U.S. Medical Foods For Orphan Disease Market Size, Share & Trends Analysis Report By Route Of Administration, By Product, By Application, By Sales Channel, And Segment - Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2023-2032

The U.S. medical foods for orphan disease market size was exhibited at USD 419 million in 2022 and is projected to hit around USD 729.4 million by 2032, growing at a CAGR of 5.7% during the forecast period 2023 to 2032.

Key Takeaways:

• The oral route segment accounted for the highest revenue share in terms of route of administration in 2022 and its revenue share was 71.8%. 
• The enteral segment is expected to expand at the fastest CAGR over the forecast period. 
• The powder segment accounted for 36.3% of the revenue share in 2022.
• The liquid segment is also expected to grow at a lucrative rate over the forecast period.
• The other segment accounted for 37.5% of the revenue share in 2022.
• The FPIES segment is also expected to grow at a lucrative rate over the forecast period. 
• Institutional sales held the majority share of 42.1% in 2022.
• The online sales segment is expected to grow lucratively over the forecast period.

U.S. Medical Foods For Orphan Disease Market Report Scope

Increasing healthcare expenditure, awareness about rare diseases, the prevalence of rare diseases, and early screening, are some of the key factors driving the growth of the market. As per the U.S. FDA, phenylketonuria affects about 1 in 15,000 people in the U.S. Similarly, as per the data published by UTAH’s Newborn Screening, tyrosinemia type II affects approximately 1 in 250,000 babies in the U.S.

A unique medical diet is essential for a number of rare disorders in order to prevent severe impairments and promote healthy growth in children and adults. For instance, maple syrup urine disease, food protein-induced enterocolitis syndrome, and short bowel syndrome are some of the common orphan diseases that have specific dietary requirements. Hypoallergenic formulas free of wheat, soy, dairy, and other possible allergens are frequently provided to new-borns and kids with FPIES. These factors continue to be crucial for the expansion.

The COVID-19 pandemic increased the burden on healthcare services and of treatment sensitivity for critically ill patients. Patients who tested positive for COVID-19 typically suffered from weakened immunity and disruption in respiratory & other systems. For instance, according to an article published in Elsevier Public Health Emergency Collection, around half of the critically ill COVID-19 patients developed gastrointestinal problems, such as gastrointestinal hypomotility. Patients experienced various other abdominal issues, which led to increased adoption of medical foods.

The U.S. medical foods for orphan disease market is consolidated, wherein Danone, Abbott, Nestlé, Mead Johnsons, and Relief Therapeutics account for the majority share. These players are adopting several strategies to increase their shares. The development of new products and high R&D investments to develop disease-specific formulas are some of the strategies players implement.

Route Of Administration Insights

The oral route segment accounted for the highest revenue share in terms of route of administration in 2022 and its revenue share was 71.8%. Key factors responsible for the largest market share include the high commercial viability of the orally administered products and higher preference for orally administered foods for special medical purposes owing to the ease of consumption provided by them. In addition, the increase in the manufacturing of various products such as pills, powders, and pre-thickened products is boosting growth.

The enteral segment is expected to expand at the fastest CAGR over the forecast period. The key players are launching products that can be administered through the enteral route, thereby propelling growth. Thus, there is a significant potential for enteral products.

Product Insights

The powder segment accounted for 36.3% of the revenue share in 2022. The segment dominated the market owing to a high preference for powdered formulations due to ease of consumption. The medical food market in the U.S., specifically in the orphan disease powder segment, serves individuals with uncommon and hereditary conditions like phenylketonuria (PKU), maple syrup urine disease (MSUD), and homocystinuria. These medical foods are formulated with specific amino acids, vitamins, and minerals to meet the unique nutritional needs of patients with these conditions.

The liquid segment is also expected to grow at a lucrative rate over the forecast period. Growing preference for these products owing to ease of administration and convenience in consumption is a key factor expected to fuel the growth. Companies catering to this segment are placing a greater emphasis on patient safety and product quality to ensure that medical foods for orphan diseases meet the highest standards. Some of the companies offering food in this segment include Cambrooke Therapeutics, Nutricia North America, and Danone North America, among others.

Application Insights

The other segment accounted for 37.5% of the revenue share in 2022. The segment dominated the market owing to various initiatives pertaining to the development of treatment alternatives for rare diseases, an increase in awareness about rare diseases, and funding provided for the development of orphan products.

The FPIES segment is also expected to grow at a lucrative rate over the forecast period. The awareness about this condition is growing in the U.S. There are several educational and other initiatives, such as conferences, videos, webinars, & events, including Food Allergy Awareness Day and Rare Disease Day, being undertaken by organizations such as International FPIES Organization that are contributing to the growth of this market.

Sales Channel Insights

Institutional sales held the majority share of 42.1% in 2022. The international sales of medical foods for orphan diseases is driven by growing awareness of these conditions and the need for specialized nutrition support. Medical foods are consumed under physician supervision and consumption of enteral & oral foods is high in healthcare institutions such as hospitals, clinics, and care centers. The companies are expanding their reach into international markets to meet the growing demand for medical foods for orphan diseases and to provide specialized nutrition support to patients around the world. 

The online sales segment is expected to grow lucratively over the forecast period. The trend of e-commerce and online sales of these foods for orphan diseases is growing, as more patients seek convenient and accessible options for purchasing these specialized nutrition products. The online sales of medical foods for orphan diseases are expected to increase in the coming years owing to the growing demand for these products and the convenience of online purchasing options.

Key Companies & Market Share Insights

The key players in the market are adopting strategies such as partnerships, collaboration, mergers, and acquisitions, to increase their market position. Several market players are attempting to put demand-friendly strategic plans into action. The development of new products and high R&D investments to develop disease-specific formulas are some of the strategies being implemented by market players. Key players are also collaborating with policymakers to address the issue of nutritional imbalance in patients suffering from orphan diseases in the country.

In August 2020, Nestle Health Science announced the acquisition of IM HealthScience, a nutrition science company. IM HealthScience owns brands such as FDgard, IBgard, REMfresh, and Fiber Choice. This acquisition was aimed at helping the company expand and create a robust product portfolio in the nutrition business. Some of the prominent players in the U.S. medical foods for orphan disease market include:

• Danone
• Abbott
• Nestlé
• Mead Johnson & Company
• Relief Therapeutics

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the U.S. Medical Foods For Orphan Disease market.

By Route Of Administration 

• Oral
• Enteral

By Product 

• Powder
• Pills
• Liquid
• Others

By Application 

• Phenylketonuria
• Tyrosinemia
• Eosinophilic Esophagitis
• FPIES
• MSUD
• Homocystinuria
• Others

By Sales Channel 

• Online Sales
• Retail Sales
• Institutional Sales