-
A third of the new drugs identified as innovative therapies with novel
mechanisms of action different from existing therapies -
The likelihood that a drug entering clinical development would be a
success was 11 percent, down from 14 percent in 2017 -
Eight identified trends could increase R&D productivity by double
digits during next five years
DANBURY, Conn. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–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 heavily 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.
About the IQVIA Institute for Human Data Science
The IQVIA Institute for Human Data Science contributes to the
advancement of human health globally through timely research, insightful
analysis and scientific expertise applied to granular non-identified
patient-level data.
Fulfilling an essential need within healthcare, the Institute delivers
objective, relevant insights and research that accelerate understanding
and innovation critical to sound decision making and improved human
outcomes. With access to IQVIA’s institutional knowledge, advanced
analytics, technology and unparalleled data, the Institute works in
tandem with a broad set of healthcare stakeholders to drive a research
agenda focused on Human Data Science, including government agencies,
academic institutions, the life sciences industry and payers. More
information about the IQVIA Institute can be found at www.IQVIAInstitute.org.
About IQVIA
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics,
technology solutions and contract research services to the life sciences
industry. Formed through the merger of IMS Health and Quintiles, IQVIA
applies human data science — leveraging the analytic rigor and clarity
of data science to the ever-expanding scope of human science — to enable
companies to reimagine and develop new approaches to clinical
development and commercialization, speed innovation and accelerate
improvements in healthcare outcomes. Powered by the IQVIA CORE™, IQVIA
delivers unique and actionable insights at the intersection of
large-scale analytics, transformative technology and extensive domain
expertise, as well as execution capabilities. With more than 58,000
employees, IQVIA conducts operations in more than 100 countries.
IQVIA is a global leader in protecting individual patient privacy. The
company uses a wide variety of privacy-enhancing technologies and
safeguards to protect individual privacy while generating and analyzing
information on a scale that helps healthcare stakeholders identify
disease patterns and correlate with the precise treatment path and
therapy needed for better outcomes. IQVIA’s insights and execution
capabilities help biotech, medical device and pharmaceutical companies,
medical researchers, government agencies, payers and other healthcare
stakeholders tap into a deeper understanding of diseases, human
behaviors and scientific advances, in an effort to advance their path
toward cures. To learn more, visit www.iqvia.com.
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Contacts
Andrew Markwick, IQVIA Investor Relations (andrew.markwick@iqvia.com)
+1.973.257.7144
Tor Constantino, IQVIA Media Relations (tor.constantino@iqvia.com)
+1.484.567.6732