Market Overview
The global market for the fixed-dose combination (FDC) of netupitant and palonosetron hydrochloride, commonly known as Akynzeo, has been experiencing significant growth driven by several key factors. This combination therapy is specifically designed to prevent acute and delayed chemotherapy-induced nausea and vomiting (CINV), a common side effect of cancer chemotherapy.
Market Size and Growth
As of 2015, the global netupitant-palonosetron FDC market was valued at $257,162 million. It is projected to reach $527,187 million by 2022, growing at a Compound Annual Growth Rate (CAGR) of 10.8% during the forecast period[1].
Mechanism of Action
The efficacy of Akynzeo is rooted in its dual mechanism of action. Netupitant acts as a selective antagonist of human substance P/neurokinin 1 (NK1) receptors in the central nervous system, preventing the binding of endogenous tachykinin neuropeptide substance P, which is involved in CINV. Palonosetron, on the other hand, blocks serotonin at 5-hydroxytryptamine type 3 (5-HT3) receptors, further reducing the incidence of CINV[4].
Clinical Efficacy
Clinical studies have demonstrated the superiority of the netupitant-palonosetron FDC over palonosetron alone in preventing both acute and delayed phases of CINV. For instance, in a pivotal trial, the combination showed a complete response (CR) rate of 87.4% to 89.6% compared to 76.5% for palonosetron alone over the 0-120 hours post-chemotherapy period[3].
Market Segmentation
The global netupitant-palonosetron FDC market is segmented based on patient pool type and geography. Geographically, the market is analyzed across North America, Europe, Asia-Pacific, and Latin America, Middle East, and Africa (LAMEA). North America and Europe are the dominant regions, driven by the increasing incidence of CINV among patients undergoing chemotherapy[1].
Key Drivers
Increasing Incidence of CINV
The rise in the number of patients undergoing chemotherapy is a significant driver for the market. As more patients receive chemotherapy, the demand for effective antiemetic treatments like Akynzeo increases[1].
Technological Advancements
Advancements in drug delivery systems, such as needle-free and painless transdermal patches, are expected to enhance patient compliance and efficacy. Novel methods like multiple dosing and variable drug delivery rates are being developed to improve treatment outcomes[1].
Approval of New Drugs
The approval of new drugs, such as rolapitant (Varubi) and Sustol (APF-530), has expanded the treatment options for CINV, further boosting the market growth. These new drugs provide cancer patients with more effective treatments for preventing delayed-phase nausea and vomiting[1].
Market Challenges
Genetic Variability
One of the challenges faced by the market is the variability in genes encoding enzymes and proteins involved in the metabolism, transport, and receptors related to antiemetic drugs. This variability can lead to suboptimal responses to current antiemetic therapies, which have an efficacy of about 70%-80% in patients treated with highly emetogenic cytotoxic drugs[1].
Safety Profile
While Akynzeo has an acceptable safety profile, common adverse events include headache, constipation, and fatigue. However, these events are generally mild to moderate in intensity. Rare but serious adverse reactions such as anaphylaxis and QT interval prolongation also need to be considered[2][4].
Competitive Landscape
The market is competitive, with major players including Helsinn Holding S.A., Heron Therapeutics, Inc., Eisai Pharmaceutical Pvt Ltd., and Acacia Pharma. These companies are adopting various strategies to sustain a competitive environment and increase their market share, including technological advancements and the development of new delivery methods[1].
Financial Trajectory
The financial trajectory of the netupitant-palonosetron FDC market is robust, driven by the increasing demand for effective antiemetic treatments. Here are some key financial highlights:
- Market Value: The market was valued at $257,162 million in 2015 and is estimated to reach $527,187 million by 2022[1].
- Revenue Growth: The market is expected to grow at a CAGR of 10.8% during the forecast period, indicating a strong financial trajectory[1].
- Regional Revenue: North America and Europe are the leading regions in terms of revenue, driven by the high incidence of CINV and the adoption of new antiemetic drugs[1].
Technological Advancements and Future Outlook
Companies are investing in technological advancements to lower production costs and discover new high-potential FDC drugs. For example, the development of rolapitant (Varubi) by Tesaro has gained significant traction in the market. These advancements are expected to continue driving the market forward by improving patient compliance and treatment efficacy[1].
Key Takeaways
- The global netupitant-palonosetron FDC market is growing rapidly, driven by the increasing incidence of CINV and technological advancements.
- The combination therapy has shown superior efficacy over single-agent treatments in clinical trials.
- Market segmentation is based on patient pool type and geography, with North America and Europe being the dominant regions.
- Challenges include genetic variability affecting drug efficacy and potential safety concerns.
- The competitive landscape is marked by major players adopting strategies to enhance market share.
- The financial trajectory is robust, with a projected market value of $527,187 million by 2022.
FAQs
What is the primary mechanism of action of the netupitant-palonosetron FDC?
The primary mechanism involves netupitant blocking substance P/neurokinin 1 (NK1) receptors and palonosetron blocking serotonin at 5-hydroxytryptamine type 3 (5-HT3) receptors to prevent CINV[4].
Which regions dominate the netupitant-palonosetron FDC market?
North America and Europe are the dominant regions in terms of revenue, driven by the high incidence of CINV and the adoption of new antiemetic drugs[1].
What are the common adverse events associated with Akynzeo?
Common adverse events include headache, constipation, and fatigue, which are generally mild to moderate in intensity[2][4].
How does genetic variability impact the efficacy of antiemetic treatments?
Genetic variability in genes encoding enzymes and proteins involved in drug metabolism and receptors can lead to suboptimal responses to antiemetic therapies, affecting about 20%-30% of patients treated with highly emetogenic cytotoxic drugs[1].
What technological advancements are expected to impact the market?
Advancements in drug delivery systems, such as transdermal patches with multiple dosing and variable drug delivery rates, are expected to enhance patient compliance and treatment efficacy[1].
Sources
- Allied Market Research: Netupitant – Palonosetron FDC Market Size - Analysis 2022
- Health Products and Food Branch: Summary Basis of Decision for Akynzeo
- FDA: 205718Orig1s000 - accessdata.fda.gov
- EMA: Akynzeo, INN-netupitant & palonosetron hydrochloride
- FDA: Akynzeo® (netupitant-palonosetron hydrochloride) Capsules - FDA
