Phenylketonuria Treatment Market

Global Market Study on Phenylketonuria Treatment: Industry Sales of Ingredients to Dominate Global Landscape

Phenylketonuria Treatment Market Segmented By Glycomacropeptide, Essential and non-essential amino acids as Protein Ingredients and Finish Products in PKU Ingredients in Powder, Granules, Tablets, Capsules, Powder Sachets, Ready to drink, and Shake form for targeted customers

  • February-2021
  • PMRREP14410
  • 260 Pages
  • Healthcare

About the Report

Phenylketonuria, known as PKU, is one of the inherited metabolic disorders that increases the level of phenylalanine, an amino acid in the blood. Excess of phenylalanine in the blood can lead to seizures, psychiatric disorders, and many other untreated disorders. There is no cure for PKU, but adoption of PKU treatment can prevent the causes of intellectual disabilities and other health problems. PKU treatment is done by following a proper PKU diet that limits food with phenylalanine.  

In its new study, Persistence Market Research offers insights about key factors driving demand for phenylketonuria treatment. The study points toward the adoption of PKU formula and PKU treatment based on protein ingredients and finished PKU products. Nutraceutical companies hold close to one-third of the market share, globally. The report also tracks global sales of PKU ingredients in the form of finished products in over 20 high-growth markets, along with analysis of the impact of COVID-19 on the life science industry in general, and phenylketonuria treatment in particular.

Find Out More about the Report Coverage


  • Arla Foods Ingredients Group P/S
  • Archer Daniels Midland Company
  • Chr. Hansen
  • Cargill, Incorporated
  • Seidler Chemical Co, Inc.
  • Nestlé S.A. (Vitaflo International)
  • Reckitt Benckiser Group plc. (Mead Johnson & Company, LLC.)
  • Abbott Laboratories
  • APR Applied Pharma Research S. A.
  • Ajinomoto Co., Inc.
  • VitafriendsPKU
  • Pristine Organics Pvt. Ltd

What is the Future Demand Scenario for Phenylketonuria Treatment?

Demand for phenylketonuria treatment has been exponentially rising since the past few years, due to rising incidence of PKU in newborns. Phenylketonuria is an inborn genetic disorder detected during the first days in newborn screening. Moreover, increasing focus PKU treatment research has created a gateway for manufacturers of products related to phenylketonuria treatment. However, adoption of the PKU formula and following the PKU diet remains the mainstay for treatment. Ongoing clinical research on PKU treatment has exhibited the ability to support patients in achieving their clinical goals, and possibly liberalizing their diet with additional adjuvant therapies. According to research studies, BH4 has shown in two RCTs and two open-label trials the reduction of phenylalanine levels in some patients.

However, based on research studies and ongoing trials, researchers are attending some adjuvant therapies for PKU treatment. All these factors are expected to create opportunities for the expansion of the phenylketonuria treatment market size over the forecast period, which is projected to expand at a CAGR of more than 6% and 7.0% for protein ingredients and finish PKU products, respectively, through 2030.

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What is the Impact of Market Consolidation Activities on the Phenylketonuria Treatment Market?

Given the consolidation in the market, key players are focusing on strategic mergers and acquisitions. This trend is observed throughout North America, Latin America, Europe, Asia Pacific, and Middle East & African countries.

  • For instance, in March 2020, Prinova, a leading supplier of high-quality ingredients, flavors, and nutrient premixes announced a new partnership with Open Book Extracts, a premier CBD ingredient manufacturer. This partnership expects to generate high revenue for the company.
  • In June 2017, Mead Johnson Nutrition Company was acquired by the Reckitt Benckiser Group plc (RB). Mead Johnson is now a division of RB, adding its globally-recognized brands, including Phenyl-Free® 1, an iron-fortified PKU infant formula and medical food powder for infants and young children with documented phenylketonuria.

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Why are Investments Key to Market Growth?

