The enzyme replacement therapy market size has grown strongly in recent years. It will grow from $11.58 billion in 2024 to $12.48 billion in 2025 at a compound annual growth rate (CAGR) of 7.8%. The growth in the historic period can be attributed to growing early therapeutic discoveries, pioneering treatment approvals, expanded disease understanding, clinical success stories, regulatory support and incentives.
The enzyme replacement therapy market size is expected to see strong growth in the next few years. It will grow to $17.81 billion in 2029 at a compound annual growth rate (CAGR) of 9.3%. The growth in the forecast period can be attributed to increasing patient access to healthcare, tailored therapies and personalized medicine, regulatory landscape changes, and growing patient population awareness. Major trends in the forecast period include digital health integration, focus on patient-centric solutions, emerging biomarker research, and precision medicine approach.
The increasing prevalence of rare, chronic, and inherited disorders is anticipated to drive the growth of the enzyme replacement therapy market in the coming years. Chronic disease is defined as an illness lasting three months or more that may worsen over time. Such diseases are more prevalent among the elderly and are typically manageable but not curable. For example, in July 2024, the American Lung Association, a U.S.-based non-profit organization, reported that in 2022, 44.2 million Americans (or 13.5% of the population) had been diagnosed with asthma by a healthcare provider, up from 12.9% in 2021. Thus, the rising prevalence of rare, chronic, and inherited disorders is expected to fuel growth in the enzyme replacement therapy market.
The increase in healthcare spending is projected to drive the growth of the enzyme replacement therapy (ERT) market in the future. Healthcare expenditure represents the total funds allocated to healthcare services, goods, and activities within a healthcare system or economy over a given period. This spending supports ERT due to the highly specialized and often costly nature of these treatments, covering research, development, clinical trials, and testing. For example, in December 2022, the U.S.-based federal agency Centers for Medicare & Medicaid Services reported that U.S. healthcare spending grew by 4.1% to reach $4.5 trillion in 2022, outpacing the 3.2% growth in 2021. Thus, rising healthcare expenditures are fueling the growth of the enzyme replacement therapy market.
Product approvals have become a prominent trend gaining traction in the enzyme replacement therapy market. Various enzyme replacement therapy medications introduced by major players are securing approvals in the market. For example, in February 2023, Lamzede (velmanase alfa) received approval from the Food and Drug Administration, a US-based federal agency of the Department of Health. Lamzede is the first enzyme replacement therapy sanctioned in the United States for treating non-central neurological indications of alpha-mannosidosis, a rare genetic disorder characterized by the absence of the alpha-mannosidase enzyme. Administered as a 10mg injection once a week, Lamzede aids patients in regaining normal cellular function by mimicking the action of the alpha-mannosidase enzyme, thereby restoring healthy cellular functioning.
Major companies in the enzyme replacement therapy (ERT) market are strategically focusing on innovative treatment products and obtaining approvals for Pompe disease therapy to address the unmet medical needs of patients with late-onset Pompe disease. In response to the pressing medical needs for late-onset Pompe disease patients in the European Union, Amicus Therapeutics, a US-based biotechnology company, secured approval and launched a new Pompe disease therapy in June 2023. The treatment, comprising Pombiliti (cipaglucosidase alfa) and Opfolda (miglustat), serves as an enzyme replacement therapy for adults with late-onset Pompe disease, supported by clinical data and driven by potential market opportunities and regulatory backing.
In July 2024, Crosswalk Therapeutics Inc., a biotechnology company based in the United States, acquired Codexis Inc. for an undisclosed sum. This acquisition allows Crosswalk Therapeutics to broaden its expertise, integrating Codexis’s advanced enzyme engineering technology into its offerings. Codexis Inc. is a U.S.-based company specializing in enzyme engineering.
Major companies operating in the enzyme replacement therapy market include Biomarin Pharmaceutical Inc., Leadiant Biosciences Inc., Pfizer Inc., Sanofi S.A., AbbVie Inc., Johnson & Johnson Services Inc., Alexion Pharmaceuticals Inc., Recordati Rare Diseases Inc., Sangamo Therapeutics Inc., JCR Pharmaceuticals Co. Ltd., Horizon Pharma Public Limited Company, Protalix Biotherapeutics Ltd., Amicus Therapeutics Inc., AstraZeneca plc, Novartis AG, Roche Holding AG, GlaxoSmithKline plc, Merck & Co. Inc., Eli Lilly and Company, Bristol-Myers Squibb Company, Retrophin Inc., Abeona Therapeutics Inc., Orchard Therapeutics plc, Ultragenyx Pharmaceutical Inc.
