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 2009 through 2017. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain. 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.


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Code: MCP-1127
Price: $4500
Companies: 98
Pages: 433
Date: February 2012
Market Data Tables: 7

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 TABLE OF CONTENTS


 
   Study Reliability and Reporting Limitations.....I-1  
   Disclaimers.....I-2
Data Interpretation & Reporting Level.....I-2
Quantitative Techniques & Analytics.....I-2
  
   Product Definitions and Scope of Study.....I-3  
   Gene Therapy – Promising Therapy for Future.....II-1
Approved Gene Therapies Fail to Gather Momentum.....II-1
1$100
   Manufacturers Eye International Markets.....II-21$100
   2009 – A Tumultuous Year for Gene Therapy Industry.....II-3
Hope Floats in Gene Therapy.....II-3
1$100
   China – First to Approve Gene Therapy Worldwide.....II-4
The Wait Continues for First Gene Therapy in Major Markets.....II-4
Table 1: Gene Therapy Clinical Development (2009): Percentage Share Breakdown by Stage (includes corresponding Graph/Chart).....II-4
1$350
   Cancer Remains the Key Target for Gene Therapy.....II-5
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).....II-5
Adenovirus – The Leading Vector Employed in Gene Therapy.....II-5
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).....II-5
Efficacy – The Key Challenge for Gene Therapy.....II-5
1$350
   Gene Therapy Pipeline Strengthens in Asia.....II-6
Counting on the Success Factors.....II-6
1$100
   Factors Influencing Gene Therapy Future Development.....II-7
Human Genome Analysis.....II-7
Gene Therapy - The Next Generation Cardiovascular Therapy.....II-7
Public Support for Gene Therapy.....II-7
RNAi Bodes Bright Prospects.....II-7
1$100
   Factors Hampering Market Growth.....II-8
Stringent Regulatory Laws in US and Europe Prolong Gene Therapy Development.....II-8
Identifying Genetic Fault.....II-8
Immune Response.....II-8
Delivering Genetic Materials into Patient Cells.....II-8
1$100
   Multigene Disorders.....II-9
Side Effects.....II-9
Push Towards Germline Gene Transfer.....II-9
Technical Limitations.....II-9
1$100
   Alliances and Acquisitions – Strategy for Success.....II-10
Patent Pooling: Yet Another Obstacle.....II-10
Commercialization: A Road Uphill.....II-10
1$100
   Time Line in Gene Therapy Drug Development.....II-11
Target Diseases and Players Involved.....II-11
1$100
   Key Players by Application Area.....II-12
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).....II-12
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).....II-13
Select Gene Therapy Products in Phase III Development (2010).....II-13
1$350
   Select Gene Therapy Products in Phase II Development (2010).....II-14
Select Gene Therapy Products in Phase I and Pre-Clinical Development (2010).....II-14
1$100
   Overview of Select Drugs in Pipeline.....II-15
Allovectin-7® (Vical Inc.).....II-15
Generx (Cardium Therapeutics).....II-15
Trinam® (Ark Therapeutics).....II-15
1$100
   TroVax® (Oxford BioMedica).....II-16
Collategene™ (AnGes MG Inc.).....II-16
1$100
   The United States.....II-17
Regulatory Environment.....II-17
Food and Drug Administration.....II-17
FDA Requires Additional Toxicology and Biodistribution Studies.....II-17
1$100
   IRB and IBC.....II-18
NIH.....II-18
1$100
   Europe.....II-19
Germany and UK- The Hub of European Gene Therapy Market.....II-19
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).....II-20
Regulatory Environment.....II-20
Gene Therapy Advisory Committee.....II-20
1$350
   European Society of Gene and Cell Therapy (ESGCT).....II-21
Study of Regulatory Environment in Select European Countries.....II-21
United Kingdom.....II-21
Germany.....II-21
1$100
   Italy.....II-22
Sweden.....II-22
The Netherlands.....II-22
Switzerland.....II-22
