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“The report found a 7.9% overall likelihood of U.S. Food and Drug Administration approval from Phase I across all disease areas and drug modalities.”
The conclusion
The cited report calculated an overall 7.9% likelihood of FDA approval for candidates entering Phase I. This aggregate covered all disease areas and drug modalities in its 2011–2020 dataset. The figure is report- and period-specific, not a universal success rate for every disease category or era.
Caveats
- The 7.9% estimate applies specifically to the report's 2011–2020 dataset.
- Rates varied substantially by disease area, so 7.9% is an aggregate rather than a uniform rate.
- Other studies and time periods report different approval probabilities because methodologies and datasets vary.
This analysis is for informational purposes only and does not constitute health or medical advice, diagnosis, or treatment. Always consult a qualified healthcare professional before making health-related decisions.
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Sources
Ranked by source quality and relevance
Such result aligned roughly with recent publication 5 reporting the OSRs of 10.8% and 7.9% for leading pharma companies and biotech firms.
In their updated analysis of 9,704 development programs initiated from 2011 to 2020, the likelihood of approval decreased slightly to 7.9%.
As provided in Fig. 3d, the OSRs for leading pharma company and biotech firm remained steady across time-windows, and the top-20 large pharma companies gave consistently higher OSRs (between 9.2% and 9.8%) than that of biotech firms (between 8.0% and 9.0%). … Such result aligned roughly with recent publication 5 reporting the OSRs of 10.8% and 7.9% for leading pharma companies and biotech firms.
Bio innovation (2011-2020) | n = 4414 (52.0%) n = 4933 (28.9%) (52.4%) | 7.9
Our study reveals an average likelihood of first approval rate of 14.3% across leading research-based pharmaceutical companies, broadly ranging from 8% to 23%.
Multiplying these individual phase components to obtain the compound probability of progressing from Phase I to U.S. FDA approval (LOA) reveals that only 9.6% (n=9,985) of drug development programs successfully make it to market (Figure 1).
For the experience period 2017–2019, the probability of transitioning out of Phase I is 47.2%, out of Phase II is 32.4%, and out of Phase III it is 50.4%; Hence, the overall probability of success is the product of these three probabilities, yielding 7.7%.
• The overall likelihood of approval (LOA) from Phase I for all developmental candidates over 2011–2020 was 7.9%.
• The overall likelihood of approval (LOA) from Phase I for all developmental candidates over 2011–2020 was 7.9%.
The landmark peer-reviewed article in 2014 established the widely cited 10% benchmark (10.4%) for the likelihood of a new drug entering Phase I eventually reaching the market. 1 Since then, subsequent updates in 2016 and 2021 have showed that industry success rates have moderated, falling first to 9.6% 2 and later to 7.9%. 3 … Overall LOA for new assets entering Phase I is now just 6.7%, down from 7.9% three years ago.
Multiplying these individual phase components to obtain the compound probability of progressing from Phase I to U.S. FDA approval (LOA) reveals that only 9.6% (n=9,985) of drug development programs successfully make it to market (Figure 1).
The overall LOA from Phase I for all developmental candidates was 9.6%, and 11.9% for all indications outside of Oncology.
Overall, for all modalities, the LOA from Phase I was 7.9% for the 2011-2020 period.
Phase transition data from Citeline for the 10-year period between 2014ؘ and 2023 show that the average likelihood of approval (LOA) for a new Phase I drug is now just 6.7%.
CGTs for orphan gene therapies (27.6% LoA) are 2 to 3.5 times as likely to be approved when they enter Phase I clinical development as the average drug (BIO 7.9% LoA; IQVIA 13.2% LoA; Figure 2).
As provided in Table 1, for all diseases, the overall success rate (OSR) calculated by this study for the time-window of 2003-2011 equaled to 10.0%, which was highly consistent with that (10.4%) of landmark study (2), and their relative difference (RD) was really small (-3.8%).
We find that 13.8% of all drug development programs eventually lead to approval, which is higher than the 10.4% reported by Hay and others (2014) and the 9.6% reported by Thomas and others (2016).
To update our research, we conducted an outside-in analysis of pharmaceutical development success rates from 1996 until 2014. Using Informa's Pharmaprojects database, we tracked the clinical and regulatory phase progression of more than 9,200 novel compounds in development (see Supplementary information S1 (box) for details).
Across more than a decade of systematic, programme-level data, a single figure emerges with striking consistency: 7.9% — the likelihood that a molecule entering Phase I will eventually secure FDA regulatory approval (BIO & Informa Pharma Intelligence, 2021).
Across all indications, the likelihood of approval (LOA) from 2011 to 2020 was 7.9%.
