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jmunda@firstanalysis.com
tmarshbanks@firstanalysis.com
- The costs and risks associated with developing new therapeutics – mainly related to drug trials – continue to increase, a trend that is likely to see additional momentum with the advent of more complex opportunities in orphan treatments and personalized medicine. At the same time, the proliferation of virtual pharma companies means entities without traditional large-scale pharma capabilities are responsible for a greater proportion of the therapeutics pipeline. In the face of these pressures, eClinical solutions, which help minimize drug development costs and improve efficiency by automating and streamlining the clinical trial process, are key to optimizing return on investment in new drug development.
- We believe there are roughly 25-30 discrete application steps in the clinical trial workflow process. We identify several highly capable privately held companies that provide software to drug sponsors and contract research organizations (CROs) to automate portions of this process. Large eClinical solutions developers such as Medidata and Oracle account for about 25% of this market; however, many smaller technology providers we profile in this report are having an outsized impact on the direction of the market.
- Clinical trial management systems (CTMS) and electronic data capture (EDC) are the most prominent eClinical solutions. With these solutions, sponsors and trial managers are able to better manage increasing data volumes while enabling the speed and flexibility needed to execute on emerging trial concepts that allow sponsors to more effectively pursue commercialization. We see risk-based monitoring (RBM) as the most sizable emerging opportunity for eClinical solutions providers.
TABLE OF CONTENTS
Includes profiles of 21 public and private companies
Introduction
Running the R&D Gauntlet
Collecting and Managing Clinical Data
Competitive Landscape
Emerging eClinical Solutions
Featured eClinical Solutions Providers
INTRODUCTION
Since the results from the first randomized clinical study were published in 1948, clinical trials have become the bedrock of medical research, a key component of the rigorous and stringent approval process employed by the U.S. Food and Drug Administration (FDA) to show that drugs and medical devices have been demonstrated to be safe and effective for their respective indications. A lot has changed since that first study. Pharmaceutical and medical device companies now face a number of challenges to commercializing existing and developing new products, such as competitive pricing pressure, patent expiry, and rising regulatory burdens exacerbated by increases in clinical trial complexity, data volumes, and development costs.
The drug R&D process is inefficient, complex, bureaucratic, and, above all else, expensive. According to the Tufts Center for the Study of Drug Development, it takes an average of $2.6 billion, including cost of failures, and 10-15 years to discover, develop, and win approval for a new drug. Additionally, only one of every 10 drugs that starts trials ends up being approved by the FDA.
Historically, industry stakeholders have been slow to adopt new technologies. In our view, the highly regulated nature of the development and approval of new medicines has resulted in an understandable level of conservatism toward changing processes.
Despite the challenges, sponsors, contract research organizations (CROs), and regulatory agencies worldwide are committed to improving R&D efficiency, most notably by making greater use of technology-enabled software called eClinical solutions. These eClinical solutions are increasingly viewed as being essential to manage trial data requirements, reduce development costs, support faster go/no-go decisions for potential new drug candidates, and increase efficiency throughout the clinical trial process.