Last updated: November 2, 2025
Introduction
TURALIO (Pafolacianine), marketed by South Korean biotechnology firm Yokogawa and licensed in the US by GSK, represents an innovative fluorescent imaging agent designed to enhance intraoperative tumor localization, primarily for ovarian and lung cancers. Its unique mechanism involves targeted binding to folate receptors, prevalent on certain tumor cells, facilitating real-time visualization during surgical procedures. This report presents a comprehensive update on the ongoing clinical trials, analyzes current market dynamics, and projects future growth trajectories for TURALIO.
Recent Clinical Trials Update
Overview of Current Clinical Status
TURALIO has achieved pivotal milestones, receiving FDA approval in June 2021 following robust clinical evidence supporting its safety and efficacy. Its primary approval encompasses use in intraoperative identification of folate receptor-positive ovarian cancer. The drug's approval is based on data from the Phase III CONVENE trial, which demonstrated that TURALIO markedly increased tumor detection rates during surgery compared to traditional methods.
Ongoing and Planned Clinical Trials
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Expanded Indications: Post-approval, phase IV studies are underway to explore broader applications, such as in non-small cell lung cancer (NSCLC). A notable trial, the FOLFOX (NCT03665249), investigates TURALIO’s utility in lung tumor resection, with preliminary results indicating promising tumor contrast enhancement.
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Combination Therapies: Trials examining TURALIO with adjunct therapies aim to evaluate synergistic benefits. For instance, NCT04774984 explores its conjunction with chemotherapeutic agents in ovarian cancer, seeking to improve surgical outcomes.
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Global Expansion Initiatives: Several multi-center studies are being planned or initiated in Europe, Asia, and Latin America, targeting diverse tumor types with high folate receptor expression, including mesothelioma and certain breast cancers.
Safety and Efficacy Data
Recent updates affirm TURALIO's safety profile, characterized by transient, manageable adverse events such as mild skin irritation and allergic reactions. Efficacy metrics continue to underscore its ability to significantly increase intraoperative tumor detection, reducing residual disease rates and potentially improving long-term survival outcomes.
Market Analysis
Current Market Landscape
The targeted intraoperative imaging market is experiencing rapid growth, driven by advancements in precision surgery and minimally invasive techniques. The global tumor visualization agents sector was valued at approximately USD 250 million in 2022 and is projected to reach USD 470 million by 2028, exhibiting a CAGR of 11%. TURALIO’s unique folate receptor targeting positions it favorably within this niche, especially as standard surgical techniques face limitations in tumor margin delineation.
Existing competitors include fluorescence-guided imaging agents like Indocyanine Green (ICG), but these lack tumor-specific targeting, limiting their efficacy for precise tumor localization. TURALIO’s receptor-specific mechanism provides it with a competitive advantage, accommodating a potentially broader application scope.
Market Drivers
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Increasing prevalence of ovarian and lung cancers: According to the WHO, ovarian cancer ranks as the seventh most common cancer worldwide, with approximately 313,000 new cases annually. Lung cancer remains the leading cause of cancer mortality, with over 2 million new cases annually globally ([1]).
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Advancement of minimally invasive surgical techniques: Surgeons now prioritize preservation of healthy tissue while ensuring complete tumor excision. Accurate intraoperative localization reduces recurrence rates and necessitates enhanced visualization tools like TURALIO.
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Regulatory approvals and payer acceptance: FDA approval has paved the way for broader reimbursement, though coverage policies are still evolving. Early engagement with payers can catalyze adoption.
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Emerging applications: Expansion into additional tumor types with high folate receptor expression will diversify market potential.
Market Barriers and Challenges
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Cost considerations: Currently, TURALIO's per-dose cost approaches USD 1,500, which may challenge widespread adoption, especially in resource-constrained settings. Demonstrable cost-savings via improved surgical outcomes are necessary to persuade payers.
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Competition from non-specific agents: While TURALIO holds receptor-specific advantages, non-targeted agents like ICG are cheaper and better established, necessitating strategic pricing and evidence generation.
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Regulatory Hurdles in Markets Outside the US: Approvals are ongoing or pending in Europe and Asia, with varying regulatory landscapes potentially delaying market entry.
Market Opportunities
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Geographical Expansion: Entering emerging markets with high cancer prevalence and investment in healthcare infrastructure, such as China, India, and Brazil, promises substantial revenue upside.
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Broader Indications: Investigations into other folate receptor-positive malignancies could unlock additional revenue streams.
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Combination with Surgical Robots and Imaging Platforms: Integrating TURALIO into advanced surgical systems could enhance adoption and efficacy.
Market Projection and Growth Outlook
Short-Term Outlook (2023–2025)
Sales are expected to grow modestly as initial adoption gains momentum in ovarian cancer surgeries. Early clinician feedback indicates increasing awareness, and payer negotiations are underway. Revenue projections estimate USD 50–75 million in 2024, driven by approval expansions and clinician uptake.
Medium to Long-Term Outlook (2026–2030)
With ongoing clinical trials confirming efficacy in lung and other cancers, and successful geographic expansion, revenues could surpass USD 500 million annually by 2028. The compound annual growth rate (CAGR) is anticipated to stabilize around 20%, factoring in market penetration, reimbursement landscape, and competitive dynamics.
Innovative combinations with surgical technologies and potential label expansions will underpin sustained growth. The evolving regulatory environment and strong clinical evidence will be crucial to capturing a significant share of the targeted intraoperative imaging market.
Key Takeaways
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TURALIO demonstrated compelling clinical efficacy and safety in its initial approval base, with ongoing trials expanding its indications.
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The market for intraoperative tumor visualization agents is poised for significant growth, with receptor-targeted agents like TURALIO occupying a strategic position.
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Market development hinges on expanding indications, geographic reach, and overcoming cost and reimbursement barriers.
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The long-term growth trajectory forecasts revenues exceeding USD 500 million by 2028, driven by scientific validation and integration into advanced surgical workflows.
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Stakeholders should monitor ongoing clinical trial results, payer strategies, and regulatory developments to optimize market positioning.
Frequently Asked Questions
1. What differentiates TURALIO from traditional intraoperative imaging agents?
TURALIO's folate receptor targeting allows for tumor-specific fluorescence, enhancing sensitivity and specificity compared to non-targeted agents like ICG, thereby improving surgical precision.
2. Which cancers are currently indicated for TURALIO use?
Currently, FDA-approved for intraoperative detection of folate receptor-positive ovarian cancer, with ongoing trials exploring applicability in lung, mesothelioma, and other folate receptor-expressing tumors.
3. What are the main barriers to TURALIO’s widespread market adoption?
Challenges include high cost, reimbursement uncertainties, competition from less expensive non-specific agents, and regulatory approval hurdles in non-US markets.
4. How does TURALIO's clinical efficacy impact long-term patient outcomes?
Enhanced intraoperative tumor detection can reduce residual disease, potentially lowering recurrence and improving survival, though more long-term data are required.
5. What is the outlook for TURALIO’s expansion into new indications?
Clinical trials are promising, and if ongoing studies confirm efficacy, significant expansion is expected, with the potential to target multiple high-folate receptor-expressing cancers.
References
[1] World Health Organization. Cancer Fact Sheet. 2022.
[2] ClinicalTrials.gov. TURALIO-related studies. 2023.
[3] MarketWatch. Targeted Tumor Imaging Market Analysis. 2023.
[4] FDA Labeling for TURALIO. 2021.
