Medical Foods for Orphan Diseases Market Report 2025

The medical foods for orphan diseases market size has grown strongly in recent years. It will grow from $1.33 billion in 2024 to $1.42 billion in 2025 at a compound annual growth rate (CAGR) of 7%. The growth in the historic period can be attributed to orphan drug designation, research & development advances, government funding & grants, regulatory frameworks, improved diagnosis.

The medical foods for orphan diseases market size is expected to see strong growth in the next few years. It will grow to $1.82 billion in 2029 at a compound annual growth rate (CAGR) of 6.4%. The growth in the forecast period can be attributed to telemedicine and remote monitoring, healthcare system integration, emerging technologies in food science, precision nutrition, increased patient demand. Major trends in the forecast period include long-term efficacy studies, disease-specific formulations, education and training programs, focus on gut microbiome, nutritional supplements innovation.

The anticipated growth in the medical foods for orphan diseases market is driven by the increasing incidence of orphan diseases, also known as rare diseases, which affect a relatively small number of individuals within a population. These medical conditions necessitate specialized nutritional interventions, and medical foods play a crucial role in meeting the specific dietary requirements of patients with orphan diseases. The rise in the prevalence of orphan diseases, such as non-Hodgkin lymphoma and idiopathic pulmonary fibrosis, contributes to the expansion of the medical foods for orphan diseases market. For example, in January 2023, the American Cancer Society reported that non-Hodgkin lymphoma accounted for approximately 4% of cancer cases in the United States, with an estimated 80,550 new diagnoses in 2023. Additionally, a research study published in September 2022 revealed an increasing prevalence of idiopathic pulmonary fibrosis, reaching 36 cases per 100,000 people in 2021.

The growth of the medical foods for orphan diseases market is also fueled by the increasing incidence of chronic diseases. Chronic diseases, characterized by their long-lasting nature, lasting for three months or more, drive the demand for medical foods to address specific nutritional deficiencies and metabolic imbalances associated with these conditions. The World Health Organization (WHO) reported in September 2023 that chronic diseases contribute significantly to global mortality, with 41 million deaths annually, representing 74% of all fatalities. The specific breakdown includes 17.9 million deaths from cardiovascular diseases, 9.3 million from cancer, 4.1 million from chronic respiratory diseases, and 2 million from diabetes. This increasing incidence of chronic diseases underscores the growing need for medical foods in managing and improving outcomes for individuals with orphan diseases.

Product innovation is a prominent trend gaining traction in the medical foods for orphan diseases market, with major companies strategically introducing innovative products to solidify their market positions. Notably, in October 2022, Relief Therapeutics, a Switzerland-based biopharmaceutical company, unveiled PKU GOLIKE, a groundbreaking medical food product developed with the company's patented Physiomimic Technology platform. This innovation targets the dietary management of phenylketonuria (PKU), an inherited rare disorder. PKU GOsuch as stands out as the first prolonged-release amino acid product, featuring a specialized coating that ensures the physiological absorption of amino acids while concealing the unpleasant taste, odor, and aftertaste associated with these compounds. The product is classified as a phenylalanine-free food designed for special medical purposes (FSMP) in the United States.

Major players in the medical foods for orphan diseases market are actively involved in the development of PKU GOLIKE, a revolutionary product tailored for managing symptoms of phenylketonuria (PKU). Launched by Relief Therapeutics in October 2022, PKU GOsuch as represents a phenylalanine-free food created for special medical purposes (FSMP). It is the first prolonged-release amino acid supplement, leveraging Relief Therapeutics' patented physiomimic technology platform to ensure physiological amino acid absorption, mimicking the natural protein absorption process.

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 include Nestle S.A., Abbott Laboratories Inc., Danone S.A., Ajinomoto Co. Inc., Meiji Holdings Co. Ltd., Fresenius Kabi AG, BioMarin Pharmaceutical Inc., Halyard Health, Alfasigma spA, Ultragenyx Pharmaceutical Inc., Immedica Group AB, Vitaflo International Ltd., Leadiant Biosciences Inc., Alcresta Therapeutics Inc., Cambrooke Therapeutics Inc., Primus Pharmaceuticals Inc., CANbridge Pharmaceuticals Inc., Cerecin Inc., AMNIOX Medical Inc., Targeted Medical Pharma Inc., Solace Nutrition LLC, Orphan Therapeutics LLC, Metagenics Inc., Farma Genetics Inc.

North America was the largest region in the medical foods for orphan diseases market in 2024. 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, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the medical foods for orphan diseases market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Specialized nutritional products tailored for orphan diseases encompass medical foods designed to address the distinct dietary requirements of individuals affected by rare, genetic, or orphan diseases. These products, available in pill, powder, liquid, and other forms, serve as targeted solutions for patients dealing with rare orphan diseases.

Medical food pills represent specific oral formulations crafted to deliver precise nutrients, dietary components, or therapeutic agents in a convenient pill format. These pills aim to meet unique nutritional needs and tackle metabolic imbalances associated with orphan diseases. Administered orally and through enteral routes, these medical foods play a crucial role in the treatment of conditions such as phenylketonuria, tyrosinemia, eosinophilic esophagitis, food protein-induced enterocolitis syndrome (FPIES), maple syrup urine disease (MSUD), homocystinuria, and others. These specialized products are available for purchase online, through institutes, and in retail stores, catering to the needs of individuals grappling with orphan diseases.

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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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