North America was the largest region in the enzyme replacement therapy market in 2024. Asia-Pacific is expected to be the fastest-growing region in the global enzyme replacement therapy market report during the forecast period. The regions covered in the enzyme replacement therapy market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the enzyme replacement therapy market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
Enzyme replacement therapy (ERT) refers to a sort of medical treatment in which patients with chronic disorders brought on by insufficient or failing enzymes are given alternative enzymes. The body can complete the processes inhibited by the deficit by getting enzyme replacements. It is particularly effective at returning urinary GAG levels to normal and boosting liver and spleen development.
The main types of enzymes used in enzyme replacement therapy include agalsidase alfa, agalsidase beta, galsulfase, other enzyme types that are used in gaucher disease, pompe disease, fabry disease, others. Agalsidase alfa refers to a recombinant human alpha-galactosidase that is used in the treatment of fabry’s disease as an enzyme replacement therapy. It has a long half-life and a broad therapeutic spectrum. Patients should be advised about the possibility of infusion-related symptoms and sensitivity. Agalsidase alfa is beneficial to enzyme replacement therapy because it aids in the treatment of Fabry disease. The enzyme replacement therapy is used by hospitals, infusion centers and others that is administered through oral and parenteral route.
The enzyme replacement therapy market research report is one of a series of new reports that provides enzyme replacement therapy market statistics, including enzyme replacement therapy industry global market size, regional shares, competitors with enzyme replacement therapy market share, detailed enzyme replacement therapy market segments, market trends, and opportunities, and any further data you may need to thrive in the enzyme replacement therapy industry. This enzyme replacement therapy market research report deliver a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.
The enzyme replacement therapy market includes revenues earned by entities by providing Sebelipase alfa, Elosulfase alfa, Idursulfase, AL glucosidase alfa and Alpha1-Proteinase inhibitor enzyme replacement therapies. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 3-5 business days.
The enzyme replacement therapy market size is expected to see strong growth in the next few years. It will grow to $17.81 billion in 2029 at a compound annual growth rate (CAGR) of 9.3%. The growth in the forecast period can be attributed to increasing patient access to healthcare, tailored therapies and personalized medicine, regulatory landscape changes, and growing patient population awareness. Major trends in the forecast period include digital health integration, focus on patient-centric solutions, emerging biomarker research, and precision medicine approach.
The increasing prevalence of rare, chronic, and inherited disorders is anticipated to drive the growth of the enzyme replacement therapy market in the coming years. Chronic disease is defined as an illness lasting three months or more that may worsen over time. Such diseases are more prevalent among the elderly and are typically manageable but not curable. For example, in July 2024, the American Lung Association, a U.S.-based non-profit organization, reported that in 2022, 44.2 million Americans (or 13.5% of the population) had been diagnosed with asthma by a healthcare provider, up from 12.9% in 2021. Thus, the rising prevalence of rare, chronic, and inherited disorders is expected to fuel growth in the enzyme replacement therapy market.
The increase in healthcare spending is projected to drive the growth of the enzyme replacement therapy (ERT) market in the future. Healthcare expenditure represents the total funds allocated to healthcare services, goods, and activities within a healthcare system or economy over a given period. This spending supports ERT due to the highly specialized and often costly nature of these treatments, covering research, development, clinical trials, and testing. For example, in December 2022, the U.S.-based federal agency Centers for Medicare & Medicaid Services reported that U.S. healthcare spending grew by 4.1% to reach $4.5 trillion in 2022, outpacing the 3.2% growth in 2021. Thus, rising healthcare expenditures are fueling the growth of the enzyme replacement therapy market.
Product approvals have become a prominent trend gaining traction in the enzyme replacement therapy market. Various enzyme replacement therapy medications introduced by major players are securing approvals in the market. For example, in February 2023, Lamzede (velmanase alfa) received approval from the Food and Drug Administration, a US-based federal agency of the Department of Health. Lamzede is the first enzyme replacement therapy sanctioned in the United States for treating non-central neurological indications of alpha-mannosidosis, a rare genetic disorder characterized by the absence of the alpha-mannosidase enzyme. Administered as a 10mg injection once a week, Lamzede aids patients in regaining normal cellular function by mimicking the action of the alpha-mannosidase enzyme, thereby restoring healthy cellular functioning.
