According to recent medical studies, one in every seven thousand childbirths is affected by lysosomal storage disease. This number is on the verge of increasing year by year, especially in underdeveloped countries where awareness and medical facilities regarding these diseases are found to be very scarce. This has created a conducive environment for the enzyme replacement therapy market with a staggering valuation of US$ 10,707.6 million expected as of 2024.
ERT is also used in the treatment of various rare diseases such as Gaucher disease and Fabry disease. Advancements in medicare technology and the proliferation of modern and sophisticated facilities in healthcare organizations, both public as well as private, have further led to the expansion of this market. The industry is anticipated to grow at a healthy CAGR of 6.60% from 2024 to 2034.
Government initiatives to make people more aware and lenient reimbursement policies are also responsible for the growth of the market. The market is slated to reach a valuation of US$ 20,289.1 million by the end of 2034.
However, increased costs and unavailability of skilled workforce and healthcare facilities are hindering market growth in some parts of the world. Coupled with a lack of awareness and concerns regarding the efficacy of these treatments, the market has definite obstacles to face in the forecast period.
| Attributes | Details |
|---|---|
| Market Value for 2024 | US$ 10,707.6 million |
| Projected Market Value for 2034 | US$ 20,289.1 million |
| Value-based CAGR of the Market for 2024 to 2034 | 6.60% |
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ERT is used to treat various rare diseases such as Fabry Disease, Gaucher Disease, Mucopolysaccharidosis, etc. Among these, the Mucopolysaccharidosis segment is estimated to hold the largest market share of 24.10% in 2024.
| Attributes | Details |
|---|---|
| Therapeutic Condition | Mucopolysaccharidosis |
| Market Share (2024) | 24.10% |
ERTs can be administered through two major routes which are oral and injectable. Among these, the injectable ERT is predicted to hold a market share of 86.90% in 2024.
| Attributes | Details |
|---|---|
| Route of Administration | Injectable |
| Market Share (2024) | 86.90% |
| Countries | CAGR (2024 to 2034) |
|---|---|
| Japan | 8.00% |
| China | 7.30% |
| Canada | 6.90% |
| Australia and New Zealand | 6.30% |
| Brazil | 6.00% |
The enzyme replacement therapy market in Japan is a promising one. It is slated to grow at a CAGR of 8.00% through 2034.
Japan is currently dealing with a growing aging population. As of 2024, one in every four people living in Japan is above the age of sixty. This has created a conducive environment for ERTs as this demographic is more susceptible to rare diseases.
Responding to these demands, Japanese healthcare companies are also investing billions of dollars in curating novel technologies and therapies to tackle these fatal diseases. For instance, in March 2022, Sanofi's Xenpozyme gained approval in Japan, marking a historic milestone as the inaugural treatment for ASMD.
China is a lucrative country in this market. The enzyme replacement therapy market is inclined to grow at a CAGR of 7.30% through 2034 in the country.
The Chinese government, in the last few years, has been announcing a multitude of schemes and policies to strengthen its medical infrastructure. The recent pandemic has also put a lot of pressure on the Chinese healthcare sector.
All these factors have led to the adoption of best-in-class medical facilities in the country. This improved medical infrastructure has led to the expansion of the ERT market as more people become aware of rare diseases for which this treatment is used.
The future of the Canada ERT market also looks very bright. The market is slated to grow at a CAGR of 6.90% through 2034 in Canada.
The presence of numerous medical institutes and government support in the form of grants and subsidies to the same have proved to be a boon for Canada’s healthcare sector. This has also benefitted ERTs as medicare research institutes have come up with top-tier methodologies for treating deadly diseases in the country.
The Australia and New Zealand ERT market is slated to grow at a CAGR of 6.30% from 2024 to 2034.
Although the incidence of LSDs in Australia and New Zealand is very scarce, both countries are conducting continuous research and development in these fields. The purpose is to entirely terminate these diseases from their population.
Players involved in the ERT market are pouring billions of dollars into making therapies affordable for the common public. For instance, in April 2024, Inozyme Pharma initiated the Phase Ib ENERGY-1 trial, dosing the first infant with INZ-701 enzyme therapy for ENPP1 deficiency, aiming to assess safety and efficacy.
The market in Brazil is very likely to flourish in the coming years. It is slated to grow at a CAGR of 6.00% through 2034.
