......72
1$100
   MolMed SpA Buys Rights to RectroNectin.......73
Avigen Receives US FDA Approval.......73
Targeted Genetics Receives Patents.......73
Enzo Biochem Conducts Phase I Studies Related to HIV Treatment.......73
Eurogene Acquires Oy Quattrogene.......73
1$100
   Cardion AG Acquires Tolerance Pharmaceuticals.......74
Aventis Restructures Gene-Therapy Alliance with Introgen.......74
Boehringer Ingelheim Austria GmbH Inks Agreement with BIA Separations.......74
Cell Genesys Establishes New Subsidiary.......74
Chiron Divests Gene Therapy Manufacturing Facility.......74
ViroMed Conducts Clinical Trials on Gene Therapy Drug.......74
1$100
   EG009 Gene Therapy Doubles Survival Rate of Malignant Glioma Patients in Phase I/II
  Clinical Trials.......75
Genteric Receives Patent for Insulin Gene Pill System.......75
Bayer Corp. Receives Marketing and Distribution Rights to Coagulin-B.......75
Avigen Receives Patent for Parkinson’s Disease Gene Therapy.......75
Aventis Acquires License form Electrofect.......75
DeveloGen Acquires Hepavec.......75
1$100
   Targeted Genetics Acquires Genovo Inc.......76
GenStar Acquires Allegro Inc.......76
Argonex and Rohm & Haas Company Enter into a Joint Venture.......76
Nexell Therapeutics and Takara Shuzo Join Forces.......76
BTG International Inks Licensing Agreement with Avigen.......76
1$100
   Oxford BioMedica Awarded US Patents Concerning Retroviral and Lentiviral
  Systems.......77
Genteric Receives Gene Therapy Patent.......77
GenVec Granted Broad Gene Therapy Patent.......77
1$100
  14. FOCUS ON SELECT GLOBAL PLAYERS.......784 $395  
   AnGes MG, Inc. (Japan).......78
BioSante Pharmaceuticals (US).......78
1$100
   GenVec (US).......791$100
   Genzyme Corp. (US).......80
Oxford BioMedica (UK).......80
1$100
   Shenzhen SiBiono GeneTech Co., Ltd (China).......81
Transgene (France).......81
Vical, Inc. (US).......81
1$100
  15. GLOBAL MARKET PERSPECTIVE.......82   
   Table 7: World Current & Future Market Analysis for Gene Therapy – Annual Sales Figures in US$ Million for Years 2007 through 2015 (includes corresponding Graph/Chart).......821$350
COMPETITION 359$995
  
Total Companies Profiled: 101 (including Divisions/Subsidiaries - 106)

Region/Country                 Players


The United States                 65   
Canada                             2
Japan                              2
Europe                            31
     France                        4
     Germany                       7
     The United Kingdom            9
     Italy                         2
     Rest of Europe                9
Asia-Pacific (Excluding Japan)     6
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