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Pompe Disease Treatment Market

Global Pompe Disease Treatment Market Share, Size, Growth: By Indication Type: Infantile-Onset Pompe Disease (IOPD), Late-Onset Pompe Disease (LOPD), Others; By Diagnosis Methods: Blood Tests, Genetic Tests, Others; By Therapy Type; By Route of Administration; By End User; Regional Analysis; Supplier Landscape; 2024-2032

Global Pompe Disease Treatment Market Outlook

The global Pompe disease treatment market size is expected to grow at a CAGR of about 4.80% during the forecast period of 2024-2032. The market is anticipated to attain a value of about USD 1.74 billion by 2032, driven by the rising prevalence of the disease.

 

pompe disease treatment market

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Pompe Disease Insights: Types, Causes, Symptoms, Diagnosis, and Treatment

Pompe disease is a rare genetic disorder causing the accumulation of complex sugars called glycogen in the body’s cells. This disease is caused due to the deficiency of an enzyme, acid alfa glucosidase, responsible for the metabolism of glycogen in the body. The disease is a result of the mutations caused in the GAA gene, that assist in the breakdown of glycogen.

 

There are three main types of Pompe disease, classic infantile, non-classic infantile, and late-onset depending on the onset of the disease. The disease is rare and affects nearly 1 in 40,000 people in the United States. 

 

The signs and symptoms of Pompe disease depend on the indication type, however, some common symptoms are weak muscles, enlarged organs, difficulty in breathing, slower muscular movements, irregular heartbeat, hearing problems, frequent lung infections, weight loss and tiredness.

 

Pompe disease is diagnosed with the help of several tests including blood tests, breathing tests, cardiac tests, sleep tests, and electromyography. Blood tests are examined to know the concentration of enzymes present in the body. Pulmonary tests aid in the measurement of lung capacity. Electromyography is a technique used to assess the working of muscular movements. Cardiac tests such as electrocardiogram, echocardiogram, and X-rays are being incorporated to check the functioning of the heart. DNA testing is the confirmatory test done after all the preliminary diagnostic tests.

 

The treatment for Pompe disease is based on the symptoms, affected organs, and the type of indication. Enzyme replacement therapy is the only approved treatment for the management of Pompe disease in all patients.

 

According to the Pompe disease treatment market research report, the market can be categorised into the following segments:

 

pompe disease treatment market by segments

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Market Breakup by Indication Type

  • Infantile-Onset Pompe Disease (IOPD)
  • Classic Infantile Form
  • Non-Classic Infantile Form
  • Late-Onset Pompe Disease (LOPD)
  • Others

 

Market Breakup by Diagnosis Methods

  • Blood Tests
  • Genetic Tests
  • Prenatal Tests
  • Others

 

Market Breakup by Therapy Type

  • Enzyme Replacement Therapy (ERT)
  • Chaperone-Advanced Replacement Therapy (CART)
  • Substrate Replacement Therapy (SRT)
  • Supportive Care
  • Others

 

Market Breakup by Route of Administration

  • Oral
  • Intravenous
  • Others

 

Market Breakup by End User

  • Hospitals
  • Diagnostic Centres
  • Ambulatory Surgical Centres
  • Others

 

Market Breakup by Region

  • North America
    • United States of America
    • Canada
  • Europe
    • United Kingdom
    • Germany
    • France
    • Italy
    • Others
  • Asia Pacific
    • China
    • Japan
    • India
    • ASEAN
    • Australia
    • Others
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • United Arab Emirates
    • Nigeria
    • South Africa
    • Others

 

pompe disease treatment market by region

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Market Scenario

The Pompe disease treatment market is primarily driven by the increasing disease burden, thus attributing to the increased demand for diagnostics and therapeutics, leading to market growth and development. 

