Mexico Pharmaceutical & Medical Device Market Worth $22.5B & $5.4B by 2020 Says a New Report at

Share Article adds, “CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – Mexico,” to its store. The report is an essential source of information and analysis on the healthcare, regulatory, and reimbursement landscape in Mexico.

The healthcare market of Mexico has significant potential for growth. The increasing elderly population, prevalence of non-communicable diseases, improvements in regulatory guidelines, government support for the healthcare sector, and the North American Free Trade Agreement, which assures its members protection of intellectual property rights, provide the impetus for the growth of the Mexican pharmaceutical market.

The pharmaceutical market was valued at approximately $10 billion in 2008, and is projected to reach approximately $22.5 billion by 2020 at a Compound Annual Growth Rate (CAGR) of 7%. In 2010, the Mexican pharmaceutical market was the 14th largest pharmaceutical market in the world, and second in Latin America after Brazil (Daiichi Sankyo, News Release, August 2, 2011).

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The prevalence of non-communicable disease is increasing due to the increasing elderly population, which accounted for approximately 7% of the population in 2013, as well as changes to food and lifestyle habits. The government has been successful in implementing steps needed to achieve universal healthcare coverage, such as reforms in the System of Social Protection in Health (Sistema de Protección Social en Salud). In 2012, approximately 56 million people in Mexico were covered by Public Health Insurance (Seguro Popular, PHI) (Bristol, 2014; OECD, 2011). The rest of the population uses either social security coverage for healthcare or private healthcare insurance.

Regulatory regulations have attracted significant investment in Mexico’s pharmaceutical industry. The pharmaceutical sector had a cumulative Foreign Direct Investment (FDI) of $2.9 billion from 2005 to 2012. In 2012, Mexico received a total of $981M in FDI in pharmaceutical sector. The US, Luxemburg, Ireland, Canada, and Japan were main investors in the Mexican industry. The share of multi-national companies in Mexico is high, compared with the share of domestic companies in the total pharmaceutical market. The leading multi-national companies are Pfizer, Merck, Sanofi, and Novartis, the leading domestic players are Genomma Lab Internacional and Laboratorios Liomont.

The Mexican medical device market was valued at $2.8 billion in 2008, and is projected to grow at a CAGR of 5.7% to an estimated $5.4 billion in 2020. Ophthalmic devices (15.4%), nephrology and urology devices (14.8%), and orthopedic devices (14.5%) were the major segments in the medical device market in 2013. The key challenges being faced by the medical device industry in Mexico are Mexico’s dependency on the US for the import of devices and low expenditure on R&D by the domestic sector.

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The Mexican regulatory authority provides a transparent and strong regulatory environment with a shorter lag time to facilitate the approval of pharmaceutical products and medical devices.

In Mexico, the Federal Commission for Protection against Health Risks (Creación de la Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS), working under the guidance of the Ministry of Health (Secretaría de Salud, Salud), is the main regulatory authority for pharmaceutical products and medical devices. Marketing authorization of new drugs and medical devices requires the execution of good laboratory practices and satisfactory compliance reviews for safety, efficacy, and quality of drugs by COFEPRIS and Salud. To manufacture pharmaceutical products in Mexico, the major requirement is a Good Manufacturing Practice (GMP) certificate, which is provided by COFEPRIS after inspection of the establishment and review of the relevant documents. COFEPRIS also regulates the exports and imports of pharmaceutical products in Mexico.

Increasing access to healthcare facilities through an open, premium-based system is driving healthcare services in Mexico, and high out-of-pocket payment is a major concern.

The Mexican government provides easy access to healthcare facilities to the population through its high number of primary care services, hospitals, and national specialty institutions with highly sophisticated medical care. The primary care centers are prevalent in rural as well as urban areas to provide healthcare services.

In 2012, the share of public healthcare expenditure in Mexico was valued at 52%, while the private expenditure share was at 48% (World Bank, 2014r). The share of healthcare expenditure shows the high Out-of-Pocket (OOP) payment system in Mexico. The Mexican population enjoys public healthcare coverage either through social coverage for healthcare or federal- and state-funded services. The major social insurances are the Mexican Social Security Institute (Instituto Mexicano del Seguro Social, IMSS) and the Institute of Security and Social Services for State Workers (Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, ISSSTE). The state-and federal-funded public insurance is covered under PHI and Oportunidades. In 2012, IMSS and ISSSTE covered more than 50% of the population of Mexico (Knaul et al, 2012).

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Ritesh Tiwari
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