US Clinical Nutrition Market Analysis

US Clinical Nutrition Market Executive Summary

The US Clinical Nutrition Market is at around $12881.4 Mn in 2023 and is projected to reach $16212.2 Mn in 2030, exhibiting a CAGR of 3.34% during the forecast period 2023-2030.

Clinical nutrition is the application of nutrition principles to promote health and prevent disease in individuals, particularly in a healthcare setting. It involves assessing patients' nutritional needs, creating personalized nutrition plans, and implementing evidence-based interventions to improve health outcomes. Clinical nutrition centres on the prevention, diagnosis, and management of nutritional changes in patients linked to chronic diseases and conditions primarily in health care. Clinical in this sense refers to the management of patients, including not only outpatients at clinics and in private practice, but also inpatients in hospitals. It incorporates primarily the scientific fields of nutrition and dietetics. Furthermore, clinical nutrition aims to maintain a healthy energy balance, while also providing sufficient amounts of nutrients such as protein, vitamins, and minerals to patients.

Clinical malnutrition refers to a condition that can be treated with clinical intervention by using specialized nutrients that are considered proper medications rather than as supplements. Clinical nutrition products are useful in maintaining the patient's health and enable the improvement of the body's metabolic system by providing adequate supplements, such as minerals, vitamins, and other supplements. The clinical nutrition sector is undergoing a transformation fuelled by progress in medical research and technology. Key trends such as innovative formulations, personalized nutrition solutions, and the use of bioactive ingredients are emerging. Manufacturers are dedicating resources to R&D to produce products that not only fulfil fundamental nutritional requirements but also provide added health advantages. This emphasis on innovation is fostering competition among industry participants, resulting in a constant flow of new products and therapies tailored to various patient demographics.

Clinical nutritionists or registered dietitians work in hospitals, clinics, and other healthcare facilities to, assess patients' nutritional status, develop personalized nutrition plans, provide nutrition education, manage nutrition-related diseases like diabetes, malnutrition etc, support optimal health and well-being. Some areas of focus in clinical nutrition include, critical care nutrition, paediatric nutrition, oncology nutrition, gastrointestinal nutrition, sports nutrition etc.

In the U.S, chronic diseases like diabetes, cancer, and cardiovascular diseases affect over 133 million Americans, accounting for 7 out of 10 deaths each year. The major drivers of Clinical Nutrition industry in US are, increasing prevalence of chronic diseases and metabolic disorders, aging population, increasing awareness of the importance of nutrition for health, product innovations and technological advancements, government initiatives and rising healthcare expenditure, rising incidence of malnutrition especially in paediatric patients.

February 2023, Danone’s specialized nutrition business segment Nutricia developed its first plant-based ready-to-drink medical nutrition supplement “Fortimel”. The product is intended for people with malnourishment or those at risk of malnutrition due to medical conditions. The Some of the major players operating in the US Clinical Nutrition market are, Abbott Nutrition, Pfizer Inc, Bayer AG, Nestle, Baxter International Inc., Otsuka Holdings Co., Ltd, Mead Johnson & Company, LLC among others.

Market Dynamics

Market Drivers

Rising prevalence of chronic diseases: In the U.S, chronic diseases like diabetes, cancer, and cardiovascular diseases affect over 133 million Americans, accounting for 7 out of 10 deaths each year. The increasing burden of chronic diseases is a major driver for the clinical nutrition market, as specialized nutrition products are crucial for managing these conditions.

Growing geriatric population: The U.S. geriatric population (aged 65 and older) is expected to grow from 54 million in 2019 to 95 million by 2060, comprising nearly 23% of the total population. As the population ages, the demand for clinical nutrition products to manage age-related health issues is rising.

Increasing incidence of premature births and rising birth rate: In 2021, the U.S. birth rate increased for the first time in 7 years, reaching 3.6 million births. Premature births account for about 10% of all births in the US, driving demand for specialized paediatric clinical nutrition products.

Market Restraints

High cost of clinical nutrition products: Clinical nutrition products can be expensive, with costs ranging from $5 to $50 per day for enteral nutrition and $10 to $100 per day for parenteral nutrition. The high costs can limit patient access and adoption of these products.

Potential side effects and complications: Clinical nutrition products, especially parenteral nutrition, carry risks of complications like infections, liver disease, and metabolic disturbances. These potential side effects can discourage the use of clinical nutrition products.

Reimbursement limitations: Only formulations deemed medically necessary qualify for reimbursement under public drug and medical plans in the US. This narrow coverage can restrict access to outpatient and community-based clinical nutrition services.

Regulatory Landscape and Reimbursement Scenario

The regulation of clinical nutrition in the United States involves a complex network of federal agencies, professional organizations, and state-level bodies. At the federal level, the Food and Drug Administration (FDA) plays a central role, overseeing the safety and efficacy of foods, dietary supplements, medical foods, and drugs used in nutritional therapy. The FDA's various centres, including the Centre for Drug Evaluation and Research (CDER), the Centre for Food Safety and Applied Nutrition (CFSAN), and the Centre for Devices and Radiological Health (CDRH), regulate different aspects of clinical nutrition. The United States Pharmacopeia (USP) sets quality standards for medicines and dietary supplements. Clinical research in nutrition is overseen by multiple bodies, including the FDA, the Office for Human Research Protections (OHRP), Institutional Review Boards (IRBs), and the National Institutes of Health (NIH). The US Department of Agriculture (USDA) contributes to nutrition research and policy, while the Federal Trade Commission (FTC) regulates nutrition-related advertising claims.

The reimbursement system for clinical nutrition services in the United States is multifaceted and varies depending on the payer, setting, and type of service provided. Medicare, the federal health insurance program for adults 65 and older and certain younger individuals with disabilities, provides coverage for Medical Nutrition Therapy (MNT) for beneficiaries with diabetes, kidney disease, or post-kidney transplant, when provided by a registered dietitian or nutrition professional. This coverage is limited to a specific number of hours per year and requires a physician referral. Medicaid, the joint federal and state program for individuals with limited income, offers varying levels of nutrition services coverage, as each state has flexibility in determining its Medicaid benefits. Private insurance coverage for nutrition services varies widely among plans. Many private insurers follow Medicare's lead in terms of covered diagnoses and service limitations. Professional organizations like the Academy of Nutrition and Dietetics (AND) and the American Society for Parenteral and Enteral Nutrition (ASPEN) play crucial roles in developing guidelines and advocating for appropriate reimbursement.

Competitive Landscape

Key Players

Here are some of the major key players in the US Clinical Nutrition Market:

• Abbott Nutrition
• Pfizer Inc.
• Bayer AG
• Nestle
• Baxter International Inc.
• Otsuka Holdings Co., Ltd.
• Mead Johnson & Company, LLC
• Danone
• Abbvie
• Baxter