研发的全球趋势

关键发现

Exhibit 1: Clinical Trial Activity

Total Number of Clinical Trials by Phase 2010-2020

• Despite significant societal disruptions from the COVID-19 pandemic, overall clinical trial activity rose 8% in 2020, the fourth consecutive year with an increase above 7%.
• 在2020年的课程中，即使没有COVID-19的试验，每月试验的开始就在第一季度显着下降，但在2019年中的水平也比2019年更高。
• While the intention to start trials continued with relatively small disruption, the operation of trials — including recruiting patients and completing studies — may have been disrupted differently, and these trends should be interpreted with caution.
  

Exhibit 20: Clinical Development Productivity by Phase and Overall 2010-2015

自2015年以来下降后，综合临床发展生产力指数在2020年增加

• Most diseases areas have been declining in clinical development productivity – a composite metric of success rates, clinical trial complexity and trial duration – over the past decade, which embeds the challenges of achieving clinical results in well-satisfied traditional disease areas such as cardiovascular and endocrinology, as well as shifts in research priorities to more difficult areas such as oncology and rare diseases.
• 2020年临床试验生产力指数的增加主要是由于III期试验的改善，通过I期试验扩大了差距，该试验的得分明显降低。
• Phase II trials have consistently been above the overall index as success rates have been trending up and durations have been trending down, even as complexity has been rising in Phase II as rising numbers of endpoints and eligibility criteria are attributes of these trials.
• Productivity remains below historic levels as success rates are below the long-term average, while complexity attributes of trials are generally rising, as are trial durations in many diseases.

图表36：根据公司总部位置2005-2020，随着时间和国家 /地区份额的毒品数量

Drugs from China-headquartered companies have risen to 12% of the early-stage pipeline from 2% a decade ago.

• 在过去的15年中，美国在全球早期研发的份额一直保持稳定。
• Europe’s share has declined from 33% to 22% over the past five years, while the absolute number of active programs declined by 175 — from 1,604 to 1,429.
• 从十年前的2％到2％，来自中国阶段的公司的产品现在占早期管道的12％。

图表47：由NAS发布年发布和提交FDA监管提交的公司的公司和启动百分比

新兴的生物制药公司在2020年起源并推出了所有新药的40％，反映了开发活动的独立性更大

• Traditional development and launch models for innovative medicines relied predominantly on large or mid-sized companies, which often partnered with or acquired smaller companies that originated the medicine.
• That traditional pattern has largely changed in recent years with the last three years having more than 40% of NAS originated and launched by emerging biopharma companies (those with less than $500 million in sales and less than $200 million in R&D spend per year).

Exhibit 42: Percentage of Trials Under-representative of Racial/Ethnic Groups in the U.S. and the Median Share (%) of Subjects Included in Trials by Ethnic Group Per Year, 2015-2020

• African Americans or races identified as Black account for 13.4% of the U.S. population, while the clinical trials used to approve new medicines had a median participation of only 3% in the past six years and were under-representative 79% of the time from 2015 to 2020.
• 估计亚洲血统的人占美国人口的6.5％，但直到2015年才是该阈值高于此阈值的中位数，而在过去六年中，FDA使用的试验中有52％的试验批准了药物的代表性不足。。
• Hispanic or Latino ethnicity is estimated at 16% of the U.S. population, and consistently the median participation in trials is less than half that level, though patients may not always identify themselves.
• Interpretation of race/ethnicity data of approval trials and the representation of the U.S. population is complicated by the role that ex-U.S. subjects often play in those trials that are executed globally.