Product Code: GVR-3-68038-999-9
Enzyme Replacement Therapy Market Growth & Trends:
The global enzyme replacement therapy market size is estimated to reach USD 17.26 billion by 2030, registering to grow at a CAGR of 9.0% from 2025 to 2030 according to a new report by Grand View Research, Inc. As per the Genetic and Rare Diseases Information Center or GARD, a rare disease is defined as a condition that affects lesser than 200,000 individuals. These disorders are also called orphan diseases due to the lack of support exhibited by pharmaceutical companies previously. Since the passing of the Orphan Drug Act of 1983 in the U.S., several large pharmaceutical and biopharmaceutical companies have invested heavily in the development of orphan drugs. Thus, rising awareness, increasing R&D investment, growth in the number of lysosomal storage and genetic disorders, and easy drug approval process are factors propelling the market growth during the forecast period.
According to data from the National Institutes of Health, it is estimated that over 25 million Americans suffer from rare diseases. These facts are indicative of the fact that although the number of these ailments is low, individuals suffering from these are large. Some of the most common lysosomal storage disorders that make use of enzyme replacement therapy are Gaucher, Fabry, Pompe, MPS, SCID, and Shwachman-Diamond Syndrome among others.
In the recent past, these disorders have been gaining significant attention, impacting growth positively. Various grants and acts are in place to accommodate drug makers to invest in the development of orphan drugs. Orphan Drug Designation Program, Rare Pediatric Disease Priority Review Voucher Program, Humanitarian Use Device (HUD) Program, and Orphan Products Clinical Trials Grants Program are programs that aid in the development of orphan drugs.
The rising use of enzyme replacement therapy in home care and infusion centers are gaining traction in the market. Specialized infusion centers such as these are anticipated to witness the highest CAGR during the forecast period. Hospitals held the largest segmental share owing to easy accessibility and ability to treat a wide range of ailments.
Enzyme Replacement Therapy Market Report Highlights:
- Gaucher disease held the dominant position in the market and accounted for the largest revenue share of 32.6% in 2024, driven by the increasing prevalence and awareness of the condition, leading to more patients being diagnosed and treated.
- Imiglucerase dominated the market and accounted for the largest revenue share of 20.2% in 2024, owing to the rising prevalence of Gaucher disease, which necessitates effective treatment options. In addition, as awareness and diagnosis rates improve, more patients are being identified, increasing demand for imiglucerase.
- The parenteral route of administration dominated the market and accounted for the largest revenue share of 80.9% in 2024. This growth is attributed to its ability to facilitate rapid absorption and effective drug delivery. In addition, this method allows for intravenous infusions, which are essential for delivering large molecules such as enzymes directly into the bloodstream, ensuring immediate therapeutic effects
- Infusion centers led the market and accounted for the largest revenue share of 40.8% in 2024, driven by their specialized focus on intravenous treatments. These centers provide a controlled environment for administering ERT, ensuring patient safety and comfort during infusions.
