PUBLISHER: The Business Research Company | PRODUCT CODE: 1667705
PUBLISHER: The Business Research Company | PRODUCT CODE: 1667705
Enzyme replacement therapy (ERT) refers to a sort of medical treatment in which patients with chronic disorders brought on by insufficient or failing enzymes are given alternative enzymes. The body can complete the processes inhibited by the deficit by getting enzyme replacements. It is particularly effective at returning urinary GAG levels to normal and boosting liver and spleen development.
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 is one of a series of new reports from The Business Research Company that 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 size has grown strongly in recent years. It will grow from$11.58 billion in 2024 to $12.48 billion in 2025 at a compound annual growth rate (CAGR) of 7.8%. 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 size is expected to see strong growth in the next few years. It will grow to $17.81 billion in 2029 at a compound annual growth rate (CAGR) of 9.3%. The growth in the forecast period can be attributed to increasing patient access to healthcare, tailored therapies and personalized medicine, regulatory landscape changes, and growing patient population awareness. Major trends in the forecast period include digital health integration, focus on patient-centric solutions, emerging biomarker research, and precision medicine approach.
The increasing prevalence of rare, chronic, and inherited disorders is anticipated to drive the growth of the enzyme replacement therapy market in the coming years. Chronic disease is defined as an illness lasting three months or more that may worsen over time. Such diseases are more prevalent among the elderly and are typically manageable but not curable. For example, in July 2024, the American Lung Association, a U.S.-based non-profit organization, reported that in 2022, 44.2 million Americans (or 13.5% of the population) had been diagnosed with asthma by a healthcare provider, up from 12.9% in 2021. Thus, the rising prevalence of rare, chronic, and inherited disorders is expected to fuel growth in the enzyme replacement therapy market.
The increase in healthcare spending is projected to drive the growth of the enzyme replacement therapy (ERT) market in the future. Healthcare expenditure represents the total funds allocated to healthcare services, goods, and activities within a healthcare system or economy over a given period. This spending supports ERT due to the highly specialized and often costly nature of these treatments, covering research, development, clinical trials, and testing. For example, in December 2022, the U.S.-based federal agency Centers for Medicare & Medicaid Services reported that U.S. healthcare spending grew by 4.1% to reach $4.5 trillion in 2022, outpacing the 3.2% growth in 2021. Thus, rising healthcare expenditures are fueling the growth of the enzyme replacement therapy 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 July 2024, Crosswalk Therapeutics Inc., a biotechnology company based in the United States, acquired Codexis Inc. for an undisclosed sum. This acquisition allows Crosswalk Therapeutics to broaden its expertise, integrating Codexis's advanced enzyme engineering technology into its offerings. Codexis Inc. is a U.S.-based company specializing in enzyme engineering.
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
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 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.
Enzyme Replacement Therapy Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on enzyme replacement therapy market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for enzyme replacement therapy ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward? The enzyme replacement therapy market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the Russia-Ukraine war, rising inflation, higher interest rates, and the legacy of the COVID-19 pandemic.