More than 800 new cell therapies are being developed for five blood cancers, which experts believe is not sustainable for the market if they all get regulatory approval.
The warning comes from analysts GlobalData, who say cell therapies are among the most researched treatment types for acute lymphocytic leukaemia (ALL), B-cell non-Hodgkin’s lymphoma (B-NHL), acute myeloid leukaemia (AML), multiple myeloma, and chronic lymphocytic leukaemia.
The product pipeline is oversaturated, they warn.
The most competition will be for drugs intended to treat ALL, which has more than 300 cell therapies in development, plus two that have already received FDA approval.
The total market for oncology cell therapies is expected to exceed $37 billion in value globally by 2028.
Dr Sakis Paliouras, managing oncology & haematology analyst at GlobalData, said: “Cell therapies have seen some strong successes in the oncology market, with Gilead’s Yescarta and Novartis’ Kymriah paving the way for other developers to build upon the success of their chimeric antigen receptor T-cells (CAR-T) cells.
“However, this success has brought about an abundance of products in development. Oncology is unlike other therapy areas such as cardiology or immunology, where the commercialisation of a large number of products with similar attributes is the norm.
“If all of the in-development drugs for blood cancer got the go-ahead from the FDA, competition would be much too fierce.”
He said despite the market size for B-NHL being at least five times the size of ALL, B-NHL has a smaller pipeline of cell therapies. This means that the ALL pipeline is “congested”, Dr Paliouras says.
“Unfortunately, most of the pipeline CAR-T cell products in ALL will never reach the market due to strategic decisions, potentially prioritising other cancers,” he added.
About 80% of the pipeline is autologous cell therapies, even though they are unproven in large-scale trials and despite allogeneic technology having significant advantages.
“Despite the cell therapy field having advanced significantly in the past five years, newer technologies are thought to be necessary to allow its full fruition,” said Dr Paliouras.
“Key opinion leaders interviewed by GlobalData believe that the next iterations of the technology will become the most successful ones by solving several current challenges of cell therapies.”
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