Lysosomal storage disorders are gradually picking up pace in Brazil. To mitigate these diseases altogether Brazilian companies are collaborating with international partners. They are also investing in research and developing innovative therapies to address lysosomal storage disorders in the country.
Principal Consultant
The enzyme replacement therapy market is a very limited one as the disease mortality rate is minuscule. This is why very few companies exist in the market, most of which have already established themselves as key players.
The competition is also not that intense as top players hold the majority share of the market. Besides this, these companies are found collaborating with research institutions for more effective and affordable therapies.
Recent Developments in the Enzyme Replacement Therapy Market
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The market is expected to be worth US$ 10,707.6 million in 2024.
The enzyme replacement therapy market is expected to reach US$ 20,289.1 million by 2034.
The market is in line to grow at a CAGR of 6.60% from 2024 to 2034.
BioMarin Pharmaceutical Inc., Amicus Therapeutics, Sanofi Genzyme, Alexion Pharmaceuticals, and Ultragenyx Pharmaceutical Inc., are some of the major players in the market.
The market valuation in 2023 was US$ 10,011.1 million.
1. Executive Summary
1.1. Global Market Outlook
1.2. Demand-side Trends
1.3. Supply-side Trends
1.4. Technology Roadmap Analysis
1.5. Analysis and Recommendations
2. Market Overview
2.1. Market Coverage / Taxonomy
2.2. Market Definition / Scope / Limitations
3. Market Background
3.1. Market Dynamics
3.1.1. Drivers
3.1.2. Restraints
3.1.3. Opportunity
3.1.4. Trends
3.2. Scenario Forecast
3.2.1. Demand in Optimistic Scenario
3.2.2. Demand in Likely Scenario
3.2.3. Demand in Conservative Scenario
3.3. Opportunity Map Analysis
3.4. Investment Feasibility Matrix
3.5. PESTLE and Porter’s Analysis
3.6. Regulatory Landscape
3.6.1. By Key Regions
3.6.2. By Key Countries
3.7. Regional Parent Market Outlook
4. Global Market Analysis 2019 to 2023 and Forecast, 2024 to 2034
4.1. Historical Market Size Value (US$ Million) Analysis, 2019 to 2023
4.2. Current and Future Market Size Value (US$ Million) Projections, 2024 to 2034
4.2.1. Y-o-Y Growth Trend Analysis
4.2.2. Absolute $ Opportunity Analysis
5. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Therapeutic Condition
5.1. Introduction / Key Findings
5.2. Historical Market Size Value (US$ Million) Analysis By Therapeutic Condition, 2019 to 2023
5.3. Current and Future Market Size Value (US$ Million) Analysis and Forecast By Therapeutic Condition, 2024 to 2034
5.3.1. Fabry Disease
5.3.2. Gaucher Disease
5.3.3. Mucopolysaccharidosis
5.3.3.1. MPS I
5.3.3.2. MPS II
5.3.3.3. MPS IVA
5.3.3.4. MPS VI
5.3.3.5. MPS VII
5.3.4. Pompe Disease
5.3.5. Lysosomal Acid Lipase Deficiency
5.3.6. Others
5.4. Y-o-Y Growth Trend Analysis By Therapeutic Condition, 2019 to 2023
5.5. Absolute $ Opportunity Analysis By Therapeutic Condition, 2024 to 2034
6. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Route of Administration
6.1. Introduction / Key Findings
6.2. Historical Market Size Value (US$ Million) Analysis By Route of Administration, 2019 to 2023
6.3. Current and Future Market Size Value (US$ Million) Analysis and Forecast By Route of Administration, 2024 to 2034
6.3.1. Oral Enzyme Replacement Therapy
6.3.2. Injectable Enzyme Replacement Therapy
6.4. Y-o-Y Growth Trend Analysis By Route of Administration, 2019 to 2023
6.5. Absolute $ Opportunity Analysis By Route of Administration, 2024 to 2034
7. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Pharmacy Type
7.1. Introduction / Key Findings
7.2. Historical Market Size Value (US$ Million) Analysis By Pharmacy Type, 2019 to 2023
