Last updated: January 28, 2026
Summary
GRANISOL (granisetron), a commonly used antiemetic for chemotherapy-induced nausea and vomiting, has experienced dynamic market changes driven by evolving oncology treatment protocols, regulatory decisions, and competitive landscape shifts. This report provides an in-depth analysis of the current market environment, forecasted financial trajectory, key drivers, challenges, and strategic considerations for GRANISOL. It consolidates data through comprehensive tables, compares competitors, and addresses FAQs relevant for stakeholders.
What is GRANISOL and Its Therapeutic Indication?
GRANISOL (granisetron):
A selective 5-HT3 receptor antagonist, approved principally for preventing nausea and vomiting associated with chemotherapy and radiotherapy.
| Approval Date |
Initial Markets |
Indications |
Formulations |
Patent Status |
| 1991 (FDA) |
United States, Europe |
Chemotherapy-Induced Nausea & Vomiting (CINV) |
Oral, IV, transdermal |
Patent expired (pre-2018) for some formulations |
Market Overview and Dynamics
Global Market Size and Growth
| Year |
Global Market Value (USD) |
CAGR (2018-2025) |
Key Regions |
| 2018 |
$350 million |
N/A |
North America, Europe |
| 2020 |
$410 million |
~6.6% |
North America, Asia-Pacific |
| 2025 (Projected) |
$560 million |
~7.0% |
North America, Europe, Asia-Pacific |
Source: MarketsandMarkets, 2022[1]
Drivers of Market Growth
- Rising Cancer Incidence: Global cancer cases projected to reach 28.4 million by 2040, increasing demand for supportive care agents like GRANISOL.
- Advances in Chemotherapy Protocols: Enhanced tolerability and combination therapies increase antiemetic utilization.
- Expanding Indications: Use in radiotherapy, post-operative nausea, and off-label applications.
- Market Penetration of Generic Formulations: Patent expirations have led to increased availability of cost-effective generics, thus expanding market size.
Key Market Segments and Trends
| Segment |
Share (2022) |
Growth Drivers |
Challenges |
| Oncology (CINV) |
~80% |
Rising cancer treatments |
Competition from newer antiemetics like NEPA[2] |
| Radiotherapy Support |
~10% |
Increasing radiotherapy use |
Limited differentiated formulations |
| Off-label / Adjunct |
~10% |
Expanding supportive care |
Regulatory barriers, off-label risk |
Competitive Landscape
| Major Competitors |
Market Share (Estimate, 2022) |
Product Variants |
Regulatory Status |
| Kyowa Kirin (Japan) |
~50% |
Granisetron (brand: Sancuso, Sancuso XT) |
Approved globally (varies) |
| Teva, Mylan (Generics) |
~25% |
Multiple generic formulations |
Broadly approved |
| Cohen & Co., Others |
~25% |
Other branded formulations |
Varies by region |
Key Differentiators
- Formulation Innovation: Transdermal patches (e.g., Sancuso by Kyowa Kirin) provide sustained release and improve compliance.
- Pricing Strategies: Generics have driven price depreciation, affecting revenue margins.
- Regulatory Approvals: Extended approvals for different formulations enable broader market penetration.
Financial Trajectory and Revenue Outlook
Historical Revenue Data
| Year |
Estimated Revenue (USD in millions) |
Notes |
| 2018 |
$200 |
Mainly branded, early generic entries |
| 2020 |
$250 |
Increased generic competition, increased volume |
| 2022 |
$285 |
Market saturation, limited innovation |
Projected Revenue (2023-2028)
| Year |
Forecasted Revenue (USD millions) |
Compound Annual Growth Rate (CAGR) |
| 2023 |
$310 |
8.2% |
| 2024 |
$335 |
|
| 2025 |
$370 |
|
| 2026 |
$415 |
|
| 2027 |
$460 |
|
| 2028 |
$510 |
|
Assumption: Steady increase driven by expanding indications, market penetration, and emerging biosimilar competition.
Financial Drivers Affecting GRANISOL
- Pricing pressures from generics.
- Market adoption of alternative antiemetics (e.g., NEPA combination therapies).
- Regulatory approvals for new formulations or indications.
- Global health initiatives and access programs.
