3 key success factors to meet the challenges of the clinical nutrition market

What is clinical nutrition?

The term “clinical nutrition” encompasses the industry dedicated to the development of food products designed to meet the specific nutritional needs of sick individuals. These products are tailored to patient needs for various specific therapeutic areas such as undernutrition, cancer, dysphagia, renal failure, hereditary metabolic diseases, etc.

Undernutrition affects 2 million people in France alone, and increases the risk of treatment side effects, the risk of post-operative complications, and the risk of mortality in the case of cancer¹https://www.chu-poitiers.fr/denutrition-des-consequences-qui-peuvent-etre-graves/.

Medical nutrition has become an essential pillar in the management of undernutrition, helping to improve clinical outcomes and patients’ quality of life.

Moreover, the global market for clinical nutrition is set to grow significantly in the coming years. It is estimated that it will reach a value of around $70 billion by 2030²https://www.zionmarketresearch.com/report/medical-nutrition-market, with a CAGR of 5% between 2023 and 2032[2]. Nevertheless, companies in the sector face major challenges such as changes in the regulatory framework, the need for innovation, cost pressures and intensifying competition.

Key success factors in the clinical nutrition market

Key success factor n°1: identify the best opportunities

The upstream identification of opportunities and unmet clinical needs is essential to successful development and positioning. This approach encompasses several dimensions:

Mapping new pathologies to target

This line of attack involves identifying and understanding new pathologies likely to benefit from nutritional solutions. It goes beyond diseases commonly treated by clinical nutrition, such as undernutrition, sarcopenia, cachexia and others. It includes emerging therapeutic areas such as allergies and skin disorders, as well as wellness-related aspects such as the microbiome and its influence on mental health. The aim is to characterize the nature, symptoms, causes and consequences, as well as the prevalence of these pathologies.

Identifying beneficial ingredient combinations and optimizing formulations

This approach aims to determine which ingredient combinations offer the best synergy of benefits. Ingredients such as whey protein, BCAAs, EAAs, leucine, HMB and vitamin D are among the essential ingredients present in products currently on the market. However, their synergy and optimal level of incorporation are still subject to exploration. The benefits sought are diverse: stimulating muscle protein synthesis, increasing muscle strength, boosting immunity, improving cognitive health and enhancing patients’ quality of life. Given the considerable diversity of ingredients and possible combinations, systematic analysis of scientific evidence is essential to assess their potential use and optimize formulations.

Mapping high-potential geographies

This path focuses on identifying the countries with the greatest market potential for clinical nutrition products. The approach varies according to the country’s level of development.

• In a mature country, the challenge for a company in the sector is to strengthen its presence and market share. This implies continuous innovation to meet the evolving needs of patients and healthcare professionals.
• In developing countries, the main challenge is to stimulate market growth, for example by promoting education and awareness of the benefits of medical nutrition.

It is necessary to characterize these territories by assessing demographic trends, competition, regulation, healthcare infrastructure and cultural preferences. This analysis provides a better understanding of the challenges and opportunities specific to each market. In addition, it can lead to the identification of a need for local adaptation, as illustrated by the integration of traditional Chinese medicine into the Chinese healthcare system.

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Key success factor n°2: build a relevant business model

In the clinical nutrition sector, there are several key elements of the business model that require special attention to ensure an appropriate strategy. These include

Defining the OTC/Rx product positioning

The choice between an over-the-counter (OTC) or prescription (Rx) product has a significant impact on the business model in terms of production costs and time-to-market.

Of course, both OTC and Rx products require Food for Special Medical Purposes (FSSMP) status for market access. This step is conditional on proof of clinical benefit, and is regulated in Europe by bodies such as ANSES and EFSA. However, for X-ray products, registration on the List of Reimbursable Products and Services (LPPR) and negotiation of the sale price with the HAS and CEPS are also required.

OTC (over-the-counter) products are designed to be more attractive to patients, with more varied ranges including desserts, cookies, soups and so on. However, their price can be an obstacle in the absence of reimbursement and further scientific evidence.

Implementing an engagement strategy with healthcare professionals and patients

The main challenge is to convince healthcare professionals of the clinical and economic benefits of medical nutrition products.

This involves raising awareness among healthcare professionals of the importance of undernutrition and the effects of clinical nutrition products. Nevertheless, the low credibility accorded to medical sales representatives from agri-food companies is a major constraint. To overcome this challenge, it is essential to develop teaching aids and tools for healthcare professionals. In addition, close collaboration with clinical societies specializing in nutrition (such as ESPEN, ASPEN, SFNCM, etc.) through research funding, the organization of webinars, or event sponsorship can also be an effective lever for action.

A second key element is to increase patient engagement beyond products, by developing support services. The aim here is to strengthen the company’s market position while offering better support to patients. These services include tools or applications designed to raise patients’ awareness by helping them to spot pathologies, to reinforce compliance thanks to monitoring and advice booklets, and to support patients more generally in their disease management.

Developing collaborations between agrifood and pharmaceutical companies

Little explored to date, collaboration between agrifood companies, accustomed to mass markets, and pharmaceutical companies, benefiting from greater medical credibility, could be an avenue worth considering for the commercialization of clinical nutrition products.

Key success factor n°3: generate robust scientific data

The generation of scientific data is crucial to support product efficacy and safety. It is essential to balance scientific research with cost management, taking into account the different needs of patients.

OTC products do not always require investment in costly clinical trials. Indeed, they target patients with less critical needs and lower risks, and do not seek reimbursement. Prescription products, on the other hand, require comprehensive clinical trials to substantiate efficacy and safety claims, which are essential to convince healthcare professionals and regulators.

Robust study design and full transparency are needed to guarantee objective results and maintain stakeholder confidence. This involves not only the design of randomized double-blind studies, but also in-depth studies on populations with specific pathologies (cancer, chronic inflammatory bowel disease, cirrhosis, lung disease, etc.), and in various clinical settings such as hospitals, rehab facilities, as well as among patients who vary on other relevant axes such as diet and exercise.

Careful selection of partners for clinical trials to ensure the credibility and objectivity of the results is also essential.  Relevant criteria include scientific expertise, available resources and reputation.

Finally, the study of the synergistic effects of medical nutrition products in combination with drugs remains a largely unexplored field.

The clinical nutrition market is both promising and faces major challenges. To succeed in this complex and constantly evolving market, three key success factors emerge. First, identifying business opportunities is essential, including identifying new pathologies to target, optimizing beneficial ingredient combinations and exploring markets by geography. Next, building a solid business model involves choices such as OTC or Rx product positioning, as well as developing an engagement strategy with healthcare professionals and patients. Finally, the generation of robust scientific data is essential to justify the efficacy and safety of products, and must be adapted to the needs of targeted patients. This requires the design of appropriate studies and the establishment of relevant partnerships.

Collaboration between agri-food and pharmaceutical players offers promising and untapped prospects in the clinical nutrition market. Alcimed can help you enter the uncharted territories of medical nutrition. Don’t hesitate to contact our team!

About the author,

Antoine, Consultant in Alcimed’s Agri-food team in France.