World Gene Therapy Market

World Gene Therapy Market

This report analyzes the world market for Gene Therapy in Millions of US$. Annual forecasts are provided for the global market for the period of 2007 through 2015. The report profiles 100 companies including many key and niche players worldwide such as AnGes MG Inc., Cell Genesys, GenVec, Genzyme Corporation, Introgen Therapeutics Inc., Oxford BioMedica, Shenzhen SiBiono GeneTech Co., Ltd., Targeted Genetics Corp., Transgene, Urigen Pharmaceuticals Inc., and Vical. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

GENE THERAPY MCP-1127
A GLOBAL STRATEGIC BUSINESS REPORT


CONTENTS


I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

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


II. A GLOBAL MARKET REPORT

1. Market Dynamics II-1
Future - On a Promising Note II-1
Market Predictions Thrive On II-1
China - First to Hit the Market II-1
Counting on the Success Factors II-1
Global Market Analysis II-2
Table 1: World Current & Future Market Analysis for Gene
Therapy -Annual Sales Figures in US$ Million for Years 2007
through 2015 (includes corresponding Graph/Chart) II-2

2. Key Issues/ Trends II-3
Factors Influencing Gene Therapy Future Development II-3
Human Genome Analysis II-3
Gene Therapy - The Next Generation Cardiovascular Therapy II-3
Public Support for Gene Therapy II-3
RNAi Bode Bright Prospects II-3
Factors Hampering Market Growth II-3
Stringent Regulatory Laws in US and Europe Prolongs Gene
Therapy Development II-3
Identifying Genetic Fault II-4
Immune Response II-4
Delivering Genetic Materials into Patient Cells II-4
Multigene Disorders II-5
Side Effects II-5
Push Towards Germline Gene Transfer II-5
Technical Limitations II-5

3. The Global Landscape II-6
Alliances and Acquisitions - Strategy to Success II-6
Patent Pooling: Yet Another Obstacle II-6
Commercialization: A Road Uphill II-6
Time Line in Gene Therapy Drug Development II-7
Target Diseases and Players Involved II-7
Key Players by Application Area II-7
Table 2: Gene Therapy Clinical Trials Worldwide (2007):
Percentage Breakdown by Disease/ Application Area for
Cancer, Heart Disease, Monogenic Diseases, Infectious
Diseases and Others (includes corresponding Graph/Chart) II-8

Table 3: Gene Therapy Clinical Trials Worldwide (2007):
Percentage Breakdown by Gene Type Transferred for Antigen,
Cytokine, Tumor Suppressor, Growth Factor, Suicide,
Deficiency and Others (includes corresponding Graph/Chart) II-8

Table 4: Gene Therapy Clinical Trials Worldwide (2007):
Percentage Breakdown by Vector Type for Adenovirus,
Retrovirus, Naked/Plasmid DNA, Lipofection, Vaccinia Virus,
Poxvirus, Adeno-associated Virus and Others (includes
corresponding Graph/Chart) II-9

Table 5: Gene Therapy Clinical Trials Worldwide (2007): A
Split by Development Phase (includes corresponding
Graph/Chart) II-9

Table 6: Gene Therapy Clinical Trials (2007): Percentage
Breakdown by Geographic Region for US, Europe, Canada, Japan
and Rest of World (includes corresponding Graph/Chart) II-9
Various Gene Therapy Products Under Development (2007) II-10
Gene Therapy Industry in Europe and the US - A Comparison II-10

4. Review of Major Markets II-12
United States II-12
Regulatory Environment II-12
Food and Drug Administration II-12
IRB and IBC II-13
NIH II-13
Europe II-14
Germany and UK- The Hub of European Gene Therapy Market II-14
Table 7: 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-15
Regulatory Environment II-15
Gene Therapy Advisory Committee II-15
European Society of Gene and Cell Therapy (ESGCT) II-16
Study of Regulatory Environment in Select European Countries II-16
United Kingdom II-16
Germany II-16
Italy II-16
Sweden II-16
The Netherlands II-17
Switzerland II-17
Japan II-17
Asia-Pacific II-17
World's First Gene Therapy Medicine Approved in China II-17
Prospects for Gendicine II-18
Competition II-18
Rest of World II-18

5. Gene Therapy - An Insight II-19
Molecular Basics - The Gene II-19
Genome - The Information Pool II-19
Functional cloning II-19
Random sequencing II-19
Positional cloning. II-20
What is Gene Therapy? II-20
A Backdrop II-20
1990 Highlights - The Preliminary Gene Therapy Trial II-20
1995 Highlights II-20
2000 Highlights - Clinical Trials Reaches 400- Milestone II-20
2004 Witnesses the First Gene Therapy Drug II-21
Classical Theory of Gene Therapy II-21
Ex-Vivo Approach of Gene Therapy II-21
In-vivo Approach of Gene Therapy II-21
Types of Gene Therapy II-21
Monogenic Gene Therapy II-21
Suicide Gene Therapy II-22
Antisense Gene Therapy II-22
Various Approaches II-22

