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Indicates the estimated research and development investment needed for an average company to bring one of these products to market based on aggregate clinical trial success rates. Individual companies may have spent more or less on their respective development pipelines, based on their individual success rates. Question How much do drug companies spend on research and development to bring a new medicine to market? Data were mainly accessible for smaller firms, products in certain therapeutic areas, orphan drugs, first-in-class drugs, therapeutic agents that received accelerated approval, and products approved between and Meaning This study provides an estimate of research and development costs for new therapeutic agents based on publicly available data; differences from previous studies may reflect the spectrum of products analyzed and the restricted availability of data in the public domain. Objective To estimate the research and development investment required to bring a new therapeutic agent to market, using publicly available data. Design and Setting Data were analyzed on new therapeutic agents approved by the US Food and Drug Administration FDA between and to estimate the research and development expenditure required to bring a new medicine to market. Exposures Conduct of preclinical and clinical studies of new therapeutic agents. Main Outcomes and Measures Median and mean research and development spending on new therapeutic agents approved by the FDA, capitalized at a real cost of capital rate the required rate of return for an investor of All amounts were reported in US dollars. Results The FDA approved new drugs and biologics over the study period. Data were mainly accessible for smaller firms, orphan drugs, products in certain therapeutic areas, first-in-class drugs, therapeutic agents that received accelerated approval, and products approved between and Results varied in sensitivity analyses using different estimates of clinical trial success rates, preclinical expenditures, and cost of capital. Conclusions and Relevance This study provides an estimate of research and development costs for new therapeutic agents based on publicly available data. Differences from previous studies may reflect the spectrum of products analyzed, the restricted availability of data in the public domain, and differences in underlying assumptions in the cost calculations. Rising drug prices have attracted public debate in the United States and abroad on fairness of drug pricing and revenues. In , Prasad and Mailankody estimated the research and development costs of new cancer drugs using public data reported by pharmaceutical firms to the US Securities and Exchange Commission SEC. This present study estimates the research and development investment required to bring a new therapeutic agent to market using publicly available data for products approved by the US Food and Drug Administration FDA between and To capture innovation, we determined whether an agent was first in class using publications by FDA officials. Therapeutic areas were obtained from the anatomical therapeutic chemical classification system database. For each agent, we identified start and end dates of clinical studies phases 1, 2, and 3 for the FDA-approved indication from ClinicalTrials. If there were multiple studies in the same phase, the earliest start date was selected. We classified combined phase 1 and 2 trials as phase 2 and combined phase 2 and 3 trials as phase 3, consistent with other studies. No data were collected from human participants, and all data in this study were publicly available. Quiz Ref ID Publicly traded US companies are legally required by the SEC to file annual K and quarterly Q forms, which are reports of key financial performance indicators that include audited financial statements and data on research and development expenditures. For every agent in our sample, we searched the SEC website for reports from the firm that received FDA approval for it. As reports for private US drug firms and foreign companies listed on non-US stock exchanges were unavailable, their products were excluded. For firms with available reports, we screened K and Q filings for data on research and development expenditures on individual drug candidates. We excluded products developed by companies that only reported total research and development expenditures across all drug candidates or across therapeutic areas. For excluded products, we searched the K and Q forms and online press releases of manufacturers at the time that agents were approved to see if any were developed in collaboration with other firms via licensing deals. If so, we searched for K and Q forms from those firms in case there were research and development data for the product in question. For each therapeutic agent with available data, we extracted direct and indirect research and development expenditures in each year of development. Drugs were tracked across years in SEC filings using the brand, generic, or compound names of agents, as appropriate. Direct research and development expenses included all resources directly allocated to a particular agent. Indirect research and development expenses, which included personnel and overhead costs, were sometimes reported as a lump sum across all drug development programs. If so, we applied the same percentage of direct research and development costs attributable to a particular agent to estimate indirect costs for the same agent. The proportional allocation of personnel and overhead expenses is common practice in costing studies. Costs were tracked from the year a company started reporting costs for a particular drug candidate in their financial statements until the quarter of approval, which often included 1 or more years of preclinical costs. In some cases, at the first mention of the candidate in SEC filings, companies reported the costs incurred since inception of the drug development program. Certain companies only started tracking costs at late stages of preclinical development or at the start of phase 1 of development, resulting in an underreporting of preclinical costs. Some drugs