Global Market for Clinical Nutrition and Dairy Ingredients

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Asher Cole
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1 Global Market for Clinical Nutrition and Dairy Ingredients Published in September

2 Agenda 1. Introduction 2. Global market overview 3. Clinical nutrition ingredients 4. Conclusions 5. Appendix 2

Latin America Rest of World Market values Market volumes CAGR 2015-2020 Top 5 players Brands Products Regional players

3 Market research approach - clinical nutrition markets and dairy ingredients used Product scope Market scope Key players Market trends Dairy ingredients in CN Infant Standard Special Enteral Oral Tube Parenteral Global Europe North America Asia- Pacific Latin America Rest of World Market values Market volumes CAGR Top 5 players Brands Products Regional players Distribution channels Demographics Regulation Usage of dairy ingredients WPC WPI MPC MPI MCC MCI Casein Caseinates Emerging minor ingredients 3

Clinical nutrition terminology Clinical Nutrition in this report encompasses the total market for products made available to consumers through prescriptions from healthcare professionals, i.

critically ill, malnourished, and patients with metabolic disorders The clinical nutrition market can be categorised into three primary market segments in line with industry norms: Infant

4 Clinical nutrition terminology Clinical Nutrition in this report encompasses the total market for products made available to consumers through prescriptions from healthcare professionals, i.e. doctors, medical personnel, pharmacies, or OTC that must be administered under medical supervision These products are designed for people with specific nutritional needs that cannot be met through a normal diet, e.g. critically ill, malnourished, and patients with metabolic disorders The clinical nutrition market can be categorised into three primary market segments in line with industry norms: Infant clinical nutrition: Refers to infant formula products for infants between 0-6 months of age and specially formulated products for infants with specific nutritional needs Enteral clinical nutrition: Comprised of two subcategories oral nutritional supplements and enteral tube feeding for people who are unable to meet their nutritional needs through an oral diet Parenteral clinical nutrition: Refers to products delivered intravenously, straight into the blood stream when nutritional needs cannot be met through oral or enteral nutrition 4

5 Market drivers and constraints - clinical nutrition market and dairy ingredients used Several market drivers and constraints for the clinical nutrition market and the use of dairy ingredients in this market can be identified and are listed below: Market drivers Market constraints Population demographics Regulation Increased incidence of diagnosed diseases Increased awareness of nutrition benefits in disease management Evidence of effect Financial perspectives Physicians knowledge of (dairy) nutrition benefits in disease management Consumer confidence in products health claims Product pricing 5

Clinical nutrition market split by category -

Clinical nutrition Total market size (2015):

(2015): USD xx mio CAGR 2010-2015: 5% CAGR

1% 13% 41% Infant formula (0-6 months) Market

1% CAGR 8% 36% Infant formula 2010-2015: 9.

6 Clinical nutrition market split by category - infant formula is the largest category Clinical nutrition Total market size (2015): USD xx mio Parenteral nutrition Market size (2015): USD xx mio CAGR : 5% CAGR : 5.1% 13% 41% Infant formula (0-6 months) Market size (2015): USD xx mio Enteral nutrition Market size (2015): USD xx mio CAGR : 7.1% CAGR : 5.8% 36% Infant formula Market size (2015): USD xx mio CAGR : 9.7% CAGR : 6.6% 10% Special infant formula Market size (2015): USD xx mio 6

size (2015): USD xx m Total volume (2015): xx MT Total value: USD xx m Total volume: xx MT Market size (2015):

7 Infant clinical nutrition - market size by region Infant clinical nutrition market size and growth - segmented by regions Europe North America Total value (2015): USD xx m Total volume (2015): xx MT Asia-Pacific Market size (2015): USD xx m Total volume (2015): xx MT Total value: USD xx m Total volume: xx MT Market size (2015): USD xx m Total volume (2015): xx MT Rest of the World Market size (2015): USD xx m Total volume (2015): xx MT 7

8 USD mio Enteral nutrition market by region - North America dominated sales in 2015 Enteral nutrition market size and forecast to 2020 Regional split of global enteral nutrition market, % 5.8% CAGR 12% 31% 7.1% CAGR 23% % North America Europe Asia-Pacific Latin America Rest of World 8

