U.S. naloxone market is estimated to witness high growth, owing to growing substance abuse and increasing government initiatives
U.S. Naloxone Market is estimated to be valued at USD 550.4 Mn in 2024, exhibiting a CAGR of 10.2% over the forecast period (2024-2031). The market growth is driven by growing incidence of substance abuse such as opioids and increasing government initiatives to prevent drug overdose deaths. Furthermore, introduction of generic naloxone formulations can also drive the market growth during the forecast period.
Market Dynamics:
Substance abuse has increased in the U.S. over the past few years, especially abuse of opioids. Easy availability of illicit drugs and growing acceptance of drug use in society has contributed to the problem. This has led to growing need for drug overdose treatment and prevention measures including wider availability and use of naloxone. Various federal, state, and local administrations have launched programs to expand access to naloxone and train communities and first responders in its administration. The CDC has also issued guidelines for co-prescribing naloxone for high-risk opioid users. Such policy measures create more awareness about naloxone and boosts its adoption in the country.
Rising overdose deaths due to opioids can boost demand for naloxone
U.S. naloxone market growth is driven by rising rate of opioid overdose deaths in the U.S. According to the data published by Centers for Disease Control and Prevention (CDC), over 93,000 people lost their lives to drug overdoses in 2020, with opioid related deaths accounting for over 69,000 of these. The misuse of synthetic opioids like fentanyl is a major factor contributing to the higher fatality numbers. As more people misuse or abuse prescription opioid painkillers and heroin, there is greater risk of overdose. This has boosted demand and prescribing of naloxone, which is an antidote used to reverse opioid overdoses. Public health initiatives are also promoting wider distribution of naloxone through community programs to make it more accessible when an overdose occurs. If the opioid epidemic continues on its current trajectory, there will be huge need for naloxone products.
Increased public and private insurance coverage can expand access to naloxone
U.S. naloxone market growth is driven by increasing insurance coverage for these drugs which has improved access and affordability. Both public programs like Medicaid as well as private health insurers have expanded coverage for naloxone nasal sprays and auto-injectors in recent times. This addressed the high mortality rates due to opioid overdose. When insurers cover naloxone prescription costs, it encourages more at risk patients and family members to obtain these overdose reversal medications. The Affordable Care Act also requires most health plans to cover prescription drugs approved by the USFDA, which naloxone products easily meet. Improved reimbursement environment through public and commercial coverage can boost sales of naloxone products.
Cost pressures and budget constraints can hamper the market growth
Cost and affordability concerns can hamper the market name. Name brand naloxone drugs available as nasal sprays and auto-injectors are quite expensive, with list prices up to several hundred dollars for a single dose. This places significant cost burden on public programs trying fund wider distribution through community based initiatives. Healthcare budget constraints at federal and state level limit the availability of funding for naloxone stockpiling programs. The high price of branded products also impacts individuals and families trying to purchase out-of-pocket when insurance does not provide coverage. Development of lower cost generic naloxone could help address the affordability aspect.
Short duration of action discouraging repeated and proper use
Short duration of action of existing naloxone formulations, which averages around 30-90 minutes, can hamper the market growth. This short window has the potential to undermine rescue efforts if the person experiences a return of opioid overdose symptoms once the drug wears off. It may also discourage bystanders and first responders from administering repeat doses if signs and symptoms re-emerge which could be dangerous. The short effective period also makes it difficult for at-risk opioid dependent individuals to self-administer naloxone prophylactically. Development of naloxone products providing longer duration of protective effects can counterbalance this restraint by encouraging appropriate and repeated use when required.
Opportunities in public health collaborations for distribution
Increasing partnerships between public health organizations, first responder groups as well as community non-profits focused on addiction treatment and recovery can offer growth opportunities. Collaborative distribution programs that improve access to naloxone through pharmacies, syringe exchange sites, mobile medical vans and community programs can help address the opioid overdose crisis. Companies supporting such harm reduction initiatives through product donations or access programs stand to benefit from greater utilization as well public goodwill.
Room for development of user-friendly delivery formats
With continued opioid morbidity and mortality, there remains significant need for user-friendly naloxone delivery systems effective for lay administration. Whilst nasal spray and auto-injector options exist, further innovations such as pre-filled syringes, mucosal atomizing devices or intramuscular syringe options can support easier rescue attempts. Competition to develop more accessible delivery formats appeals to a range of possible responders and meets situational needs. Additional line extensions present opportunities to reach new users and drive repeat sales important for public health impact.
Link - https://www.coherentmarketinsights.com/market-insight/us-naloxone-market-4953
Key Developments:
- In May 2024, Walgreens launched its own Naloxone HCI Nasal Spray for US$ 34.99, which is cheaper than the national brand. The product, available online now and in all stores can reverse opioid overdoses and will be located in the pain aisle, enhancing access for the millions of customers and patients served daily.
- In May 2024, Amneal Pharmaceuticals started supplying its OTC Naloxone HCI Nasal Spray, 4mg, to U.S. retail pharmacies and California. Approved by the FDA in April 2024, this generic version of NARCAN HCI Nasal Spray will be distributed through the CalRx Naloxone Access Initiative.
- In April 2024, Amneal Pharmaceuticals launched an Over-the-Counter (OTC) Naloxone Hydrochloride Nasal Spray, 4mg, following FDA approval. This generic version of NARCAN HCI Nasal Spray is designed to treat opioid overdoses.
- In August 2023, Emergent BioSolutions Inc. announced that NARCAN Naloxone HCl Nasal Spray 4 mg will be available nationwide and online. This Over-the-Counter (OTC) access enhances the ability to respond to opioid emergencies, potentially saving lives as synthetic opioids, like fentanyl, continue to drive the crisis.
Key Players: Adapt Pharma Inc., Mylan N.V., Hospira Inc. (Pfizer Inc.), Kaleo Inc., Amphastar Pharmaceuticals Inc., Emergent BioSolutions Inc., Indivior PLC, Akorn, Inc., Hikma Pharmaceuticals PLC, Viatris Inc., Sandoz (a Novartis division), Teva Pharmaceuticals, Amneal Pharmaceuticals, Somerset Pharma, LLC, Orexo AB, UCB Pharma, West Ward Pharmaceuticals, Purdue Pharma
