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Post Marketing Clinical (PMC) |
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Phase IV Studies – A Market With A Proactive Approach For Growth Of A Pharmaceutical Business
Summary
Phase IV studies are required as a condition of market approval. The companies look at venturing into Post marketing studies to improve the potential of the marketed product. This
Phase has been the fastest growing segment in the area of clinical research. It supports in finding data for newer indications and new markets for which the drug product had not been
initially approved. These studies should be randomized1 and to maximize the informational value. The Phase IV research environment is driven by the varying regulatory environment,
increasing safety concerns of new medicines, and the need for real-world data on the marketed drugs. This paper gives an overview of the Phase IV studies which form an integral part of the drug evaluation process and is a promising phase of advancement in the area of marketed drugs.
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India, an emerging global hub for vaccine industry
ASIA is emerging as the vaccine hub of the world and India is poised to play a key role in the vaccine market.
Competition to increase with traditional cos entry
The supply chain: Vaccines have to be strictly monitored for specific temperature which adds to the costing woes of the manufacturer.
Clear regulatory guidelines are still under development in India.
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“G7 SYNERGON has been recognized by the Department of Scientific and Industrial Research (DSIR)” |
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Vaccine Industry in India – An Emerging Global Hub |
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Asia is emerging as the vaccine hub of the world and India is on the go to play a key role in the vaccine market. The Global vaccine market is expected to reach $10 billion during the current year 2011. This is forecasted to scale up to $23.8 Billion by the year 2012 and to reach $40 billion by the year 2015. A sharp increase in sales is expected in areas of Influenza and Hepatitis vaccines. The vaccines for cancer are expected to have a phenomenal growth due to increased disease incidence in the areas of cervical, prostrate and lung cancer. Though the pediatric vaccines were dominating the vaccine market in the past, a change in this trend is expected due to a high demand forecasted for the adult vaccines. Global adult vaccine market was around $3.7 billion during 2005 and this market is estimated to reach $7.5 billion in 2012. The major contributors to the growth of the adult vaccine market would be Influenza vaccines, HIV vaccines and Cancer Vaccines. Cancer vaccines will also become a major player in the vaccine market, rising from its current level of $135 million to more than $8 billion by 2012.
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