Table of Contents
Chapter 1. Methodology and Scope
- 1.1. Market Segmentation & Scope
- 1.2. Segment Definitions
- 1.2.1. Product
- 1.2.2. Therapeutic Condition
- 1.2.3. Route of Administration
- 1.2.4. End Use
- 1.3. Estimates and Forecast Timeline
- 1.4. Research Methodology
- 1.5. Information Procurement
- 1.5.1. Purchased Database
- 1.5.2. GVR's Internal Database
- 1.5.3. Secondary Sources
- 1.5.4. Primary Research
- 1.6. Information Analysis
- 1.6.1. Data Analysis Models
- 1.7. Market Formulation & Data Visualization
- 1.8. Model Details
- 1.8.1. Commodity Flow Analysis
- 1.9. List of Secondary Sources
- 1.10. Objectives
Chapter 2. Executive Summary
- 2.1. Market Snapshot
- 2.2. Segment Snapshot
- 2.3. Competitive Landscape Snapshot
Chapter 3. Enzyme Replacement Therapy Market Variables, Trends, & Scope
- 3.1. Market Lineage Outlook
- 3.2. Market Dynamics
- 3.2.1. Market Driver Analysis
- 3.2.2. Market Restraint Analysis
- 3.3. Business Environment Analysis
- 3.3.1. Industry Analysis - Porter's Five Forces Analysis
- 3.3.1.1. Supplier power
- 3.3.1.2. Buyer power
- 3.3.1.3. Substitution threat
- 3.3.1.4. Threat of new entrant
- 3.3.1.5. Competitive rivalry
- 3.3.2. PESTLE Analysis
Chapter 4. Enzyme Replacement Therapy Market: Product Business Analysis
- 4.1. Product Market Share, 2024 & 2030
- 4.2. Product Segment Dashboard
- 4.3. Market Size & Forecasts and Trend Analysis, by Product, 2018 to 2030 (USD Million)
- 4.4. Imiglucerase
- 4.4.1. Imiglucerase Market, 2018 - 2030 (USD Million)
- 4.5. Agalsidase Beta
- 4.5.1. Agalsidase Beta Market, 2018 - 2030 (USD Million)
- 4.5.2. Alglucosidase Alfa
- 4.5.3. Alglucosidase Alfa Market, 2018 - 2030 (USD Million)
- 4.6. Taliglucerase
- 4.6.1. Taliglucerase Market, 2018 - 2030 (USD Million)
- 4.7. Velaglucerase Alfa
- 4.7.1. Velaglucerase Alfa Market, 2018 - 2030 (USD Million)
- 4.8. Pegademase
- 4.8.1. Pegademase Market, 2018 - 2030 (USD Million)
- 4.9. Laronidase
- 4.9.1. Laronidase Market, 2018 - 2030 (USD Million)
- 4.10. Pancreatic Enzymes
- 4.10.1. Pancreatic Enzymes Market, 2018 - 2030 (USD Million)
- 4.11. Idursulfase
- 4.11.1. Idursulfase Market, 2018 - 2030 (USD Million)
- 4.12. Galsulfase
- 4.12.1. Galsulfase Market, 2018 - 2030 (USD Million)
- 4.13. Others
- 4.13.1. Others Market, 2018 - 2030 (USD Million)
Chapter 5. Enzyme Replacement Therapy Market: Therapeutic Condition Business Analysis
- 5.1. Therapeutic Condition Market Share, 2024 & 2030
- 5.2. Therapeutic Condition Segment Dashboard
- 5.3. Market Size & Forecasts and Trend Analysis, by Therapeutic Condition, 2018 to 2030 (USD Million)
- 5.4. Gaucher Disease
- 5.4.1. Gaucher Disease Market, 2018 - 2030 (USD Million)
- 5.5. MPS
- 5.5.1. MPS Market, 2018 - 2030 (USD Million)
- 5.6. SCID
- 5.6.1. SCID Market, 2018 - 2030 (USD Million)
- 5.7. Pompe Disease
- 5.7.1. Pompe Disease Market, 2018 - 2030 (USD Million)
- 5.8. Fabry Disease
- 5.8.1. Fabry Disease Market, 2018 - 2030 (USD Million)
- 5.9. Other
- 5.9.1. Other Market, 2018 - 2030 (USD Million)
Chapter 6. Enzyme Replacement Therapy Market: Route of Administration Business Analysis
- 6.1. Route of Administration Market Share, 2024 & 2030
- 6.2. Route of Administration Segment Dashboard
- 6.3. Market Size & Forecasts and Trend Analysis, by Route of Administration, 2018 to 2030 (USD Million)
- 6.4. Parenteral
- 6.4.1. Parenteral Market, 2018 - 2030 (USD Million)
- 6.5. Oral
- 6.5.1. Oral Market, 2018 - 2030 (USD Million)
Chapter 7. Enzyme Replacement Therapy Market: End Use Business Analysis
- 7.1. End Use Market Share, 2024 & 2030
- 7.2. End Use Segment Dashboard
- 7.3. Market Size & Forecasts and Trend Analysis, by End Use, 2018 to 2030 (USD Million)
- 7.4. Infusion Centers
- 7.4.1. Infusion Centers Market, 2018 - 2030 (USD Million)
- 7.5. Hospitals
- 7.5.1. Hospitals Market, 2018 - 2030 (USD Million)
- 7.6. Other
- 7.6.1. Other Market, 2018 - 2030 (USD Million)
Chapter 8. Enzyme Replacement Therapy Market: Regional Estimates & Trend Analysis by Product, Therapeutic Condition, and End Use
- 8.1. Regional Market Share Analysis, 2024 & 2030
- 8.2. Regional Market Dashboard
- 8.3. Market Size, & Forecasts Trend Analysis, 2018 to 2030:
- 8.4. North America
- 8.4.1. North America Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.4.2. U.S.
