Mexico Autosomal Dominant Polycystic Kidney Disease Therapeutics Market Analysis

Mexico Autosomal Dominant Polycystic Kidney Disease Therapeutics Market Analysis

The Mexico Autosomal Dominant Polycystic Kidney Disease Therapeutics Market is at around US $ 17 Mn in 2022 and is projected to reach US $26 Mn, exhibiting a CAGR of 6.05% during the forecast period.

Autosomal dominant polycystic kidney disease (ADPKD) is a genetic condition affecting multiple systems caused by mutations in the genes PKD1 and PKD2. It is characterized by the development of numerous cysts within the kidneys, resulting in renomegaly, often progressing to end-stage kidney disease (ESKD) in most patients. The symptoms of the condition include pain, urinary tract infections, and fatigue, among other manifestations. Currently, there is no cure available for this rare disease, and the treatment regimens rely on preventive management. Tolvaptan (Jinarc), manufactured by Otsuka Pharmaceutical, is the only approved medication available that is a vasopressin blocker and has shown a reduction in cyst formation in a subset of patients. Additional options include pain management and lifestyle changes as preventive measures.

Mexico is a country in southern North America that borders the United States. The incidence of ADPKD is around 457 per 1,00,000 individuals in Mexico. With improved healthcare infrastructure, rapid diagnosis, environmental variables, genetic predisposition, and modifiable risk factors, the prevalence of ADPKD is projected to increase. The market is therefore driven by major factors like the increased prevalence of ADPKD cases, government initiatives and public health programs, and evolving healthcare infrastructure in the industry. However, conditions such as high costs of treatment, a lack of local research activities, and others hinder the growth and potential of the market.

Market Dynamics

Market Growth Drivers

Surge in the incidence of ADPKD: The country of Mexico has an incidence of 457/1,00,000 individuals, which is the highest in the world. These estimates translate into a huge pool of patients requiring treatment like dialysis, resulting in the growth of the market.

Government initiatives: Government initiatives and public health programs such as Seguro Popular (Popular Insurance) are helping to bridge the gap in affordability and accessibility of essential medicines for eligible patients.

Increased awareness: Groups such as the Mexican Association of PKD and Genetic Kidney Disease and the Medical Gazette of Mexico are expanding public knowledge about ADPKD, potentially leading to earlier diagnosis and greater demand for treatment.

Evolving healthcare infrastructure Mexico's investments in modern medical facilities and nephrology departments are increasing ADPKD patients' access to specialized care and diagnostic equipment. 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 Tolvaptans, 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 the non-compliance of patients, digressing the growth of the Mexican market.

Access to specialist care: Even with improvements in healthcare infrastructure, discrepancies in accessing nephrologists and specialized ADPKD care persist in certain areas of Mexico. This limitation can hinder prompt diagnosis, optimal treatment commencement, and holistic care for patients, which distorts the growth of the market.

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

Dependence on import medicines: Mexico 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.

Notable Updates

June, 2023: COFEPRIS has begun an accelerated evaluation procedure for a novel oral ADPKD medicine, potentially expediting its release in the Mexican market. This implies a greater emphasis on streamlining approvals for novel ADPKD treatments.

April, 2023, COFEPRIS, Mexico's health regulatory authority, granted approval for Jinarc (tolvaptan) registration to treat ADPKD. This notable decision substantially enhances access to the initial medication explicitly designed for ADPKD in Mexico.

Healthcare Policies and Regulatory Landscape

In Mexico, various significant authorities and agencies manage the healthcare policies and regulatory framework. The primary entity overseeing healthcare products, including pharmaceuticals, is the Federal Commission for Protection against Sanitary Risk (COFEPRIS). COFEPRIS holds responsibility for regulating, supervising, and authorizing health-related products, encompassing all therapeutics.

Besides COFEPRIS, the Mexican healthcare system involves a blend of public and private healthcare provisions. The public healthcare sector is managed by the Ministry of Health (Secretaría de Salud), entrusted with the responsibility of delivering healthcare services to the population.

Compliance with COFEPRIS requirements is a prerequisite for obtaining a license in Mexico. Before commercializing therapeutics, companies are required to get registration and marketing licenses from COFEPRIS. Technical and scientific data proving the product's efficacy, safety, and quality must be submitted as part of the registration process.

Mexico has a strong regulatory framework and a resilient healthcare system, creating an advantageous setting for businesses to function effectively. Additionally, its geographical proximity to the United States provides favourable market access, allowing companies to reach and engage with North American markets.

Competitive Landscape

Key Players

• Otsuka Pharmaceutical Co., Ltd
• Janssen Pharmaceuticals
• Reata Pharmaceuticals
• AbbVie Inc
• Sanofi
• Galapagos NV
• Biogen Inc
• Pfizer
• Roche
• AstraZeneca