 

The market is further driven by the increasing launches and approvals of novel therapeutic products. The growing research and developmental activities and rising expenditure by the public and private firms has also stimulated the expansion of the Pompe disease treatment market. For example, Genethon, a key market player, initiated a gene therapy clinical trial for the treatment of the late-onset Pompe disease, based on novel developed technologies.

 

Additionally, the improvements and developments in enzyme replacement therapy and gene therapy are anticipated to provide lucrative growth opportunities to the Pompe disease treatment market. Further, the high costs of the treatment can hamper the market growth during the forecasted period.

 

Market Trends: Therapy Type and Region Type

Enzyme replacement therapy is expected to account for the highest share in the Pompe disease treatment market owing to the fact that it is the only effective and available treatment that aids in eradicating the deficiency of the acid alpha-glucosidase enzyme. In this therapy, the enzyme-filled injections are administered parenterally into the patient’s body.

 

North America is anticipated to dominate the Pompe disease treatment market due to the increasing adoption of advanced therapies, rising disease prevalence, improved healthcare infrastructure and significant presence of many key players. 

 

According to the International Journal of Neonatal Screening of March 2020, Pompe disease was diagnosed in 1 in every 25,000 patients, thus contributing to the higher prevalence.

 

The market growth in North America is further bolstered by the supporting government initiatives and programs that have led to increased awareness and better healthcare opportunities. For example, in 2020, an organisation, The Assistance Fund (TAF) implemented a novel program to aid the patients suffering from Pompe disease and their families who can’t avail of the high treatment costs.

 

The Pompe disease treatment market in North America is accelerated by the increasing product launches and approvals by the United States Food and Drug Administration. Recently, the United States FDA accepted the immediate review of the biologics license application for the Aval glucoside alfa for the management of patients with Pompe disease.

 

Therapeutic Landscape

The treatment of Pompe disease is patient-centric, type-specific, supportive, and based on the disease’s symptoms. Enzyme replacement therapy is the only approved treatment for the management of the disease in all patients. In Lumizyme therapy, intravenous administration of recombinant human acid alpha-glucosidase takes place and has benefitted in increasing the life expectancy of patients living with infantile-onset Pompe disease. 

 

Nexviazyme (avalglucoside alfa-ngpt) is another ERT therapy approved by the FDA for treating patients one year of age and older suffering from late-onset Pompe disease.

 

Additional supportive treatments may be incorporated for the management of associated problems such as pulmonary disorders, cardiac disorders, and impaired muscular movements.  Some of the supportive and add-on treatments are respiratory support, physical therapy, physiotherapy, occupational therapy, speech therapy, and orthopaedic treatment.

 

Specialised teams of cardiologists, pulmonologists, neurologists, and physiotherapists, among others, are required for the treatment of the symptoms and offer supportive care to the patients living with Pompe disease.

 

Clinical Trials Landscape

Despite the availability of enzyme replacement therapy, several other therapies and products are required for the better and more effective treatment of Pompe disease. Many novel targeted therapies are in pipeline and require further clinical investigation to analyse their efficacy, tolerability, safety, and adverse effects. 

 

Pompe disease is a gene-mediated disorder and hence, gene therapies remain the viable and best suitable option in the treatment of Pompe’s disease further undergoing research is in the process of development. The gene therapy is aimed at restoring the acid alpha-glucosidase production and therapeutic activity in critical tissues to restore impaired cardiac and respiratory capacity.

 

Other novel gene therapies are targeted to increase the body’s ability to produce acid alpha-glucosidase by administering the normal copy of the GAA gene in the patient’s hepatic cells or bone marrow stem cells through the intravenous method.

 

At present, many groups of clinical researchers are working on the discovery of novel therapies and facilitating them forward towards the advanced stages of clinical trials. A further exploratory study is being conducted for the industrial rhGAA used in enzyme replacement therapy. For example, carbohydrate side chains of industrial rhGAA are modified and altered to increase the muscle cell uptake and chaperones are incorporated to stabilise and balance the I.V. administered form of rhGAA.

