Enzyme Replacement Therapy Market Size Projects USD 24.71 Bn by 2034

The enzyme replacement therapy market size is calculated at USD 11.34 billion in 2025 and is expected to reach around USD 24.71 billion by 2034, growing at a CAGR of 9.04% for the forecasted period.

Ottawa, Sept. 24, 2025 (GLOBE NEWSWIRE) -- The global enzyme replacement therapy market size was valued at USD 10.4 billion in 2024 and is predicted to hit around USD 24.71 billion by 2034, rising at a 9.04% CAGR, a study published by Towards Healthcare a sister firm of Precedence Research.

Because of increasing prevalence of rare genetic and metabolic disorders along with improving diagnostic tools, better regulatory support, and advances in biotechnology solutions, demand for enzyme replacement therapies is surging globally.

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Market Overview:

The market for Enzyme Replacement Therapy (ERT) is continuously growing, fuelled by the increasing recognition of the importance of enzyme replacement therapy for patients and health care professionals and payers treatment of conditions related to enzyme deficiency disorders and, specifically lysosomal storage disorder indications. With this recognition the anticipated goals of morbidity reduction, quality of life improvement, and sometimes longevity will become a standard expectation of care.

In conjunction with enhanced knowledge about early diagnosis and treatment, there is improvement in prospects of morbidity reduction, quality of life, and longevity. Biotech advancements toward producing recombinant enzymes and improved purification methods, continue to contribute toward safer and more effective therapies.

Major Growth Drivers

One of the key factors is the increasing incidence and identification of inherited metabolic disorders and lysosomal storage diseases. With the expansion of newborn screening programs and genetic testing, more cases which would have previously gone undiagnosed are diagnosed early, resulting in demand. In addition, biotechnological advances are yielding enzymes with higher purity, greater stability and often better pharmacokinetics.

Regulatory and policy efforts also contribute: multiple national and international organizations are providing expedited pathways, orphan drug designations and favourable reimbursement for rare diseases. In addition to these factors, increasing investment in healthcare, primarily in developing markets, is facilitating access to costly biological therapies. Patient advocacy and real-world evidence are working against barriers in stigma, awareness and diagnostic delays. Finally, the expansion of product pipelines and exploration of new indications is rendering the market anticipatory and dynamic.

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Key Drifts:

One of the primary developments is the progression toward alternative routes of administration, including developing more oral and subcutaneous formulations rather than standard IV infusions, due to patient desire, ease of use, and cost, in light of treatment of conditions that require frequent dosing.

Given that many ERTs are high-cost biologics, manufacturers are now challenging financial models by pursuing the development of biosimilars or analogues to their original products, developing cost-efficient manufacturing strategies and finding partners to reduce the cost of goods.

ERTs are being initiated earlier in the disease spectrum, including patients with less severe phenotypes and both approved and under study for additional manifestations. New indications including non-neural manifestations or as a part of combination therapy are emerging.

Significant Challenge:

High Cost & Reimbursement Barriers:

A continuing and major barrier in the enzyme replacement therapy market is the extremely high cost of therapy. Producing biologic enzymes with the necessary purity, stability, and safety is expensive, and the prices of many therapies reflect this expense. Many healthcare systems or insurers are not willing to reimburse the full cost of therapy, particularly in lower or middle-income countries.

In addition, individuals from emerging regions may have to wait to receive treatment due to the absence of coverage or delay in approval of treatment. Regularly scheduled, often life-long, infusions require a level of infrastructure to administer the therapy, resulting in added logistical cost. Immune responses, infusion-related adverse events, or issues relating to the chain of supply add additional complexity with respect to cost and access. So, although demand for enzyme replacement therapy is very high, actual uptake may be limited due to complex financial, regulatory, and infrastructure issues.

Regional Analysis:

By overall indication North America represents the largest segment by 40% of the enzyme replacement therapies market with its advanced healthcare infrastructure, early adoption of policies supporting treatment of rare diseases, a strong presence of leading biotech and pharmaceutical organizations, substantial spending on biologics, and favourable reimbursement policies.