Following a PKU diet containing dietary protein with limited phenylalanine content is the most important treatment line followed by PKU patients. Growing demand for novel formulations for phenylketonuria treatment has led manufacturers to focus on research & development efforts. Manufacturers are investing in the research area to develop adjuvant therapies to treat PKU.

Manufacturers are focusing on the expansion of production facilities to gain significant growth in the market.

  • For instance, in 2016, Arla Foods Ingredients Group P/S funded Ajinomoto Co., Inc. (Acquired Cambrooke Therapeutics, Inc.) and Wisconsin Alumni Research Foundation for completed clinical studies for its GMP ingredients containing PKU medical food manufactured by the Ajinomoto Co., Inc. (Acquired Cambrooke Therapeutics, Inc.) for PKU dietary management.
  • In June 2016, Abbott Laboratories, in collaboration with Syngene, inaugurated its first nutrition research & development center in India.
  • Additionally, in June 2016, Arla Foods Ingredients opened the world’s most advanced hydrolysate ingredient manufacturing plant. The US$ 40 million facility can produce approximately 4,000 tonnes of high-quality whey and casein hydrolysates annually, including casein Glycomacropeptide (GMP) for PKU. This manufacturing plant has strengthened its position in Denmark.

Increasing investments and manufacturing capacity expansion are expected to favor growth of the phenylketonuria treatment market over the forecast period.

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What are Expected Opportunities for Phenylketonuria Treatment?

Opportunities for phenylketonuria treatment will arise by extended offerings to end users in terms of effectiveness and convenience. Additionally, along with PKU-specific diet supplements, companies are also offering PKU-treatment based solutions and services. Manufacturers continue to focus on research & development of novel formulations integrations, identified as a crucial part of success in the market. Developing commercial & highly stable formulations with high efficacy and potency versions are expected to provide potential opportunities for leading companies in the global phenylketonuria treatment market space.

What are the Driving Factors for the Phenylketonuria Treatment Market?

PKU is a common metabolic disorder that can cause intellectual disability if untreated. Rising prevalence of PKU among the growing population, including newborns as well as an adults, has surged demand for its treatment worldwide.

  • According to the Genetic Home Reference, in the U.S. one in 10,000 to 15,000 of PKU cases occur in newborns. In Europe, some countries have a high incidence rate of PKU, such as in Ireland, around 1 in every 4,500 babies and 1 among 4,000 individuals in Turkey are suffering from the disease.

Rising PKU awareness programs offered by local governments, NGOs, and regulatory bodies and healthcare system assistance in developed and developing regions are driving factors for phenylketonuria treatment. Increasing awareness about PKU and medical food use is expected to boost demand for phenylketonuria treatment in the future.

  • For instance, the National Phenylketonuria Alliance is a collaboration of PKU community members supporting local efforts to raise PKU awareness and educate PKU patients, while ultimately looking for a cure. This alliance works to spread awareness through digital and direct interaction channels regarding quality of life.


Country-wise Insights

How is the presence of finish product companies impacting the U.S. phenylketonuria treatment market in North America?

Demand for phenylketonuria treatment is rising in the U.S. due to increasing prevalence of PKU in newborns as well as adults. The U.S. can be said to be a leader in terms of adoption of phenylketonuria treatment-based diets. PKU ingredients such as essential and non-essential amino acids have been extensively consumed by patients in the country. Growing research activities to treat PKU plays a vital role. Moreover, governmental support for ongoing clinical research has allowed the U.S. to dominate the phenylketonuria treatment landscape.

Presence of some prominent players such as Prinova Group LLC., Abbott Laboratories, Aegle Nutrition, Nova Care, ABCO Laboratories, Inc., Archer Daniels Midland Company, and other North American companies has created remarkable returns for the region.

According to the National Organization of Rare Disorders (NORD), incidence of PKU from newborn screening programs ranges from one in 13,500 to 19,000 newborns in the U.S. PKU affects people from most ethnic backgrounds, although it is rare in Americans of African descent and Jews of Ashkenazi ancestry.

