North America Enzyme Replacement Therapy Market Forecast to 2028 – COVID-19 Impact and Regional Analysis – by Enzyme Type (Alglucosidase Alfa, Agalsidase Beta, Imiglucerase, Idursulfase, Galsulfase, Velaglucerase Alfa, and Other Enzymes), Therapeutic Conditions (Gaucher's Disease, Fabry's Disease, MPS, Pompe's Disease, SCID, and Other Therapeutic Conditions), Route of Administration (Parenteral and Oral), and End User (Hospitals, Infusion Centers, and Others)

Code: BMIRE00027296 | Pages: 162 | Industry: Biotechnology | Date: Oct 2022 | Type: Regional

The enzyme replacement therapy market in North America is expected to grow from US$ 4,108.69 million in 2022 to US$ 6,120.01 million by 2028; it is estimated to grow at a CAGR of 6.9% from 2022 to 2028.

 

Rapid Regulatory Approval with Other Benefits for Drugs with Orphan Drug Designation

 

A condition that affects fewer than 200,000 people nationwide is termed as orphan disease. Fabry's disease, Pompe disease, and Hunter syndrome are among a few examples. Supporting the development and evaluation of new therapies for rare diseases is a key priority for the Food and Drug Administration (FDA). The FDA has the authority to grant orphan drug designation to a drug or biological product. Additionally, stakeholders involved in the development of orphan drug molecules are eligible for the following benefits:

  • 7-year marketing exclusivity is provided to sponsors of approved orphan products
  • 25% federal tax credit for expenses is incurred in conducting clinical research within the US
  • Tax credits may be applied to the prior year or applied over as many as 20 years to future taxes
  • Prescription Drug User Fee Act (PDUFA) waivers fee for orphan drugs
  • Ability to qualify to compete for research grants from the Office of Orphan Products Development (OOPD) to support clinical studies for orphan drugs
  • Eligibility to receive regulatory assistance and guidance from the FDA in designing an overall drug development plan.

Thus, the rapid regulatory approval with other marketing benefits for the drug with orphan drug designation is driving the enzyme replacement therapy market growth.

 

Market Overview

The North America enzyme replacement therapy market is segmented into the US, Canada, and Mexico. The US enzyme replacement therapy market holds the largest share of the market. The market growth is due to the rise in the prevalence of lysosomal storage diseases and increasing regulatory approval of enzyme replacement therapy products. Intravenous (IV) infusions are used in enzyme replacement therapy (ERT) to treat the underlying enzyme shortage that underlies rare diseases, including Gaucher, Fabry's, and Hunter's syndrome. With the help of a modified form of the enzyme, ERT balances low levels of the glucocerebrosidase (GCase) enzyme, which builds up in the bodies of patients with Gaucher, Hunter, and Fabry's disease and is broken down by this enzyme. Therefore, rising cases of these rare diseases will require the need of developing novel treatments. For instance, according to the National Organization for Rare Disorders (NORD), the number of people in the US who had Gaucher disease was ~6,000 in  2021. According to statistics released by the National Institute of Neurological Disorders and Stroke in August 2021, there are an estimated 32,950 cases of Pompe disease in the US, affecting 1 in 40,000 persons. The National Fabry Foundation estimates that there were ~7,713 Fabry patients in the US as of May 2020. Thus, a restricted number of rare diseases are treated through enzyme replacement therapies, which is boosting the market growth across the region.

 North America Enzyme Replacement Therapy Market Revenue and Forecast to 2028 (US$ Million)

 North America Enzyme Replacement Therapy Market Revenue and Forecast to 2028 (US$ Million)

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North America Enzyme Replacement Therapy Market Segmentation 

The North America enzyme replacement therapy market is segmented into enzyme type, therapeutic conditions, route of administration, end user, and country.

  • Based on enzyme type, the North America enzyme replacement therapy market is segmented into alglucosidase alfa, agalsidase beta, imiglucerase, idursulfase, galsulfase, velaglucerase alfa, and other enzymes. The other enzymes segment registered the largest market share in 2022.
  • By therapeutic conditions, the North America enzyme replacement therapy market is segmented into Gaucher's disease, Fabry's disease, MPS, Pompe's disease, SCID, and other therapeutic conditions. The Gaucher's disease segment held the largest market share in 2022.
  • In terms of route of administration, the North America enzyme replacement therapy market is bifurcated into parenteral and oral. The parenteral segment held a larger market share in 2022.
  • From end user point of reference, the North America enzyme replacement therapy market is segmented into hospitals, infusion centers, and others. The hospitals segment held the largest market share in 2022.
  • Based on country, the North America enzyme replacement therapy market is segmented into the US, Canada, and Mexico. The US dominated the market in 2022.