 

Undergoing Clinical Trials and Emerging Drug Therapies

Aro Biotherapeutics, a key market player, recently granted rare paediatric drug designation for its novel therapeutic agent ABX1100 used for the treatment of Pompe disease.

 

Astellas Pharma is conducting clinical trials for an adeno-associated virus gene replacement therapy, AT 485 that is expected to show some promising effects in the treatment of the late-onset Pompe disease. This therapy is investigated to assess its efficacy in delivering a functional GAA gene, that will subsequently be converted to GAA directly in the affected tissues, and will further help in the treatment of Pompe disease.

 

Maze Therapeutics is also performing clinical trials for the MZE001, which is expected to be a potential therapy for patients suffering from late-onset Pompe disease. This drug acts by inhibiting the activity of the glycogen-producing enzyme, glycogen synthase (GYS1), thus preventing the build-up of complex sugars in the body tissues.

 

Another set of clinical trials is performed by Amicus Therapeutics, for the investigational therapy, AT-GAA, that is expected to provide improved pulmonary functions and muscular movements.

 

Novel diagnostic measures and tools are also being discovered for the improved diagnosis of Pompe disease. In the United Kingdom, an ongoing clinical trial is being conducted to evaluate a non-invasive MRI-based tool that will aid in the monitoring of glycogen build-up and Pompe disease without the requirement of any invasive muscle biopsies. 

 

Implementing new technologies and innovations in healthcare has already provided enormous benefits to human health. Researchers’ tremendous efforts have anticipated a rapid increase in the approvals for intelligent therapies. Several ongoing clinical trials are emerging as a driving factor for Pompe disease treatment market growth and development.

 

Competitive Landscape

The report gives an in-depth analysis of the key players involved in the Pompe disease treatment market, sponsors manufacturing the therapies, and putting them through trials to get FDA approvals. The companies included in the market are as follows:

 

  • Amicus Therapeutics, Inc.
  • BioMarin
  • Genzyme (Sanofi)
  • Audentes Therapeutics (Astellas Pharma Inc.)
  • EpiVax, Inc
  • Oxyrane
  • Sangamo Therapeutics
  • Bayer AG
  • AVROBIO, Inc.
  • Nova Biomedical
  • Trinity Biotech

 

Key Highlights of the Report

REPORT FEATURES DETAILS
Base Year 2023
Historical Period 2017-2023
Forecast Period 2024-2032
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Indication Type
  • Diagnosis Methods
  • Therapy Type
  • Route of Administration
  • End User
  • Region
Breakup by Indication Type
  • Infantile-Onset Pompe Disease (IOPD)
  • Late-Onset Pompe Disease (LOPD)
  • Others
Breakup by Diagnosis Methods
  • Blood Tests
  • Genetic Tests
  • Prenatal Tests
  • Others
Breakup by Therapy Type
  • Enzyme Replacement Therapy (ERT)
  • Chaperone-Advanced Replacement Therapy (CART)
  • Substrate Replacement Therapy (SRT)
  • Supportive Care
  • Others
Breakup by Route of Administration
  • Oral
  • Intravenous
  • Others
Breakup by End User
  • Hospitals
  • Diagnostic Centres
  • Ambulatory Surgical Centres
  • Others
Breakup by Region
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa
Market Dynamics
  • SWOT Analysis
  • Porter's Five Forces Analysis
  • Key Indicators for Demand
  • Key Indicators for Price
Supplier Landscape
  • Market Structure
  • Company Profiles
    • Company Overview
    • Product Portfolio
    • Demographic Reach and Achievements
    • Mergers and Acquisitions
    • Certifications
Companies Covered
  • Amicus Therapeutics, Inc.
  • BioMarin
  • Genzyme (Sanofi)
  • Audentes Therapeutics (Astellas Pharma Inc.)
  • EpiVax, Inc
  • Oxyrane
  • Sangamo Therapeutics
  • Bayer AG
  • AVROBIO, Inc.
  • Nova Biomedical
  • Trinity Biotech

 

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.