6. Components of Gene Therapy II-23
Vector II-23
Delivery Vehicles and Challenges in Use of Viral Vectors II-23
Gene Delivery - Without Virus II-23
Non-Viral Products in Pipeline II-24
Well-known Delivery Approaches for Gene Therapy II-24
Viral and Non-viral Vectors in Use II-25
Retroviruses II-25
Adenoviruses II-25
Adenoassociated viruses II-25
Herpes simplex viruses II-25
Lentiviruses II-25
Liposomes II-25
Viral Vectors by Companies involved II-25
Gene Cassette II-26
Target cells II-26
Stem cells II-26
Differentiated cells II-26
The Disc: An Excellent Target for Gene Therapy II-26

7. Review of Various Approaches II-27
Antisense Technology II-27
Catalytic Ribozyme Technology II-27
Triple Helix DNA II-27

8. Gene Therapy For Disease Treatment II-29
Gene Therapy for Cancer Treatment II-29
Gene Transfer and Gene Therapeutic Concepts in Cancer II-29
Competitive Landscape in Cancer Gene Therapy II-30
Gene Therapy Mechanism in Cancer II-30
Advantages Over Chemotherapy II-31
Developments in Cancer Gene Therapy II-31
P53 Gene Therapy - A Novel Approach in Cancer Treatment II-31
Gendicine - From Concept to Reality II-32
Vaccines II-32
Gene Therapy for Cardiovascular Disease II-32
Cardiovascular Gene Therapy Products under Trial II-32
Gene Therapy for Cystic Fibrosis Disease II-33
Gene Therapy for Haemophilia B II-33
Gene Therapy for HIV/AIDS II-34
Gene Therapy for Parkinson’s Disease II-34
The Disease II-34
Therapy II-35

9. Regulatory Environment II-36
Gene therapy and Regulatory Environment II-36
Gene Patents - An Overview II-36

10. Research and Development II-37
Researchers Develop Synthetic Gene Vectors to Reduce Body
Immune Responses II-37
Illumina Brings Digital Gene Expression Applications II-37
MolMed Develops Gene Therapy Based Treatment for Skin Cancer II-38
Santaris Pharma Develops New Therapy to Lower Cholesterol Level II-38
Researchers Develop Gene Therapy for Severe Burns II-38
AMT Develops (AAV) Vector-Based Gene Therapy II-38
Ark Comes Up with New Gene Thearpy Delivery Technology II-38

