Aarkstore Enterprise - Biotech For Wellness: Driving Successful R&d And Licensing In Nutraceuticals

Table of Contents :

Table of Contents :

Biotech for Wellness

Executive summary 10

Introduction 10

R&D approaches 11

Product development and lifecycle management 12

Marketing strategies and new opportunities 13

Regulation and intellectual property 14

Food vs biotech the future 15

Chapter 1 Introduction 18

Summary 18

Drivers for change in the food industry 19

Impact of the ageing population on chronic, lifestyle-related health problems 20

Increased consumer awareness 21

Global health economics 22

Economics and disease prevention 23

Defining nutraceuticals 24

Nutraceutical markets: food versus biotech 26

Report structure 28

Chapter 2 R&D approaches 30

Summary 30

Introduction 31

Identifying new ingredients 32

Sourcing novel ingredients 33

In vitro and in vivo studies 35

Case study: InterMed Discovery 36

Case study: screening for taste-modulating nutraceuticals 38

Case study: Wellgen Inc 40

Clinical research 41

Trials to show disease risk reduction 44

Clinical trials expertise in the food industry 45

Cost of clinical trial programs in the food industry 46

Companies undertaking the clinical development of novel nutraceuticals 47

Case study: Provexis 47

Case study: Clasado Ltd 49

Conclusions 50

Nutraceutical discovery 50

Nutraceutical development 51

Chapter 3 Product development and lifecycle management 54

Summary 54

Introduction 55

Product development 55

Case study: product development of probiotics 56

Case study: plant stanols and sterols 58

Case study: medical foods 59

Issues in creating new product types 61

Formulation and delivery of nutraceuticals 61

Case study: GAT Food Essentials (Austria) 63

Case study: Nutralease 64

Identification of new health benefits 66

New sources of nutraceuticals 68

Case study: sustainable sources of omega-3 fatty acids 68

Case study: microbial engineering 70

Product development for novel ingredients 73

US-based companies 74

EU-based companies 75

Conclusions 77

Chapter 4 Marketing strategies and new opportunities 80

Summary 80

Introduction 81

Market penetration 81

Product differentiation key factors for success 81

Product promotion: educating consumers and healthcare providers 84

Connecting with consumers: using digital media 93

New opportunities 94

Expansion into new market segments 94

Creating new geographical markets 94

Conclusions 97

Chapter 5 Regulation and intellectual property 100

Summary 100

Introduction 100

Regulatory considerations: Foods 101

Japan 103

United States 105

Europe 109

Regulatory considerations: Dietary supplements 118

United States 118

European Union 118

Regulatory considerations: medical foods 119

Intellectual property considerations 121

IP, regulation and future changes 125

Intellectual property 125

Regulation 126

Future change 127

Conclusion 129

Chapter 6 Food vs biotech the future 132

Summary 132

Introduction 133

Food and biotech approaches to R&D 134

Discovery 134

Development 135

Personalizing products 136

New business models 137

Opportunities for biotech in nutraceuticals 141

Nutraceuticals from biotech consumer health divisions 142

Influence of product failures 143

Medicalizing nutraceuticals 144

Moving into medical foods 145

Ethical considerations: a challenge for the future 145

Conclusions 146

Appendix 149

Primary research methodology 149

Acknowledgments 150

Glossary 151

Index 154

Bibliography 155

Endnotes 157

List of Figures

Figure 1.1: Drivers for health focus in the food and beverage industry 19

Figure 1.2: Proportions of the population over 60 (1950-2050) 20

Figure 1.3: Healthcare expenditure as a share of GDP (2006) 22

Figure 1.4: Examples of nutraceuticals 25

Figure 1.5: The health and nutrition sector 26

Figure 1.6: Key US consumer health concerns, 2007 27

Figure 1.7: The role of food and pharmaceuticals in the healthcare continuum 28

Figure 2.1: InterMed Discoverys novel nutraceutical pipeline 37

Figure 2.2: Senomyxs product development process 38

Figure 2.3: WellGens nutrigenomics-based discovery program 40

Figure 2.4: Extrapolation of clinical trial populations to healthy people 42

Figure 3.1: BioGaias probiotic straw 57

Figure 3.2: Reasons for choosing a novel formulation for a nutraceutical 62

Figure 3.3: Nutralease technology 65

Figure 3.4: Potential advantages of nutraceutical production by fermentation 71

Figure 3.5: Business models adopted by innovative nutraceutical companies 73

Figure 4.1: Key attributes for product differentiation and success 82

Figure 4.2: Differences in marketing approach for Danones Essensis and Nestls Glowelle 91

Figure 4.3: Keys to the success of alli marketing 92

Figure 4.4: Danones predicted growth in emerging economies 95

Figure 5.1: Comparison of the regulatory processes for nutraceuticals in foods and pharmaceuticals in the EU and US 103

Figure 5.2: A flow chart for FOSHU approval 104

Figure 5.3: Composition of a GRAS Notice 107

Figure 5.4: The data package for novel foods approval in the EU 110

Figure 5.5: Types of EFSA health claims 112

Figure 5.6: Different types of medical food and their uses 119

Figure 5.7: Patent types relevant to nutraceuticals 121

Figure 5.8: Number of new nutraceuticals patents published, 1999-2009 123

Figure 5.9: Nutraceutical patent applications by region/country, 1999-2009 124

Figure 5.10: Nutraceutical patent applications by applicant, 1999-2009 124

Figure 6.1: Key challenges for the global functional foods industry 133

Figure 6.2: Research activities of the International Life Sciences Institute Functional Foods group 134

Figure 6.3: Biotechs discovery and development paradigm 135

Figure 6.4: Diversify & de-risk through externalization 137

Figure 6.6: Innovation partnerships at Nestl 140

Figure 6.7: Evolving hierarchical model in the food and beverage industry 141

List of Tables

Table 1.1: Definitions of terms relating to nutraceuticals 24

Table 2.1: Companies identifying novel ingredients 32

Table 2.2: Compound libraries available for natural product screening 34

Table 2.3: Companies developing novel nutraceuticals through clinical trials 47

Table 2.4: Products or projects in development at Provexis 48

Table 3.1: Probiotics: proven and exploratory health benefits 67

Table 3.2: Sources of key nutraceuticals 68

Table 4.1: Estimates of pharmaceutical marketing expenditures in the US ($bn), 2004 85

Table 4.2: Return on investment for direct to consumer advertising in the US, 2008 87

Table 4.3: Scientific gaps and barriers to the development of functional foods in different regions 97

Table 5.11: Examples of GRAS Notices pending March 2010 106

Table 5.2: Health claims meetaing significant scientific agreement 108

Table 5.13: Examples of EFSA opinions on Article 13.1 claims published in February 2010 113

Table 5.14: Examples of published EFSA opinions on Article 13.5 and 14 claims 116

Table 5.15: Differences in approach to regulation of functional food and nutraceuticals 129

Table 6.1: Strategic alliances of leading food and ingredients companies with innovating companies (2008-March 2010) 138

Table 6.2: Nutraceutical or personalized nutrition companies participated in by DSM Venturing 139

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