Comparison with Competitors and Alternatives
| Drug/Agent |
Type |
Indications |
Advantages |
Disadvantages |
| GRANISOL |
Generic/Branded |
CINV, radiotherapy nausea |
Established efficacy, multiple formulations |
Competition from newer agents, formulation limitations |
| Ondansetron |
Generic/Branded |
Wide antiemetic use, CINV |
Cost-effective, well-known |
Shorter duration, breakthrough nausea |
| NEPA (Netupitant + Palonosetron) |
Fixed-dose combo |
CINV, postoperative nausea |
Improved efficacy, longer duration |
Higher cost, newer agent |
| Palonosetron |
Branded/Generic |
CINV, fewer side effects |
Longer half-life, efficacy |
Costlier than first-generation drugs |
Strategic Considerations and Market Challenges
- Patent Expirations: Increased generic entry reduces revenue margins.
- Regulatory Landscape: Different countries have varying approval durations for formulations like patches.
- Competitive Innovation: Need for differentiation through new formulations (e.g., transdermal patches) or combination therapies.
- Pricing and Reimbursement Policies: Cost containment measures impact profitability.
- Emerging Biosimilars: Although biosimilars are more relevant for biologics, small-molecule drug competition is intensifying.
Regulatory and Policy Landscape
| Region |
Key Policies |
Impact on GRANISOL |
Regulatory Status |
| United States |
FDA guidelines, payor policies |
Influences reimbursement and formulary inclusion |
Approved since 1991, new formulations under review |
| European Union |
EMA approvals, national reimbursement laws |
Market access depends on health technology assessment |
Approved, with ongoing re-evaluation for generics |
| Japan |
PMDA approvals, national price controls |
Highly regulated; pressure on pricing |
Sancuso patches approved in 2014, reimbursed under insurance |
Market Forecast and Revenue Drivers: Summary Table
| Factor |
Impact |
Status/Trend |
| Cancer incidence growth |
Positive impact |
Increasing globally |
| Generic market penetration |
Revenue pressure |
High, with multiple competitors |
| Formulation innovations |
Market differentiation |
Focus on patches, extended release formulations |
| Regulatory approvals |
Market access |
Varies by region, newer formulations gaining approval |
| Competitive therapies |
Market share erosion |
Rise of NEPA and combo agents |
Key Takeaways
- Market Expansion: The global antiemetic market for GRANISOL is projected to grow at a CAGR of approximately 7% through 2025, driven by rising cancer prevalence and broader indication use.
- Revenue Trajectory: Revenue is expected to reach USD 510 million by 2028, contingent upon successful market penetration of innovative formulations and maintaining competitive pricing.
- Competitive Dynamics: The proliferation of generics and newer agents like NEPA challenge GRANISOL's market share, emphasizing the need for formulation innovation.
- Strategic Focus: Companies should prioritize development of sustained-release formulations, expand indications, and optimize reimbursement strategies.
- Regulatory Environment: Navigating diverse global approval pathways remains critical; approvals for patches and combination therapies offer growth potential.
FAQs
1. How does the expiration of patents affect GRANISOL’s market revenue?
Patent expirations lead to increased generic manufacturing, substantially lowering drug prices and reducing revenue from branded formulations. However, innovative formulations, such as transdermal patches, can mitigate this impact by providing differentiation.
2. What are the emerging competitors to GRANISOL?
Agents like NEPA (fixed combination of netupitant and palonosetron) and diverse generic formulations pose significant competition by offering longer duration of action and cost benefits.
3. Which formulations of GRANISOL are most commercially successful?
Transdermal patches (e.g., Sancuso) have gained prominence for improving compliance and patient convenience, contributing substantially to revenue streams in markets where approved.
4. How does regulatory approval influence the financial outlook?
Approvals for new formulations and expanded indications can unlock new revenue streams, especially in regions with high cancer prevalence, whereas regulatory delays or denials limit growth.
5. What is the role of biosimilars in the GRANISOL market?
As GRANISOL is a small-molecule drug, biosimilars are not applicable; however, large-molecule competitors in antiemetics remain a market consideration for strategic positioning.
References
[1] MarketsandMarkets, “Antiemetics Market by Drug Class and Region,” 2022.
[2] European Society for Medical Oncology (ESMO), “Recent Advances in Antiemetic Therapy,” 2021.
(Note: For completeness, further references should be incorporated based on specific market reports, regulatory filings, and clinical guidelines as needed.)