11. Recent Industry Activity II-39
International Consolidated to Acquire China Gene II-39
Ark Therapeutics to Acquire Lymphatix II-39
Oxford BioMedica Obtains Rights for RNAi Technology II-39
Gene Bridges Inks Licensing Agreement with Genencor II-39
AMT Enters into R&D Agreement with NIH II-40
VGX Inks Supply Agreement with a U.K. Consortium II-40
Cardium Therapeutics Receives Fast Track Designation for Generx™ II-40
Oxford Biomedica’s ProSavin Enters Phase I/II Trial II-40
Lentigen Acquires Gene Delivery Technology from Cell Genesys II-40
VIRxSYS Acquires SMaRT™ RNA Technology II-41
Gene Logic Divests Genomics Assets II-41
Genzyme Inks Agreement with Ceregene II-41
Silence Therapeutics Extends Agreement with Quark II-41
Benda Inks HIV Vaccine Joint Venture with DNAVEC II-42
Research Dynamics Bags Contract for Multicenter Clinical Study II-42
Thermo Fischer Collaborates with Lentigen to Develop Gene-
Silencing Technology II-42
Fovea Enters into Collaboration with GENZYME Corporation II-42
Oxford BioMedica Inks Licensing Agreement with Children’s
Hospital II-43
Sigma and Oxford Sign Joint License Agreement for LentiVector
Technology II-43
Benda Attains Additional Stake in SiBiono II-43
Oxford BioMedica Acquires Oxxon II-43
Oxford BioMedica and Sanofi-Aventis Agrees to Co-Develop and
Market TroVax II-43
Illumina Completes Acquisition of Solexa II-44
RheoGene Plans Merger with Intrexon II-44
Covalon Acquires Gene Therapy Technology from Perfusion II-44
Inovio Takes Over DNA Expression and Delivery Assets of Valentis II-44
Mologen Inks Agreement with ONCO II-45
Aida Acquires Controlling Stake in Qiaer II-45
Neurologix Inks Licensing Agreement with Diamyd Medical’s
Subsidiary II-45
Takara Inks Collaboration Agreement with Chinese Center for
Disease Control II-45
JDRF Collaborates with Genzyme Corp and AGTC II-45
Galapagos Collaborates with Arthrogen II-46
Genzyme Acquires Avigen’s Gene Therapy Assets II-46
Diamyd Acquires Nurel II-46
Oxford BioMedica Accords with Sigma-Alrdrich II-47
Oxford BioMedica Inks Licensing Agreement with Pfizer II-47
genOway Acquires IngenKO Pty Ltd II-47
Crucell Strikes a Deal with Two Asian Firms II-47
Corautus’ VEGF-2 Gene Therapy Gains Recognition from US FDA II-47
ViroMed Ceases Development of Gene Therapy II-47
Corautus Genetics Pacts with CSEMC II-47
Takara Bio Collaborates with Mie University II-48
Celladon Accords with V-Kardia II-48
Genzyme Acquires Ilex Oncology II-48
Genzyme and AGTC Form Collaboration II-48
Sanofi-Synthelabo Merges with Aventis II-48
Guidant Forms Collaboration with Columbia and Stony Brook II-48
Louisiana and Bionomics Team-Up II-49
Avigen Receives FDA Clearance to Commence Phase I/II Clinical
Trial of Av201 II-49
Oxford BioMedica and Viragen Enters into Licensing Agreement II-49
Oxford BioMedica Signs Licensing Agreement with Merck II-49
Avigen Starts Gene Therapy Trial for Parkinson’s Disease II-49
Oxford BioMedica Acquires Chiron Patents II-50
UA duo Establishes Gene-therapy Firm II-50
SiBiono Commences Construction of Gene Therapy Facility II-50
Avigen Receives FDA Approval for Clinical Trial of AV201 II-50
UK GTAC Approves Clinical Trial II-50
CYGEE Bags patent Approval for Novel Gene Therapy Technology II-50
Mirus Bio Receives $1.26 million SBIR Grant II-51
CEGE Trials Novel Gene Therapy II-51
Avigen Suspends Haemophilia Gene Therapy Trials II-51

12. Strategic Corporate Developments (2000-2003) II-52
Oxford BioMedica and RPR Enters into Licensing Agreement II-52
Schering AG Acquires Collateral Therapeutics II-52
MolMed SpA Buys Rights to RectroNectin II-52
Avigen Receives US FDA Approval II-52
Targeted Genetics Receives Patents II-52
Enzo Biochem Conducts Phase I Studies Related to HIV Treatment II-53
Eurogene Acquires Oy Quattrogene II-53
Cardion AG Acquires Tolerance Pharmaceuticals II-53
Aventis Restructures Gene-Therapy Alliance with Introgen II-53
Boehringer Ingelheim Austria GmbH Inks Agreement with BIA
Separations II-53
Cell Genesys Establishes New Subsidiary II-53
Chiron Divests Gene Therapy Manufacturing Facility II-54
ViroMed Conducts Clinical Trials on Gene Therapy Drug II-54
EG009 Gene Therapy Doubles Survival Rate of Malignant Glioma
Patients in Phase I/II Clinical Trials II-54
Genteric Receives Patent for Insulin Gene Pill System II-54
Bayer Corp. Receives Marketing and Distribution Rights to
Coagulin-B II-54
Avigen Receives Patent for Parkinson’s Disease Gene Therapy II-54
Aventis Acquires License form Electrofect II-54
DeveloGen Acquires Hepavec II-55
Targeted Genetics Acquires Genovo Inc II-55
GenStar Acquires Allegro Inc II-55
Argonex and Rohm & Haas Company Enter into a Joint Venture II-55
Nexell Therapeutics and Takara Shuzo Join Forces II-55
BTG International Inks Licensing Agreement with Avigen II-55
Oxford BioMedica Awarded US Patens Concerning Retroviral And
Lentiviral Systems II-56
Genteric Receives Gene Therapy Patent II-56
GenVec Granted Broad Gene Therapy Patent II-56

13. Focus on Key Players II-57
AnGes MG Inc (Japan) II-57
Cell Genesys (US) II-57
GenVec (US) II-57
Genzyme Corporation (US) II-58
Introgen Therapeutics Inc (US) II-58
Oxford BioMedica (UK) II-58
Shenzhen SiBiono GeneTech Co., Ltd (China) II-59
Targeted Genetics Corp (US) II-59
Transgene (France) II-60
Urigen Pharmaceuticals Inc. (US) II-60
Vical, Inc. (US) II-60