Major companies in the enzyme replacement therapy (ERT) market are strategically focusing on innovative treatment products and obtaining approvals for Pompe disease therapy to address the unmet medical needs of patients with late-onset Pompe disease. In response to the pressing medical needs for late-onset Pompe disease patients in the European Union, Amicus Therapeutics, a US-based biotechnology company, secured approval and launched a new Pompe disease therapy in June 2023. The treatment, comprising Pombiliti (cipaglucosidase alfa) and Opfolda (miglustat), serves as an enzyme replacement therapy for adults with late-onset Pompe disease, supported by clinical data and driven by potential market opportunities and regulatory backing.
In July 2024, Crosswalk Therapeutics Inc., a biotechnology company based in the United States, acquired Codexis Inc. for an undisclosed sum. This acquisition allows Crosswalk Therapeutics to broaden its expertise, integrating Codexis’s advanced enzyme engineering technology into its offerings. Codexis Inc. is a U.S.-based company specializing in enzyme engineering.
Major companies operating in the enzyme replacement therapy market include Biomarin Pharmaceutical Inc., Leadiant Biosciences Inc., Pfizer Inc., Sanofi S.A., AbbVie Inc., Johnson & Johnson Services Inc., Alexion Pharmaceuticals Inc., Recordati Rare Diseases Inc., Sangamo Therapeutics Inc., JCR Pharmaceuticals Co. Ltd., Horizon Pharma Public Limited Company, Protalix Biotherapeutics Ltd., Amicus Therapeutics Inc., AstraZeneca plc, Novartis AG, Roche Holding AG, GlaxoSmithKline plc, Merck & Co. Inc., Eli Lilly and Company, Bristol-Myers Squibb Company, Retrophin Inc., Abeona Therapeutics Inc., Orchard Therapeutics plc, Ultragenyx Pharmaceutical Inc.
North America was the largest region in the enzyme replacement therapy market in 2024. Asia-Pacific is expected to be the fastest-growing region in the global enzyme replacement therapy market report during the forecast period. The regions covered in the enzyme replacement therapy market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the enzyme replacement therapy market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
Enzyme replacement therapy (ERT) refers to a sort of medical treatment in which patients with chronic disorders brought on by insufficient or failing enzymes are given alternative enzymes. The body can complete the processes inhibited by the deficit by getting enzyme replacements. It is particularly effective at returning urinary GAG levels to normal and boosting liver and spleen development.
The main types of enzymes used in enzyme replacement therapy include agalsidase alfa, agalsidase beta, galsulfase, other enzyme types that are used in gaucher disease, pompe disease, fabry disease, others. Agalsidase alfa refers to a recombinant human alpha-galactosidase that is used in the treatment of fabry’s disease as an enzyme replacement therapy. It has a long half-life and a broad therapeutic spectrum. Patients should be advised about the possibility of infusion-related symptoms and sensitivity. Agalsidase alfa is beneficial to enzyme replacement therapy because it aids in the treatment of Fabry disease. The enzyme replacement therapy is used by hospitals, infusion centers and others that is administered through oral and parenteral route.
The enzyme replacement therapy market research report is one of a series of new reports that provides enzyme replacement therapy market statistics, including enzyme replacement therapy industry global market size, regional shares, competitors with enzyme replacement therapy market share, detailed enzyme replacement therapy market segments, market trends, and opportunities, and any further data you may need to thrive in the enzyme replacement therapy industry. This enzyme replacement therapy market research report deliver a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.
The enzyme replacement therapy market includes revenues earned by entities by providing Sebelipase alfa, Elosulfase alfa, Idursulfase, AL glucosidase alfa and Alpha1-Proteinase inhibitor enzyme replacement therapies. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 3-5 business days.