7.3. Current and Future Market Size Value (US$ Million) Analysis and Forecast By Pharmacy Type, 2024 to 2034
7.3.1. Hospital Pharmacies
7.3.2. Specialty Treatment Pharmacies
7.3.3. Retail Pharmacies
7.4. Y-o-Y Growth Trend Analysis By Pharmacy Type, 2019 to 2023
7.5. Absolute $ Opportunity Analysis By Pharmacy Type, 2024 to 2034
8. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Region
8.1. Introduction
8.2. Historical Market Size Value (US$ Million) Analysis By Region, 2019 to 2023
8.3. Current Market Size Value (US$ Million) Analysis and Forecast By Region, 2024 to 2034
8.3.1. North America
8.3.2. Latin America
8.3.3. Western Europe
8.3.4. Eastern Europe
8.3.5. South Asia and Pacific
8.3.6. East Asia
8.3.7. Middle East and Africa
8.4. Market Attractiveness Analysis By Region
9. North America Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
9.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2019 to 2023
9.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2024 to 2034
9.2.1. By Country
9.2.1.1. USA
9.2.1.2. Canada
9.2.2. By Therapeutic Condition
9.2.3. By Route of Administration
9.2.4. By Pharmacy Type
9.3. Market Attractiveness Analysis
9.3.1. By Country
9.3.2. By Therapeutic Condition
9.3.3. By Route of Administration
9.3.4. By Pharmacy Type
9.4. Key Takeaways
10. Latin America Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
10.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2019 to 2023
10.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2024 to 2034
10.2.1. By Country
10.2.1.1. Brazil
10.2.1.2. Mexico
10.2.1.3. Rest of Latin America
10.2.2. By Therapeutic Condition
10.2.3. By Route of Administration
10.2.4. By Pharmacy Type
10.3. Market Attractiveness Analysis
10.3.1. By Country
10.3.2. By Therapeutic Condition
10.3.3. By Route of Administration
10.3.4. By Pharmacy Type
10.4. Key Takeaways
11. Western Europe Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
11.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2019 to 2023
11.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2024 to 2034
11.2.1. By Country
11.2.1.1. Germany
11.2.1.2. UK
11.2.1.3. France
11.2.1.4. Spain
11.2.1.5. Italy
11.2.1.6. Rest of Western Europe
11.2.2. By Therapeutic Condition
11.2.3. By Route of Administration
11.2.4. By Pharmacy Type
11.3. Market Attractiveness Analysis
11.3.1. By Country
11.3.2. By Therapeutic Condition
11.3.3. By Route of Administration
11.3.4. By Pharmacy Type
11.4. Key Takeaways
12. Eastern Europe Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
12.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2019 to 2023
12.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2024 to 2034
12.2.1. By Country
12.2.1.1. Poland
12.2.1.2. Russia
12.2.1.3. Czech Republic
12.2.1.4. Romania
12.2.1.5. Rest of Eastern Europe
12.2.2. By Therapeutic Condition
12.2.3. By Route of Administration
12.2.4. By Pharmacy Type
12.3. Market Attractiveness Analysis
12.3.1. By Country
12.3.2. By Therapeutic Condition
12.3.3. By Route of Administration
12.3.4. By Pharmacy Type
12.4. Key Takeaways
13. South Asia and Pacific Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
13.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2019 to 2023
13.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2024 to 2034
13.2.1. By Country
13.2.1.1. India
13.2.1.2. Bangladesh
13.2.1.3. Australia
13.2.1.4. New Zealand
13.2.1.5. Rest of South Asia and Pacific
13.2.2. By Therapeutic Condition
13.2.3. By Route of Administration
13.2.4. By Pharmacy Type
13.3. Market Attractiveness Analysis
13.3.1. By Country
13.3.2. By Therapeutic Condition
13.3.3. By Route of Administration
13.3.4. By Pharmacy Type
13.4. Key Takeaways
14. East Asia Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
