Pharmaceutical Industry

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1 Pharmaceutical Industry January 2018

2 Index The Industry in Mexico 1.1 Industry Indicators in Mexico The Pharmaceutical Industry in México 1.3 Production and Consumption 1.4 Mexico s International Trade 1.5 Foreign Direct Investment (FDI) 1.6 Companies 1.7 Chambers and Associations 1.8 Legal Framework

3 1. The Industry in Mexico

4 1.1 Industry Indicators in México 2016 Production 2016 US$10,103 million Imports of the pharmaceutical industry ,745 MDD CAGR % Consumption 2016 US$13,595 million Foreign Direct Investment (FDI) US$5,297 millions Main investor countries in the sector: Canada, France, India, Germany and Netherlands CAGR % Companies in Mexico: Sanofi, Bayer, Pfizer, MSD, Novartis Group, GlaxoSmithKline Exports of the pharmaceutical industry 2016 US$1,376million Total employees ,473 Source: Trade Atlas

5 1.2 The Pharmaceutical Industry in Mexico Mexico has become an attractive destination for investment in the pharmaceutical industry due to an improved regulatory framework and to the increase in quality certifications. 12 out of the 20 most important companies worldwide have presence in the country. Mexico is the second largest market in Latin America in the pharmaceutical industry and also an important producer of high-tech drugs.

6 1.3 Production and Consumption In 2016, Mexico s pharmaceutical sector produced US$10,103 million. It is expected an CAGR of 6 % between 2016 and Mexico has a consumption of US$13,595 million of pharmaceutical products. It is expected to record a 1 % CAGR for the period. Pharmaceutical Production Forecast (Millions of US dollars) Pharmaceutical Consumption Forecast (Millions of US dollars) 13, , , , , , , , , , , , , , Source: INEGI and IHS

7 1.4 Mexico s International Trade In 2016, Mexico was the leading pharmaceutical exporter in Latin America, with total exports of US $1,376 million. Main Export Destinations 2016 Country Millions of US dollars 2016 % Share 1 United States 291,770, Panama 186,355, Colombia 100,813, Chile 92,566, Switzerland 83,479, Guatemala 63,781, Ecuador 61,456, Canada 55,638, Brazil 52,782, Australia 47,090, Others 340,430, Total 1,376,160, Main products exported by Mexico: Medicines containing alkaloids or their derivatives Drugs containing antibiotics Antiserums The same year, Mexico imported pharmaceutical products for a total of US $3,745 million. Mexico s main suppliers were United States, Germany and France. Country Main Suppliers 2016 Millions of US dollars 2016 % Share 1 United States 973,786, Germany 683,322, France 411,284, Switzerland 243,648, Italy 159,751, Espain 153,565, Canada 152,694, Irland 105,446, India 94,752, Brazil 86,100, Others 681,178, Total 3,745,526, Source: Trade Atlas

8 1.5 Foreign Direct Investment Between 2010 and 2016, the accumulated investment of the pharmaceutical sector was US$5,297 million of FDI. FDI by country (millions of US dollars) Country FDI (MDD) Israel 2,012 United States 1,200 Germany 531 France 402 Luxembourg 268 Others 885 Total 5,297 Source: Ministry of Economy

9 1.5 Foreign Direct Investment (FDI Investment announcements in Mexico between 2010 and 2016 : Compaies 22 Projects 26 Jobs 2, Expantion Projects New Investments Betting on Mexico in 2016 Country Canada France India Germany Netherlands Capital Investment (millions of US dollars) Companies Main Destination: Mexico City, Jalisco, Mexico. Source: FDI Markets. March 2017.

10 * Considering the pharmaceutical manufacturing, Mexico has 17.1% savings in operating costs compared with the U.S.A. Costs savings in pharmaceutical manufacturing 0.0% 6.4% 6.6% 8.2% 8.7% 9.2% 9.7% 10.1% 11.2% U.S.A. Japan Germany France Australia United Kingdom Italy Netherlands Canada 17.1% Mexico Fuente: KPMG 2017

11 1.6 Companies There are a total of 793 economic units* in Mexico that specialize in the pharmaceutical industry. Currently, the pharmaceutical sector generates approximately 41,473 jobs. The companies are located mainly in Mexico City, Jalisco, Mexico and Puebla. Main companies in Mexico Company Country Pfizer USA Novartis Group Mexico Switzerland Roche Switzerland Merck & Co. USA Sanofi France *Includes companies, plants and administrative and sales offices Unidades Económicas State # Economic Units MEXICO CITY 232 JALISCO 166 MEXICO 82 PUEBLA 37 MORELOS 35 NUEVO LEÓN 25 GUANAJUATO 25 QUERÉTARO 24 VERACRUZ 23 MICHOACÁN 18 OTROS 126 TOTAL 793 Source: DENUE

12 1.6 Companies The mexican pharmaceutical industry stands out because it counts with the presence of 12 out of the 25 largest companies worldwide, but also because its national companies are well-known for their quality and experience. Mexican companies: International: 1. Pfizer Edo. Mex 2. Novartis Mex. City 3. MSD Edo. Mex. 4. Sanofi - Edo. Mex 5. GlaxoSmithKline Mex. City 6. Astra Zeneca Edo. Mex. 7. Teva Edo. Mex. Jalisco 8. Bristol-Myers Squibb Mex. City 9. Bayer Edo. Mex. 10. Boehringer Ingelheim Mex. City Aguascalientes Queretaro 1. Pisa - Jalisco 2. Liomont Mex. City 3. Probiomed Edo. Mex 4. Neolpharma Mex.City 5. Chinoin Ags. / Mex. City 6. Novag infancia Mex. City 7. Kener Edo. Mex. 8. Silanes Edo. Mex. 9. Hormona Edo. Mex. 10. Zurich - Queretaro Estado de Mexico Mexico City

13 1.7 Chambers and Associations Ministry of Health Mexican Social Security Institute State Workers Social Insurance Institution Federal Health Risk Protection Commission National Chamber of the Pharmaceutical Industry Mexican Association of Pharmaceutical Research Industries National Association of Drug Manufacturers Mexican Pharmaceutical Association

14 1.8 Legal Framework The Mexican regulatory system is one of the most developed ones in Latin America. Under the General Health Law, the authority in charge of regulating, controlling and promoting health is the Ministry of Health, through the Federal Health Risk Protection Commission (COFEPRIS). Thefollowingaresomeofthedocumentsthatregulate the pharmaceutical industry in Mexico: Regulations of the General Health Law for Health Research Regulations of the Federal Health Risk Protection Commission Regulations for Health Inputs Guidelines to comply with Good Clinical Practices in Health Research Guidelines for Provisions for Bioequivalence Studies

15 +52 (55) Camino a Santa Teresa 1679, Col. Jardines del Pedregal CP 01900, Mexico City.

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