Medical Foods for Orphan Diseases Market Report 2026

The medical foods for orphan diseases market size has grown strongly in recent years. It will grow from $1.41 billion in 2025 to $1.49 billion in 2026 at a compound annual growth rate (CAGR) of 5.9%. The growth in the historic period can be attributed to increasing diagnosis of rare and genetic disorders, expansion of clinical nutrition research, rising physician awareness of medical foods, growth in institutional nutrition programs, availability of regulated medical food frameworks.

The medical foods for orphan diseases market size is expected to see strong growth in the next few years. It will grow to $1.94 billion in 2030 at a compound annual growth rate (CAGR) of 6.8%. The growth in the forecast period can be attributed to increasing focus on precision nutrition therapies, rising investments in orphan disease treatment solutions, growing demand for patient-centric nutritional care, expansion of home-based medical nutrition, increasing regulatory clarity for medical foods. Major trends in the forecast period include increasing development of disease-specific nutritional formulations, rising focus on personalized medical nutrition, growing adoption of ready-to-consume medical foods, expansion of specialized clinical nutrition products, enhanced compliance with regulatory nutrition standards.

The rising incidence of orphan diseases is expected to drive the growth of the medical foods for orphan diseases market going forward. Orphan diseases, also known as rare diseases, are medical conditions affecting a relatively small number of individuals within a population. Medical foods are used to manage these disorders by providing specialized nutrition tailored to patients’ needs. For instance, in January 2023, according to the American Cancer Society, a US-based voluntary health organization, non-Hodgkin lymphoma, a rare disease, was among the most common types of cancer in the United States, accounting for approximately 4% of cancer cases, with around 80,550 new diagnoses estimated for 2023. Therefore, the increasing prevalence of orphan diseases is fueling the medical foods for orphan diseases market.

Major companies in this market are focusing on technological advancements, such as vitamin- and mineral-fortified micro-tablet protein substitutes, to meet rising demand driven by improved diagnosis of metabolic disorders (particularly Phenylketonuria, PKU), growing awareness of lifelong dietary management, and the need for convenient, palatable, and nutritionally complete medical foods. These micro-tablets deliver essential and non-essential amino acids along with a broad spectrum of vitamins and minerals in a compact solid form, offering easier daily consumption, better nutrient completeness, and greater convenience compared with bulky powders or unpalatable liquid mixtures. For instance, in October 2023, Galen Medical Nutrition, an Ireland-based medical nutrition company, launched PKU EASY Microtabs Plus, a phenylalanine-free micro-tablet protein substitute enriched with vitamins, minerals, and all essential and non-essential amino acids for patients with PKU. The coated micro-tablet format improves palatability and ease of use, while the slow-release, solid-dose delivery supports better compliance and more manageable daily dietary management compared with traditional powder-based formulas. This launch reflects the broader trend toward more patient-friendly, nutritionally complete, and convenient medical foods for orphan metabolic diseases.

In July 2023, Pentec Health, a US-based company specializing in innovative medication management solutions for patients with complex medical needs, acquired ZOIA Pharma for an undisclosed amount. This acquisition is intended to enhance Pentec Health's medical food services as a Complex Care Provider, ensuring that ZOIA Pharma customers can access innovative solutions for managing phenylketonuria (PKU) while addressing common patient concerns. ZOIA Pharma is a US-based organization dedicated to developing medical foods specifically for the treatment of orphan diseases.

Major companies operating in the medical foods for orphan diseases market are Abbott Laboratories Inc., Danone S.A., Nestle S.A., Ajinomoto Co Inc., Fresenius Kabi AG, Reckitt, Baxter International Inc., B Braun Melsungen AG, Dr Schar AG, Solace Nutrition LLC, Alcresta Therapeutics Inc., Cerecin Inc., Primus Pharmaceuticals Inc., Metagenics Inc., Targeted Medical Pharma Inc., Leadiant Biosciences Inc., Ultragenyx Pharmaceutical Inc., BioMarin Pharmaceutical Inc., Perrigo Company plc, Nestle Health Science.

North America was the largest region in the medical foods for orphan diseases market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the medical foods for orphan diseases market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the medical foods for orphan diseases market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Italy, Spain, Canada.

The medical foods for orphan diseases market consist of sales of nutritionally complete formulas and nutritionally incomplete formulas. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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