2021 Centre for Medicines Research (CMR) Pharmaceutical R&D Factbook from Clarivate Finds Drug Approvals at a 10-year High Despite the Challenges of COVID-19

LONDON,Sept. 15,2021 --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 impact[1]

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 innovation[2]

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 visithttps://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.

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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

3The 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.

4The 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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