Pharmaceutical Outsourcing, June 2014
Pharmaceutical companies will continue to struggle to sustain profitability as more drugs reach the end of their patent life. In 2013, 120 companies had patents expire on drugs that accounted for approximately $29B in annual sales — a figure that was double the predicted revenue loss. As a result, many biopharmaceutical companies are implementing strategies to boost revenue and profit margins while reducing fixed and variable costs.
These strategies include increasing merger and acquisition activity as well as greater efforts to in-license therapeutics developed by smaller firms. The tactics of the past decade remain in play in terms of staff reductions and a strong emphasis on outsourcing. The goal of all efforts is to contain the ever-increasing costs associated with drug development and to sustain profitability by streamlining the cost of clinical trials – in part by looking to emerging market CROs.
Valid concerns have been raised about the globalization of biomedical research. However, it is important to recognize the critical role of emerging markets in the advancement of medical science. Increased drug compound production over the past decade raised the demand for clinical trial subjects, but it has also coincided with lower participation rates in developed countries. With increasing difficulty in sourcing patients for clinical trials, the concept of expanding the pool of available patients in emerging countries, combined with cost savings, works out to a double win.
According to the results of the Nice Insight 2014 outsourcing survey, 84% of respondents who outsource clinical research would consider using CROs in emerging markets, and 43% of respondents are already working with emerging market CROs.
Emerging countries are subject to the same global standards when it comes to clinical trials, especially industry-sponsored trials aimed at gaining regulatory approval for a new medicine. Also, local governments have made concerted efforts to improve their business environment and regulatory adherence. This has led to some emerging markets implementing stricter practices than developed regions. Sponsors in North America and Europe are taking notice.According to the results of the Nice Insight 2014 outsourcing survey, 84% of respondents who outsource clinical research would consider using CROs in emerging markets, and 43% of respondents are already working with emerging market CROs.
As a sponsor, one of the best ways to reap the advantage of conducting clinical trials in emerging markets while limiting risk exposure is to use a global, full-service CRO. These businesses tend to maintain their ‘developed market’ mentality when expanding to the emerging market sites. At Nice Insight, we looked at several global CROs that have expanded clinical trials to Eastern Europe, China and Latin America in the past five years to see how their performance in Quality, Regulatory and Affordability outsourcing drivers compared to the CRO benchmarks for clinical research. The data from both 2011 and 2014 was reviewed to see if there were any patterns that appeared over a short period of time. The CROs examined were ICON, Quintiles, PPD, PRA International, Chiltern and Inventiv Health (PharmaNet data used for the 2011 comparison).
The goal was to examine whether these businesses had any significant differences in customer perception scores relative to the CRO benchmarks. When looking at the 2014 clinical research benchmarks for the CROs included in the Nice Insight study, the guiding score for affordability was 70%, while quality was 72% and regulatory 74%. These benchmarks were consistent from 2011 to 2014, with the exception of affordability. Respondents identified that CROs have scored somewhat better on affordability in 2014, increasing the benchmark two percentage points, up from 68% in 2011.
When comparing the scores of the selected global CROs with quality, regulatory and affordability benchmarks, we found no significant differences in these outsourcing drivers. Quality averaged 72%, affordability averaged 72% (up two percentage points), and regulatory averaged 75% (up one percentage point). Looking at the changes in the average score from 2011 to 2014, the data showed a positive shift in affordability, with a four percentage point improvement, but no statistically significant changes in quality or regulatory. These score evaluations imply that choosing a global CRO when outsourcing clinical trials to an emerging market is a low risk approach to accessing both cost savings and the necessary patient populations.
The FDA put forth regulations that apply to all foreign studies in 2008, dictating that clinical studies conducted in association with a drug or medical device must follow GCP guidelines. It also requires review by an independent ethical committee (IEC), which should reduce concerns regarding unethical or poor quality research. Furthermore, selecting a global CRO that operates in both established and emerging markets can provide added comfort as these businesses rank at parity with or above industry standards. Conducting clinical trials in emerging markets benefits both sponsor pharmaceutical companies and CROs – with reduced expenses and a bigger pool of patients. It is also beneficial for the local healthcare system and the economy of the developing country.