The global enzyme replacement therapy market was valued at USD 9,955.4 Million in 2019 and is projected to reach USD 16,362.2 Million by 2027, expanding at a CAGR of 6.8% during the forecast period. Enzyme replacement therapy (ERT) is one of the important medical treatments prescribed to provide the enzymes that are deficient in the body. It replenishes the deficient enzymes in the patient’s body either through the intravenous (IV) or oral routes of administration. The IV route is widely accepted by people, these drugs are easily and rapidly absorbed in the body. Enzyme deficiencies in body can hamper the metabolism of glycogen, which results in the accumulation of glycogen in tissue, bones, and cardiac muscle. Deficiency of enzyme can result in a life-changing or life-threatening conditions. Enzyme replacement therapy is used for the treatment of ailments such as Gaucher Disease, Fabry Disease, Pompe Disease, SCID, and MPS Disease. These diseases are genetic disorders and can be transferred from parents to their children, if both the parents suffer from the ailment. These diseases cannot be cured completely; however, they can be controlled by replacing the enzymes that are lacking in the human body.
In terms of route of administration, the enzyme replacement therapy market has been bifurcated into injectable agents and oral agents. Solid dosage form in enzyme replacement therapy are given through the oral route of administration to fulfil the enzyme deficiency in the body. Enzyme replacement therapy through oral route include the tablets dosage form containing the enzyme. These enzymes are administered to fulfil the enzyme deficiency in the patient’s body. Zavesca is the oral drug developed by Actelion Pharmaceuticals Ltd indicated for the treatment of Gaucher’s disease. The oral route is more convenient than the parenteral route, as these drugs are easy to store and transport. Moreover, tablets are premeasured doses, which eliminates the need for measuring the medicine. These factors are fuelling the growth of oral route of administration segment. Parenteral and oral medicines are available in market and are used for the treatment of ERT to treat diseases such as Gaucher’s diseases and Fabry diseases. Key players in the market are focused on developing drugs for both these routes of administration.
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Market Dynamics
Increased Prevalence of Chronic Diseases
Increasing prevalence of chronic diseases and life-threatening lysosomal storage diseases such as Gaucher, Pompe, Fabry, and SCID is expected to boost the global enzyme replacement therapy market. Rising awareness among people about the availability of ERT is encouraging and driving the market growth.
Technological Advancement Leading to Adoption of Technologies
Growing technological advancements have led to the adoption of technologies, which has increased the focus of manufacturers on drug development processes and the development of innovative therapies. This, in turn, is expected to propel the market growth during the forecast period. High absorption rate and rapid drug delivery through parenteral route of administration is driving the demand for parenteral dosage. Increasing financial support for rare diseases (including lysosomal storage diseases) by government and non-governmental organizations (NGOs) is projected to boost the market.
Regional Outlook
In terms of regions, the market has been fragmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America is a promising region for the market. It constituted a 31.1% share of the market in 2019. Asia Pacific held significant market share of 25.7% in 2019. Availability of technological advancements and awareness among people drive the market in North America, followed by Europe. A majority of manufacturers are focused on developing the enzyme replacement therapy for treating a number of diseases. This is expected to boost the market during the forecast period. The market in Asia Pacific is expected to grow at a significant pace due to increasing population and growing prevalence of chronic and rare diseases.
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Competitive Landscape
- Key players in the market include Sanofi, Takeda Pharmaceutical Company Limited, BioMarin, AbbVie Inc, Alexion Pharmaceuticals, Inc., Horizon Therapeutics plc, RECORDATI S.p.A., PROTALIX BIOTHERAPEUTICS, INC., Allergan, Pfizer Inc., and Leadiant Biosciences, Ltd. These companies are considered as key manufacturers of enzyme replacement based on their revenue, research & development (R&D) activities, regional presence, and supply chain management system.
- The players are adopting key strategies such as acquisition, product launch, and geographical expansion where potential opportunity for the enzyme replacement is added in the company’s capacity.
- In March 8, 2018, Sanofi acquired Bioverativ Inc. The acquisition has helped the company strengthen its pharmaceutical segments. The company’s net sales at a constant exchange rate rose by 2.5%, reflecting the acquisition of Bioverativ Inc.’s rare blood disorder products.
- In 2018, January 8, 2019, Takeda Pharmaceutical Company Limited acquired SHIRE PLC. The acquisition helped the company with a substantial rise in their product offerings and their geographical presence.
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