Nutrigenomics

Chapter 1. Introduction

1.1. Background to Scientific Developments
1.2. Definitions and Concepts
The Concept of Genetic Variation
-Oat Fiber and Serum Cholesterol
-Osteoporosis, Caffeine, and the Vitamin D Receptor Gene
1.3. From Pharmacogenomics to Nutrigenomics
Pharmacogenomics Has Its Own Value Chain
-Pharmaceutical Companies Are Early Adopters of Genomic Tools
Nutrigenomics: Similar Biotech Tools, Different Questions
Additional Distinctions between Food and Drug Applications
1.4. Nutrigenomics: A Business Definition
Where Are We Today?
Genomics and Genetic Tools—Implications along the Entire Food Value Chain

Chapter 2. Science & Technology

2.1. Introduction
2.2. Survey Overview
2.3. Technologies Used in Nutrigenomic Research
Microarrays
Bioinformatics
Cell Culture
Genetic Strategies
Biomarkers
2.4. Clinical Diagnostics: Nutritional Genomic Tests
Introduction: Polygenic Genetic Testing
Nutritional Genomic Clinical Diagnostic Business Development Activity
Cardiovascular Disease
Bone Health
Immune Health
Detoxification
B Vitamin Health (Folic Acid)
Antioxidation
Insulin Resistance (Insensitivity)
Diabetes
Kidney Disease
Obesity
Familial Hypercholesterolemia
Metabolic Syndrome
Non-Specific Diseases
2.5. Ag-Biotech Nutrigenomic Technologies

Chapter 3. Nutritional Genomics: The Business Landscape

3.1. Introduction
3.2. Agricultural Biotechnology
Will Nutritional Enhancement of Food Crops Move Agricultural Biotechnology Forward?
Golden Rice: A Public-Private Partnership Model for Nutritionally Enhanced Commodity Crops?
3.3. Value-Added Food, Feed, and Dietary Supplement Ingredient Industries
Utilizing Genomic Technologies in Pursuit of New Products with Health Benefits
Ingredient Industry Perspectives on Nutritional Genomics
-Nutrigenomic Diagnostic Testing: Validity and Potential Value
-Animal Health
-Business Models: Internal Development versus Alliances
-Role of the Health Professional
-Scope of the Business Opportunity
-Barriers to the Technology’s Success
-Ethical or Liability Issues
3.4. Laboratory Testing for Food Safety and Quality Control
The Scope of Microbiology Testing in the Food Industry
Non-Traditional Microbiological Methods
-PCR Methods
-DNA-Based Microarrays
-DNA-Hybridization Methods
3.5. Nutrigenomics and Consumer Packaged Foods—Not Ready for Prime Time
Industry Trends, Dynamics, and Driving Forces
-The Wal-Mart Phenomenon
-The Packaged-Food Industry Continues to Consolidate
-Strong Internal Competency in the Nutritional Sciences is De-Emphasized
-The Obesity Epidemic Challenges Industry Image and Growth
-“Culinology” Comes to Food Product Development
-Food Ingredient Suppliers—Key Players in Food Product Development Today
-Higher-Risk Technical Innovation in Universities and Start-Up Companies
-Packaged-Food Industry Viewpoints on Nutrigenomics
-Industry Definitions
-Why is Nutrigenomics Important?
-How Will the Business Evolve for Consumer-Product Companies?
-How the Evolving Science Should Impact the Industry
-The Role of Health Professionals
-Regulatory Issues
-Packaged-Food Executives’ Perspectives on How Nutrigenomics Will Affect the Industry
--Nestle and Unilever Are Exceptions to the Rule
3.6. Dietary Supplement Companies Enter the Nutrigenomics Market via Alliances with Diagnostic Companies
Dietary Supplement Companies Utilize Nutrigenomics as a Marketing Tool
Industry Trends, Driving Forces, and Market Dynamics
-Dietary Supplement Company Culture and Business
Dietary Supplement Industry Viewpoints on the Business Opportunity
-R&D Vice Presidents’ Viewpoints on How Nutrigenomics Will Impact the Food and Nutritional Product Industries
-The Role of Health Professionals
3.7. Medical Food Companies
Perceived Regulatory Issues
The Pharmaceutical Industry’s Interest and Response
3.8. Diagnostic Services and Biotechnology
Research Applications in Nutritional Genomics
Applications in Food and Dietary Ingredients
Nutritional Genomic and Metabolomic Applications in Drug and Diagnostic Research
Clinical Applications of Nutrigenomics
Nutrigenetic Testing for Personalized Nutrition
-Costs of Nutrigenetic Testing and Supplements
Nutritional Genomic Clinical Diagnostics
-Diabetes
-Familial Hypercholesterolemia (FH)
-Obesity
-Non Specific
-Relevant Patents
3.9. Expert Interviews

