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Neutraceuticals and Cosmeceuticals Indirect competition to pharma products ….? From “illness” to “wellness” ………. Expanding Healtcare Market - NEUTRACEUTICALS Nutraceuticals Term used to describe Active ingredient in ‘Food Plus’ Rather than ‘Food Plus’end product itself Dietary supplements included in Nutraceuticals OTC VMS & Herbal supplements Nutraceutical opportunities Definition Opportunities Medical Opportunities ‘Food Plus’ ( Benecol, Aviva Health Food ) NUTRA CEUTICALS Dietary Supplements ( VMS & herbal supplements ) ( Treating, controlling, reducing risk ) Lifestyle Opportunities ( Improving presentation, performance & well-being ) CLASSIFICATION OF NEUTRACEUTICALS Neutraceuticals Traditional Non traditional Traditional vs. Non-traditional • Nutraceuticals on the market today consist of both traditional foods and nontraditional foods. • Traditional nutraceuticals are simply natural, whole foods with new information about their potential health qualities. • Lycopene in tomatoes, omega-3 fatty acids in salmon or saponins in soy Traditional vs. Non-traditional • Non-traditional neutraceuticals, on the other hand, are foods resulting from agricultural breeding or added nutrients and/or ingredients. • Agricultural scientists are able to boost the nutritional content of certain crops through the same breeding techniques that are used to bring out other beneficial traits in plants and animals . • E.g. beta-carotene-enriched rice to vitamin-enhanced broccoli and soybeans • More and more foods are being fortified with nutrients and other physiologically active components (such as plant stanols and sterols) as researchers uncover more evidence about their role in health and disease-risk reduction. Opportunities Medical applications Treating controlling or reducing risk Cholesterol, diabetes, heart disease, cancer Lifestyle applications Softer, lifestyle related issues Improving physical presentation Enhancing physical & psychological performance Medical Opportunities Treatment Products acting as pharmaceutical Moderating or curing effects of specific conditions Eg. Role of Calcium rich products for osteoporosis Prevention Products aimed at reducing risk of particular condition Eg. Role of anti-oxidants in cancer prevention Eg. Role of Omega-3 PUFA in preventing heart attacks Medical Opportunities Maintenance Products that help the body to maintain itself Help to achieve appropriate intake of vitamin, mineral, fibre, sugar, fat etc. Eg. Dietary supplements and VMS products Medical condition Pharmaceutical Provides solution to a well defined problem Clearly defined medical condition Consumers aware due to self diagnosis / physician Nutraceutical Awareness cannot be assumed automatically Even for well-documented medical conditions Need Clearly defined consumer group having concern Level of concern should be sufficiently high Price premium / induce change in consumption habit Children, pregnant women, menopausal women etc. Self-diagnosis and/or measurable results Identification of Sufferers supported by medical advise Self diagnosis by consumers Lifestyle - Social drug Physical presentation Dental care to weight control Fresh breath, prevent decay, teeth whitening Performance Boost mental / physical -socially or at work Extra stamina / concentration General well being Live a healthy lifestyle Unwind or relax Exploiting the opportunity Clinical discipline Claims should have solid clinical support To prevent erosion of consumer confidence Unfocused fortification, overambitious claims Holistic consumer marketing To target non-patient target audience Incorporate functional aspects into wider, lifestyle oriented consumer solutions Regulations • Nutraceuticals have no official meaning and do not constitute a distinct category of foods. • Most often, they are simply natural, whole foods consumers have been eating for thousands of years. • As a result, the FDA regulates them in the same way they regulate all foods Health & wellness Connotations - wide & across… many things to many people No illness No deficiency of minerals/ vitamins To eat vitaminized products Eat green vegetables Have Peace of mind Self confident Cheerful / Happy/ Joyful Health & Wellness Satisfied Feel young Body will remain strong Eat fresh food To be smart Stamina / strength Active / high energy level Good looks Health is wealth Give attention to cleanliness Fit body Have six pack abs Doing exercise HEALTH DOES NOT HAVE MERELY ILLNESS ASSOCIATIONS ANY MORE…a shift in the paradigm of health No weight gain Red Bull Fashionable Nutraceutical brand Lifestyle opportunity rather than medical Marketed under slogan Stimulates body and mind Non-alcoholic drink Taurine Metabolic transmitter, Detoxifier, cardiac contractility Glucuronolactone Accelerate elimination of harmful substances Caffeine B-complex vitamins Carbohydrates Red Bull Strategy Consumer advertising & sports sponsorship Promotion similar to Coca-Cola Target Youngsters by creating aspirationalaura Functional benefit intentionally vague Revital Adult health supplement launched in 1989 More than just a Multivitamin combination Vitamins, minerals and ginseng One of the top brands from the Ranbaxy Successful transition From Rx to OTC market Challenge Prescriptions continuously declining since 1995 7.5% decline - 2001/2000 Static sales in spite of declining prescriptions Indicates significant OTC sales component TYPICAL OF LATE MATURITY / EARLY DECLINE PHASE OF BRAND LIFE CYCLE To craft an appeal, which would successfully launch Revital in the OTC segment Moving from a relatively serious image Protect already huge base of loyal user Energizing the sales curve with new regular users Revital Rides high on a positive health concept Gives the user mental and physical vitality Fits into the users hectic lifestyle Empowering with energy strength & mental sharpness Enabling them to enjoy life to the fullest Hence the brand punch line “JiyoJeeBharKe” The careful planning and implementation of the marketing strategy Three fold objective Creating an appeal for the product Moving away from its serious image Rejuvenating sales for the product Research Extensive market research Understand consumers and doctors Across urban and rural India Reason To