Sanofi; BioMarine Pharmaceutical Inc; Takeda Pharmaceutical Company Limited; AbbVie Inc; Janssen Pharmaceutical (Johnson & Johnson Services, Inc.); Alexion Pharmaceutical, Inc. (AstaZeneca); Amicus Therapeutics; Recordati S.p.A; Recordati S.p.A; CHIESI farmaceutici S.p.A; and Pfizer Inc are the leading companies operating in the enzyme replacement therapy market in North America.   

1.         Introduction

1.1         Scope of the Study

1.2         The Insight Partners Research Report Guidance

1.3         Market Segmentation

1.3.1        North America Enzyme Replacement Therapy Market – By Enzyme Type

1.3.2        North America Enzyme Replacement Therapy Market – By Therapeutic Conditions

1.3.3        North America Enzyme Replacement Therapy Market – By Route of Administration

1.3.4        North America Enzyme Replacement Therapy Market – By End User

1.3.5        North America Enzyme Replacement Therapy Market – By Country

2.           North America Enzyme Replacement Therapy Market– Key Takeaways

3.        Research Methodology

3.1         Coverage

3.2         Secondary Research

3.3         Primary Research

4.           North America Enzyme Replacement Therapy Market – Market Landscape

4.1         Overview

4.2         PEST Analysis

4.2.1        North America – PEST Analysis

4.3         Expert Opinion

5.           North America Enzyme Replacement Therapy Market – Key Market Dynamics

5.1         Market Drivers

5.1.1        Rising Prevalence of Lysosomal Storage Diseases (LSDs)

5.1.2        Rapid Regulatory Approval with Other Benefits for Drug with Orphan Drug Designation

5.2         Market Restraints

5.2.1        Cutthroat Competition among Market Players

5.3         Market Opportunities

5.3.1        Increasing Partnerships and Collaborations to Synergize the Business

5.4         Future Trends

5.4.1        Innovative Developments in ERT

5.5         Impact Analysis

6.           Enzyme Replacement Therapy Market– North America Analysis

6.1         North America Enzyme Replacement Therapy Market Revenue Forecast and Analysis

7.           North America Enzyme Replacement Therapy Market Revenue and Forecasts To 2028– by Enzyme Type

7.1         Overview

7.2         North America Enzyme Replacement Therapy Market, By Enzyme Type 2021 & 2028 (%)

7.3         Alglucosidase Alfa

7.3.1        Overview

7.3.2        Alglucosidase Alfa Revenue and Forecast to 2028 (US$ Million)

7.4         Agalsidase Beta

7.4.1        Overview

7.4.2        Agalsidase Beta - Revenue and Forecast to 2028 (US$ Million)

7.5         Imiglucerase

7.5.1        Overview

7.5.2        Imigluceras - Revenue and Forecast to 2028 (US$ Million)

7.6         Idursulfase

7.6.1        Overview

7.6.2        Idursulfase - Revenue and Forecast to 2028 (US$ Million)

7.7         Galsulfase

7.7.1        Overview

7.7.2        Galsulfase - Revenue and Forecast to 2028 (US$ Million)

7.8         Velaglucerase Alfa

7.8.1        Overview

7.8.2        Velaglucerase Alfa - Revenue and Forecast to 2028 (US$ Million)

7.9         Other Enzymes

7.9.1        Overview

7.9.2        Other Enzymes - Revenue and Forecast to 2028 (US$ Million)

8.           North America Enzyme Replacement Therapy Market Analysis and Forecasts To 2028 – By Therapeutic Conditions

8.1         Overview

8.2         North America Enzyme Replacement Therapy Market, By Therapeutic Conditions 2021 & 2028 (%)

8.3         Gaucher's Disease

8.3.1        Overview

8.3.2        Gaucher's Disease - Market Revenue and Forecast to 2028 (US$ Million)

8.4         Fabry's Disease

8.4.1        Overview

8.4.2        Fabry's Disease - Market Revenue and Forecast to 2028 (US$ Million)

8.5         Mucopolysaccharidosis (MPS)

8.5.1        Overview

