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Enzyme Replacement Therapy Market

Enzyme Replacement Therapy Market by Therapeutic Condition (Fabry Disease, Gaucher Disease, Mucopolysaccharidosis, MPS I, II, IVA, VI & VII, Pompe Disease, Lysosomal Acid Lipase Deficiency, Others), Route of Administration (Oral, Injectable), Distribution Channel & Region – Forecast 2022 – 2028

Enzyme Replacement Therapy Market by Therapeutic Condition (Fabry Disease, Gaucher Disease, Mucopolysaccharidosis, MPS I, II, IVA, VI & VII, Pompe Disease, Lysosomal Acid Lipase Deficiency, Others), Route of Administration (Oral, Injectable), Distribution Channel & Region – Forecast 2022 – 2028

Enzyme Replacement Therapy Market - Analysis, Outlook, Growth, Trends, Forecasts

Enzyme Replacement Therapy Market Outlook (2022-2028)

[305 Pages Report] The global Enzyme Replacement Therapy Market is set to be valued at US$ 9.3 Bn in 2022, and is predicted to expand at a CAGR of 6.7% to attain a net worth of US$ 13.8 Bn by the end of 2028. 

Enzyme Replacement Therapy Market Size (2022)

US$ 9.3 Bn

Revenue Estimation (2028)

US$ 13.8 Bn

Global Market Growth Rate (2022-2028)

6.7% CAGR

North America Market Share


Revenue from enzyme replacement therapy (ERT) accounts for around 63% share of the global hormone replacement market. Increasing prevalence of rare diseases has majorly led to the deployment of enzyme replacement therapies, and medical research is expected to further advance these developments.

Enzyme Replacement Therapy Demand Analysis (2013 to 2021) Vs Market Predictions (2022 to 2028)

The enzyme replacement therapy market is expected to flourish over the coming years as instances of rare and unknown diseases increase on a global scale. There has been a surge in the emergence of rare and ultra-rare diseases over the past few years, and this trend is not expected to slow down anytime soon. The need for orphan disease management and orphan drugs has seen a substantial increase as rare diseases have become more frequent.

Enzyme replacement therapy demand increased at a CAGR of 6.4% from 2013 to 2021 and ended up with a value of US$ 8.8 Bn in 2021. Increasing instances of rare diseases that require unique treatment approaches, rising availability of enzyme replacement therapies, increasing awareness, and less tough regulations for rare disease treatment are primarily driving demand for ERT.

Increasing medical research and rising awareness about enzyme replacement therapies are expected to be common factors propelling ERT market growth across the world.

All in all, the global enzyme replacement therapy market is predicted to progress at a CAGR of 6.7% from 2022 to 2028.

Which Region is Most Lucrative for Enzyme Replacement Therapy Providers?

This enzyme replacement therapy industry survey by FMI covers market statistics on a global scale, and especially gives metrics specific to regions such as North America, Latin America, Europe, East Asia, South Asia & Pacific, and the Middle East & Africa (MEA).

Leading the global market landscape, the North America enzyme replacement therapy market holds a dominant market share of 28.6% in 2022.

This region is expected to be one of the most lucrative markets for enzyme replacement treatment, and ERT demand is expected to be driven by rising healthcare expenditure in the region. The U.S. is expected to lead the North American enzyme replacement therapy industry.

Following closely is the Western Europe enzyme replacement therapy market. The region, over the past few years, has experienced tremendous increase in rare disease instances, and this has influentially shaped the enzyme replacement therapy demand growth.

For instance, Germany and the U.K. have a high incidence of Fabry’s disease and other rare diseases as well that drives demand for enzyme replacement therapy.

East Asia, South Asia, and the Pacific regions are expected to exhibit lucrative opportunities for enzyme replacement therapy providers over the coming years.

Rising disposable income, developing healthcare systems, increasing awareness are major factors influencing the enzyme replacement therapy market potential in these regions. Japan, India, and China are expected to be leading nations in these regions.

Demand for enzyme replacement treatment in MEA is anticipated to rise at a steady pace over the forecast period; the region currently holds around 3% of the global market share.

Country-wise Analysis

What’s Driving Demand for Enzyme Replacement Therapy in Japan?

Japan is one of the most technologically advanced nations in the world and has an advanced healthcare system to accommodate the nation’s healthcare needs in the most efficient manner possible. Advancements in the medical research field in Japan are expected to propel enzyme replacement therapy market growth majorly in the nation.

Apart from this, growing geriatric population and increasing incidence of rare diseases are also anticipated to complement enzyme replacement therapy demand over the forecast period. Japan accounts for nearly 23% share of the global enzyme replacement therapy market in terms of volume, at present.

How Can Enzyme Replacement Therapy Providers Maximize their Revenue Potential in the U.S.?

The U.S. is one of the most important healthcare markets of the world and also one of the most advanced ones. Enzyme replacement therapy solution providers can target this nation to take advantage of the advanced and developed healthcare infrastructure that provides a lucrative setting for major medical research breakthroughs and promotes novel drug development practices.

Adoption of advanced and innovative technologies, presence of leading ERT providers, and increasing investments in medical research & development are some other factors driving demand for enzyme replacement therapy in the U.S.

Leading as well as new enzyme replacement therapy providers can target this market to make their mark in the global industry landscape and further establish themselves.

