IQVIA Institute for Human Data Science Study: Record 59 New Drugs in 2018

Ongoing changes in the clinical development process led to a record number of drug approvals in 2018, with 59 novel treatments reaching patients in the United States alone. During the next five years, trial productivity will be influenced by key trends, including wider use of biomarkers, pre-screened patient pools, regulatory shifts and application of artificial intelligence and predictive analytics. 

To examine historical and future clinical trial productivity trends across therapy areas a new report from the IQVIA Institute for Human Data science titled, The Changing Landscape of Research and Development: Innovation, Drivers of Change, and Evolution of Clinical Trial Productivity puts forth a proprietary Clinical Development Productivity Index that reflects changes in trial complexity, success and duration. 

Using this index, the report takes a 10-year historical view of these metrics and recasts the data with a future perspective that identifies critical productivity changes expected through 2023. IQVIA experts shed light on those productivity shifts using the proprietary IQVIA Clinical Development Trends Impact Assessment, identifying the quantitative impact of the eight key trends driving change in clinical development at a therapy- area level. Those drivers are: 

• Digital health technologies to enable the capture of drug efficacy and safety data remotely, which can improve patient safety, enable virtual trial formats and ease site work burden. 

• Patient-reported outcomes that will shed new light on patient experience and drug efficacy and safety outside the clinical setting and lead to accelerated trial times as endpoints shift. 

• Real-world data to optimize trial design, speed investigator and site selection, and enable new trial designs by acting as virtual control arms and supporting pragmatic, adaptive and RWE registry trials. 

• Predictive analytics and artificial intelligence to identify new clinical hypotheses, reduce trial design risks and speed enrollment by identifying protocol-ready patients. 

• Shifts in types of drugs tested, for instance, to targeted therapies and next-generation biotherapeutics that improve efficacy and success rates and have accelerated development timelines but require longer-term patient follow-up. 

• Biomarker testing availability to help narrow patient populations to those more likely to see effect, resulting in improvements in efficacy, safety and success. 

• Regulatory landscape changes that will encourage the adoption of precision medicine approaches, novel trial designs and endpoints while providing means for accelerated drug approvals and regulatory success. 

• Pools of pre-screened patients and direct-to-patient recruitment, which will facilitate enhanced trial enrollment, shortened trial duration and faster market availability. 

“As advances in science, technology and data gradually find application within clinical development, the length of time that trials take to complete, the resources required due to trial complexity and likelihood of trial success are all shifting, with impacts varying by therapy area,” said Murray Aitken, IQVIA senior vice president and executive director of the IQVIA Institute for Human Data Science. “Our study assesses the current activity within research and development, the productivity levels of the clinical development process and how key trial trends will transform clinical development over the next five years.” 

Additional highlights in the report include: 

• Emerging biopharma companies account for 72 percent of all late-stage pipeline activity, up from 61 percent a decade ago. Large pharma companies with more than $10 billion in annual pharmaceutical sales have seen their R&D share drop from 31 percent to 20 percent during the same period. This pipeline mix reflects smaller companies being most active in the fastest growing areas of oncology and orphan drugs, and their diminishing need for partnering or acquisition to develop and commercialize their innovative medicines. 

• Investment in medical innovation grew in 2018, reflecting confidence in scientific development to propel new treatments to tackle unmet health needs across a broad range of diseases. In 2018, more than 1,300 life science venture capital deals were closed with an aggregate value of more than $23 billion, up from roughly $10 billion in deal value five years earlier, according to the National Venture Capital Association.

• Developing innovative medicines continues to be a slow process with the 2018 cohort taking a median of 13.7 years from the time of first patent filing to product launch, almost six months faster than the median of the past five years. Of the 2018 new drug launches, four new molecular entities launched in less than eight years, while another 12 drugs launched more than 20 years after their first patent filing, reflecting in some cases older mechanisms of action and the approval of drugs that had launched in countries outside the U.S. 

• Dramatic R&D successes and failures occurred in 2018. Within chronic liver disease research, nine new drugs were added to the late-stage pipeline in 2018 as drugs with several mechanisms continue to show promise within that therapeutic area. However, within the Alzheimer’s category, four drugs failed in development, bringing the total number of failures to 85 during the past 10 years even as unmet needs remain significant and potential healthcare cost impacts loom over future generations. 

None of the analytics in this report are derived from proprietary sponsor trial information but are instead based on proprietary IQVIA databases and/or third-party information. The full version of the report, including a detailed description of the methodology, is available at www.IQVIAInstitute.org. 

The study was produced independently as a public service without industry or government funding.