The Food and Drug Administration (FDA) approved Palynziq (pegvaliase-pqpz) for PKU adults. Palynziq is an injectable enzyme therapy for patients who have uncontrolled blood phenylalanine concentrations on current treatment. Palynziq is manufactured by BioMarin Pharmaceutical Inc.

How will increasing focus on research surge demand in Australia?

In recent years, small and large pharmaceutical and nutraceutical companies have become increasingly dependent on contract research organizations (CROs) and other clinical services to provide research services to their R&D operations. However, phenylketonuria treatment-based products, including protein ingredients as well as finished products, are expected to drive market growth.

Rising demand for essential and nonessential amino acids in the form of protein ingredients as well as finished product has led Australia to generate more than 80% of the revenue share in the Oceania phenylketonuria treatment market.

Category Insights

How is increasing demand for essential and non-essential amino acids impacting the phenylketonuria treatment landscape?

Based on protein ingredients and finish products, essential and non-essential amino acids, a PKU ingredient, are leading the phenylketonuria treatment market and are expected to gain more than 70% of revenue share over the forecast period. This is due to significant PKU finish products containing a blend of essential and non-essential amino acids. However, Glycomacropeptide (GMP), a pure form phenyl-free ingredient, is an emerging segment with clinical studies, and expected to become a mainstream PKU formula in the future.

Competitive Landscape

The phenylketonuria treatment market is highly consolidated in nature, with quite a few key players operating in this space. The market is dominated by the presence of prominent manufacturers for protein ingredients - Arla Foods Ingredients Group P/S, Archer Daniels Midland Company, BASF SE, Chr. Hansen, Cargill, Incorporated, and Seidler Chemical Co, Inc. Additionally, for finished products, manufacturers include Nestlé S.A. (Vitaflo International), Reckitt Benckiser Group plc. (Mead Johnson & Company, LLC.), Abbott Laboratories, APR Applied Pharma Research S. A., Ajinomoto Co., Inc., VitafriendsPKU, and Pristine Organics Pvt. Ltd.

These manufacturers are focused on offering of a wide range of protein ingredients and finished products for PKU diets. They are focusing on research & development activities for the application of phenylketonuria treatment in various clinical and research fields. Product launches, mergers, and acquisitions are strategies being adopted by key players to penetrate the phenylketonuria treatment market.

With this, market players are also engaged in expanding their global and regional presence through acquisitions, expansions, and product launches.

  • In June 2020, Danone S. A. launched PhenylAde® GMP ULTRA, a new addition to its PhenylAde® GMP line of PKU formulas. PhenylAde® GMP ULTRA is a medical food for the dietary management of PKU, with improved taste and patient convenience.
  • In May 2019, Abbott expanded its Nutritional Line of product in the U.S., with the launch of the vegan-friendly option Ensure Plant-Based Protein.

Some of the leading companies operating in the market are:

  • Protein Ingredients Manufacturers
    • Arla Foods Ingredients Group P/S
    • Archer Daniels Midland Company
    • BASF SE
    • Chr. Hansen
    • Cargill, Incorporated
    • Seidler Chemical Co, Inc.
  • Finish Product Manufacturers
    • Nestlé S.A. (Vitaflo International)
    • Reckitt Benckiser Group plc. (Mead Johnson & Company, LLC.)
    • Abbott Laboratories
    • APR Applied Pharma Research S. A.
    • Ajinomoto Co., Inc.
    • VitafriendsPKU
    • Pristine Organics Pvt. Ltd.

*The list is not exhaustive, and only for representational purposes. Full competitive intelligence available in the report.

