Last updated: November 2, 2025
Introduction
SUSTOL (granisetron transdermal system) represents a significant advancement in antiemetic therapy, primarily targeting chemotherapy-induced nausea and vomiting (CINV). As a transdermal patch delivering granisetron, SUSTOL offers a non-invasive alternative to oral and injectable formulations, promising improved patient compliance and reduced side effects. This analysis provides a comprehensive update on SUSTOL's clinical trial landscape, market dynamics, and future projections, equipping stakeholders with data-driven insights for strategic decision-making.
Clinical Trials Update
Recent and Ongoing Clinical Evaluations
SUSTOL’s clinical development has primarily focused on efficacy, safety, and tolerability in managing CINV, especially among patients undergoing highly emetogenic chemotherapy (HEC). Key clinical trials include:
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Phase III Trials
The pivotal Phase III trials demonstrated that SUSTOL is non-inferior to injectable granisetron in preventing both acute and delayed CINV. A notable study published in the Journal of Clinical Oncology indicated that SUSTOL effectively controls nausea and emesis with a favorable safety profile, comparable to existing treatments [1].
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Combination Therapy Studies
Recent investigations explore SUSTOL as part of combination regimens with NK1 antagonists and corticosteroids. Results suggest additive antiemetic efficacy, potentially broadening its usage in multi-drug antiemetic protocols [2].
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Post-Market Surveillance and Real-World Evidence (RWE)
Post-approval, multiple observational studies assess SUSTOL’s performance in everyday clinical settings. Real-world data indicates high patient satisfaction, improved adherence, and low adverse event rates, reinforcing its role in supportive cancer care [3].
Clinical Trial Pipeline and Future Directions
While SUSTOL has achieved regulatory approval (FDA, EMA), ongoing studies aim to expand its indications. These include:
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Use in pediatric populations
Investigations are underway to evaluate safety and efficacy among children receiving chemotherapy.
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Extended-release formulations
Research into novel transdermal systems with prolonged drug release is ongoing, potentially enabling once-weekly dosing.
Additionally, head-to-head trials comparing SUSTOL with newer antiemetics like olanzapine are planned to clarify its position in evolving treatment algorithms [4].
Market Analysis
Market Overview
The global antiemetic market, valued at approximately USD 1.8 billion in 2022, continues to expand due to rising cancer prevalence and advanced chemotherapy protocols [5]. SUSTOL, as a transdermal drug, competes in a segment emphasizing convenience and adherence, especially appealing in outpatient settings.
Competitive Landscape
Market Penetration and Adoption
Early adoption has been driven by oncology centers prioritizing patient quality of life and adherence. The adoption rate varies significantly across regions; North America leads, supported by reimbursement policies and clinician familiarity. Europe is experiencing increasing uptake, aided by regulatory approvals and the rising prevalence of chemotherapy treatments.
Regulatory and Reimbursement Outlook
In the U.S., SUSTOL is covered under most major insurance plans, including Medicare and Medicaid, facilitating broader access. Reimbursement success hinges on demonstrating cost-effectiveness; studies showing reduced hospitalization due to better nausea control bolster its case [6].
Challenges and Barriers
- Pricing concerns: The higher cost of transdermal systems compared to oral generics may hinder widespread adoption, especially in low-resource settings.
- Competition from oral and injectable formulations: Established therapies with low cost and familiarity remain dominant.
- Market awareness: Continuous educational efforts are necessary to inform clinicians about SUSTOL's benefits.
Market Projection
Forecast for the Next 5 Years
Based on current clinical evidence, market trends, and regulatory trajectories, the following projections are noted:
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Market Growth:
The antiemetic market is expected to grow at a CAGR of 6-8%, with SUSTOL likely contributing a significant share post-penetration increases [5].
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Sales Projections:
By 2028, global sales of SUSTOL could reach USD 400-600 million, driven by increased adoption in HEC protocols, expanded indications, and geographic reach. North America will remain the leading market, with Asia-Pacific showing rapid growth due to expanding oncology services.
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Key Drivers:
- Improving formulation and ease of use
- Increasing prevalence of cancer
- Incorporation into standard antiemetic guidelines
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Potential Growth Opportunities:
- Pediatric applications
- Use in stem cell transplantation settings
- Combination with other supportive care agents
Risk Factors
- Pricing resistance in cost-sensitive markets
- Emergence of alternative transdermal or long-acting antiemetics
- Regulatory delays in new indications
Conclusion
SUSTOL's clinical development trajectory affirms its efficacy and safety profile, with ongoing trials indicating promising avenues for expansion. The market landscape favors growth, particularly as supportive care standards evolve in oncology. Strategic positioning—focusing on increasing clinician awareness, optimizing reimbursement, and expanding indications—is vital for capitalizing on its potential.
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Key Takeaways
- SUSTOL has established efficacy in preventing both acute and delayed CINV, supported by robust Phase III data and real-world evidence.
- Its unique transdermal delivery offers compliance advantages over traditional oral and injectable antiemetics.
- Market growth hinges on educational efforts, reimbursement strategies, and geographic expansion, especially into Asia-Pacific markets.
- Competitive advantages include convenience, long-acting coverage, and favorable safety profiles, yet cost considerations remain a barrier.
- Future prospects involve clinical trials for pediatric use, expanded indications, and formulation innovations, fostering sustained growth opportunities.
FAQs
1. What distinguishes SUSTOL from other antiemetics currently on the market?
SUSTOL’s transdermal system provides a sustained release of granisetron over several days, reducing the need for repeated dosing and eliminating the oral or injectable route, thereby enhancing convenience and adherence.
2. Are there any notable side effects associated with SUSTOL?
SUSTOL generally exhibits a favorable safety profile. Common side effects include headache, constipation, and fatigue, similar to other 5-HT3 receptor antagonists. Serious adverse events are rare and comparable to existing formulations.
3. How does SUSTOL compare in cost-effectiveness to oral antiemetics?
While the initial cost of SUSTOL may be higher than generic oral agents, its potential to reduce hospitalization from uncontrolled nausea and improve compliance can offer cost savings, as evidenced in pharmacoeconomic studies.
4. Is SUSTOL approved for pediatric use?
As of now, SUSTOL’s approval is limited to adult populations receiving chemotherapy. Clinical trials exploring pediatric applications are underway, but definitive approval has yet to be granted.
5. What are the primary barriers to broader adoption of SUSTOL?
Key barriers include higher pricing compared to oral alternatives, clinician familiarity with existing therapies, and limited awareness of its benefits in some regions. Addressing these through education and reimbursement strategies is essential.
References
[1] Smith TJ, et al. "Efficacy and Safety of Granisetron Transdermal System in Prevention of Chemotherapy-Induced Nausea and Vomiting." J Clin Oncol. 2020.
[2] Lee JW, et al. "Combination Anti-Emetic Therapy Including SUSTOL: A Multicenter Trial." Supportive Care in Cancer. 2021.
[3] Patel SN, et al. "Real-World Data on SUSTOL in Oncology Supportive Care." Oncology Practice. 2022.
[4] Global Oncology Society. "Upcoming Trials in Anti-Emetic Therapy." 2022.
[5] MarketWatch. "Global Anti-Emetic Market Report." 2022.
[6] Johnson D, et al. "Cost-Effectiveness of SUSTOL in Chemotherapy Patients." Healthcare Economics. 2021.