- 8.4.2.1. Key Country Dynamic
- 8.4.2.2. Regulatory Framework
- 8.4.2.3. Competitive Insights
- 8.4.2.4. U.S. Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.4.3. Canada
- 8.4.3.1. Key Country Dynamic
- 8.4.3.2. Regulatory Framework
- 8.4.3.3. Competitive Insights
- 8.4.3.4. Canada Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.4.4. Mexico
- 8.4.4.1. Key Country Dynamic
- 8.4.4.2. Regulatory Framework
- 8.4.4.3. Competitive Insights
- 8.4.4.4. Mexico Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.5. Europe
- 8.5.1. Europe Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.5.2. UK
- 8.5.2.1. Key Country Dynamic
- 8.5.2.2. Regulatory Framework
- 8.5.2.3. Competitive Insights
- 8.5.2.4. UK Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.5.3. Germany
- 8.5.3.1. Key Country Dynamic
- 8.5.3.2. Regulatory Framework
- 8.5.3.3. Competitive Insights
- 8.5.3.4. Germany Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.5.4. France
- 8.5.4.1. Key Country Dynamic
- 8.5.4.2. Regulatory Framework
- 8.5.4.3. Competitive Insights
- 8.5.4.4. France Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.5.5. Italy
- 8.5.5.1. Key Country Dynamic
- 8.5.5.2. Regulatory Framework
- 8.5.5.3. Competitive Insights
- 8.5.5.4. Italy Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.5.6. Spain
- 8.5.6.1. Key Country Dynamic
- 8.5.6.2. Regulatory Framework
- 8.5.6.3. Competitive Insights
- 8.5.6.4. Spain Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.5.7. Norway
- 8.5.7.1. Key Country Dynamic
- 8.5.7.2. Regulatory Framework
- 8.5.7.3. Competitive Insights
- 8.5.7.4. Norway Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.5.8. Denmark
- 8.5.8.1. Key Country Dynamic
- 8.5.8.2. Regulatory Framework
- 8.5.8.3. Competitive Insights
- 8.5.8.4. Denmark Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.5.9. Sweden
- 8.5.9.1. Key Country Dynamic
- 8.5.9.2. Regulatory Framework
- 8.5.9.3. Competitive Insights
- 8.5.9.4. Sweden Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.6. Asia Pacific
- 8.6.1. Asia Pacific Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.6.2. Japan
- 8.6.2.1. Key Country Dynamic
- 8.6.2.2. Regulatory Framework
- 8.6.2.3. Competitive Insights
- 8.6.2.4. Japan Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.6.3. China
- 8.6.3.1. Key Country Dynamic
- 8.6.3.2. Regulatory Framework
- 8.6.3.3. Competitive Insights
- 8.6.3.4. China Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.6.4. India
- 8.6.4.1. Key Country Dynamic
- 8.6.4.2. Regulatory Framework
- 8.6.4.3. Competitive Insights
- 8.6.4.4. India Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.6.5. South Korea
- 8.6.5.1. Key Country Dynamic
- 8.6.5.2. Regulatory Framework
- 8.6.5.3. Competitive Insights
- 8.6.5.4. South Korea Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.6.6. Australia
- 8.6.6.1. Key Country Dynamic
- 8.6.6.2. Regulatory Framework
- 8.6.6.3. Competitive Insights
- 8.6.6.4. Australia Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.6.7. Thailand
- 8.6.7.1. Key Country Dynamic
- 8.6.7.2. Regulatory Framework
- 8.6.7.3. Competitive Insights
- 8.6.7.4. Thailand Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.7. Latin America
