Phenylketonuria Treatment Market by Drug and Geography - Forecast and Analysis 2022-2026

  • Published: Jan 2022
  • Pages: 120
  • SKU: IRTNTR72140

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The phenylketonuria treatment market share is expected to increase by USD 481.45 milion from 2021 to 2026, and the market’s growth momentum will accelerate at a CAGR of 9.06%.

This phenylketonuria treatment market research report provides valuable insights on the post-COVID-19 impact on the market, which will help companies evaluate their business approaches. Furthermore, this report extensively covers phenylketonuria treatment market segmentation by geography (North America, Europe, Asia, and ROW) and drug (sapropterin and pegvaliase-pqpz). The phenylketonuria treatment market report also offers information on several market vendors, including American Gene Technologies, BioMarin Pharmaceutical Inc., Codexis Inc., Evox Therapeutics Ltd., Homology Medicines Inc., Jnana Therapeutics, SOM INNOVATION BIOTECH SA, and Synlogic Inc. among others.

What will the Phenylketonuria Treatment Market Size be During the Forecast Period?

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Phenylketonuria Treatment Market: Key Drivers, Trends, and Challenges

The rising investments in genomic research and development is notably driving the phenylketonuria treatment market growth, although factors such as the high cost of treatment may impede the market growth. Our research analysts have studied the historical data and deduced the key market drivers and the COVID-19 pandemic impact on the phenylketonuria treatment industry. The holistic analysis of the drivers will help in deducing end goals and refining marketing strategies to gain a competitive edge.

Key Phenylketonuria Treatment Market Driver

The rising investments in genomic research and development is one of the key factors driving the phenylketonuria treatment market growth. The introduction of breakthrough technologies in genetics has significantly attracted investments in genomic research. Investments help genomic research institutions and organizations develop novel therapeutics and personalized medicines for targeted therapies and incurable diseases. Government organizations such as the NHGRI, Genome Canada, and the EU invest significantly in genomic research. For instance, in 2019, the Government of Canada announced that it would support 36 genomic research projects by funding $22.7 million through Genome Canada. As of 2019, Genome Canada had invested about $1.5 billion in federal funds for genomic research since its inception in 2000. Hence, such organizations coming forward to invest in genomic research are expected to witness growth during the forecast period.

Key Phenylketonuria Treatment Market Trend

The rising strategic alliances by the vendors is another factor supporting the phenylketonuria treatment market growth. The market is dominated by the presence of prominent manufacturers for protein ingredients such as Archer Daniels Midland Company, BASF SE, and others. On the other hand, manufacturers for finished products include Reckitt Benckiser Group plc. (Mead Johnson & Company, LLC.), Nestlé S.A. (Vitaflo International), and others. These vendors are focused on offering a wide range of protein ingredients and finished products for phenylketonuria diets. They are focusing on research & development activities for the application of phenylketonuria treatment in various clinical and research fields. Key vendors are adopting various strategies such as M&A, product launches, and collaborations to stay competitive in the global phenylketonuria treatment market. Thus, the growing adoption of such strategic alliances by the key vendors will further enhance the growth of the market during the forecast period.

Key Phenylketonuria Treatment Market Challenge

The high cost of treatment has been hindering the phenylketonuria treatment market growth. The overall cost structure includes the cost of treatment, medication, and hospital stay. Meanwhile, the specially manufactured low-protein medical foods and medical formulae are extremely expensive and cannot be afforded by the low-income group. On an average, it costs $15,000 per person per year for PKU treatment, including $5,000 for medical food and formula. Thus, the high cost of PKU treatment is expected to have a negative impact on the market during the forecast period.

This phenylketonuria treatment market analysis report also provides detailed information on other upcoming trends and challenges that will have a far-reaching effect on the market growth. The actionable insights on the trends and challenges will help companies evaluate and develop growth strategies for 2022-2026.

Parent Market Analysis

Technavio categorizes the phenylketonuria treatment market as a part of the global pharmaceuticals market. Our research report has extensively covered external factors influencing the parent market growth potential in the coming years, which will determine the levels of growth of the phenylketonuria treatment market during the forecast period.

