对中国新药研发成本与市场回报的一些分析
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对中国新药研发成本与市场回报的一些分析
研发一个新药要多少钱？这是一个人人都想知道又都说不清的一个问题，一台分析设备不可能只用于一个项目，一次员工培训不可能只为了一个项目，一个公司更不可能只有一个项目。大公司每年都是50亿美元以上的研发投入，但没有一家企业平均每年能产出2个新药，这样算下来平均每个新药的研发成本是大于50亿美元的。 但是企业财务报表里的研发费用与我们最关心的研发费用并不是一回事，我们想知道的是一个药物分子从发现到FDA批准所需要费用，而不是夹杂了一堆乱七八糟的费用及上市后的研究及监测。我比较相信EliLilly报出的数据，一个项目如果进展非常顺利，从发现到上市只需要2.64亿美元。 然而问题是新药研发的风险大、周期长，最新数据显示I期到上市的成功率是10.4%，EliLilly报出的数据是11.7%，AstraZeneca自爆年的成功率数据是5.3%。Eli Lilly将研发风险与资金成本纳入计算后，平均每个药物分子从发现到上市需要17.78亿美元。 Eli Lilly的数据告诉我们一个道理，新药研发不怕一个项目耗费多少钱，怕的是十个项目九个报废。一个新药从发现到上市需要10多年的时间，今天向银行借1个亿现金，10年后如果手头没有2个亿就赔本了。 一个新药的市场独占期大约10年，回收研发成本至少需要2亿美元的年销售额，实际可能是平均4亿美元的年销售额才能赚钱。大公司一般都有年销售额30亿美元以上的品种，欧美新药市场大环境决定创新型制药企业是赚钱的。 需要说明的是孤儿药（罕见病药物），这类药物达到4亿美元的年销售额是有难度的，但不意味开发孤儿药赚不到钱。据统计孤儿药研发的成功率是32.9%，足足是普通药物的3倍，研发成本自然就降低了。 中国建国以来没做出几个新药，评估国内的新药研发成本和新药市场比较困难，但我们还是可以从一些零碎的数据中看出些问题。 先说中国的新药研发成本，现在买一个1.1类新药临床批件怎么也要2000万以上，一个好的首仿品种都要这个价，几百万买个新药基本不可能。比如信立泰从复星医药买复格列汀是2500万，石药集团从四川大学买SKLB1028的价格是2000万。 新药研发有临床前、I期、II期、III期四个阶段，如果临床前在2000万，越到后期成本越高，埃克替尼当年III期买阳性药对照用了2600万，现在一个药物分子从发现到上市至少耗资1亿。如果从国外引入，成本就高得多了，比如正大天晴从BioLineRx买入BL-8030花了3000万美元，这还只做到了临床前。 我认为中国研发一个新药平均成本是2个亿（不计算风险、利息等），信立泰从艾力斯买阿利沙坦酯花了3.4亿，分5期付清。当时阿利沙坦酯已经获批，算下来该药的研发成本应该在3亿以下，鼓吹10亿的年销售额就有点自欺欺人，这也太低估艾力斯的智商了。 按Eli Lilly的比例计入风险成本和资金成本，那么平均每个药物分子从发现到上市大约耗费14亿，按10年的市场独占期计算，回收研发成本至少要1.5亿的年销售额，因为不是上市就立即变现，实际赚钱应该需要3亿以上的年销售额。 中国新药单品种平均年销售额能达到3亿以上吗？我觉得现在远远达不到，埃克替尼上市第3年（2013）销售额4.75亿，益赛普上市第8年销售额4.7亿，恩度上市第3年（2007）销售额3亿，后面就没怎么涨了。这些都算起步早、国家全力扶持的大品种，相当于欧美的重磅炸弹，后面跟着的低技术含量的品种市场就更小了。 据新英格兰医学杂志的数据，2013年中国、美国的药物研发投入分别为84、1193亿美元，折算下来美国每个新药40亿美元，至少说明40%以上的研发投入用在新药上，如果中国84亿美元投入中有20%真正用于新药研发，中国每年上市的新药个数应该达到7个，未来5年达到这个数字有难度。 从新英格兰的数据看，中国新药研发的成功率可能低于国际的10%，但中国部分企业的成功率可能高于10%。比如恒瑞医药2013年的研发投入才5.63亿[6]，10年累计投入不足30亿，其中很大一部分放在仿制药上，但已上市或处于后期开发的新药已经有艾瑞昔布、阿帕替尼、瑞格列汀三个。 我一直在想怎样才能打开中国新药市场，近来觉得或许可以低价放量。中国市场最大的优势是患者数量大，最大的劣势是患者普遍没钱，国外天价药规则在中国可能行不通。 比如埃克替尼的定价如果是3000元/月，加上医保报销一部分，整个花费可能低于印度代购易瑞沙，如果取代印度代购的市场，应该是利国利民的好事。埃克替尼的生产成本基本是可以忽略的，但我不能确定的是印度代购易瑞沙市场分量有多大，毕竟这东西属于黑市交易，百度搜“印度易瑞沙”有168万条结果。我国每年新增肺癌患者70万，其中30%存在EGFR突变（NSCLC占整个肺癌的80%，NSCLC中有40%的EGFR突变），市场绝对不止几个亿。 中国新药研发的大环境是不赚钱的，这与欧美的新药市场环境相反。中国的人均GDP本来就低，其中只有5%用于医疗，与欧美的差距不是一点半点。这种市场环境不适合与资本的全面介入，却非常适合于探险，只有卓越的公司才能通过新药研发获利。来源：新浪博客 疑夕
