药物开发成本和美国的研发强度,2000-2018年
Aylin Sertkaya1, Trinidad Beleche2, Amber Jessup2,3
1Eastern Research Group, Inc, Lexington, Massachusetts.
JAMA network open
|June 28, 2024
概括
开发新药的平均成本为1.72亿7000万美元,如果增加失败成本,则增加到8.793亿美元. 尽管药物开发成本稳定,但制药研发强度增加,为政策决策提供了信息.
科学领域:
- 卫生经济学 卫生经济学
- 制药政策 制药政策
- 药物开发 药物开发
背景情况:
- 了解药物开发成本对于为旨在降低开支,促进创新和提高患者获取机会的政策提供信息至关重要.
- 以前对药物开发成本的估计有所不同,这凸显了全面经济评估的必要性.
研究的目的:
- 为了估计不同治疗类别的药物开发成本.
- 分析药品研发 (R&D) 强度的趋势.随着时间的推移.
主要方法:
- 使用药物开发的分析模型,利用2000年至2018年的公开和专有数据.
- 估计了三个成本指标:自用成本,预期成本和预期资本化成本.
- 从2008年到2019年分析了制药研发强度 (研发支出与销售比率).
主要成果:
- 开发新药的平均成本为1.72亿美元 (2018年美元),根据治疗类别从725万美元到2972万美元不等.
- 包括失败和资本成本,平均预期资本化成本增加到879.3亿美元,按类别有很大差异.
- 从2008年到2019年,整体制药研发强度上升至17.7%,而大型公司的研发强度上升至19.3%,尽管开发成本稳定,收入增长.
结论:
- 药物开发成本保持相对稳定,但研发强度增加,特别是在收入不断增长的大型制药公司.
- 调查结果表明,目前的政策可能无法充分捕捉与开发成本相对的研发投资动态.
- 这些见解可以指导与毒品有关的政策的设计,以有效地影响创新和市场竞争.
相关概念视频
01:11Clinical Trials: Overview
2.9K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
2.9K
01:26Drug Discovery: Overview
7.8K
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
7.8K
01:28Preclinical Development: Overview
4.4K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.4K
01:25Drug Regulation
1.3K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.3K
01:26Drug Administration and Therapy Phases: Overview
446
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
446
01:14Time Course of Drug Effect
2.0K
The progression of a drug's impact can be analyzed by examining both the concentration-time course and the effect-time course. The concentration-time course is determined by the drug's half-life and is influenced by factors such as its pharmacokinetics, including absorption, distribution, metabolism, and elimination. The effect of the drug is often related to its concentration in the plasma and is calculated using the maximum drug effect and the plasma concentration that generates 50...
2.0K