The global outlook series on Genetic Engineering provides a collection of market briefs and concise summaries of research findings. The report offers an aerial view of the industry, highlights latest developments, and discusses demand drivers, issues and concerns, and regulatory environment. Discussion on the industry’s most noteworthy regional market, the US, is amply detailed with unbiased research commentary to provide the reader a rudimentary understanding of the prevailing market climate. Market discussions in the report are punctuated with fact-rich market data tables. Regional markets elaborated upon include United States, Canada, India, China, and South Africa among others. Also included is an indexed, easy-to-refer, fact-finder directory listing the addresses, and contact details of 153 companies active in the market.
Global Genetically Modified Organism, GMO Industry
1. INDUSTRY OVERVIEW 1
Genetic Engineering: A Prelude 1
Genetic Engineering: Not the Same As Biotechnology 1
The Evolution and Progress of GM Crops 2
M Crops Gain Global Acceptance 2
GM Cultivation Gains Prominence in Developing Nations 2
Rising Prices, Food Shortage Make Biotech Grains Attractive 2
Socio-Economic Impacts of Biotech Crops 3
Impact of GM Crops on Biodiversity 3
Challenges to GM Crops Adoption 3
Biotech Regulatory Measures Hinder Crop Domestication 4
Genetic Modification of Forest Trees and Associated Issues 4
Biosafety: a Key Criterion Associated 4
Governments Not to Give Up on GM Hope 4
US - The Largest Producer of GM Crops 5
Leading Countries by Biotech Crop Area (2009) 5
Table 1: Current and Future Analysis of the Global Biotech
Crops Market By Geographic Region for the US, Canada,
Asia-Pacific, Latin America and Rest of World Independently
Analyzed with Annual Sales Figures in US$ Million for 2010
through 2015 6
Major Market Participants 7
2. MARKET DYNAMICS 8
Global Food Demand to Drive Need for GM Crops 8
Developing Countries: Major Share Holders for Biotech Crop
Production 8
Status of Biotech Rice in the World 8
Genetic Engineering - A Solution for Food Crisis! 9
Harmful or Healthy: Breaking The Myth About GM Crops 9
Non-food Sectors to Benefit from GE Technology 9
Genetic Engineering and Enzymes 9
GE to Help Starch and Sugar Processing Enzyme Market 10
GE to Drive Demand for Bakery Enzymes 10
Genetic Engineering Revolutionizes Vaccines 10
Plant Expression Systems to Replace Traditional Expression
Systems 11
Approved Gene Therapies Fail to Gather Momentum 12
P53 Gene Therapy - A Novel Approach in Cancer Treatment 12
3. ISSUES AND CONCERNS 13
The GM Food Issue Continues 13
Nations at Crossroads to Accept or Object GE Crops 13
Nations Set Global Agenda to Settle GM Crop Controversies 14
Challenges Confronting the Biotechs 14
Efficacy - The Key Challenge for Gene Therapy 14
Key Factors Affecting the Indian Biotechnology Industry 15
4. REGIONAL TRENDS 16
Genetic Engineering: A Fast Catching Trend in Developing
Countries 16
Future of GE Technologies 17
US: Owns a Lion’s Share of the World Biotech Produce 17
Table 2: US Biotech Crop Produce By Year in Millions of
Hectares 17
GM Crops Fail to Live up to Expectations in the US 18
US Soybean and Corn Crop to Witness Robust Growth 18
FDA Compliance to Spur Growth in the US Biotech Industry 18
Canada Reaches Million Acres Mark 18
Table 3: Canadian Biotech Crop Produce by Leading Crops
(2011) 19
Table 4: Biotech Maize in Canada: Percentage Share Breakdown
by Varieties with Single Stacked gene, Two Stacked genes, and
Triple Stacked genes (2011) 19
Small and Medium Sized Biotech Enterprises to Grow in Europe 19
Germany and UK- The Hub of European Gene Therapy Market 20
Spain Garners Leading Spot in Europe’s GM Maize Market 20
Table 5: Biotech Maize Hectarage in Europe (2011) 20
GMO Crops’ Future Hinges on Co-Existence Measures in EU 21
European Commission Downplays Impact of GM Crops 21
Biotech Crops Remain in a Political Standstill in Europe 21
European Nations Ban GM Potato and Maize 21
UK Government’s GM Crops Proposal Faces Rebuff 22
Spanish Transgenic Corn Plantation Increases 22
Ireland: A GM-free Zone 22
Gene Therapy Pipeline Strengthens in Asia 23
GM Foods Trends in Asia 23
Bt Cotton Fails in Asia 24
Chinese Biopharmaceutical Market to Continue its Growth Spurt 24
Government to Support Biopharmaceutical Innovation 24
Biotech Crop Research Gains Momentum in India 25
The Great Indian Bt Brinjal Controversy 25
India - The Leading Cultivator of Bt Cotton 25
