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Opportunities and Challenges for Bioequivalent Generic Drugs in Brazil
Espicom Business Intelligence Ltd, April 2007, Pages: 190
THE BRAZILIAN GENERIC MARKET IN CONTEXT
A number of products are due to lose their patent protection between 2007 and 2012, bringing market opportunities worth US$307.2 million to the generics sector. Key products affected include Plavix in 2007, Mercilon in 2009 and Viagra and Lipitor, both in 2011. At manufacturers’ prices, their respective sales stood at US$41.1 million, US$58.3 million, US$73.1 million and US$53.4 million in 2005.
Furthermore, in March 2007, ANVISA authorised the registration of generic alternatives to oral contraceptives and endogenous hormones. This sector was valued at US$481 million in 2006 and generic producers are expected to account for 60% by 2012. The leading producers, including Medley, EMS-Sigma Pharma and Eurofarma, have indicated that they will enter this market.
Meeting the challenge of AIDS
Since 1996, antiretrovirals have been provided free of charge to HIV/AIDS patients. The cost per patient fell from R$8,500 (US$4,574) in 1999 to R$3,400 (US$1,162) in 2004, but rose to US$2,500 in 2005. Costs remain high as imported antiretrovirals represent between 80% and 85% of the national AIDS programme’s expenditure. According to the Ministry of Health, public domestic manufacturers produce eight of the 17 antiretrovirals used.
Brazil can issue compulsory licences and allow local generic production of imported antiretrovirals. So far, it has negotiated drug price reductions and encouraged local production under licence. However, the rising number of patients, increasing levels of drug resistance, rising costs, the lack of systematic surveillance of HIV prevalence and high-risk behaviour might still be a threat.
Domestic producers dominate…for now?
There were 66 producers with registrations of generic medicines in 2006, but the four leading producers, which are indigenous, controlled over 80% of the sector. Medley and EMS were the leaders, with a combined 65% market share, followed by Eurofarma and Aché. Mergers & acquisitions will continue to consolidate the Brazilian generics market.
Local producers dominate with low prices and increasing production capabilities. They also have the local know-how to deal with bureaucracy and the government favours them. With the global generics markets consolidating into ever bigger groups, markets such as Brazil are increasingly under scrutiny from large generic corporates. All – with the exception of Teva – have some presence or alliance in Brazil, but it is probably only a question of time before the domination of the market by local companies changes.
The prescribing challenge.
If the generics market is to reach its full potential then it will have to tackle the prescribing habits of a great number of doctors who continue to prescribe branded products. Prescription of generic medicines is still low, representing 15.8% of the total in 2006, compared to 15.2% in 2005 or 11.8% in 2002. For some specific substances, however, generic medicines have achieved high prescription levels, for instance omeprazole (88%), cephalexin (77%) and fluconazole (65%). Using generics, consumers saved about US$2.2 billion in 2006.
Domestic producers of generic pharmaceuticals evaluated in the report:
- Aché-Biosintética
- Americano (FARMASA)
- Arrow (Erowlabs)
- Brainfarma
- Cimed
- Cristália
- EMS-Sigma Pharma
- Eurofarma
- Hipolabor
- LAFEPE
- Medley
- Neo Química
- Prati, Donaduzzi
- Teuto
- União Química
Foreign producers of generic pharmaceuticals evaluated in the report:
- Abbott
- Apotex
- Mepha-ratiopharm
- Merck
- Ranbaxy
- Sandoz
The report answers key questions such as:
- What is the estimated value of the bioequivalent generic market now and in 2012?
- What is the current regulatory situation for bioequivalent generics and how might it change?
- What are the opportunities for international players looking to expand operations in Brazil?
- How many products have just a single producer of a bioequivalent generic? What are they and which company is currently producing?
- What key educational challenges must the industry overcome if it is to see the wider adoption of generics throughout the country.
About the Author:
This report has been written by Ricardo Vicente. Ricardo has over 5 years market analysis experience in pharmaceuticals. Among his recent studies are:
- The Latin American Market for Generic Drugs
- The Outlook for Pharmaceuticals in Latin America to 2011
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