Global Naloxone Market Size, Share, Analysis, Trends, Growth, 2032

Naloxone Industry Prospective:

The global naloxone market size was worth around USD 1,247.30 million in 2023 and is predicted to grow to around USD 2,754.20 million by 2032 with a compound annual growth rate (CAGR) of roughly 9.20% between 2024 and 2032.

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Naloxone Market: Overview

Naloxone is a medicinal drug that is used for rapidly reversing the effects of opioid overdose. Researchers consider it an opioid antagonist. The drug, when in action, attaches itself to the opioid receptor. Furthermore, it reverses and limits the impact of other opioids. Market research indicates that naloxone is highly effective in normalizing the breathing pattern of a person suffering from stopped or slowed breathing due to an opioid overdose.

However, the drug cannot be used for opioid use disorder since it has no effect on a person who does not have an opioid in the system. Some of the most common opioids include hydrocodone (Vicodin®), heroin, oxycodone (OxyContin®), fentanyl, morphine, and codeine.

According to the National Institute of Drug Abuse, the medicine should be given to a person who is suspected of drug abuse or is showing signs of the same. It can be given either by injecting under the skin, into the muscle, or into the veins. It can also be given as a nasal spray. The demand for naloxone is growing rapidly due to the increasing number of cases related to opioid addiction.

Furthermore, market players can generate more revenue by expanding into new territories. One of the crucial factors limiting the industry’s growth rate is the complexity associated with regulatory protocols and the illegal trafficking of medicine.

Key Insights:

• As per the analysis shared by our research analyst, the global naloxone market is estimated to grow annually at a CAGR of around 9.20% over the forecast period (2024-2032)
• In terms of revenue, the global naloxone market size was valued at around USD 1,247.30 million in 2023 and is projected to reach USD 2,754.20 million by 2032.
• The market is projected to grow at a significant rate due to the rising number of opioid addictions.
• Based on the type, the intranasal segment is growing at a high rate and will continue to dominate the global market as per industry projections.
• Based on the application, the opioid overdose segment is anticipated to command the largest market share
• Based on region, North America is projected to dominate the global market during the forecast period.

Naloxone Market: Growth Drivers

Rising number of opioid addictions worldwide to drive market demand rate

The global naloxone market is expected to grow due to the growing number of cases associated with opioid addiction. Naloxone is a highly effective medicine that can reverse the effect of opioid overdose in a person. According to the World Health Organization (WHO), opioids are regularly used for treating pain.

However, prolonged and irresponsible non-medicinal use of opioids can result in opioid dependence and cause serious health problems. In 2019, more than 600,000 cases globally were attributed to drug abuse with around 80% of these cases being related to overuse of opioids. The three most common signs of opioid overdose include unconsciousness, pinpoint pupils, and difficulty in breathing.

WHO estimates that the number of opioid abusers has increased in several countries in the last few years. Certain risk factors are associated with opioid overdose. Some of them are injecting opioids, suffering from opioid use disorder, high prescribed doses of opioids, and dealing with several medical conditions at once such as mental health disorder, liver or lung disease, or others. Furthermore, consuming opioids in combination with other substances such as alcohol or mixing medications can also lead to opioid overdose.

Unregulated sale of over-the-counter (OTC) opioids or medical errors to drive demand for naloxone

Opioids are prescribed by medical professionals to patients in certain conditions such as following a serious injury or managing fatal diseases such as cancer. According to the Centers for Disease Control and Prevention (CDC), opioids can be prescribed by medical professionals in case of treating acute-to-chronic pain.

However, in recent times, several reports have emerged from across the globe highlighting the rising number of medical errors including wrong prescriptions including that of opioids.

WHO estimates that more than 100 mg of morphine or equivalent daily is classified as the high dosage of opioids which can put the lives of the recipient at risk. Furthermore, the unregulated sale of the drug through OTC channels will also impact the demand rate in the global naloxone market according to industry findings.

Naloxone Market: Restraints

Illegal trafficking of naloxone and increasing sale of counterfeit drugs may limit the market’s expansion rate

The global industry for naloxone is projected to be restricted due to the growing incidents of illegal trafficking of the medicinal drug. Unlawful sales of naloxone outside the medical world can result in severe health hazards.

Furthermore, it also promotes higher use of opioids as users can obtain naloxone from unauthorized personnel encouraging them to continue using opioids without medical supervision. In addition to this, the rising incidents of the sale of counterfeit naloxone or the variants made of substandard raw materials can put the lives of many people at risk.

