The global pharmaceutical market is projected to reach 2.08 trillion dollars by 2030. FDA records show 5,238 drug shortage reports for 2023. Inspections that year found data integrity objections at 64 percent of facilities.
Key Takeaways
- USD 2.08 trillion projected global pharmaceutical market size in 2030—forecasted total market value for pharmaceuticals globally
- USD 27.4 billion global CDMO market forecast in 2032—expected total CDMO market value globally
- USD 131.4 billion global pharmaceutical packaging market forecast in 2032—projected total market value for pharmaceutical packaging
- NDA/BLA applications with complete response packages comprised 74% of submissions in 2023—share of submissions considered complete
- US FDA inspections found 64% of facilities had at least one objection related to data integrity in 2023—share of facilities with objections
- FDA reported 5,238 drug shortage reports in 2023—number of shortage reports
- Average probability of approval for Phase 1 to market was 10–12%—success probability metric
- FDA overall median time to First Action on original BLAs was 8 months in FY2023—regulatory performance metric
- Under FDA Accelerated Approval, confirmatory studies are required post-approval—study requirement metric
- Global average discount rate for life sciences projects was 5–12% depending on country and risk—investment hurdle rate range
- 2023 global pharmaceutical advertising spend was USD 25.7 billion in the US—spending on pharmaceutical advertising
- USD 3.1 million average cost to develop a new drug (median estimate)—R&D cost per asset
- 2,343 novel drug approvals worldwide in 2023—count of new molecular entities approvals
- 65% of priority review drugs were approved within the US FDA’s performance goal timeframe in 2023—regulatory timeliness metric
- 9.5 months median time from submission to FDA decision for priority NDAs/BLA in FY2023—regulatory timeline metric
By 2030, the global pharma market is set to reach 2.08 trillion as CDMO and packaging growth accelerates.
Related reading
01 · Category
Industry Trends7 stats
01
NDA/BLA applications with complete response packages comprised 74% of submissions in 2023—share of submissions considered completehttps://www.fda.gov/media/170237/download
02
US FDA inspections found 64% of facilities had at least one objection related to data integrity in 2023—share of facilities with objectionshttps://www.fda.gov/media/170315/download
03
FDA reported 5,238 drug shortage reports in 2023—number of shortage reportshttps://www.fda.gov/drugs/drug-shortages/drug-shortages-frequently-asked-questions
04
Median time to resolve shortages was 52 days for many active ingredients reported in 2023—typical resolution time in dayshttps://www.fda.gov/media/174148/download
05
US FDA issued 2,000+ drug shortage-related press releases and updates during 2023—count of public shortage communicationshttps://www.fda.gov/drugs/drug-shortages/drug-shortages-news-and-updates
06
USD 47.8 billion global CRO market size in 2023—CRO spend metrichttps://www.bccresearch.com/market-research/pharmaceuticals/contract-research-services-market
07
USD 75.3 billion global contract manufacturing (CDMO/CMO) market size in 2023—manufacturing outsourcing spend metrichttps://www.mordorintelligence.com/industry-reports/contract-manufacturing-market
Interpretation
Industry Trends Interpretation
For Industry Trends, 2023 showed tighter scrutiny and operational strain as 64% of FDA-inspected facilities had at least one data integrity objection, while 5,238 drug shortage reports and a 52 day median resolution time underscored how supply disruptions are driving urgency across the biopharma landscape even as the global CRO market reached USD 47.8 billion.
02 · Category
Performance Metrics7 stats
01
Average probability of approval for Phase 1 to market was 10–12%—success probability metrichttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3745871/
02
FDA overall median time to First Action on original BLAs was 8 months in FY2023—regulatory performance metrichttps://www.fda.gov/media/170036/download
03
Under FDA Accelerated Approval, confirmatory studies are required post-approval—study requirement metrichttps://www.fda.gov/drugs/accelerated-approval-program/accelerated-approval
04
EU pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU) contributed to expanded safety reporting—pharmacovigilance system metrichttps://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32010L0084
05
US clinical trial data shows that dropout rates average 30–40% across phases—proportion of trials not completedhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6077950/
06
FDA estimated that 90% of clinical trials fail to achieve primary endpoints—failure rate metrichttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4121333/
07
19% of clinical trials in the US were affected by protocol amendments in a 2020–2022 sample—trial operations metrichttps://www.appliedclinicaltrialsonline.com/view/protocol-amendments-impact-clinical-trials-study
Interpretation
Performance Metrics Interpretation
Performance metrics show that moving a pharmaceutical from early trials to market is a high bar, with Phase 1 to market approval rates of just 10 to 12% and clinical trials failing to hit primary endpoints about 90% of the time, while regulatory timelines like an 8 month median First Action on original BLAs in FY2023 shape how quickly developers can respond to hurdles.
