The global Phenylketonuria (PKU) Market was strong in 2023 and is expected to have steady growth over the forecast period, due to a rise in awareness of PKU and advancements in healthcare. PKU is a rare hereditary disorder in which the body produces too much phenylalanine, and it is caused by a mutation in a gene that aids in the production of phenylalanine hydroxylase. PKU symptoms can be stopped, and brain damage can be avoided with early diagnosis and treatment. Increased phenylalanine levels can be caused by a high protein diet, and both parents must pass on a faulty variant of the PAH gene for an infant to inherit PKU.
Increased research in the field of genomics and bioinformatics, as well as increased development and commercialization of new drugs, are some of the key factors driving the PKU treatment market. Rising PKU awareness programs sponsored by local governments, NGOs, and regulatory agencies, as well as healthcare system help in established and emerging nations, are driving PKU therapy.
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The global PKU market growth is substantially hampered by government regulations, high therapy costs, unfavorable reimbursement, and a lack of awareness about the disease among patients. Researchers are looking at several adjuvant medicines for PKU treatment based on research papers and ongoing trials. Extended options to end-users in terms of effectiveness and convenience will create opportunities for PKU treatment. Companies are also delivering PKU treatment-based products and services, in addition to PKU-specific food supplements.
The PKU treatment market is divided into drugs and nutrition supplements. The drugs market is further divided into Kuvan and Biopten, and the Kuvan Phenylketonuria Treatment Segment is expected to hold a significant market share. Kuvan, made by BioMarin Pharmaceuticals, is now the sole medicine available for effective treatment of PKU.
North America dominates the PKU diagnostic and treatment market because of its growing population, increasing number of screening procedures, presence of prominent manufacturers, and technical improvements. The prevalence of PKU in newborns and adults is increasing in the United States, which is driving up demand for PKU treatment. The United States has dominated the PKU therapeutic landscape due to government backing for ongoing clinical research.
Major companies profiled in the report include Daiichi Sankyo Company Limited, Cambrooke Therapeutics, American Gene Technologies International, Inc., Dimension Therapeutics, Inc., Synthetic Biologics, Inc., BioMarin Pharmaceutical, Inc., Erytech Pharma SA, Danone Nutricia, Censa Pharmaceuticals, Homology Medicines, Inc., SOM Innovation Biotech SL, Mayo Foundation for Medical Education and Research, and Rubius Therapeutics, Inc. Strategies and objectives of major companies include developing marketable and highly stable formulations with high efficacy and potency versions.
Phenylketonuria (PKU) market Segmentation:
Treatment Type Outlook (Revenue, USD Billion; 2018-2028)
- Drugs
- Nutrition Supplements
- Others
Type Outlook (Revenue, USD Billion; 2018-2028)
- Hyperphenylalaninemia
- Mild PKU
- Moderate Variant
- Classic PKU
End User Outlook (Revenue, USD Billion; 2018-2028)
- Hospital Pharmacies
- Online Pharmacies
- Drug Stores
- Pediatric Clinics
- Others
Region Outlook (Revenue, USD Billion; 2018-2028)
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- U.K.
- France
- Italy
- Spain
- Benelux
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- South Korea
- Rest of Asia Pacific
- Latin America
- Brazil
- Rest of Latin America
- Middle East Africa
- Saudi Arabia
- UAE
- South Africa
- Rest of Middle East Africa
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