Last updated: January 7, 2025
Introduction
Granisetron hydrochloride is a potent antiemetic drug used primarily to prevent nausea and vomiting induced by chemotherapy, radiation therapy, and postoperative recovery. Here, we will delve into the clinical trials, market analysis, and projections for this crucial medication.
Clinical Trials Overview
Chemotherapy-Induced Nausea and Vomiting (CINV)
Granisetron hydrochloride has been extensively tested in clinical trials to evaluate its efficacy in preventing CINV. In a double-blind, randomized trial, granisetron hydrochloride tablets (1 mg twice a day and 2 mg once a day) were compared to placebo and other antiemetic treatments. The results showed that granisetron hydrochloride was significantly superior to placebo in all efficacy parameters, including complete response, no vomiting, no nausea, and total control[1].
For instance, in a trial involving 119 cancer patients receiving high-dose cisplatin, granisetron hydrochloride tablets (1 mg twice a day) demonstrated a complete response rate of 52%, no vomiting rate of 56%, and no nausea rate of 45%, all of which were statistically superior to placebo[1].
Extended-Release Formulation
The FDA approved an extended-release formulation of granisetron (Sustol) based on a multicenter double-blind trial involving 733 patients. This trial compared the efficacy of subcutaneous granisetron (10 mg) to intravenous palonosetron (0.25 mg). The results indicated that the extended-release granisetron was noninferior to palonosetron in both acute and delayed phases of CINV, providing protection for up to 5 days[4].
Radiation-Induced Nausea and Vomiting
In a double-blind randomized study, granisetron hydrochloride tablets (2 mg daily) were found to offer significantly greater antiemetic protection compared to conventional antiemetics in patients undergoing total body irradiation. The study showed that granisetron hydrochloride significantly prolonged the time to the first episode of vomiting and nausea[1].
Pharmacokinetics and Dosage
Hepatic Impairment
Pharmacokinetic studies have shown that in patients with hepatic impairment, the total clearance of granisetron hydrochloride is approximately halved compared to patients without hepatic impairment. However, due to the wide variability in pharmacokinetic parameters, dosage adjustment in patients with hepatic functional impairment is not necessary[1].
Pediatric Patients
In pediatric cancer patients (2 to 16 years of age), the pharmacokinetics of granisetron hydrochloride were found to be similar to those in adult patients when adjusted for body weight. This suggests that no specific dosage adjustments are needed for pediatric patients based on age alone[1].
Market Analysis
Market Size and Growth
The granisetron hydrochloride market was valued at USD 1.4 billion in 2023 and is projected to reach USD 2 billion by 2031, growing at a CAGR of 5.2% from 2024 to 2031. This growth is driven by the increasing incidence of cancer, the need for efficient antiemetics, and advancements in drug delivery technologies[2].
Segmentation
The market is segmented based on application (oral tablets, injection solutions, patch formulations) and product (nausea and vomiting, chemotherapy-induced nausea, postoperative nausea). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[2].
Key Drivers
The market growth is primarily driven by the rising prevalence of cancer and the subsequent increase in chemotherapy and radiation treatments. Technological advancements in drug formulations, increased healthcare spending, and a focus on improving patient quality of life are also significant factors[2][5].
Competitive Landscape
The granisetron hydrochloride market includes both established and emerging players. The report provides extensive lists of prominent companies, their market entry year, and various market-related factors. Companies are investing in research and development to improve the efficacy and convenience of granisetron hydrochloride formulations[2].
Market Projections
Future Trends
The demand for granisetron hydrochloride is expected to rise significantly due to the increasing focus on patient-centric care and the development of better drug delivery systems. The growing preference for outpatient cancer treatments and advances in medical technology are also driving the market forward[2][5].
Regulatory Environment
Regulatory agencies such as the FDA and EMA have established standards for the approval and use of antiemetics, including granisetron hydrochloride. Compliance with these regulations drives pharmaceutical companies to invest in manufacturing and developing high-quality granisetron hydrochloride API[5].
Key Takeaways
- Clinical Efficacy: Granisetron hydrochloride has demonstrated significant efficacy in preventing CINV and radiation-induced nausea and vomiting in clinical trials.
- Market Growth: The market is expected to grow at a CAGR of 5.2% from 2024 to 2031, driven by increasing cancer incidence and advancements in drug delivery technologies.
- Segmentation: The market is segmented by application, product, and geography, with a focus on improving patient quality of life.
- Regulatory Compliance: Adherence to regulatory standards is crucial for the development and approval of granisetron hydrochloride formulations.
FAQs
Q: What is the primary use of granisetron hydrochloride?
A: Granisetron hydrochloride is primarily used to prevent nausea and vomiting induced by chemotherapy, radiation therapy, and postoperative recovery.
Q: What are the key findings from clinical trials on granisetron hydrochloride?
A: Clinical trials have shown that granisetron hydrochloride is significantly superior to placebo in preventing CINV and radiation-induced nausea and vomiting, with efficacy rates comparable to or better than other antiemetics like palonosetron.
Q: How does the extended-release formulation of granisetron hydrochloride work?
A: The extended-release formulation (Sustol) provides protection against CINV for up to 5 days, making it a novel option for managing delayed CINV, which is particularly challenging to control[4].
Q: What are the market drivers for granisetron hydrochloride?
A: The market is driven by the increasing incidence of cancer, advancements in drug delivery technologies, increased healthcare spending, and a focus on improving patient quality of life.
Q: What is the projected market size for granisetron hydrochloride by 2031?
A: The granisetron hydrochloride market is expected to reach USD 2 billion by 2031, growing at a CAGR of 5.2% from 2024 to 2031[2].
Sources
- FDA Label: Granisetron Hydrochloride Tablets - Clinical Trials and Pharmacokinetics[1].
- Market Research Intellect: Granisetron Hydrochloride Market Size and Forecast[2].
- GitHub: Granisetron Hydrochloride Market Report[3].
- OncLive: FDA Approves Extended-Release Granisetron for CINV[4].
- Verified Market Research: Granisetron HCl API Market Size, Share, Trends, Scope & Forecast[5].
