Enzyme Replacement Therapy Market To Reach $17.26 Billion By 2030

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.  

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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.

Enzyme Replacement Therapy Market Segmentation

Grand View Research has segmented the global enzyme replacement therapy market based on product, therapeutic condition, route of administration, end-use, and region:

Enzyme Replacement Therapy Product Outlook (Revenue, USD Million, 2018 - 2030)

• Imiglucerase

• Agalsidase Beta

• Alglucosidase Alfa

• Taliglucerase

• Velaglucerase Alfa

• Pegademase

• Laronidase

• Pancreatic Enzymes

• Idursulfase

• Galsulfase

• Others

Enzyme Replacement Therapy Therapeutic Condition Outlook (Revenue, USD Million, 2018 - 2030)

• Gaucher Disease

• MPS

• SCID

• Pompe Disease

• Fabry Disease

• Others

Enzyme Replacement Therapy Route of Administration Condition Outlook (Revenue, USD Million, 2018 - 2030)

• Parenteral

• Oral

Enzyme Replacement Therapy End-use Outlook (Revenue, USD Million, 2018 - 2030)

• Infusion Centers

• Hospitals

• Others

Enzyme Replacement Therapy Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North America

  • U.S.

  • Canada

  • Mexico

• Europe

  • Germany

  • UK

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

• Asia Pacific

  • China

  • India

  • Japan

  • Australia

  • South Korea

  • Thailand

• Latin America

  • Brazil

  • Argentina

• Middle East & Africa

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait

List of Key Players in Enzyme Replacement Therapy Market

• Shire Plc; Sanofi S.A.

• Biomarin Pharmaceutical Inc.

• AbbVie

• Alexion Pharmaceuticals Inc.

• Allergan plc

• Horizon Pharma Public Limited Company

• Actelion (Janssen)

• Recordati Rare Diseases

• Protalix Biotherapeutics

• Amicus Therapeutics, Inc.