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Enzyme Replacement Therapy Global Market Insights 2025, Analysis and Forecast to 2030, by Market Participants, Regions, Technology, Application, Product Type

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  • 87 Pages
  • May 2025
  • Region: Global
  • Prof Research
  • ID: 5407873
Description Jump to:
Enzyme replacement therapies (ERTs), including imiglucerase, agalsidase beta, and alglucosidase alfa, treat lysosomal storage disorders like Gaucher disease (1/100,000 prevalence) and Fabry disease (1/40,000). The market is driven by rising diagnosis rates, with newborn screening boosting detection by 15%, and orphan drug policies, offering 7-year exclusivity. Approximately 3 billion people are affected by rare diseases, with 6,000 Gaucher and 32,950 Pompe patients in the U.S. Novel therapies and early intervention (20% higher treatment rates for Pompe) fuel growth. The global ERT market is estimated at USD 6.0-10.0 billion in 2025, with a CAGR of 6%-10% through 2030.

Regional Market Trends

  • North America: The U.S. leads with advanced screening and ERT access, while Canada emphasizes rare disease care.
  • Europe: Germany, France, and the UK drive growth with robust orphan drug policies.
  • Asia Pacific: Japan expands ERT access, while China focuses on genetic screening.
  • Rest of the World: Brazil improves rare disease infrastructure, while the Middle East addresses genetic disorders.

Application Analysis

  • Infusion Centers: Expected growth of 6.5%-10.5%, driven by ERT administration. Trends focus on specialized care.
  • Hospitals: Projected growth of 6.0%-10.0%, linked to acute cases. Advances emphasize inpatient management.
  • Others: Anticipated growth of 5.5%-9.5%, covering home infusions. Trends highlight patient convenience.

Type Analysis

  • Imiglucerase: Expected growth of 6.2%-10.2%, for Gaucher disease. Trends focus on high efficacy.
  • Agalsidase Beta: Projected growth of 6.0%-10.0%, for Fabry disease. Advances emphasize long-term outcomes.
  • Alglucosidase Alfa: Anticipated growth of 6.5%-10.5%, for Pompe disease. Trends highlight early intervention.
  • Taliglucerase: Expected growth of 5.8%-9.8%, for Gaucher. Developments prioritize cost-effectiveness.
  • Velaglucerase Alfa: Expected growth of 6.0%-10.0%, for Gaucher. Trends focus on patient outcomes.
  • Pegademase: Expected growth of 5.5%-9.5%, for SCID. Trends highlight niche applications.
  • Laronidase: Expected growth of 6.0%-10.0%, for MPS I. Advances emphasize pediatric use.
  • Pancreatic Enzymes: Expected growth of 5.8%-9.8%, for digestion. Trends focus on high-potency formulations.
  • Idursulfase: Expected growth of 6.2%-10.2%, for MPS II. Developments prioritize long-term efficacy.
  • Galsulfase: Expected growth of 5.8%-9.8%, for MPS VI. Trends highlight rare indications.
  • Others: Expected growth of 5.5%-9.5%, covering novel ERTs. Developments prioritize new enzymes.

Key Market Players

  • Sanofi: Offers imiglucerase for Gaucher disease.
  • BioMarin: Develops ERTs for MPS disorders.
  • Takeda: Provides laronidase for MPS I.
  • Amicus Therapeutics: Focuses on Fabry disease therapies.
  • Alexion: Supplies ERTs for rare diseases.

Porter’s Five Forces Analysis

  • Threat of New Entrants: Low, due to high R&D costs and orphan drug regulations.
  • Threat of Substitutes: Low, as ERTs are primary for lysosomal disorders, though gene therapies pose future risks.
  • Bargaining Power of Buyers: Moderate, with insurers negotiating prices, but limited alternatives strengthen providers.
  • Bargaining Power of Suppliers: Low, with multiple recombinant enzyme providers.
  • Competitive Rivalry: Moderate, with players competing on efficacy and indications.

