Pharma R&D Pipeline and New Product Launches Reach Record Levels in 2021 According to New IQVIA Institute for Human Data Science Report
February 10 2022 - 8:00AM
Business Wire
- Clinical trial activity saw sustained growth through the
pandemic with 5,500 new planned clinical trial starts in 2021, a
14% increase over 2020
- The total number of products in active development exceeded
6,000, up 68% from 2016
- A record 84 novel active substances were initially launched
globally in 2021, double the number of five years ago
- The composite R&D success rate across all therapy areas
declined to 5% in 2021, due to the more challenging clinical
development programs being deployed
- Emerging biopharma companies are responsible for a record 65%
of the molecules in the R&D pipeline — up from less than 50% in
2016
Biopharmaceutical R&D continued at a record-breaking pace in
2021 despite the COVID-19 pandemic, according to a new report,
“Global Trends in R&D – Overview Through 2021,” by the IQVIA
Institute for Human Data Science. The data show 5,500 new planned
clinical trial starts occurred last year, a 14% increase over
2020.
Also in 2021, new drug approvals and launches accelerated, with
84 novel active substances launched, double the number five years
ago. With a pipeline of more than 6,000 products in active
development, up 68% compared to 2016, the speed of pharma R&D
is on pace to be sustained for years to come.
“Almost all indicators are up, demonstrating astonishing
achievements of the global life sciences industry. This activity
reflects the strength of the global biomedical innovation system to
discover, develop, and secure regulatory approvals for new
therapeutics,” said Murray Aitken, IQVIA senior vice president and
executive director of the IQVIA Institute for Human Data Science.
“Concerns that the pandemic would slow down innovation have not
been confirmed. On the contrary, the pandemic has accelerated
biopharmaceutical innovation. Stakeholder efforts to accelerate
innovation and bring scientific breakthroughs to patients faster
and safer is an enduring feature of the post-pandemic, R&D
landscape.”
The only decline in indicators occurred in clinical development
productivity, which fell to its lowest point in 2021. The composite
success rate across all therapy areas declined to 5% in 2021, due
to the more challenging clinical development programs being
deployed. In addition, the bar for efficacy and safety has risen
and there have been more pauses in product development due to the
pandemic.
A few key highlights of the report include:
- New Drug Approvals and Launches: A record 84 novel
active substances (NASs) were launched globally in 2021, double the
number of five years ago. Among the 72 NASs launched in the U.S. in
2021, a record 44 (over 60%) were deemed by the FDA as
“first-in-class” — drugs that use a new and unique mechanism of
action for treating a medical condition — and more than half (40)
carried an orphan drug designation for patients with rare diseases.
A range of clinical trial designs was used to support regulatory
submissions in 2021, reflecting the diversity of therapeutic
innovation approaches to clinical development. This included
increased use of real-world evidence as part of FDA approval
decisions. Achieving appropriate race and ethnicity representation
in the clinical trials used as the basis for U.S. FDA approval
remains a challenge, though some progress is seen among recently
approved NASs.
- R&D Pipeline: The total number of products in active
development globally exceeds 6,000, up 68% over the 2016 level.
This shows how the life sciences sector continues to invest in and
advance innovative therapeutics and vaccines across a wide range of
disease areas despite the COVID-19 pandemic disruption. Pipeline
expansion has been most significant in oncology, gastrointestinal
disorders, and neurology. While infectious diseases and vaccines
had declining numbers of pipeline products until recently, they saw
significant growth, largely driven by COVID-19-related treatments
and vaccines. Almost all of the oncology pipeline is some type of
targeted therapy. More than 40% of the pipeline is for rare cancers
for which next-generation biotherapeutics — including cell and gene
therapies — are increasingly being deployed.
- Clinical Trial Activity: Clinical trial activity has
been sustained through the pandemic, as the industry has adapted
and developed new approaches to enable research to continue. Last
year saw 5,500 new clinical trial starts, a 14% increase over the
number started in 2020 and 19% more than started in 2019. While the
number of intended clinical trial starts dipped significantly in
early 2020, the recovery began in June 2020 and has increased to
record levels since then. This excludes the surge of clinical
trials related to COVID-19 vaccines and treatments, which has
resulted in over 1,200 industry-sponsored interventional trial
starts since the beginning of 2020.