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主办：青华工作室出版：中国模具研究中心51家上市药企研发费过亿 14家研发费用占营收比超10%|研发_新浪财经_新浪网
51家上市药企研发费过亿 14家研发费用占营收比超10%
51家上市药企研发费过亿 14家研发费用占营收比超10%
　　在国家重视创新药、推进仿制药获得一致性评价之时，生物医药企业的研发费用投入引起了市场的关注。
　　截至4月19日，A股生物医药行业总计有153家上市公司披露了2017年研发费用数据。其中51家企业研发费用超亿元，其中、（港股02196）去年研发费用超十亿元。此外，14家企业研发费用占营业收入的比例超10%。
　　“研发费用的投入与企业的研发项目、管线药物等存在关联。”一位行业人士在接受《证券日报》记者采访时表示，相比仿制药，创新药的研发投入会很高。
　　恒瑞医药研发费用居榜首
　　2017 年 10 月 1 日，中央办公厅、国务院办公厅印发《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》，提出 36 项重要改革措施，明确提倡新药创新、促进仿制药发展。
　　近日，国务院常务会议召开，确定对进口抗癌药实施零关税并鼓励创新药进口；此外，国务院办公厅此前发布了《关于改革完善仿制药供应保障及使用政策的意见》，通过仿制药一致性评价的药品受到多地监管部门“优待”等，将大大刺激企业研发创新。
　　数据显示，行业多家大型药企加大了对研发费用的投入。
　　恒瑞医药位居A股上市公司研发费用投入榜首。2017年，恒瑞医药投入研发费用17.59亿元，同比增长48.53%。恒瑞医药介绍，围绕公司药物开发“创新+仿制药+国际注册”功能板块建设，加强研发队伍建设，提升公司药物开发实力。此外，还积极推动仿制药质量和疗效一致性评价工作等。2017年，公司投入研发费用较多的品种分别是马来酸吡咯替尼及片、PD-1、脯氨酸恒格列净及片等。
　　复星医药去年投入的研发费用也较高。数据显示，复星医药去年研发投入共计人民币 15.3亿元，较2016年增加人民币42317.39万元，增长38.26%，其中，研发费用人民币10.23亿元，较2016年增加人民币31178.88万元，增长43.62%。复星医药称，本集团持续加大对单克隆抗体生物创新药及生物类似药、小分子创新药的研发投入，推进一致性评价，持续完善“仿创结合”的药品研发体系，推进创新体系建设，提高研发能力，努力提升核心竞争力。
　　此外，、（港股02607）的研发费用投入也较高。上海医药称，去年，公司研发费用化投入合计79035万元，同比增长20.79%，占工业销售收入5.27%。其中，21.14%投向创新药研发，22.59%投向仿制药研发，35.43%投向现有产品的二次开发，20.84%投向仿制药质量和疗效一致性评价。公司创新药研发主要聚焦抗肿瘤、全身性免疫及心血管领域。
　　14家企业研发费用占比超10%
　　“公司研发投入持续稳步增长，可以使得企业不断保持新品立项和上市销售，有助于企业的业绩稳步增长和（港股00001）良性发展，也是公司竞争力的体现。”上述行业人士向记者表示，在生物医药行业，企业的研发费用不仅看投入的金额，还要看投入占营业收入的比重。
　　数据显示，在发布研发费用的生物医药企业中，总计有14家企业的研发费用占营业收入的比重高于10%。
　　其中、、所投入的研发费用占营业收入比重较高。
　　作为研发创新的受益者，贝达药业2017年年报显示，公司投入研发费用3.8亿元，占营业收入的比重高达37.09%。2016年，该值仅为15.6%。贝达药业介绍，公司研发投入总额占营业收入的比重同比发生显著变化的原因是：报告期内公司新药研发工作加紧开展，新项目的立项推进，以及多个新药进入临床试验阶段，研发投入增加较多。
　　广生堂介绍，2015年至2017年，公司研发投入分别为2626.06万元、6819.31万元、7533.25万元，分别占营业收入的8.5%、21.8%、25.44%。
　　与上述企业形成对比的是，69家企业的研发费用占营收的比重不足4%，17家企业的研发费用占营收的比重不足1%。