Market Opportunities and Challenges

Opportunities:

  • Addressing rare diseases, affecting 3 billion people.
  • Leveraging newborn screening, improving diagnosis by 15%.
  • Utilizing orphan drug policies, offering 7-year exclusivity.
  • Supporting early intervention, raising Pompe treatment by 20%.
  • Expanding ERT access in emerging markets.
  • Benefiting from EMA’s 20 recombinant enzyme approvals.

Challenges:

  • High costs of ERTs limiting access.
  • Regulatory delays for novel therapies.
  • Limited infrastructure in low-income regions.
  • Competition from emerging gene therapies.
  • Patient adherence issues with lifelong treatments.

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Table of Contents

Chapter 1 Executive SummaryChapter 2 Abbreviation and Acronyms
Chapter 3 Preface
3.1 Research Scope
3.2 Research Sources
3.2.1 Data Sources
3.2.2 Assumptions
3.3 Research Method
Chapter 4 Market Landscape
4.1 Market Overview
4.2 Classification/Types
4.3 Application/End Users
Chapter 5 Market Trend Analysis
5.1 Introduction
5.2 Drivers
5.3 Restraints
5.4 Opportunities
5.5 Threats
Chapter 6 Industry Chain Analysis
6.1 Upstream/Suppliers Analysis
6.2 Enzyme Replacement Therapy Analysis
6.2.1 Technology Analysis
6.2.2 Cost Analysis
6.2.3 Market Channel Analysis
6.3 Downstream Buyers/End Users
Chapter 7 Latest Market Dynamics
7.1 Latest News
7.2 Merger and Acquisition
7.3 Planned/Future Project
7.4 Policy Dynamics
Chapter 8 Historical and Forecast Enzyme Replacement Therapy Market in North America (2020-2030)
8.1 Enzyme Replacement Therapy Market Size
8.2 Enzyme Replacement Therapy Market by End Use
8.3 Competition by Players/Suppliers
8.4 Enzyme Replacement Therapy Market Size by Type
8.5 Key Countries Analysis
8.5.1 United States
8.5.2 Canada
8.5.3 Mexico
Chapter 9 Historical and Forecast Enzyme Replacement Therapy Market in South America (2020-2030)
9.1 Enzyme Replacement Therapy Market Size
9.2 Enzyme Replacement Therapy Market by End Use
9.3 Competition by Players/Suppliers
9.4 Enzyme Replacement Therapy Market Size by Type
9.5 Key Countries Analysis
9.5.1 Brazil
9.5.2 Argentina
9.5.3 Chile
9.5.4 Peru
Chapter 10 Historical and Forecast Enzyme Replacement Therapy Market in Asia & Pacific (2020-2030)
10.1 Enzyme Replacement Therapy Market Size
10.2 Enzyme Replacement Therapy Market by End Use
10.3 Competition by Players/Suppliers
10.4 Enzyme Replacement Therapy Market Size by Type
10.5 Key Countries Analysis
10.5.1 China
10.5.2 India
10.5.3 Japan
10.5.4 South Korea
10.5.5 Southeast Asia
10.5.6 Australia
Chapter 11 Historical and Forecast Enzyme Replacement Therapy Market in Europe (2020-2030)
11.1 Enzyme Replacement Therapy Market Size
11.2 Enzyme Replacement Therapy Market by End Use
11.3 Competition by Players/Suppliers
11.4 Enzyme Replacement Therapy Market Size by Type
11.5 Key Countries Analysis
11.5.1 Germany
11.5.2 France
11.5.3 United Kingdom
11.5.4 Italy
11.5.5 Spain
11.5.6 Belgium
11.5.7 Netherlands
11.5.8 Austria
11.5.9 Poland
11.5.10 Russia
Chapter 12 Historical and Forecast Enzyme Replacement Therapy Market in MEA (2020-2030)
12.1 Enzyme Replacement Therapy Market Size
12.2 Enzyme Replacement Therapy Market by End Use
12.3 Competition by Players/Suppliers
12.4 Enzyme Replacement Therapy Market Size by Type
12.5 Key Countries Analysis
12.5.1 Egypt
12.5.2 Israel
12.5.3 South Africa
12.5.4 Gulf Cooperation Council Countries
12.5.5 Turkey
