BioPharma, Pharma

CAR-T therapies face logistical bottleneck as market set to see major growth

Experts say proliferation of products makes standardization crucial, as ballooning complexity risks overwhelming apheresis centers and forcing service cuts.

T-cells attacking cancer cell illustration of microscopic photosT-cells attacking cancer cell illustration of microscopic photos

Amid all the excitement around CAR-T cell therapies, some experts are concerned that a coming wave of new products on the market may overwhelm the medical centers that administer them. Because of this, they said, manufacturers need to streamline the processes that centers and physicians must undergo when giving them to patients.

To illustrate, a report Tuesday from ResearchAndMarkets forecast that the global CAR-T market will grow at a 63.15 percent annual rate through 2022. Meanwhile, Pratap Khedkar, managing principal at consulting firm ZS, said in an in-person interview that his company anticipates there will be 15 CAR-Ts on the market by 2024.

The only two CAR-Ts currently approved are Novartis’ Kymriah (tisagenlecleucel), for aggressive forms of pediatric leukemia and adult lymphoma, and Gilead Sciences’ Yescarta (axicabtagene ciloleucel), for the lymphoma indication alone. The next likely approvals are bluebird bio and Celgene’s bb2121, for multiple myeloma, and Celgene subsidiary Juno Therapeutics’ JCAR017, for adult lymphoma, according to ZS.

With only around half of the centers offering the two approved CAR-Ts actually offering both simultaneously, Khedkar said the competitive situation remains early. “So it sounds like there’s a lot of competition, but if I’m a patient, I may have one choice or in some rare cases two,” he said. Kymriah and Yescarta are offered at 68 and 61 centers nationwide, respectively, while 33 centers have both, according to a comparison between their respective product websites.

As the selection is set to grow, medical centers’ “customer experience” around the products and the procedures involved becomes more important, Khedkar said. Oncologists have overwhelmingly told him that experience – such as having to fill out paper versus electronic forms – is crucial, but drug companies haven’t been paying enough attention to it.

“Ultimately, there is a patient at the end of this, and it can be a life-and-death situation,” said Amy Ronneberg, president of Minneapolis-based cell therapy supply chain organization Be The Match BioTherapies, in a phone interview. The growing number of CAR-Ts, whether approved or in clinical trials, means that standardization will become especially important. That way, she said, instead of having to learn five or, to Khedkar’s point, 15 different systems, there could be a single system that the centers could use. “We all know what happens when we humans are asked to do many things in different ways – mistakes happen,” she said.

A worry Ronneberg has is that as the logistical challenges around CAR-T grow, some centers performing apheresis – collection of cells – may decide to forego collection for the sake of allogeneic stem cell transplant due to the greater returns they get from CAR-T, especially those centers not connected to academic institutions. One center that is a longstanding client of Be The Match has already stopped collecting for unrelated allogeneic transplant, she said, though she declined to disclose which one.

Standardization, Ronneberg said, comes down to apheresis, as well as ordering, logistics and tracking. One example where processes can be streamlined is in auditing. Apheresis centers, she said, find themselves audited every week by a different company asking questions that are mostly the same, meaning their capacity for collecting is diminished. If all that duplication of questions was reduced, it would significantly open the centers’ capacity, she said.

Photo: royaltystockphoto, Getty Images

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