South & Central America Enzyme Replacement Therapy Market

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 Strategic Insights

Strategic insights for the South & Central America Enzyme Replacement Therapy provides data-driven analysis of the industry landscape, including current trends, key players, and regional nuances. These insights offer actionable recommendations, enabling readers to differentiate themselves from competitors by identifying untapped segments or developing unique value propositions. Leveraging data analytics, these insights help industry players anticipate the market shifts, whether investors, manufacturers, or other stakeholders. A future-oriented perspective is essential, helping stakeholders anticipate market shifts and position themselves for long-term success in this dynamic region. Ultimately, effective strategic insights empower readers to make informed decisions that drive profitability and achieve their business objectives within the market.

South & Central America Enzyme Replacement Therapy Report Scope

South & Central America Enzyme Replacement Therapy Regional Insights

The geographic scope of the South & Central America Enzyme Replacement Therapy refers to the specific areas in which a business operates and competes. Understanding local distinctions, such as diverse consumer preferences (e.g., demand for specific plug types or battery backup durations), varying economic conditions, and regulatory environments, is crucial for tailoring strategies to specific markets. Businesses can expand their reach by identifying underserved areas or adapting their offerings to meet local demands. A clear market focus allows for more effective resource allocation, targeted marketing campaigns, and better positioning against local competitors, ultimately driving growth in those targeted areas.

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.