Chapter 13 Summary For Global Enzyme Replacement Therapy Market (2020-2025)
13.1 Enzyme Replacement Therapy Market Size
13.2 Enzyme Replacement Therapy Market by End Use
13.3 Competition by Players/Suppliers
13.4 Enzyme Replacement Therapy Market Size by Type
Chapter 14 Global Enzyme Replacement Therapy Market Forecast (2025-2030)
14.1 Enzyme Replacement Therapy Market Size Forecast
14.2 Enzyme Replacement Therapy Application Forecast
14.3 Competition by Players/Suppliers
14.4 Enzyme Replacement Therapy Type Forecast
Chapter 15 Analysis of Global Key Vendors
15.1 Sanofi
15.1.1 Company Profile
15.1.2 Main Business and Enzyme Replacement Therapy Information
15.1.3 SWOT Analysis of Sanofi
15.1.4 Sanofi Enzyme Replacement Therapy Revenue, Gross Margin and Market Share (2020-2025)
15.2 Biomarin Pharmaceutical
15.2.1 Company Profile
15.2.2 Main Business and Enzyme Replacement Therapy Information
15.2.3 SWOT Analysis of Biomarin Pharmaceutical
15.2.4 Biomarin Pharmaceutical Enzyme Replacement Therapy Revenue, Gross Margin and Market Share (2020-2025)
15.3 Takeda Pharmaceutical
15.3.1 Company Profile
15.3.2 Main Business and Enzyme Replacement Therapy Information
15.3.3 SWOT Analysis of Takeda Pharmaceutical
15.3.4 Takeda Pharmaceutical Enzyme Replacement Therapy Revenue, Gross Margin and Market Share (2020-2025)
15.4 JCR Pharmaceuticals
15.4.1 Company Profile
15.4.2 Main Business and Enzyme Replacement Therapy Information
15.4.3 SWOT Analysis of JCR Pharmaceuticals
15.4.4 JCR Pharmaceuticals Enzyme Replacement Therapy Revenue, Gross Margin and Market Share (2020-2025)
15.5 Alexion Pharmaceuticals
15.5.1 Company Profile
15.5.2 Main Business and Enzyme Replacement Therapy Information
15.5.3 SWOT Analysis of Alexion Pharmaceuticals
15.5.4 Alexion Pharmaceuticals Enzyme Replacement Therapy Revenue, Gross Margin and Market Share (2020-2025)
15.6 AbbVie
15.6.1 Company Profile
15.6.2 Main Business and Enzyme Replacement Therapy Information
15.6.3 SWOT Analysis of AbbVie
15.6.4 AbbVie Enzyme Replacement Therapy Revenue, Gross Margin and Market Share (2020-2025)
15.7 Allergan
15.7.1 Company Profile
15.7.2 Main Business and Enzyme Replacement Therapy Information
15.7.3 SWOT Analysis of Allergan
15.7.4 Allergan Enzyme Replacement Therapy Revenue, Gross Margin and Market Share (2020-2025)
15.8 Horizon Pharma Public Limited Company
15.8.1 Company Profile
15.8.2 Main Business and Enzyme Replacement Therapy Information
15.8.3 SWOT Analysis of Horizon Pharma Public Limited Company
15.8.4 Horizon Pharma Public Limited Company Enzyme Replacement Therapy Revenue, Gross Margin and Market Share (2020-2025)
15.9 Protalix Biotherapeutics
15.9.1 Company Profile
15.9.2 Main Business and Enzyme Replacement Therapy Information
15.9.3 SWOT Analysis of Protalix Biotherapeutics
15.9.4 Protalix Biotherapeutics Enzyme Replacement Therapy Revenue, Gross Margin and Market Share (2020-2025)
15.10 Recordati Rare Diseases
15.10.1 Company Profile
15.10.2 Main Business and Enzyme Replacement Therapy Information
15.10.3 SWOT Analysis of Recordati Rare Diseases
15.10.4 Recordati Rare Diseases Enzyme Replacement Therapy Revenue, Gross Margin and Market Share (2020-2025)
15.11 Amicus Therapeutics
15.11.1 Company Profile
15.11.2 Main Business and Enzyme Replacement Therapy Information
15.11.3 SWOT Analysis of Amicus Therapeutics
15.11.4 Amicus Therapeutics Enzyme Replacement Therapy Revenue, Gross Margin and Market Share (2020-2025)
