Rapid growth, high unmet clinical needs and increasing regulation are changing the face of Latin American pharmaceuticals. What are the opportunities and challenges for companies and investors wanting to develop or enter this growing market? This major strategic study compares 7 key markets.

Key Areas Addressed:

5-Year market forecast to 2010
Analysis of trends
Intellectual property protection
GMP/bioequivalence progress
Health provision and plans
Domestic production and review of leading companies

Answering important questions about the future of generic drugs in Latin America
What effect is the move to better GMP and bioequivalence having on the market now, and what impact might it have on domestic companies in the future?

Patents and intellectual property have risen to the top of the industry's agenda, but is there political will to enforce compliance?

What role are ambitious Indian generic manufacturers taking in the region and what is their on going impact likely to be?

In 2005, the generic sector in Latin America was valued at US$1.7 billion, which represented a 26.9% increase over the 2004 figure of US$1.3 billion. Regional generic expenditure per capita stood at US$3.8. Venezuela had the highest expenditure per capita at US$8.0, followed by Argentina at US$5.8.

Throughout the region, pharmaceutical patenting remains a relatively new concept - and an on-going issue. Many countries have local industries geared to producing branded versions of drugs still under patent in their country of origin. These copycats tend to be priced cheaper than branded originals, and this diminishes 'pure' generic penetration.

The traditional proliferation of non-bioequivalent, branded generic or copycat products is slowly being replaced by the steady introduction of bioequivalent generics in Latin America. In an effort to increase local demand, raise awareness and increase export opportunities, bioequivalence standards are slowly being implemented. ARGENTINA
The generic sector was valued at US$180 million in 2004, compared to US$121 million in 2003. Around 78.2% of generic sales take place in the hospital sector. Pharmacy penetration is very low; generic pharmacy sales stood at US$26.4 million in 2003, equal to 1.4% of the total. The international industry argues that most of the 'generics' available in Argentina are copy products rather than true generics because they do not have to demonstrate bioequivalence with the originator products.

.BRAZIL
The National Medicines Agency (ANVISA) has increased the number of generic registrations and presentations in recent years. By July 2005, 58.5% of generic registrations and 22.2% of total presentations had been marketed. Generics are outperforming the overall pharmacy sector and the pharmaceutical market as a whole. Between January and October 2005, generics increased their pharmacy market share by 1.5% in value. Sales in the first nine months of 2005 reached US$486.5 million, which represented a 52% increase over the same period in 2004.

.CHILE
Due to low prices, generic penetration is very high in volume terms, compared to Chile's neighbours. In 2004, there were 76.2 million generics units sold, equal to 39.6% of the pharmacy sector. The average price of a generic medicine stood at US$0.9 in 2004, compared to US$4.4 for a branded generic and US$7.6 for an original drug. TRIPS-related patent enforcement and the new health reform will increase pharmaceutical spending in the long term. Domestic manufacturing is expected to shift from copycats to originals and generics under licence from multinationals, a trend that could see many smaller manufacturers merge or be acquired by larger groups.

.COLOMBIA
Prescription medicines accounted for 80% of the pharmacy sector in 2003, equal to US$712 million at manufacturers' prices. Bioequivalent generics accounted for 12.6% of the POM sector, or 10.1% of the pharmacy sector in 2003, equal to US$90 million. The healthcare reform programme has been instrumental in boosting consumption of pharmaceuticals; growth has been largely in volume terms, since the drugs eligible for reimbursement are primarily cheap generics.

.MEXICO
Mexico has a small generic sector in comparison to its pharmaceutical market size. Local producers are SMEs but only a few are equipped to demonstrate bioequivalence. But this has to change, as new rules were enforced in 2005. Bioequivalent generics are expected to penetrate the market of similar drugs and explore new markets. There is a new wave of generic producers looking for business opportunities in Mexico.

.PERU
The Peruvian generic sector is expected to increase by 6% annually in the next five years, reaching US$179 million by 2010. Pharmacy sales of generics represented 21% of the total in 2005, equal to US$28 million. They are expected to increase by 7% annually in the next five years, reaching US$39 million by 2010. According to Espicom estimates, the generic sector represented 19.6% of the pharmaceutical market as a whole in 2005. Pharmacy sales of generics represented 4.1% of the pharmaceutical market as a whole or 7.2% of the overall pharmacy sector in 2005, which is a relatively high percentage.

.VENEZUELA
Generics (branded & unbranded) are between 20% and 70% cheaper than original drugs. Price continues to be their distinctive advantage. Price competition between generic producers, however, has put the average price of generics at US$2.3 in 2005, compared to US$3.3 in 2001. As a result, growth in generic sales fell to 10.7% in 2005, reaching US$221 million. Currently, there are 1,934 generic presentations in the Venezuelan pharmaceutical market, which represent 20.7% of the total. The generic sector comprises around 87 companies, but four leading producers concentrate around 75% of the sector by volume.

EXTENSIVE CONTENTS
The Latin American Market Overview
KEY DATA
EXECUTIVE SUMMARY
GENERIC REGULATORY ENVIRONMENT
Pan American Pharmaceutical Regulation Harmonisation
Generic Prescription Trends in Latin America
Generic Bioequivalence in Latin America
Patent Protection & IP Rights Weaknesses in Latin America
Pricing & Reimbursement Encouraging Generics in Latin America

GENERIC MARKET
Pharmaceutical Market Overview in Latin America
Generic Market Size in Latin America
Generic Market Projections in Latin America to 2010
Generic Production in Latin America
Generic Market Developments in Latin America
Increasing Generic Manufacturing & Clinical Capabilities in Latin America
Further Generic Industry Consolidation in Latin America
Competition Arises from Indian Generic Producers in Latin America
Generic HIV/AIDS Availability in Latin America ...

Each market profile typically provides
KEY DATA
EXECUTIVE SUMMARY
GENERIC REGULATORY ENVIRONMENT
Generic Regulation
Generic Prescribing
Bioequivalence
Patent Protection & Intellectual Property Rights
Pricing & Reimbursement

GENERIC MARKET
Pharmaceutical Market Overview
Generic Market Size
Generic Market Projections to 2010
Generic Production
Generic Trade Association
Domestic Generic Producers
Generic Research & Development

Compelling reasons to buy The Latin American Market for Generic Drugs report
Unparalleled comparative study of 7 leading markets
Unique and original market forecasts
Insightful interpretation of market trends and developments
Includes much primary source information not available in English elsewhere
No-one else produces such quality data so cost effectively
Over 25 years continuous pharmaceutical market experience
A team of full-time researchers and analysts
Unbeatable access to primary sources
Independent and impartial
Formats to suit every distribution need and budget