　　59家企业研发费用资本化
　　东方高圣财务总监兼董秘杨秀仁向《证券日报》记者介绍，企业被认定为国家高新技术企业，享受15%税收优惠政策的前提是研发费用要达到一定比例要求。此外，在一定程度上，研发费用还可以起到平滑业绩的作用（如果不当应用，有可能成为企业调节利润的工具）。投资者除了关注研发费用外，还需要注意公司对研发费用采取的会计处理方式，特别是资本化的研发费用。
　　据了解，研发费用分为研究阶段和开发阶段，费用得按照不同的阶段划分。一般情况下，以上阶段处于临床Ⅲ期之前的属于研究阶段，临床Ⅲ期及之后属于开发阶段。按会计准则规定，研发费用有两种处理方式，一是费用化，作为管理费用计入当期损益，二是资本化，作为无形资产计入资产。
　　“如果企业将研发费用一次性计入费用，会体现财务稳健性，同时如果金额相对比较大，会影响企业当年净利润。而研发费用资本化是实际上是将已发生的研发费用分多个会计年度列入当年费用中。”杨秀仁表示。
　　据同花顺数据，去年有59家药企将研发费用进行资本化处理。其中16家企业资本化的研发费用占研发费用的比重超过40%。、、亿帆生物、等多家企业的比例高于60%。
　　数据还显示，去年，有56家企业的研发费用直接计入费用，未进行资本化处理，包括恒瑞医药、等。
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Journal of Health Economics 22 (–330
New estimates of drug development costs

1. Introduction
DiMasi et al. (2003) (hereafter DHG) have estimated the average costs of bringing a new
drug (or more precisely a new chemical entity (NCE)) to market to be US$ 403 million in
2000 dollars. Accounting for the time between investment and marketing raises the cost to
US$ 802 million. These are impressively large numbers, usually associated with purchase
of a squadron of jet fighters (40 F16s in fact). The estimates have been a matter of heated
debate since they were first made public in 2001. The Public Citizen (2002) referred to
the “US$ 802 million myth” prompting the Pharmaceutical Research and Manufacturers
Association (PhRMA, 2001) to respond that the estimate of US$ 802 million was likely to
be conservative.1
Critics of the pharmaceutical industry, and of current public policy towards pharmaceuticals,
believe that prices and rates of return in the prescription drug market are supra
competitive. They refer to accounting rates of return on the order of 18% in the late 1990s
as evidence. The industry in contrast claims that rates of return in the industry, when research
and development (R&D) costs are appropriately accounted for, are approximately
competitive. Estimates of high costs for developing drugs play into this debate by reducing
the estimated profitability of the drug industry.