were initially developed by companies that subsequently licensed out their drug candidates to other firms, which then brought these products to market. In these cases, it was assumed that any preclinical and clinical costs incurred during initial development was included in licensing fees and milestone payments. Hence, where these fees and payments were recorded as research and development expenses for the agent in question, these costs were extracted. Data on costs incurred by the originator firms were not collected. If SEC filings were missing for 3 or fewer years since the inception of the drug development program eg, if a company was privately held during early years of development and the product did not move between development phases ie, either from 1 to 2 or 2 to 3 , we extrapolated costs from the closest available year. Products were excluded if more than 3 years of SEC filings were missing. Three investigators independently extracted all research and development data used in this study. Discrepancies were resolved through discussions. Where disagreements existed, we assumed the higher estimate of research and development expenditures. Consistency and completeness of company reporting in SEC filings varied over time. Many reported detailed research and development costs, which allowed us to track outlays over time for individual candidates. Others reported costs inconsistently or with missing data for some years, requiring various assumptions, for example on timings of transitions between phases and extrapolations when SEC filings were missing. To aid interpretation, we categorized each estimate as high, medium, or low quality, depending on the availability and consistency of reported data. The categorization was developed through discussion between all authors. High-quality estimates comprised drugs discovered internally, allowing tracking of costs back to inception of the development program, and products licensed at preclinical or phase 1 stages with minimal up-front fees or milestone payments captured in SEC filings. Late commercialization deals related to marketing of products in non-US markets were also deemed high-quality estimates, as they would have had little or no effect on research and development expenses incurred on trials required for FDA approval. Low-quality estimates comprised all acquisitions, licensing deals, or other collaboration agreements in phases 2 or 3, earlier deals in which it was unclear whether all costs were captured in data extraction, and estimates requiring extrapolation of 2 to 3 years of data. We classified estimates as medium quality when other judgment calls regarding financial reporting, as agreed upon by the authors, had to be made. Two investigators independently categorized the quality of estimates and resolved discrepancies through discussions. Accurate information on costs of failures, ie, research and development outlays on candidates being developed by companies but not ultimately approved, is essential to estimating the costs of drug development. We accounted for failures using data on aggregate clinical trial success rates from a recent study by Wong et al Table 1. Wong et al reported that the percentages of FDA approvals were Wong et al 18 provided success rates through phase 3. We supplemented these rates with a recent estimate of the proportion of biologics license applications and new drug applications that are approved by the FDA For each agent, we estimated the expected research and development investment to bring the drug to market in 3 steps. First, we summed direct and indirect research and development spending on a therapeutic agent in each year. All sums were inflation adjusted to dollars using the US consumer price index. Second, we accounted for failed projects by dividing total research and development expenditures on a drug in a particular year by the corresponding aggregate phase-specific probability of success, similar to what was done in previous studies of costs of drug development. We used phase 1 rates to adjust preclinical expenditures, and we used the proportion of biologics license applications and new drug applications that are approved by the FDA to adjust costs once these applications were submitted to the agency for regulatory approval. Licensing fees and milestone payments, where captured, were adjusted using the success rate for the trial phase that was ongoing when the payments were made. When a phase shift took place within the financial year, we allocated the cost proportionally to the time spent in each phase. For example, if development moved from phase 1 to phase 2 on July 1 of a given year, we divided the costs equally between each phase. Similarly, in the year of approval, we multiplied the total cost by the fraction of the year elapsed by the time of approval. Third, we applied a real cost of capital rate of We ran 4 univariate sensitivity analyses. First, as the results were sensitive to the choice of aggregate clinical trial success rates by phase , we recalculated the results using aggregate rates reported in 2 other studies Table 1. For example, oncology drugs in phase 1 have a 3. Fourth, to account for potentially missing preclinical expenditures, we adopted the same assumption around preclinical costs as DiMasi et al, who reported that preclinical costs represented No imputations were performed for products acquired through purchase after clinical development had begun since it was assumed that licensing fees and milestone payments reflected preclinical costs incurred by the company that sold the rights to the product. Additionally, we ran another sensitivity analysis but with imputations done for all products, including agents acquired through purchase. As a subgroup analysis, we reported mean and median amounts by therapeutic area, using area-specific rates to adjust for costs of failure. We estimated the mean and median research and development investments across our sample in the base case and sensitivity analyses. We then restricted the sample to high-quality estimates and recalculated the mean and median amounts. We used Kruskal-Wallis and Mann-Whitney U tests, as appropriate, to identify