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.

In March, the U.S. FDA approved 30 new drugs, marking the highest monthly count in BioWorld’s records. The previous highest month of June 2020, with 29 FDA approvals, is followed by November 2017’s 27 approvals.

In February, the U.S. FDA greenlit 11 new drugs, a slight decrease from the 14 approvals seen in the same month the previous year but an increase from January’s tally of eight FDA approvals.

In February, deals formed by biopharma firms reached $7.76 billion, down from January, which marked the sixth-highest month in BioWorld’s records going back to 2016. Meanwhile, biopharma M&As amounted to $18.22 billion for the month, positioning it among the top 10 highest-value months in the past four years.

Biopharma deals in January reached $26.97 billion, marking the sixth-highest month in BioWorld’s records going back to 2016. It is an increase of nearly 25% from the $21.64 billion in deals in January 2023 and also is up from December. Value the first month of the year is more than 2023’s average monthly value of $18.14 billion, and likewise more than the average monthly value of any previous year.

The biopharma industry started 2024 on the upswing, with all four categories of financings tracked by BioWorld up in value compared to last January, and also up from December. In comparison to January 2023, IPO value soared 262%, follow-ons surged by 247%, public/other offerings saw a 381% rise, and private financings experienced a 21% bump.

Biopharma stocks saw a resurgence in 2023, with the BioWorld Stock Index finishing the year with a gain of 33.59%, in contrast to the 32.75% decline in 2022. An analysis of 516 stocks from the index showed that 193 companies (37%) concluded the year on a positive note, while shares of 322 companies (62%) experienced a downturn. Anebulo Pharmaceuticals Inc. (NASDAQ:ANEB), a biopharma focused on substance use disorders, saw its stock end 2023 at the same price as its 2022 closing. Meanwhile, the BioWorld Biopharmaceutical Index ended November up 4.37%.

Biopharma deals totaled $18.97 billion in November, marking a notable decrease from October’s historic deal value of $44.91 billion. Even still, through the first 11 months of 2023 cumulative deal value reached $194.26 billion, an 18.65% gain over the $163.73 billion recorded in the same period in 2022.