Pune, India, March 09, 2022 (GLOBE NEWSWIRE) -- The global enzyme replacement therapy market size is predicted to reach USD 20.58 billion by 2028 at a CAGR of 8.8% during the forecast period. Fortune Business InsightsTM has presented this information in its report titled, “Global Enzyme Replacement Therapy Market, 2022-2028”. Enzyme replacement therapy is a method in which patients are given various types of enzymes to help them overcome enzyme shortages or malfunctions. The increasing prevalence of rare, chronic, and inherited ailments, such as lysosomal storage diseases and genetic disorders, is driving the need for efficient treatment alternatives. The market size stood at USD 10.56 billion in 2020 and USD 11.43 billion in 2021.
Industry Development-
January 2021: Hunterase ICV has been approved for production and sale in Japan to treat Hunter syndrome, according to Clinigen Group plc.
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Report Scope & Segmentation
| Report Coverage | Details |
| Forecast Period | 2021 to 2028 |
| Forecast Period 2021 to 2028 CAGR | 8.8% |
| 2028 Value Projection | USD 20.58 Billion |
| Base Year | 2020 |
| Market Size in 2020 | USD 10.56 Billion |
| Historical Data for | 2017 to 2019 |
| No. of Pages | 150 |
| Segments covered | By Drugs, Route of Administration, Indication, end-Users and Geography |
| Growth Drivers | High Cost of Treatment to Limit Market Growth |
| Higher Adoption of Pancrelipase for the Treatment of EPI Led to its Dominant Position in 2020 | |
| Increasing Prevalence of Rare Diseases to Drive Market Growth |
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Increased Government Financing and Awareness in Individuals to Drive Market Growth
The global prevalence of lysosomal storage disorders such as Gaucher, Fabry, Pompe, and MPS is gradually increasing. According to data published by the National Institute of Neurological Disorders and Stroke in August 2021, approximately one in 40,000 people in the U.S. suffers from Pompe disease, with an estimated 32,950 cases. According to the National Fabry Foundation, the overall Fabry patient population in the U.S. was roughly 7,713 in May 2020. As a result, the presence of a large patient population with uncommon lysosomal storage disorders raises demand for effective treatment alternatives such as enzyme replacement therapy.
Furthermore, increased government and non-profit initiatives in various countries to raise public awareness about rare diseases lead to a progressive increase in the detection rate of uncommon diseases. As a result, major factors such as favorable reimbursement policies and government financing for treatment in developed nations are increasing the rate of acceptance of this therapy. As a result, this is driving the market expansion over the projection period. However, shortage of experienced healthcare personnel for this therapy and insufficient reimbursement regulations in emerging nations are limiting the global enzyme replacement therapy market growth.
COVID-19 Positively Impacted the Market
The global market has benefited from the COVID-19 pandemic. Major players in this market, such as BioMarin, Sanofi, AbbVie Inc., and Takeda Pharmaceutical Company Limited, have seen a significant increase in revenue from drug sales used in this therapy. For example, BioMarin reported 14.6% increase in revenue from drug sales used in this therapy in 2020. In addition, AbbVie Inc. reported 7.0% increase in sales of CREON, which is used to treat exocrine pancreatic insufficiency, in 2020 compared to 2019.
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Furthermore, during the pandemic, safety precautions and recommendations were observed in many healthcare settings, including hospitals and infusion facilities, resulting in the continuation of this therapeutic method. Furthermore, boosting healthcare providers' efforts to give patient training sessions for self-administration avoided treatment delays during the COVID-19 pandemic. The enzyme replacement technique, for example, was continued during the pandemic for Fabry disease in certain safe healthcare settings, according to a paper released by Oxford University Press. Furthermore, according to the safety requirements, treatment in these settings proved useful in overcoming the danger of developing COVID-19.
Drug Class, Route of Administration, Indication, End-User, and Region are Studied
On the basis of drug class, the market is divided into Imiglucerase, Agalsidase, Alglucosidase Alfa, Pancrelipase, Idursulfase, Laronidase, Velaglucerase alfa, Elosulfase alfa, Asfotase alfa, Galsulfase, and others. On the basis of route of administration, the market is split into oral and parenteral. On the basis of indication, the market is divided into Pompe Disease, Type 1 Gaucher disease, MPS (Mucopolysaccharidosis), Fabry Disease, Hypophosphatasia, Exocrine Pancreatic Insufficiency (EPI), and others. On the basis of end-user, the market is divided into home care settings & infusion centers and hospitals. Geographically, the market is classified into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
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North America to be a Leader of the Global Market
In 2020, the market in North America was estimated to be worth USD 5.09 billion. The increased prevalence of rare lysosomal storage disorders, such as Fabry disease, Pompe disease, and others, and the strong direct presence of key industry participants in this region contribute to this region's dominance in the global market. In addition, the existence of a large number of infusion facilities in this region is boosting the market growth. According to Healio, about 3,600 infusion sites were open in the U.S. in 2019, serving a huge patient population undergoing enzyme replacement therapy for a variety of uncommon disorders.
In 2020, Europe had the second-largest share of the global market. This is attributed to advantageous payment policies in a few European nations for several rare lysosomal disorders such as Gaucher disease, MPS, and others. According to F1000 Research Ltd., the Polish National Health Fund developed a national drug program in 2019, under which a patient was reimbursed for the first time in ERT for Fabry disease.
The market in Asia Pacific is also growing due to significant advancements in healthcare infrastructure and the rising need for treatment alternatives for rare diseases. During the projection period, Asia Pacific is expected to develop at a considerable CAGR. The rising number of patients suffering from uncommon conditions as well as increased government and private-sector measures to raise knowledge about this therapy is surging the demand and adoption of this therapy among the general public, thereby increasing the global enzyme replacement therapy market share.
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Key Players to Offer a Wide Range of Products to Create Strong Market Presence
BioMarin, Sanofi, AbbVie Inc., and Takeda Pharmaceutical Company Limited are among the market's most established participants. One of the main reasons for these firms' market domination is their significant focus on acquisition and alliance with other important market players to increase their product reach globally. For example, in September 2021, Takeda Pharmaceutical Company Limited signed a collaboration and partnership arrangement with JCR Pharmaceuticals Co., Ltd. with the goal of commercializing JR-141 outside of the U.S. to treat Hunter syndrome.
Emerging players, such as TEIJIN LIMITED, Clinigen Group plc, and others, on the other hand, are constantly focusing on new product introductions for various therapeutic diseases. In addition, a strong focus on obtaining regulatory approval is supporting them in meeting the increased demand for the treatment of lysosomal storage disorders in both developed and developing countries. For example, in May 2019, TEIJIN LIMITED released Revcovi 2.4 mg, with the goal of treating Adenosine deaminase (ADA) insufficiency via parenteral administration.
List of Key Market Players:
- BioMarin (San Rafael, U.S.)
- Leadiant Biosciences, Inc. (Gaithersburg, U.S.)
- Pfizer Inc. (New York, U.S.)
- Sanofi (Paris, France)
- AbbVie Inc. (Lake Bluff, U.S.)
- Takeda Pharmaceutical Company Limited (Tokyo, Japan)
- JCR Pharmaceutical Co., Ltd. (Ashiya, Japan)
- Nestlé (Vevey, Switzerland)
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