The Worldwide Enzyme Replacement Therapy Industry is Expected to Reach $15 Billion by 2028

DUBLIN, Sept. 16, 2022 /PRNewswire/ -- The "Enzyme Replacement Therapy Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Enzyme Type, Therapeutic Conditions, Route of Administration, and End User" report has been added to  ResearchAndMarkets.com's offering.

The enzyme replacement therapy market is expected to grow from US$ 9,673.39 million in 2021 to US$ 15,184.70 million by 2028; it is estimated to grow at a CAGR of 6.8% from 2022 to 2028.

Companies Mentioned

• Sanofi
• BioMarin Pharmaceutical Inc.
• Takeda Pharmaceutical Company Limited
• AbbVie Inc.
• Janssen Pharmaceuticals (Johnson & Johnson Services, Inc.)
• Alexion Pharmaceuticals, Inc (AstraZeneca)
• Amicus Therapeutics
• Recordati S.p.A.
• CHIESI Farmaceutici S.p.A.
• Pfizer Inc.

The report highlights trends prevailing in the market and factors driving the market growth. The growth of the global enzyme replacement therapy market is attributed to the rising prevalence of lysosomal storage diseases (LSDs) and rapid regulatory approval with other marketing benefits for drug with orphan drug designation. However, cutthroat competition among market players hinders the overall market growth.

Enzyme replacement therapy (ERT) is performed to treat congenital enzyme deficiencies by using enzyme or protein having enzymatic activity. Animal, human, and recombinant engineered enzymes are a few sources of enzyme required for treatment. The therapy is generally applied in rare and lysosomal storage diseases, including Pompe's disease, Fabry's disease, Gaucher's disease, Tay-Sachs disease, and Hurler syndrome. The most common ERT method is IV infusions, in which the replacement enzyme is administered directly into the bloodstream through a controlled drip of fluids.

European Medicines Agency (EMA) approves orphan drugs. For instance, according to EMA, if a product that has an orphan drug designation receives EMA marketing approval for the indication for which it has such designation, the product is entitled to orphan market exclusivity. It means the EMA may not approve any other application to market a similar drug for the same indication for 10 years.

Furthermore, in March 2016, the EMA launched the Priority Medicines ("PRIME") scheme to facilitate the development of product candidates in indications, often rare, for which few or no therapies currently exist. The PRIME scheme also provides several benefits to drug producers; once a candidate medicine is selected for PRIME. Below mentioned are the benefits provided by the EMA:- Appoint a rapporteur from the Committee for Medicinal Products for Human Use (CHMP) and help to build knowledge ahead of a marketing-authorization application- Early and proactive regulatory dialogue with the EMA to guide the overall development plan and regulatory strategy;- Provide scientific advice at key development milestones, involving additional stakeholders such as health-technology-assessment bodies, to facilitate quicker access for patients to the new medicine;- Confirm potential for accelerated assessment at the time of an application for marketing authorization.

Therefore, owing to the benefit and incentives associated with drugs designated as orphan drugs, key players operating in the market are putting efforts into developing drugs for orphan diseases. For instance, Amicus Therapeutics, Inc. recently obtained an orphan medicinal product designation in Europe from the EMA for Galafold to treat Fabry disease and the combination product, ATB200/AT2221, for treating Pompe disease. Additionally, in September 2020, Amicus Therapeutics, Inc. was granted PRIME designation for AT-GTX-501, therapy for CLN6 Batten disease.

Thus, the rapid regulatory approval with other marketing benefits for the drug with orphan drug designation is driving the market growth.

Impact of COVID-19 Pandemic on Global Enzyme Replacement Therapy Market

The COVID-19 pandemic significantly affected the global healthcare system. To combat the spread of SAR-CoV-2 virus, governments imposed stringent policies to prevent and reduce the infection and mortality rates. According to the Department of Emergency Medicine, in many cities across various countries in North America, emergency department (ED) visits decreased by ~40% in 2020. Moreover, outpatient appointments and elective treatments were postponed or replaced by telemedicine practices.

Key Topics Covered:

1. Introduction

2. Enzyme Replacement Therapy Market- Key Takeaways

3. Research Methodology

4. Global Enzyme Replacement Therapy Market - Market Landscape
4.1 Overview
4.2 PEST Analysis
4.2.1 North America - PEST Analysis
4.2.2 Europe - PEST Analysis
4.2.3 Asia Pacific - PEST Analysis
4.2.4 Middle East & Africa - PEST Analysis
4.2.5 South & Central America - PEST Analysis
4.3 Expert Opinion

5. Enzyme Replacement Therapy Market - Key Market Dynamics
5.1 Market Drivers
5.1.1 Rising Prevalence of Lysosomal Storage Diseases (LSDs)
5.1.2 Rapid Regulatory Approval with Other Benefits for Drug with Orphan Drug Designation
5.2 Market Restraints
5.2.1 Cutthroat Competition among Market Players
5.3 Market Opportunities
5.3.1 Increasing Partnerships and Collaborations to Synergize the Business
5.4 Future Trends
5.4.1 Innovative Developments in ERT
5.5 Impact Analysis

6. Enzyme Replacement Therapy Market- Global Analysis
6.1 Global Enzyme Replacement Therapy Market Revenue Forecast and Analysis
6.1.1 Global Enzyme Replacement Therapy Market Revenue Forecast and Analysis
6.1.2 Global Enzyme Replacement Therapy Market - Market Potential Analysis, By Region
6.2 Market Share Analysis of Key Players in Enzyme Replacement Therapy Market
6.2.1 Company Analysis
6.2.2 Growth Strategy Analysis
6.2.3 Performance of Key Players
6.2.3.1 Sanofi S.A.
6.2.3.2 BioMarin Pharmaceutical Inc.

7. Global Enzyme Replacement Therapy Market Revenue and Forecasts To 2028- by Enzyme Type

8. Enzyme Replacement Therapy Market Analysis And Forecasts To 2028 - By Therapeutic Conditions

9. Enzyme Replacement Therapy Market Analysis And Forecasts To 2028 - By Route of Administration

10. Global Enzyme Replacement Therapy Market Analysis- By End User

11. Enzyme Replacement Therapy Market Revenue and Forecasts to 2028 - Geographical Analysis

12. Impact Of COVID-19 Pandemic on Enzyme Replacement Therapy Market
12.1 North America: Impact Assessment of COVID-19 Pandemic
12.2 Europe: Impact Assessment of COVID-19 Pandemic
12.3 Asia-Pacific: Impact Assessment of COVID-19 Pandemic
12.4 South and Central America: Impact Assessment of COVID-19 Pandemic
12.5 Middle East and Africa: Impact Assessment of COVID-19 Pandemic

13. Enzyme Replacement Therapy Market-Industry Landscape
13.1 Overview
13.2 Growth Strategies in the Enzyme Replacement Therapy Market
13.3 Inorganic Growth Strategies
13.3.1 Overview
13.4 Organic Growth Strategies
13.4.1 Overview

14. Company Profiles

15. Appendix

For more information about this report visit https://www.researchandmarkets.com/r/8tzkjn

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