statistically significant differences in median estimated research and development investments across therapeutic areas and other drug characteristics. All statistical tests were 2-tailed and used a type I error rate of 0. The data were analyzed using Stata version 15 StataCorp. Between and , the FDA approved new drugs and biologics. Research and development expenditures from SEC government filings were available for 63 of these products, developed by 47 different companies Figure 1. The sample covered Twenty-three of the estimates were judged of high quality, 18 medium quality, and 22 low quality. Table 2 presents statistics for the 63 included therapeutic agents. The sample contained a larger proportion of orphan drugs, therapeutic agents that benefited from expedited development or approval pathways, and first-in-class drugs compared with all FDA-approved products between and , although these differences were not statistically significant. Differences in the breakdown of products by therapeutic area, accelerated vs regular approval, and approval dates were statistically significant. Without adjustments for costs of failed trials, no statistically significant differences in the median research and development investment required to bring a new drug to market were observed across any of the drug characteristics shown in Table 2 , except median costs for biologic drugs that were higher than those for pharmacologic drugs eTable 3 in the Supplement. The mean SD number of years of data per drug was 8. Quiz Ref ID After accounting for costs of failed trials, the estimated median research and development investment required to bring a new drug to market, capitalized at a rate of Table 3 shows the results of univariate sensitivity analyses. When the aggregate success rates reported by Hay et al 20 were used instead of those reported by Wong et al, 18 the estimated median research and development investment, capitalized at a rate of When the rates from Thomas et al 19 were used, the estimated median research and development investment, capitalized at an annual rate of When therapeutic-area—specific rates from Wong et al, 18 rather than aggregate rates, were used to account for costs of failed trials for each agent, the estimated median research and development investment, capitalized at a rate of When costs were not capitalized, rather than capitalized at an annual rate of Estimates differed across therapeutic areas, with costs of developing cancer drugs the highest. The results included costs of failed clinical trials and varied in sensitivity analyses using different estimates of trial success, preclinical expenditures, and cost of capital. Most of the companies included in their study appeared to be more successful than the average company. The results of the present study varied widely when subject to sensitivity analyses, especially using different success rates. The methods employed by Wong et al to handle missing data were an improvement on earlier studies of trial success rates, and their study was based on a larger sample. There are challenges in isolating preclinical investments by drug companies. It is especially difficult to identify the exact date from which costs should start being allocated to individual agents during the early stages of preclinical research. The base case scenario in this study relied on preclinical costs reported by firms in SEC filings, which were likely underestimated since many companies did not attribute costs during the drug discovery stages to individual candidates. DiMasi et al estimated that preclinical costs accounted, on average, for For these products, preclinical costs generally accounted for a lower share of the total capitalized costs ranging from 0. For comparison, however, the Further validation work is needed to establish the preclinical share of research and development estimates for individual products. Greater transparency around research and development costs is essential for analysts to check the veracity of claims by companies that the steep prices of new drugs are driven by high development outlays. While these expenditures are undoubtedly high, as shown in this study, it is important for policy makers, regulators, and payers to know the exact scale of these investments. This knowledge can inform the design of pricing policies that give adequate rewards for innovative drugs that bring value to health care systems. This study has several limitations. First, data were unavailable for many products approved by the FDA during the study period. No data were available for products developed by non-US companies not listed on a US stock exchange and large drug firms that did not report research and development figures for individual drug candidates. Thus, there was likely an overrepresentation of smaller firms, which may have run leaner operations than larger ones. This limited the generalizability of the results to all products. Second, the included agents differed from other drugs approved by the FDA between and , although not all differences were statistically significant. The sample included a larger proportion of orphan drugs, products in certain therapeutic areas, first-in-class drugs, therapeutic agents that received accelerated approval, and products approved between and Third, there were inconsistencies in research and development reporting between companies, which made it difficult to ensure perfect comparability of research and development figures between firms. These inconsistencies may have been explained by differences in accounting policies. For instance, some firms allocated overhead and administrative costs to direct research and development figures, while others reported these costs separately. Some reported preclinical research costs as a separate line item, while others incorporated them in overhead costs. Companies also reported costs associated with licensing deals, drug acquisitions, and collaboration agreements differently, so it is likely that not all costs were fully reflected in some estimates. Fourth, uncertainties in the analysis may have resulted in under- or overestimations of research and development expenditures for some products. It is