Enzyme Replacement Therapy Market Size - By Enzyme (Alglucosidase alfa, Agalsidase beta, Imiglucerase), Indication (Gaucher, MPS, Pompe, SCID, Fabry), Route of Administration, End-user, Global Forecast 2023-2032

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Enzyme Replacement Therapy Market size is set to exhibit over 7% CAGR from 2023 to 2032, driven by the broader acceptance of biologics and standard treatments for various genetic disorders.

Biologics, including enzyme replacement therapy (ERT) are gaining prominence as advanced and targeted treatments for genetic disorders, such as Gaucher disease and Fabry disease. The therapeutic efficacy and specificity of biologics and the subsequently rising adoption amongst patients and healthcare providers will also boost the market growth. For instance, in November 2023, Takeda's ADZYNMA received clearance from the U.S. FDA as the first and only recombinant ADAMTS13 enzyme replacement medication for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP).

The enzyme replacement therapy industry is segmented into enzyme type, indication, route of administration, end-user, and region.

With respect to enzyme type, the market value from imiglucerase segment is anticipated to attain 8.4% CAGR from 2023-2032. Imiglucerase has emerged as an effective enzyme replacement therapy for the treatment of Gaucher disease. The expanding patient pool coupled with the rising awareness and diagnosis of rare diseases is amplifying the demand for Imiglucerase-based ERTs. Moreover, the rising advancements in biotechnology and continuous research will contribute to the segment growth.

Based on end-user, the ERT industry from the infusion centers segment is likely to record 7.5% CAGR through 2032. The rising prevalence of enzyme deficiency disorders coupled with the increasing acceptance of enzyme replacement therapies is adding significantly to the demand for infusion center services. Additionally, the increasing patient preference for infusion centers due to the availability of convenient and controlled environment for the treatment is likely to support the segment growth.

Regionally, the Europe enzyme replacement therapy market size is slated to observe 6.8% CAGR through 2032 driven advanced healthcare infrastructure, increasing awareness, and the rising prevalence of enzyme deficiency disorders. Moreover, collaborations between pharmaceutical companies and research institutions in Europe will contribute to increasing advancements in ERT technologies. Additionally, the growing commitment to improving patient outcomes through innovative therapies will augment the regional industry outlook. For instance, in May 2023, the European Commission granted marketing authorization for pegunigalsidase alfa, the Poly (ethylene glycol) (PEG) ylated enzyme for Fabry disease.

Product Code: 6680

Chapter 1 Methodology & Scope

1.1 Market definition
1.2 Base estimates & calculations
1.3 Forecast calculation
1.4 Covid-19 impact analysis at global level
1.5 Data validation
1.6 Data sources
- 1.6.1 Primary
- 1.6.2 Secondary
  - 1.6.2.1 Paid sources
  - 1.6.2.2 Public sources

Chapter 2 Executive Summary

2.1 Enzyme replacement therapy 360 degree synopsis, 2018 - 2032 (USD Million)
- 2.1.1 Business trends
- 2.1.2 Region trends
- 2.1.3 Enzyme type trends
- 2.1.4 Indication trends
- 2.1.5 Route of Administration trends
- 2.1.6 End-user trends

Chapter 3 Enzyme Replacement Therapy Market Insights

3.1 Industry landscape, 2018 - 2032 (USD Million)
3.2 Industry impact forces
- 3.2.1 Growth drivers
  - 3.2.1.1 Increasing incidence of rare genetic disorders
  - 3.2.1.2 Rising demand for effective treatment options
  - 3.2.1.3 Growing awareness of rare genetic diseases
  - 3.2.1.4 Advancements in biotechnology and genetic engineering
- 3.2.2 Industry pitfalls & challenges
  - 3.2.2.1 High cost of therapy
  - 3.2.2.2 Limited availability of ERT products
3.3 Growth potential analysis
- 3.3.1 By enzyme type
- 3.3.2 By indication
- 3.3.3 By route of administration
- 3.3.4 By end-user
- 3.3.5 By region
3.4 COVID-19 impact analysis
3.5 Regulatory landscape
3.6 Technology landscape
3.7 Porter's analysis
3.8 PESTEL analysis

Chapter 4 Competitive Landscape, 2022

4.1 Introduction
4.2 Company matrix analysis, 2022
4.3 Competitive positioning matrix, 2022
4.4 Strategic dashboard, 2022

Chapter 5 Enzyme Replacement Therapy Market Estimates and Forecast, By Enzyme Type, 2018-2032 (USD Million)

5.1 Key trends, by enzyme type
5.2 Imiglucerase
5.3 Agalsidase beta
5.4 Taliglucerase
5.5 Velaglucerase alfa
5.6 Laronidase
5.7 Alglucosidase alfa
5.8 Galsulfase
5.9 Idursulfase
5.10 Pancreatic enzymes
5.11 Pegademase
5.12 Other enzyme types

Chapter 6 Enzyme Replacement Therapy Market Estimates and Forecast, By Indication, 2018-2032 (USD Million)

6.1 Key trends, by indication
6.2 Gaucher disease
6.3 Fabry disease
6.4 Pompe disease
6.5 Plasma cell disorders
6.6 SCID
6.7 Mucopolysaccharidosis (MPS)
- 6.7.1 MPS I - Hurler, Hurler Scheie and Scheie
- 6.7.2 MPS II - Hunter
- 6.7.3 MPS III - Sanfilippo
- 6.7.4 Other mucopolysaccharidosis
6.8 Other indications

Chapter 7 Enzyme Replacement Therapy Market Estimates and Forecast, By Route of Administration, 2018-2032 (USD Million)

7.1 Key trends, by route of administration
7.2 Parenteral
7.3 Oral

Chapter 8 Enzyme Replacement Therapy Market Estimates and Forecast, By End-user, 2018-2032 (USD Million)

8.1 Key trends, by end-user
8.2 Hospitals
8.3 Infusion centers
8.4 Other end-users

Chapter 9 Enzyme Replacement Therapy Market Estimates and Forecast, By Region, 2018-2032 (USD Million)

9.1 Key trends, by region
9.2 North America
- 9.2.1 U.S.
- 9.2.2 Canada
9.3 Europe
- 9.3.1 Germany
- 9.3.2 UK
- 9.3.3 France
- 9.3.4 Spain
- 9.3.5 Italy
- 9.3.6 Rest of Europe
9.4 Asia Pacific
- 9.4.1 China
- 9.4.2 Japan
- 9.4.3 India
- 9.4.4 Australia
- 9.4.5 South Korea
- 9.4.6 Rest of Asia Pacific
9.5 Latin America
- 9.5.1 Brazil
- 9.5.2 Mexico
- 9.5.3 Rest of Latin America
9.6 Middle East & Africa
- 9.6.1 South Africa
- 9.6.2 Saudi Arabia
- 9.6.3 Rest of Middle East & Africa

Chapter 10 Company Profiles

10.1 Sanofi
10.2 Biomarin Pharmaceutical Inc.
10.3 AbbVie Inc.
10.4 Pfizer, Inc.
10.5 Alexion Pharmaceuticals Inc.
10.6 Allergan plc
10.7 Horizon Pharma Public Limited Company
10.8 Recordati Rare Diseases
10.9 Protalix Biotherapeutics
10.10 Amicus Therapeutics, Inc.