South & Central 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)
The enzyme replacement therapy market in South & Central America is expected to grow from US$ 498.11 million in 2022 to US$ 688.58 million by 2028; it is estimated to grow at a CAGR of 5.5% from 2022 to 2028.
Innovative Developments in Enzyme Replacement Therapy
Enzyme replacement therapy administration typically requires 1–2 hours and is repeated monthly. Infusions are usually administered at infusion centers; however, under certain conditions, they can be administered at home by a nurse. Enzyme testing is usually the initial diagnostic test, but genetic analysis of gene mutations adds precision. For instance, small-molecule therapies, including substrate reduction and chaperone therapies, have also been developed and are approved for a few lysosomal storage diseases (LSDs). Additionally, companies are working to develop new therapies at the genomic level. For instance, SmartPharm is working to replace the administration of recombinant proteins by introducing the gene into the body to make the protein available over a long period. Successful gene-encoded therapeutics are expected to prolong the period between treatments. It could eliminate the infrastructure of infusion now required to deliver these proteins, thus freeing the patients from burdens related to current enzyme replacement therapy administration. Therefore, the trend of combining gene therapy with enzyme replacement therapy is expected to grow during the forecast period.
Market Overview
The enzyme replacement therapy market in South & Central America is segmented into Brazil, Argentina, and the Rest of South & Central America. The Brazil enzyme replacement therapy market holds the largest share of the market. The enzyme replacement therapy market growth in Brazil is attributed to the increasing cases and types of Mucopolysaccharidosis (MPS) and rising number of clinical trials for validating drug efficacy and safety profile. Mucopolysaccharidoses (MPS) are a group of lysosomal storage disorders caused by the deficiency of enzymes involved in the catabolism of glycosaminoglycans (GAGs). Enzyme replacement therapy (ERT) improves somatic manifestations in mucopolysaccharidoses (MPS). Due to the rising cases and development of new products for MPS, many pieces of research are conducted in Brazil; for instance, "Enzyme Replacement Therapy with Pabinafusp Alfa for Neuronopathic Mucopolysaccharidosis II: An Integrated Analysis of Preclinical and Clinical Data"—a study published in the International Journal of Molecular Sciences (MDPI) in 2021. As intravenously administered enzymes cannot cross the blood–brain barrier (BBB), ERT is ineffective against the progressive neurodegeneration and results in severe central nervous system (CNS) symptoms in patients with neuronopathic MPS. The research was conducted to find possible ways for an ERT drug to cross BBB. Administration of pabinafusp alfa, a human iduronate-2-sulfatase fused with a BBB-crossing anti-transferrin receptor antibody, showed both central and peripheral efficacy in a mouse model. Additionally, clinical trials in 62 patients with MPS-II (Hunter syndrome) in Brazil substantiated this dual efficacy and provided an acceptable safety profile. Additionally, heavy investments in R&D and clinical trials by key players operating in the regional market to develop an effective therapy for rare diseases is adding impetus to the market growth. For instance, in January 2022, PTC Therapeutics, Inc. announced that Waylivra (volanesorsen) received Category 1 classification from Câmara de Regulação do Mercado de Medicamentos - CMED (Drug Market Regulation Chamber) in Brazil. Waylivra is Brazil's only treatment for familial chylomicronemia syndrome (FCS). Thus, the growing research and clinical trial in Brazil is expected to fuel enzyme replacement therapy in Brazil during the forecast period.
South & Central America Enzyme Replacement Therapy Market Revenue and Forecast to 2028 (US$ Million)
South & Central America Enzyme Replacement Therapy Market Segmentation
The South & Central America enzyme replacement therapy market is segmented into enzyme type, therapeutic conditions, route of administration, end user, and country.
- Based on enzyme type, the 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 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 market is bifurcated into parenteral and oral. The parenteral segment held a larger market share in 2022.
- From end user point of reference, the market is segmented into hospitals, infusion centers, and others. The hospitals segment held the largest market share in 2022.
- Based on country, the market is segmented into Brazil, Argentina, and the Rest of South & Central America. Brazil 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 South & Central America.
