In 2021, Biogen Inc.’s Aduhelm (aducanumab) became the first amyloid-targeting therapy to win U.S. FDA approval in Alzheimer’s disease. After decades and dozens of failed phase III trials, the drug was granted accelerated approval in June 2021. In January 2022, however, the U.S. Center for Medicare & Medicaid Services said it would only cover use of Alzheimer’s MAbs targeting amyloid in NIH trials or trials it approved, thus appearing to call into question the rigor of FDA-approved trials.
As the biopharma industry moves away from the COVID-19 pandemic and expands research in other areas, the amount of money flowing into companies through deals with nonprofit or government entities and grants has plummeted 53% in comparison with 2021. The drop is mainly due to a diminishing number and a lower overall value of bio/nonprofit partnerships. Grants, on the other hand, have risen in both areas.
By several measures, and despite economic hardships leading to layoffs at some companies, the med-tech industry fared well throughout 2022. Financing amounts were greater than nearly every year before the COVID-19 pandemic; deals reached their highest volume to date and mergers and acquisitions did better than most recent years.
Biopharma just wouldn’t be biopharma without continuing innovation. Even in a year rife with economic and regulatory turmoil, the industry still achieved major advancements set to change the health care landscape going forward. Standouts for 2022 include cell therapy and gene editing approaches making significant gains, while industry celebrated a new checkpoint inhibitor added to the oncology armamentarium.
It was a grueling year for life sciences companies trying to raise money and keep afloat. Despite the industry’s front-line position in fighting COVID-19, sparking an overzealous enthusiasm, the soaring financings and rising stock prices of 2020 took an about-face beginning in 2021 and dropping even further in 2022. Share prices plummeted amid economic turmoil that included rising inflation, geopolitical pressures, and budgetary threats. Investors closed their wallets just as burn rates increased and funds diminished. Partnering fell to pre-pandemic levels and mergers and acquisitions hit a five-year low. Without capital, the uncertainty led companies to the only other option, workforce reductions and restructurings, pushing aside promising candidates at the expense of patients.
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