Biotech for Wellness: Driving successful R&D and licensing in nutraceuticals through new business models and collaboration

Over the past 5 years all of the major food and beverage companies have undergone a fundamental strategy shift to take into account the increasing consumer focus on health and wellness. The demand for these products will continue to be driven by a growing and ageing population with increased chronic, lifestyle-related health problems, the rising costs of healthcare and potential savings from preventive measures and increased consumer awareness.
Nutraceuticals can be included in a functional food or taken as dietary supplements. Examples of nutraceuticals include omega-3 fatty acids, phytosterols and stanols, probiotics and prebioitics and aim to support health or target risk factors for chronic diseases such as cholesterol. The biotech and nutraceutical industries are targeting some of the same lifestyle disease growth markets, but from a different standpoint and with different goals. Consequently, a number of factors are leading to the convergence of the food and biotech sectors including the increasing use of ingredients that claim to have health benefits and which have been studied in clinical trials to demonstrate these benefits; and the increasing scientific evidence for a link between diet and the cause or treatment of a number of diseases.
This report reviews the business strategies of leading companies regarding the development of nutraceuticals/ingredients and the adoption of biotech technologies and business models to maximize their return on investment and develop products that offer a more personalized approach to nutrition and promote health and wellness.

Key features of this report

• Identify leading companies at the forefront of nutraceutical research who will drive the market towards a more personalized approach to health and wellness.
• Assess current approaches to R&D and use of clinical assessment tools such as biomarkers of risk reduction, in the development of food and drinks with enhanced nutritional content and bioactive components, that can modify taste and promote health benefits
• Review the backgrounds, strategies and business models of food and drinks companies and the adoption of a more biotech–like approach to the development of food.
• Discuss the regulatory, ethical and IP issues associated with the development of nutraceutical products which promote health and wellness

Scope of this report

• Identify the companies leading the field in nutraceutical research from food and drinks manufacturers.
• Review their key products and business alliances that enable them to participate in this consumer driven marketplace.
• Compare and contrast areas of biotechnology and strategic development adopted by the food and drinks markets which are influencing the way in which nutraceuticals are identified, clinically assessed and promoted to the consumer
• Review market drivers regarding the adoption of nutraceuticals and the personalization of nutrition in the promotion of health and wellness.

Key Market Issues

• Ingredients with functional properties that are often added to food and drinks or are found naturally in them include essential fatty acids such as omega-3 oils, probiotics, prebiotics, plant sterols, botanicals etc. Over the past few years, most of these nutraceutical ingredients have made good progress in the marketplace in a variety of end products including foods, beverages and supplements. Some of these products have had limited success or have been withdrawn.
• Regulations in this competitive marketplace are evolving to encourage innovation whilst protect consumer safety. These changing regulations, particularly in the EU, are likely to have a profound effect on the industry in the near future.
• The food market is changing: Over the past decade, consumers have become more concerned for their health and wellbeing. The roll of the food and drinks industry is changing and shifting towards a more benefit driven and preventative approach. In order to respond to market dynamics the companies have needed to adopt an “open network” model to gain access to innovative research and technologies which will drive future product development.

Key findings from this report

• Synergies exist between the food and drinks industry and the biotech industry in clinical research and the identification of new ingredients that may create new opportunities (e.g. biomarker discover). However, the costs of developing novel nutraceutical ingredients, and carrying out a program of clinical research to support an application for a relevant health claim are clearly rising. To this end, many food and drinks companies have already adopted a biotech-like open network business model and product development strategies (outsourcing) to develop the next generation of health promoting products.
• The food and drinks industry has been undergoing major regulatory changes during the last few years, particularly with respect to health and dietary claims. Added to this, the adoption and application of nutrigenomic, genomic, proteomic and metabolomic technologies, may provide additional clinical data to substantiate claims and provide new opportunities to develop products which target consumer sub groups. This may require further adjustments in the regulatory framework to stimulate innovation but ensure consumer safety.
• The ability of innovative companies to generate intellectual property is a key driver for the sector as more and more companies are looking to use novel technologies such as nutrigenomics and incorporating nutraceutical to meet consumer demand for personalized nutrition. A search for worldwide patents including the word ‘nutraceutical’ in the title revealed 221 patents in total. Of these, 60 covered ingredients or processes that could be applied to either nutraceuticals or pharmaceuticals.
• Product development and lifecycle management are critical for the sustained profitability of biotechs; the allocation of resources to support the investigation of new indications for both marketed and developmental products and their potential reformulation are pivotal in maintaining brand leadership and expanding market penetration. In particular, drug repurposing – finding new indications for existing drugs – is a growing trend in the pharma industry. Similar goals are no being applied by the food an drinks industry .

Key questions answered

• Which companies are involved in the development of food and drinks which promote health and wellness and how may they influence the uptake of personalized nutrition?
• How are Health and Nutrition market leaders applying nutraceutical research in their R&D programs to develop new products or create new marketing opportunities?
• What potential lessons may be learnt from the biotech industry in the development of niche products which promote health and wellness and provide a more personalised approach to nutrition.
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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
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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 meeting 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
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 Discovery’s novel nutraceutical pipeline 37
Figure 2.2: Senomyx’s product development process 38
Figure 2.3: WellGen’s nutrigenomics-based discovery program 40
Figure 2.4: Extrapolation of clinical trial populations to healthy people 42
Figure 3.1: BioGaia’s 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 Danone’s Essensis and Nestlé’s Glowelle 91
Figure 4.3: Keys to the success of alli marketing 92
Figure 4.4: Danone’s 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: Biotech’s discovery and development paradigm 135
Figure 6.4: Diversify & de-risk through externalization 137
Figure 6.6: Innovation partnerships at Nestlé 140
Figure 6.7: Evolving hierarchical model in the food and beverage industry 141
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