Who are the Major Phenylketonuria Treatment Market Vendors?

The report analyzes the market’s competitive landscape and offers information on several market vendors, including:


  • American Gene Technologies
  • BioMarin Pharmaceutical Inc.
  • Codexis Inc.
  • Evox Therapeutics Ltd.
  • Homology Medicines Inc.
  • Jnana Therapeutics
  • Synlogic Inc.


This statistical study of the phenylketonuria treatment market encompasses successful business strategies deployed by the key vendors. The phenylketonuria treatment market is concentrated and the vendors are deploying growth strategies such as M&A, product launches, and collaborations to compete in the market.

Product Insights and News

  • American Gene Technologies - The company offers Phenylketonuria (PKU) cure program for the treatment of Phenylketonuria in adults.

To make the most of the opportunities and recover from post COVID-19 impact, market vendors should focus more on the growth prospects in the fast-growing segments, while maintaining their positions in the slow-growing segments.

The phenylketonuria treatment market forecast report offers in-depth insights into key vendor profiles. The profiles include information on the production, sustainability, and prospects of the leading companies.

Phenylketonuria Treatment Market Value Chain Analysis

Our report provides extensive information on the value chain analysis for the phenylketonuria treatment market, which vendors can leverage to gain a competitive advantage during the forecast period. The end-to-end understanding of the value chains is essential in profit margin optimization and evaluation of business strategies. The data available in our value chain analysis segment can help vendors drive costs and enhance customer services during the forecast period.

The value chain of the pharmaceuticals market includes the following core components:

  • Research and development (R&D) and drug discovery
  • Integration and product development
  • Manufacturing
  • Outbound logistics
  • Marketing and sales
  • Support services
  • Innovation

The report has further elucidated on other innovative approaches being followed by service providers to ensure a sustainable market presence.


Which are the Key Regions for Phenylketonuria Treatment Market?

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34% of the market’s growth will originate from North America during the forecast period. US and Canada are the key markets for the phenylketonuria treatment market in North America. Market growth in this region will be faster than the growth of the market in ROW.

The rising incidence of phenylketonuria in newborns will facilitate the phenylketonuria treatment market growth in North America over the forecast period. This market research report entails detailed information on the competitive intelligence, marketing gaps, and regional opportunities in store for vendors, which will assist in creating efficient business plans.

The outbreak of COVID-19 has brought about a dynamic transformation in the population's lifestyles in North America in 2020. The lockdowns imposed to curb the spread of COVID-19 restricted the manufacturing and supplying activities of phenylketonuria in the region. The hospital services were either delayed or postponed due to the spread of COVID-19 in 2020. This majorly affected the demand for phenylketonuria treatment in the region. However, the initiation of large-scale COVID-19 vaccination drives from Q4 2020 resulted in the gradual resumption of logistic operations and increasing awareness regarding the importance of nutritional products. 

What are the Revenue-generating Drug Segments in the Phenylketonuria Treatment Market?

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The phenylketonuria treatment market share growth by the sapropterin segment will be significant during the forecast period. Sapropterin is approved for the treatment of hyperphenylalaninaemia in patients greater than or equal to 4 years of age with tetrahydrobiopterin-responsive phenylketonuria in the European Union (EU). On the other hand, in the US, it is approved to reduce blood phenylalanine levels in patients with hyperphenylalaninaemia due to tetrahydrobiopterin-responsive phenylketonuria. The drug is for use in combination with a Phenylketonuria diet, but it doesn't work for everyone with phenylketonuria. This would lead to an increase in the usage of sapropterin in order to increase the tolerance of Phenylalanine which would drive the market's growth during the forecast period.

This report provides an accurate prediction of the contribution of all the segments to the growth of the phenylketonuria treatment market size and actionable market insights on post COVID-19 impact on each segment.


