How big is the phenylketonuria (pku) market today, and what are its future growth expectations?
The phenylketonuria (PKU) market size has grown strongly in recent years. It will grow from $0.85 billion in 2024 to $0.93 billion in 2025 at a compound annual growth rate (CAGR) of 9.1%. The growth in the historic period can be attributed to rising newborn screening programs, increasing awareness of metabolic disorders, PKU dietary management, growing availability of medical foods, and regulatory approvals for PKU treatments.
The phenylketonuria (PKU) market size is expected to see strong growth in the next few years. It will grow to $1.30 billion in 2029 at a compound annual growth rate (CAGR) of 8.8%. The growth in the forecast period can be attributed to increasing adoption of gene therapy, expansion of enzyme replacement therapies, rising investment in rare disease research, growing demand for personalized medicine, and government support for PKU treatment coverage. Major trends in the forecast period include development of RNA-based therapies, digital health solutions for PKU management, rising collaborations between biotech firms and research institutions, focus on non-dietary treatment alternatives, and expansion of telehealth services for PKU patients.
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What have been the primary factors driving the phenylketonuria (pku) market’s growth?
The increasing cases of genetic disorders are expected to propel the growth of the phenylketonuria (PKU) market going forward. Genetic disorders refer to medical conditions caused by abnormalities in an individual’s DNA, such as mutations, deletions, or duplications of genes or chromosomes. The increasing cases of genetic disorders are attributed to factors such as rising maternal age, environmental influences, advancements in diagnostic technologies, and higher awareness, leading to improved detection rates. Phenylketonuria contributes to understanding genetic disorders by demonstrating how inherited enzyme deficiencies can lead to severe metabolic complications. For instance, in March 2024, Gene People, a UK-based registered charity, genetic conditions affect an estimated 1 in 25 children, impacting over 2.4 million children and adults in the UK. Additionally, around 30,000 newborns and children in the UK are diagnosed with a genetic condition each year. Therefore, the increasing cases of genetic disorders are driving the growth of the phenylketonuria (PKU) market.
What are the key segments within the phenylketonuria (pku) market?
The phenylketonuria (PKU) market covered in this report is segmented –
1) By Type: Hyperphenylalaninemia, Mild Phenylketonuria (PKU), Moderate And Variant, Classic Phenylketonuria (PKU)
2) By Treatment Type: Enzyme Replacement Therapy, Gene Therapy, Medication, Dietary Therapy
3) By Diagnosis: Genetic Testing, Biochemical Testing, Newborn Screening
4) By End-User: Specialty Clinics, Research Institutes, Home Healthcare, Hospitals
Subsegments:
1) By Hyperphenylalaninemia: Mild Hyperphenylalaninemia, Moderate Hyperphenylalaninemia, Severe Hyperphenylalaninemia
2) By Mild Phenylketonuria (PKU): Mild PKU with dietary management, Mild PKU with enzyme supplementation
3) By Moderate And Variant: Moderate PKU with medication, Variant PKU with treatment variations
4) By Classic Phenylketonuria (PKU): Classic PKU with strict dietary management, Classic PKU with enzyme replacement therapy
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Which key players are shaping the phenylketonuria (pku) market?
Major companies operating in the phenylketonuria (PKU) market are Abbott Laboratories, Merck KGaA, Agios Pharmaceuticals Inc., BioMarin Pharmaceutical Inc., PTC Therapeutics Inc., Ultragenyx Pharmaceutical Inc., Nutricia International Private Limited, Codexis Inc., Eton Pharmaceuticals Inc., Vitaflo International Ltd., American Gene Technologies International Inc., Cambrooke Therapeutics Inc., Generation Bio Co., Mead Johnson & Company, LLC, Relief Therapeutics Holding SA, SOM Innovation Biotech S.A., Synlogic Inc., Galen Ltd, Aptatek Biosciences Inc., Homology Medicines Inc
How will emerging trends drive the phenylketonuria (pku) market throughout the forecast period?
Major companies operating in the phenylketonuria (PKU) market are focusing on the development of innovative products by using various technologies, such as physiognomic technology, to enhance the efficacy and safety of PKU treatments by replicating human physiological conditions for better drug absorption and metabolism. Physiomimic technology is a comprehensive set of hardware, consumables, and assay protocols designed to replicate complex human biology and predict human drug responses precisely. For instance, in October 2022, Relief Therapeutics Holding SA, a Switzerland-based biopharmaceutical company, announced the launch of PKU Golike. PKU Golike is a next-generation medical food product developed with patented, pharmaceutical-grade Physiomimic technology for the dietary management of phenylketonuria (PKU). PKU Golike is a prolonged-release amino acid product available as granules, packets, and medical food bars. Its unique coating ensures the physiological absorption of amino acids, such as natural proteins, while masking their unpleasant taste, odor, and aftertaste.
How do regional factors impact the phenylketonuria (pku) market, and which region is the largest contributor?
North America was the largest region in the phenylketonuria (PKU) market in 2024. Europe is expected to be the fastest-growing region in the forecast period. The regions covered in the phenylketonuria (PKU) market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
What Does The Phenylketonuria (PKU) Market Report 2025 Offer?
The phenylketonuria (pku) market research report from The Business Research Company offers global market size, growth rate, regional shares, competitor analysis, detailed segments, trends, and opportunities.
Phenylketonuria (PKU) is a rare inherited metabolic disorder in which the body cannot break down an amino acid called phenylalanine (Phe) found in many protein-containing foods. This inability is due to a deficiency or malfunction of the phenylalanine hydroxylase (PAH) enzyme, which normally converts phenylalanine into another amino acid called tyrosine.
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