- Clinical Development Productivity: One measure of
clinical development productivity is to relate molecule success
rates to the complexity and duration of clinical trials. Efforts to
improve productivity are largely focused on these areas. By these
measures, clinical development productivity fell to its lowest
point in 2021. The decline was driven by a lower success rate that
was offset by reduced trial complexity. Across disease areas,
2021’s composite success rate fell below the 10-year trend except
for vaccines and cardiovascular, although the probability of
success varied considerably across diseases. The low success rate
reflects efforts by drug developers to take on tougher clinical
challenges in the hopes of achieving clinical breakthroughs, even
though these remain rare. These lower success rates have been
offset by higher volumes of investigational drugs in recent years.
These factors have resulted in a higher number of new drug
approvals and launches.
- R&D Funding: Venture capital deal activity and
investment flows accelerated in the past two years as interest in
life sciences intensified. Specifically, in 2021, there were more
than 2,000 deals and over $45 billion of deal value. The 15 largest
pharmaceutical companies invested a record $133 billion of R&D
expenditure in 2021, representing an increase of 45% since 2016 and
a level of investment close to 20% of their recorded sales. Over
the past five years, deal activity has shifted geographically to
include more companies headquartered in China, Korea and other APAC
countries, and fewer Europe-based companies. North American
companies represent the largest number and total increase of deal
activity over the five-year period.
- Emerging Biopharmaceutical (EBP) Companies’ Contribution to
Innovation: Emerging biopharma companies — those with an
estimated R&D expenditure of less than $200 million and annual
revenue of less than $500 million — are responsible for a record
65% of the molecules in the R&D pipeline. That’s a significant
increase compared to less than 50% in 2016 and 33% in 2001. EBPs
headquartered in China now account for 17% of the EBP innovation
pipeline, up from 6% just five years ago. While 20% come from
Europe-based companies and 46% from U.S.-based companies, both have
lost share over the same period.
- Accelerators of Innovation Cycles: Novel trial designs
have been embraced as a means to accelerate innovation and are now
incorporated into 8% of new trial starts. That equated to roughly
400 trials in 2021, with oncology trials responsible for almost 60%
of this activity. The median time from first patent filing to
launch for U.S. NASs fell to its lowest level in 2020 and 2021.
This includes 21 drugs that were launched less than five years into
their patent terms, compared to 16 over the prior nine years.
Reducing the “white space” — the difference between the time a
molecule takes to progress through clinical development and its
clinical trial duration — is a major area of focus. In the case of
COVID-19 vaccines, pivotal trial white space and execution
timelines were reduced by 70% — an estimated 26-month time savings
over benchmark. The main time-intensive elements of clinical trials
include partner selection, trial startup, patient enrollment,
database lock, and analysis. Key factors that enable faster trial
cycles are regulatory allowances, patient interest, leadership
focus, and government funding that de-risk critical
decision-making, process innovation, and resource utilization
agencies.
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 clinical research services to
the life sciences industry. IQVIA creates intelligent connections
across all aspects of healthcare through its analytics,
transformative technology, big data resources and extensive domain
expertise. IQVIA Connected Intelligence™ delivers powerful insights
with speed and agility — enabling customers to accelerate the
clinical development and commercialization of innovative medical
treatments that improve healthcare outcomes for patients. With
approximately 77,000 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220210005216/en/
Nick Childs, IQVIA Investor Relations (Nchilds@us.imshealth.com)
+1.973.316.3828
Tor Constantino, IQVIA Media Relations
(tor.constantino@iqvia.com) +1.484.567.6732
IQVIA (NYSE:IQV)
Historical Stock Chart
From Jun 2024 to Jul 2024
IQVIA (NYSE:IQV)
Historical Stock Chart
From Jul 2023 to Jul 2024