Global Phenylketonuria Market Size, Share, and COVID-19 Impact Analysis, By Product Type (Drugs, Nutrition Supplements, Others), By Type (Hyperphenylalaninemia, Mild PKU, Moderate and Variant, Classic PKU), By End Users (Hospital Pharmacies, Online Pharmacies, Drug Stores, Pediatric Clinics, & Others), By Region (North America, Europe, Asia-Pacific, Latin America, Middle East, and Africa), Analysis and Forecast 2022- 2032

Industry: Healthcare


Global Phenylketonuria Market Insights Forecasts to 2030

  • The Global Phenylketonuria Market Size was valued at USD 610.3 Million in 2022.

  • The Market is Growing at a CAGR of 6.2% from 2022 to 2032.
  • The Worldwide Phenylketonuria Market Size is expected to reach USD 1121.1 Million by 2032.
  • Europe is expected To Grow the fastest during the forecast period.

Global Phenylketonuria Market

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The Phenylketonuria Market Size is expected to reach USD 1121.01 Million by 2032, at a CAGR of 6.2% during the forecast period 2022 to 2032. Phenylketonuria is a rare genetic disorder that affects approximately 1 in 10,000 to 15,000 newborns worldwide. With advances in genetic testing and newborn screening programs, more cases of phenylketonuria are being diagnosed, which is increasing the demand for phenylketonuria diagnostic tests and treatments.


Market Overview

A rare inherited disorder called phenylketonuria causes the body to overproduce the amino acid phenylalanine. Phenylalanine is an amino acid that is present in all proteins as well as some artificial sweeteners. Tyrosine is a non-essential amino acid that is produced by the human body via the enzyme phenylalanine hydroxylase. Tyrosine is necessary for the body to produce neurotransmitters including dopamine, norepinephrine, and epinephrine. A change in the PAH gene, which gives instructions for producing the phenylalanine hydroxylase enzyme, results in PKU. The digestion of the amino acid phenylalanine, which is present in many meals, is carried out by this enzyme. Phenylalanine can accumulate to hazardous levels in the brain and cause intellectual impairment and other neurological issues because people with PKU are unable to break it down. The global phenylketonuria market includes diagnostic tests, therapies, and nutritional supplements for individuals with PKU.


Report Coverage

This research report categorizes the phenylketonuria market based on various segments and regions and forecasts revenue growth and analyses trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the phenylketonuria market. Recent market developments and competitive strategies such as expansion, product launch, and development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segments of the phenylketonuria market. Technological innovation and advancement will further optimize the performance of the product, enabling it to acquire a wider range of applications in the downstream market.


Global Phenylketonuria Market Report Coverage

Report CoverageDetails
Base Year:2021
Market Size in 2021:USD 610.3 Million
Forecast Period:2022-2032
Forecast Period CAGR 2022-2032 :6.2%
2032 Value Projection:USD 1121.1 Million
Historical Data for:2020-2021
No. of Pages:200
Tables, Charts & Figures:146
Segments covered:By Product Type, By Type, By End User, By Region, and COVID-19 Impact Analysis
Companies covered::Daiichi Sankyo Company Limited, Cambrooke Therapeutics, American Gene Technologies International, Inc., Dimension Therapeutics, Inc., Synthetic Biologics, Inc., BioMarin Pharmaceutical, Inc., Erytech Pharma SA, Danone Nutricia, Censa Pharmaceuticals, Homology Medicines, Inc., SOM Innovation Biotech SL, Mayo Foundation for Medical Education and Research, Rubius Therapeutics, Inc.
Pitfalls & Challenges:COVID-19 has the potential to impact the global market

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Driving Factors

Major factors that are expected to boost the growth of the phenylketonuria market during the forecast period, such as the growing awareness of phenylketonuria among healthcare professionals and the general public is also contributing to the growth of the market. Also, Increased awareness has led to more timely diagnosis and treatment of the disorder, which is crucial for preventing long-term complications and improving outcomes. There have been significant advancements in the development of new therapies for PKU, including enzyme replacement therapy, gene therapy, and drug therapies. These new treatments offer the potential to improve outcomes and quality of life for individuals with PKU and are driving the growth of the market. Moreover, the governments and regulatory agencies are providing support and funding for research and development of new PKU treatments, which is helping to drive innovation and bring new products to market. In addition, individuals with PKU require specialized medical foods and nutritional supplements to meet their dietary needs. The growing demand for these products is contributing to the growth of the PKU market.


