Enzyme Replacement Therapy Global Market Report 2024

The enzyme replacement therapy market has grown strongly in recent years. It will grow from $10.85 billion in 2023 to $11.72 billion in 2024 at a compound annual growth rate (CAGR) of 8.0%. The growth in the historic period can be attributed to growing early therapeutic discoveries, pioneering treatment approvals, expanded disease understanding, clinical success stories, regulatory support and incentives.

The enzyme replacement therapy market is expected to see strong growth in the next few years. It will grow to $16.21 billion in 2028 at a compound annual growth rate (CAGR) of 8.5%. The growth in the forecast period can be attributed to increasing patient access to healthcare, tailored therapies and personalized medicine, regulatory landscape changes, growing patient population awareness. Major trends in the forecast period include digital health integration, focus on patient-centric solutions, emerging biomarker research, precision medicine approach.

The anticipated growth in the enzyme replacement therapy market is expected to be driven by the increasing prevalence of rare, chronic, and inherited disorders. Chronic diseases, which persist for three months or more and tend to worsen over time, are becoming more prevalent, especially among the elderly population. For example, a report from the US-based National Library of Medicine projected a 99.5% increase in the number of people aged 50 and older with at least one chronic condition in the USA, rising from 71.522 million in 2020 to 142.66 million by 2050. Thus, the growing incidence of rare, chronic, and inherited disorders is poised to fuel the growth of the enzyme replacement therapy market.

The increasing expenditure on healthcare is expected to contribute to the growth of the enzyme replacement therapy (ERT) market. Healthcare expenditure encompasses the total amount of money spent on healthcare services, goods, and related activities within a specific healthcare system or economy over a defined period. The specialized and often costly nature of enzyme replacement therapy (ERT) necessitates substantial spending on research and development, as well as clinical trials and testing. For instance, a report from the UK-based Office for National Statistics indicated that between 2020 and 2021, healthcare spending in the UK increased by 9.4% in nominal terms and 9.7% in real terms. The total healthcare expenditure in the UK in 2021 was $367.25 billion (£280.7 billion), with pharmaceutical expenditure reaching $51.84 billion (£39.6 billion) and spending on preventive care doubling to $45.93 billion (£35.1 billion) in 2021. As a result, the rise in healthcare expenditures is propelling the growth of the enzyme replacement therapy (ERT) market.

Product approvals have become a prominent trend gaining traction in the enzyme replacement therapy market. Various enzyme replacement therapy medications introduced by major players are securing approvals in the market. For example, in February 2023, Lamzede (velmanase alfa) received approval from the Food and Drug Administration, a US-based federal agency of the Department of Health. Lamzede is the first enzyme replacement therapy sanctioned in the United States for treating non-central neurological indications of alpha-mannosidosis, a rare genetic disorder characterized by the absence of the alpha-mannosidase enzyme. Administered as a 10mg injection once a week, Lamzede aids patients in regaining normal cellular function by mimicking the action of the alpha-mannosidase enzyme, thereby restoring healthy cellular functioning.

Major companies in the enzyme replacement therapy (ERT) market are strategically focusing on innovative treatment products and obtaining approvals for Pompe disease therapy to address the unmet medical needs of patients with late-onset Pompe disease. In response to the pressing medical needs for late-onset Pompe disease patients in the European Union, Amicus Therapeutics, a US-based biotechnology company, secured approval and launched a new Pompe disease therapy in June 2023. The treatment, comprising Pombiliti (cipaglucosidase alfa) and Opfolda (miglustat), serves as an enzyme replacement therapy for adults with late-onset Pompe disease, supported by clinical data and driven by potential market opportunities and regulatory backing.

In May 2021, Aceragen Inc., a US-based biopharmaceutical company, completed the acquisition of Enzyvant Therapeutics GmbH for an undisclosed amount. This strategic move is aimed at providing Aceragen access to a promising therapy for a devastating rare disease, leveraging Aceragen's expertise in the field, and reinforcing its position in the rare disease market. Enzyvant Therapeutics GmbH, a US-based company, specializes in developing and commercializing enzyme replacement therapy solutions for rare metabolic disorders.

Major companies operating in the enzyme replacement therapy market report are Biomarin Pharmaceutical Inc., Leadiant Biosciences Inc., Pfizer Inc., Sanofi S.A., AbbVie Inc., Genzyme Corporation, Johnson & Johnson Services Inc., Alexion Pharmaceuticals Inc., Shire plc, Recordati Rare Diseases Inc., Actelion Pharmaceuticals Ltd., Sangamo Therapeutics Inc., JCR Pharmaceuticals Co. Ltd., Horizon Pharma Public Limited Company, Protalix Biotherapeutics Ltd., Amicus Therapeutics Inc., AstraZeneca plc, Zoetis Inc., Novartis AG, Roche Holding AG, GlaxoSmithKline plc, Merck & Co. Inc., Eli Lilly and Company, Bristol-Myers Squibb Company, Sangamo Therapeutics Inc., Retrophin Inc., Abeona Therapeutics Inc., Orchard Therapeutics plc, Ultragenyx Pharmaceutical Inc., Catalyst Biosciences.

North America was the largest region in the enzyme replacement therapy market in 2023. 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. The countries covered in the enzyme replacement therapy market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The main types of enzymes used in enzyme replacement therapy include agalsidase alfa, agalsidase beta, galsulfase, other enzyme types that are used in gaucher disease, pompe disease, fabry disease, others. Agalsidase alfa refers to a recombinant human alpha-galactosidase that is used in the treatment of fabry’s disease as an enzyme replacement therapy. It has a long half-life and a broad therapeutic spectrum. Patients should be advised about the possibility of infusion-related symptoms and sensitivity. Agalsidase alfa is beneficial to enzyme replacement therapy because it aids in the treatment of Fabry disease. The enzyme replacement therapy is used by hospitals, infusion centers and others that is administered through oral and parenteral route.

The enzyme replacement therapy market research report provides enzyme replacement therapy market statistics, including enzyme replacement therapy industry global market size, regional shares, competitors with enzyme replacement therapy market share, detailed enzyme replacement therapy market segments, market trends, and opportunities, and any further data you may need to thrive in the enzyme replacement therapy industry. This enzyme replacement therapy market research report deliver a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The enzyme replacement therapy market includes revenues earned by entities by providing Sebelipase alfa, Elosulfase alfa, Idursulfase, AL glucosidase alfa and Alpha1-Proteinase inhibitor enzyme replacement therapies. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.


This product will be delivered within 3-5 business days.