India Ousts China in Bt Cotton Cultivation 25
Indian Agri-Bio Industry on a Roll 26
India: Ban on Genetically Engineered Crops? 26
Legalization of Genetic Engineering in Indonesia 26
GM Crops to Earn Good Returns for Australia 26
Biotechnology - A Boon for Agriculture in Malaysia 27
Poor Biotech Crops Adoption in Africa 27
Biotech Crops Cultivation Zooms in South Africa 27
Table 6: Percentage Share Breakdown of Biotech Maize by Type
(2011) in South Africa 28
Table 7: Percentage Share Breakdown of Biotech Cotton by Type
(2011) in South Africa 28
Uruguayan Community Resist GM Plants 28
GM Crop Adoption Rate Grows Exponentially in Brazil 28
5. GENETIC ENGINEERING: AN OVERVIEW 29
The Concept 29
Molecular Basics - The Gene 30
Genome - The Information Pool 30
Evolution of Genetic Engineering 30
Historical Developments in Genetic Engineering: 31
The Human Genome Project 31
Significant Events in the Past 32
Gene Therapy 32
Types of Gene Therapy 33
Monogenic Gene Therapy 33
Suicide Gene Therapy 33
Antisense Gene Therapy 33
Human Genetic Engineering 33
Genetic Engineering in Animals 33
Role of Biotechnology in Agriculture 34
Insect Resistant Crops Vs. Herbicide Tolerant Crops 34
Some Interesting GM Crop Facts 35
Myths and Fads Associated to Genetically Engineered Crops 35
Improvement of Genetic Characters in Wheat 36
Agrobacterium tumifaciens Mediated Transformation 36
The Biolistic Transformation Method 37
Genetically Modified Foods 37
GM Food Faces Worldwide Criticism During Initial Years 37
Benefits of Genetically Modified Foods 38
Pest Resistance 39
Cold Tolerance 39
Herbicide Tolerance 39
Drought and Salinity Tolerance 39
Disease Resistance 39
Phytoremediation 40
Nutrition 40
Pharmaceuticals 40
Negative Impacts of GM Foods 40
Possibility of Crosspollination 40
Decreased Pesticides Effectiveness 40
Unintentional Destruction of Other Species 41
Health Concerns Related to GM Foods 41
Cost Concerns Related to GM Foods 41
Genetic Engineering and Food Processing 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 Others 51
Table 12: Gene Therapy Clinical Development by Vectors Used
(2011): Percentage Breakdown of Number of Trials for
Adenovirus, Retrovirus, Plasmid DNA, Vaccinia Virus,
Lipofection and Others 51
Gene Therapy Industry in Europe and the US - A Comparison 51
7. GENE AMPLIFICATION TECHNOLOGY 53
Definition of Gene Amplification 53
Target vs. Signal Amplification 53
Available Types of Gene Amplification Technologies 53
Polymerase Chain Reaction 53
The PCR comprises four major components: 53
Reagents and Equipment Required for PCR 54
Reaction Steps 54
Denaturation 54
Annealing 54
Extension 54
Detection of Amplified Product/DNA 55
(Q&Q) PCR 55
Reverse Transcriptase PCR (RT-PCR) 56
Alternative Technologies to PCR 56
OmniPlex 56
Genome-wide disease association studies 56
Pharmacogenomics studies 56
Molecular diagnostics and forensics 56
Additional OmniPlex Applications in Development 56
Strand Displacement Amplification 57
Ligase Chain Reaction 57
LCR Involves a Cyclic two-Step Reaction 57
Gene Amplification Technology (GAT) 57
Hybrid Capture 57
Isothermal DNA Amplification Techniques 58
Rolling Circle Amplification in Diagnostics 58
Ican Isothermal Gene Amplification Technology 58
BioHelix HDA Technology 58
Other Amplification Technologies 58
Signal Amplification Technology 58
Transcription Mediated Amplification 59
DNA Cleavage-based Signal Amplification 59
Ramification Amplification Method 59
End Use Market Analysis 59
Medical and Diagnostics 59
Role of Amplification Technology in the Diagnoses of
Infectious Diseases 60
Diagnosis of Infectious Diseases by PCR 60
Detection of Antimicrobial Resistance 61
PCR Based Nucleic Acid Amplification for Detection of
Antimicrobial Agents 61
Nucleic Acid Amplification Testing (NAT) 61
Nucleic Acid Amplification Methods 62
DNA Amplification Technology in the Diagnosis of Infectious
Diseases 62
Advantages 62
Limitations 62
Forensic and Paternity Testing 62
Food Safety 63
Table 13: Current and Future Analysis for Global Gene
Amplification Technology Market by Segment Independently
Analyzed with Annual Sales Figures in US$ Million for 2010
Through 2015 64
Table 14: Global Gene Amplification Market (2012): Percentage
Breakdown of Value Sales by Geographic Region- the US,
Canada, Japan, Europe and Rest of World 64
8. RESEARCH AND DEVELOPMENT 65
9. MERGERS & ACQUISITIONS 70
10. RECENT INDUSTRY ACTIVITY 76
11. PRODUCT/SERVICE LAUNCHES 91
GLOBAL DIRECTORY