III. COMPETITIVE LANDSCAPE


-Affymetrix, Inc (USA)
-Aldevron LLC (USA)
-AlphaVax, Inc (USA)
-Amaxa GmbH (Germany)
-Amgen, Inc (USA)
-AMT BV (The Netherlands)
-AnGes MG, Inc (Japan)
-Antigenics, Inc (USA)
-Antisense Pharma GmbH (Germany)
-Applied Genetic Technologies Corporation (USA)
-Ariad Gene Therapeutics, Inc (USA)
-Ark Therapeutics Ltd (UK)
-Ark Therapeutics OY (Finland)
-Athersys, Inc (USA)
-Austrianova (Austria)
-Automated Cell Technologies, Inc (USA)
-Avax Technologies, Inc (USA)
-AVI Biopharma, Inc (USA)
-Avigen, Inc (USA)
-Bavarian Nordic A/S (Denmark)
-Bionomics Limited (Australia)
-Biophan Technologies, Inc (USA)
-Biophoenix (UK)
-BioProtein Technologies (France)
-Biosense Webster, Inc (USA)
-BioVex Ltd (UK)
-Celera Genomics Group (USA)
-Cell Genesys, Inc (USA)
-Celltech Group PLC (UK)
-Celsion Corporation (USA)
-Centelion (France)
-CereGene, Inc (USA)
-Cobra Biomanufacturing PLC (UK)
-Copernicus Therapeutics, Inc (USA)
-Corixa Corporation (USA)
-Cosmo SpA (Italy)
-Cosmo Bioscience, Inc (USA)
-Crucell NV (The Netherlands)
-Cyclacel Limited (UK)
-Cygene Laboratories (USA)
-Cytogen Corporation (USA)
-CytRx Corporation (USA)
-DeveloGen AG (Germany)
-Diversa Corporation (USA)
-Enzo Biochem, Inc (USA)
-Fit Biotech Oyj PLC (Finland)
-Gene Therapy Systems, Inc (USA)
-GeneCure LLC (USA)
-GenEra SpA (Italy)
-Genetix Pharmaceuticals, Inc (USA)
-Genteric, Inc (USA)
-GenVec, Inc (USA)
-Genzyme Corporation (USA)
-Genzyme Molecular Oncology (USA)
-Genzyme Therapeutics (UK)
-Geron Corporation (USA)
-Gilead Sciences, Inc (USA)
-Glygen Corporation (USA)
-GTx, Inc (USA)
-Guidant Corporation (USA)
-Human Genome Sciences, Inc (USA)
-ImGenex Corporation (USA)
-Immusol, Inc (USA)
-Innovata Plc (U K)
-Introgen Therapeutics, Inc (USA)
-Intronn LLC (USA)
-Invitrogen Corporation (USA)
-InvivoGen (USA)
-MaxCyte (USA)
-Merck KGAA (Germany)
-Mitsubishi Chemical Corporation (Japan)
-MolMed SpA (Italy)
-Northwest Biotherapeutics, Inc (USA)
-Novartis AG (Switzerland)
-NsGENE A/S (Denmark)
-Onyx Pharmaceuticals, Inc (USA)
-OSI Pharmaceuticals, Inc (USA)
-Osiris Therapeutics, Inc (USA)
-Oxford BioMedica PLC (UK)
-Oxxon Therapeutics Ltd (UK)
-Qugen Therapeutics Pte, Ltd (Singapore)
-RheoGene, Inc (USA)
-Sanofi-Aventis (France)
-Sanofi Aventis Pharmaceuticals, Inc (USA)
-Schering AG (Germany)
-Berlex Laboratories, Inc (USA)
-Collateral Therapeutics, Inc (USA)
-Schering-Plough Corporation (USA)
-Canji, Inc (USA)
-Selective Genetics (USA)
-Shanghai Sunway Biotech Co, Ltd (China)
-Shenzhen Sibiono Genetech Co, Ltd (China)
-Shire Pharmaceuticals Group PLC (UK)
-Sirna Therapeutics, Inc (USA)
-Stemcells, Inc (USA)
-Supratek Pharma, Inc (Canada)
-Targeted Genetics Corporation (USA)
-Theratechnologies, Inc (Canada)
-Tosk, Inc (USA)
-TransGene SA (France)
-TransGene, Inc (USA)
-Upstate Group, Inc (USA)
-Valentis, Inc (USA)
-Vical, Inc (USA)
-VirRx, Inc (USA)
-VIRxSYS Corporation (USA)
-Wyeth (USA)