1    Preface
    1.1    Objectives of the Study
    1.2    Key Assumptions
    1.3    Report Coverage – Key Segmentation and Scope 
2    Research Methodology
3    Executive Summary
4    Pompe Disease Overview 

    4.1    Guidelines and Stages
    4.2    Pathophysiology
    4.3    Screening and Diagnosis
    4.4    Treatment Pathway 
5    Patient Profile
    5.1    Patient Profile Overview
    5.2    Patient Psychology and Emotional Impact Factors
    5.3    Risk Assessment and Treatment Success Rate
6    Current Scenario Evaluation and Regulatory Framework 
    6.1    Emerging Therapies and Clinical Trials
    6.2    Patent Landscape 
        6.2.1    Patent Overview
            6.2.1.1    Patent Status and Expiry
            6.2.1.2    Timelines from Drug Development to Commercial Launch
            6.2.1.3    New Drug Application
                6.2.1.3.1    Documentation and Approval Process
    6.3    Cost of Treatment
    6.4    Regulatory Framework
        6.4.1    Regulatory Overview
            6.4.1.1    US FDA
            6.4.1.2    EU EMA
            6.4.1.3    INDIA CDSCO
            6.4.1.4    JAPAN PMDA
            6.4.1.5    Others
7    Challenges and Unmet Needs
    7.1    Treatment Pathway Challenges
    7.2    Compliance and Drop-Out Analysis
    7.3    Awareness and Prevention Gaps
8    Global Pompe Disease Treatment Market
    8.1    Global Pompe Disease Treatment Market Overview
    8.2    Global Pompe Disease Treatment Market Analysis 
        8.2.1    Market Overview
            8.2.1.1    Global Pompe Disease Treatment Market Historical Value (2017-2023) 
            8.2.1.2    Global Pompe Disease Treatment Market Forecast Value (2024-2032)
        8.2.2    Global Pompe Disease Treatment Market by Indication Type
            8.2.2.1    Market Overview
                8.2.2.1.1    Infantile-Onset Pompe Disease (IOPD)
                    8.2.2.1.1.1    Classic Infantile Form
                    8.2.2.1.1.2    Non-Classic Infantile Form
                8.2.2.1.2    Late-Onset Pompe Disease (LOPD)
                8.2.2.1.3    Others
        8.2.3    Global Pompe Disease Treatment Market by Diagnosis Type
            8.2.3.1    Market Overview
                8.2.3.1.1    Blood Tests
                8.2.3.1.2    Genetic Tests
                8.2.3.1.3    Prenatal Tests
                8.2.3.1.4    Others
        8.2.4    Global Pompe Disease Treatment Market by Therapy Type
            8.2.4.1    Market Overview
                8.2.4.1.1    Enzyme Replacement Therapy (ERT)
                8.2.4.1.2    Chaperone-Advanced Replacement Therapy (CART)
                8.2.4.1.3    Substrate Replacement Therapy (SRT)
                8.2.4.1.4    Supportive Care
                8.2.4.1.5    Others
        8.2.5    Global Pompe Disease Treatment Market by Route of Administration
            8.2.5.1    Market Overview
                8.2.5.1.1    Oral
                8.2.5.1.2    Intravenous
                8.2.5.1.3    Others
        8.2.6    Global Pompe Disease Treatment Market by End User
            8.2.6.1    Market Overview
                8.2.6.1.1    Hospitals
                8.2.6.1.2    Diagnostic Centres
                8.2.6.1.3    Ambulatory Surgical Centres
                8.2.6.1.4    Others
        8.2.7    Global Pompe Disease Treatment Market by Region
            8.2.7.1    Market Overview
                8.2.7.1.1    North America
                8.2.7.1.2    Europe
                8.2.7.1.3    Asia Pacific
                8.2.7.1.4    Middle East and Africa
                8.2.7.1.5    Latin America
9    North America  Pompe Disease Treatment Market
    9.1    Market Share by Country
    9.2    United States of America
        9.2.1    Historical Trend (2017-2023)
        9.2.2    Forecast Trend (2024-2032)
    9.3    Canada
        9.3.1    Historical Trend (2017-2023)
        9.3.2    Forecast Trend (2024-2032)
10    Europe Pompe Disease Treatment Market
    10.1    Market Share by Country
    10.2    United Kingdom
        10.2.1    Historical Trend (2017-2023)
        10.2.2    Forecast Trend (2024-2032)
    10.3    Germany
        10.3.1    Historical Trend (2017-2023)
        10.3.2    Forecast Trend (2024-2032)
    10.4    France
        10.4.1    Historical Trend (2017-2023)
        10.4.2    Forecast Trend (2024-2032)
    10.5    Italy
        10.5.1    Historical Trend (2017-2023)
        10.5.2    Forecast Trend (2024-2032)
    10.6    Others
11    Asia Pacific Pompe Disease Treatment Market
    11.1    Market Share by Country
    11.2    China
        11.2.1    Historical Trend (2017-2023)
        11.2.2    Forecast Trend (2024-2032)
    11.3    Japan