Gene Therapy Industry in Europe and the US – A Comparison.....II-22
1$100
   Japan.....II-23
Asia-Pacific.....II-23
Gene Therapy Industry in Europe and the US – A Comparison.....II-23
1$100
   World's First Gene Therapy Medicine Approved in China.....II-24
Prospects for Gendicine.....II-24
Competition.....II-24
1$100
   Rest of World.....II-251$100
   Molecular Basics – The Gene.....II-26
Genome – The Information Pool.....II-26
Functional Cloning.....II-26
Random Sequencing.....II-26
1$100
   Positional Cloning.....II-27
What is Gene Therapy?.....II-27
A Backdrop.....II-27
1990 Highlights - The Preliminary Gene Therapy Trial.....II-27
1995 Highlights.....II-27
1$100
   2000 Highlights – Clinical Trials Reaches 400- Milestone.....II-28
2004 Witnesses the First Gene Therapy Drug.....II-28
Classical Theory of Gene Therapy.....II-28
Ex-Vivo Approach of Gene Therapy.....II-28
In-vivo Approach of Gene Therapy.....II-28
1$100
   Types of Gene Therapy.....II-29
Monogenic Gene Therapy.....II-29
Suicide Gene Therapy.....II-29
Antisense Gene Therapy.....II-29
Various Approaches.....II-29
1$100
   Vector.....II-30
Delivery Vehicles and Challenges in Use of Viral Vectors.....II-30
Gene Delivery – Without Virus.....II-30
1$100
   Non-Viral Products in Pipeline.....II-31
Well-known Delivery Approaches for Gene Therapy.....II-31
1$100
   Viral and Non-viral Vectors in Use.....II-32
Retroviruses.....II-32
Adenoviruses.....II-32
Adenoassociated viruses.....II-32
Herpes simplex viruses.....II-32
Lentiviruses.....II-32
Liposomes.....II-32
Viral Vectors by Companies involved.....II-32
1$100
   Gene Cassette.....II-33
Target cells.....II-33
Stem cells.....II-33
Differentiated cells.....II-33
The Disc: An Excellent Target for Gene Therapy.....II-33
1$100
   Antisense Technology.....II-34
Catalytic Ribozyme Technology.....II-34
Triple Helix DNA.....II-34
2$200
   Gene Therapy for Cancer Treatment.....II-36
Gene Transfer and Gene Therapeutic Concepts in Cancer.....II-36
1$100
   Competitive Landscape in Cancer Gene Therapy.....II-37
Gene Therapy Mechanism in Cancer.....II-37
1$100
   Advantages Over Chemotherapy.....II-38
Developments in Cancer Gene Therapy.....II-38
P53 Gene Therapy – A Novel Approach in Cancer Treatment.....II-38
1$100
   Gendicine – From Concept to Reality.....II-39
Vaccines.....II-39
Gene Therapy for Cardiovascular Disease.....II-39
1$100
   Cardiovascular Gene Therapy Products under Trial.....II-40
Gene Therapy for Cystic Fibrosis Disease.....II-40
Gene Therapy for Haemophilia B.....II-40
1$100
   Gene Therapy for AIDS/HIV.....II-41
Gene Therapy for Parkinson’s Disease.....II-41
The Disease.....II-41
1$100
   Therapy.....II-42
Development Pipeline of Gene Therapies in Parkinson’s Disease.....II-42
1$100
   Gene therapy and Regulatory Environment.....II-43
Gene Patents - An Overview.....II-43
1$100
   Amsterdam Molecular Therapeutics to Develop Gene Therapy for Parkinson's
  Disease.....II-44
Researchers Develop Synthetic Gene Vectors to Reduce Body Immune Responses.....II-44
1$100
   Illumina Brings Digital Gene Expression Applications.....II-45
MolMed Develops Gene Therapy Based Treatment for Skin Cancer.....II-45
Santaris Pharma Develops New Therapy to Lower Cholesterol Level.....II-45
Researchers Develop Gene Therapy for Severe Burns.....II-45
1$100
   AMT Develops (AAV) Vector-Based Gene Therapy.....II-46
Ark Comes Up with New Gene Therapy Delivery Technology.....II-46
1$100
   Sanofi-Aventis Snaps Up Genzyme Corp......II-47
Ceregene Initiates Enrolment for Phase IIb Study for CERE-120 in Parkinson’s
  Disease.....II-47
Oxford BioMedica Releases Phase III Trial Results of TroVax® in Renal Cancer.....II-47
AnGes To Carry Out Additional Trial for Collategene™.....II-47
1$100
   Vical Receives Positive Review for Allovectin-7® Phase III Trial.....II-48
Cardium and bioRASI Ink Master Services Agreement for Generx.....II-48
