The enzyme replacement therapy market has seen considerable growth due to a variety of factors.
•In recent years, the market size of enzyme replacement therapy has seen considerable growth. The market is projected to expand from $11.58 billion in 2024 to $12.48 billion in 2025, marking a compound annual growth rate (CAGR) of 7.8%.
The significant growth experienced during the historic period can be credited to various factors such as advancements in early therapeutic discoveries, approval of innovative treatments, increased comprehension of diseases, successful clinical trials, as well as regulatory support and incentives.
The enzyme replacement therapy market is expected to maintain its strong growth trajectory in upcoming years.
• The market size of enzyme replacement therapy is predicted to experience robust growth in the upcoming years, reaching "$17.81 billion by 2029 with a compound annual growth rate (CAGR) of 9.3%.
The projected growth during the forecast period can be credited to the expanded access of patients to healthcare, customized therapies and personalized medicine, alterations in the regulatory landscape, and increased awareness among the patient population. Notable trends during the forecast period will encompass the integration of digital health, emphasis on patient-oriented solutions, the rise of biomarker research, and the application of precision medicine.
The increasing occurrence of rare, long-term, and genetic diseases is anticipated to boost the expansion of the enzyme replacement therapy market in the future. Chronic illnesses are those that persist for three months or longer and may worsen over time. Elderly people are more likely to have these chronic diseases, which can typically be managed but not entirely eliminated. For example, the American Lung Association, a non-profit organization based in the US, reported in July 2024 that in 2022, asthma had been diagnosed in 44.2 million Americans, or 13.5% of the population, by a medical professional, a rise from 12.9% in 2021. So, the growing occurrence of rare, chronic, and genetic disorders is set to enhance the progress of the enzyme replacement therapy market.
The enzyme replacement therapy market covered in this report is segmented –
1) By Enzyme Type: Agalsidase Alfa, Agalsidase Beta, Galsulfase, Other Enzyme Types
2) By Route Of Administration: Oral, Parenteral
3) By Application: Gaucher Disease, Pompe Disease, Fabry Disease, Other Applications
4) By End-Users: Hospitals, Infusion Centers, Other End-Users
Subsegments:
1) By Agalsidase Alfa: Fabry Disease Treatment
2) By Agalsidase Beta: Fabry Disease Treatment
3) By Galsulfase: Mucopolysaccharidosis VI (MPS VI) Treatment
4) By Other Enzyme Types: Alglucosidase Alfa, Idursulfase, Velaglucerase Alfa
The enzyme replacement therapy market is seeing an increasing trend of product approvals becoming a dominant factor. Numerous enzyme replacement treatments introduced by major market players are securing market approvals. In February 2023, for example, Lamzede (velmanase alfa) received approval from the US Food and Drug Administration, a federal agency under the Department of Health. This marked the first approval in the US for an enzyme replacement therapy intended for treating non-central neurological signs of alpha-mannosidosis. This rare genetic disorder is distinguished by a lack of alpha-mannosidase enzyme in the body. Lamzede essentially functions like the missing enzyme in patients' bodies, thereby regaining healthy cellular activity. Patients are typically administered a 10mg Lamzede injection on a weekly basis.
Major companies operating in the enzyme replacement therapy market include:
• Biomarin Pharmaceutical Inc.
• Leadiant Biosciences Inc.
• Pfizer Inc.
• Sanofi S.A.
• AbbVie Inc.
• Johnson & Johnson Services Inc.
• Alexion Pharmaceuticals Inc.
• Recordati Rare Diseases Inc.
• Sangamo Therapeutics Inc.
• JCR Pharmaceuticals Co. Ltd.
• Horizon Pharma Public Limited Company
• Protalix Biotherapeutics Ltd.
• Amicus Therapeutics Inc.
• AstraZeneca plc
• Novartis AG
• Roche Holding AG
• GlaxoSmithKline plc
• Merck & Co. Inc.
• Eli Lilly and Company
• Bristol-Myers Squibb Company
• Retrophin Inc.
• Abeona Therapeutics Inc.
• Orchard Therapeutics plc
• Ultragenyx Pharmaceutical Inc.
North America was the largest region in the enzyme replacement therapy market in 2024.Asia-Pacific is expected to be the fastest-growing region in the global enzyme replacement therapy market report during the forecast period. The regions covered in the enzyme replacement therapy market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa