Enzyme Replacement Therapy Market Size, Share, Industry, Forecast and outlook (2023-2030)

Global Enzyme Replacement Therapy Market Is Segmented By Enzyme Type(Alglucerase alfa, Imiglucerase, Taliglucerase alfa, Velaglucerase alfa), By Indication Type Segment (Gaucher Disease, Fabry Disease, Pompe Disease, Hurler Syndrome, Others), By Route of Administration (Oral, Injectable), By End-Users (Hospitals & Clinics, Homecare, Others), And By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030.

Global Enzyme Replacement Therapy Market Overview

(200pages) A Report by DataM Intelligence estimates the Global Enzyme Replacement Therapy market to grow at a high CAGR Of 5.1%during the forecast period 2023- 2030. The market is expected to grow due to increasing demand from Hospitals & Clinics, Homecare. The competitive rivalry intensifies with AbbVie PLC, Alexion Pharmaceuticals Inc.., Allergan plc, and others operating in the market.

Enzyme Replacement Therapy (ERT) is the treatment involved for rare diseases. According to Global genes.org, around 80.0% of rare diseases are categorized under genetic origin. There are more than 7,000 different types of rare diseases discovered globally. Around 50.0% of the people globally affected by rare diseases are infants and children. The FDA-approved drugs are not available for 95.0% of rare diseases, per the Kakkis Every life Foundations. ERT replenishes an enzyme that is not present in the body. ERT is available for diseases such as Gaucher disease, Fabry disease, mucopolysaccharidosis, Pompe disease, and lysosomal acid lipase deficiency. An increase in healthcare spending and the rising prevalence of rare diseases globally are among the key factors driving the enzyme replacement therapy market. Moreover, the growth in the demand for enzyme replacement therapy to improve the treatment of rare diseases is expected to drive the market during the forecast period.

As per DataM Intelligence, Enzyme Replacement Therapy Market study analysis offers an in-depth outlook on the market containing quantitative and qualitative data. It gives an outlook and forecast of the global market based on market segmentation. It also provides global Enzyme Replacement Therapy Market size, and growth, along with the latest trends, opportunities, and forecast till 2029 for the global market with esteem to major countries such as the United States, Canada, Brazil, Germany, Italy, Spain, United Kingdom, Russia, European countries, United Arab Emirates, Saudi Arabia, South Africa, Japan, China, India, South Korea, Australia, and rest of the countries over the globe.

Among all regions, the North American region is expected to hold the largest share of the global market over the forecast period. Enzyme Replacement Therapy Market in the United States and Canada produces the utmost share. Whereas the European Enzyme Replacement Therapy Market is projected to continue its presence globally during the period of 2023- 2030.

Global Enzyme Replacement Therapy Market Scope

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Global Enzyme Replacement Therapy Industry Trends

Rising prevalence of rare diseases drives market growth.

According to the data published in 2021 by the Orphan drug Act, a rare disease is a disease or condition that impacts less than 200,000 people in the U.S. There are about 7000 known rare diseases, and collectively about 1 in 10 people (or 30 million people) in the United States have a rare disease. The most commonly occurring lysosomal storage diseases include Fabry, Pompe, Gaucher, various forms of MPS, and SCID diseases. Such type of rare diseases occurs in low frequencies. For instance, Gaucher’s disease is expected to be prevalent in 1 in over 100,000 individuals, according to Orphanet. The low prevalence of rare diseases is one of the key aspects of its limited growth in the pharmaceutical industry.

Also, Government initiatives for rare diseases drive market growth. Governments are significantly focussing on driving R&D in rare diseases to address the rising prevalence of rare diseases across the globe. The Government of the U.K. has set out a strategy to escalate the diagnosis and treatment of rare diseases. As per the framework, the government has planned to improve the lives of over 3.5 million people with rare diseases in the country. This would speed up the diagnosis and will simultaneously increase the awareness, treatment, and care for rare diseases. Therefore, with such supportive government initiatives, the demand for enzyme replacement therapy will increase during the forecast period.

However, the wide availability of alternative treatment solutions lack of skilled healthcare professionals is a factors expected to restrict the market growth during the forecast period. 

Global Enzyme Replacement Therapy Market Segmentation Analysis

Agalsidase Alfa segment accounted for the highest share in global enzyme replacement therapy market.

Agalsidase Alfa segment led the overall market with a share in 2022 and is likely to register the fastest CAGR during the forecast period. It is a recombinant formulation of human a-galactosidase (AGAL) that is especially being used for the treatment of Fabry disease. This enzyme is manufactured by Shire, a subsidiary of Takeda Pharmaceutical, with the brand name Replagal.

Based on the indication type, the enzyme replacement therapy market has been classified into Gaucher disease, Fabry disease, Pompe disease, and hurler syndrome. Gaucher disease segment dominated the global enzyme replacement therapy market in 2022. It is attributed to the high incidence of Gaucher disease across the globe. It is expected to occur in one of 50,000 to 10,000 individuals. According to Clinicaltrials.gov, more than 60 studies are undergoing for Gaucher’s disease, primarily funded by pharmaceutical companies. Considering such wide scope analyzed for Gaucher disease, the market for enzyme replacement therapy will increase during the forecast period.

Global Enzyme Replacement Therapy Geographical Penetration

North America is the dominating region during the forecast period.

North America dominates the global enzyme replacement therapy market with the largest share in terms of value and volume globally, followed by Europe. The US dominated the North America enzyme replacement therapy market in 2019. The adoption of advanced technologies, and well-developed healthcare infrastructure, are certain factors that will enhance the market growth in the region during the forecast period.

Asia Pacific is expected to project a considerable CAGR in the market during the forecast period. The expansion of healthcare giants in rapidly emerging markets, such as China, India, and others, drives the market growth. These multinational companies are significantly investing in the healthcare sector in the Asia Pacific region.

Global Enzyme Replacement Therapy Competitive Landscape

The enzyme replacement therapy market is highly competitive, owing to the large presence of enzyme replacement therapy brands. The key enzyme replacement therapy players include AbbVie PLC, Alexion Pharmaceuticals Inc., Allergan plc, BioMarin Pharmaceutical Inc., Horizon Pharma Public Limited Company, Protalix Biotherapeutics, Recordati Rare Diseases, Johnson & Johnson Services Inc., Sanofi SA, Shire PLC. The crucial players are adopting new product launches and expansion strategies for global growth in the enzyme replacement therapy market. In January 2021, Horizon Therapeutics plc acquired Viela Bio, Inc. to significantly expand the development pipeline and grow the rare disease medicine portfolio. This acquisition Strengthens current R&D capability by adding a team with early-stage research, translational and clinical development capabilities along with deep scientific knowledge in autoimmune and severe inflammatory diseases. In June 2022, Recordati Rare Diseases announces positive data from phase III Linc 4, Phase III Linc 3, and Illustrate ISTURISA studies presented at ENDO 2022 meeting in Atlanta, Georgia. This drug is well tolerated in most patients without any side effects.

COVID-19 Impact on Global Enzyme Replacement Therapy

Positive impact on the global enzyme replacement therapy market.

The people dealing with the Fabry disease are at a major risk for the development of rare diseases. The impact of COVID-19 on patients dealing with Fabry disease and undergoing enzyme replacement therapy is still unknown. However, the new diagnosis rate has reduced to some extent; the market is mainly driven by the people that were previously diagnosed with the disease. Therefore, considerable growth can be projected in the enzyme replacement therapy market in 2020.