IQVIA, one of the premier resources for health research data, released a report this week that provides an overview of pharmaceutical innovation in America in 2018. The Axios headline heralding the study says it all: “Prescription drug R&D is thriving” in the United States.
According to IQVIA, in 2018:
- 59 new drugs were launched – a figure that was higher than in any of the past 5 years.
- The list of new treatments included 16 new drugs to address cancer (27 percent of all new drugs on the market) and 12 to address infectious diseases (20 percent of all new drugs on the market).
- More than half of the new drugs released last year fell into the “orphan drug” category, a designation that, as Axios explains, means they “serve small patient populations.”
- The top 15 largest companies spent more than $100 billion on research and development (R&D), a 32 percent increase from 2017. It was the first time these companies have hit that investment mark.
Unsurprisingly, IQVIA also determined it still take a long time for a drug make it to market. Among the 59 news drugs launched last year, 12 took more than 20 years from their first patent filing to launch. The average timeline from the date the first patent filing to launch was 13.6 years for all 59 drugs. That figure improved from the two previous years, but, as the report also explains, “The average progression time for a drug from beginning of Phase I trials to the end of development has increased by 26 percent over the past 10 years and rose by six months in 2018 to 12.5 years.”
The success rate for R&D also has fallen. The composite success rate for clinical development stages from Phase I trials to regulatory submission fell to 11.4 percent in 2018 from 14.4 percent in 2017. That figure also declined from an average 14 percent approval rate over the last 10 years.
Still innovators have not been deterred. In fact, the number of small innovators entering the market appears to be growing. According to IQVIA, emerging biopharma (EBP) companies patented 64 percent of new drugs launched in 2018 and registered 47 percent of them. Larger companies patented only one-quarter. Ed Silverman at STAT News put this shift into context. According to Silverman, in 2010, half of the drugs that earned U.S. Food and Drug Administration approval began in the laboratories of small biotech companies.
Silverman also noted, EBP companies accounted for 72 percent of the nearly 3,000 late-stage drugs in the collective industry pipeline last year.
The news from the IQVIA report is good – research and development is thriving. With good state and federal policy, it will continue.