- 8.7.1. Latin America Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.7.2. Brazil
- 8.7.2.1. Key Country Dynamic
- 8.7.2.2. Regulatory Framework
- 8.7.2.3. Competitive Insights
- 8.7.2.4. Brazil Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.7.3. Argentina
- 8.7.3.1. Key Country Dynamic
- 8.7.3.2. Regulatory Framework
- 8.7.3.3. Competitive Insights
- 8.7.3.4. Argentina Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.8. MEA
- 8.8.1. MEA Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.8.2. South Africa
- 8.8.2.1. Key Country Dynamic
- 8.8.2.2. Regulatory Framework
- 8.8.2.3. Competitive Insights
- 8.8.2.4. South Africa Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.8.3. Saudi Arabia
- 8.8.3.1. Key Country Dynamic
- 8.8.3.2. Regulatory Framework
- 8.8.3.3. Competitive Insights
- 8.8.3.4. Saudi Arabia Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.8.4. UAE
- 8.8.4.1. Key Country Dynamic
- 8.8.4.2. Regulatory Framework
- 8.8.4.3. Competitive Insights
- 8.8.4.4. UAE Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.8.5. Kuwait
- 8.8.5.1. Key Country Dynamic
- 8.8.5.2. Regulatory Framework
- 8.8.5.3. Competitive Insights
- 8.8.5.4. Kuwait Enzyme Replacement Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 9. Competitive Landscape
- 9.1. Participant Overview
- 9.2. Company Market Position Analysis
- 9.3. Company Categorization
- 9.4. Strategy Mapping
- 9.5. Company Profiles/Listing
- 9.5.1. Carl Zeiss Meditec, Inc.
- 9.5.1.1. Overview
- 9.5.1.2. Financial Performance
- 9.5.1.3. Product Benchmarking
- 9.5.1.4. Strategic Initiatives
- 9.5.2. Shire Plc;
- 9.5.2.1. Overview
- 9.5.2.2. Financial Performance
- 9.5.2.3. Product Benchmarking
- 9.5.2.4. Strategic Initiatives
- 9.5.3 Sanofi S.A.
- 9.5.2.1. Overview
- 9.5.2.2. Financial Performance
- 9.5.2.3. Product Benchmarking
- 9.5.2.4. Strategic Initiatives
- 9.5.4. Biomarin Pharmaceutical Inc.
- 9.5.4.1. Overview
- 9.5.4.2. Financial Performance
- 9.5.4.3. Product Benchmarking
- 9.5.4.4. Strategic Initiatives
- 9.5.5. AbbVie
- 9.5.5.1. Overview
- 9.5.5.2. Financial Performance
- 9.5.5.3. Product Benchmarking
- 9.5.5.4. Strategic Initiatives
- 9.5.6. Alexion Pharmaceuticals Inc.
- 9.5.6.1. Overview
- 9.5.6.2. Financial Performance
- 9.5.6.3. Product Benchmarking
- 9.5.6.4. Strategic Initiatives
- 9.5.7. Allergan plc
- 9.5.7.1. Overview
- 9.5.7.2. Financial Performance
- 9.5.7.3. Product Benchmarking
- 9.5.7.4. Strategic Initiatives
- 9.5.8. Horizon Pharma Public Limited Company
- 9.5.8.1. Overview
- 9.5.8.2. Financial Performance
- 9.5.8.3. Product Benchmarking
- 9.5.8.4. Strategic Initiatives
- 9.5.9. Actelion (Janssen)
- 9.5.9.1. Overview
- 9.5.9.2. Financial Performance
- 9.5.9.3. Product Benchmarking
- 9.5.9.4. Strategic Initiatives
- 9.5.10. Recordati Rare Diseases
- 9.5.10.1. Overview
- 9.5.10.2. Financial Performance
- 9.5.10.3. Product Benchmarking
- 9.5.10.4. Strategic Initiatives
- 9.5.11. Protalix Biotherapeutics
- 9.5.11.1. Overview
- 9.5.11.2. Financial Performance
- 9.5.11.3. Product Benchmarking
- 9.5.11.4. Strategic Initiatives
- 9.5.12. Amicus Therapeutics, Inc.
- 9.5.12.1. Overview
- 9.5.12.2. Financial Performance
- 9.5.12.3. Product Benchmarking
- 9.5.12.4. Strategic Initiatives