Cellular Therapies in Hematologic Malignancies: Trends & Market Access Implications Across Care Settings

Clinical Momentum is Driven by Early Line Use, Combinations, and Next Generation Innovation

CAR-T therapies have expanded beyond late-line use and are now approved in second-line for certain B-cell lymphomas and multiple myeloma. In parallel, the growing number of BsAB treatment options has created somewhat of a dichotomy in how patients access these two classes of cellular therapy.

Emerging clinical trends may further disrupt the treatment paradigm:

• Combination therapies: MAJESTEC-3, presented at ASH 2025, demonstrated a survival advantage when combining BsAB teclistamab with daratumumab, a CD-38 monoclonal antibody (mAB), which may shift BsAB to compete directly with CAR-T in early line and potentially displace CAR-T in some sites of care like community oncology.
• Front line use of CAR-T: ALPHA3, proposed at ASCO 2025, aims to use minimal residual disease (MRD) assessment to predict patients who would benefit from CAR-T in newly diagnosed B-cell lymphoma. The dependence on MRD and broader biomarker testing may drive more standardization and automation in testing approaches.
• Next-generation CAR-T: Allogeneic constructs (e.g., CTX112, zugocaptagene geleucel) and trispecific designs aim to overcome resistance mechanisms and improve persistence, but they also introduce new complexities and added costs.
• Rapid manufacturing platforms: Technologies like UF-Kure19 enable CAR-T production in under 24 hours, potentially reducing costs and improving scalability, and will introduce competitive pressures to an already dynamic market.
• Sequencing: As additional therapies are studied and approved with similar targets, such as BCMA or CD-19, there may be greater scrutiny on treatment sequencing, which may increase the prevalence of pathways or clinical decision support.
• ctDNA driven durations of therapy: As access to ctDNA testing and other MRD modalities expand, they may be used to individualize the duration of therapy.

Despite these innovations, access to cellular therapies remains uneven and largely depends on patient location and proximity to a major academic hub.

Academic Centers Maintain a CAR-T Stronghold

In the U.S., academic institutions remain the primary sites for CAR-T delivery. Real-world data confirm that most CAR-T infusions occur in academic settings, supported by:

• Established infrastructure for apheresis, cryopreservation, critical care, and inpatient beds
• Specialized staff trained in managing unique toxicities and high acuity patient cases
• Financial incentive alignment, including access to 340B and resources to navigate complex reimbursement and high acquisition costs

However, this concentration creates geographic and socioeconomic barriers that limit patients in rural and underserved populations' access to novel treatments.

Community Oncology is the Powder Keg to Broad Cellular Therapy Access

Community practices treat as many as 55% of U.S. cancer patients, yet it is estimated that less than 10% of community oncologists are able to offer CAR-T at their sites.

While BsABs have been more community-friendly disruptors, access barriers remain:

• Inpatient step-up dosing protocols
• Infrastructure to support patient monitoring & referrals
• EHR integration to support clinical decisions and automation
• REMS compliance burden
• Access to subspecialized staff
• Misaligned reimbursement models & entry costs

Despite these barriers, the easing of REMS requirements for CAR-T, the recently proposed FACT Fit for Purpose accreditation standards, and successful examples of innovative delivery models have primed the market to accelerate community oncology access.

Proprietary OncoGenius® data indicate that over a third of organizations delivering BsABs routinely initiate treatment entirely in the outpatient setting, and this proportion is increasing month over month, suggesting a growing comfort with these therapies and an appetite to trial new approaches.

As CAR-T and BsAbs vie for position in treatment algorithms, the site-of-care question will remain central to market access strategies. Academic centers will continue to anchor CAR-T delivery, but community practices — empowered by BsAb feasibility and evolving partnership models — are poised to play a larger role in the next wave of hematology innovation.

The Road Ahead Will be Paved by Collaboration

Given the evolving clinical landscape, dynamic financial incentives, and shifting operational approaches, it is critical to recognize that each customer, provider, site of care, and patient has distinct needs.

Real-time trending of these nuances allows for site-specific strategies to collaborate & support access, such as:

• Developing community oncology onboarding tools
• Providing EHR resource guides to drive automation in patient identification, toxicity management, and clinical decision support
• Generating real-world evidence to support access to innovative technology, such as remote patient monitoring
• Supporting staff and patient education
• Enabling peer-to-peer connections
• Providing support resources to lessen the logistical barriers to cellular therapy
• Engaging with payers to ensure site-agnostic coverage

To learn more about the solutions to overcome access barriers to cellular therapy, meet with the oncology experts on our OncoGenius team. 

Madeline Waldron, PharmD, BCOP, Vice President, Clinical Oncology Solutions is a board-certified oncology pharmacist with over a decade of experience in oncology clinical practice, research, and administrative leadership at a Cleveland Clinic. Madeline brings deep knowledge of oncology pathways, EHR optimization, and market access strategy, plus a passion for helping life sciences companies overcome acecss challenges and accelerate time to therapy.