• Clinical trials take 6-7 years to complete

• Average FDA approval rate = 13.8%,

• Average FDA approval rate for oncology trials is disproportionately low: 3.4%. In other words, 97% of oncology trials fail.

• The growth and market cap of these riskier therapeutic areas are significantly larger (10.8 billion in 2019 with a CAGR of 5.4%)

• Oncology makes up 35% of the entire clinical trial market size:

  

• One problem is the lack of patient accruement due to the stringent and unclear selection criteria (noted to be the problem for 60+% of all oncology trials found in clinicaltrials.gov)

• More effective target validation as well as earlier proof-of-concept studies could reduce attrition in phase II clinical trials by 24%, lowering cost of developing new drugs for novel MoAs by 30%

"Using these two approaches (better target validation and early POC studies) we have estimated that the p(TS) of Phase II compounds can be increased to approximately 50%. As can be seen in our sensitivity analysis [Fig. 3 in the paper; image below in this notion], reducing Phase II attrition by this much will by itself lower the cost per NME by approximately 30%." (Source)

(Source)

• Biomarkers are essential for personalized medicine (if we want to go down that path).
  • The percentage of personalized medicines gaining FDA approval has been growing over the past five years, from ~21 percent of all NME approvals in 2014 to ~42 percent in 2018. (Source)

A review of clinical trials conducted between 2006-2015 (9985 trials) reveal a low Phase-I to approval success rate for oncology drugs compared to other non-oncology disease areas (5.1% vs. 11.8% respectively) [12]. Further, the success of a biomarker-driven clinical trial was 3-times higher than a trial without biomarkers (25.9% vs. 8.4% respectively) (Source)

• In 2020, 61 novel drugs (not necessarily for oncology) were approved in the USA, European Union and Japan. Some of these also have novel mechanism of action (MoA) biomolecular targets.

• Median cost of developing cancer drugs was $648 Million. (Source)

  Caveats:

  • The range was $157.3 million to $1950.8 million (pretty wide spread). The cost for novel drugs specifically is likely on the higher end of the spectrum.
  • This estimate was based on a sample size of 10 companies.
  • The sources were SEC filings.
  • Another source (Tufts Center for the Study of Drug Development) estimated that the cost to bring a single new drug to market was $2.7 billion. However, this was estimated based on private data from 10 pharmaceutical firms, so it could not be scrutinized.

• The global Drug Repositioning market size is projected to reach USD 34620 million by 2027, from USD 24960 million in 2020, at a CAGR of 4.7% during 2021-2027. (Source)

  • This source is from 2021

• The global market for drug repurposing will grow from nearly $24.4 billion in 2015 to nearly $31.3 billion by 2020, with a compound annual growth rate (CAGR) of 5.1% for the period of 2015-2020. (Source)

  • This source is from 2016

The regulatory and phase III costs may remain more or less the same for a repurposed drug as for a new drug in the same indication, but there could still be substantial savings in preclinical and phase I and II costs. Together, these advantages have the potential to result in a less risky and more rapid return on investment in the development of repurposed drugs, with lower average associated costs once failures have been accounted for (indeed, the costs of bringing a repurposed drug to market have been estimated to be US$300 million on average, compared with an estimated ~$2–3 billion for a new chemical entity). [Source]

My feeling is that the proportion of drugs that in theory could be repositioned is probably around 75%,” says Bernard Munos, a senior fellow at FasterCures, a drug-development advocacy organization in Washington DC, and a member of the advisory council of the National Center for Advancing Translational Sciences (NCATS) at the NIH. [Source]

But the fraction is probably quite a bit smaller in practice, he concedes. Repositioned drugs still have to make it through phase II and III clinical trials for their new purpose — trials that respectively eliminate 68% and 40% of every compound that gets that far.

• 30 articles on cases of drug repositioning are now being published in scientific journals every month – a sixfold increase since 2011.
• And some estimates suggest that the number of repositioned drugs entering the regulatory-approval pipeline is rising, and could account for about 30% of all drugs approved every year.