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Global Genetic Engineering Industry
Date:4/26/2012

essing 42

Genetic Engineering and Regulatory Environment 42

Patents - An Overview 43

 

6. GENE THERAPY - A REVIEW 44

Factors Influencing Gene Therapy's Future Development 44

Human Genome Analysis 44

Gene Therapy - The Next Generation Cardiovascular Therapy 44

Public Support for Gene Therapy 44

RNAi Bode Bright Prospects 44

Factors Hampering Gene Therapy Future Development 45

Stringent US and European Regulatory Laws Prolongs Gene

Therapy Development 45

Identifying Genetic Fault 45

Immune Response 45

Delivering Genetic Materials into Patient Cells 45

Multigene Disorders 46

Side Effects 46

Push Towards Germline Gene Transfer 46

Technical Limitations 46

Commercialization: A Road Uphill 47

Time Line in Gene Therapy Drug Development 47

Table 8: Gene Therapy Clinical Trials (2011): Percentage

Breakdown by Geographic Region for the US, Europe, Canada,

Japan and Rest of World 47

 

Table 9: Gene Therapy Clinical Development (2011):

Percentage Share Breakdown by Stage 48

Select Gene Therapy Products in Phase III Development (2010) 48

Select Gene Therapy Products in Phase II Development (2010) 49

Select Gene Therapy Products in Phase I and Pre-Clinical

Development (2010) 49

Target Diseases and Players Involved 50

Key Players by Application Area 50

Table 10: Clinical Development of Gene Therapy by Targeted

Indication (2011): Percentage Breakdown of Number of Trials

for Cancer Diseases, Cardiovascular Diseases, Infectious

Diseases, Monogenic Diseases, Neurological Diseases and

Others 50

 

Table 11: Gene Therapy Clinical Trials Worldwide (2011):

Percentage Breakdown by Gene Type Transferred - Antigen,

Cytokine, Tumor Suppressor, Growth Factor, Deficiency,

Suicide, and O
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