Enzyme Replacement Therapy Market
Number of pages: 100 | Report Format: PDF | Published date: February 08, 2023
Historical Years – 2020 | Base Year – 2021 | Forecasted Years – 2022-2030
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Report Attribute |
Details |
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Market Size Value in 2021 |
US$ 10.2 billion |
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Revenue Forecast in 2030 |
US$ 21.25 billion |
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CAGR |
8.5% |
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Base Year for Estimation |
2021 |
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Forecast Period |
2022-2030 |
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Historical Year |
2020 |
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Segments Covered |
Drug Class, Route of Administration, By Indication, End User, and Region |
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Regional Scope |
North America, Europe, Asia Pacific, and the Rest of the World (RoW) |
According to the deep-dive market assessment study by Growth Plus Reports, the global enzyme replacement therapy market was valued at US$ 10.2 billion in 2021 and is expected to register a revenue CAGR of 8.5% to reach US$ 21.25 billion by 2030.
Enzyme Replacement Therapy Market Fundamentals
Enzyme replacement therapy (ERT) is a medical treatment in which patients with chronic diseases caused by enzyme shortages or failure are given replacement enzymes. The most frequent type of ERT is IV infusions, which deliver the replacement enzyme directly into the bloodstream via a regulated drip of fluids.
ERT replacement enzymes are obtained from human, animal, and plant cells, which are then genetically engineered and processed before being administered to the patient. The body is able to successfully complete the functions inhibited by the deficit by getting these enzyme replacements. The success of ERT varies depending on an individual and the condition being treated; however, in some circumstances, it is the only accessible therapeutic option. ERT is most used to treat lysosomal storage disorders (LSDs), such as Pompe’s disease, Fabry’s disease, Gaucher’s disease, Tay-Sachs disease, and Hurler syndrome. The most common ERT method is IV infusions. These rare, persistent, hereditary disorders occur when enzymes in the lysosomes are deficient or malfunctioning. Lysosomes are responsible for breaking down proteins and other macromolecules in the body, so when they fail to do so, a variety of symptoms and illnesses occur, frequently with major effects on an individual’s everyday life. Furthermore, the earliest successful ERT used plasma-derived purified human A1AT to treat alpha-1-antitrypsin (A1AT) deficiency. A1AT deficiency is linked to early-onset emphysema, which is caused by a lack of leukocyte elastase inhibitors, resulting in progressive lung damage. Small prospective trials suggested that augmentation therapy, which involves infusing the enzyme purified from human serum, may be beneficial. Despite being generated from human plasma, this medication was later demonstrated to be useful, particularly in patients with early or intermediate pulmonary dysfunction, and was quite safe, with no development of viral hepatitis. Additionally, infants and children account for approximately 50.0% of those affected by uncommon diseases worldwide.
According to the Kakkis Every Life Foundations, FDA-approved medications are not accessible for 95.0% of rare disorders. ERT replaces an enzyme that is depleted in the body. Gaucher’s disease, Fabry’s disease, mucopolysaccharidosis, Pompe’s disease, and lysosomal acid lipase deficiency can all be treated with ERT. One of the important factors driving the enzyme replacement therapy market is a rise in healthcare spending and increased occurrence of uncommon diseases globally. Furthermore, the market is likely to be driven by an increase in demand for ERT to enhance the treatment of uncommon disorders.
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Enzyme Replacement Therapy Market Dynamics
The increasing availability of ERT, increased awareness, and less stringent standards for rare disorders are generating significant revenue growth opportunities in the market. A rare disease is one that affects fewer than 200,000 people, according to the Genetic and Rare Diseases Information Center. Various organizations are launching strategic initiatives to raise awareness about these diseases and help people live longer lives. Rising awareness and expanding number of market participants venturing into orphan disease management are driving market expansion. Orphan pharmaceuticals used to treat these disorders are expected to thrive during the forecast period due to an increase in the number of players investing in R&D activities to cure these uncommon diseases.
Enzyme Replacement Therapy Market Ecosystem
The global enzyme replacement therapy market has been analyzed from five perspectives: drug class, route of administration, indication, end user, and region.