List of Tables and Figures
Table Abbreviation and Acronyms
Table Research Scope of Enzyme Replacement Therapy Report
Table Data Sources of Enzyme Replacement Therapy Report
Table Major Assumptions of Enzyme Replacement Therapy Report
Figure Market Size Estimated Method
Figure Major Forecasting Factors
Figure Enzyme Replacement Therapy Picture
Table Enzyme Replacement Therapy Classification
Table Enzyme Replacement Therapy Applications
Table Drivers of Enzyme Replacement Therapy Market
Table Restraints of Enzyme Replacement Therapy Market
Table Opportunities of Enzyme Replacement Therapy Market
Table Threats of Enzyme Replacement Therapy Market
Table COVID-19 Impact For Enzyme Replacement Therapy Market
Table Raw Materials Suppliers
Table Different Production Methods of Enzyme Replacement Therapy
Table Cost Structure Analysis of Enzyme Replacement Therapy
Table Key End Users
Table Latest News of Enzyme Replacement Therapy Market
Table Merger and Acquisition
Table Planned/Future Project of Enzyme Replacement Therapy Market
Table Policy of Enzyme Replacement Therapy Market
Table 2020-2030 North America Enzyme Replacement Therapy Market Size
Figure 2020-2030 North America Enzyme Replacement Therapy Market Size and CAGR
Table 2020-2030 North America Enzyme Replacement Therapy Market Size by Application
Table 2020-2025 North America Enzyme Replacement Therapy Key Players Revenue
Table 2020-2025 North America Enzyme Replacement Therapy Key Players Market Share
Table 2020-2030 North America Enzyme Replacement Therapy Market Size by Type
Table 2020-2030 United States Enzyme Replacement Therapy Market Size
Table 2020-2030 Canada Enzyme Replacement Therapy Market Size
Table 2020-2030 Mexico Enzyme Replacement Therapy Market Size
Table 2020-2030 South America Enzyme Replacement Therapy Market Size
Figure 2020-2030 South America Enzyme Replacement Therapy Market Size and CAGR
Table 2020-2030 South America Enzyme Replacement Therapy Market Size by Application
Table 2020-2025 South America Enzyme Replacement Therapy Key Players Revenue
Table 2020-2025 South America Enzyme Replacement Therapy Key Players Market Share
Table 2020-2030 South America Enzyme Replacement Therapy Market Size by Type
Table 2020-2030 Brazil Enzyme Replacement Therapy Market Size
Table 2020-2030 Argentina Enzyme Replacement Therapy Market Size
Table 2020-2030 Chile Enzyme Replacement Therapy Market Size
Table 2020-2030 Peru Enzyme Replacement Therapy Market Size
Table 2020-2030 Asia & Pacific Enzyme Replacement Therapy Market Size
Figure 2020-2030 Asia & Pacific Enzyme Replacement Therapy Market Size and CAGR
Table 2020-2030 Asia & Pacific Enzyme Replacement Therapy Market Size by Application
Table 2020-2025 Asia & Pacific Enzyme Replacement Therapy Key Players Revenue
Table 2020-2025 Asia & Pacific Enzyme Replacement Therapy Key Players Market Share
Table 2020-2030 Asia & Pacific Enzyme Replacement Therapy Market Size by Type
Table 2020-2030 China Enzyme Replacement Therapy Market Size
Table 2020-2030 India Enzyme Replacement Therapy Market Size
Table 2020-2030 Japan Enzyme Replacement Therapy Market Size
Table 2020-2030 South Korea Enzyme Replacement Therapy Market Size
Table 2020-2030 Southeast Asia Enzyme Replacement Therapy Market Size
Table 2020-2030 Australia Enzyme Replacement Therapy Market Size
Table 2020-2030 Europe Enzyme Replacement Therapy Market Size
