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New Potential Leads to New Challenges in Pharma Today

Almost a quarter million clinical trials worldwide are registered on the database ClinicalTrials.gov. Today’s top treatments and diseases are seeing billions of dollars in investments from venture capitalists, governments, and others. Recent outbreaks of infectious diseases like Zika virus and Ebola have stoked demand for more, and faster, drug development. All of this points to boom times in clinical research. But a challenge has arisen from this urgency in the form of increased competition among pharma companies. What we see in clinical research today is two inversely related trends: as the need for more clinical activity grows, the period in which an innovative new drug enjoys market exclusivity diminishes.

In investigating the cause of the increased demand for clinical trials, there are several factors worth considering. One is the worldwide increase in life expectancy in the last century. As the average person starts to live longer, more people enter the age of highest susceptibility to certain diseases and other conditions. The increase in rates of Alzheimer’s, expected to continue well into the future1, reflects this trend. Another factor is the increased rate of obesity across much of the United States over the last several decades. This increase mirrors a rise in diabetes over a similar time period2, and puts those affected at higher risk for conditions such as heart disease. And in some ways, clinical research can spur itself: as new diagnostic technology is developed and approved, we could see a trend toward earlier and more frequent disease detection, leading to more treatment opportunities and larger patient pools.


A More Competitive Market

But while these developments create myriad opportunities for advancements in healthcare, they also create significant challenges from an economic perspective. On Applied Clinical Trials, the Tufts Center for the Study of Drug Development recently discussed a study investigating changes in the duration of market exclusivity for first-in-class drugs over two six-year periods. The study found that between the periods of 1998 to 2004 and 2005 to 2011, the time it took for competitors to begin challenging the market share of first-in-class drugs dropped by over 50 percent. In the first period, the average first-in-class drug would remain free of competition for almost five years; in the second, that period of exclusivity dropped to 2.3 years3. And while increased competition can be beneficial for consumers, it can make drug companies’ efforts to turn a profit more laborious, especially considering how quickly drug development costs are rising.

This, coupled with heightened calls for fast-tracked clinical trials in the face of infectious disease outbreaks and other factors, has made clinical research more time-sensitive than ever. And these changes have occurred alongside advancements in clinical research-adjacent fields that could further affect the intensity of competition among drug developers. For example, services such as electronic data capture (EDC) software, recently enhanced by increasing adoption of eSource technology and cloud hosting, can help to significantly reduce study duration, leading to quicker market entrance. Reduced study build time could lengthen market exclusivity by allowing first-in-class drugs to get to market faster. In this way, the pharma company with the best EDC may be the pharma company best positioned to navigate the vibrant landscape of clinical research today.


1 2016 Alzheimer’s Disease Facts and Figures; Alzheimer’s Association; www.alz.org/facts/
2 Obesity Rates & Trends; The State of Obesity; stateofobesity.org/rates/
3 Tufts, CSDD; Competitive Pressure for First-in-Class Drugs is Intensifying; Applied Clinical Trials; 1 Feb 2016



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