Enzyme Replacement Therapy Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028)

The Enzyme Replacement Therapy Market is segmented By Enzyme Type (Agalsidase Alfa, Agalsidase Beta, Galsulfase, AND Other Enzyme Types), Application, and Geography.

Enzyme Replacement Therapy Market Size

Market Snapshot
Study Period: 2018 - 2028
Fastest Growing Market: Asia Pacific
Largest Market: North America
CAGR: 7.7 %

Major Players


*Disclaimer: Major Players sorted in no particular order


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Enzyme Replacement Therapy Market Analysis

The enzyme replacement therapy market is expected to register a CAGR of 7.7% during the forecast period. The increasing burden of rare diseases and the initiatives taken by the government and others for rare diseases is expected to be a key contributor in the enzyme replacement therapy market growth. In 2018, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) granted the marketing authorization for Lamzede used for treating Alpha-mannosidosis in the European Union. According to the EURORDIS, currently, there are over 6000 rare diseases in existence, and around 30 million of the population in Europe has been affected by it. Furthermore, at least 80% of these rare disorders are chronic and life-threatening. Hence, the treatment of rare diseases is of utmost importance, thereby, boosting the enzyme replacement therapy market growth.

Enzyme Replacement Therapy Industry Segmentation

Enzyme replacement therapy is a type of medical treatment, in which an enzyme is replaced that is deficient or absent in the body. Most commonly, this procedure is done by giving the patient an intravenous (IV) infusion of a solution containing the enzyme. The enzyme replacement therapy market is segmented by enzyme type, application, and geography.

By Enzyme Type
Agalsidase Alfa
Agalsidase Beta
Other Enzyme Types
By Application
Gaucher disease
Pompe disease
Fabry Disease
Other Applications
North America
United States
United Kingdom
Rest of Europe
South Korea
Rest of Asia-Pacific
Middle East & Africa
South Africa
Rest of Middle East & Africa
South America
Rest of South America

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Enzyme Replacement Therapy Market Trends

This section covers the major market trends shaping the Enzyme Replacement Therapy Market according to our research experts:

Agalsidase Alfa Segment is Expected to Hold a Major Market Share in the Enzyme Replacement Therapy Market

Fabry is an X-linked rare disease that comes in the group of lysosomal storage disorders. Algasidase Alfa is a recombinant formulation of human a-galactosidase (AGAL), which is being used for the treatment of Fabry disease. Currently, this enzyme is manufactured by the Shire, a subsidiary of Takeda Pharmaceutical Company, with the brand name Replagal. To date, Replagal has received approval for marketing and production in Canda, the United Kingdom, and other parts of Europe.

Furthermore, according to the study published in JIMD, in 2019, Fabry disease is more prevalent in the population, which has been undergoing dialysis. Approximately 1.2% of the dialysis population has been reported with Fabry disease worldwide. Hence, the high prevalence of Fabry disease emerges the need for treatment, which is expected to boost up the enzyme replacement therapy market in the algasidase alfa segment.

Enzyme Replacement Therapy Market Trend.png

North America is Expected to Hold a Significant Share in the Market and Expected to do Same in the Forecast Period

North America expected to hold a major market share in the global artificial disc market owing to initiatives taken by the government and other organizations related to rare diseases and its treatment. For instance, the National Institutes of Health awarded approximately USD 31 million in grants during 2019 to the 20 teams, including five new groups of scientists, clinicians, patients, families, and patients, to study a wide range of rare diseases. Additional USD 7 million has been provided to the data coordinating centers to support the research efforts. Furthermore, the National Center for Advancing Translational Sciences (NCATS), one of the centers of the National Institute of Health is solely dedicated to the treatment of patients with rare diseases. Also, the higher prevalence of rare diseases is expected to propel the enzyme replacement therapy in North America. According to the Genetic and Rare Diseases Information Center (GARD), at present, there are around 25 to 35 million people in the United States that suffer from rare diseases.

Enzyme Replacement Therapy Market - Growth Rate by Region

Enzyme Replacement Therapy Industry Overview

Companies have been taking strategic initiatives related to enzyme replacement therapy to grow their presence in the market. For instance, recently Takeda exhibited its recent advances for lysosomal storage disorders at World Symposium in Orlando. Some of the key players who have been currently dominating the market are Genzyme Corporation, Pfizer Inc., Leadiant Biosciences, Inc., Biomarin Pharmaceutical Inc., Takeda Pharmaceutical Company Limited, Protalix Biotherapeutics, Amicus Therapeutics, and Johnson & Johnson Services Inc.

Enzyme Replacement Therapy Market Leaders

  1. Genzyme Corporation

  2. Pfizer Inc.

  3. Leadiant Biosciences Inc.

  4. Biomarin Pharmaceuticals Inc.

  5. Takeda pharmaceutical Company Ltd.

*Disclaimer: Major Players sorted in no particular order

Enzyme Replacement Therapy Market Concentration.png

Enzyme Replacement Therapy Market Report - Table of Contents


    1. 1.1 Study Deliverables

    2. 1.2 Study Assumptions

    3. 1.3 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Rising Prevalence of Rare Diseases

      2. 4.2.2 Increasing Government Initiatives for Rare Diseases

    3. 4.3 Market Restraints

      1. 4.3.1 High Cost of the Treatment

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry


    1. 5.1 By Enzyme Type

      1. 5.1.1 Agalsidase Alfa

      2. 5.1.2 Agalsidase Beta

      3. 5.1.3 Galsulfase

      4. 5.1.4 Other Enzyme Types

    2. 5.2 By Application

      1. 5.2.1 Gaucher disease

      2. 5.2.2 Pompe disease

      3. 5.2.3 Fabry Disease

      4. 5.2.4 Other Applications

    3. 5.3 Geography

      1. 5.3.1 North America

        1. United States

        2. Canada

        3. Mexico

      2. 5.3.2 Europe

        1. Germany

        2. United Kingdom

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.3.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.3.4 Middle East & Africa

        1. GCC

        2. South Africa

        3. Rest of Middle East & Africa

      5. 5.3.5 South America

        1. Brazil

        2. Argentina

        3. Rest of South America


    1. 6.1 Company Profiles

      1. 6.1.1 Amicus Therapeutics

      2. 6.1.2 Biomarin Pharmaceutical Inc.

      3. 6.1.3 Genzyme Corporation

      4. 6.1.4 Johnson & Johnson

      5. 6.1.5 Leadiant Biosciences Inc.

      6. 6.1.6 Pfizer Inc.

      7. 6.1.7 Protalix Biotherapeutics

      8. 6.1.8 Takeda Pharmaceutical Company Limited

    2. *List Not Exhaustive

**Competitive Landscape covers- Business Overview, Financials, Products and Strategies, and Recent Developments
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Enzyme Replacement Therapy Market Research FAQs

The Enzyme Replacement Therapy Market is studied from 2018 - 2028.

The Enzyme Replacement Therapy Market is growing at a CAGR of 7.7% over the next 5 years.

Asia Pacific is growing at the highest CAGR over 2018 - 2028.

North America holds highest share in 2021.

Genzyme Corporation, Pfizer Inc., Leadiant Biosciences Inc., Biomarin Pharmaceuticals Inc., Takeda pharmaceutical Company Ltd. are the major companies operating in Enzyme Replacement Therapy Market .

Enzyme Replacement Therapy Industry Report

Statistics for the 2023 Enzyme Replacement Therapy market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Enzyme Replacement Therapy analysis includes a market forecast outlook to 2028 and historical overview. Get a sample of this industry analysis as a free report PDF download.

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