9 USD mio Parenteral nutrition market - Asia-Pacific region currently growing fast Parenteral nutrition market size and forecast to % CAGR 5% CAGR

10 USD mio Abbott Laboratories Inc. - No. 1 in adult clinical nutrition Sales 20,247 20,405 Vascular 14% Division share of sales, 2015 Other 11% Nutritionals 34% Pediatric 18% , Adult 16% Established pharmaceuticals 18% Diagnostics 23% Abbott is the global leader in adult nutrition, a segment mostly consisting of clinical nutrition products and accounting for 46% of Nutritionals segment and currently expanding operations in Asia, China in particular Pediatric nutrition product sales accounts for 54% of Nutritionals some of which can also be characterised as infant clinical nutrition products Abbott is estimated to have had sales of standard milk formula of approx. USD 1.6 bn in 2015 forecast to grow with a CAGR above 7% towards

products 2015 - Seprated by region 1600 1400

614 59 9 20 51 6 200 0 2010 2011 2012 2013

products were launched between 2010-2016,

by North America and Asia Out of these product

The most active NPL companies in this period

followed by Nestlé with 1057 launches, trailed

with 524 launches 428 Asia Australasia East

11 # of products launched New products development - launches in the clinical nutrition market Number of new products Separated by years Number of new products Seprated by region new clinical nutrition products were launched between , majority of which in Western Europe followed by North America and Asia Out of these product launches, 2,833 contained dairy ingredients The most active NPL companies in this period were Nutricia (Danone) launching 1733 products followed by Nestlé with 1057 launches, trailed by Abbott with 712 launches and Fresenius-Kabi with 524 launches 428 Asia Australasia East Europe Latin America Middle East North America Western Europe 267 Source: Innova Market Insights 11

Danone - infant nutrition product examples Description: Aptamil First Infant milk is a nutritionally complete

coming both in liquid and powdered forms Ingredients include: Demineralized whey powder, Vegetable Oils,

Description: Infatrini is a Food for Special Medical Purposes for use under medical supervision.

between 0-18 months with faltering growth, or who have increased nutritional requirements and/or require fluid

12 Danone - infant nutrition product examples Description: Aptamil First Infant milk is a nutritionally complete formula for infants between 0-6 months as a supplement or as an alternative to breastfeeding with products coming both in liquid and powdered forms Ingredients include: Demineralized whey powder, Vegetable Oils, Lactose, Skimmed milk powder, Galactooligosaccharides, Whey Protein Concentrate, Fructooligosaccharides, etc. Description: Infatrini is a Food for Special Medical Purposes for use under medical supervision. Infatrini is a nutritionally complete, energy dense, RTD or tube-fed product for dietary management of infants between 0-18 months with faltering growth, or who have increased nutritional requirements and/or require fluid restriction Ingredients include: Skimmed Milk Powder, Maltodextrin, Vegetable Oils, Lactose, Whey Protein Concentrate/Whey Protein Isolate, etc. 12

Nestlé - enteral nutrition product examples Description: Boost High Protein is a ready-todrink product designed for people who need to

Sunflower, Corn), Cocoa, Soy Protein Isolate, Calcium Caseinate, Sodium Caseinate, etc. Description: Peptamen is a 1.

It is a 100% whey protein based formula with 70% of the as Medium-Chain Triglycerides.

13 Nestlé - enteral nutrition product examples Description: Boost High Protein is a ready-todrink product designed for people who need to increase their protein intake Ingredients include: Water, Sugar, Milk Protein Concentrate, Corn Syrup, Vegetable Oils (Canola, High Oleic Sunflower, Corn), Cocoa, Soy Protein Isolate, Calcium Caseinate, Sodium Caseinate, etc. Description: Peptamen is a 1.0 kcal/ml enteral tube feed formulated for optimal digestion and absorption for patients with impaired gastrointestinal function. It is a 100% whey protein based formula with 70% of the as Medium-Chain Triglycerides. Peptamen is a nutritionally complete Food for Special Medical Purposes Ingredients include: Water, Maltodextrin, Hydrolysed Whey Protein (from milk), Medium-Chain Triglycerides, Corn Starch, Soybean Oil, Minerals, etc. 13