In comparison, the Asia-Pacific region represents the fastest growing region as it is experiencing growing awareness of rare diseases, expanding diagnostic and genetic screening capabilities, increasing healthcare investment, improved regulatory support for orphan indications, and expanding patient populations.

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Segmental Insights

By Product

The imiglucerase segment is the largest product category in the ERT market, due to its long history of use in Gaucher disease, its established efficacy and safety, and extensive regulatory approval.

The agalsidase beta segment is the fastest growing product segment, driven by increased diagnoses of Fabry disease, heightened patient awareness, and a favorable action profile of the enzyme. Both manufacturers and health care systems are meeting unmet needs of the Fabry patient community, contributing to increased adoption of agalsidase beta.

By therapeutic condition:

The Gaucher disease segment is dominating the therapeutic condition split. Because Gaucher disease has one of the larger diagnosed rare disease populations and multiple approved ERTs, its market share is highest among ERT-treated conditions.

The MPS segment is the fastest growing therapeutic condition segment. Growth in MPS is driven by newer subtypes being diagnosed, expanding availability of MPS-specific therapies, and enhanced disease awareness and screening.

By Route of Administration:

The parenteral segment is currently the largest, as most existing ERTs are delivered through infusion to provide direct delivery of the enzyme with a consistent clinical effect. The oral segment is the fastest growing route of administration. Although there are limited oral ERTs available, there is continued research and development of oral therapies for enzymes or enzyme stabilizers, along with patient demand for low-invasiveness.

By End-Use:

Infusion centers are the most common end-use segment, primarily because they are specialized to provide safe infusion of intravenous enzyme therapies, manage adverse effects, and make treatment observations. Infusion centers currently provide the majority of ERT infusions globally.

In contrast, hospitals are the most rapidly adopted form of end-use segment, characterized by growth in emerging markets. Hospitals are expanding because they are establishing rare disease units, improving facilities to support biologics, and acting as centers for the diagnosis, administration and follow up for ERT treatment.

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Recent Developments:

In July 2025, BioMarin announced it will acquire Inozyme Pharma for about USD 270 million, strengthening its pipeline in enzyme replacement therapy. Inozyme is developing a therapy for children deficient in the ENPP1 protein, a genetic condition affecting blood vessels, soft tissue, and bones.

Top Companies in the Enzyme Replacement Therapy Market

AbbVie
Alexion Pharmaceuticals, Inc.
Amicus Therapeutics
AstraZeneca plc
Biomarin Pharmaceutical, Inc.
Denali Therapeutics, Inc.
GC Biopharma
Genzyme Corporation
Novel Pharma
Pfizer, Inc.
Protalix BioTherapeutics, Inc.
Sanofi
Takeda Pharmaceuticals

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Segments Covered in the Report

By Product

Imiglucerase
Agalsidase Beta
Alglucosidase Alfa
Taliglucerase
Velaglucerase Alfa
Pegademase
Laronidase
Pancreatic Enzymes
Idursulfase
Galsulfase
Others

By Therapeutic Condition

Gaucher Disease
MPS
SCID
Pompe Disease
Fabry Disease
Others

By Route of Administration

Parenteral
Oral

By End-Use

Infusion Centers
Hospitals
Others

By Region

North America
- US
- Canada
Asia Pacific
- China
- Japan
- India
- South Korea
- Thailand
Europe
- Germany
- UK
- France
- Italy
- Spain
- Sweden
- Denmark
- Norway
Latin America
- Brazil
- Mexico
- Argentina
Middle East and Africa (MEA)
- South Africa
- UAE
- Saudi Arabia
- Kuwait

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Towards Healthcare is a leading global provider of technological solutions, clinical research services, and advanced analytics, with a strong emphasis on life science research. Dedicated to advancing innovation in the life sciences sector, we build strategic partnerships that generate actionable insights and transformative breakthroughs. As a global strategy consulting firm, we empower life science leaders to gain a competitive edge, drive research excellence, and accelerate sustainable growth.

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