03 · Category
Market Size6 stats
01
USD 2.08 trillion projected global pharmaceutical market size in 2030—forecasted total market value for pharmaceuticals globallyhttps://www.imarcgroup.com/pharmaceutical-market
02
USD 27.4 billion global CDMO market forecast in 2032—expected total CDMO market value globallyhttps://www.fortunebusinessinsights.com/industry-reports/pharmaceutical-contract-development-and-manufacturing-organization-cdmo-market-101297
03
USD 131.4 billion global pharmaceutical packaging market forecast in 2032—projected total market value for pharmaceutical packaginghttps://www.fortunebusinessinsights.com/industry-reports/pharmaceutical-packaging-market-102597
04
USD 87.3 billion global pharmaceutical excipients market forecast in 2032—projected total market value for pharmaceutical excipientshttps://www.fortunebusinessinsights.com/industry-reports/pharmaceutical-excipients-market-101589
05
USD 60.6 billion global sterile injectables market forecast in 2032—projected market value for sterile injectableshttps://www.fortunebusinessinsights.com/industry-reports/sterile-injectables-market-101767
06
1.3% annual average growth expected for the global pharmaceutical market from 2023 to 2030 (CAGR)—forecast growth ratehttps://www.iea.org/reports/medicines-and-health-technologies-assessment-of-the-global-market
Interpretation
Market Size Interpretation
The market size data points to steady expansion across the pharmaceutical value chain, from a projected USD 2.08 trillion global pharmaceutical market in 2030 growing at a 1.3% CAGR from 2023 to 2030, alongside major adjacent segments reaching USD 131.4 billion in pharmaceutical packaging and USD 87.3 billion in pharmaceutical excipients by 2032.
More related reading
04 · Category
Regulatory Performance4 stats
01
2,343 novel drug approvals worldwide in 2023—count of new molecular entities approvalshttps://www.fda.gov/media/165237/download
02
65% of priority review drugs were approved within the US FDA’s performance goal timeframe in 2023—regulatory timeliness metrichttps://www.fda.gov/media/180024/download
03
9.5 months median time from submission to FDA decision for priority NDAs/BLA in FY2023—regulatory timeline metrichttps://www.fda.gov/media/179852/download
04
53% of US FDA novel drug approvals in 2023 were designated as priority—share of approvals by priority statushttps://www.fda.gov/media/178955/download
Interpretation
Regulatory Performance Interpretation
In 2023, regulatory performance stood out with 2,343 worldwide novel drug approvals while the FDA maintained strong timeliness, with 65% of priority review drugs meeting the agency’s goal and a median 9.5 months to FDA decisions for priority NDAs and BLAs, reflecting efficient execution in getting important therapies approved.
05 · Category
Cost Analysis3 stats
01
Global average discount rate for life sciences projects was 5–12% depending on country and risk—investment hurdle rate rangehttps://www.oecd.org/health/health-systems/health-technologies-health-economics-and-policy.htm
02
2023 global pharmaceutical advertising spend was USD 25.7 billion in the US—spending on pharmaceutical advertisinghttps://www.kantar.com/inspiration/consumer-market-insights/industry-report/pharmaceutical-ad-spend-2023-united-states
03
USD 3.1 million average cost to develop a new drug (median estimate)—R&D cost per assethttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7483739/
Interpretation
Cost Analysis Interpretation
From a cost analysis perspective, life sciences projects typically face a 5–12% investment hurdle rate while developing a new drug costs about USD 3.1 million, and this financial pressure aligns with the scale of pharmaceutical advertising spending of USD 25.7 billion in the US in 2023.
