Report from Latin America - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Report from Latin America
Latin America's diverse growing market seeks regulatory harmonization.


Pharmaceutical Technology
Volume 37, Issue 4, pp. 52-55

Implications for successful market entry

Latin America clearly offers substantial business opportunities for pharmaceutical companies. The region represents a growing consumer base for the drug industry; by 2020 the regional population is projected to be as high as 687 million. The Latin American pharmaceutical market is now worth $45 billion and multinational companies consider success in Brazil and Mexico as essential. Some of the main challenges and opportunities in the region include:

  • Intellectual property. Legal oversight of intellectual property is often weak or not enforced in a number of Latin American countries.
  • Generics. Regional governments are making serious attempts to encourage the use of generics. This push may be a significant opportunity for pharmaceutical manufacturers with generic portfolios.
  • Clinical trials and R&D. Companies are finding Latin America attractive for R&D and clinical development. There are currently an estimated 4000 clinical trials being conducted. High enrollment rates, lower labor costs, and improving regulation have encouraged growth in outsourcing. Modernization of local regulatory guidelines is ensuring faster project start-up and shorter clinical trial approval times. There is also a strong knowledge and practice of International Conference on Harmonization (ICH) good clinical practice (GCP) guidelines and western medicine standards.
  • Political situation. Unsettling for multinational companies is the political shift to the left in some countries. However, a number of countries are working to introduce universal healthcare coverage that could create excellent long-term opportunities. Despite the political situation, many governments are highly motivated to make the region favorable for clinical studies and R&D.

Moving Forward in Latin America

As a developing market, Latin America is quite complicated and diverse in terms of regulatory, reimbursement, market, demographic, and political characteristics. As regulatory trends converge and the market continues to grow, the region represents a substantial opportunity for pharmaceutical companies, especially those that take the time to understand these characteristics and anticipate the direction each market will take.

References

1. The World Bank, Data, Population, total, 2012, http://data.worldbank.org/indicator/SP.POP.TOTL, accessed Mar. 4, 2013.

2. “Battelle R&D Magazine Annual Global Funding Forecast Predicts R&D Spending Growth will Continue While Globalization Accelerates,” Battelle R&D Magazine, 2011. http://www.battelle.org/media/news/2011/12/16/battelle-r-d-magazine-annual-global-funding-forecast-predicts-r-d-spending-growth-will-continue-while-globalization-accelerates, accessed Mar. 4, 2013.

3. Ministry of Commerce of the People’s Republic of China. http://www.mofcom.gov.cn/article/i/jyjl/j/201301/20130108520271.shtml, accessed Mar. 4, 2013.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here