Table of Contents
1. Executive Summary2. Enzyme Replacement Therapy Market Characteristics3. Enzyme Replacement Therapy Market Trends and Strategies4. Enzyme Replacement Therapy Market - Macro Economic Scenario including the impact of Interest Rates, Inflation, Geopolitics and Covid and Recovery on the Market32. Global Enzyme Replacement Therapy Market Competitive Benchmarking and Dashboard33. Key Mergers and Acquisitions in the Enzyme Replacement Therapy Market34. Recent Developments in the Enzyme Replacement Therapy Market
5. Global Enzyme Replacement Therapy Growth Analysis and Strategic Analysis Framework
6. Enzyme Replacement Therapy Market Segmentation
7. Enzyme Replacement Therapy Market Regional and Country Analysis
8. Asia-Pacific Enzyme Replacement Therapy Market
9. China Enzyme Replacement Therapy Market
10. India Enzyme Replacement Therapy Market
11. Japan Enzyme Replacement Therapy Market
12. Australia Enzyme Replacement Therapy Market
13. Indonesia Enzyme Replacement Therapy Market
14. South Korea Enzyme Replacement Therapy Market
15. Western Europe Enzyme Replacement Therapy Market
16. UK Enzyme Replacement Therapy Market
17. Germany Enzyme Replacement Therapy Market
18. France Enzyme Replacement Therapy Market
19. Italy Enzyme Replacement Therapy Market
20. Spain Enzyme Replacement Therapy Market
21. Eastern Europe Enzyme Replacement Therapy Market
22. Russia Enzyme Replacement Therapy Market
23. North America Enzyme Replacement Therapy Market
24. USA Enzyme Replacement Therapy Market
25. Canada Enzyme Replacement Therapy Market
26. South America Enzyme Replacement Therapy Market
27. Brazil Enzyme Replacement Therapy Market
28. Middle East Enzyme Replacement Therapy Market
29. Africa Enzyme Replacement Therapy Market
30. Enzyme Replacement Therapy Market Competitive Landscape and Company Profiles
31. Enzyme Replacement Therapy Market Other Major and Innovative Companies
35. Enzyme Replacement Therapy Market High Potential Countries, Segments and Strategies
36. Appendix
Executive Summary
Enzyme Replacement Therapy Global Market Report 2025 provides strategists, marketers and senior management with the critical information they need to assess the market.This report focuses on enzyme replacement therapy market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
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Description
Where is the largest and fastest growing market for enzyme replacement therapy? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward? The enzyme replacement therapy market global report answers all these questions and many more.The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.
- The market characteristics section of the report defines and explains the market.
- The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
- The forecasts are made after considering the major factors currently impacting the market. These include:
- The forecasts are made after considering the major factors currently impacting the market. These include the Russia-Ukraine war, rising inflation, higher interest rates, and the legacy of the COVID-19 pandemic.
- Market segmentations break down the market into sub markets.
- The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth. It covers the growth trajectory of COVID-19 for all regions, key developed countries and major emerging markets.
- The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
- The trends and strategies section analyses the shape of the market as it emerges from the crisis and suggests how companies can grow as the market recovers.
Scope
Markets Covered:
1) By Enzyme Type: Agalsidase Alfa; Agalsidase Beta; Galsulfase; Other Enzyme Types2) By Route of Administration: Oral; Parenteral
3) By Application: Gaucher Disease; Pompe Disease; Fabry Disease; Other Applications
4) By End-Users: Hospitals; Infusion Centers; Other End-Users
Subsegments:
1) By Agalsidase Alfa: Fabry Disease Treatment2) By Agalsidase Beta: Fabry Disease Treatment
3) By Galsulfase: Mucopolysaccharidosis VI (MPS VI) Treatment
4) By Other Enzyme Types: Alglucosidase Alfa; Idursulfase; Velaglucerase Alfa
Key Companies Mentioned: Biomarin Pharmaceutical Inc.; Leadiant Biosciences Inc.; Pfizer Inc.; Sanofi S.A.; AbbVie Inc.
Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Russia; South Korea; UK; USA; Canada; Italy; Spain
Regions: Asia-Pacific; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
Time Series: Five years historic and ten years forecast.
Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita.
Data Segmentation: Country and regional historic and forecast data, market share of competitors, market segments.
Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.
Delivery Format: PDF, Word and Excel Data Dashboard.
Companies Mentioned
- Biomarin Pharmaceutical Inc.
- Leadiant Biosciences Inc.
- Pfizer Inc.
- Sanofi S.A.
- AbbVie Inc.
- Johnson & Johnson Services Inc.
- Alexion Pharmaceuticals Inc.
- Recordati Rare Diseases Inc.
- Sangamo Therapeutics Inc.
- JCR Pharmaceuticals Co. Ltd.
- Horizon Pharma Public Limited Company
- Protalix Biotherapeutics Ltd.
- Amicus Therapeutics Inc.
- AstraZeneca plc
- Novartis AG
- Roche Holding AG
- GlaxoSmithKline plc
- Merck & Co. Inc.
- Eli Lilly and Company
- Bristol-Myers Squibb Company
- Retrophin Inc.
- Abeona Therapeutics Inc.
- Orchard Therapeutics plc
- Ultragenyx Pharmaceutical Inc.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | February 2025 |
| Forecast Period | 2025 - 2029 |
| Estimated Market Value ( USD | $ 12.48 Billion |
| Forecasted Market Value ( USD | $ 17.81 Billion |
| Compound Annual Growth Rate | 9.3% |
| Regions Covered | Global |
| No. of Companies Mentioned | 24 |
