By now, the story of last year’s dismal U.S. capital markets is hardly news. But when combined with increasing regulatory stresses, especially for biopharma and med-tech startups, there are elements of that story giving some Street-watchers pause, even as the market begins to show a few signs of recovery.

The BioWorld Cancer Index (BCI) closed out the first quarter of 2024 with a 4.66% increase, slightly down from its 11.07% rise at the end of February. This comes after an outstanding performance in 2023, when it finished the year up by 76.26%. Despite outperforming the Nasdaq Biotechnology Index, which rose by 1.36% in Q1, BCI lagged behind the Dow Jones Industrial Average, which saw a 5.62% increase in the first three months of the year. In contrast, BCI experienced a decline of 41.98% in 2022 and a 36.34% decrease in 1021.

As of Jan. 31, 2024, there were more than 300 CAR T trials registered in China, surpassing the U.S. and becoming the country with the most CAR T therapy clinical trials. Among them, CD19 is the most frequently studied target, according to BioWorld and Cortellis. The rapid evolution of CAR T-cell therapies in China has escalated over the past decade from the start of the first clinical trials in 2013 to the country becoming an established host for CAR T-cell-related trials by 2017, according to Yongxian Hu and researchers from Zhejiang University in Hangzhou, China. Chinese cell therapy companies – backed by $2.37 billion in funding in 2021 – have since significantly increased basic research and trial output for CAR Ts, which was welcomed by large patient demand.

China’s CAR T market is expected to grow from $72 million in 2022 to $342 million over the next decade. There are currently more than 400 CAR T therapies in the pipeline in China, and most of these are being developed by specialized Chinese biotechs. Research by Clarivate plc, BioWorld’s parent company, indicates that a notable proportion of CAR T-cell therapies in late-phase development in China are being developed through strategic partnerships and joint ventures between multinational corporations and domestic companies, including Johnson & Johnson and Nanjing Legend Biotech Corp., Juno Therapeutics Inc. and Wuxi Apptec Co. Ltd., and CASI Pharmaceuticals Inc. and Juventas Cell Therapy Ltd.

The process of manufacturing autologous T-cell therapies is technically challenging when compared with other oncology drugs, making the overall cost of developing CAR T therapies significantly higher. A challenging reimbursement environment for drugs listed on China’s National Reimbursement Drug List also means that most patients will have to pay out of pocket to access CAR T therapies. Taken together, complex logistics – production, manufacturing and supply chain – and complicated administration requirements are key bottlenecks that inflate the input costs involved in developing these specialized treatment options.

After concluding 2023 up 11.62%, the BioWorld Biopharmaceutical Index (BBI) extended its upward trajectory into the first quarter (Q1), posting a 6.4% increase at the close of March. BBI outperformed both the Dow Jones Industrial Average (up 5.62%) and the Nasdaq Biotechnology Index (up 1.36%) by the end of Q1.