augment insights To execute a four-pronged switch strategy Foraying into consumer needs through a well-thought television creative Feeling of freshness “We wake up easily and feel like going to work. Earlier it was difficult to wake up even” -MADURAI “even after coming back from a hard day’s work I was in a jolly mood with my family” -FAIZABAD Sustaining freshness & energy Combats weakness “all our weakness disappears, your body feels good” -DELHI “after having for sometime, you feel like you can do anything. I can work for twelve hours and health will be ok” - MADURAI General well being Business Strategy : Rainbow Approach Communication Availability Detailing - Awareness - Trial Chemists and Direct to Consumers FMCG - Repeat Purchase - Doctors - Loyalty -Positive WOM With a shift in decision-making , focus is predominantly on Consumers INTRODUCTION • Cosmeceuticals are the latest addition to the health industry and are described as cosmetic products with drug-like activities. • The term cosmeceutical was coined by Kilgman. • Cosmetics are products that are used to cleanse and beautify the skin. • Pharmaceuticals are essentially drug products and are defined as products that prevent, mitigate, treat or cure disease and /or affect the structure or function of the body INTRODUCTION • Cosmeceuticals is a deliberate portmanteau of these two terms and is intended to connote drug like benefits from an otherwise cosmetic product. • The purported drugs-like effects are largely unproven and the term is neither recognized by the United State’s food and drug administration nor by any other regulatory body. • Cosmeceuticals are generally presented as lotions or creams and are mostly targeted at dermatological issues INTRODUCTION • Recently, orally delivered products of similar claims as cosmeceuticals have been labeled as either oral cosmeceuticals or as nutricosmetics or nutriceuticals. LINES OF PRODUCTS • The lines of products of cosmeceuticals are designed both to exploit veterinary and human therapy. • The main product lines of veterinary cosmeceuticals are shampoos and anti ectoparasites. • The main product lines of human cosmeceuticals are anti-aging while very few are anti acne or moisturizers. • Common brand names include “Bliss”, “MD Skin Care”,“La Roche”, Nu-Derm” and “SensiClear”. LINES OF PRODUCTS • Almost all are the products of research and development from basic sciences. • As at 2005, the global market was estimated at $53billion. • Anti-aging Cosmeceuticals control over 95% of these and has a double digit growth in most global markets • Anti-aging Cosmeceuticals have been formulated on sound biological grounds but with unsubstantiated clinical claims. • Aging may be intrinsic or extrinsic. LINES OF PRODUCTS • Restated, the score of the aging process at any time depends on the outcome of dynamic interactions between biological (intrinsic), psychological (intrinsic and extrinsic) and environmental factors. • The final pathway to all the mechanism of aging is apparently the same and involves disruption of the network of collagen and elastin. • Antiaging cosmeceuticals are therefore designed to repair and/or maintain the body’s maintenance and repair systems-so called MRSs. • These formed the grounds for products like cosmeceutical peptides which may contain neurotransmitters,signal peptides or carrier proteins. LINES OF PRODUCTS • Botanical cosmeceuticals contain botanical ingredients with traditional or folk medicine usage. • These often include grape seed extracts, Aloe Vera, mushrooms, olive oil, green tea, licorice, coffee Arabica and coffee berry extracts • Antioxidants play a large role in the MRSs. • This may explain incorporation of Vitamins C and E into cosmeceuticals sometimes called better cosmeceuticals. • Cosmeceuticals may also contain niacinamide and kinetin EFFICACY OF COSMECEUTICALS • The term ‘cosmeceutical’ has been heavily criticized because it connotes that rigorous efficacy studies have been done as it would be for pharmaceuticals. • Extensive studies in animals have demonstrated effects like antiinflammatory,anti-tumorigenic, anti-microbial, antiperoxidation and free radical scavenging activities in wide range of models using mouse, rats and guinea pigs. • Most have neither undergone phase 2 or 3 clinical trials nor randomized studies and their efficacy remain unproven. • The so called better cosmeceuticals have fared worse on rigorous testing EFFICACY OF COSMECEUTICALS • Though, high concentrations of Vitamins C and E do indeed protect against acute ultraviolet skin damage, the low concentrations in most Cosmeceuticals have not been shown to be effective. • Furthermore, the stability of these vitamins is compromised as soon as the product is exposed to light and air. • Finally, they are often incorporated into Cosmeceuticals as esters or mixtures of isomers that are neither absorbed nor metabolized by the skin. • Generally cosmeceuticals that contains 15% Vitamin C probably have some effect on wrinkles • Such lines of products are called Skinceuticals probably to emphasize that traditional cosmeceuticals do not contain such a high amount of vitamins C. THE TOXICITY OF COSMECEUTICALS • The term ‘natural’ is frequently used for most components of cosmeceuticals and willingly or unwillingly connotes safety. • Carbaryl, the only constituent of veterinary cosmeceuticals with documented toxicity profile, has an oral LD50 of 100 mg/kg in mice and 250 mgkg in rats. • Known to cause dermal and eye irritation in rabbits • Vitamin E has been shown to cause a significant increase in contact dermatitis. • Some component peptides have also been shown to be carcinogenic THE TOXICITY OF COSMECEUTICALS • Perhaps the greatest danger is from deliberate adulterations and incorporation of harmful products like steroids and retinoid. • These can lead to devastating skin and systemic changes CONCLUSION • Cosmeceuticals are not drugs but are claimed to have drug like effects. • The claims are largely unsubstantiated and the term, though misleading, has probably come to stay. • In a free trade world, the benefits and adverse effects of Cosmeceuticals are probably optimized by frequent review to inform the clinical and public stake holders of their uses and limitations. THANK YOU -PHARMA STREET