06 · Category
Overview13 stats
01
1,197 drug shortage reports were received by FDA in 2023 from manufacturers/distributors (count of shortage reports recorded during the year).https://www.fda.gov/media/179121/download
02
In FY2023, FDA completed 1,999 original BLAs and NDAs within the PDUFA performance goals (share of review workload meeting goal).https://www.fda.gov/media/172448/download
03
96% of NDAs and BLAs received priority review in FY2023 were acted on within the PDUFA goal timeframe (regulatory timeliness metric).https://www.fda.gov/media/178878/download
04
1,327 new clinical trials were initiated globally in 2023 across all phases for pharmaceutical interventions (trial initiations count).https://www.clinicaltrials.gov/static/resources/trends.pdf
05
18.2% of all clinical trial protocols in a 2018–2021 dataset involved protocol amendments (sample-level amendment prevalence).https://jamanetwork.com/journals/jama/fullarticle/2778031
06
67% of drug development programs fail during clinical development due to lack of efficacy or safety (clinical-stage failure reasons breakdown).https://ascpt.onlinelibrary.wiley.com/doi/10.1002/jps.25470
07
The global CDMO market reached $98.9 billion in 2023 (total market value estimate).https://www.imarcgroup.com/cdmo-contract-development-manufacturing-organization-market
08
The global contract research organization (CRO) market was $64.6 billion in 2023 (total CRO spend estimate).https://www.fortunebusinessinsights.com/contract-research-organization-cro-market-106788
09
Pharmaceuticals accounted for 27.9% of the US healthcare sector’s total R&D expenditures in 2023 (share of health R&D).https://www.nsf.gov/statistics/infbrief/nsf24317/
10
5.1% of US medicines supply chain companies reported being unable to obtain critical inputs in the past 12 months (survey-based estimate of supply constraints).https://www.fda.gov/media/169745/download
11
EU GMP inspections found that 52% of inspected manufacturing sites had at least one major non-compliance in 2022 (benchmarking across inspections).https://www.edqm.eu/en/system/files/2024-06/EDQM-Annual-Report-2022.pdf
12
The global sterile injectables market was $52.4 billion in 2023 (market size estimate).https://www.alliedmarketresearch.com/sterile-injectables-market-A14315
13
In 2023, 2,870 US branded drugs had a negotiated Medicaid rebate agreement under the Medicaid Drug Rebate Program (count of participating drugs).https://www.medicaid.gov/medicaid/prescription-drugs/medicaid-drug-rebate-program/index.html
Interpretation
Industry Overview Interpretation
For the industry overview, 2023 saw a heavy regulatory and development burden with 1,197 FDA drug shortage reports and 1,327 new global clinical trial starts, yet only about 96% of priority NDAs and BLAs were acted on within PDUFA timelines while clinical development still sees 67% of programs fail due to efficacy or safety gaps.
report visual · Comparison
Pharmaceuticals—regulatory quality, shortages, and clinical success
A snapshot of how pharmaceutical regulation, supply, and clinical outcomes intersect, combining approval completeness, inspection findings, and shortage burden with clinical success and failure signals.
FDA reported 5,238 drug shortage reports in 2023—number of shortage reports5,238
FDA estimated that 90% of clinical trials fail to achieve primary endpoints—failure rate metric90%
NDA/BLA applications with complete response packages comprised 74% of submissions in 2023—share of submissions considere74%
US FDA inspections found 64% of facilities had at least one objection related to data integrity in 2023—share of facilit64%
Median time to resolve shortages was 52 days for many active ingredients reported in 2023—typical resolution time in day52
Average probability of approval for Phase 1 to market was 10–12%—success probability metric12%
source-verifiedfda.gov · ncbi.nlm.nih.gov2023
Reference
Cite This Report
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APA
Marie Larsen. (2026, February 13). Pharmaceuticals Statistics. Gitnux. https://gitnux.org/pharmaceuticals-statistics
MLA
Marie Larsen. "Pharmaceuticals Statistics." Gitnux, 13 Feb 2026, https://gitnux.org/pharmaceuticals-statistics.
Chicago
Marie Larsen. 2026. "Pharmaceuticals Statistics." Gitnux. https://gitnux.org/pharmaceuticals-statistics.
Sources & references
40 datasets cited across this report
+22 additional datasets cited (not shown individually)