Enzyme Replacement Therapy Market Growth Drivers and Challenges:
Growth Drivers
- Growing Government Spending on Healthcare Infrastructure – Governments of different nations are focusing on expanding the healthcare sector to treat people and combating health issues. As a result of rising investment in healthcare infrastructure, the size of enzyme replacement therapy market is expected to expand in the assessment period. According to an estimate, in 2020, the United States spent more than USD 3 trillion on healthcare.
- Rise in Prevalence of Rare Disease - There are between 1,000 and 2,000 new occurrences of ALSP each year, which is a rare, inherited, autosomal dominant neurological condition with strong penetrance that affects an estimated 10,000 persons in the US.
- Growing Cases of Pompe Disease - Since enzyme replacement therapy (ERT) serves as the only viable treatment option for Pompe disease. Therefore, increasing cases of the illness are anticipated to contribute to market expansion. ERT has contributed to disease course stabilization with motor and pulmonary modifications in patient populations with late-onset Pompe disease. According to experts, there are between approximate 4,000 and about 9,000 cases of Pompe disease globally.
- Technology Advancement - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that Lamzede (velmanase alfa), a long-term enzyme replacement therapy for adults, adolescents, and children with mild to moderate forms of alpha-mannosidosis, be given marketing authorization in the European Union (EU).
- Growing Genetic Disorder - A genetically based ailment will affect roughly 6 out of every 10 individuals across the globe.
Challenges
- Lack of Awareness - Lack of awareness about enzyme replacement therapy among developing nations is slowing down the adoption rate of enzyme replacement therapy. Also, the deficiency of technology and adequate infrastructure is expected to hamper the market growth.
- High Cost of Enzyme Replacement Therapy
- Stringent Reimbursement Policies
Enzyme Replacement Therapy Market Size and Forecast:
|
Base Year |
2025 |
|
Forecast Period |
2026-2035 |
|
CAGR |
8.8% |
|
Base Year Market Size (2025) |
USD 12.74 billion |
|
Forecast Year Market Size (2035) |
USD 29.61 billion |
|
Regional Scope |
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Browse key industry insights with market data tables & charts from the report:
Frequently Asked Questions (FAQ)
In the year 2026, the industry size of enzyme replacement therapy is assessed at USD 13.75 billion.
The global enzyme replacement therapy market size was valued at more than USD 12.74 billion in 2025 and is expected to register a CAGR of over 8.8%, exceeding USD 29.61 billion revenue by 2035.
The Asia Pacific enzyme replacement therapy market commands the largest share by 2035, driven by rising patient population, disposable income, healthcare growth, and government support.
Key players in the market include BioMarin, Leadiant Biosciences, Inc., Pfizer Inc., Sanofi Aventis, AbbVie Inc., Takeda Pharmaceutical Company Limited, JCR Pharmaceutical Co., Ltd., AstraZeneca plc, Clinigen Limited, Teijin Limited.