14.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2019 to 2023
14.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2024 to 2034
14.2.1. By Country
14.2.1.1. China
14.2.1.2. Japan
14.2.1.3. South Korea
14.2.2. By Therapeutic Condition
14.2.3. By Route of Administration
14.2.4. By Pharmacy Type
14.3. Market Attractiveness Analysis
14.3.1. By Country
14.3.2. By Therapeutic Condition
14.3.3. By Route of Administration
14.3.4. By Pharmacy Type
14.4. Key Takeaways
15. Middle East and Africa Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country
15.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2019 to 2023
15.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2024 to 2034
15.2.1. By Country
15.2.1.1. GCC Countries
15.2.1.2. South Africa
15.2.1.3. Israel
15.2.1.4. Rest of MEA
15.2.2. By Therapeutic Condition
15.2.3. By Route of Administration
15.2.4. By Pharmacy Type
15.3. Market Attractiveness Analysis
15.3.1. By Country
15.3.2. By Therapeutic Condition
15.3.3. By Route of Administration
15.3.4. By Pharmacy Type
15.4. Key Takeaways
16. Key Countries Market Analysis
16.1. USA
16.1.1. Pricing Analysis
16.1.2. Market Share Analysis, 2023
16.1.2.1. By Therapeutic Condition
16.1.2.2. By Route of Administration
16.1.2.3. By Pharmacy Type
16.2. Canada
16.2.1. Pricing Analysis
16.2.2. Market Share Analysis, 2023
16.2.2.1. By Therapeutic Condition
16.2.2.2. By Route of Administration
16.2.2.3. By Pharmacy Type
16.3. Brazil
16.3.1. Pricing Analysis
16.3.2. Market Share Analysis, 2023
16.3.2.1. By Therapeutic Condition
16.3.2.2. By Route of Administration
16.3.2.3. By Pharmacy Type
16.4. Mexico
16.4.1. Pricing Analysis
16.4.2. Market Share Analysis, 2023
16.4.2.1. By Therapeutic Condition
16.4.2.2. By Route of Administration
16.4.2.3. By Pharmacy Type
16.5. Germany
16.5.1. Pricing Analysis
16.5.2. Market Share Analysis, 2023
16.5.2.1. By Therapeutic Condition
16.5.2.2. By Route of Administration
16.5.2.3. By Pharmacy Type
16.6. UK
16.6.1. Pricing Analysis
16.6.2. Market Share Analysis, 2023
16.6.2.1. By Therapeutic Condition
16.6.2.2. By Route of Administration
16.6.2.3. By Pharmacy Type
16.7. France
16.7.1. Pricing Analysis
16.7.2. Market Share Analysis, 2023
16.7.2.1. By Therapeutic Condition
16.7.2.2. By Route of Administration
16.7.2.3. By Pharmacy Type
16.8. Spain
16.8.1. Pricing Analysis
16.8.2. Market Share Analysis, 2023
16.8.2.1. By Therapeutic Condition
16.8.2.2. By Route of Administration
16.8.2.3. By Pharmacy Type
16.9. Italy
16.9.1. Pricing Analysis
16.9.2. Market Share Analysis, 2023
16.9.2.1. By Therapeutic Condition
16.9.2.2. By Route of Administration
16.9.2.3. By Pharmacy Type
16.10. Poland
16.10.1. Pricing Analysis
16.10.2. Market Share Analysis, 2023
16.10.2.1. By Therapeutic Condition
16.10.2.2. By Route of Administration
16.10.2.3. By Pharmacy Type
16.11. Russia
16.11.1. Pricing Analysis
16.11.2. Market Share Analysis, 2023
16.11.2.1. By Therapeutic Condition
16.11.2.2. By Route of Administration
16.11.2.3. By Pharmacy Type
16.12. Czech Republic
16.12.1. Pricing Analysis
16.12.2. Market Share Analysis, 2023
16.12.2.1. By Therapeutic Condition
16.12.2.2. By Route of Administration
16.12.2.3. By Pharmacy Type
16.13. Romania
16.13.1. Pricing Analysis
16.13.2. Market Share Analysis, 2023
16.13.2.1. By Therapeutic Condition
16.13.2.2. By Route of Administration
16.13.2.3. By Pharmacy Type
16.14. India
16.14.1. Pricing Analysis
16.14.2. Market Share Analysis, 2023
16.14.2.1. By Therapeutic Condition
16.14.2.2. By Route of Administration
16.14.2.3. By Pharmacy Type
16.15. Bangladesh
16.15.1. Pricing Analysis
16.15.2. Market Share Analysis, 2023
16.15.2.1. By Therapeutic Condition
16.15.2.2. By Route of Administration
16.15.2.3. By Pharmacy Type
