Nutraceuticals to Medicines, is there a space in between both? Strategic marketing of nutraceutical products?

 

Dietary supplements, food supplements, nutritional products, functional foods, OTX, nutraceuticals are all words which for long have been used, substituted by and for each other, mis-used and abused also in certain cases in India and globally. In the pharma world, for long, nutraceuticals were a grey area in every aspect, especially in the go-to-market strategy, marketing communications, regulatory guidelines, legislation, and economics of these products (price and costs). Till the last decade, the ‘nutraceuticals’ (lets stick to this word for now till the time article gives you a perspective on others) were restricted to management in deficiencies of macro and micronutrients in segments like- growing children, pregnant women to supplement the daily nutritional needs for optimum health and for sports and sporting aspirants for a so called ‘top-up’ required as most thought was needed then (more than the non- sports aspirants). More science driven approach came in in the late 90s as these nutraceuticals were given as adjuvant prescription items along with antibiotic therapies then, as it was understood that the replenishment of the depleted nutritional levels due to antibiotic regimen was needed to rehabilitate the patients faster. Lots have changed in last 12 to 15 years and let’s look at some pointers in all the aspects the article spoke about earlier,

 

Þ   Go-to-market strategy: from customer to consumer to influencers; with literacy rates gone up across the demography, societal section (today, even a vegetable vendor would oversell beetroot saying that it has iron and that it good for hemoglobin) and social strata, the go-to-market strategies have  slowly shifted from pitching to customers (doctors sahab) to pitching to buyers for better health directly. Having said this, the doctor remains one of the main sources of this market and communication target. So, the doctors have remained the source of influence via their prescriptions, but more influencers have propped in. pharmacies, gym instructors, dietitians, social media influencers, google  reviews on products, place and platform where the  product is made available, etc.

 

Þ   Marketing communications: with digitalization of communications e-commerce platforms and social media, the way to communicate and pitch to the consumers have changed for sure. Passing on more information to the consumer (rightly so) has become the norm and surely it has become easy as well. For customers / doctors, the channel may not have changed  much, but the pitch has, in the way that there are specific regimens now pitched even for the nutraceuticals, specific nutraceuticals have been positioned for specific indications, conditions, organs, specializations (Astaxanthin for eyes, Glutathione for liver, Methylcobalamine for Neuro, etc.).

 

Þ   Regulatory guidelines: hope it settles somewhere sooner, as it is changing a lot and too frequently. WHO’s Recommended Daily Dose (RDA) is central to most of the regulatory guidelines framed so far and the controlling body, the FSSAI, has been actively following the same. But it still has loads of loopholes and there is a need to carving out a separate segment in between Medicines and Nutraceuticals. Something like Brazil has adopted called as ‘Functional Foods’ which has safety studies at higher doses (higher than RDA), but are indicated in specific indications, like the gut flora, foul mouth odor, vaginal hygiene, etc. The regulatory guidelines often influence the what and how to communicate to the customer/ consumer in this case.

 

Þ   Economics: The price control in a few dietary supplements have marred the economics of this segment in terms of getting investors to invest in good quality manufacturers and the R&D of some new dosage forms, delivery systems, more consumer compliant packing etc. The global manufacturing practices of the nutraceuticals are way better than that in India and the impacts the quality difference too Hence, where India manufactures have done wonders in the medicinal manufacturing in the global market they haven’t even scratched the market when it comes to nutraceuticals to be exported in these global market. The costs have been high as the economies of scales have not been achieved due to non-standardization of the products and their dosage form. India is losing a lot of opportunity globally on because of this and I believe that the regulators can play an important role in this by setting GMP standards for manufacturing of the nutraceuticals and defining a segment in between nutraceuticals and defining a segment in between nutraceuticals and defining a segment in between nutraceuticals and medicines- like a functional food to infuse investment in innovation here.

 

The per capita healthcare expenditure is around US$ 40 and is amongst the lowest in the world. In this too, the contribution from spending on health and wellness is a meagre one. Nutraceuticals for regular health and wellness is an area which will have an exponential growth in the coming times in India and other emerging markets. If we divide the same market in India by point of generation of the need to have nutraceuticals,  

 

Þ   Health and wellness: nutraceuticals for a better health. This segment has seen a growth spurt with younger and affuent class. Companies have adopted different ways to tap this market but so has to the competition grown. Currently a buyers’ market, the consumer is spoilt for choices and surprisingly price is not a factor in this segment.

 

Þ   Prophylactic and growth support: influenced by the medical practitioner, this segment has been the most growth in recent times. Nutritional supplement to support growth of the fetus in pregnancy, growing kids for overall development, increase in appetite, immunity boosters, etc. This again is a segment which is not very price sensitive and there has been innovations  and development in the products that the companies have made. Chewable tablets. Flavor in sachets, mouth melt, soft gel caps, liquid stick packs, etc. are a few to mention and  is a good sign to the overall growth for the industry as well as for the market who in turn gets value added products.

