Brazil building a future in pharma

The country is one of seven emerging market countries that are tipped to contribute a quarter of the pharmaceutical industry's global growth within the next few years.

Mr Gadre, vice president of IMS and managing director of ORG IMS Research, India, told Outsourcing-Pharma.com that the seven 'pharmerging' markets of China, Brazil, Mexico, South Korea, India, Turkey and Russia are expected to grow 12-13 per cent next year alone to be worth $85-90bn.

In terms of revenue, the pharmaceutical industry in Brazil is the tenth largest market in the world and the second largest in Latin America, after Mexico, valued at $5.2bn and directly employing 47,000 people.

Nearly 20 per cent of the companies operating in the Brazilian market are foreign, mostly from the US and Europe, with the majority of the world's large pharmaceutical companies, such as GSK, Roche and Novartis having operations there.

In addition, foreign companies account for approximately 75 per cent of the internal market, said Gadre.

On the manufacturing front, the country has 553 laboratories and 130 pharmaceuticals wholesalers and serves as a manufacturing hub in South America.

Major local manufacturers include Medley, EMS, Biosintetica, Europharma, JP Industria Farmaceutica, and Laboratorio Ache.

However, a lack of adequate domestic production and an " exorbitantly high tax structure for medicines " are considered the banes of the Brazilian pharmaceutical industry.

At 30 per cent, taxes applied to medicines in Brazil are among the highest in the world, with the government collecting over $1bn in taxes from the pharmaceutical industry a year, said Gadre.

As a result the country's pharmaceutical industry has an estimated 40 per cent idle capacity.

However, the market for generic drugs in Brazil was formally regulated in 1999 in a government effort to reduce prices of medicines and this introduction of generic drugs has been creating "dynamic investment options" in this market for companies around the world.

" The country actively encourages new entrants into its generic market by offering preferential purchase options in public tenders and special financial investment conditions through state finance organisations ", said Gadre.

For example, Canada's Apotex invested $25m to build a factory in Itatiba, São Paulo and after two years in the market, Apotex is the sixth largest company in the market for generic drugs, said Gadre.

Other companies such as India's Ranbaxy and Germany's Hexal have been actively investing in Brazil and from June 2002 to 2003 alone, income from this sector reached $224m, an increase of 47 per cent.

On the R&D front, the domestic as well as multinational companies witnessed substantial increases in the activity after the new Patent Law was introduced in 1997, with expenditures in R&D between 1994 and 2000 rose by over 500 per cent to reach $100m.

In terms of clinical trials, Gadre said that " well-equipped facilities and high quality staff " in selected Brazilian hospitals have allowed activity in the clinical research business to " grow considerably ".

The healthcare sector in Brazil is a mix of public and private services with around 7,200 hospitals containing 500,000 beds, 280,000 doctors and 12,000 diagnostics clinics across the country.

According to Graciela Racaro, Parexel's director of clinical & regulatory in Latin America, Brazil is now the dominant country in South America in the clinical trial sector.

Figures provided at last year's Drug Information Association (DIA) meeting in Atlanta by Dr Granville Garcia de Oliveira, a representative from the Brazillian regulatory authority, ANVISA, showed that 923 clinical trial applications (CTAs) and 56 new drug applications (NDAs) trials were approved there in 2006.

The clinical trials industry in Brazil finally began to evolve in 1996 when it established regulations that adhered more closely to International Conference on Harmonisation (ICH) guidelines, along with the establishment of a national bioethical committee that investigates institutional review boards (IRBs).

Cost savings is not the only factor driving the growth in this sector, but access to a large patient population of 180m people who display both 'western' and third world diseases is another major drawcard for international trial sponsors.

In addition, while regulatory timelines are still considerably long - it often takes 9 to 12 months to have a site up and running - this is often made up for by " much shorter " recruitment times, said Racaro. "

Some sites have even recruited after two days ".