        11.3.1    Historical Trend (2017-2023)
        11.3.2    Forecast Trend (2024-2032)
    11.4    India
        11.4.1    Historical Trend (2017-2023)
        11.4.2    Forecast Trend (2024-2032)
    11.5    ASEAN
        11.5.1    Historical Trend (2017-2023)
        11.5.2    Forecast Trend (2024-2032)
    11.6    Australia
        11.6.1    Historical Trend (2017-2023)
        11.6.2    Forecast Trend (2024-2032)
    11.7    Others
12    Latin America Pompe Disease Treatment Market
    12.1    Market Share by Country
    12.2    Brazil
        12.2.1    Historical Trend (2017-2023)
        12.2.2    Forecast Trend (2024-2032)
    12.3    Argentina
        12.3.1    Historical Trend (2017-2023)
        12.3.2    Forecast Trend (2024-2032)
    12.4    Mexico
        12.4.1    Historical Trend (2017-2023)
        12.4.2    Forecast Trend (2024-2032)
    12.5    Others
13    Middle East and Africa Pompe Disease Treatment Market
    13.1    Market Share by Country
    13.2    Saudi Arabia
        13.2.1    Historical Trend (2017-2023)
        13.2.2    Forecast Trend (2024-2032)
    13.3    United Arab Emirates
        13.3.1    Historical Trend (2017-2023)
        13.3.2    Forecast Trend (2024-2032)
    13.4    Nigeria
        13.4.1    Historical Trend (2017-2023)
        13.4.2    Forecast Trend (2024-2032)
    13.5    South Africa
        13.5.1    Historical Trend (2017-2023)
        13.5.2    Forecast Trend (2024-2032)
    13.6    Others
14    Global Pompe Disease Treatment Market Dynamics
    14.1    Market Drivers and Constraints
    14.2    SWOT Analysis
    14.3    Porter’s Five Forces Model 
    14.4    Key Demand Indicators 
    14.5    Key Price Indicators 
    14.6    Industry Events, Initiatives, and Trends 
    14.7    Value Chain Analysis
15    Supplier Landscape
    15.1    Amicus Therapeutics, Inc.
        15.1.1    Company Overview
        15.1.2    Product Portfolio
        15.1.3    Demographic Reach and Achievements
        15.1.4    Mergers and Acquisitions
        15.1.5    Certifications
    15.2    BioMarin
        15.2.1    Company Overview
        15.2.2    Product Portfolio
        15.2.3    Demographic Reach and Achievements
        15.2.4    Mergers and Acquisitions
        15.2.5    Certifications
    15.3    Genzyme (Sanofi)
        15.3.1    Company Overview
        15.3.2    Product Portfolio
        15.3.3    Demographic Reach and Achievements
        15.3.4    Mergers and Acquisitions
        15.3.5    Certifications
    15.4    Audentes Therapeutics (Astellas Pharma Inc.)
        15.4.1    Company Overview
        15.4.2    Product Portfolio
        15.4.3    Demographic Reach and Achievements
        15.4.4    Mergers and Acquisitions
        15.4.5    Certifications
    15.5    EpiVax, Inc
        15.5.1    Company Overview
        15.5.2    Product Portfolio
        15.5.3    Demographic Reach and Achievements
        15.5.4    Mergers and Acquisitions
        15.5.5    Certifications
    15.6    Oxyrane
        15.6.1    Company Overview
        15.6.2    Product Portfolio
        15.6.3    Demographic Reach and Achievements
        15.6.4    Mergers and Acquisitions
        15.6.5    Certifications
    15.7    Sangamo Therapeutics 
        15.7.1    Company Overview
        15.7.2    Product Portfolio
        15.7.3    Demographic Reach and Achievements
        15.7.4    Mergers and Acquisitions
        15.7.5    Certifications
    15.8    Bayer AG
        15.8.1    Company Overview
        15.8.2    Product Portfolio
        15.8.3    Demographic Reach and Achievements
        15.8.4    Mergers and Acquisitions
        15.8.5    Certifications
    15.9    AVROBIO, Inc.
        15.9.1    Company Overview
        15.9.2    Product Portfolio
        15.9.3    Demographic Reach and Achievements
        15.9.4    Mergers and Acquisitions
        15.9.5    Certifications
    15.10    Nova Biomedical 
        15.10.1    Company Overview
        15.10.2    Product Portfolio
        15.10.3    Demographic Reach and Achievements
        15.10.4    Mergers and Acquisitions
        15.10.5    Certifications
    15.11    Trinity Biotech 
        15.11.1    Company Overview
        15.11.2    Product Portfolio
        15.11.3    Demographic Reach and Achievements
        15.11.4    Mergers and Acquisitions
        15.11.5    Certifications
16    Global Pompe Disease Treatment Market Distribution Model (Additional Insight)
    16.1    Overview 
    16.2    Potential Distributors 
    16.3    Key Parameters for Distribution Partner Assessment
17    Payment Methods (Additional Insight)
    17.1    Government Funded
    17.2    Private Insurance
    17.3    Out-of-Pocket