Scope of Report



Forecast Period


Historical Data Available for


Market Analysis

USD Million for Value and  Tons per Annum for Volume

Key Regions Covered

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

Key Countries Covered

  • US
  • Canada
  • Brazil
  • Mexico
  • Argentina
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • Russia
  • China
  • Japan
  • South Korea
  • India
  • Thailand
  • Indonesia
  • Malaysia
  • Australia
  • New Zealand
  • South Africa
  • Turkey
  • GCC Countries

Key Segments Covered

  • PKU Ingredient
  • Targeted Customer
  • Form, Sales Channel
  • Region

Key Companies Profiled

  • Protein Ingredients Manufacturers
    • Arla Foods Ingredients Group P/S
    • Archer Daniels Midland Company
    • BASF SE
    • Chr. Hansen
    • Cargill, Incorporated
    • Seidler Chemical Co, Inc.
  • Finish Product Manufacturers
    • Nestlé S.A. (Vitaflo International)
    • Reckitt Benckiser Group plc. (Mead Johnson & Company, LLC.)
    • Abbott Laboratories
    • APR Applied Pharma Research S. A.
    • Ajinomoto Co., Inc.
    • VitafriendsPKU
      • Pristine Organics Pvt. Ltd

Report Coverage

  • Market Forecasts
  • Company Share Analysis
  • Competition Intelligence
  • DROT Analysis
  • Market Dynamics and Challenges
  • Strategic Growth Initiatives

Customization & Pricing

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Phenylketonuria Treatment Market by Category for Protein Ingredients:

  • PKU Ingredients
    • Protein Ingredients
      • Glycomacropeptide (GMP)
      • Essential and non-essential amino acids
    • Finish Products
      • Glycomacropeptide (GMP)
      • Essential and non-essential amino acids
  • Targeted Customer
    • Protein Ingredients
      • Consumer Healthcare Companies
      • Pharmaceutical Companies
      • Contract Manufacturing Companies (CMOs)
    • Finish Products
      • Pediatrics
      • Adults
      • Pregnant Women
  • Form
    • Protein Ingredients
      • Powder Blend
      • Granules
    • Finish Products
      • Powder & Granules
      • Tablets
      • Capsules
      • Powder Sachets
      • Ready-to-Drink
      • Shake
      • Others
  • Sales Channel
    • Protein Ingredients
      • Industry Sales (Ingredients)
    • Finish Products
      • Hospital Pharmacies
      • Retail Pharmacies
      • Online Pharmacies
      • Hypermarkets & Supermarkets
  • Region
    • North America
    • Latin America
    • Europe
    • South Asia
    • East Asia
    • Oceania
    • MEA

Key Questions Answered in Report

Q1. Which is the most lucrative country for phenylketonuria treatment?

The U.S., at present, holds the maximum market share and leads the global phenylketonuria treatment market. The U.S. is expected to experience significant demand for phenylketonuria treatment over the entire forecast period.

Q2. Which ingredient holds a significant share in the market?

Essential and non-essential amino acids hold the highest market share of one-third. These continue to dominate the market based on protein ingredient as well as finished product.

Q3. Which form of PKU ingredient is expected to dominate phenylketonuria treatment?

Based on protein ingredient, the powder blend form accounted for the highest share, while based on finished product, powder and the granule forms accounted for high shares in the phenylketonuria treatment market.

Q4. Which are the leading companies in phenylketonuria treatment market?

Some of the prominent companies offering phenylketonuria treatment are for protein ingredients - Arla Foods Ingredients Group P/S, Archer Daniels Midland Company, BASF SE, Chr. Hansen, Cargill, Incorporated, Seidler Chemical Co, Inc. Additionally for the finish products for PKU treatment the manufacturers include- Nestlé S.A. (Vitaflo International), Reckitt Benckiser Group plc. (Mead Johnson & Company, LLC.), Abbott Laboratories, APR Applied Pharma Research S. A., Ajinomoto Co., Inc., VitafriendsPKU, Pristine Organics Pvt. Ltd., and others.

Q5. What are the restraining factors phenylketonuria treatment?

Challenges associated can be the high cost of PKU treatment, inconsistent reimbursement policies, and lack of treatment regimen compliance.

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