Enzyme Replacement Therapy Market by Drug Class
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Based on drug class, the global enzyme replacement therapy market has been segmented into alglucosidasealfa, agalsidase, pancrelipase, idursulfase, laronidase, imiglucerase, elosulfasealfa, asfotasealfa, galsulfase, velaglucerasealfa, and others.
The pancrelipase segment is expected to dominate the market during the forecast period. The rising prevalence of exocrine pancreatic insufficiency drives up demand for and adoption of this drug class. Furthermore, according to the annual reports of key market players, such as AbbVie Inc. and others, this drug class was projected to be the biggest contributing segment when compared to other ERT drug classes, resulting in this segment’s domination.
Enzyme Replacement Therapy Market by Route of Administration
Based on route of administration, the global enzyme replacement therapy market has been segmented into parenteral and oral.
The parenteral segment is expected to dominate the market during the forecast period. This segment's dominance can be linked to the fact that the majority of drugs used in therapy are available in parenteral form. Furthermore, according to various research publications, parenteral administration of various medications is far more successful than oral administration routes.
Enzyme Replacement Therapy Market by Indication
Based on indication, the global enzyme replacement therapy market has been segmented into 1 Gaucher’s disease, Pompe’s disease, MPS (mucopolysaccharidosis), exocrine pancreatic insufficiency (EPI), Fabry’s disease, hypophosphatasia, and others.
The exocrine pancreatic insufficiency (EPI) segment is projected to dominate the market during the forecast period due to the increasing frequency of this condition among the general public. Furthermore, the high prevalence of exocrine pancreatic insufficiency among patients with chronic pancreatitis and cystic fibrosis contributes to an increase in this patient population. This, in turn, contributes to this segment's dominance.
Enzyme Replacement Therapy Market by End User
Based on end user, the global enzyme replacement therapy market has been segmented into hospitals, homecare settings, infusion centers, and others.
The homecare settings segment leads the global market owing to preference shifts of patients diagnosed with uncommon diseases from hospital to homecare settings. Moreover, during the COVID-19 pandemic, several governments and private hospitals are pushing patients to seek home care treatment by providing them with sufficient training to administer the drugs on their own, which is likely to drive the revenue growth of this segment throughout the forecast period.
Enzyme Replacement Therapy Market by Region
Based on region, the global enzyme replacement therapy market has been segmented into North America, Europe, Asia Pacific, Rest of the world.
The market in North America is expected to dominate during the forecast period. The increased frequency of rare lysosomal storage disorders, such as Pompe’s disease, Fabry’s disease, and others, as well as the strong direct presence of key industry participants in this region, are factors leading to this region's dominance in the global market. Furthermore, the existence of numerous infusion centers in this region is boosting market expansion. For instance, according to Healio, there were around 3,600 infusion clinics in the United States in 2019, catering to a huge patient pool undergoing ERT for a variety of uncommon disorders. Furthermore, rapid advancements in healthcare infrastructure and rising need for treatment alternatives for rare diseases drive market expansion in North America.
During the projection period, Asia Pacific is expected to develop at a considerable revenue CAGR. The growing number of patient population suffering from rare disorders, as well as increased attempts by the government and other private groups to raise awareness about this therapy, are raising demand and adoption of this therapy among the general public, driving market expansion.
Enzyme Replacement Therapy Market Competitive Landscape
The major players in the global enzyme replacement therapy market include:
Enzyme Replacement Therapy Market Strategic Developments
Asia Pacific is the key revenue growth region in the global enzyme replacement therapy market.
The increasing prevalence of rare diseases and rising government initiatives for rare diseases are propelling revenue growth in the global market.
The global enzyme replacement therapy market is expected to be valued at US$ 21.25 billion by 2030.
The global enzyme replacement therapy market is expected to register a revenue CAGR of 8.5% during the forecast period from 2022 to 2030.
Shire Plc, Sanofi S.A., Genzyme Corporation, Biomarin Pharmaceutical Inc., and AbbVie are among the leading players in the global market.
*Insights on financial performance is subject to availability of information in public domain