Phenylketonuria Treatment Market Scope

Report Coverage


Page number


Base year


Forecast period


Growth momentum & CAGR

Accelerate at a CAGR of 9.06%

Market growth 2022-2026

$ 481.45 million

Market structure


YoY growth (%)


Regional analysis

North America, Europe, Asia, and ROW

Performing market contribution

North America at 34%

Key consumer countries

US, Canada, Turkey, Ireland, UK, and Australia

Competitive landscape

Leading companies, Competitive strategies, Consumer engagement scope

Key companies profiled

American Gene Technologies, BioMarin Pharmaceutical Inc., Codexis Inc., Evox Therapeutics Ltd., Homology Medicines Inc., Jnana Therapeutics, SOM INNOVATION BIOTECH SA, and Synlogic Inc.

Market dynamics

Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID 19 impact and recovery analysis and future consumer dynamics, Market condition analysis for forecast period

Customization purview

If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized.

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What are the Key Data Covered in this Phenylketonuria Treatment Market Report?

  • CAGR of the market during the forecast period 2022-2026
  • Detailed information on factors that will drive phenylketonuria treatment market growth during the next five years
  • Precise estimation of the phenylketonuria treatment market size and its contribution to the parent market
  • Accurate predictions on upcoming trends and changes in consumer behavior
  • The growth of the phenylketonuria treatment industry across North America, Europe, Asia, and ROW
  • A thorough analysis of the market’s competitive landscape and detailed information on vendors
  • Comprehensive details of factors that will challenge the growth of phenylketonuria treatment market vendors

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1. Executive Summary                           

                1.1 Market Overview

                                Exhibit 01:  Key Finding 1

                                Exhibit 02:  Key Finding 2

                                Exhibit 03:  Key Finding 3

                                Exhibit 04:  Key Finding 5

                                Exhibit 05:  Key Finding 6

                                Exhibit 06:  Key Finding 7

                                Exhibit 07:  Key Finding 8

2. Market Landscape                             

                2.1 Market ecosystem             

                                Exhibit 08:   Parent market

                                Exhibit 09:  Market Characteristics

                2.2 Value chain analysis           

                                Exhibit 10:  Value chain analysis: Pharmaceuticals

                                2.2.1 Research and development (R&D) and drug discovery

                                2.2.2 Integration and product development

                                2.2.3 Manufacturing

                                2.2.4 Outbound logistics

                                2.2.5 Marketing and sales

                                2.2.6 Support services

                                2.2.7 Innovation

3. Market Sizing                       

                3.1 Market definition

                                Exhibit 11:   Offerings of vendors included in the market definition

                3.2 Market segment analysis 

                                Exhibit 12:   Market segments

                3.3 Market size 2021 

                3.4 Market outlook: Forecast for 2021 - 2026 

                                3.4.1    Estimating growth rates for emerging and high-growth markets

                                3.4.2    Estimating growth rates for mature markets

                                Exhibit 13:  Global - Market size and forecast 2021 - 2026 ($ million)

                                Exhibit 14:  Global market: Year-over-year growth 2021 - 2026 (%)

4. Five Forces Analysis                          

                4.1 Five Forces Summary        

                                Exhibit 15: Five forces analysis 2021 & 2026

                4.2 Bargaining power of buyers           

                                Exhibit 16: Bargaining power of buyers

                4.3 Bargaining power of suppliers       

                                Exhibit 17: Bargaining power of suppliers

                4.4 Threat of new entrants    

                                Exhibit 18: Threat of new entrants

                4.5 Threat of substitutes         

                                Exhibit 19: Threat of substitutes

                4.6 Threat of rivalry   

                                Exhibit 20: Threat of rivalry

                4.7 Market condition

                                Exhibit 21:  Market condition - Five forces 2021

5. Market Segmentation by Drug                     

                5.1 Market segments

                                The segments covered in this chapter are:

  • Sapropterin
  • Pegvaliase-pqpz

                            Exhibit 22:  Drug - Market share 2021-2026 (%)

                5.2     Comparison by Drug      

                                Exhibit 23:  Comparison by Drug

                5.3     Sapropterin - Market size and forecast 2021-2026             

                                Exhibit 24:  Sapropterin - Market size and forecast 2021-2026 ($ million)