Restraining Factors

Several restraining factors could impact the growth of the global phenylketonuria (PKU) market, such as there is still a lack of understanding among some healthcare professionals and the general public. This can result in delayed diagnosis and treatment, which can have long-term consequences for individuals with PKU. Also, the cost of PKU therapies, including enzyme replacement therapy, gene therapy, and drug therapies, can be prohibitively expensive. This can limit access to these treatments for some patients, particularly those in low- and middle-income countries. Individuals with PKU must adhere to a strict low-phenylalanine diet for their entire lives. This can be challenging and may impact the quality of life, particularly for children and adolescents who may struggle with adherence. Moreover, Clinical trials for new PKU treatments can be difficult to conduct due to the rarity of the disorder& Limited access to specialized medical foods This can limit the availability of new treatments and slow down the development of new therapies.


Market Segmentation

In 2022, the nutrition supplements segment is dominating the market with the largest market share over the forecast period.

Based on the product type, the Global Phenylketonuria Market is bifurcated into drugs, nutrition supplements, and others. Among these, nutrition supplements dominated the market over the forecast period due to the nutrition supplements segment includes specialized medical foods and nutritional supplements that are designed to provide the necessary nutrients while restricting phenylalanine intake. These products may include formulas, drinks, and snack bars that are low in phenylalanine but high in protein, vitamins, and minerals which may dominate the market share over the forecast period.


In 2022, the hospital pharmacies segment is dominating the market over the forecast period.

Based on the end users, the Global Phenylketonuria Market is segmented into hospital pharmacies, online pharmacies, drug stores, pediatric clinics, & others; the hospital pharmacies segment held the largest market share due to the hospital's facility can accommodate a significant number of patients. Additionally, the majority of people prefer to get their drugs from hospital pharmacies and then have them examined by a doctor to avoid any possible mistakes.


Global Phenylketonuria Market, By Type

Based on type, the Global Phenylketonuria Market is classified into hyperphenylalaninemia, mild PKU, moderate and variant, classic PKU, & others.


Regional Segment Analysis of the phenylketonuria market

  • North America (U.S., Canada, Mexico) 
  • Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
  • Asia-Pacific (China, Japan, India, Rest of APAC)
  • South America (Brazil and the Rest of South America) 
  • The Middle East and Africa (UAE, South Africa, Rest of MEA)


North America is dominating the market with the largest market share during the forecast period


Global Phenylketonuria Market

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North America is anticipated to grow at the highest CAGR during the forecast period owing to the increase in awareness about PKU and other rare diseases among patients and healthcare professionals in this region. Moreover, government initiatives to create awareness about such disorders are also driving market growth in this region.


Asia Pacific is projected to observe a significant amount of growth in the phenylketonuria market due to the expansion of the countries it establishes. Also, the growing alertness about healthy living is further anticipated to propel the growth of the phenylketonuria market in the region during the forecast period.


Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the phenylketonuria market along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.


List of Key Companies

  • Daiichi Sankyo Company Limited
  • Cambrooke Therapeutics
  • American Gene Technologies International, Inc.
  • Dimension Therapeutics, Inc.
  • Synthetic Biologics, Inc.
  • BioMarin Pharmaceutical, Inc.
  • Erytech Pharma SA
  • Danone Nutricia
  • Censa Pharmaceuticals
  • Homology Medicines, Inc.
  • SOM Innovation Biotech SL
  • Mayo Foundation for Medical Education and Research
  • Rubius Therapeutics, Inc.


Key Target Audience

  • Market Players
  • Investors
  • End-users
  • Government Authorities 
  • Consulting And Research Firm
  • Venture capitalists
  • Value-Added Resellers (VARs)


Recent Developments

  • In July 2022, Preclinical evidence for Jnana Therapeutics' flagship program, which could be the first oral strategy of its kind to treat PKU, has been reported. At the Vancouver, Washington, 2022 National PKU Alliance Conference, data has been presented.
  • In August 2021, to further develop the lead phenylketonuria program and small molecule pipeline based on the next-generation chemo proteomic platform, Janana Therapeutics announced the conclusion of a USD 50 million Series B funding.


Market Segment

This study forecasts revenue at global, regional, and country levels from 2019 to 2030. Spherical Insights has segmented the Global Phenylketonuria Market based on the below-mentioned segments:


Global Phenylketonuria Market, By Product Type

  • Drugs
  • Nutrition Supplements
  • Others


Global Phenylketonuria Market, By Type

  • Hyperphenylalaninemia
  • Mild PKU
  • Moderate and Variant
  • Classic PKU


Global Phenylketonuria Market, By End Users

  • Hospital Pharmacies
  • Retail Pharmacies
  • Others


Phenylketonuria Market, By Regional Analysis

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • Germany
    • Uk
    • France
    • Italy
    • Spain
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia Pacific
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Middle East & Africa
    • UAE
    • Saudi Arabia
    • Qatar
    • South Africa
    • Rest of Middle East & Africa

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