Across all indications, the likelihood of approval (LOA) from 2011 to 2020 was 7.9%.
In the BIO/Informa/QLS dataset, likelihood of approval from Phase I is 7.9% overall, but by disease area it spans 23.9% in haematology down to 3.6% in urology: a roughly seven-fold spread across fourteen areas.
BIO, Informa Pharma Intelligence, and QLS Advisors have released a new report on clinical development success rates covering 2011-2020. The report includes comparisons of success rates across indications and modalities, regulatory factors, and predictive factors driving successes and failures in drug development.
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Debate
Two AI advocates debated this claim using the research gathered.
Argument for
Multiple authoritative sources confirm that the landmark 2021 BIO/Informa report established a 7.9% overall likelihood of FDA approval from Phase I across all indications and drug modalities for the 2011–2020 period (Sources 8, 13, 19, 22). Although some recent analyses indicate this rate has since fluctuated, the specific finding of a 7.9% success rate remains a widely cited and verified benchmark in pharmaceutical research (Sources 10, 20).
The Proponent substitutes a narrower, time-qualified formulation for the motion: Source 8 states the 7.9% figure for all developmental candidates in 2011–2020, but does not itself establish the asserted combined scope of “across all disease areas and drug modalities”; Source 23 merely says the report includes comparisons across those categories. The appeal to repeated citation is an argumentum ad populum, and later 6.7% data (Source 10, citeline.com) cannot cure the motion's unsupported attribution or convert a cohort-specific benchmark into the report finding as worded.
Argument against
The claim misleadingly treats 7.9% as a general report-wide finding, although the verified BIO report language confines it to all developmental candidates in the 2011–2020 cohort (Source 8, go.bio.org), not an undated estimate across disease areas and modalities. More recent Citeline data put the Phase-I likelihood of approval at 6.7% for 2014–2023 (Source 10, citeline.com), so asserting 7.9% without its essential historical scope is inaccurate.
The Opponent relies on a red herring by citing a newer 6.7% figure from a different dataset, ignoring that the claim accurately describes the specific historical findings of the landmark BIO/Informa report. Furthermore, Source 13 and Source 22 explicitly confirm that this 7.9% likelihood of approval applied overall across all modalities and disease areas, fully validating the atomic claim as stated.
Panel Review
3 specialized AI experts evaluated the evidence and arguments.
Reviewer 1 — The Logic Examiner
Sources 8, 9, and 13 directly quote the BIO/Informa 2011–2020 report stating that overall LOA from Phase I was 7.9% for all developmental candidates and explicitly for all modalities, while Sources 15, 19, 20, 21, and 22 corroborate the same overall figure spanning disease areas; this supplies a direct, non-inferential match to the claim's wording about what the report found. The opponent's objections about later 6.7% figures or missing explicit time stamps are red herrings that do not undermine the report's documented finding, so the claim is true.
Reviewer 2 — The Source Auditor
Multiple reliable sources, including peer-reviewed journals (Nature Communications, Clinical Pharmacology & Therapeutics) and industry reports (BIO/Informa), confirm that the 2021 report established a 7.9% overall likelihood of approval from Phase I across all disease areas and modalities for the 2011-2020 period. While more recent data shows fluctuations, the claim accurately reflects the specific findings of that widely cited report.
Reviewer 3 — The Precision Analyst
Sources 8, 9, and 13 directly confirm 'the overall likelihood of approval (LOA) from Phase I for all developmental candidates over 2011-2020 was 7.9%,' and Source 13 explicitly states this applied 'for all modalities'; Source 22 corroborates that this figure is the overall LOA across disease areas in the same BIO/Informa/QLS dataset, with breakdowns by indication ranging from 3.6% to 23.9%. The claim's number (7.9%) and scope (all disease areas and modalities) closely match the specific BIO/Informa/QLS 2011-2020 report, though the claim omits the time window and newer data (6.7% for 2014-2023 per Source 10, and 7.7% per Source 7) show this figure is dataset- and period-specific rather than a timeless universal constant, a minor but real precision gap since 'the report' is unnamed and could be conflated with other studies yielding different percentages (9.6%, 10.4%, 13.8%, 14.3%).
Panel summary
Reliable primary and secondary sources directly attribute the 7.9% figure to the BIO/Informa/QLS analysis covering 2011–2020. The claim accurately describes the reported aggregate likelihood of FDA approval from Phase I across disease areas and modalities, without relying on an unsupported inference. Numerical analysis identifies omitted context: the estimate is specific to that dataset and period, and disease-specific rates varied substantially. Those limitations do not materially alter what the named report found, so they warrant warnings rather than a verdict downgrade.