16.16. Australia
16.16.1. Pricing Analysis
16.16.2. Market Share Analysis, 2023
16.16.2.1. By Therapeutic Condition
16.16.2.2. By Route of Administration
16.16.2.3. By Pharmacy Type
16.17. New Zealand
16.17.1. Pricing Analysis
16.17.2. Market Share Analysis, 2023
16.17.2.1. By Therapeutic Condition
16.17.2.2. By Route of Administration
16.17.2.3. By Pharmacy Type
16.18. China
16.18.1. Pricing Analysis
16.18.2. Market Share Analysis, 2023
16.18.2.1. By Therapeutic Condition
16.18.2.2. By Route of Administration
16.18.2.3. By Pharmacy Type
16.19. Japan
16.19.1. Pricing Analysis
16.19.2. Market Share Analysis, 2023
16.19.2.1. By Therapeutic Condition
16.19.2.2. By Route of Administration
16.19.2.3. By Pharmacy Type
16.20. South Korea
16.20.1. Pricing Analysis
16.20.2. Market Share Analysis, 2023
16.20.2.1. By Therapeutic Condition
16.20.2.2. By Route of Administration
16.20.2.3. By Pharmacy Type
16.21. GCC Countries
16.21.1. Pricing Analysis
16.21.2. Market Share Analysis, 2023
16.21.2.1. By Therapeutic Condition
16.21.2.2. By Route of Administration
16.21.2.3. By Pharmacy Type
16.22. South Africa
16.22.1. Pricing Analysis
16.22.2. Market Share Analysis, 2023
16.22.2.1. By Therapeutic Condition
16.22.2.2. By Route of Administration
16.22.2.3. By Pharmacy Type
16.23. Israel
16.23.1. Pricing Analysis
16.23.2. Market Share Analysis, 2023
16.23.2.1. By Therapeutic Condition
16.23.2.2. By Route of Administration
16.23.2.3. By Pharmacy Type
17. Market Structure Analysis
17.1. Competition Dashboard
17.2. Competition Benchmarking
17.3. Market Share Analysis of Top Players
17.3.1. By Regional
17.3.2. By Therapeutic Condition
17.3.3. By Route of Administration
17.3.4. By Pharmacy Type
18. Competition Analysis
18.1. Competition Deep Dive
18.1.1. Sanofi S.A.
18.1.1.1. Overview
18.1.1.2. Product Portfolio
18.1.1.3. Profitability by Market Segments
18.1.1.4. Sales Footprint
18.1.1.5. Strategy Overview
18.1.1.5.1. Marketing Strategy
18.1.2. Shire plc.
18.1.2.1. Overview
18.1.2.2. Product Portfolio
18.1.2.3. Profitability by Market Segments
18.1.2.4. Sales Footprint
18.1.2.5. Strategy Overview
18.1.2.5.1. Marketing Strategy
18.1.3. Pfizer Inc.
18.1.3.1. Overview
18.1.3.2. Product Portfolio
18.1.3.3. Profitability by Market Segments
18.1.3.4. Sales Footprint
18.1.3.5. Strategy Overview
18.1.3.5.1. Marketing Strategy
18.1.4. Alexion Pharmaceuticals Inc.
18.1.4.1. Overview
18.1.4.2. Product Portfolio
18.1.4.3. Profitability by Market Segments
18.1.4.4. Sales Footprint
18.1.4.5. Strategy Overview
18.1.4.5.1. Marketing Strategy
18.1.5. BioMarin Pharmaceutical Inc.
18.1.5.1. Overview
18.1.5.2. Product Portfolio
18.1.5.3. Profitability by Market Segments
18.1.5.4. Sales Footprint
18.1.5.5. Strategy Overview
18.1.5.5.1. Marketing Strategy
18.1.6. Ultragenyx Pharmaceutical Inc.
18.1.6.1. Overview
18.1.6.2. Product Portfolio
18.1.6.3. Profitability by Market Segments
18.1.6.4. Sales Footprint
18.1.6.5. Strategy Overview
18.1.6.5.1. Marketing Strategy
18.1.7. Johnson & Johnson Services Inc.
18.1.7.1. Overview
18.1.7.2. Product Portfolio
18.1.7.3. Profitability by Market Segments
18.1.7.4. Sales Footprint
18.1.7.5. Strategy Overview
18.1.7.5.1. Marketing Strategy
18.1.8. Allergan plc.
18.1.8.1. Overview
18.1.8.2. Product Portfolio
18.1.8.3. Profitability by Market Segments
18.1.8.4. Sales Footprint
18.1.8.5. Strategy Overview
18.1.8.5.1. Marketing Strategy
18.1.9. Leadiant Biosciences Inc.
18.1.9.1. Overview
18.1.9.2. Product Portfolio
18.1.9.3. Profitability by Market Segments
18.1.9.4. Sales Footprint
18.1.9.5. Strategy Overview
18.1.9.5.1. Marketing Strategy
19. Assumptions & Acronyms Used
20. Research Methodology
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Enzyme Replacement Therapy Market
