Of all the trends happening in cancer drug development, few have garnered as much attention and generated as much excitement as CAR-T cells. A new report from Research and Markets quantifies that excitement by forecasting what the market for cell therapies – the collective name for CAR-T and similar modalities – will look like over the next decade and beyond.
The report found that $8 billion worth of venture capital has been invested in firms developing cell therapies, which include CAR-Ts, T-cell receptor (TCR) therapies and tumor-infiltrating lymphocytes. While the latest report did not put a dollar amount on the cell therapy market’s value, another report, released last month by the same firm, estimated that the cell therapy market will be worth $25 billion by 2024, with 21 therapies available. A report by another firm, Coherent Market Insights, estimated that the North American market for CAR-T cells alone would be worth $3.35 billion by 2028.
To date, two CAR-T cell therapies have Food and Drug Administration approval: Novartis’ Kymriah, for pediatric acute lymphoblastic leukemia and adult diffuse large B-cell lymphoma, and Gilead Sciences’ Yescarta, for DLBCL alone. Another company, bluebird bio, under a partnership with Celgene, plans to seek approval for its CAR-T therapy, bb2121, in multiple myeloma next year.
TCR therapies, meanwhile, have lagged their CAR-T counterparts in development. Publicly traded Adaptimmune has four TCRs in clinical development, for solid tumors as well as multiple myeloma, including a partnership with GlaxoSmithKline. Kite Pharma – the developer of Yescarta that Gilead acquired last year for $11.9 billion – also has a TCR in development, as does Juno Therapeutics, which Celgene bought this year for $9 billion. CAR-Ts and TCRs both consist of T cells that are harvested and then genetically modified to recognize proteins called antigens on cancer cells, but differ in terms of the type of receptor used to target the antigen.
Meanwhile, TIL therapy consists of isolating and expanding tumor-infiltrating lyphocytes in vitro and then reinjecting them into the body. A paper published last week showed that a patient with metastatic breast cancer refractory to chemotherapy experienced a complete remission after receiving TIL therapy.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Still, some challenges to cell therapies – particularly CAR-Ts – remain. One is that they may have to compete with bispecific monoclonal antibodies that target the same antigens and, unlike most CAR-Ts, are available off-the-shelf rather than requiring harvesting of patients’ T cells. Competition from allogeneic CAR-Ts that also do not require the patient’s own T cells, present another form of competition. Meanwhile, other challenges to cell therapies involve the cumbersome infrastructure that must be set up in order to deliver them, as well as issues that can arise at the clinic.
And despite rosy forecasts from research reports, the performance of CAR-Ts on the market thus far has been less than impressive. In December, Bloomberg reported that only five patients had received Yescarta since its approval two months before, in particular because of the difficulty in obtaining insurance coverage for the therapy, which costs $373,000, plus supportive care costs that can exceed the list price. And in April, Novartis reported that Kymriah, with a list price of $475,000, had seen first-quarter 2018 sales of only $12 million.
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