8.5.2        MPS - Market Revenue and Forecast to 2028 (US$ Million)

8.6         Pompe's Disease

8.6.1        Overview

8.6.2        Pompe's Disease - Market Revenue and Forecast to 2028 (US$ Million)

8.7         SCID

8.7.1        Overview

8.7.2        SCID - Market Revenue and Forecast to 2028 (US$ Million)

8.8         Other Therapeutic Conditions

8.8.1        Overview

8.8.2        Other Therapeutic Conditions - Market Revenue and Forecast to 2028 (US$ Million)

9.           North America Enzyme Replacement Therapy Market Analysis and Forecasts To 2028 – By Route of Administration

9.1         Overview

9.2         North America Enzyme Replacement Therapy Market, By Route of Administration 2021 & 2028 (%)

9.3         Parenteral

9.3.1        Overview

9.3.2        Parenteral - Market Revenue and Forecast to 2028 (US$ Million)

9.4         Oral

9.4.1        Overview

9.4.2        Oral - Market Revenue and Forecast to 2028 (US$ Million)

10.        North America Enzyme Replacement Therapy Market Analysis– By End User

10.1      Overview

10.2      North America Enzyme Replacement Therapy Market, By End User 2021 & 2028 (%)

10.3      Hospitals

10.3.1     Overview

10.3.2     Hospitals - Market Revenue and Forecasts To 2028 (US$ Million)

10.4      Infusion Centers

10.4.1     Overview

10.4.2     Infusion Centers - Market Revenue and Forecasts To 2028 (US$ Million)

10.5      Others

10.5.1     Overview

10.5.2     Others - Market Revenue and Forecasts To 2028 (US$ Million)

11.        North America Enzyme Replacement Therapy Market Revenue and Forecasts to 2028 – Country Analysis

11.1      North America: Enzyme Replacement Therapy Market

11.1.1     Overview

11.1.3     North America: Enzyme Replacement Therapy Market, by Country, 2021 & 2028 (%)

11.1.3.1       US: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (US$ Million)

11.1.3.1.1       Overview

11.1.3.1.2       US: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (US$ Million)

11.1.3.1.3       US: Enzyme Replacement Therapy Market, by Enzyme Type, 2019-2028 (US$ Million)

11.1.3.1.4       US: Enzyme Replacement Therapy Market, by Therapeutic Conditions, 2019-2028 (US$ Million)

11.1.3.1.5       US: Enzyme Replacement Therapy Market, by Route of Administration, 2019-2028 (US$ Million)

11.1.3.1.6       US: Enzyme Replacement Therapy Market, by End User, 2019-2028 (US$ Million)

11.1.3.2       Canada: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (US$ Million)

11.1.3.2.1       Overview

11.1.3.2.2       Canada: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (US$ Million)

11.1.3.2.3       Canada: Enzyme Replacement Therapy Market, by Enzyme Type, 2019-2028 (US$ Million)

11.1.3.2.4       Canada: Enzyme Replacement Therapy Market, by Therapeutic Conditions, 2019-2028 (US$ Million)

11.1.3.2.5       Canada: Enzyme Replacement Therapy Market, by Route of Administration, 2019-2028 (US$ Million)

11.1.3.2.6       Canada: Enzyme Replacement Therapy Market, by End User, 2019-2028 (US$ Million)

11.1.3.3       Mexico: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (US$ Million)

11.1.3.3.1       Overview

11.1.3.3.2       Mexico: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (US$ Million)

11.1.3.3.3       Mexico: Enzyme Replacement Therapy Market, by Enzyme Type, 2019-2028 (US$ Million)

11.1.3.3.4       Mexico: Enzyme Replacement Therapy Market, by Therapeutic Conditions, 2019-2028 (US$ Million)

11.1.3.3.5       Mexico: Enzyme Replacement Therapy Market, by Route of Administration, 2019-2028 (US$ Million)

11.1.3.3.6       Mexico: Enzyme Replacement Therapy Market, by End User, 2019-2028 (US$ Million)

12.        North America Enzyme Replacement Therapy Market–Industry Landscape

12.1      Overview