difficult to attribute costs to individual drug candidates in the early stages of preclinical development, so only the costs reported by firms in SEC filings were considered in the base case analysis. However, since preclinical costs may have been underreported by some companies, sensitivity analyses were conducted to produce an upper-bound estimate of preclinical expenditures. Conversely, many drug firms conducted trials for a particular candidate for multiple indications, which may have led to overestimations of costs since trial expenditures were not broken down by indication but instead reported as annual lump sums for each agent. Also, the estimates did not reflect any public tax credits or subsidies, which may have led to further overestimations of costs incurred by companies. This study provides an estimate of research and development costs for new therapeutic agents based on publicly available data. Corresponding Author: Olivier J. Correction: This article was corrected on September 20, , to fix multiple data points affected by a correction in one of the sources used in some of the original calculations; affected data were corrected in the abstract, text, several tables, Figure 2, and the Supplement. Author Contributions: Dr Wouters had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Critical revision of the manuscript for important intellectual content: All authors. No other disclosures were reported. Data Sharing Statement: All data used in this study were in the public domain. An example data extraction file is available from the corresponding author upon request. Additional Contributions: We thank Evelyn S. Warner, MSc Duff and Phelps, UK , for her contribution to the study design and data collection, as well as her comments on an earlier draft of the manuscript. None of the individuals listed in the acknowledgments received compensation for their role in the study. Figure 1. Selection Process for Therapeutic Agents. View Large Download. Figure 2. Table 1. Table 2. Table 3. Table 4. The high cost of prescription drugs in the United States: origins and prospects for reform. The cost of drug development: a systematic review. The price of innovation: new estimates of drug development costs. Estimating the clinical cost of drug development for orphan versus non-orphan drugs. Estimating the cost of new drug development: is it really million dollars? Spending on new drug development. Research and development spending to bring a single cancer drug to market and revenues after approval. US Food and Drug Administration. Published Accessed March 3, An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, Novel drug approvals Accessed March 2, Drug development and FDA approval, Accessed January 27, Estimation of clinical trial success rates and related parameters. Clinical Development Success Rates Clinical development success rates for investigational drugs. US Securities and Exchange Commission. EDGAR company filings. Accessed April 2, Step 3: Clinical research phase studies. The opportunity cost of capital: development of new pharmaceuticals. Assessing pharmaceutical research and development costs. Assessing pharmaceutical research and development costs—reply. Extraordinary claims require extraordinary evidence. A much-needed corrective on drug development costs. Trends in risks associated with new drug development: success rates for investigational drugs. Olivier J. This analysis of US Securities and Exchange Commission filings provides a contemporary estimate of research and development spending to develop 10 new cancer drugs. This observational study uses publicly available data to analyze how much the pharmaceutical and health product industry spent on campaign contributions and lobbying in the US from to Save Preferences. Privacy Policy Terms of Use. View Correction. This Issue. Views , Citations View Metrics. X Facebook More LinkedIn. Original Investigation. March 3, Key Points Question How much do drug companies spend on research and development to bring a new medicine to market? Sample Identification and Characteristics. Research and Development Data Extraction. Quality Assessments. Costs of Failed Trials. Costing Method. Sensitivity and Subgroup Analyses. Statistical Analysis. Sample Characteristics. Research and Development Investments. Sensitivity Analyses. Subgroup Analyses by Therapeutic Area. Back to top Article Information. 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Pharmaceutical spending is the expenditure on prescription medicines and self-medication, often referred to as over-the-counter products. Expenditure on pharmaceuticals includes wholesale and retail margins and value-added tax. In most countries, expenditure is calculated with net spending, that is, adjusted for possible rebates payable by manufacturers, wholesalers or pharmacies. In some countries, other medical non-durable goods are also included. Pharmaceuticals consumed in hospitals and other health care settings are excluded. Skip to main content. Pharmaceutical spending Pharmaceutical spending is the expenditure on prescription medicines and self-medication, often referred to as over-the-counter products. Share Facebook Twitter LinkedIn. Access the source dataset in Data Explorer. Health expenditure and financing. Access now. Related data. See all data. Health spending. Health spending is the final consumption of health care goods and services including personal health care and collective services. Overweight or obese population. Overweight or obese population is the share of the population with excessive weight presenting health risks because of the high proportion of body fat. Life expectancy at Life expectancy at 65 years old is the average number of years that a person at that age can be expected to live, assuming that age-specific mortality levels remain constant. Life expectancy at birth. Life expectancy at birth is the average lifespan a newborn can be expected to live, assuming that age-specific mortality levels remain constant. Infant mortality rates. Infant mortality rate is the number of deaths of children under one year of age. Go to top.

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