Navigating Emerging Markets — Latin America - Latin America's diverse growing market seeks regulatory harmonization. - BioPharm International

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Navigating Emerging Markets — Latin America
Latin America's diverse growing market seeks regulatory harmonization.

BioPharm International
Volume 26, Issue 4, pp. 60-63

IMPLICATIONS FOR SUCCESSFUL MARKET ENTRYAND IN-REGION PARTNERING

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. Com-panies 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.

Jill E. Sackman, DVM, PhD, is a senior consultant at Numerof & Associates, Inc. (NAI), http://www.nai-consulting.com/

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.


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