1. Introduction
1.1 Scope of the Study
1.2 The Insight Partners Research Report Guidance
1.3 Market Segmentation
1.3.1 SAM Enzyme Replacement Therapy Market – By Enzyme Type
1.3.2 SAM Enzyme Replacement Therapy Market – By Therapeutic Conditions
1.3.3 SAM Enzyme Replacement Therapy Market – By Route of Administration
1.3.4 SAM Enzyme Replacement Therapy Market – By End User
1.3.5 SAM Enzyme Replacement Therapy Market – By Country
2. SAM Enzyme Replacement Therapy Market– Key Takeaways
3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. SAM Enzyme Replacement Therapy Market – Market Landscape
4.1 Overview
4.2 PEST Analysis
4.2.1 South & Central America – PEST Analysis
4.3 Expert Opinion
5. SAM 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– SAM Analysis
6.1 SAM Enzyme Replacement Therapy Market Revenue Forecast and Analysis
7. SAM Enzyme Replacement Therapy Market Revenue and Forecasts To 2028– by Enzyme Type
7.1 Overview
7.2 SAM 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. SAM Enzyme Replacement Therapy Market Analysis And Forecasts To 2028 – By Therapeutic Conditions
8.1 Overview
8.2 SAM 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. SAM Enzyme Replacement Therapy Market Analysis and Forecasts To 2028 – By Route of Administration
9.1 Overview
9.2 SAM 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. SAM Enzyme Replacement Therapy Market Analysis– By End User
10.1 Overview
10.2 SAM 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. SAM Enzyme Replacement Therapy Market Revenue and Forecasts to 2028 – Country Analysis
11.1 South & Central America: Enzyme Replacement Therapy Market
11.1.1 Overview
11.1.2 South and Central America: Enzyme Replacement Therapy Market, by country, 2021 & 2028 (%)
11.1.2.1 Brazil: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (USD Million)
11.1.2.1.1 Brazil: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (USD Million)
11.1.2.1.2 Brazil: Enzyme Replacement Therapy Market, by Enzyme Type, 2019–2028 (USD Million)
11.1.2.1.3 Brazil: Enzyme Replacement Therapy Market, by Therapeutic Conditions, 2019–2028 (USD Million)
11.1.2.1.4 Brazil: Enzyme Replacement Therapy Market, by Route of Administration, 2019–2028 (USD Million)
11.1.2.1.5 Brazil: Enzyme Replacement Therapy Market, by End User, 2019–2028 (USD Million)
11.1.2.2 Argentina: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (USD Million)
11.1.2.2.1 Argentina: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (USD Million)
11.1.2.2.2 Argentina: Enzyme Replacement Therapy Market, by Enzyme Type, 2019–2028 (USD Million)
11.1.2.2.3 Argentina: Enzyme Replacement Therapy Market, by Therapeutic Conditions, 2019–2028 (USD Million)
11.1.2.2.4 Argentina: Enzyme Replacement Therapy Market, by Route of Administration, 2019–2028 (USD Million)
11.1.2.2.5 Argentina: Enzyme Replacement Therapy Market, by End User, 2019–2028 (USD Million)
11.1.2.3 Rest of South and Central America: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (USD Million)
11.1.2.3.1 Rest of South and Central America: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (USD Million)
11.1.2.3.2 Rest of South and Central America: Enzyme Replacement Therapy Market, by Enzyme Type, 2019–2028 (USD Million)
11.1.2.3.3 Rest of South and Central America: Enzyme Replacement Therapy Market, by Therapeutic Conditions, 2019–2028 (USD Million)
11.1.2.3.4 Rest of South and Central America: Enzyme Replacement Therapy Market, by Route of Administration, 2019–2028 (USD Million)
11.1.2.3.5 Rest of South and Central America: Enzyme Replacement Therapy Market, by End User, 2019–2028 (USD Million)
12. SAM 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. Brazil: Enzyme Replacement Therapy Market, by Enzyme Type – Revenue and Forecast to 2028 (USD Million)
Table 2. Brazil: Enzyme Replacement Therapy Market, by Therapeutic Conditions – Revenue and Forecast to 2028 (USD Million)
Table 3. Brazil: Enzyme Replacement Therapy Market, by Route of Administration– Revenue and Forecast to 2028 (USD Million)
