The biotech industry is on the brink of a potential recovery in 2024. The past few years have witnessed the sector struggle with challenges. The initial surge in investments and interest due to COVID-19 vaccine development was followed by a normalization period as demand for these treatments waned, affecting revenues. This period also saw a reduction in FDA approvals due to factors like staffing shortages, further impacting the sector’s momentum. However, by the first quarter of 2023, approvals rebounded to pre-pandemic levels, signaling a possible turnaround. Could 2024 be the year for recovery for the biotech industry?
A challenging period for the biotech industry
The sector faced a complex financing landscape. Venture Capital (VC) investment, critical for emerging biotechs, slowed down as investors became more selective, focusing on higher-quality investments. Despite this, VC fundraising remained robust, indicating sustained interest in the sector. Moreover, the industry had to contend with the looming threat of stricter drug price regulations under the Inflation Reduction Act, posing challenges for securing reimbursement for innovations.
However, despite these challenges, the biotech sector benefited from its inherent financial robustness, innovation-driven growth, and a strong pipeline of assets transitioning to clinical phases. Additionally, the sector saw a wave of shareholder activism and mergers and acquisitions (M&A) activity, with significant transactions.
As we start 2024, the biotech sector appears well-positioned for a recovery. This optimism is bolstered by an improving IPO market. With these factors in play, the biotech sector could see a resurgence, marked by increased investment, cutting-edge innovations, and revitalized market dynamics.
FDA nods in 2023 signal biotech’s path to growth in 2024
The biotech sector is set for a potential recovery in 2024, significantly boosted by a near 50% increase in novel drug approvals by the FDA in 2023. This remarkable upswing, as reported by Reuters, marked a significant departure from the preceding year, with the FDA approving 55 novel therapies. This figure stands in contrast to the 37 approvals in 2022 and aligns more closely with historical averages of around 45 to 50 new drug approvals per year.
The diversity and significance of these approvals underscore a renewed dynamism within the sector. Among the noteworthy FDA nods were high-profile therapies like Eli Lilly’s obesity drug Zepbound and Eisai and Biogen’s Alzheimer’s treatment Leqembi. Furthermore, 2023 saw the FDA greenlighting five gene therapies, including a landmark treatment developed by Vertex Pharmaceuticals and CRISPR Therapeutics, CASGEVY.
This increase in approvals reflects a broader trend of innovation and advancement in the biotech industry. It’s a response not just to the immediate needs of healthcare but also to the evolving scientific understanding of diseases and their targets. These developments have been received positively by industry stakeholders, with expectations of enhanced investment and interest in biotech firms.