North America Fabry Disease Treatment Market Size, Share, & Industry Analysis Report By Route of Administration (Intravenous Route and Oral Route), By Therapy, By Distribution Channel, and By Country

Description

List of Tables

The north america fabry's disease treatment market size is expected to reach USD 2,173.14 million by 2034, according to a new study by Polaris Market Research. The report "North America Fabry's Disease Treatment Market Size, Share, & Industry Analysis Report By Route of Administration (Intravenous Route and Oral Route), By Therapy, By Distribution Channel, By Country - Market Forecast, 2025-2034" gives a detailed insight into current market dynamics and provides analysis on future market growth.

The North America Fabry's disease treatment market represents a dynamic landscape shaped by ongoing innovations in rare disease therapeutics and expanding access to early diagnostics. Strong clinical infrastructure supports the region's ability to deliver advanced therapies such as enzyme replacement therapy (ERT) and substrate reduction therapy (SRT), alongside the rising adoption of oral formulations aimed at improving patient convenience and long-term compliance. Increased emphasis on precision medicine is driving a shift toward targeted interventions based on genotypic and phenotypic profiling, enabling personalized treatment plans that significantly improve outcomes. Pharmaceutical companies are intensifying R&D activities in the space, focusing on next-generation biologics and gene therapies to address the limitations of current therapies. Accelerated regulatory pathways for orphan drugs continue to promote faster market entry of novel treatments, creating a favorable environment for innovation. Strategic collaborations among biopharma firms, academic institutions, and rare disease foundations are enabling joint research programs and expanding therapeutic pipelines.

Growing digital health integration supports remote monitoring and enhances disease management, particularly for chronic conditions such as Fabry's disease that require lifelong care. Trends indicate a growing preference for home infusion services and specialty pharmacies, reducing dependence on hospital-based care. Expanding awareness through advocacy efforts and professional education is improving diagnosis rates and promoting earlier therapeutic intervention.

North America Fabry's Disease Treatment Market Report Highlights

By route of administration, in 2024, the intravenous route segment accounted for approximately 68% share, due to the continued preference for enzyme replacement therapies (ERT), which require IV infusion.

Based on therapy, in 2024, the enzyme replacement therapy (ERT) segment accounted for approximately 70% of the share, driven by its established role as the first-line treatment for Fabry's disease.

The US Fabry's disease treatment market accounted for approximately 85% of share largely due to its advanced healthcare infrastructure, early adoption of innovative therapies, and robust clinical research ecosystem.

The Canada Fabry's disease treatment market is projected to register a CAGR of 6.7% from 2025 to 2034, fueled by increasing government support for rare disease programs and improvements in diagnostic infrastructure.

A few key players include Amicus Therapeutics, Inc.; CANbridge Life Sciences Ltd.; Chiesi Farmaceutici S.p.A.; Idorsia Pharmaceuticals Ltd.; ISU ABXIS Co., Ltd.; JCR Pharmaceuticals Co., Ltd.; Protalix Biotherapeutics Inc.; Sangamo Therapeutics, Inc.; Sanofi; and Takeda Pharmaceutical.

Polaris Market Research has segmented the North America Fabry's disease treatment market on the basis of route of administration, therapy, distribution channel, and region:

By Route of Administration Outlook (Revenue USD Million, 2020-2034)

Intravenous Route

Oral Route

By Therapy Outlook (Revenue USD Million, 2020-2034)

Enzyme Replacement Therapy (ERT)

Substrate Reduction Therapy (SRT)

Others

By Distribution Channel Outlook (Revenue USD Million, 2020-2034)

Hospital Pharmacies

Retail Pharmacies

Online Pharmacies

By Country Outlook (Revenue USD Million, 2020-2034)

Canada

Product Code: PM5764

1. Introduction

1.1. Report Description
- 1.1.1. Objectives of the Study
- 1.1.2. Market Scope
- 1.1.3. Assumptions
1.2. Stakeholders

2. Executive Summary

2.1. Market Highlights

3. Research Methodology

3.1. Overview
- 3.1.1. Data Mining
3.2. Data Sources
- 3.2.1. Primary Sources
- 3.2.2. Secondary Sources

4. North America Fabry's Disease Treatment Market Insights

4.1. North America Fabry's Disease Treatment Market - Market Snapshot
4.2. North America Fabry's Disease Treatment Market Dynamics
- 4.2.1. Drivers and Opportunities
  - 4.2.1.1. High Diagnostic Rates
  - 4.2.1.2. Technological Advancements in Patient Monitoring
- 4.2.2. Restraints and Challenges
  - 4.2.2.1. Lack of Awareness
4.3. Porter's Five Forces Analysis
- 4.3.1. Bargaining Power of Suppliers (Moderate)
- 4.3.2. Threats of New Entrants: (Low)
- 4.3.3. Bargaining Power of Buyers (Moderate)
- 4.3.4. Threat of Substitute (Moderate)
- 4.3.5. Rivalry among existing firms (High)
4.4. PESTEL Analysis
4.5. North America Fabry's Disease Treatment Market Trends
4.6. Value Chain Analysis

5. North America Fabry's Disease Treatment Market, by Route of Administration

5.1. Key Findings
5.2. Introduction
- 5.2.1. North America Fabry's Disease Treatment Market, by Route of Administration, 2020-2034 (USD Million)
5.3. Intravenous Route
- 5.3.1. North America Fabry's Disease Treatment Market, by Intravenous Route, by Country, 2020-2034 (USD Million)
5.4. Oral Route
- 5.4.1. North America Fabry's Disease Treatment Market, by Oral Route, by Country, 2020-2034 (USD Million)

