2022-06-23-艾昆纬-全球研发趋势_72页_7mb

Global Trends in R&D - Key Findings Summary

• New Drug Approvals & Launches

  • 2021 saw a record 84 novel active substances (NASs) launched globally, double the five-year average.
  • Many drugs were first-in-class or orphan drugs, with 44 first-in-class launches in the US, up from 2020.
  • COVID-19 vaccines and therapeutics accounted for 8 of the 2021 NASs, driving trial activity.
  • Real-world evidence (RWE) increasingly used in regulatory submissions.

• R&D Pipeline

  • Over 6,000 active drugs under development, a 67% increase since 2016.
  • Oncology (37% of pipeline), rare diseases, and neurology are top therapeutic areas.
  • Next-generation biotherapeutics (e.g., cell/gene therapies) now exceed 800 in pipeline, up from 600 in 2019.
  • Emerging biopharma companies (EBPs) now account for 12% of the pipeline, growing from 4% five years ago.

• Clinical Trial Activity

  • Plans for 5,500 new trials filed in 2021, a 14% increase.
  • COVID-19 trials surged, with over 1,200 interventional trials since 2020.
  • Trial complexity fell due to reduced sites and countries, aided by remote trial methods.
  • Real-world evidence and novel trial designs (e.g., adaptive, umbrella) accelerated development.

• Clinical Development Productivity

  • Composite success rate dropped to 5.0% in 2021, the lowest in a decade.
  • Trial duration increased but was offset by shorter white space in some cases.
  • Cancer and vaccines had the highest success rates among therapy areas.

• R&D Funding

  • The 15 largest pharma companies spent $133 billion on R&D, a 44% increase since 2016.
  • US venture capital deals surged to over 2,000 in 2021, valued at $47 billion.
  • Deal activity increased in China, South Korea, and other APAC countries.
  • EBPs originated and launched 53% of US NASs in 2021, up from 48% over five years.

• Accelerators of Innovation Cycles

  • Shorter time (median <5 years) for some drug launches, e.g., 21 drugs launched post-filing in under five years.
  • Regulatory expedited pathways (e.g., accelerated approvals) accounted for 75% of 2021 launches.
  • White space reduction and novel trial designs (e.g., master protocols) drove efficiency.

• Notable Trends

  • China-headquartered companies increased their global R&D pipeline contribution to 17%.
  • Biotherapeutics and rare disease treatments remain high-priority areas.
  • Despite productivity challenges, innovation cycles shortened due to operational efficiencies and resource allocation.

Corporate Accelerator Summary

• Trial site and enrollment timelines for COVID-19 vaccines shortened by 70%, saving 26 months over benchmarks.
• Remote/virtual trial methods expanded significantly, accounting for 400+ trials in 2021.
• White space reduction and regulatory flexibility were key drivers for COVID-19 and other pipeline successes.