 

Þ   Adjuvant to the main therapy and medicinal treatment of any indication: This is a price sensitive market to an extent as it is an additional burden on the prescription cost. The investment has been focused to make this very therapeutic specific, structure the regiment and have more science driven approach. But since the prices don’t support the return on investment in these innovations this area will find itself hitting the peak very soon and plateauing thereafter.

 

Global outlook: Even though the global pharma industry is ever- growing, it’s no more lucrative, as the medicines for specific therapies are pre-established, and there are very few new chemical entities introduced. High genericization of the products in these markets have lead to decrease in profits as well as cut short the product life cycles. Nutraceuticals can be seen as an opportunity with investment in innovation here.

 

Even though the demand for nutraceuticals in increasing, the industry faces major challenges to cater to the demand globally. Due to the increase in R&D on nutraceuticals in the developed as well as developing nations, there is an ever-increasing burden on regulators for regulation of these products. The global market exhibits limited harmonized regulations on the classification, registration and commercialization of these products.

 

The term nutraceuticals are synonymous to various commonly used words such as food supplements. Functional foods dietary supplements, medicinal food. Over the counter supplements, nutritional supplements etc. which have been misused and reused by the general population and regulators around the globe. These can be classified basis its application, usage, source of origin or chemical constituents.

 

From the regulatory point of view, the premise for classification of these products is a mix of the various classification types there in , which leads to considering the regulatory requirements, Latin American markets, is a good example of how the regulator norms and the regulatory classification varies from country to country. In Brazil, food supplements is the commonly used term when it comes to regulating and marketing the products and not nutraceuticals. The regulatory requirements have evolved in the recent past, to control the quality and safety due to new products being imported in to the country. In order to get a food supplement registered  in Brazil, ANVISA has laid down various guidelines which need to be aligned with, before the product is registered. For dietary supplements, the product  composition has to be evaluated  basis the RDA limits, Which are peculiar  to the population in the country. Following this, ANVISA has laid down guidelines for ‘’approved ingredients list’’ which has been formulated on the basis of history  of use of that ingredient in the country , and the safety profile, which is established globally for well-known ingredients. Once the product conforms to these requirements, the labelling of the product is a critical factor, which determines how the product will be marketed, and via which channels will it be sold. Considering all these constraints, it becomes hard for any organization trying to enter this market , as it may take almost 4-6 months just to get the product classified before registration. The second category is called ‘’functional foods’’ such as enzymes and probiotics, where in it’s important for ANVISA to understand the safety profile of the probiotic/ enzyme basis the source of its  origin. Hence, the product registration is in two parts, firstly, the probiotic strain has to be filed with clinical and toxicity studies, which establish the safety of the strain. Once the strain is approved, the manufacturer can file the finished formulation of the product. When it comes to the labelling of these products, one can have ‘’functional claims’’ i.e., claims basis the proof of safety via clinical studies, for a specific indication which does not encompass the claims made in a medicine such as prevention, treatment, but can use terms like “support” “assist” “maintain” “restore” to help companies market the product  to the doctors better.

In Mexico and other Latin American countries such as Peru, Costa Rica and Colombia the products are categorized broadly in to medicines, food supplements and medical devices. However, there is a grey area when it comes to regulation. The large corporations which develop new products, strains, enzymes and phytochemicals, are actively  involved in shaping the regulation with the regulators. For example. Most of the probiotics, studied since a long time, having established safety profile, are regulated as medicines, even if the application of these food supplements or probiotics does not have medicinal claims. This is a new age strategy adopted by the big pharma, to extend the commercial life cycle of the product, This makes it hard for niche products to be made available to the population at a faster and cheaper rate.

 

As the demand for value added products in this category is evolving faster, as compared to the use of medicines, there is an ever-growing need for the manufacturers and marketers to find their niche. There are 2 ways in which entities are focusing and investing in, to cater to this demand.

 

The first is with respect to the technologies which enhance the look, feel, taste and compliance of the product, as the target population is majorly kids, pregnant women  and geriatrics. Hence there are new products with foreign technologies which are formulated in gummies, mouth melts, unit dose liquids, oral drops, which helps the target population adhere to the therapy.

 

Secondly, appropriate focus on designing patient and therapy  centric portfolio. As food supplements have different  mechanisms of action for different therapies, companies, are investing in to research and  development  on the products with focus on the  therapy  it caters, the mechanism of action at various doses and its positive effect on the body. The best example is cancer nutrition, which provides supplements specifically to cancer patients for active maintenance and adherence  to the cancer therapy such as chemo.

 

In foresight, it will be critical for regulators as well as the industry to take equal measures to have control on the products entering the markets for protection of the consumers.

 

 

 

By, 

Mr. Sameer Kolhe

President - Business operations

 

 

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