Table 4. Brazil: Enzyme Replacement Therapy Market, by End User – Revenue and Forecast to 2028 (USD Million)
Table 5. Argentina: Enzyme Replacement Therapy Market, by Enzyme Type – Revenue and Forecast to 2028 (USD Million)
Table 6. Argentina: Enzyme Replacement Therapy Market, by Therapeutic Conditions – Revenue and Forecast to 2028 (USD Million)
Table 7. Argentina: Enzyme Replacement Therapy Market, by Route of Administration– Revenue and Forecast to 2028 (USD Million)
Table 8. Argentina: Enzyme Replacement Therapy Market, by End User – Revenue and Forecast to 2028 (USD Million)
Table 9. Rest of South and Central America: Enzyme Replacement Therapy Market, by Enzyme Type – Revenue and Forecast to 2028 (USD Million)
Table 10. Rest of South and Central America: Enzyme Replacement Therapy Market, by Therapeutic Conditions – Revenue and Forecast to 2028 (USD Million)
Table 11. Rest of South and Central America: Enzyme Replacement Therapy Market, by Route of Administration– Revenue and Forecast to 2028 (USD Million)
Table 12. Rest of South and Central America: Enzyme Replacement Therapy Market, by End User – Revenue and Forecast to 2028 (USD 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. SAM Enzyme Replacement Therapy Market Segmentation
Figure 2. SAM Enzyme Replacement Therapy Market Segmentation, By Country
Figure 3. SAM Enzyme Replacement Therapy Market Overview
Figure 4. SAM Enzyme Replacement Therapy Market, By Enzyme Type
Figure 5. SAM Enzyme Replacement Therapy Market, By Country
Figure 6. South & Central America: PEST Analysis
Figure 7. Expert Opinion
Figure 8. SAM Impact Analysis
Figure 9. SAM Enzyme Replacement Therapy Market– Revenue Forecast and Analysis – 2019- 2028
Figure 10. SAM Enzyme Replacement Therapy Market, by Enzyme Type 2021 & 2028 (%)
Figure 11. SAM Alglucosidase Alfa Revenue and Forecasts to 2028 (US$ Million)
Figure 12. SAM Agalsidase Beta - Revenue and Forecasts to 2028 (US$ Million)
Figure 13. SAM Imiglucerase - Revenue and Forecasts to 2028 (US$ Million)
Figure 14. SAM Idursulfase - Revenue and Forecasts to 2028 (US$ Million)
Figure 15. SAM Galsulfase - Revenue and Forecasts to 2028 (US$ Million)
Figure 16. SAM Velaglucerase Alfa - Revenue and Forecasts to 2028 (US$ Million)
Figure 17. SAM Other Enzymes - Revenue and Forecasts to 2028 (US$ Million)
Figure 18. SAM Enzyme Replacement Therapy Market, by Therapeutic Conditions 2021 & 2028 (%)
Figure 19. SAM Gaucher's Disease - Market Revenue and Forecasts to 2028 (US$ Million)
Figure 20. SAM Fabry's Disease - Market Revenue and Forecasts to 2028 (US$ Million)
Figure 21. SAM MPS - Market Revenue and Forecasts to 2028 (US$ Million)
Figure 22. SAM Pompe's Disease - Market Revenue and Forecasts to 2028 (US$ Million)
Figure 23. SAM SCID - Market Revenue and Forecasts to 2028 (US$ Million)
Figure 24. SAM Other Therapeutic Conditions - Market Revenue and Forecasts to 2028 (US$ Million)
Figure 25. SAM Enzyme Replacement Therapy Market, by Route of Administration 2021 & 2028 (%)
Figure 26. SAM Parenteral - Market Revenue and Forecasts to 2028 (US$ Million)
Figure 27. SAM Oral - Market Revenue and Forecasts to 2028 (US$ Million)
Figure 28. SAM Enzyme Replacement Therapy Market, by End User 2021 & 2028 (%)
Figure 29. SAM Hospitals - Market Revenue and Forecasts To 2028 (US$ Million)
Figure 30. SAM Infusion Centers - Market Revenue and Forecasts To 2028 (US$ Million)
Figure 31. SAM Others- Market Revenue and Forecasts To 2028 (US$ Million)
Figure 32. South and Central America: Enzyme Replacement Therapy Market, by Key Country – Revenue (2021) (US$' Million)
Figure 33. South and Central America: Enzyme Replacement Therapy Market, by country, 2021 & 2028 (%)
Figure 34. Brazil: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (USD Million)
Figure 35. Argentina: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (USD Million)
Figure 36. Rest of South and Central America: Enzyme Replacement Therapy Market – Revenue and Forecast to 2028 (USD Million)
- 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.
- CHIESI farmaceutici S.p.A.
- Pfizer Inc.
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