12.2      Inorganic Growth Strategies

12.2.1     Overview

12.3      Organic Growth Strategies

12.3.1     Overview

13.        Company Profiles

13.1      Sanofi

13.1.1     Key Facts

13.1.2     Business Description

13.1.3     Products and Services

13.1.4     Financial Overview

13.1.5     SWOT Analysis

13.1.6     Key Developments

13.2      BioMarin Pharmaceutical Inc.

13.2.1     Key Facts

13.2.2     Business Description

13.2.3     Products and Services

13.2.4     Financial Overview

13.2.5     SWOT Analysis

13.2.6     Key Developments

13.3      Takeda Pharmaceutical Company Limited

13.3.1     Key Facts

13.3.2     Business Description

13.3.3     Products and Services

13.3.4     Financial Overview

13.3.5     SWOT Analysis

13.3.6     Key Developments

13.4      AbbVie Inc.

13.4.1     Key Facts

13.4.2     Business Description

13.4.3     Products and Services

13.4.4     Financial Overview

13.4.5     SWOT Analysis

13.4.6     Key Developments

13.5      Janssen Pharmaceuticals (Johnson & Johnson Services, Inc.)

13.5.1     Key Facts

13.5.2     Business Description

13.5.3     Products and Services

13.5.4     Financial Overview

13.5.5     SWOT Analysis

13.5.6     Key Developments

13.6      Alexion Pharmaceuticals, Inc. (AstraZeneca)

13.6.1     Key Facts

13.6.2     Business Description

13.6.3     Products and Services

13.6.4     Financial Overview

13.6.5     WOT Analysis

13.6.6     Key Developments

13.7      Amicus Therapeutics

13.7.1     Key Facts

13.7.2     Business Description

13.7.3     Products and Services

13.7.4     Financial Overview

13.7.5     SWOT Analysis

13.7.6     Key Developments

13.8      Recordati S.p.A.

13.8.1     Key Facts

13.8.2     Business Description

13.8.3     Products and Services

13.8.4     Financial Overview

13.8.5     SWOT Analysis

13.8.6     Key Developments

13.9      CHIESI Farmaceutici S.p.A.

13.9.1     Key Facts

13.9.2     Business Description

13.9.3     Products and Services

13.9.4     Financial Overview

13.9.5     SWOT Analysis

13.9.6     Key Developments

13.10   Pfizer Inc.

13.10.1  Key Facts

13.10.2  Business Description

13.10.3  Products and Services

13.10.4  Financial Overview

13.10.5  SWOT Analysis

13.10.6  Key Developments

14.        Appendix

14.1      About The Insight Partners

14.2      Glossary of Terms

 

 

LIST OF TABLES

Table 1.             US: Enzyme Replacement Therapy Market, by Enzyme Type – Revenue and Forecast to 2028 (US$ Million)

Table 2.             US Enzyme Replacement Therapy Market, by Therapeutic Conditions – Revenue and Forecast to 2028 (USD Million)

Table 3.             US Enzyme Replacement Therapy Market, by Route of Administration – Revenue and Forecast to 2028 (USD Million)

Table 4.             US Enzyme Replacement Therapy Market, by End User – Revenue and Forecast to 2028 (USD Million)

Table 5.             Canada Enzyme Replacement Therapy Market, by Enzyme Type – Revenue and Forecast to 2028 (US$ Million)

Table 6.             Canada Enzyme Replacement Therapy Market, by Therapeutic Conditions – Revenue and Forecast to 2028 (USD Million)

Table 7.             Canada Enzyme Replacement Therapy Market, by Route of Administration – Revenue and Forecast to 2028 (USD Million)

Table 8.             Canada Enzyme Replacement Therapy Market, by End User – Revenue and Forecast to 2028 (US$ Million)

Table 9.             Mexico Enzyme Replacement Therapy Market, by Enzyme Type – Revenue and Forecast to 2028 (US$ Million)

Table 10.          Mexico Enzyme Replacement Therapy Market, by Therapeutic Conditions – Revenue and Forecast to 2028 (USD Million)

Table 11.          Mexico Enzyme Replacement Therapy Market, by Route of Administration – Revenue and Forecast to 2028 (USD Million)

