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The Pharmaceutical Market: Mexico
Espicom Business Intelligence Ltd, Sep 2009, Pages: 166
This in-depth pharmaceutical market report is ideal for executives wanting to understand the key drivers in pharmaceutical markets and have access to a wealth of statistical data. Each report opens with an outlook section that provides analysis of the market, 5-year market forecasts, national data projections, market outlook and key developments such as regulation, pricing/reimbursement, intellectual property, health facilities and government policy. The report also provides extensive background information, population trends, health status, health expenditure, organisation & administration, hospital services, medical personnel, healthcare development, market access information, trade data for raw materials and finished products and essential industry contacts. Included with the report are 3 free quarterly updated outlook reports, enabling you to keep up to date with market developments for a year.
Executive Summary
In June 2009, Mexico finally approved the modification of the General Health Law that will allow the sale and production of biologic and biosimilar medicines for the treatment of chronic diseases. Article 222 Bis defines and regulates biologic and biosimilar medicines, including the requirements to register and market these medicines. The new regulation represents sizeable opportunities for both local and foreign producers. Local producers such as Probiomed, Silanes and Landsteiner Scientific already produce biologic medicines in Mexico. Competition, however, is expected to arise from foreign producers. On a patient level, the new regulation provides product safety and availability.
Under a decree published on 5th August 2008, local manufacturing plant requirements are being phased out over a two- year period. Competition from foreign producers is going to increase, particularly from those which until now did not have the resources to establish manufacturing facilities in Mexico. Imports of antiretrovirals were released in August 2008. Imports of vitamins, homeopathic medicines, vaccines, sera, haemoderivatives and biologic hormones were released in February 2009. Producers of other biologics such as insulin and erythropoietin will also be able to export to Mexico from August 2009. The market will be fully open by the second half of 2010.
The reform of the Health Supplies Regulation, published in the Official Bulletin on 2nd January 2008, has ‘improved’ the renewal and registration processes of pharmaceuticals, and there will only be patented and bioequivalent generic drugs in the market from 24th February 2010. Of the 10,500 pharmaceuticals whose registrations need to be renewed, the Federal National Commission for Protection against Health Risks (COFEPRIS) estimates that about 17% will exit the market. Many local producers believe that this is a frontal attack against the local pharmaceutical industry. In June 2009, COFEPRIS indicated that nearly three quarters of the registrations were in process; it believes completion will be on time.
The devaluation of the Mexican peso against the US dollar is resulting in uncertainty for the pharmaceutical industry, with increasing costs of imported raw materials and finished medicines. This is expected to affect the level of pharmaceutical imports and exports registered in previous years. The overall pharmacy sector is facing stagnation, if not negative growth, in 2009. On a positive note, the downturn is fuelling generics consumption. As a result, the pharmacy generic sector is expected to grow by between 35% and 40% by value in 2009. sanofi-aventis has strengthened its market positioning by acquiring a local generic producer in the first quarter 2009; in March 2009, the company also announced an agreement with the Mexican government to build a US$127 million vaccine facility.
IMSS represents nearly half of public drug expenditure, therefore it is able to negotiate competitive drug prices due to the volume of its acquisitions. IMSS is currently planning a tender for the supply of medicines for a 30-month period starting from October 2009. In June 2009, IMSS met with representatives to discuss the tender and the effects of the devaluation of the peso against the US dollar in on-going contracts. ANAFAM believes that it will be difficult to implement a tender for a 30-month period, due to the economic uncertainty and the volatile exchange rate. Also, if IMSS is able to fix drug prices for the period, it will miss the market opportunity represented by bioequivalent generics from 24th February 2010.
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