Report : North America Enzyme Replacement Therapy Market Forecast to 2028 – COVID-19 Impact and Regional Analysis – by Enzyme Type (Alglucosidase Alfa, Agalsidase Beta, Imiglucerase, Idursulfase, Galsulfase, Velaglucerase Alfa, and Other Enzymes), Therapeutic Conditions (Gaucher's Disease, Fabry's Disease, MPS, Pompe's Disease, SCID, and Other Therapeutic Conditions), Route of Administration (Parenteral and Oral), and End User (Hospitals, Infusion Centers, and Others)

At 6.9% CAGR, the North America Enzyme Replacement Therapy Market is speculated to be worth US$ 6,120.01 million by 2028, says Business Market Insights         

According to the Insight Partners’ research, the North America enzyme replacement therapy market was valued at US$ 4,108.69 million in 2022 and is expected to reach US$ 6,120.01 million by 2028, registering an annual growth rate of 6.9% from 2022 to 2028.Rising prevalence of lysosomal storage diseases (lsds) and rapid regulatory approval with other benefits for drug with orphan drug designation are the critical factors attributed to the market expansion.                

A lysosome is a membrane-bound cell organelle that contains digestive enzymes. A lysosome is the key cellular hub for macromolecule catabolism, recycling, and signaling. Any defect in these functions leads to the accumulation or storage of macromolecules in lysosomes, resulting in cellular damage. The leading cause of lysosomal storage diseases (LSDs) is mutations in the genes responsible for encoding a lysosomal enzyme. Additionally, LSDs are characterized as an inborn metabolism error that results in an enzyme's absence or deficiency. Infants and children suffer more severely compared to adults as children can inherit the defective gene from one or both parents. However, since the last decade, the pattern has been changing, and LSDs are more common in adults. Moreover, LSDs are approximately 70 diseases, including Gaucher disease, Niemann-Pick disease, Fabry disease, Tay-Sachs disease, Mucopolysaccharidoses (MPS) diseases, and Pompe disease. These disorders are individually rare, but collectively they are significantly prevalent and affect 1 in 5,000 live births. Furthermore, lysosomal storage diseases (LSDs) are rare; there are limited specific treatments for many of these diseases. However, progress is being made in terms of therapies and treatments available for some lysosomal storage disorders that significantly improve the quality of life for those affected. For instance, enzyme replacement therapy (ERT) has proven effective for individuals with Gaucher disease type I, II, and III. ERT helps improve anemia symptoms, low platelet counts, and skeletal issues and helps reduce liver and spleen enlargement. Thus, the rising prevalence of LSDs and limited therapies to cure the disease are driving the growth of the North America enzyme replacement therapy market.  

On the contrary, cutthroat competition among market players hurdles the growth of North America enzyme replacement therapy market.

  • Based on enzyme type, the North America enzyme replacement therapy market is segmented into alglucosidase alfa, agalsidase beta, imiglucerase, idursulfase, galsulfase, velaglucerase alfa, and other enzymes. The other enzymes segment held 42.7% market share in 2022, amassing US$ 1,754.66 million. It is projected to garner US$ 2,701.52 million by 2028 to expand at 7.5% CAGR during 2022–2028.
  • Based on therapeutic conditions, the North America enzyme replacement therapy market is segmented into gaucher's disease, fabry's disease, MPS, pompe's disease, SCID, and other therapeutic conditions. The gaucher's disease segment held 26.5% market share in 2022, amassing US$ 1,088.65 million. It is projected to garner US$ 1,705.26 million by 2028 to expand at 7.8% CAGR during 2022–2028.
  • Based on route of administration, the North America enzyme replacement therapy market is bifurcated into parenteral and oral. The parenteral segment held 79.4% market share in 2022, amassing US$ 3,262.31 million. It is projected to garner US$ 4,903.84 million by 2028 to expand at 7.0% CAGR during 2022–2028.
  • Based on end user, the North America enzyme replacement therapy market is segmented into hospitals, infusion centers, and others. The hospitals segment held 39.5% market share in 2022, amassing US$ 1,623.88 million. It is projected to garner US$ 2,311.03 million by 2028 to expand at 6.1% CAGR during 2022–2028.

Based on country, the North America enzyme replacement therapy market has been categorized into US, Canada, and Mexico.  Our regional analysis states that US captured 85.0% market share in 2022. It was assessed at US$ 3,491.06 million in 2022 and is likely to hit US$ 5,271.57 million by 2028, exhibiting a CAGR of 7.1% during the forecast period.  

Key players dominating the North America enzyme replacement therapy market are Sanofi; BioMarine Pharmaceutical Inc; Takeda Pharmaceutical Company Limited; AbbVie Inc; Janssen Pharmaceutical (Johnson & Johnson Services, Inc.); Alexion Pharmaceutical, Inc. (AstaZeneca); Amicus Therapeutics; Recordati S.p.A; Recordati S.p.A; CHIESI farmaceutici S.p.A; and Pfizer Inc, among others.

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