Enzyme Replacement Therapy Market Worth $15.18 Billion by 2028 at 6.8% CAGR Led by Hospitals Segment (49% Market Share in 2021) Global Analysis by The Insight Partners

The global enzyme replacement therapy market size is expected to grow from $9.67 Billion in 2021 to $15.18 Billion by 2028; it is estimated to grow at a CAGR of 6.8% from 2022 to 2028.


New York, July 22, 2022 (GLOBE NEWSWIRE) -- The Insight Partners published latest research study on “Enzyme Replacement Therapy Market Forecast to 2028 - COVID-19 Impact and Global 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)”, the global enzyme replacement therapy market research report provides deep dive regional and country level analysis of 18+ countries across 5 key regions, 30+ key company profiles, detailed SWOT and PEST analysis, in-depth market segmentation and industry landscape to provide latest market initiatives and competitive landscape, impact of COVID-19 pandemic on ecosystem.


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Enzyme Replacement Therapy Market Report Scope & Strategic Insights:

Report Coverage Details
Market Size Value in US$ 9.67 Billion in 2021
Market Size Value by US$ 15.18 Billion by 2028
Growth rate CAGR of 6.8% from 2022 to 2028
Forecast Period 2022-2028
Base Year 2021
No. of Pages 226
No. Tables 111
No. of Charts & Figures 86
Historical data available Yes
Segments covered Enzyme Type, Therapeutic Conditions, Route of Administration, and End-User
Regional scope North America; Europe; Asia Pacific; Latin America; MEA
Country scope US, UK, Canada, Germany, France, Italy, Australia, Russia, China, Japan, South Korea, Saudi Arabia, Brazil, Argentina
Report coverage Revenue forecast, company ranking, competitive landscape, growth factors, and trends


Global Enzyme Replacement Therapy Market: Competitive Landscape and Key Developments
Takeda Pharmaceutical Company Limited; Sanofi S.A.; AbbVie Inc.; BioMarin Pharmaceutical Inc.; Amicus Therapeutics; Alexion Pharmaceuticals, Inc. (AstraZeneca); Janssen Pharmaceuticals (Johnson & Johnson Services, Inc.); Recordati S.p.A.; Pfizer Inc.; and CHIESI Farmaceutici S.p.A are among the key companies operating in the global enzyme replacement therapy market. Leading players focus on expanding and diversifying their market presence and clientele, thereby tapping prevailing business opportunities.


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In September 2021, Takeda Pharmaceutical Company Limited signed a collaboration and partnership arrangement with JCR Pharmaceuticals Co., Ltd. to commercialize JR-141 outside of the US to treat Hunter syndrome.

In June 2019, BioMarin Pharmaceutical Inc. announced that Vimizim (elosulfase alfa) has been approved by the National Medical Products Administration (NMPA) for the treatment of patients suffering from mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio A syndrome. Vimizim is the first treatment in China approved for this condition.

Enzyme Replacement Therapy Market: Key Insights
The enzyme replacement therapy market growth is attributed to the rising prevalence of lysosomal storage diseases (LSDs) and rapid regulatory approval with other marketing benefits for a drug with orphan drug designation. However, cutthroat competition among market players hinders overall market growth.

North America dominates the global enzyme replacement therapy market. The US holds the largest share of the market in the region due to the rising prevalence of LSDs and increasing regulatory approval of enzyme replacement therapy products. Intravenous (IV) infusions are used in enzyme replacement therapy to treat the underlying enzyme shortage that underlies rare diseases, including Gaucher, Fabry's, and Hunter's syndrome. Therefore, rising cases of these rare diseases propel the need for developing novel treatments.


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According to the National Organization for Rare Disorders (NORD), in 2021, males and females are equally affected by various types of Gaucher disease. Around 6,000 people in the US are suffering from Gaucher disease. Gaucher disease is the most prevalent genetic illness in the people of Ashkenazic Jewish origin. Its prevalence potentially hit 1 in 450 births. According to statistics released by the National Institute of Neurological Disorders and Stroke in August 2021, there are an estimated 32,950 instances of Pompe disease in the US, affecting one in 40,000 persons. The National Fabry Foundation estimates that there were around 7,713 Fabry patients in the US as of May 2020. Thus, the vast majority of rare diseases remain beyond possibilities of treatment and with continued research, it would be able to offer therapies to the affected patients. Therefore, this rise in the prevalence of rare diseases would drive the growth of the regional market in the coming years.

Rising Prevalence of LSDs and Rapid Regulatory Approval Positively Influence Overall Market Growth:
Enzyme replacement therapy is performed to treat congenital enzyme deficiencies by using an enzyme or protein having enzymatic activity. The therapy is generally applied in rare and lysosomal storage diseases, including Pompe disease, Tay-Sachs disease, Fabry disease, Gaucher disease, and Hurler syndrome. Researchers and players are actively involved in the enzyme replacement therapy industry and are constantly focusing on advancing technologies that can offer better alternatives to conventional techniques.

In August 2021, the US Food and Drug Administration (FDA) approved Nexviazyme (avalglucosidase alfa-ngpt) for the treatment of patients aged one year and above suffering from late-onset Pompe disease. Nexviazyme is an ERT designed to specifically target the mannose-6-phosphate (M6P) receptor, the key pathway for cellular uptake of enzyme replacement therapy in Pompe disease. Nexviazyme has been shown in clinical trials to provide patients with improvements in respiratory function and walking distance.