In this Editorial, I discuss how economists and economic policy makers might
interpret the estimates offered by DHG. My aim is not to critique the cost-finding
methods nor to take sides in the profitability debate, but to place the results of a very
carefully conducted empirical investigation into context. The remarks I will
make below are organized into three sections. First, I will note some clear lessons from
the DHG paper. Then, I present some facts and background on pharmaceutical research
and development (R&D) spending that are helpful in interpreting the DHG estimates.
Finally, I consider the cost estimates in context of economic choices in the

I am grateful to Ernie Berndt, Tom McGuire and Joe Newhouse for helpful discussion of the issues in this
editorial.
1 See statement of Christopher Mollineaux of PhRMA, July 23, 2001 available at:
press/index.
/$ – see front matter & 2003 Elsevier Science B.V. All rights reserved.
doi:10.-02-X
326 Editorial / Journal of Health Economics 22 (–330
2. Some lessons
DHG carefully assess the average costs of developing a new chemical entity (NCE). An
NCE is a new therapeutic molecule or compound that has not previously been tested on
humans. The unit of observation in terms of the product is the NCE developed “in-house”
by prescription drug manufacturers. The analysis is built on a cost survey of 10 large
pharmaceutical manufacturers. The survey results represent self-reports from the 10 manufacturers
about the various types of costs they incurred in developing different drug
products during the
period. The surveyed manufacturers allocated R&D costs
according to those drugs developed in house, those licensed or acquired and products
that were already approved. Thus, the cost estimates are made for the segment of total
R&D costs that are attributed to in-house developed NCEs.2 Sixty-eight drugs were
studied. They include drugs that made it to market, drugs that were not brought to market,
and some that are still in development. Building on methods developed in a previous
paper (DiMasi et al., 1991) and by the Office of Technology Assessment (1993) the estimates
are meticulously built up for both the average out-of-pocket cost estimates and
the average economic cost estimate, which takes into account the opportunity cost of
The detailed construction of the estimates serves as a primer on the economics and
industrial process of drug development. As a result, it contains a wealth of useful facts and
explanations regarding how drugs are tested and evaluated during the multi-stage process
of drug development. By analyzing the drug development process in such detail DHG
remind policy makers of some important features of the prescription drug market. First,
the drug development process is risky. The paper contains an analysis of the transition
probabilities of moving from the pre-clinical phase of testing through the three phases of
human testing that are part of the FDA regulatory process. Based on a data analysis of
a panel of drugs they estimate that only 21.5% of drugs that began the Phase I human
trials are eventually brought to market. Second, DHG show that the development process
is time-consuming, 90.3 months on average span the start of clinical testing to marketing
approval, a number that is lower for the
period than for the earlier period
covered by DiMasi et al. (1991). This delay relates to the third key feature: regulations
can matter a lot to the cost of drug development. Improvement in FDA approval times
has been central to reducing development time. DHG report a decline in the duration of
the FDA approval period from 30.3 months in their earlier study to 18.2 months in this
Most importantly, the study highlights the point that regardless of the exact cost figure
estimated, if we are not cognizant of the complex, risky and costly process of drug development,
public policy can damage an industry that has over the past generation bestowed
enormous benefits on society by improving the effectiveness of health care.
2 The self-report data have been viewed with skepticism by some critics. DHG have made an effort to obtain
data from other sources as crosschecks of the self report information. It should be noted that the OTA (1993) study
found variation in how firms measure and report R&D costs. Some specific issues including the timing of when
capital expenditures are counted and how and when R&D costs are attributed to individual drugs. Gluck (2002)
discusses these and other issues in cost reporting.
Editorial / Journal of Health Economics 22 (–330 327
3. R&D spending in context
In order to understand the meaning of the average economic cost of an NCE, it is useful
to consider the various types of new products that pharmaceutical manufacturers introduce
and the role that R&D plays in bringing each type to market. In 2000, the FDA approved 98
new drug applications (NDA). Among the 98 new drugs approved, 27 were new molecular
entities (NME).3 The balance are products that represent newformulations and newmethods
of delivering existing drugs. This second type of new drug product is excluded from the
DHG analysis. These drugs are of course “less new” than NCEs, but they often account for
substantial sales and offer therapeutic advantages in terms of efficacy, administration and
patient compliance. CMR International (2002) estimates that about 30% of R&D spending
is devoted to bringing “line extensions” to market.4
The average cost of an NCE is therefore an important component of the average cost of
all potential new drug products that were assessed and or marketed during the
period, but it is not the whole story. The costs per NCE and per new product of any type
are different. The cost data for estimating the cost per new product would include R&D
spending for line extensions in the numerator. The denominator would include the number
of marketed new products. Such an alternative average cost figure would reflect the average
cost of bringing a new drug to market across the entire spectrum of new products sold by
pharmaceutical manufacturers. My guess is that number would be much lower than the
average cost per NCE.
