Brazil Autosomal Dominant Polycystic Kidney Disease Therapeutics Market Analysis

Brazil Autosomal Dominant Polycystic Kidney Disease Therapeutics Market Analysis

The Brazil Autosomal Dominant Polycystic Kidney Disease Therapeutics Market is at around US $28 Mn in 2022 and is projected to reach US $47 Mn in 2030, exhibiting a CAGR of 6.8% during the forecast period.

ADPKD is a hereditary syndrome caused by mutations in the PKD1 and PKD2 genes that result in the production of fluid-filled cysts in the kidneys. Frequently, these cysts expand, causing renomegaly and, finally, renal failure. Pain, fatigue, urinary tract infections, and other symptoms are common with ADPKD. While there is no cure for ADPKD, several therapy options focus on symptom management and disease progression. Tolvaptan (Jinarc), manufactured by Otsuka Pharmaceuticals, is the only licensed medicine for ADPKD. It operates as a vasopressin blocker and has been found to minimize cyst formation in some patients. Other treatment options include pain management and lifestyle modifications.

Brazil is a country situated in South America. Evidence suggests that the incidence of ADPKD is around 1 per 5,000 individuals in Brazil. The incidence of ADPKD is anticipated to increase in the forecasted years as a result of advancements in healthcare infrastructure that improve diagnosis rates and a change in demography characterised by an increased aging population that requires treatments like dialysis. The market is therefore driven by major factors like increased incidence, government initiatives and public health programs, and increased awareness of the population. However, conditions such as high costs of treatments like dialysis, regulatory challenges, a gap in research, and others hinder the growth and potential of the market.

Market Dynamics

Market Growth Drivers

Surge in the incidence of ADPKD: Epidemiological data from retrospective and observational studies suggests that the incidence of ADPKD is approximately 1/5,000 individuals in Brazil. These estimates translate into a huge pool of patients requiring treatment like dialysis, resulting in growth of the market.

Government initiatives: Government initiatives and public health programs such as the Unified Health System (SUS) and Framacia Popular (Popular Pharmacy) are helping to bridge the gap in affordability and accessibility of essential medicines for eligible patients.

Emerging treatment options: The Brazilian government is actively taking steps in research and development initiatives. Improvements in ADPKD research and development yield novel treatments and medications like gene therapy, bringing prospects for improved disease control and potentially attractive market investments.

Market Restraints

High costs of treatment: Treatments for ADPKD, such as Tolvaptan, can be costly, causing a considerable financial burden on both patients and the healthcare system. These out-of-pocket expenditures hinge on treatment, especially for those with inadequate insurance coverage, and can result in non-compliance of patients, digressing the growth of the Brazilian market.

Research gap: In contrast to certain developed nations, there's a lack of extensive local research on ADPKD in Brazil. This constraint impedes the creation of culturally suitable and economical solutions tailored to the distinct requirements of the Brazilian population.

Dependence on imported medicines: Brazil heavily depends on imported medications for ADPKD, leaving the market vulnerable to fluctuations in exchange rates and potential disruptions in the supply chain. Consequently, this may result in price hikes, shortages of medications, and inconsistencies in patient access.

Lack of public awareness: There is a general lack of public awareness about ADPKD symptoms and early detection, particularly in impoverished communities. This deficit may result in neglected possibilities for early intervention, thereby reducing treatment opportunities and restricting growth.

Notable Updates

May, 2023, ANVISA, Brazil's health regulatory agency, has approved a streamlined registration procedure for tolvaptan (Jynarque), potentially easing faster access to the country's first drug designed specifically for ADPKD.

Healthcare Policies and Regulatory Landscape

The National Health Surveillance Agency (ANVISA) of Brazil is the major governing agency for pharmaceuticals and healthcare supplies. ANVISA is in charge of the registration, regulation, and management of pharmaceuticals and medical devices. In addition to ANVISA, the National Health Council (CNS) and the National Supplementary Health Agency (ANS) play important roles in healthcare regulation in Brazil. The ANS governs the private healthcare industry by establishing and monitoring norms for healthcare activities.

Brazil has a decentralized, universal public healthcare system that is funded by taxes and donations from the federal, state, and municipal governments. Municipalities, or states, are in charge of managing and providing healthcare services.

Compliance with ANVISA standards is required in order to receive a license in Brazil. Companies are required to obtain an ANVISA registration and marketing authorization before commercializing treatments. As part of the registration procedure, technical and scientific data verifying the product's efficacy, safety, and quality must be presented.

In general, various authorities and agencies participate in Brazil's healthcare policy and regulatory framework, with ANVISA playing a critical role.

Competitive Landscape

Key Players

• Otsuka Pharmaceutical Co., Ltd
• Janssen Pharmaceuticals
• Reata Phrmaceuticals
• AbbVie Inc
• Sanofi
• Galapagos NV
• Biogen Inc
• Vertex Pharmaceuticals
• Roche
• Pano Therapeutics, Inc