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Phenylketonuria Market

Phenylketonuria Market: information by Product Type (Drugs, Dietary Supplement) Rout of Administration (Oral Route), Distribution Channel (Hospital Pharmacies, Drug Stores)—Forecast Till 2026

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Market Overview

The Phenylketonuria market accounted for around USD 858.2 million in 2018 and is expected to grow at a CAGR of 6.3% during the forecast period, 2019–2026.

Phenylketonuria is an inborn genetic disorder, in which decreased metabolism of the amino acid phenylalanine. It is a rare genetic disorder that increases the level of phenylalanine in the blood and causes problems throughout the body. Phenylketonuria is major causes of seizures, intellectual disability, mental disorder, and behavioral problems.high prevalence of phenylketonuria across the globe is driving the growth of market. For instance, according to the Boston Children's Hospital, around one in 15,000 babies are born with PKU in the United States every year.

Growing number of pipeline of product for treatment of phenylketonuria is boosting the growth of market. For instance, CNSA-001 developed by Censa pharmaceuticals, Inc. is under Phase 2.

Market Snapshot

market snapshot
Base Year
: 2017
Study Period
: 2016–2026
: 6.3 %
Fastest Growing Market
: North America
Largest Market
: Europe
Market Size
: USD 858.2 million
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Segmental Analysis

Phenylketonuria market is segmented by product type, rout of administration and distribution channel.

On the basis of product type, the market is segmented into drugs and dietary supplement.drug is further segmented into kuvan and biopten.

Based on rout of administration, the market is segmented into oral route and parenteral route.oral route is further segmented into tablets & capsules, syrups and powder.parenteral route is further segmented into intravenous and subcutaneous. oral route is expected to hold major market share owing to dose flexibility and acceptable size and volume.  

On the distribution channel, the market is segmented into hospital pharmacies, drug stores, online pharmacies and pediatric clinics. hospital pharmacies is expected to hold major market share over the forecast period.

Regional Analysis

Geographically, the phenylketonuria market is segmented into four North America, Europe, Asia Pacific, and Latin America and the Middle East & Africa (LAMEA).

North America is dominating the market and expected to grow over forecast period.According to the CanPKU in U.S.  Phenylketonuria test is recommended as the first condition widely tested for through newborn screening. Increasing research and development and development for development of advanced treatment is propelling the growth of market. For instance, May 2018, U.S. Food and Drug Administration approved Palynziq (pegvaliase-pqpz) for treatment of phenylketonuria.

Europe accounted for second largest share for phenylketonuria market. Increasing number incidences of phenylketonuria in several European countries is boosting the growth of market. For instance, according to the NHS England, during 2015–2016, it was estimated approximately, 1 per 10,000/14,000 diagnosed with phenylketonuria. Furthermore, Different nonprofit organization work for management of phenylketonuria is fueling the growth of market. For instance, - European Society for Phenylketonuria and Allied Disorders, has been published in the Orphanet Journal of Rare Diseases for increasing awareness of phenylketonuria.

Phenylketonuria Market Regional Analysis
Regional Growth Insights Download Free Sample

Top Key Players of Phenylketonuria Market

Some of the key players in the phenylketonuria market include 

  1. ambrooke Therapeutics
  2. Daiichi Sankyo Company Limited
  3. American Gene Technologies International INC.
  4. Danone Nutricia
  5. Dimension Therapeutics INC.
  6. Synthetic Biologics INC.
  7. SOM Innovation Biotech SL
  8. Codexis INC.
  9. BioMarin Pharmaceutical INC.
  10. Erytech Pharma SA

Report Scope

Report Metric Details
CAGR 6.3%
Forecast Period 2023-2031
Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends
Segments Covered
  1. By Product Type
    1. Drugs
    2. Kuvan
    3. Biopten
    4. Dietary Supplement
  2. By Rout of Administration
    1. Oral Route
    2. Tablets and Capsules
    3. Syrups
    4. Powder
    5. Parenteral Route
    6. Intravenous
    7. Subcutaneous
  3. By Distribution Channel
    1. Hospital Pharmacies
    2. Drug Stores
    3. Online Pharmacies
    4. Pediatric Clinics
Geographies Covered
  • North America
  • Europe
  • APAC
  • Middle East and Africa

Recent Developments

What will be the Future Developments in Phenylketonuria Market?

  • Historical inferences, findings & analysis of the market from 2016 to 2018
  • Projections and performance forecast analysis for the future from 2019 to 2026
  • Production and consumption point of view (POV) analysis
  • Market drivers, restraint and opportunity analysis, to define market dynamics covering industry, regulatory, innovation, technological & pricing trends
  • Comprehensive competitive landscape mapping with recent development covering market leadership, competency, sustainability, and prospects

Phenylketonuria Market Segmentation

By Product Type

  • Drugs
  • Kuvan
  • Biopten
  • Dietary Supplement

By Rout of Administration

  • Oral Route
  • Tablets and Capsules
  • Syrups
  • Powder
  • Parenteral Route
  • Intravenous
  • Subcutaneous

By Distribution Channel

  • Hospital Pharmacies
  • Drug Stores
  • Online Pharmacies
  • Pediatric Clinics

Regions Covered

North America

  • U.S.
  • Canada
  • Mexico


  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Rest of Europe


  • China
  • India
  • Japan
  • South Korea
  • Australia
  • Rest of Asia-Pacific


  • Brazil
  • Saudi Arabia
  • South Africa
  • Rest of LAMEA
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