The naloxone market is estimated to be valued at USD 1,341.5 MN in 2024, growing at a CAGR of 10.4% over the forecast period (2024 – 2031). Growing awareness regarding opioid overdose reversal with naloxone administration and improving access to naloxone are further expected to propel the market growth.
Market Dynamics:
The growth of the naloxone market is driven by an increasing incidence of opioid overdose deaths and rising adoption of naloxone nasal spray. Opioid overdose deaths have surged significantly worldwide in the past few years. Thus, the growing demand for effective opioid overdose reversal therapies is expected to upsurge the sales of naloxone. Moreover, advantages of naloxone nasal spray such as ease of administration, non-invasive nature, and fewer side effects compared to injection are increasing its adoption among first responders and laypeople. This is anticipated to boost the growth of the naloxone market over the forecast period.
Increasing Opioid Overdose Cases are Driving the Demand for Naloxone
One of the key drivers promoting growth in the naloxone market is the rising incidence of opioid overdose cases across the world. Opioids, both prescription and illicit, have been widely abused, leading to a surge in overdose deaths in recent times. According to the Centers for Disease Control and Prevention (CDC), over 70,000 Americans died due to drug overdose in 2019, with nearly 50,000 of these deaths involving opioids. The growing availability and misuse of opioids has put many lives at risk. This has bolstered the demand for naloxone, which is highly effective in reversing opioid overdose if administered promptly. Various government programs aimed at making naloxone more accessible have further supported its uptake.
Implementation of Standing Orders is Boosting Naloxone Access
Another key factor driving the naloxone market is the implementation of standing order policies allowing naloxone to be dispensed without a prescription. Several states in the U.S. and other countries have instituted such standing orders, enabling take-home naloxone kits to be provided over the counter via community-based programs. This has significantly enhanced public access to the life-saving opioid antagonist. It has eliminated the need to procure a doctor's prescription in emergency overdose situations. With more users and caregivers having easy access to naloxone, its demand and sales have experienced a marked increase in recent times. Standing orders have thus emerged as a critical market driver by facilitating wider distribution and adoption of naloxone products.
High Drug Development Costs Limiting Market Growth
One of the major restraints faced by players in the naloxone market is the high research and development expenditures required to bring new products to commercialization. Developing novel formulations such as auto-injectors, nasal sprays, and biphasic formulations entails enormous investments, rigorous clinical testing, and regulatory approvals. The capital infused goes into conducting bioequivalence and human factor studies to support pharmaceutical equivalence. This makes it difficult for companies, especially start-ups and smaller enterprises, to introduce affordable innovations. The substantial drug development costs have restricted market expansion to some degree.
Unfavorable Reimbursement Scenario Hindering Adoption
Reimbursement challenges represent another key barrier negatively impacting the naloxone market. There is inadequate or no insurance coverage for naloxone products in certain countries. Even in regions where reimbursement is available, the coverage rates are low and restrict widespread uptake. The out-of-pocket costs deter many consumers and community programs from procuring naloxone regularly. International participants also face hindrances in terms of non-availability of established reimbursement frameworks. These reimbursement issues have posed adoption hurdles, limiting the revenue opportunities for industry players. Addressing the shortcomings in the reimbursement system remains crucial to unlock the market's complete potential.
Increasing Acceptance of Take-Home Naloxone Kits
One significant opportunity area for naloxone market players lies in the rising popularity of take-home naloxone (THN) programs. Several harm reduction initiatives are promoting THN kits that allow opioid users, their friends, and family members to administer naloxone in the event of an overdose. They are being distributed via community-based organizations and pharmacies without a prescription. Many countries have also introduced policies favoring home-based administration of naloxone. This growing adoption of THN approaches presents lucrative revenue prospects, with the demand projected to be sustained over the coming time.
Emergence of User-Friendly Formulations Driving Gains
The development of easy-to-administer naloxone formulations such as nasal sprays, auto-injectors, and multiphasic systems creates new opportunities in the market. Their user-friendly attributes encourage uptake, particularly among the layperson demographic involved in self-administration. These innovations deliver the drug in a simpler, non-invasive manner versus vials/ampoules requiring reconstitution. They negate the need for medical training or assistance during emergencies. The rising popularity of such next-generation formats will support market expansion through increased sales volumes over the forecast period.
Link: https://www.coherentmarketinsights.com/market-insight/naloxone-market-1804
Key Development
- In August 2023, Emergent BioSolutions Inc., a multinational specialized biopharmaceutical corporation, disclosed that NARCAN Naloxone HCl Nasal Spray 4 mg will be accessible for purchase across the entire state and online commencing September 2023. The manufacturer's recommended retail price for NARCAN Nasal Spray stands at USD 44.99 per carton, translating to approximately USD 22.50 per dose.
- On August 30, 2023, Walgreens, a prominent pharmacy retail chain in the U.S., declared the forthcoming availability of over-the-counter (OTC) NARCAN Nasal Spray at Walgreens stores and online platforms, commencing September 5, 2023, with statewide accessibility slated for September 7, 2023.
- In March 2023, Amneal Pharmaceuticals, Inc., a distinguished generics and specialty pharmaceutical entity, disclosed that the U.S. Food and Drug Administration (FDA) acknowledged the submission for review of the Abbreviated New Drug Application (ANDA) pertaining to naloxone hydrochloride nasal spray, USP, 4mg. This generic formulation serves as an alternative to Narcan for the management of known or suspected opioid overdose emergencies.
- In December 2021, Sandoz, a prominent global entity specializing in generic and biosimilar medicines, officially launched its authorized generic iteration of Narcan (naloxone hydrochloride) Nasal Spray 4mg in the United States. This product, designed to combat opioid overdoses, is readily accessible to consumers across the nation through retail pharmacies and institutional channels, including hospitals.
Key Players: EMERGENT, Indivior PLC, Akorn, Inc, Hikma Pharmaceuticals PLC, Viatris Inc., Sandoz, Teva Pharmaceuticals, Amphastar Pharmaceuticals, Inc., Kaleo, Inc., Pfizer Inc., Amneal Pharmaceuticals, Viatris Inc., Somerset Pharma, LLC, Orexo AB, and UCB Pharma.