Chapter 4. Market Potential

4.1. Seed Commodities with Enhanced Nutritional Composition
Edible Oils Low In or Free of Trans Fatty Acids
-Bringing High Omega-3 Oilseeds to Market
-The Nutritional Rationale for Increased Omega-3 Consumption
-A Possible Genomic Approach for High Omega-3 Oilseeds
-Key Components for Success
--Consumer Interest
--Acceptance by the Academic Community and Public Health Policymakers
-Regulatory, Technical, and Logistic Hurdles
-Estimating the Business Opportunity
U.S. Consumer Attitudes towards Genetically Modified Foods
-The Role of Consumer Education
-Media Coverage Drives Public Opinion
-Consumers Support Labeling of Genetically Modified Foods or Ingredients
-Consumer Attitudes towards Genetically Modified Foods in Canada, Europe, and Asia
-Overcoming Consumer Reluctance to Genetically Engineered Foods
4.2. Nutrigenomics and Food-Producing Animals
Applications to Meat-Producing Animals
Applications to Milk and Eggs
-A Cow That Produces Lactose-Free Milk is a Research Goal
Farm Animals Used for Low-Cost Pharmaceutical Production
Consumer Attitudes toward Genetic Modification of Animals
4.3. Future Outlook for Molecular and Gene-Based Testing for Monitoring Food Safety and Food Quality Control
4.4. Personalized Nutrition Testing Services for Consumers
Trends Driving Interest in Personalized Nutrition
Challenges of a Business Model that Relies on a Doctor’s Recommendation
Benefits and Risks of a Direct-to-Consumer (DTC) Business
U.S. Consumer Interest in Nutrigenomics
The Business Outlook for Personalized Genetic Testing
4.5. Genomics and Genetics: Technology Applications to Food and Drugs, and Implications for Consumers
Nutrigenomics and Pharmacogenomics
-Current Scientific Issues
-Regulatory Guidelines Address Personalized Medicine
-Gene-Based Methods Identify Bioactive Food Components and May Support Product Claims for -Food and Dietary Ingredients
Nutrigenetics and Pharmacogenetics
-Clinical Validation of Nutrigenetic and Pharmacogenetic Tests
-Ethical Management of Genetic Information
-Global Legistators Address Ethical Issues Surrounding Genetic Tests
-Protecting Consumers from Genetic Discrimination by Health Insurers and Employers
-Health Insurance Reimbursement Issues
-Current Genetic Test Regulations in the U.S. May Allow Expansion of DTC Marketing
-DTC Advertising for Genetic Tests Raises Issues for Healthcare Policymakers, Providers, and Consumers

Chapter 5. Conclusions

5.1. Current and Developing Technologies
5.2. Genomics Technologies Influence All Segments of the Food Value Chain
5.3. How Might Markets Unfold Along the Food Value Chain?
-The Agricultural Biotechnology Industry Could Positively Impact Public Perception of Genetically Engineered Foods
-Device Development for Food Production Quality Control and Food Safety
-Systems Biology Tools Are a Strategic and Competitive Asset for Value-Added Ingredient Companies with a Health Platform
-The Dietary Supplement Industry Embraces Genomics as a Marketing Tool
-The Packaged-Food Industry May Be Slow to Link Their Products to Their Consumers’ Genetic Profiles
-The New Business of Consumer Nutrigenetic Testing