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Institute Report
Emerging Biopharma’s Contribution to Innovation
Jun 13, 2022
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Web Summary

The majority of biomedical innovation is developed by emerging biopharma (EBP) companies, many of which have never marketed a therapy before. Over time, those companies either successfully bring their products to market or, in many cases, their assets or whole companies are acquired by others. These EBP companies are at the root of early-stage drug development and their performance, the environment in which they operate, and their relationship to other stakeholders in the health system play a critical role in determining the future of many novel therapies and health technologies.

This report is intended to inform executives from these emerging biopharma companies (EBPs), their investors, the large pharma company executives who engage with EBPs and often purchase their assets, as well as policymakers focused on the overall innovation ecosystem. It also has a global focus – as innovation knows no borders – and includes novel analytics across a range of relevant topics.

The report provides clarity on the current landscape of EBP companies and their emerging product pipelines, as well as associated clinical trial activity and levels of trial success. In addition, the report focuses on the financial deals, technology, and approaches to enable and accelerate these companies’ efforts, profiling the drugs these companies have launched or originated, and an assessment of the success of launches in recent years, including nuances beyond simply sales uptake.

Key findings

  • Emerging biopharma companies are responsible for a record 65% of the molecules in the R&D pipeline without a larger company involved, up from less than 50% in 2016 and 34% in 2001
  • The number of products filed with the FDA by emerging biopharma companies has grown four-fold over the last decade and now accounts for 42% of products filed with the FDA, up from 11% in 2012
  • EBPs headquartered in China now account for 17% of the overall EBP innovation pipeline, up from 6% just five years ago
  • A significant portion of oncology drug development comes from emerging biopharma companies, with oncology representing 39% of the emerging biopharma pipeline and more than 1,500 oncology products in development
  • Emerging biopharma companies are more focused on oncology, infectious disease, and vaccines than their larger counterparts, but less on neurology and immunology

Other Findings

  • The number of products under development by emerging biopharma companies has doubled since 2016 despite slower growth in 2021, with 90% of emerging biopharma R&D activity concentrated in five major geographies.
  • U.S.-headquartered EBP companies continue to account for nearly half of the pipeline, although this share has declined slightly in recent years from a peak of 52% in 2016 to 46% in 2021.
  • China-headquartered EBP companies have seen significant growth in the pipeline in recent years with 456% growth since 2016. China-headquartered companies now represent 17% of the EBP pipeline, up from 6% five years ago, highlighting the increasing contribution of Chinese companies to innovation in drug development.
  • The number of deals among companies has been rising over the last five years with emerging biopharma companies becoming more involved.
  • In 2021, 90% of all deal activity involved an emerging company, up from 81% five years ago.
  • A significant portion (62%) of deals is between emerging biopharma companies and do not involve larger companies, with a rising degree of emerging companies partnering and not involving larger companies.
  • Emerging biopharma companies sponsored 3,386 clinical trials starting in 2021, nearly triple that of a decade ago and potentially an understatement as this does not include trials where these companies may partner with a larger company.
  • Emerging biopharma sponsored trials have been driving growth in the number of trial starts over the last decade as total trial starts grew 43% since 2011, with EBP sponsored trials growing 193% over the same period and offset by a decline in large pharma sponsored trial starts of 33%.
  • Emerging biopharma companies sponsored 59% of trial starts in 2021, up from 29% a decade ago, while large pharma companies’ in-house trials showed the inverse pattern, dropping from 59% in 2011 to 28% in 2021.
  • Dynamics of the development and sale of companies or specific drugs are reflected in the launch trends over the past decade.
  • EBP-originated NAS represent 55% of NAS in the past decade, and when launching, EBP companies were the FDA filing company for 76% in 2021 and 62% over the past five years, up from an average 42% in the prior five years.
  • A greater share of NAS are being launched by EBP companies as they increasingly target niche and rare disease targets, potentially making commercialization more achievable by companies with fewer resources.
  • Emerging biopharma companies are consistently the source of new products with the highest sales, but most often when they are launched by a larger company.
  • EBP originated products have generally achieved lower sales when they launch themselves compared to when larger companies launch the products.
  • For launches over the five years from 2016–2020, the most successful drugs were those originated by emerging biopharma companies and launched by larger companies, with the median sales at the end of the second year on the market seven times higher than other launches.

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