                                Exhibit 25:  Sapropterin - Year-over-year growth 2021-2026 (%)

                5.4     Pegvaliase-pqpz  - Market size and forecast 2021-2026    

                                Exhibit 26:  Pegvaliase-pqpz  - Market size and forecast 2021-2026 ($ million)

                                Exhibit 27:  Pegvaliase-pqpz  - Year-over-year growth 2021-2026 (%)

                5.5     Market opportunity by Drug       

                                Exhibit 28:  Market opportunity by Drug

6. Customer landscape                         

                6.1     Overview           

                                Exhibit 29:  Customer landscape

7. Geographic Landscape                     

                7.1 Geographic segmentation

                                The regions covered in the report are:

  • North America
  • Europe
  • Asia
  • ROW

                           Exhibit 30:  Market share by geography 2021-2026 (%)

                7.2 Geographic comparison   

                                Exhibit 31:  Geographic comparison

                7.3     North America - Market size and forecast 2021-2026        

                                Exhibit 32:  North America - Market size and forecast 2021-2026 ($ million)

                                Exhibit 33:  North America - Year-over-year growth 2021-2026 (%)

                7.4     Europe - Market size and forecast 2021-2026       

                                Exhibit 34:  Europe - Market size and forecast 2021-2026 ($ million)

                                Exhibit 35:  Europe - Year-over-year growth 2021-2026 (%)

                7.5     Asia - Market size and forecast 2021-2026             

                                Exhibit 36:  Asia - Market size and forecast 2021-2026 ($ million)

                                Exhibit 37:  Asia - Year-over-year growth 2021-2026 (%)

                7.6     ROW - Market size and forecast 2021-2026           

                                Exhibit 38:  ROW - Market size and forecast 2021-2026 ($ million)

                                Exhibit 39:  ROW - Year-over-year growth 2021-2026 (%)

                7.7     Key leading countries    

                                Exhibit 40:  Key leading countries

                7.8     Market opportunity by geography           

                                Exhibit 41:  Market opportunity by geography ($ million)