DHG analyze the probability that an NCE that enters the human testing phase will eventually
be brought to market. As noted above, about 78% of NCEs are never marketed.
Pharmaceutical manufacturers terminate development of NCEs for a variety of reasons.
Walker (2002) reports the reasons for termination of development of new products among a
group of 28 pharmaceutical manufacturers, estimating that clinical safety issues accounted
for 20.2% of terminations in 2000. In addition, 19.4% of terminations involved toxicology
concerns, 22.5% were due to disappointing clinical efficacy results, 16.2% were due to
various other factors and 21.7% were based on “portfolio considerations”.5 Risk of failure
stems from both “exogenous” factors such as unanticipated safety problems, but also from
business decisions, grouped under the “portfolio considerations” in the Walker study. The
implication is that the cost of drug development should not be taken as a given number
against which to compare revenue expectations. Changes on the revenue side would lead
to different decisions about which drugs to carry forward in the development process, and
would thus change the average cost picture.
3 The distinction between an NCE and an NME is small. NCE are new molecules or compounds that have not
been tested in humans before. NME is an FDA term used to describe new compounds. Data cited are from FDA
4 It should be noted that in 1999 PhRMA estimated the share of R&D devoted to line extension to be about 18%
(PhRMA, 2001).
5 DHG also discuss how the costs at each stage of development are partly made by strategic concerns and are
not just the result of regulatory dictates. For example, they note that one reason that the costs of clinical trials may
have been increasing is because of a desire to make efficacy claims against other drugs in addition to placebo. This
competitive motivation would result in larger clinical trials in order to have sufficient power to detect differences
in efficacy against other drugs.
328 Editorial / Journal of Health Economics 22 (–330
4. Development costs and economic decisions
I would like to consider two issues concerning how we might make use of DHG’s average
cost estimate for purposes of economic analysis or policy assessment. The first is the implications
of the average cost estimates for informing us about the revenues that are required to
cover development costs in order to sustain investment in drug R&D. The second concerns
how we might view the estimates made by DHG in the context of development decisions
for the marginal NCE.
If the average net revenues (revenues minus production costs) from sales of new drugs
brought to market do not cover the average costs of developing, new drugs capital would
tend to migrate away from drug development. The average cost of developing an NCE is
a major component of the average cost of developing a new drug, and is important for
assessing the ability of sales to cover development costs.
DHG characterize the drug development process as a multi-stage, multi-period set of
choices. It may, therefore be useful to interpret R&D costs as the result of a multi-period
set of decisions. Development costs are incurred sequentially. Learning occurs within each
stage of testing and evaluation. Lessons are learned about the expected costs of the next stage
of research, the likelihood of achieving FDA approval, and the expected revenues following
launch (Wiggins, 1981). The speed and the amount of learning that takes place depend in
part on the resources allocated to the development process. Profit maximization implies that
investment projects will be evaluated according to the net present value to the firm of the
investment.6 The profit-maximizing pharmaceutical company considering development of
anNCEmust only consider the investment to be made at a particular stage in the development
process given what it knows about expected costs of development and expected net revenues
at the time. Learning permits the firm to update its assessment of the net present value of
making an additional investment in the development of a specific NCE. At each stage of
development, the firm also has the opportunity to choose the level of resources to be invested
which will affect the speed and the learning in the subsequent stage. Some development
costs will have already been sunk. Applying the NPV standard to future streams of revenue
and cost will lead profit-maximizing firms to continue any project where the expected
NPV of the investment is positive. The average economic value of R&D resources across
projects does not directly enter into the optimizing choice for the individual or marginal
It is worth recalling that the multi-stage nature of the choices is reflected in the DHG
analysis. NCE development is halted for strategic reasons at different rates across the phases
of development. The size of clinical trials has increased dramatically overtime.7 The time
taken in each stage differs and has changed since their earlier study. The data presented
6 There is an extensive literature that examines the net present value criteria in the context of uncertainty and
irreversibility in investment. Much of that literature holds important lessons for modeling pharmaceutical R&D. I,
however, limit my comments to a very simplified conception of a multi-period investment model. For an excellent
review see Pindyck (1991).
