Insights from the comprehensive report show there are two main factors in the pharmaceutical industry that are causing the increase in drug approvals and subsequently the decrease in cost per new molecular entity (NME). The first is an increased focus on rare diseases. Of the 57 NMEs launched in 2018, 22 had an orphan drug designation, indicating that they targeted a rare disease.
The second contributing factor is increased activity from smaller pharmaceutical companies. In 2018, 74% of drug launches were developed by companies with an R&D spend of $700 million to $2 billion, which is almost double the contribution this group made in 2009. Major pharma companies (R&D spend of greater than $2 billion) accounted for just 26% of drug launches.
The report reveals that while the number of drug approvals is up, estimated sales per approval is on the decline. The average peak sales per asset almost halved between 2015 and 2018. This indicates older and legacy products continue to make up the vast majority of global sales, accounting for more than 85% worldwide. Additionally, these new drug approvals continue to target smaller patient populations. Between 2010 and 2018, the number of addressable patients per drug approval decreased by 15%.1
The CMR International Factbook also provides insights into pharmaceutical companies' investment strategies, where external innovation plays a key role. In the first half of 2019 alone, global spend for pharma M&A and licensing activities was nearly $140 billion. This outpaced projected 2019 R&D spend by more than 60%.
"It is extremely encouraging to see the increase in new drug approvals driven by smaller pharma companies. This suggests size is no longer a prerequisite to bring a drug to market and R&D programs are becoming more efficient," said Mukhtar Ahmed, President, Science Group, Clarivate Analytics. "What is concerning, however, is that forecasted sales per approval are declining. Even though the overall volume of new approvals is healthy, this raises questions about long term sustainability, particularly for large pharma."
He continued, "Given the cost and risk associated with the drug development process, it is essential for researchers and decision makers to have access to accurate, comprehensive information and historical insights. This allows R&D investments to be allocated to the most promising areas of discovery and development and enables companies to better accelerate innovation."
The 2019 CMR International Pharmaceutical R&D Factbook provides analyses in the following areas:
Resources and pipeline volume
Clinical development success rates and cycle times
Therapeutic area breakdown
Biopharmaceutical trends and predictions by active substance type
Clinical study durations
Global generics market approvals, suppliers and challenges
As a part of Clarivate Analytics, CMR International is uniquely positioned to access leading life sciences intelligence while maintaining objectivity as an independent legal entity. Since 2003, CMR has been interpreting and analyzing data from Cortellis™; Newport™, a Cortellis solution; Derwent World Patents Index™; and The Centre for Innovation in Regulatory Science (CIRS) to provide customers with an objective analysis of pharmaceutical R&D trends. CMR International performance metrics programs, on which the report is based, are ongoing and focus on key issues across the pharmaceutical R&D lifecycle with datasets built over 20 years of rigorous development. These programs are trusted by 80% of the top 20 pharmaceutical companies to assess R&D and clinical productivity as well as provide actionable information and insights.
About The Centre for Medicines Research International The Centre for Medicines Research (CMR) International, a Clarivate Analytics business, is a leader in global pharmaceutical research and development (R&D) performance measures, bringing together data sets from prominent sources to provide objective information and insights. For more than 20 years, CMR International has worked with the leading global pharmaceutical companies to assess R&D productivity and provide insights into industry trends, helping to strengthen R&D planning and effectiveness. CMR International performance metrics programs cover every aspect of pharmaceutical R&D and are stratified into three categories – Global R&D, Global Clinical, and Asia Pacific. CMR programs are ongoing and focused on key issues, with datasets built on over two decades of rigorous development. The datasets have the unique depth and historical perspective to uncover reliable industry trends, set in context against the changing marketplace. For more information, please visit: https://clarivate.com/cortellis/solutions/benchmarking-services/
About Cortellis Cortellis™, a Clarivate Analytics solution, gives life to science by unlocking the hidden insights in data by curating broad and deep sources of intelligence to enable precise, actionable answers to specific questions across the R&D lifecycle — from discovery and clinical development through regulatory submission and commercialization. By supporting data-driven decisions, Cortellis helps pharmaceutical companies, biotech and medical device/diagnostic firms accelerate innovation. For more information, please visit clarivate.com/cortellis.
About Clarivate Analytics Clarivate Analytics™ is a global leader in providing trusted insights and analytics to accelerate the pace of innovation. We have built some of the most trusted brands across the innovation lifecycle, including Web of Science™, Cortellis™, Derwent™, CompuMark™, MarkMonitor™ and Techstreet™. Today, Clarivate Analytics is on a bold entrepreneurial mission to help customers reduce the time from new ideas to life-changing innovations. For more information, please visit clarivate.com.
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