Global Enzyme Replacement Therapy Market - 2022-2029

Market Overview

Enzyme Replacement Therapy Market was valued at USD XX million in 2021. It is forecasted to reach USD XX million by 2029, growing at a CAGR of 5.1 % during the forecast period (2022-2029).

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.

Market Dynamics: 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.

Market Segmentation: 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.

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.

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: 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.