SPI Infoamtion

Table of Contents

Executive summary

Introduction
R&D approaches
Product development and lifecycle management
Marketing strategies and new opportunities
Regulation and intellectual property
Food vs biotech - the future

Chapter 1 Introduction

Summary
Drivers for change in the food industry

Impact of the ageing population on chronic, lifestyle-related health problems

Increased consumer awareness

Global health economics

Economics and disease prevention

Defining nutraceuticals
Nutraceutical markets: food versus biotech
Report structure

Chapter 2 R&D approaches

Summary
Introduction
Identifying new ingredients

Sourcing novel ingredients

In vitro and in vivo studies

Case study: InterMed Discovery

Case study: screening for taste-modulating nutraceuticals

Case study: Wellgen Inc

Clinical research

Trials to show disease risk reduction

Clinical trials expertise in the food industry

Cost of clinical trial programs in the food industry

Companies undertaking the clinical development of novel nutraceuticals

Case study: Provexis

Case study: Clasado Ltd

Conclusions

Nutraceutical discovery

Nutraceutical development

Chapter 3 Product development and lifecycle management

Summary
Introduction
Product development

Case study: product development of probiotics

Case study: plant stanols and sterols

Case study: medical foods

Issues in creating new product types

Formulation and delivery of nutraceuticals

Case study: GAT Food Essentials (Austria)

Case study: Nutralease

Identification of new health benefits
New sources of nutraceuticals

Case study: sustainable sources of omega-3 fatty acids

Case study: microbial engineering

Product development for novel ingredients

US-based companies

EU-based companies

Conclusions

Chapter 4 Marketing strategies and new opportunities

Summary
Introduction
Market penetration

Product differentiation . key factors for success

Product promotion: educating consumers and healthcare providers

Connecting with consumers: using digital media

New opportunities

Expansion into new market segments

Creating new geographical markets

Conclusions

Chapter 5 Regulation and intellectual

property
Summary
Introduction
Regulatory considerations: Foods

Japan

United States

Europe

Regulatory considerations: Dietary supplements

United States

European Union

Regulatory considerations: medical foods
Intellectual property considerations
IP, regulation and future changes

Intellectual property

Regulation

Future change

Conclusion

Chapter 6 Food vs biotech . the future

Summary
Introduction
Food and biotech approaches to R&D

Discovery

Development

Personalizing products

New business models
Opportunities for biotech in nutraceuticals

Nutraceuticals from biotech consumer health divisions

Influence of product failures

Medicalizing nutraceuticals

Moving into medical foods

Ethical considerations: a challenge for the future
Conclusions

Appendix

Primary research methodology
Acknowledgments
Glossary
Index
Bibliography
Endnotes

List of Figures
Figure 1.1: Drivers for health focus in the food and beverage industry
Figure 1.2: Proportions of the population over 60 (1950-2050)
Figure 1.3: Healthcare expenditure as a share of GDP (2006)
Figure 1.4: Examples of nutraceuticals
Figure 1.5: The health and nutrition sector
Figure 1.6: Key US consumer health concerns, 2007
Figure 1.7: The role of food and pharmaceuticals in the healthcare continuum
Figure 2.1: InterMed Discovery’s novel nutraceutical pipeline
Figure 2.2: Senomyx’s product development process
Figure 2.3: WellGen’s nutrigenomics-based discovery program
Figure 2.4: Extrapolation of clinical trial populations to healthy people
Figure 3.1: BioGaia’s probiotic straw
Figure 3.2: Reasons for choosing a novel formulation for a nutraceutical
Figure 3.3: Nutralease technology
Figure 3.4: Potential advantages of nutraceutical production by fermentation
Figure 3.5: Business models adopted by innovative nutraceutical companies
Figure 4.1: Key attributes for product differentiation and success
Figure 4.2: Differences in marketing approach for Danone’s Essensis and Nestle’s Glowelle
Figure 4.3: Keys to the success of alli marketing
Figure 4.4: Danone’s predicted growth in emerging economies
Figure 5.1: Comparison of the regulatory processes for nutraceuticals in foods and pharmaceuticals in the EU and US
Figure 5.2: A flow chart for FOSHU approval
Figure 5.3: Composition of a GRAS Notice
Figure 5.4: The data package for novel foods approval in the EU
Figure 5.5: Types of EFSA health claims
Figure 5.6: Different types of medical food and their uses
Figure 5.7: Patent types relevant to nutraceuticals
Figure 5.8: Number of new nutraceuticals patents published, 1999-2009
Figure 5.9: Nutraceutical patent applications by region/country, 1999-2009
Figure 5.10: Nutraceutical patent applications by applicant, 1999-2009
Figure 6.1: Key challenges for the global functional foods industry
Figure 6.2: Research activities of the International Life Sciences Institute Functional Foods group
Figure 6.3: Biotech’s discovery and development paradigm
Figure 6.4: Diversify & de-risk through externalization
Figure 6.6: Innovation partnerships at Nestle
Figure 6.7: Evolving hierarchical model in the food and beverage industry

List of Tables
Table 1.1: Definitions of terms relating to nutraceuticals
Table 2.1: Companies identifying novel ingredients
Table 2.2: Compound libraries available for natural product screening
Table 2.3: Companies developing novel nutraceuticals through clinical trials
Table 2.4: Products or projects in development at Provexis
Table 3.1: Probiotics: proven and exploratory health benefits
Table 3.2: Sources of key nutraceuticals
Table 4.1: Estimates of pharmaceutical marketing expenditures in the US ($bn), 2004
Table 4.2: Return on investment for direct to consumer advertising in the US, 2008
Table 4.3: Scientific gaps and barriers to the development of functional foods in different regions
Table 5.11: Examples of GRAS Notices pending March 2010
Table 5.2: Health claims meeting significant scientific agreement
Table 5.13: Examples of EFSA opinions on Article 13.1 claims published in February 2010
Table 5.14: Examples of published EFSA opinions on Article 13.5 and 14 claims
Table 5.15: Differences in approach to regulation of functional food and nutraceuticals
Table 6.1: Strategic alliances of leading food and ingredients companies with innovating companies (2008-March 2010)
Table 6.2: Nutraceutical or personalized nutrition companies participated in by DSM Venturing