Tuesday, 29 September 2015

Drug Discovery Technologies Market 2012-18

Drug discovery technologies play a significant role in the field of pharmaceuticals as they heavily contribute to the introduction of drugs to the market. The application of drug discovery technologies have a significant opportunity in  the launch of drugs for severe diseases such as cancer, cardiovascular diseases, Parkinson’s disease, central nervous system disorders and others. However, the slow growth in the introduction of blockbuster drugs could pose a major threat for the growth of this market.

The major technologies in the drug discovery market are proteomics, genomics, QPCR, DNA and protein microarrays, high-throughput screening, mass spectrometry, laboratory information management systems, microfluidics, gel electrophoresis, chromatography, and protein and nucleic acid isolation.

As the global population ages, there is a growing pressure to keep the healthcare costs under control. Senior citizens are more prone to chronic diseases. It is in the nation’s best interests to keep its population healthy. In addition to this the pressure is paired with the government’s and administration’s responsibility to pay for healthcare. This situation will magnify in intensity if nothing is done to improve the status of treatment and prevention of diseases among the aging population. 

Apart from facing these pressures, the pharmaceutical manufacturers also face an impending surge of expiring patents. This will result in reduced profits of pharma companies. The market players in this field have begun to respond to these factors by restructuring their strategies and bringing innovation in their products thus, improving their productivity and efficiency. Despite these measures, pharmaceutical companies face the fact that drug discovery and development consumes a huge amount of time and money. For instance, drug discovery and development from scratch may take around 15 years and costs about USD 500 million until it is introduced in the market.

Big Data Analytics: The Next Evolution In Drug Development

The drug development process is complex and financially risky. A recent study by The Tufts Center for the Study of Drug Development estimates the cost of developing a new drug at $2.6 billion and suggests that costs of drug development are rising with a compound annual growth rate of 8.5 percent. These rising costs are largely driven by increases in out-of-pocket costs, such as larger clinical trial sizes and higher failure rates for drugs required to demonstrate superiority. Even when considering the efficacy of the 10 highest-grossing approved drugs in the United States, the fact is that for every patient a drug does help, between three and 24 patients fail to show improvement after treatment. Clinicians are typically forced to address this variability in patient outcomes with a trial-and-error approach to intervention, increasing healthcare costs and adding a burden to the patient.

Drug Developers, Providers, And Patients Need A Better Option 

High-throughput technologies are ushering in the era of Big Data in drug development, allowing researchers to assay patients in terms of their genome, epigenome, proteome, metabolome, and microbiome. Precision medicine initiatives are being undertaken to tailor disease treatment by taking into account individual variability in molecular and cellular systems. A biomarker- and technology-driven approach to developing targeted therapies and patient selection strategies has the potential to increase success in the drug development process, decrease cost, and ultimately improve patient outcomes with directed intervention. Read More

S. Pandarinath, Pharmacist, Certified Pharmacovigilance Professional.

Serious Event or Serious Suspected Adverse Reaction in Pharmacovigilance Practice

Image result for serious adverse drug reaction
An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes :

-Death
-A life-threatening adverse event
-Inpatient hospitalization, or prolonged of existing hospitalization
-A persistent disability to conduct normal functions
-A congenital anomaly/birth defect

Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious, when based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Author- Sirisha Boidapu, Pharmacist, PV Professional