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

Latest Issue
PharmTech

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


Russia. The Russian pharmaceutical sales market, estimated at $7 billion and growing at double-digit rates, is dominated by foreign pharmaceutical companies such as Johnson & Johnson (Raritan, NJ), Novo Nordisk, Roche (Basel, Switzerland), Sanofi-Aventis (Paris), Nycomed (Zurich, Switzerland), and Menarini (Florence), as well as by foreign generic-drug companies such as Gedeon Richter (Budapest) and Lek (Ljubljana, Slovenia) (2).

The main attractions of the Russian market are its large population, growing middle class with access to private insurance, willingness to pay out-of-pocket for many high-cost drugs, and large demand for drugs to treat chronic conditions. Among the challenges facing any drugmaker are the sheer size of the country and poor infrastructure outside of the most populated areas. In addition, intellectual property enforcement in Russia continues to be lax and counterfeiting of pharmaceuticals is a major problem, while corruption, lack of transparency, and red tape often cause delays in market approval. There are also questions about the sustainability of the state drug program, DLO (Dopolnitelnoe Lekarstvennoe Obespechenie, which translates into the Provision of Supplemental Medicines), launched in 2005 to make medicines more accessible to veterans, retirees, and low-income individuals.

During the past few years, a number of foreign generics companies, including Stada Arzneimittel AG (Bad Vilbel, Germany), Polpharma (Warsaw, Poland), and Actavis (Hafnarfjordur, Iceland), have acquired Russian dose-manufacturing sites and, together with them, instant market share. Stada, through its subsidiaray Nizhpharm in Nizhny Novgorod, which it acquired in 2004, last year purchsased three companies belonging to the Makiz group with facilities in Moscow and Ryazan. Polpharma acquired a stake in Akrihin in Staraya Kuparna near Moscow, and Actavis purchased a majority stake in Zio Zdorovje in Podolsk, near Moscow. Others, among them Slovenia's Krka, have built their own manufacturing sites in Russia from scratch. Krka opened a facility near Moscow for manufacturing solid-dose forms. It has been reported that Teva is considering building or buying a plant in Russia by May 2009.

Generics are not the only ones looking to acquire or build manufacturing facilities in Russia. Among pharma companies that have already built a facility in Russia is Servier (Paris); Servier's manufacturing facility is located in Sofyino, near Moscow. Nycomed and Pfizer (New York) are speculated to be looking for construction sites or existing facilities that they can upgrade. Setting up a manufacturing base in Russia helps foreign companies take advantage of the country's lower cost base and provide insulation against potential protectionist measures by the Russian government.


Figure 1: The number of established, less established, and potential future active pharmaceutical ingredient (API) manufacturing groups headquartered in India and China. Established groups have several years of experience supplying APIs to regulated markets. Less established groups have regulated market experience with fewer products or fewer years of experience than established groups. Potential future companies would like to start supplying to regulated markets.
India. India, the fourth largest pharmaceutical market by volume and 13th largest by value, is experiencing an economic boom, and the size of its middle class is growing, giving more people access to medicines (3). Together with the growth in incomes, the rates of certain diseases, among them diabetes and cardiovascular problems, also have been increasing.

Major pharmaceutical companies have been selling their older brand products in India for many years. During the past decade, they also have launched some products in India that still enjoy patent protection in the rest of the world, among them AstraZeneca's (London) "Nexium" (esomeprazole) and Pfizer's "Viagra" (sildenafil). Taking things a step further, Pfizer is planning to develop several products specifically for the Indian market. Novo Nordisk also has announced growth plans for India's market and is expanding its collaboration with Torrent Pharma (Ahmedabad), which is running a dedicated insulin manufacturing facility for Novo Nordisk.


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
35%
Breakthrough designations
12%
Protecting the supply chain
35%
Expedited reviews of drug submissions
12%
More stakeholder involvement
6%
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
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
USP Faces New Challenges
Source: Pharmaceutical Technology,
Click here