7 Critics (Public Citizen, 2001) of the DHG study suggest that the costs of clinical trials estimated by DHG are
larger than that of NIH trials, which they contend, suggests bias. The fact that the trials are conducted for different
purposes makes the comparison to NIH trials as a type of gold standard misleading.
Editorial / Journal of Health Economics 22 (–330 329
by DHG offers a rich source of information that informs us about both economic parameters
governing the net present value assessment at each stage of the development process
as well as the outcomes of those choices. Information about the cost of capital, and the
structure of drug investigation required at different stages by the FDA are economic parameters
that are given to decision-makers. Investment intensity, durations of testing at
each stage and project abandonment rates are each at least partly matters of choice to economic
decision-makers. The average costs of drug development are therefore reflections
of the choices made by prescription drug manufacturers in response to economic parameters
such as the user cost of capital, prescription drug prices and formulary designs. These
cost estimates will necessari input cost and procurement parameters
The average out-of-pocket costs of an NCE estimate of US$ 403 million and the average
economic cost of an NCE of US$ 802 million are not cost parameters that decision-makers
use to evaluate the value of investing in development of a new product. They reflect the
outcomes of profit-maximizing choices given a complex set of economic, institutional and
technological circumstances.
DHG provide carefully constructed estimates of the average cost implications of profitmaximizing
choices about developing NCEs overall. This is significant because NCEs
are generally considered the source of major therapeutic advances. The estimates provide
useful lessons about drug development. The previous study by DiMasi et al. (1991) has
been extremely influential in educating the field on the economics of developing prescription
drugs. That study has been widely cited and debated, andDHGhave expanded and improved
upon the earlier work. This new and valuable effort is already the subject of intense interest.
This research group continues to advance our understanding about the complexity, risk and
cost of the R&D process for new drug products.
References
DiMasi, J.A., Hansen, R.W., Grabowski, H.G., 2003. The price of innovation: new estimates of drug development
costs, Journal of Health Economics.
Food and Drug Administration (FDA), C.D.E.R., 2001. Report to the Nation: Improving Health Through Human
Drugs, FDA, Rockville, MD.
Gluck, M., 2002. Federal Policy Affecting the Cost and Availability of New Pharmaceuticals. Kaiser Family
Foundation.
DiMasi, J.A., Hansen, R.W., Grabowski, H.G., Lasagna, L., 1991. Cost of Innovation in the Pharmaceutical
Industry. Journal of Health Economics 10, 107–142.
Pharmaceutical Investment and Output. In: Proceedings of the CMR International, 2002, London.
PhRMA, Pharmaceutical Industry Profile 2001. Pharmaceutical Research and Manufacturers of America,
Washington, DC.
Pindyck, R., 1991. Irreversibility, Uncertainty and Investment. Journal of Economic Literature 29 (3), 1110–
Public Citizen, 2002. America’s Other Drug Problem: A Briefing Book on the Rx Drug Debate. Public Citizen,
Washington, DC.
Gress, O.T.A., 1993. Pharmaceutical R&D: Costs, Risks, and Rewards. U.S. Government Printing Office,
Washington, DC.
Walker, S., 2002. New Drugs for Old Trends in New Drug Development. In: Proceedings of the DrKW Health
Care Industry Seminar, London, England.
330 Editorial / Journal of Health Economics 22 (–330
Wiggins, S., 1981. Product quality and regulation and new drug introductions: some new evidence from the 1970s.
The Review of Economics and Statistics 63 (4), 615–619.
Richard G. Frank
Department of Health Care Policy, Harvard Medical School
180 Longwood Avenue, Boston, MA 02127, USA
Tel.: +1-617-432-0178; fax: +1-617-432-1219
E-mail address:
(R.G. Frank)
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