8. Drivers, Challenges, and Trends                   

                8.1 Market drivers     

                                8.1.1    Rising investments in genomic research and development

                                8.1.2    Increasing prevalence of PKU

                                8.1.3    Strong pipeline of PKU drugs

                8.2 Market challenges              

                                8.2.1    High cost of treatment

                                8.2.2    Stringent regulatory framework

                                8.2.3    Lack of awareness among the patients and physicians

                                Exhibit 42:  Impact of drivers and challenges

                8.3 Market trends      

                                8.3.1    Rising strategic alliances by the vendors

                                8.3.2    Increasing development and commercialization of new drugs

                                8.3.3    Advancements in the health care industry

9. Vendor Landscape                             

                9.1     Overview           

                                Exhibit 43:  Vendor landscape

                9.2     Landscape disruption    

                                Exhibit 44:  Landscape disruption

                                Exhibit 45:  Industry risks

10. Vendor Analysis               

                10.1 Vendors covered              

                                Exhibit 46:  Vendors covered

                10.2 Market positioning of vendors    

                                Exhibit 47:  Market positioning of vendors

                10.3  American Gene Technologies    

                                Exhibit 48:  American Gene Technologies - Overview

                                Exhibit 49:  American Gene Technologies - Product and service

                                Exhibit 50:  American Gene Technologies - Key offerings

                10.4  BioMarin Pharmaceutical Inc.    

                                Exhibit 51:  BioMarin Pharmaceutical Inc. - Overview

                                Exhibit 52:  BioMarin Pharmaceutical Inc. - Business segments

                                Exhibit 53:  BioMarin Pharmaceutical Inc. - Key offerings

                10.5  Codexis Inc.       

                                Exhibit 54:  Codexis Inc. - Overview

                                Exhibit 55:  Codexis Inc. - Business segments

                                Exhibit 56:  Codexis Inc. - Key offerings

                                Exhibit 57:  Codexis Inc. - Segment focus

                10.6  Evox Therapeutics Ltd.  

                                Exhibit 58:  Evox Therapeutics Ltd. - Overview

                                Exhibit 59:  Evox Therapeutics Ltd. - Product and service

                                Exhibit 60:  Evox Therapeutics Ltd. - Key offerings

                10.7  Homology Medicines Inc.             

                                Exhibit 61:  Homology Medicines Inc. - Overview

                                Exhibit 62:  Homology Medicines Inc. - Product and service

                                Exhibit 63:  Homology Medicines Inc. - Key offerings

                10.8  Jnana Therapeutics        

                                Exhibit 64:  Jnana Therapeutics - Overview

                                Exhibit 65:  Jnana Therapeutics - Product and service

                                Exhibit 66:  Jnana Therapeutics - Key offerings

                10.9  SOM INNOVATION BIOTECH SA

                                Exhibit 67:  SOM INNOVATION BIOTECH SA - Overview

                                Exhibit 68:  SOM INNOVATION BIOTECH SA - Product and service

                                Exhibit 69:  SOM INNOVATION BIOTECH SA - Key offerings

                10.10                Synlogic Inc.      

                                Exhibit 70:  Synlogic Inc. - Overview

                                Exhibit 71:  Synlogic Inc. - Product and service

                                Exhibit 72:  Synlogic Inc. - Key offerings

11. Appendix                            

                11.1 Scope of the report         

                                11.1.1 ????Market definition

                                11.1.2 Objective

                                11.1.3 Notes and caveats

                11.2 Currency conversion rates for US$            

                                Exhibit 73:  Currency conversion rates for US$

                11.3 Research Methodology 

                                Exhibit 74:  Research Methodology

                                Exhibit 75:  Validation techniques employed for market sizing

                                Exhibit 76:  Information sources

                11.4 List of abbreviations        

                                Exhibit 77:  List of abbreviations

Research Framework

Technavio presents a detailed picture of the market by way of study, synthesis, and summation of data from multiple sources. The analysts have presented the various facets of the market with a particular focus on identifying the key industry influencers. The data thus presented is comprehensive, reliable, and the result of extensive research, both primary and secondary.


Primary sources

  • Manufacturers and suppliers
  • Channel partners
  • Industry experts
  • Strategic decision makers

Secondary sources

  • Industry journals and periodicals
  • Government data
  • Financial reports of key industry players
  • Historical data
  • Press releases


Data Synthesis

  • Collation of data
  • Estimation of key figures
  • Analysis of derived insights

Data Validation

  • Triangulation with data models
  • Reference against proprietary databases
  • Corroboration with industry experts



  • Market drivers
  • Market challenges
  • Market trends
  • Five forces analysis


  • Market size and forecast
  • Market segmentation
  • Geographical insights
  • Competitive landscape
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The phenylketonuria treatment market growth will increase by $481.45 million during 2021-2026.
The phenylketonuria treatment market is expected to grow at a CAGR of 9.06% during 2021-2026.
Technavio has segmented the phenylketonuria treatment market by other1 (Sapropterin and Pegvaliase-pqpz) and geographic (North America, Europe, Asia, and ROW).
American Gene Technologies, BioMarin Pharmaceutical Inc., Codexis Inc., Evox Therapeutics Ltd., Homology Medicines Inc., Jnana Therapeutics, SOM INNOVATION BIOTECH SA, Synlogic Inc. are a few of the key vendors in the phenylketonuria treatment market.
North America will register the highest growth rate of 33.50% among the other regions. Therefore, the phenylketonuria treatment market in North America is expected to garner significant business opportunities for the vendors during the forecast period.
  • US
  • Canada
  • Turkey
  • Ireland
  • UK
  • Australia
The key factors driving the phenylketonuria treatment market growth are:
  • Rising investments in genomic research and development
The phenylketonuria treatment market vendors should focus on grabbing business opportunities from the sapropterin segment as it accounted for the largest market share in the base year.
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