Figure 2020-2030 Europe Enzyme Replacement Therapy Market Size and CAGR
Table 2020-2030 Europe Enzyme Replacement Therapy Market Size by Application
Table 2020-2025 Europe Enzyme Replacement Therapy Key Players Revenue
Table 2020-2025 Europe Enzyme Replacement Therapy Key Players Market Share
Table 2020-2030 Europe Enzyme Replacement Therapy Market Size by Type
Table 2020-2030 Germany Enzyme Replacement Therapy Market Size
Table 2020-2030 France Enzyme Replacement Therapy Market Size
Table 2020-2030 United Kingdom Enzyme Replacement Therapy Market Size
Table 2020-2030 Italy Enzyme Replacement Therapy Market Size
Table 2020-2030 Spain Enzyme Replacement Therapy Market Size
Table 2020-2030 Belgium Enzyme Replacement Therapy Market Size
Table 2020-2030 Netherlands Enzyme Replacement Therapy Market Size
Table 2020-2030 Austria Enzyme Replacement Therapy Market Size
Table 2020-2030 Poland Enzyme Replacement Therapy Market Size
Table 2020-2030 Russia Enzyme Replacement Therapy Market Size
Table 2020-2030 MEA Enzyme Replacement Therapy Market Size
Figure 2020-2030 MEA Enzyme Replacement Therapy Market Size and CAGR
Table 2020-2030 MEA Enzyme Replacement Therapy Market Size by Application
Table 2020-2025 MEA Enzyme Replacement Therapy Key Players Revenue
Table 2020-2025 MEA Enzyme Replacement Therapy Key Players Market Share
Table 2020-2030 MEA Enzyme Replacement Therapy Market Size by Type
Table 2020-2030 Egypt Enzyme Replacement Therapy Market Size
Table 2020-2030 Israel Enzyme Replacement Therapy Market Size
Table 2020-2030 South Africa Enzyme Replacement Therapy Market Size
Table 2020-2030 Gulf Cooperation Council Countries Enzyme Replacement Therapy Market Size
Table 2020-2030 Turkey Enzyme Replacement Therapy Market Size
Table 2020-2025 Global Enzyme Replacement Therapy Market Size by Region
Table 2020-2025 Global Enzyme Replacement Therapy Market Size Share by Region
Table 2020-2025 Global Enzyme Replacement Therapy Market Size by Application
Table 2020-2025 Global Enzyme Replacement Therapy Market Share by Application
Table 2020-2025 Global Enzyme Replacement Therapy Key Vendors Revenue
Figure 2020-2025 Global Enzyme Replacement Therapy Market Size and Growth Rate
Table 2020-2025 Global Enzyme Replacement Therapy Key Vendors Market Share
Table 2020-2025 Global Enzyme Replacement Therapy Market Size by Type
Table 2020-2025 Global Enzyme Replacement Therapy Market Share by Type
Table 2025-2030 Global Enzyme Replacement Therapy Market Size by Region
Table 2025-2030 Global Enzyme Replacement Therapy Market Size Share by Region
Table 2025-2030 Global Enzyme Replacement Therapy Market Size by Application
Table 2025-2030 Global Enzyme Replacement Therapy Market Share by Application
Table 2025-2030 Global Enzyme Replacement Therapy Key Vendors Revenue
Figure 2025-2030 Global Enzyme Replacement Therapy Market Size and Growth Rate
Table 2025-2030 Global Enzyme Replacement Therapy Key Vendors Market Share
Table 2025-2030 Global Enzyme Replacement Therapy Market Size by Type
Table 2025-2030 Enzyme Replacement Therapy Global Market Share by Type

Companies Mentioned

  • Sanofi
  • Biomarin Pharmaceutical
  • Takeda Pharmaceutical
  • JCR Pharmaceuticals
  • Alexion Pharmaceuticals
  • AbbVie
  • Allergan
  • Horizon Pharma Public Limited Company
  • Protalix Biotherapeutics
  • Recordati Rare Diseases
  • Amicus Therapeutics

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