US Clinical Nutrition for Chronic Kidney Diseases Market Analysis

US Clinical Nutrition for Chronic Kidney Diseases Market Executive Summary

US Clinical Nutrition for Chronic Kidney Diseases Market was valued at $659.40 Mn in 2023 and is predicted to grow at a CAGR of 4.03% from 2023 to 2030, to $869.50 Mn by 2030.

Chronic kidney disease (CKD) is a gradual loss of kidney function over at least three months, often progressing silently due to the absence of early symptoms. The main causes include diabetes and high blood pressure, though family history and other conditions also contribute. As CKD advances through stages, it may necessitate dialysis or a kidney transplant and is associated with increased risks of heart disease, stroke, and bone issues. Management focuses on slowing disease progression, symptom management, and preventing complications through dietary changes, medications, and blood pressure control. Key dietary adjustments include moderating protein intake, managing fluid levels, controlling electrolytes like sodium, potassium, and phosphorus, and ensuring sufficient calorie intake to avoid malnutrition. Early detection and screening are crucial for those at risk.

In the US, more than 1 in 7 adults, or approximately 35.5 Mn people (14%), are estimated to have chronic kidney disease (CKD), with 9 out of 10 unaware of their condition, emphasizing the need for increased awareness and early detection. CKD prevalence is higher among older adults, affecting 34% of those aged 65 and older, 12% of those aged 45-64, and 6% of those aged 18-44. It is slightly more common in women (14%) than men (12%), and varies by race/ethnicity, with the highest prevalence in non-Hispanic Black adults (20%), followed by non-Hispanic Asian adults (14%), non-Hispanic White adults (12%), and Hispanic adults (14%).

The market therefore is driven by significant factors like the rising prevalence of CKD, growing awareness and diagnosis, advancements in medical research, and the aging population. However, the high cost of treatment, limited reimbursement, and scarcity of qualified dietitians restrict the growth and potential of the market.

Prominent players in this field are Abbott Nutrition, Pfizer Inc., Bayer AG, and Nestlé Health Science among others.

Market Dynamics

Market Growth Drivers

Rising Prevalence of CKD: The increasing incidence of CKD in the US driven by factors such as diabetes and hypertension, creates a growing demand for specialized nutritional products tailored to CKD management.

Growing Awareness and Diagnosis:  Increased efforts to educate both healthcare providers and patients about the benefits of clinical nutrition in managing CKD are driving market growth. Awareness campaigns and professional training programs are helping to bridge the knowledge gap.

Aging Population: The aging US population, susceptible to CKD, drives demand for CKD-specific clinical nutrition products. In 2022, 17% of the population was aged 65+, projected to reach 23% by 2050, highlighting the growing need for tailored healthcare solutions.

Advancements in Medical Research: Innovations in delivery systems and formulation technologies for clinical nutrition products are making these products more accessible and easier to use for CKD patients, driving adoption and market growth.

Market Restraints

High Cost of Treatment: The high cost of specialized clinical nutrition products for CKD patients often makes them inaccessible, especially for those lacking comprehensive health insurance coverage. This financial barrier significantly limits the availability of these essential nutritional solutions for many individuals.

Limited Reimbursement: Reimbursement for CKD-specific clinical nutrition products is not widespread in the US. Both public and private health insurance often do not cover these specialized products, which can be a significant barrier for patients.

Scarcity of Qualified Dietitians: The shortage of dietitians in the US with expertise in CKD nutrition restricts patients' access to specialized nutritional guidance and tailored dietary management plans. This limitation results in reduced demand for clinical nutrition products in the chronic kidney disease market.

Regulatory Landscape and Reimbursement Scenario

The US regulatory landscape for CKD-specific clinical nutrition is primarily overseen by the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS). The FDA regulates medical foods and enteral nutrition products used for CKD management, ensuring they meet safety, labeling, and intended use standards. The FDA classifies certain specialized formulas for CKD patients as "medical foods" or "enteral nutrition products," requiring specific labeling and quality standards. Additionally, the Dietary Guidelines for Americans, published by the USDA and HHS, provide recommendations for managing chronic diseases like CKD, indirectly influencing the development and marketing of CKD nutritional products.

Reimbursement for CKD clinical nutrition in the US varies widely. Medicare Part B may cover enteral nutrition products and some oral nutritional supplements for patients meeting specific criteria, such as severe CKD complications requiring tube feeding. Medicaid coverage for CKD nutritional interventions varies by state, with some states providing broader coverage for enteral nutrition and certain oral supplements. Private insurance plans also offer varying levels of coverage for CKD nutritional products and dietitian consultations, so patients need to review their specific plan details to understand their coverage options.

Competitive Landscape

Key Players

Here are some of the major key players in the US Clinical Nutrition for Chronic Kidney Diseases Market

• Abbott Nutrition
• Pfizer Inc.
• Bayer AG
• Nestlé Health Science
• Otsuka Pharmaceutical
• Mead Johnson & Company, LLC
• Danone S.A.
• Victus, Inc.
• B. Braun Melsungen AG
• Fresenius Kabi AG