14 Whey proteins for infant formula - whey protein concentrate volume estimation Standard infant formula Special infant formula Volume Protein content (avg. 11%) % whey Whey protein WPC share WPC (100% protein) WPC (80% protein) 570,000 MT 62,700 MT 60% 37,600 MT 40% 15,000 MT 18,800 MT 130,000 MT 14,300 MT 50% 7,200 MT 90% 6,500 MT 8,100 MT Total 700,000 MT 77,000 MT 44,800 MT 21,500 MT 26,900 MT Using the same methodology applied in estimating volumes of DWP used in infant formula, it has been possible to estimate the volume usage of WPC in infant formula Assuming that WPC accounted for the remaining 40% of whey protein content in standard infant formula, 90% in special infant formula, and adjusting for a protein content of 80%, it has been estimated that approx. 18,800 MT of WPC was used in standard infant formula, approx. 8,100 MT in special infant formula, amounting to a total demand of WPC for infant clinical nutrition of approx. 26,900 MT in 2015 Applying the CAGR of 5% towards 2020, it can be estimated that demand for WPC in infant clinical nutrition will grow approx. 1,500 MT per year to reach approx. 34,000 MT in

Volume (MT) Dairy ingredients in enteral nutrition - estimation of milk protein ingredient volumes Milk protein As per the assumptions for milk protein and

It is estimated that around half of this demand is for MPC/MPI and the other half is for caseinates Assuming volume growth to be similar to the value CAGR of 5.

15 Volume (MT) Dairy ingredients in enteral nutrition - estimation of milk protein ingredient volumes Milk protein As per the assumptions for milk protein and adjusting for a protein content of 80%, it is estimated that demand for milk proteins for enteral nutrition amounted to approx. 20,000 MT in It is estimated that around half of this demand is for MPC/MPI and the other half is for caseinates Assuming volume growth to be similar to the value CAGR of 5.8%, the enteral nutrition market has been forecasted grow, the demand for these proteins will grow approx. 1,300 MT each year towards 2020 ultimately reaching a demand of approx. 26,400 MT 15

Emerging dairy ingredients Protein Hydrolysates are easily ingestible dairy proteins as they are already partially digested through the breakdown into peptides, thereby permitting better absorption

16 Emerging dairy ingredients Protein Hydrolysates are easily ingestible dairy proteins as they are already partially digested through the breakdown into peptides, thereby permitting better absorption in the stomach and making the protein non-allergenic. Low viscosity of these proteins makes them suitable for enteral nutrition, however bitter taste makes them more ideal for tube feeding products α-lactalbumin is the primary whey protein found in human breast milk accounting for 20% of total protein and containing all essential amino acids and BCAAs needed by humans, thus making it an important protein for growth in infants. In whey from cow s milk, β-lactoglobulin which is not contained in human breast milk accounts for approx. 50%, and α-lactalbumin for around 20-25%. Some premium infant formulas are produced using α-lactalbumin for this reason Galactooligosaccharides are prebiotics that raises levels of certain probiotic bacteria supporting healthy gut flora and immune system function. Usage of GOS in infant formula has increased strongly in recent years. Increased use has also been seen in enteral nutrition, but at a slower rate Lactoferrin is a glycoprotein present in both cow and human milk with highest concentrations in the latter. It is an essential factor in immune response and particularly important to the health and functioning of the intestinal tract. In Asia, Lactoferrin is widely used in the infant formula Transforming Growth Factor-β2 (TGF-β2) is an exogenous polypeptide present in both human and cow milk. TGF-β2 has immune modulating functions that have been used in enteral nutrition to treat inflammatory bowel disease and Crohn s disease 16

17 Global Clinical Nutrition Report project management and costs Team team: Managing partner - Tage Affertsholt Junior consultant Daniel Pedersen Time Cost Report available in PDF format in total more than 90 slides from September 2016 EUR 3,700 17

Global Market for Infant Formula and Dairy Ingredients

Global Market for Infant Formula and Dairy Ingredients 2015-2020 Published in September 2016 1 Report outline 1. Introduction 2. Infant formula market 3. Infant formula industry 4. Dairy ingredients used