The BRIC Countries: Opportunities for Regulated Market Players - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

The BRIC Countries: Opportunities for Regulated Market Players
The author outlines the opportunities and challenges for manufacturers aiming to enter the BRIC-country markets.

Pharmaceutical Technology

Figure 2: The number of final abbreviated new drug application (ANDA) approvals belonging to groups headquartered in India and the number of Indian groups holding final ANDAs, 1998–2007.
However, many pharmaceutical companies have remained very cautious about the Indian market, primarily because of problems surrounding intellectual property protection. For example, Novartis was denied a product patent for "Gleevec" (imatnib mesylate) and, in March 2008, the Delhi High Court rejected an injunction plea by Roche to prevent Cipla (Mumbai) from selling generic copies of Roche's "Tarceva" (erlotinib).

Several North American and European generics companies, among them Watson (Corona, CA) and Sandoz, have established a dose-manufacturing presence in India. Sandoz's Indian dose-manufacturing facilities include three sites in Maharashtra: an antituberculosis drug plant in Kolshet, a cephalosporin plant in Turbhe, and an oral solid-dosage plant in Kalwe. In 2005, Watson acquired from Dr. Reddy's (Hyderabad) an oral solid-dose manufacturing facility in Goa. To date, only a few foreign generics companies seem to be eyeing the Indian drug market. Although Mylan (Canonsburg, PA) gained presence in the Indian dose market through the acquisition of Matrix (Secunderabad), we believe the main impetus behind the acquisition was to access to Matrix's API and finished-dose manufacturing capabilities.

There are a number of reasons why generics players have shied away from entering the Indian market with their dose products. Major challenges include the large number of local generic-drug manufacturers with access to inexpensive APIs, intense price competition, and the need for considerable marketing presence.

China. The Chinese pharmaceutical market is currently estimated at $12 billion and growing at double-digit rates (4). By 2010, China is expected to be the fifth largest pharmaceutical market after the US, Japan, Germany, and France. As the world's most populous country is getting wealthier, the awareness of diseases and treatments is improving and more people have access to medicines. Together with improving living standards, the rates of Western diseases such as heart disease and cancer, also have been increasing, contributing to increased demand for pharmaceuticals.

Major pharmaceutical companies such as Abbott (Abbott Park, IL), AstraZeneca, and Boehringer Ingelheim (Ingelheim, Germany) have been marketing their products in China for several years, however, even the largest companies have not penetrated all the corners of this vast country. Earlier this year, for example, Pfizer announced that it will be increasing the number of Chinese cities that it serves from 110 to more than 650. To reach the smaller cities and rural areas, pharmaceutical companies must expand their distribution networks and hire hundreds or even thousands of sales people.

Several foreign generics companies, among them Stada, Actavis, and Teva, also have been marketing their finished-dose products in the Chinese market for a number of years. For example, Teva inherited a presence in the Chinese generics market through the acquisition of Sicor (Irvine, CA) and Ivax (Miami). Both Sicor and Ivax had established joint ventures with Chinese partners, Tianjin Pharmaceutical Holdings and Kunming Pharmaceutical Factory, respectively. Meanwhile, Sandoz acquired a generic-drug manufacturing facility in the Guangdong Province at the end of 2007. The facility used to belong to Grünenthal and is reportedly already supplying products to major Chinese cities. This is Sandoz's second facility in China. As a result of acquiring Hexal (Holzkirchen, Germany) in 2005, Sandoz inherited Hexal's facility in Tianjin.

In addition to competition from local generics players, accessing distribution channels and reaching different corners of China are only a few of the major challenges facing generics companies interested in the Chinese market. In China, many companies focus only on one province, so partnering with those companies would not necessarily help a foreign company penetrate this fragmented market. Generics companies also must keep in mind that not all drugs have been approved in China, so clinical trials may be required before a particular generic drug can be introduced in the Chinese market.


blog comments powered by Disqus
LCGC E-mail Newsletters

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

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here