6. North America Fabry's Disease Treatment Market, by Therapy

6.1. Key Findings
6.2. Introduction
- 6.2.1. North America Fabry's Disease Treatment Market, by Therapy, 2020-2034 (USD Million)
6.3. Enzyme Replacement Therapy (ERT)
- 6.3.1. North America Fabry's Disease Treatment Market, by Enzyme Replacement Therapy (ERT), by Country, 2020-2034 (USD Million)
6.4. Substrate Reduction Therapy (SRT)
- 6.4.1. North America Fabry's Disease Treatment Market, by Substrate Reduction Therapy (SRT), by Country, 2020-2034 (USD Million)
6.5. Others
- 6.5.1. North America Fabry's Disease Treatment Market, by Others, by Country, 2020-2034 (USD Million)

7. North America Fabry's Disease Treatment Market, by Distribution Channel

7.1. Key Findings
7.2. Introduction
- 7.2.1. North America Fabry's Disease Treatment Market, by Distribution Channel, 2020-2034 (USD Million)
7.3. Hospital Pharmacies
- 7.3.1. North America Fabry's Disease Treatment Market, by Hospital Pharmacies, by Country, 2020-2034 (USD Million)
7.4. Retail Pharmacies
- 7.4.1. North America Fabry's Disease Treatment Market, by Retail Pharmacies, by Country, 2020-2034 (USD Million)
7.5. Online Pharmacies
- 7.5.1. North America Fabry's Disease Treatment Market, by Online Pharmacies, by Country, 2020-2034 (USD Million)

8. North America Fabry's Disease Treatment Market, by Geography

8.1. Key Findings
8.2. Introduction
- 8.2.1. North America Fabry's Disease Treatment Market Assessment, By Geography, 2020-2034 (USD Million)
8.3. North America Fabry's Disease Treatment Market - North America
- 8.3.1. North America: North America Fabry's Disease Treatment Market, by Route of Administration, 2020-2034 (USD Million)
- 8.3.2. North America: North America Fabry's Disease Treatment Market, by Therapy, 2020-2034 (USD Million)
- 8.3.3. North America: North America Fabry's Disease Treatment Market, by Distribution Channel, 2020-2034 (USD Million)
- 8.3.4. North America Fabry's Disease Treatment Market - U.S.
  - 8.3.4.1. U.S.: North America Fabry's Disease Treatment Market, by Route of Administration, 2020-2034 (USD Million)
  - 8.3.4.2. U.S.: North America Fabry's Disease Treatment Market, by Therapy, 2020-2034 (USD Million)
  - 8.3.4.3. U.S.: North America Fabry's Disease Treatment Market, by Distribution Channel, 2020-2034 (USD Million)
- 8.3.5. North America Fabry's Disease Treatment Market - Canada
  - 8.3.5.1. Canada: North America Fabry's Disease Treatment Market, by Route of Administration, 2020-2034 (USD Million)
  - 8.3.5.2. Canada: North America Fabry's Disease Treatment Market, by Therapy, 2020-2034 (USD Million)
  - 8.3.5.3. Canada: North America Fabry's Disease Treatment Market, by Distribution Channel, 2020-2034 (USD Million)

9. Competitive Landscape

9.1. Expansion and Acquisition Analysis
- 9.1.1. Expansion
- 9.1.2. Acquisitions
9.2. Partnerships/Collaborations/Agreements/Exhibitions

10. Company Profiles

10.1. Amicus Therapeutics, Inc.
- 10.1.1. Company Overview
- 10.1.2. Financial Performance
- 10.1.3. Product Benchmarking
- 10.1.4. Recent Development
10.2. CANbridge Life Sciences Ltd.
- 10.2.1. Company Overview
- 10.2.2. Financial Performance
- 10.2.3. Product Benchmarking
- 10.2.4. Recent Development
10.3. Chiesi Farmaceutici S.p.A.
- 10.3.1. Company Overview
- 10.3.2. Financial Performance
- 10.3.3. Product Benchmarking
- 10.3.4. Recent Development
10.4. Idorsia Pharmaceuticals Ltd.
- 10.4.1. Company Overview
- 10.4.2. Financial Performance
- 10.4.3. Product Benchmarking
- 10.4.4. Recent Development
10.5. ISU ABXIS Co., Ltd.
- 10.5.1. Company Overview
- 10.5.2. Financial Performance
- 10.5.3. Product Benchmarking
- 10.5.4. Recent Development
10.6. JCR Pharmaceuticals Co., Ltd.
- 10.6.1. Company Overview
- 10.6.2. Financial Performance
- 10.6.3. Product Benchmarking
- 10.6.4. Recent Development
10.7. Protalix Biotherapeutics Inc.
- 10.7.1. Company Overview
- 10.7.2. Financial Performance
- 10.7.3. Product Benchmarking
- 10.7.4. Recent Development
10.8. Sangamo Therapeutics, Inc.
- 10.8.1. Company Overview
- 10.8.2. Financial Performance
- 10.8.3. Product Benchmarking
- 10.8.4. Recent Development
10.9. Sanofi
- 10.9.1. Company Overview
- 10.9.2. Financial Performance
- 10.9.3. Product Benchmarking
- 10.9.4. Recent Development
10.10. Takeda Pharmaceutical
- 10.10.1. Company Overview
- 10.10.2. Financial Performance
- 10.10.3. Product Benchmarking
- 10.10.4. Recent Development