Phenylketonuria Treatment Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The Phenylketonuria Treatment Market is Segmented by Drug (Kuvan and Playnziq) and Geography.

Phenylketonuria Treatment Market Snapshot

Phenylketonuria Treatment Market Growth
Study Period: 2018 - 2026
Base Year: 2021
Fastest Growing Market: Asia Pacific
Largest Market: North America
CAGR: 11 %
Phenylketonuria Treatment Market Major Players

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Market Overview

The phenylketonuria treatment market is expected to register a CAGR of around 11 % over the forecast period. The growing burden of phenylketonuria disease and the novel treatments emerging related to phenylketonuria is expected to boost the phenylketonuria treatment market growth. According to the National PKU Alliance, the chances of the gene carrier is around one in fifty people, and the chances of two carriers mating are expected to be around 25%. The degree of affecting the disease is majorly based upon ethnicity and geographical region. According to the same source, in Ireland, around 1 out of 4,500 population is diagnosed with it. Similarly, in Asia, 1 out of 20,000 is diagnosed with it, while in Turkey the incidence is high, i.e., 1 in 4,000.

Scope of the Report

Phenylketonuria is a birth defect, which occurs due to the mutation of the gene that is responsible for encoding phenylalanine hydroxylase. The presence of phenylalanine is higher in blood levels in the affected people. The phenylketonuria treatment market is segmented by drug and geography.

By Drug
Other Drugs
North America
United States
United Kingdom
Rest of Europe
South Korea
Rest of Asia-Pacific
Rest of the World

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Key Market Trends

Kuvan Phenylketonuria Treatment Segment is Expected to Hold a Major Market Share in the Phenylketonuria Treatment Market

Kuvan is the only drug present currently for the efficient treatment of phenylketonuria, which is being manufactured by BioMarin Pharmaceuticals. It adds more BH4 compound, helps in stimulating phenylalanine hydroxylase enzyme, which then breakdown the phenylalanine protein. In 2017, it lost its patent, and BioMarin Pharmaceuticals gave license to Par Pharmaceuticals to develop a generic version of Kuvan.

Phenylketonuria Treatment Market Trends

North America is Expected to Hold a Significant Share in the Market during the Forecast Period

North America expected to hold a major market share in the global phenylketonuria treatment market due to a higher incidence rate of phenylketonuria and the development in treatment type. For instance, Homology Medicines Inc., a US-based genetic company, is developing a gene therapy, HMI-102, for phenylketonuria. Currently, its IND (Investigational New Drug) application has been approved by the USFDA (Food & Drug Administration), and it is undergoing the first phase of clinical trials to test safety and efficacy. According to the National Organization for Rare Disorders, there have been approximately 13,500 to 19,000 newborns diagnosed with phenylketonuria disease in the United States. According to the National Centre for Biotechnology Information published study “Phenylketonuria”, the disease is mostly found in Native Americans, and the incidence rate is around 1 in 15,000 people.

Phenylketonuria Treatment Market Analysis

Competitive Landscape

The phenylketonuria treatment market is consolidated and consists of a few major players. Some of the companies currently dominating the market are BioMarin Pharmaceuticals Inc., Censa Pharmaceutical, Synlogic Inc., Erytech Pharma SA, Codexis Inc., SOM Innovation Biotech SL, Homology Medicines Inc., and Ultragenyx (Dimension Therapeutics).

Table of Contents


    1. 1.1 Study Assumptions

    2. 1.2 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Prevalence Rate of Phenylketonuria

      2. 4.2.2 Increasing Research and Development Activities in relation to Phenylketonuria Treatment

    3. 4.3 Market Restraints

      1. 4.3.1 High Cost of Treatment

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry


    1. 5.1 By Drug

      1. 5.1.1 Kuvan

      2. 5.1.2 Playnziq

      3. 5.1.3 Other Drugs

    2. 5.2 Geography

      1. 5.2.1 North America

        1. United States

        2. Canada

        3. Mexico

      2. 5.2.2 Europe

        1. Germany

        2. United Kingdom

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.2.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.2.4 Rest of the World


    1. 6.1 Company Profiles

      1. 6.1.1 BioMarin Pharmaceuticals Inc.

      2. 6.1.2 Censa Pharmaceuticals

      3. 6.1.3 Codexis Inc.

      4. 6.1.4 Erytech Pharma SA

      5. 6.1.5 Homology Medicines Inc.

      6. 6.1.6 Synlogic Inc.

      7. 6.1.7 SOM Innovation Biotech SL

      8. 6.1.8 Ultragenyx (Dimension Therapeutics)

    2. *List Not Exhaustive

**Competitive Landscape covers- Business Overview, Financials, Products and Strategies, and Recent Developments

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Frequently Asked Questions

The Phenylketonuria Treatment Market market is studied from 2018 - 2026.

The Phenylketonuria Treatment Market is growing at a CAGR of 11% over the next 5 years.

Asia Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

BioMarin Pharmaceuticals, Censa Pharmaceutical , SOM Innovation Biotech SL , Codexis Inc. , Homology Medicines Inc. are the major companies operating in Phenylketonuria Treatment Market.

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