The Economic Times in its August 24, 2011 edition reported that Sanofi-Aventis has acquired the nutraceuticals business of Universal Medicare to scale up their business operations in the ‘wellness’ space of the healthcare sector in India.
What are ‘Nutraceuticals’?
Dr. Stephen DeFelice of the ‘Foundation for Innovation in Medicine’ coined the term ‘Nutraceutical’ from “Nutrition” and “Pharmaceutical” in 1989. The term nutraceutical is being commonly used in marketing such drugs/substances but has no regulatory definition.
It is often claimed that nutraceuticals are not just dietary supplements, but also help prevention and/or treatment of disease conditions.
Besides diseases, nutrition related risk factors contributing to more than 40% of deaths in the developing countries like India, nutraceutical products do show a promise as an emerging business opportunity within the healthcare space of the country.
The global nutraceuticals market is currently estimated to be around US$ 117 billion and expected to reach US$ 177 billion by 2013 with a CAGR of 7%, driven mainly by functional foods segment with a CAGR of 11%. The top countries in this category are Japan, USA and Europe with the former two together enjoying around 58% market share of the total nutraceuticals consumption of the world. In 2008 Indian nutraceuticals market was around US$ 1.0 billion, 54% of which being functional foods.
The prices of most nutraceuticals products, being outside government price regulations in India, are usually high.
Although current market share of India in the global nutraceuticals market is less than even 1%, a report from PwC predicts that India will join the league of top 10 by 2020. Increasing discretionary spending, changing lifestyles and growing awareness among Indians about healthy living, coupled with current overall low market penetration of high priced nutraceuticals products in India, could create a powerful trigger for the market growth.
Sanofi could sniff the opportunity in India:
Sniffing the market opportunity in this segment, especially in India, the Sanofi group’s Aventis Pharma, as mentioned above, has acquired the nutraceuticals business of Universal Medicare Private Ltd of worth Rs.110 Crore, in August, 2011. The nutraceuticals product portfolio of Universal Medicare consists of more than 40 brands, which include cod liver oil capsules, vitamins/ mineral supplements, antioxidants and liver tonics to name a few.
It will be interesting to watch whether Sanofi takes these nutraceutical products to other markets of the world, especially in Japan, Europe and the US.
Currently most global pharma companies are engaged in evidence based therapeutic substances:
So far, the large global pharmaceutical players have been focusing mainly, if not only on Evidence Based Medicines (EVM). Companies like, GlaxoSmithKline (GSK), were reported to have discontinued marketing those products, which do not fall under ‘Evidence Based Medicines (EVM), even in India.
Evidence-Based Medicine (EBM):
The term and concept of EBM originated at McMaster University of Canada in early 1990 and has been defined as “the integration of best research evidence with clinical expertise and patient values” (Sackett, 2000).
EBM is thus a multifaceted process of systematically reviewing, appraising and using clinical research findings to aid the delivery of optimum clinical care to patients/user. EBM also seeks to assess the strength of evidence of the risks and benefits of any particular treatment claim. This is mainly because increasingly the users are looking to authentic scientific evidence in clinical/wellness practice.
Thus many global pharmaceutical companies believe that EBM offers the most objective way to determine and maintain consistently high quality and safety standards of healthcare products in the healthcare practice.
The span of nutraceuticals ranges from prescription to OTC Products:
In India, nutraceuticals are being used/prescribed even by the medical profession, not only as nutritional supplements but also for the treatment of disease conditions, like arthritis, osteoporosis, cardiology, diabetes, pain management etc.
The challenge: Some experts believe, robust clinical data support is essential to substantiate ‘wellness’ claim with nutraceuticals:
Therapeutic efficacy in the treatment of a disease condition is established with pharmaceutical, pharmacokinetic and pharmacodynamics studies of the substances concerned. Some experts believe that these studies are very important also for nutraceuticals, as they are involved in a series of various reactions within the body, especially while making any therapeutic claims, directly or indirectly.
Similarly, to establish any long term toxicity problem with such products, generation of credible data including those with animal reaction to the products, both short and long term, using test doses several times higher than the recommended ones, is critical.
These experts, therefore, quite often say, “A lack of reported toxicity problems with any nutraceutical should not be interpreted as evidence of safety.”
The status in the USA:
In the USA, Congress passed the ‘Dietary Supplement Health and Education Act’ in 1994. This act allows ‘functional claims’ to Dietary supplements without drug approval, like “Vitamin A promotes good vision” or “St. Johns Wort maintains emotional well-being”, as long as the product label contains a specific disclaimer that the said claim has not been evaluated by the FDA and that the product concerned is not intended to diagnose, treat, cure or prevent disease.
The above Act bestows some important responsibility to the doctors in particular, who are required to provide specific and accurate scientific information for nutraceutical products to their patients. This process assumes critical importance as the patients would expect the doctors to describe to them about the usefulness of nutraceutical products as alternatives to approved drugs. In such cases, if any doctor recommends a dietary supplement instead of pharmaceutical products, the doctor concerned must be aware of the risk that the patient’s health may suffer, for which the affected patient could sue the doctor for malpractice.
The Point to ponder: What happens if nutraceuticals are regulated as pharmaceuticals?
It is worth mentioning, if generation of clinical data, though albeit less than the pharmaceuticals, ever becomes mandatory regulatory requirements for getting marketing approval of nutraceutical products in India, commensurate increase in price for such products could indeed push their commercial survival in jeopardy.
Nutraceuticals bearing a tag of promise, in a conducive regulatory environment, to provide desirable therapeutic benefits with less or no side effects as compared to conventional medicines, is growing well with reasonably good financial success, across the world. India is no exception.
In India, many nutraceuticals products, which are currently in the market, do not seem to have been adequately tested to generate robust clinical data, leave aside being peer reviewed and published in the reputed international journals for either safety or efficacy. Entry of global majors, like Sanofi, with a sharp focus on EBM, brings in a hope and promise to get these loose knots, in this very important area, tightened very significantly, while driving their business growth in the country.
Under this backdrop, it is widely expected that Sanofi, with its well proven global marketing and technical leadership, would change the ball game of nutraceutical products business in the healthcare space of India.
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.