Mexico Central Nervous System (CNS) Therapeutics Market Analysis

Mexico Central Nervous System (CNS) Therapeutics Market Executive Summary

The Mexico Central Nervous System (CNS)Therapeutics Market is at around $3.150 Bn in 2022 and is projected to reach $5.272 Bn in 2030, exhibiting a CAGR of 6.65% during the forecast period.

Neurological disorders cover a wide range of conditions affecting both the central and peripheral nervous system, including the brain, spinal cord, and nerves. These disorders give rise to various symptoms, such as headaches, limb numbness or weakness, dizziness, cognitive difficulties, speech and vision impairments, and tremors. Common examples of neurological disorders include Alzheimer's disease, epilepsy, multiple sclerosis, and Parkinson's disease. The origins of these disorders are multifaceted, involving factors like genetics, infections, lifestyle-related issues, environmental influences, and underlying health conditions. Treatment approaches for neurological disorders are diverse, encompassing medications, physical therapy, occupational therapy, and, in specific cases, surgical interventions. Recognizable companies actively involved in producing, researching, and developing therapeutics for neurological disorders include UCB, Eisai, Biogen, Novartis, and Roche, indicating a dynamic landscape of initiatives aimed at addressing these intricate conditions.

More than 3,00,000 individuals are suffering from dementia like Parkinson's in Mexico. Approximately 15% of Mexicans face some form of mental disorder according to WHO. The market therefore is driven by major factors like the rising prevalence of neurological diseases, expanding healthcare access, and technological advancements in the therapeutics industry. However, limited R&D in the country, stringent regulatory environment, and challenges with the healthcare system limit the growth and potential of the market.

Market Dynamics

Market Growth Drivers

Increasing prevalence of CNS diseases: Mexico experiences an increasing prevalence of neurodegenerative disorders such as Alzheimer's disease and Parkinson's disease. As reported by the Alzheimer's Association International, approximately 1.1 Mn Mexicans are currently living with dementia. Additionally, Parkinson's disease affects more than 300,000 individuals in the country. The World Health Organization notes that almost 15% of Mexicans encounter a mental disorder annually, with depression and anxiety emerging as the most prevalent conditions. This translates into a huge pool of patients requiring effective treatment which drives the market.

Expanding healthcare access: The Seguro Popular health insurance program, led by the Mexican government, is broadening its coverage for CNS disorders, enhancing the accessibility of treatment for a larger segment of the population. Concurrently, efforts such as the National Mental Health Plan are striving to enhance mental health services in the country. Projections indicate a continual uptrend in both public and private healthcare spending in Mexico, which is expected to furnish additional resources for CNS diagnostics, therapies, and research. This augmented investment has the potential to open doors to advanced treatments and innovative drugs, fostering improved healthcare outcomes.

Technological advancements: Progress in personalized medicine and targeted treatments provides optimism for enhancing the efficacy of CNS disorder therapies. Innovations in biomarker and genetic factor research are expected to propel advancements in this field. Additionally, the use of digital tools such as telemedicine consultations and online support groups holds the potential to enhance access to care and boost patient engagement, especially in remote regions.

Market Restraints

Challenges in the healthcare system: The public healthcare infrastructure is growing but faces challenges in terms of resources and specialists, especially in rural regions. This hinders accessibility to diagnosis, treatment, and specialized therapies for CNS disorders. A considerable portion of the population finds many crucial CNS medications financially out of reach, even with insurance coverage, especially in cases of CNS cancers like glioblastomas. Consequently, this financial barrier poses challenges to treatment adherence and achieving optimal outcomes.

Regulatory challenges: The approval process for novel drugs and therapies is time-consuming, often spanning several years, thereby causing delays in patients' access to potentially transformative treatments. The demanding regulatory standards and frequent scrutinies by health authorities impose substantial financial burdens on pharmaceutical companies, affecting their capacity to introduce new products to the Mexican market.

Limited R&D: Mexico falls behind developed nations in terms of funding for research related to the CNS, impeding the progress of innovative therapies designed to address the unique requirements of the Mexican population. The lack of robust collaboration among academia, industry, and government further obstructs the effective transfer of knowledge and translation of research discoveries into practical clinical applications.

Notable Updates

December 2023, IGC Pharma, Inc., a pharmaceutical company in the clinical stage, has disclosed that the Divisional Direction of Patents in Mexico has issued a Granting Office Action (GOA) for its Alzheimer's disease treatment titled "Method and Composition for Treating CNS Disorder."

November 2023, Acorda Therapeutics, Inc. has reported the submission of fresh regulatory documents seeking approval for INBRIJA® (levodopa inhalation powder) in Mexico through its collaborator, Biopas Laboratories (Biopas). INBRIJA is specifically designated for the intermittent management of OFF episodes in adults undergoing treatment for Parkinson's disease (PD) with carbidopa/levodopa.

Healthcare Policies and Regulatory Landscape

The regulatory authority for therapeutics in Mexico is the Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios or COFEPRIS). COFEPRIS is responsible for regulating and ensuring the safety, efficacy, and quality of therapeutic products, including pharmaceuticals and medical devices, in Mexico.

To obtain licensure for therapeutics in Mexico, pharmaceutical companies typically need to submit a comprehensive dossier to COFEPRIS. If the product complies with regulatory requirements, COFEPRIS grants marketing authorization. The process is designed to ensure that only safe and effective therapeutics enter the Mexican market, promoting public health and aligning with international regulatory standards.

For new entrants into the therapeutic market in Mexico, the regulatory environment can be rigorous, requiring adherence to strict standards and documentation. However, COFEPRIS aims to foster a transparent and efficient regulatory process. New entrants need to navigate the regulatory landscape, comply with COFEPRIS guidelines, and demonstrate the quality, safety, and efficacy of their therapeutic products.

Competitive Landscape

Key Players

• Pfizer
• Janssen Pharmaceuticals
• Teva Pharmaceuticals
• Eli Lilly
• Zhejiang Haisen Pharmaceuticals
• GSK plc
• Genomma Lab International
• Biogen
• Otsuka Pharmaceutical
• Sunovion Pharmaceuticals