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In July 2019, Takeda Pharmaceutical Company launched an enzyme replacement therapy portfolio for LSD in India, expanding its range of rare disease therapies in the country. Under lysosomal storage disorders, India has been recording the prevalence of hunter syndrome, gaucher disease, and fabry disease. To address these, Takeda brought idursulfase for hunter syndrome, velaglucerase alpha for gaucher disease, and agalsidase alfa for fabry disease to the market. Such advancements and the rise in investments are propelling the global enzyme replacement therapy market growth significantly.

Global Enzyme Replacement Therapy Market: Segmental Overview
Based on enzyme type, the global enzyme replacement therapy market is segmented into alglucosidase alfa, velaglucerase alfa, agalsidase beta, imiglucerase, galsulfase, idursulfase, and other enzymes. The others enzyme segment held the largest market share in 2021 and is anticipated to register the highest CAGR during 2022–2028. Based on therapeutic conditions, the market is segmented into Gaucher's disease, Fabry's disease, Pompe's disease, SCID, MPS, and other therapeutic conditions. The Gaucher’s disease segment held the largest market share in 2021 and is expected to register the highest CAGR during 2022–2028. Based on the route of administration, the global enzyme replacement therapy market is bifurcated into oral and parenteral. The parenteral segment held a larger market share in 2021 and is anticipated to register a higher CAGR during 2022–2028. Based on end users, the global enzyme replacement therapy market is segmented into hospitals, infusion centers, and others. The hospitals segment held the largest market share in 2021. However, the infusion centers segment is expected to register the highest CAGR during 2022–2028.

SARS-CoV-2 infection can cause a high risk for patients suffering from inborn errors of metabolism (IEM), since they often suffer from a multisystem disease, including respiratory and cardiovascular system involvement. Due to multi-systemic involvement, including crucial organs, people affected by rare metabolic abnormalities were at severe risk during the pandemic because of lysosomal dysfunction and inflammatory cascades activation. The major reason involved was the fear of getting infected at the hospital or during traveling to the hospital by using public transportation.


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Many patients missed their infusions in March 2020, due to the inadequacy of hospital services dealing with the burden of COVID-19 patients. Patients claimed to feel anxious during hospital admissions or regarding drug supply, and studies revealed that they had depression and an increased amount of anxiety. Thus, the facts mentioned above indicate the overall negative impact of the COVID-19 pandemic on the global enzyme replacement therapy market.




Browse Adjoining Reports:
Pompe Disease Treatment Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Type (Late-Onset Pompe Disease, Classic Infantile-Onset Pompe Disease, Non-Classic infantile-onset Pompe Disease); Therapy (Enzyme Replacement Therapy, Gene Therapy, Others) and Geography

Pompe Disease Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Therapy Type (Enzyme Replacement Therapy, Substrate Reduction Therapy); Molecule Type (Biologics, Small Molecules); Route of Administration (Oral, Parenteral); Dosage Forms (Solid, Liquid) and Geography

Gaucher Disease Treatment Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Disease Type (Neuropathic, Perinatal Lethal, Slow Neurogenic Decay); Treatment Approach (Enzyme Replacement Therapy, Substrate Reduction Therapy, Surgery); End Users (Hospitals, Ambulatory Surgical Centers, Clinical research institutes) and Geography

Gaucher Disease Drugs Market Forecast to 2028 - Covid-19 Impact and Global Analysis - By Disease Type ( Type I, Type II, Type III ); Treatment Type ( Enzyme Replacement Therapy (ERT), Substrate Reduction Treatment (SBT) ) and Geography

Fabry Disease Treatment Market Forecast to 2028 - Covid-19 Impact and Global Analysis - by Drug Type (Enzyme Replacement Therapy (ERT), Chaperone Treatment, Substrate Reduction Therapy (SRT), Others)

Mucopolysaccharidosis Treatment Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Treatment (Enzyme Replacement Therapy, Stem Cell Therapy); MPS Type (MPS-I, MPS-II, MPS-IV, MPS-VI, MPS-VII, Others); End User (Hospitals, Specialty Clinics, Others) and Geography

Metabolic Disorders Therapeutics Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Type (Gene Therapy, Drug Therapy, Enzyme Replacement Therapy, Cellular Transplantation, Small Molecule Based Therapy, Substrate Reduction Therapy); Indication (Lysosomal Storage Diseases, Diabetes, Obesity, Inherited Metabolic Disorders, Hypercholesterolemia); Route of Administration (Oral, Parenteral, Others), and Geography

Metabolism Drugs Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Therapy Type (Enzyme Replacement Therapy, Substrate Reduction Therapy, Small Molecule Drugs, Others); Application (Glycogen Metabolism Disease, Lipid Metabolism Disease, Amino Acid Metabolism Disease, Others); Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies) and Geography

Lysosomal Acid Lipase Deficiency Treatment Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Disease Indication (Cholesteryl Ester Storage Disease (CESD), and Wolman Disease (WD)); Treatment Type (Liver Transplant, Enzyme Replacement Therapy, Lipid-Modifying Agents, and Others) and Geography




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