*Additional insights provided are customizable as per client requirements.

Key Questions Answered in the Report

The market is primarily driven by the rising prevalence of Pompe disease, increasing research and developmental activities and novel product launches and approvals and favouring government initiatives.

North America is anticipated to hold a maximum share of the market during the forecast period.

Based on the diagnosis type, the market is segmented into blood tests, genetic tests, prenatal tests, and others.

Based on the indication type, the market is bifurcated into infantile-onset Pompe disease and late-onset Pompe disease. The infantile-onset Pompe disease is further classified into classic infantile form and non-classic infantile form.

Based on the end users, the market is divided into hospitals, diagnostic centres, ambulatory and surgical centres, among others.

Based on the route of administration, the market is categorised into oral and intravenous, among others.

Based on the therapy type, the market is segmented into Enzyme Replacement Therapy (ERT), Chaperone-Advanced Replacement Therapy (CART), Substrate Replacement Therapy (SRT), supportive care and others.

The different regions in the market are North America, Europe, Asia Pacific, Latin America and the Middle East and Africa.

The key companies involved in the market are Amicus Therapeutics, Inc., BioMarin, Genzyme (Sanofi), Audentes Therapeutics (Astellas Pharma Inc.), EpiVax, Inc, Oxyrane, Sangamo Therapeutics, Bayer AG, AVROBIO, Inc., Nova Biomedical, and Trinity Biotech, among others.

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