Annual pharmaceutical R&D industry highlights impact of
pandemic on drug launches, development times and approvals
LONDON, Sept. 15, 2021 /PRNewswire/ -- Clarivate
Plc (NYSE:CLVT), a global leader in providing trusted
information and insights to accelerate the pace of innovation,
today announced the release of the 2021 Centre for Medicines
Research (CMR) International Pharmaceutical R&D
Factbook. The 2021 CMR R&D Factbook centers on how the
pandemic may have impacted drug launches, development times and
approvals. This year's report finds that the pharmaceutical
industry has responded well to the challenges of COVID-19. In fact,
2020 saw a 10-year high of new molecular entities (NMEs) launched
into the world market.
The Centre for Medicines Research, a wholly owned subsidiary of
Clarivate, has released the 2021 Centre for Medicines Research
(CMR) Pharmaceutical R&D Factbook to help pharma and biotech
companies benchmark their drug development efforts against industry
leaders. The new Factbook provides insights on R&D
expenditures, cycle times, pipeline growth and more to allow
companies to access and analyze success rates and key activities
from drug discovery through commercialization. These insights can
ultimately help them establish reliable internal KPIs throughout
the entire drug development lifecycle.
COVID impact1
Amid a global pandemic as the
world has shone a spotlight on the industry's COVID-19 vaccine and
therapeutic development race, biopharma companies have been anxious
to see how COVID-19 could impact R&D. From the CMR Factbook we
can infer that there has been no major impact from COVID-19 on the
R&D pipeline thus far. While it typically takes a drug two to
three years to transition through a clinical phase, the longer-term
impact remains to be seen.
- 2020 saw a 10-year high for NME launches indicating that
COVID-19 did not negatively impact drug R&D. There were 59 NMEs
launched in 2020 as compared to 31 in 2011 and 46 in 2019.
- The pandemic did not impact drug development times as they have
stayed relatively constant from 2019 to 2020 at 10.5 and 10.4 years
respectively.
- Approval times for FDA, EMA, and PMDA remained stable despite
the pandemic:
-
- The FDA took on average 244 days in 2020 as compared to 243 in
2019.
- The EMA took on average 426 days in 2020 as compared to 423 in
2019.
- The PDMA took on average 313 days in 2020 as compared to 304 in
2019.
Industry innovation2
In addition to
pandemic-related impacts, now more than ever, biopharma companies
are focused on truly innovative and differentiated therapies.
According to 2020 FDA approvals, 58% were for rare indications
while 68% were granted at least one regulatory designation:
breakthrough, fast-track, accelerated, or priority. Both these
points put together suggest that biopharma is increasingly focusing
on innovative and differentiated therapies.
- TNF alpha ligand was the most popular target in 2020 with 69
companies actively researching the area.3
- These innovative therapies are mainly being researched by
emerging biopharma companies rather than top 30 innovators. Of the
69 companies researching the TNF alpha ligand, only three of them
are top 30 innovators.4
- However, despite this innovation, most biopharma companies rely
on only a few products for the majority of their sales. 43% of
sales across all member companies in 2019 were attributed to the
top three selling products. On the other hand, new products have
accounted for a minority of total sales. Only 11% of total
pharmaceutical industry revenues came from products launched in the
last five years. These findings indicate that biopharma's revenues
have not yet caught up with their R&D innovation.
Mukhtar Ahmed, President, Science
Group, Clarivate, said: "We are all waiting to see the
long-term impacts the pandemic will have on the biopharma industry.
Preliminary data indicate that drug launches, development times and
approvals were not impacted in 2020. It takes an average of 10
years to develop and launch a drug. We anticipate the impact of
COVID-19 will be seen even more clearly through the data CMR
collects over the next decade, with next year's CMR Factbook set to
show the immediate impacts of the pandemic on drug
development."
CMR International has published the Pharmaceutical R&D
Factbook, an annual report designed to equip the pharmaceutical
clinical sector with a reliable quotable source of key reference
metrics and an insight into current industry trends since 2006.
This analysis was derived from proprietary, anonymized data
gathered from more than 25 leading Pharma and Biotech companies of
all sizes and therapy areas in order to aid the industry in making
more strategic decisions and bringing life-saving therapies to
patients as quickly and safely as possible.
To learn more about the 2021 Centre for Medicines Research (CMR)
International Pharmaceutical R&D Factbook, visit here.
CMR International is the world's most reputable source of
industry metrics and trends analysis. Experience, independence and
integrity paired with a dedication to providing industry-leading
data, insights and opinions, make CMR International the partner of
choice for the world's major pharmaceutical innovators. CMR
International is distinguished by its unique ability to collect,
validate and analyze industry-wide proprietary R&D performance
metrics, using a proven and secure process. This capability enables
CMR International to provide partners with readily accessible
information designed to maximize the effectiveness and efficiency
of their R&D operations. As a result, CMR International is the
world's most authoritative source of pharmaceutical R&D
performance metrics, facts and trends.
To learn more about CMR International
visit https://clarivate.com/cortellis/solutions/benchmarking-services/.
About Clarivate
Clarivate™ is a global leader in
providing solutions to accelerate the lifecycle of innovation. Our
bold mission is to help customers solve some of the world's most
complex problems by providing actionable information and insights
that reduce the time from new ideas to life-changing inventions in
the areas of science and intellectual property. We help customers
discover, protect and commercialize their inventions using our
trusted subscription and technology-based solutions coupled with
deep domain expertise. For more information, please visit
clarivate.com.
Media Contact
Catherine Daniel
media.enquiries@clarivate.com
1 "2021 CMR International Pharmaceutical R&D
Factbook" September 2021. Source: The
Centre for Medicines Research
2 "2021 CMR International Pharmaceutical R&D
Factbook" September 2021. Source: The
Centre for Medicines Research
3 The list of the most popular targets was
determined by evaluating individual companies filing patent
applications on novel small molecules with therapeutic activity
where no previous patents from the organization claiming novel
small molecules against the same target already exist.
4 The top 30 innovative companies are defined by
the number of patents filed on novel targets as sourced from data
found in Cortellis Competitive Intelligence.
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