Category-wise Analysis

Which Route of Administration for ERT is Expected to Hold Highest Share?

Administration of enzyme replacement therapy is majorly through oral or injectable means, and of these two, injectable ERT is expected to lead the global market in terms of share over the forecast period. Increase in demand for injectable ERT drugs is expected to majorly drive the injectable segment to domination over the coming years.

Injectable ERT is predicted to account for more than 80% of the global enzyme replacement therapy market while accounting for major revenue generation opportunities.

COVID-19 Crisis Analysis

The COVID-19 pandemic completely changed the way the world approached healthcare and led to some major changes and advancements in the medical industry. Coronavirus infections spread rampantly throughout the world and revolutionized the healthcare systems across the world. Countries went into a complete lockdowns and many essential activities and operations stopped abruptly and halted markets.

The ERT industry was also disrupted due to the abrupt shutdown of supply and demand chains across the world. The enzyme replacement therapy market also saw a negative impact on the research and development aspect due to lockdown restrictions across the world.

But this has changed and is expected to change further in the post-pandemic era as the world returns to normalcy and research & development related to enzyme replacement therapy pick up pace.

Competitive Landscape

Enzyme replacement therapy providers are focusing on medical research & development to develop effective treatments for various rare diseases. Companies developing enzyme replacement therapies can target regions where instances of rare diseases are frequent and rising.

  • In August 2021, the U.S. Food and Drug Administration (FDA) approved the use of Nexviazyme (avalglucosidase alfa-ngpt) for the treatment of Pompe disease. The approved drug would be used in the treatment of patients of one year of age or older with late-onset Pompe disease. It is an enzyme deficiency that leads to the accumulation of complex sugar called glycogen in skeletal and heart muscles, and is a rare disease.
  • In May 2021, Aceragen, a biopharmaceutical firm focused on transformational therapeutics, announced the acquisition of Enzyvant’s RVT-801 (now ACG-801). It is an investigational enzyme replacement therapy for ceramidase deficiency presenting itself as Farber disease for which no disease-specific therapy is present.

Enzyme Replacement Therapy Industry Report Scope



Forecast Period


Historical Data Available for


Market Analysis

US$ Mn for Value

Key Regions Covered

  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia & Pacific
  • Middle East & Africa (MEA)

Key Countries Covered

  • United States
  • Canada
  • Brazil
  • Mexico
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • China
  • Japan
  • South Korea
  • India
  • Indonesia
  • Malaysia
  • Singapore
  • Australia
  • New Zealand
  • Turkey
  • South Africa
  • and GCC Countries

Key Market Segments Covered

  • Therapeutic Condition
  • Route of Administration
  • Distribution Channel
  • Region

Key Companies Profiled

  • Sanofi S.A. (Genzyme Corporation)
  • Shire plc.
  • Pfizer Inc.
  • Alexion Pharmaceuticals Inc.
  • BioMarin Pharmaceutical Inc.
  • Ultragenyx Pharmaceutical Inc.
  • Johnson & Johnson Services Inc.
  • Allergan plc.
  • Leadiant Biosciences Inc.


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Key Segments of Enzyme Replacement Therapy Industry Survey

Enzyme Replacement Therapy Market by Therapeutic Condition:

  • Enzyme Replacement Therapy for Fabry Disease
  • Enzyme Replacement Therapy for Gaucher Disease
  • Enzyme Replacement Therapy for Mucopolysaccharidosis
    • MPS I
    • MPS II (Hunter Syndrome)
    • MPS IVA (Morquio Syndrome, Type A)
    • MPS VI (Maroteaux-Lamy Syndrome)
    • MPS VII (Sly Syndrome)
  • Enzyme Replacement Therapy for Pompe Disease
  • Enzyme Replacement Therapy for Lysosomal Acid Lipase Deficiency
  • Others

Enzyme Replacement Therapy Market by Route of Administration:

  • Oral Enzyme Replacement Therapy
  • Injectable Enzyme Replacement Therapy

Enzyme Replacement Therapy Market by Distribution Channel:

  • Hospital Pharmacies
  • Specialty Treatment Pharmacies
  • Retail Pharmacies

Enzyme Replacement Therapy Market by Region:

  • North America Enzyme Replacement Therapy Market
  • Latin America Enzyme Replacement Therapy Market
  • Europe Enzyme Replacement Therapy Market
  • East Asia Enzyme Replacement Therapy Market
  • South Asia & Pacific Enzyme Replacement Therapy Market
  • Middle East & Africa (MEA) Enzyme Replacement Therapy Market

Key Questions Answered in the Report

At what pace is the enzyme replacement therapy market expected to rise?

The global enzyme replacement therapy market is predicted to expand at a CAGR of 6.7% from 2022 to 2028.
In 2022, the global enzyme replacement therapy market is set to be worth US$ 9.3 Bn.
Leading players such as Sanofi S.A. (Genzyme Corporation), Shire Plc., Pfizer Inc., Alexion Pharmaceuticals Inc., BioMarin Pharmaceutical Inc., Ultragenyx Pharmaceutical Inc., etc., are profiled in this report.
Enzyme replacement therapy market revenue is predicted to attain an estimated value of US$ 13.8 Bn by the end of 2028.
The Japan ERT market accounts for a share of 22.8% in the global market.

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