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A genetic metabolic condition called Phenylketonuria Therapeutics Market affects how the body processes protein. Phenylalanine is an amino acid that patients with PKU are unable to effectively break down, which can result in the accumulation of harmful chemicals in the body. PKU can result in severe intellectual disabilities, convulsions, and other neurological issues if left untreated.

The availability of cutting-edge medicines and rising awareness of the condition are what are driving the growth of the global PKU therapeutics market. A growing number of genetic screening programmes and diagnostic tests that aid in the early detection of PKU patients are also helping the industry.

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During the projected period of 2023–2033, the global market for phenylketonuria therapeutics is anticipated to expand at a compound annual growth rate (CAGR) of 8.6%, according to a recent market research analysis from Future Market Insights.

Phenylalanine restriction is the mainstay of treatment for PKU and must be adhered to for the remainder of one's life. However, many patients have trouble sticking to this diet, which means they could need extra treatments. These include drugs that help lower blood levels of phenylalanine as well as enzyme replacement therapies that aid in more efficient phenylalanine breakdown.

It should be emphasised that the market will gain from the creation of fresh and cutting-edge PKU treatments. For instance, gene therapy is a young field of study that tries to fix the genetic flaws that lead to PKU. Other promising strategies include the use of RNA interference to lessen the liver's production of phenylalanine as well as the use of more efficient enzyme replacement therapy.

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.

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


  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia
  • Oceania
  • Middle East & Africa


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