Table 12.          Mexico Enzyme Replacement Therapy Market, by End User – Revenue and Forecast to 2028 (US$ Million)

Table 13.          Recent Inorganic Growth Strategies in the Enzyme Replacement Therapy Market

Table 14.          Recent Organic Growth Strategies in the Enzyme Replacement Therapy Market

Table 15.          Glossary of Terms

 

 

LIST OF FIGURES

Figure 1.           North America Enzyme Replacement Therapy Market Segmentation

Figure 2.           North America Enzyme Replacement Therapy Market Segmentation, By Country

Figure 3.           North America Enzyme Replacement Therapy Market Overview

Figure 4.           North America Enzyme Replacement Therapy Market, By Enzyme Type

Figure 5.           North America Enzyme Replacement Therapy Market, By Country

Figure 6.           North America: PEST Analysis

Figure 7.           Expert Opinion

Figure 8.           North America Impact Analysis

Figure 9.           North America Enzyme Replacement Therapy Market– Revenue Forecast and Analysis – 2020- 2028

Figure 10.        North America Enzyme Replacement Therapy Market, by Enzyme Type 2021 & 2028 (%)

Figure 11.        North America Alglucosidase Alfa Revenue and Forecasts to 2028 (US$ Million)

Figure 12.        North America Agalsidase Beta - Revenue and Forecasts to 2028 (US$ Million)

Figure 13.        North America Imiglucerase - Revenue and Forecasts to 2028 (US$ Million)

Figure 14.        North America Idursulfase - Revenue and Forecasts to 2028 (US$ Million)

Figure 15.        North America Galsulfase - Revenue and Forecasts to 2028 (US$ Million)

Figure 16.        North America Velaglucerase Alfa - Revenue and Forecasts to 2028 (US$ Million)

Figure 17.        North America Other Enzymes - Revenue and Forecasts to 2028 (US$ Million)

Figure 18.        North America Enzyme Replacement Therapy Market, by Therapeutic Conditions 2021 & 2028 (%)

Figure 19.        North America Gaucher's Disease - Market Revenue and Forecasts to 2028 (US$ Million)

Figure 20.        North America Fabry's Disease - Market Revenue and Forecasts to 2028 (US$ Million)

Figure 21.        North America MPS - Market Revenue and Forecasts to 2028 (US$ Million)

Figure 22.        North America Pompe's Disease - Market Revenue and Forecasts to 2028 (US$ Million)

Figure 23.        North America SCID - Market Revenue and Forecasts to 2028 (US$ Million)

Figure 24.        North America Other Therapeutic Conditions - Market Revenue and Forecasts to 2028 (US$ Million)

Figure 25.        North America Enzyme Replacement Therapy Market, by Route of Administration 2021 & 2028 (%)

Figure 26.        North America Parenteral - Market Revenue and Forecasts to 2028 (US$ Million)

Figure 27.        North America Oral - Market Revenue and Forecasts to 2028 (US$ Million)

Figure 28.        North America Enzyme Replacement Therapy Market, by End User 2021 & 2028 (%)

Figure 29.        North America Hospitals - Market Revenue and Forecasts To 2028 (US$ Million)

Figure 30.        North America Infusion Centers - Market Revenue and Forecasts To 2028 (US$ Million)

Figure 31.        North America Others- Market Revenue and Forecasts To 2028 (US$ Million)

Figure 32.        North America: Enzyme Replacement Therapy Market, by Key Country – Revenue (2021) (US$ Million)

Figure 33.        North America: Enzyme Replacement Therapy Market, by Country, 2021 & 2028 (%)

Figure 34.        US: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (US$ Million)

Figure 35.        Canada: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (US$ Million)

Figure 36.        Mexico: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (US$ Million)

  1. Sanofi.
  2. BioMarine Pharmaceutical Inc.
  3. Takeda Pharmaceutical Company Limited.
  4. AbbVie Inc.
  5. Janssen Pharmaceutical ( Johnson & Johnson Services,Inc.).
  6. Alexion Pharmaceutical, Inc.(AstaZeneca).
  7. Amicus Therapeutics.
  8. Recordati S.p.A.
  9. CHIESI farmaceutici S.p.A.
  10. Pfizer Inc.
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