Cell Therapies in Transition: Outpatient CAR-T and BiTEs as Growth Engines

CAR-T and BiTEs: reshaping oncology’s future. 

 Cell therapies are transforming what’s possible in cancer care. CAR-T therapies have shown that long-term remission is achievable for some patients who previously had few options, changing the standard of care in hematologic malignancies. Bispecific T-cell engagers (BiTEs) are emerging as an equally exciting class—designed for easier administration, compatible with community oncology settings, and being actively studied in both frontline and maintenance roles. 

 

Together, these therapies represent a powerful shift: CAR-T offers the potential for durable, one-time treatment, while BiTEs bring scalable, repeatable access across broader patient populations. Both are shaping a more hopeful future for patients and a more dynamic market for innovators. 

Market momentum: dual growth trajectories. 

The cell therapy market is expanding rapidly, with both CAR-T and bispecific T-cell engagers (BiTEs) driving growth. 

• CAR-T: Global sales were estimated at $6.37 billion in 2024 and are projected to reach $16.35 billion by 2032. Other forecasts anticipate even faster expansion, from $10.39 billion in 2024 to $128.55 billion by 2034. 

• BiTEs (bispecific T‑cell engagers): The broader bispecific antibody market — which includes BiTEs — is poised to surge from $8.0 billion in 2023 to $192.6 billion by 2033. While this category includes other bispecific formats, it underscores the explosive growth opportunity for BiTEs in oncology. 

Together, these trajectories highlight a turning point: CAR-T is likely to remain the high-impact, potentially curative option for complex cases, while BiTEs expand as a more accessible, scalable therapy across diverse care settings. 

 

At Current Health, we see this shift firsthand. Our clinical operating system supports outpatient CAR-T and BiTE programs with continuous safety monitoring, efficient escalation pathways, and integrated documentation. These capabilities position our partners to adapt quickly as this category grows—ensuring both modalities can be delivered safely and at scale in the community. 

 

Bridging the rural access gap through outpatient-enabled trials. 

 

Rural communities face persistent obstacles in oncologic care—including fewer specialists, longer travel distances, and exclusion from clinical trials. Despite this, an estimated 62 million Americans live in rural areas, many of whom struggle to reach advanced cancer care.  

 

In addition, only about 3% of oncologists practice in rural settings, yet they often serve a disproportionately high share of patients. 

 

Outpatient-based trials, especially when coupled with decentralized elements like telehealth, remote monitoring, and community infusion sites, can dramatically expand access. By reducing the burden of frequent long-distance trips, outpatient protocols enable participation from rural patients who otherwise remain excluded. 

 

Evidence and regulatory tailwinds: a converging opportunity. 

 

Operationally and clinically, outpatient CAR‑T is no longer hypothetical. Studies such as the OUTREACH trial (liso‑cel) demonstrate safe outpatient delivery with maintained efficacy and reduced hospitalization. Systematic reviews report comparable response rates in outpatient versus inpatient settings (80–82% vs. 72–80%), with lower costs. Sarah Cannon’s experience further underscores the operational upside—over 75% of patients treated outpatient, saving thousands of bed days and cutting median hospital stay from 16 to 4 days. 

Regulatory and reimbursement tailwinds are aligning: FDA guidance increasingly supports decentralized trial models, while CMS has taken important steps toward enabling outpatient CAR-T care—such as designating CAR-T administration codes as separately reimbursable under OPPS and issuing detailed billing guidance for outpatient settings. While reimbursement structures for commercial and non-hospital providers are still evolving, these developments signal a growing openness to outpatient models. 

 

Strategic edge: trials built for tomorrow. 

 

Designing CAR‑T trials with outpatient protocols improves trial accessibility and supports future commercial advantage. Trial enrollment expands by including rural and underserved populations, accelerating recruitment and improving diversity of data.  

 

Operational efficiency increases as hospital stays shorten, freeing up capacity at high-demand centers. Payers benefit from more cost-efficient care, as outpatient treatment reduces the expense of prolonged hospitalization. And commercially, proving outpatient CAR‑T creates a pathway for delivery in community-based specialty centers, not just large academic hubs, strengthening long-term adoption. 

 

Shaping the path forward.

 

To fully capture the opportunity of outpatient CAR‑T, pharma leaders will need to think differently about how they design and deliver trials. That means building outpatient elements into protocols from the start, treating them as a core part of development strategy rather than exceptions. It also requires extending trial networks beyond academic hubs to include community and rural infusion centers, where much of the patient population actually receives care. 

 

Equally important is building confidence in safety and continuity of care. Safety monitoring, rapid-response escalation protocols for CRS and ICANS, and well-equipped caregiver networks will be central to making outpatient models sustainable. Finally, developers who can quantify these benefits—lower costs, reduced hospital burden, expanded reach—and communicate them clearly to payers and providers will be positioned to accelerate both trial enrollment and eventual adoption in the market. 

 

Conclusion. 

The CAR‑T market is booming, but success will go to companies that transcend traditional trial designs and embrace outpatient-enabled, patient-centric models. By doing so, they unlock faster enrollment, deepen community and rural reach, deliver cost-efficient care, and build a sustainable commercial pathway post-launch. Outpatient CAR‑T trials don’t just deliver therapy—they deliver access, equity, and strategic advantage. 

 

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