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

By: HDIN Research Published: 2025-05-25 Pages: 87
Market Research Report Price
  • Single User License (1 Users) $ 3,200
  • Team License (2~5 Users) $ 4,200
  • Corporate License (>5 Users) $ 5,200
Enzyme Replacement Therapy Market Summary
Introduction and Market Overview
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.
Table of Contents
Chapter 1 Executive Summary
Chapter 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 Southest 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 Sales, Revenue, Price and Gross Margin (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 Sales, Revenue, Price and Gross Margin (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 Sales, Revenue, Price and Gross Margin (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 Sales, Revenue, Price and Gross Margin (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 Sales, Revenue, Price and Gross Margin (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 Sales, Revenue, Price and Gross Margin (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 Sales, Revenue, Price and Gross Margin (2020-2025)
Please ask for sample pages for full companies list
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
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 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
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
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
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
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
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
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
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

Figure Market Size Estimated Method
Figure Major Forecasting Factors
Figure Enzyme Replacement Therapy Picture
Figure 2020-2030 North America Enzyme Replacement Therapy Market Size And Cagr
Figure 2020-2030 South America Enzyme Replacement Therapy Market Size And Cagr
Figure 2020-2030 Asia & Pacific Enzyme Replacement Therapy Market Size And Cagr
Figure 2020-2030 Europe Enzyme Replacement Therapy Market Size And Cagr
Figure 2020-2030 Mea Enzyme Replacement Therapy Market Size And Cagr
Figure 2020-2025 Global Enzyme Replacement Therapy Market Size And Growth Rate
Figure 2025-2030 Global Enzyme Replacement Therapy Market Size And Growth Rate

Research Methodology

  • Market Estimated Methodology:

    Bottom-up & top-down approach, supply & demand approach are the most important method which is used by HDIN Research to estimate the market size.

1)Top-down & Bottom-up Approach

Top-down approach uses a general market size figure and determines the percentage that the objective market represents.

Bottom-up approach size the objective market by collecting the sub-segment information.

2)Supply & Demand Approach

Supply approach is based on assessments of the size of each competitor supplying the objective market.

Demand approach combine end-user data within a market to estimate the objective market size. It is sometimes referred to as bottom-up approach.

  • Forecasting Methodology
  • Numerous factors impacting the market trend are considered for forecast model:
  • New technology and application in the future;
  • New project planned/under contraction;
  • Global and regional underlying economic growth;
  • Threatens of substitute products;
  • Industry expert opinion;
  • Policy and Society implication.
  • Analysis Tools

1)PEST Analysis

PEST Analysis is a simple and widely used tool that helps our client analyze the Political, Economic, Socio-Cultural, and Technological changes in their business environment.

  • Benefits of a PEST analysis:
  • It helps you to spot business opportunities, and it gives you advanced warning of significant threats.
  • It reveals the direction of change within your business environment. This helps you shape what you’re doing, so that you work with change, rather than against it.
  • It helps you avoid starting projects that are likely to fail, for reasons beyond your control.
  • It can help you break free of unconscious assumptions when you enter a new country, region, or market; because it helps you develop an objective view of this new environment.

2)Porter’s Five Force Model Analysis

The Porter’s Five Force Model is a tool that can be used to analyze the opportunities and overall competitive advantage. The five forces that can assist in determining the competitive intensity and potential attractiveness within a specific area.

  • Threat of New Entrants: Profitable industries that yield high returns will attract new firms.
  • Threat of Substitutes: A substitute product uses a different technology to try to solve the same economic need.
  • Bargaining Power of Customers: the ability of customers to put the firm under pressure, which also affects the customer's sensitivity to price changes.
  • Bargaining Power of Suppliers: Suppliers of raw materials, components, labor, and services (such as expertise) to the firm can be a source of power over the firm when there are few substitutes.
  • Competitive Rivalry: For most industries the intensity of competitive rivalry is the major determinant of the competitiveness of the industry.

3)Value Chain Analysis

Value chain analysis is a tool to identify activities, within and around the firm and relating these activities to an assessment of competitive strength. Value chain can be analyzed by primary activities and supportive activities. Primary activities include: inbound logistics, operations, outbound logistics, marketing & sales, service. Support activities include: technology development, human resource management, management, finance, legal, planning.

4)SWOT Analysis

SWOT analysis is a tool used to evaluate a company's competitive position by identifying its strengths, weaknesses, opportunities and threats. The strengths and weakness is the inner factor; the opportunities and threats are the external factor. By analyzing the inner and external factors, the analysis can provide the detail information of the position of a player and the characteristics of the industry.

  • Strengths describe what the player excels at and separates it from the competition
  • Weaknesses stop the player from performing at its optimum level.
  • Opportunities refer to favorable external factors that the player can use to give it a competitive advantage.
  • Threats refer to factors that have the potential to harm the player.
  • Data Sources
Primary Sources Secondary Sources
Face to face/Phone Interviews with market participants, such as:
Manufactures;
Distributors;
End-users;
Experts.
Online Survey
Government/International Organization Data:
Annual Report/Presentation/Fact Book
Internet Source Information
Industry Association Data
Free/Purchased Database
Market Research Report
Book/Journal/News

Why HDIN Research.com?

More options to meet your budget: you can choose Multi-user report, customized report even only specific data you need

 

Plenty of third-party databases and owned databases support

 

Accurate market information supported by Top Fortune 500 Organizations

 

24/7 purchase support and after-service support

 

Protect customer privacy

ABOUT HDIN RESEARCH

HDIN Research focuses on providing market consulting services. As an independent third-party consulting firm, it is committed to providing in-depth market research and analysis reports.

OUR LOCATION

Room 208-069, Floor 2, Building 6, No. 1, Shangdi 10th Street, Haidian District, Beijing, PR China
+86-010-82142830
sales@hdinresearch.com

QUICK LINKS