Ceregene Commences New Phase I/II Trial for CERE-120 in Parkinson's Disease.....II-48
1$100
   GeneVec Discontinues TNFerade Trial in Pancreatic Cancer.....II-49
Transgene Grants Novartis an Option to Acquired License to TG4010.....II-49
Helmholtz and SIRION Team Up to Develop Gene Therapy for Lymphoid Tumors.....II-49
1$100
   Targeted Genetics to Merge with Biocontrol.....II-50
BioSante Merges with Cell Genesys.....II-50
Targeted Genetics Sells Off Gene Therapy IP to Genzyme.....II-50
Ark Therapeutics Obtains Clearance for Cerepro for Named Patient Use.....II-50
1$100
   StemCells Acquires Stem Cell Sciences.....II-51
FDA Clears Ark Therapeutics to Commence Phase III Clinical Trial of Trinam®.....II-51
1$100
   Introgen Therapeutics Files for Bankruptcy.....II-52
Cell Genesys Terminates ITAL-2 Trial of GVAX Vaccine in Advanced Prostate
  Cancer.....II-52
Roche Takes Over Mirus Bio Corp......II-52
1$100
   FDA Declines Accepting Approval Application for Advexin.....II-53
Transgene's TG4010 Therapeutic Vaccine Meets Primary Endpoint in NSCLC.....II-53
Ark Therapeutics Obtains SPA for Phase III Study of Trinam® from FDA.....II-53
International Consolidated Acquires China Gene.....II-53
1$100
   Ark Therapeutics Acquires Lymphatix.....II-54
Oxford BioMedica Obtains Rights for RNAi Technology.....II-54
Gene Bridges Inks Licensing Agreement with Genencor.....II-54
AMT Enters into R&D Agreement with NIH.....II-54
1$100
   VGX Inks Supply Agreement with a U.K. Consortium.....II-55
Cardium Therapeutics Receives Fast Track Designation for Generx™.....II-55
Oxford Biomedica’s ProSavin Enters Phase I/II Trial.....II-55
Lentigen Acquires Gene Delivery Technology from Cell Genesys.....II-55
1$100
   VIRxSYS Acquires SMaRT™ RNA Technology.....II-56
Gene Logic Divests Genomics Assets.....II-56
Genzyme Inks Agreement with Ceregene.....II-56
Silence Therapeutics Extends Agreement with Quark.....II-56
Benda Inks HIV Vaccine Joint Venture with DNAVEC.....II-56
1$100
   Research Dynamics Bags Contract for Multicenter Clinical Study.....II-57
Thermo Fischer Collaborates with Lentigen to Develop Gene-Silencing Technology.....II-57
Fovea Enters into Collaboration with GENZYME Corporation.....II-57
Oxford BioMedica Inks Licensing Agreement with Children’s Hospital.....II-57
1$100
   Sigma and Oxford Sign Joint License Agreement for LentiVector Technology.....II-58
Benda Attains Additional Stake in SiBiono.....II-58
Oxford BioMedica Acquires Oxxon.....II-58
Oxford BioMedica and Sanofi-Aventis Agrees to Co-Develop and Market TroVax.....II-58
Illumina Completes Acquisition of Solexa.....II-58
1$100
   RheoGene Plans Merger with Intrexon.....II-59
Covalon Acquires Gene Therapy Technology from Perfusion.....II-59
Inovio Takes Over DNA Expression and Delivery Assets of Valentis.....II-59
Mologen Inks Agreement with ONCO.....II-59
1$100
   Aida Acquires Controlling Stake in Qiaer.....II-60
Neurologix Inks Licensing Agreement with Diamyd Medical’s Subsidiary.....II-60
Takara Inks Collaboration Agreement with Chinese Center for Disease Control.....II-60
JDRF Collaborates with Genzyme Corp and AGTC.....II-60
1$100
   Galapagos Collaborates with Arthrogen.....II-611$100
   AnGes MG, Inc. (Japan).....II-62
BioSante Pharmaceuticals (US).....II-62
1$100
   GenVec (US).....II-631$100
   Oxford BioMedica (UK).....II-64
Shenzhen SiBiono GeneTech Co., Ltd (China).....II-64
Transgene (France).....II-64
1$100
   Vical, Inc. (US).....II-651$100
   Table 7: World Current & Future Market Analysis for Gene Therapy – Annual Sales Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart).....II-661$350
  
Total Companies Profiled: 131 (including Divisions/Subsidiaries - 143)

Region/Country Players

The United States 55 Canada 2 Japan 7 Europe 41 France 6 Germany 5 The United Kingdom 11 Spain 2 Rest of Europe 17 Asia-Pacific (Excluding Japan) 34 Latin America 2 Middle East 2
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