Naloxone Market: Opportunities

Increasing number of regulatory approvals and expansion into new markets to generate growth opportunities

The global naloxone market is projected to generate growth opportunities due to the rising number of regulatory approvals worldwide. In July 2023, the US Food & Drugs Administration (FDA) authority announced the approval of a second over-the-counter sale of naloxone nasal spray.

The solution is called RiVive and consists of 3 milligrams (mg) of naloxone hydrochloride. RiVive is the second OTC product to be approved by the agency in the backdrop of growing cases of opioid abuse in the country. Furthermore, market players have also targeted increased sales by making the products available through major retail stores.

For instance, in August 2023, Emergent, a leading producer of naloxone nasal spray, made its product NARCAN available across grocery stores, pharmacies, and online portals. The medicine can be purchased at more than 32,000 retailers and e-commerce websites since its commercial launch.

In December 2021, Teva Pharmaceuticals announced the launch of a generic version of Narcan®1 across the US. The product is the first-to-market and will allow greater use of naloxone in preventing deaths due to opioid overuse.

Naloxone Market: Challenges

Regulatory complexities, price variability, and limited public awareness may challenge the overall growth rate

The global industry for naloxone is projected to be challenged by several technical constraints. For instance, the production and use of naloxone are highly regulated with varying laws depending on the region.

Furthermore, the lack of sufficient medical reimbursements covering the use of naloxone which can be highly priced in certain parts of the world will further inhibit the industry’s growth rate. Public awareness around the use and benefits of naloxone is widely limited leading to slow growth in the market.

Naloxone Market: Report Scope

Naloxone Market: Segmentation

The global naloxone market is segmented based on type, end-user vertical, application, distribution channel, and region.

Based on the type, the global market segments are intranasal and injectable. In 2023, the highest growth was listed in the intranasal segment. More than 70% of the total revenue was generated by intranasal naloxone in 2023 and the same trend is expected in the future. According to market analysis, intranasal naloxone is easy to administer with minimal risk of error in quantity. Injectables are generally provided under medical supervision.

Based on the end-user vertical, the global naloxone industry is divided into rehabilitation centers, ambulatory surgical centers, and hospitals.

Based on the application, the global market segments are chronic pain management and opioid overdose reversal. In 2023, around 80% of the final revenue was listed in the opioid overdose reversal segment. The surge in the number of opioid abuse-related incidents has led to increased demand for naloxone. Additionally, positive government initiatives to improve the commercial availability of naloxone will further help the segment thrive.

Based on distribution channels, the global market segments are online pharmacies, retail pharmacies, and hospital pharmacies.

Naloxone Market: Regional Analysis

North America to maintain its dominance during the projection period

The global naloxone market will be led by North America during the forecast period. The regional market dominance will be fueled by increasing demand for naloxone in the US and Canada regions. North America is witnessing a rising number of opioid consumers, especially for non-medical purposes.

According to the National Center for Drug Abuse Statistics, around 3.8% of American adults are known to abuse opioids annually resulting in a growing number of drug overdose-related deaths. The increase in the number of FDA approvals for naloxone will further help the region thrive in the coming years.

In April 2024, the FDA announced the approval of an abbreviated new drug application for naloxone hydrochloride nasal spray by Amneal Pharmaceuticals. The USP 4 mg formulation by the company which is a generic equivalent to OTC Narcan HCI nasal spray is now available as an OTC drug.

In December 2023, the US General Services Administration (GSA) and Department of Health and Human Services (HHS) announced recommendations encouraging the OTC sale of naloxone making the medication readily available for application.

Naloxone Market: Competitive Analysis

The global naloxone market is led by players like:

• UCB Pharma
• Adapt Pharma Inc.
• Hikma Pharmaceuticals PLC
• Mylan N.V. (now Viatris Inc.)
• Teva Pharmaceuticals
• Hospira Inc. (a subsidiary of Pfizer Inc.)
• Somerset Pharma LLC
• Amphastar Pharmaceuticals Inc.
• Amneal Pharmaceuticals
• Emergent BioSolutions Inc.
• Sandoz (a division of Novartis)
• Kaleo Inc.
• Orexo AB
• Indivior PLC
• Akorn Inc.

The global naloxone market is segmented as follows:

By Type

• Intranasal
• Injectable

By End-User Vertical

• Rehabilitation Centers
• Ambulatory Surgical Centers
• Hospitals

By Application

• Chronic Pain Management
• Opioid Overdose Reversal

By Distribution Channel

• Online Pharmacies
• Retail Pharmacies
• Hospital Pharmacies

By Region

• North America
  • The U.S.
  • Canada
• Europe
  • France 
  • The UK
  • Spain
  • Germany
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Southeast Asia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • South Africa
  • Rest of Middle East & Africa