The global phenylketonuria therapeutics market is poised for significant growth, projected to escalate from US$ 1 billion in 2023 to US$ 2.28 billion by 2033, with a robust compound annual growth rate (CAGR) of 8.6%. This forecast follows a growth pattern established from 2018 to 2022, during which the market experienced a CAGR of 5.2%.
Phenylketonuria is a genetic metabolic disorder that impedes the body’s ability to metabolize the amino acid phenylalanine, leading to potential accumulation of harmful substances. Untreated, PKU can cause severe intellectual disabilities, convulsions, and other neurological complications.
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The surging market growth is primarily driven by the development of advanced therapeutic drugs and increased global awareness about the condition. Additionally, the expansion in genetic screening programs and diagnostic testing facilitates early detection of PKU, which is crucial for effective management of the disease.
Treatment for PKU typically involves a lifelong diet restricting phenylalanine intake. However, adherence to such dietary restrictions can be challenging for many, necessitating alternative or supplementary treatments. These include medications designed to reduce phenylalanine levels in the blood and enzyme replacement therapies that enhance the breakdown of this amino acid.
The PKU therapeutics sector is expected to benefit significantly from ongoing innovations and the introduction of new treatments. Emerging therapeutic approaches, such as gene therapy, aim to correct the genetic defects causing PKU. Additionally, developments in RNA interference technologies that reduce phenylalanine production in the liver and more effective enzyme replacement therapies are also showing promise.
As the PKU therapeutics market continues to evolve, the introduction of groundbreaking treatments will likely offer new hope to patients and families affected by PKU, improving both the quality of life and health outcomes.
Key Takeaways from the Market Study:
- From 2018 to 2022, the phenylketonuria therapeutics market grew at a CAGR of 5.2%.
- The global phenylketonuria therapeutics market is expected to grow with an 8.6% CAGR from 2023 to 2033.
- As of 2033, the phenylketonuria therapeutics market is expected to reach US$ 2.28 Billion.
- According to the FMI analysis, the hospital pharmacies segment accounts for the largest market share.
- North America is expected to possess 40% market share for the Phenylketonuria Therapeutics market.
- The East & South Asia market is predicted to increase significantly throughout the forecast period, with a share of 20% during the forecast period.
“A series of international level collaborations involving healthcare stakeholders across various institutional settings are fuelling further clinical trials and research studies dedicated to discovering phenylketonuria therapeutics,” says an FMI analyst.
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Market Competition:
Key players in the market include companies such as Competition Deep Dive, Cigna, BioMarin Pharmaceuticals, Codexis, Inc., Erytech Pharma, SOM Innovation Biotech SL, Synthetic Biologics, Inc., Retrophin, Inc., Danone, Censa Pharmaceuticals, Homology Medicines, Inc., along with healthcare providers and technology companies among other global players.
- In January 2023, Jnana Therapeutics was granted clearance by the FDA for its Investigational New Drug (IND) application for JNT-517, a drug being developed to treat phenylketonuria (PKU), a condition that is difficult to treat. The biotechnology company is using its advanced chemoproteomics platform to discover drugs for challenging targets.
- The Phase 1 program of JNT-517 is currently underway in healthy volunteers in Australia, and will expand to include clinical sites in the U.S. The Phase 1b sub-study will evaluate the drug’s effectiveness in individuals with PKU, with the potential to demonstrate clinical proof of concept that supports a subsequent registrational program.
Key Segments Profiled in the Phenylketonuria Therapeutics Industry Survey:
Drug Type:
- Kuvan
- Playnziq
Route of Administration:
- Oral
- Parenteral
- Intravenous
- Subcutaneous
Distribution Channel:
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
Region:
- North America
- Latin America
- Europe
- East Asia
- South Asia
- Oceania
- Middle East & Africa
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