Frequent Launches and Approvals of Novel Naloxone Products Fuel the Global Naloxone Market Growth

Increasing drug abuse in key regions is expected to increase demand for its treatment drugs


Seattle, WA -- (SBWire) -- 10/01/2019 --Naloxone is an opioid antagonist used for the treatment of opioid overdose such as of morphine and heroine. In the U.S., the federal agency Food and Drug Administration (FDA) lists naloxone under prescription drugs. However, in several other countries such as Italy and Australia, naloxone can be bought over-the-counter (OTC). Naloxone is available in various strengths of 0.4 mg/ml, 1mg/ml, 0.4mg/0.4ml, 4mg/0.1ml, and others. The drug can be administrated using various routes such as intranasal, intramuscular/subcutaneous, and intravenous. The recently launched intranasal naloxone products can be administrated by anyone (non-medical professional). However, only medical professionals are allowed to administrate intravenous products of naloxone.

Key players in the market are focused on approval and launch of novel naloxone products, which is expected boost growth of the market over the forecast period. For instance, in January 2017, the U.S. Food and Drug Administration (FDA) approved Adapt Pharma Inc.'s NARCAN Nasal Spray 2 mg formulation for emergency treatment of known or suspected opioid overdose. In 2016, Mylan N.V. launched its naloxone hydrochloride injection USP, 0.4 mg/mL packaged in 1 mL single-dose vials. It is therapeutically equivalent to the naloxone hydrochloride injection 0.4 mg/mL, of Hospira Inc. In September 2017, Mundipharma International Limited received approval from European Medicines Agency (EMA) for its product (intranasal naloxone 1.8 mg) to use in emergency reversal of opioid overdose.

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Increasing number of opioid overdose cases is expected to lead to high demand for naloxone products, thereby aiding in growth of the global naloxone market. For instance, according to the data published by the U.S. Department of Health and Human Services (HHS) in 2016, around 11.5 million people misuse prescription drugs and around 948,000 people use heroin. According to the data published by National Institute on Drug Abuse, 2018, in the U.S., everyday over 115 people die due to opioid overdosing. According to same source, in the U.S. opioid overdose increased by 30% from July 2016 through September 2017 in 52 areas in 45 states.

Favorable reimbursement scenario in major countries in North America and Europe is expected to increase adoption of naloxone. Currently, several insurances cover and reimburse for naloxone administered directly in a medical setting.

Moreover, in the U.S., increasing number of states have started covering take-home naloxone, which is further expected to increase adoption of take-home naloxone. For instance, from January 2014, New York State Medicaid program began to cover the intramuscular formulation of take-home naloxone.

The market in North America is expected to hold dominant position over the forecast period. This is owing to presence of novel naloxone products such as Narcan nasal spray and EVZIO (naloxone hydrochloride injection), which is still not present in any other region. Moreover, increasing company and organization initiatives to increase access of naloxone is also expected to contribute to the market growth. For instance, in February 2018, Loyola Medicine collaborated with the Cook County Department of Homeland Security and Emergency Management to train police officials to use Narcan in case of opioids overdose. In 2016, Adapt Pharma Limited partnered with Smith Medical Partners, LLC for distribution of free Narcan (Naloxone HCl) nasal spray in all high schools in the U.S.

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Increasing approval and launch of novel naloxone products is expected to boost the market growth in Europe over the forecast period. For instance, in July 2017, Indivior Inc., a subsidiary of Indivior Plc., received marketing authorization (MA) from French Regulatory Agency ANSM for its new Nalscue naloxone hydrochloride nasal spray indicated for emergency treatment of characterized or suspected opioid overdose in France. In February 2017, Adapt Pharma Limited filed marketing application for its product Naloxone Hydrochloride (HCl) nasal spray in Europe.

In 2016, Therapeutic Goods Administration (TGA) placed naloxone on Schedule 3 when used for the treatment of opioid overdose, thus allowing the over-the-counter (OTC) purchase of naloxone in Australia.

In Europe, several countries allow take-home naloxone due to high rate of opioid overdose in this region. Denmark, Estonia, Germany, Italy, Norway, Spain, and the U.K. (EMCDDA, 2015c) support take-home naloxone programs.

According to the data published by Regulatory Affairs Professional Society, naloxone is still not approved by the U.S. FDA as an over-the-counter (OTC) drug. However, some organizations such as Walgreens pharmacies are providing naloxone products over-the-counter in over 5,800 of its 8,200 stores to increase the access of naloxone.

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Detailed Segmentation:

Global Naloxone Market, By Strength:

0.4 mg/ml



4mg/0.1ml and Others

Global Naloxone Market, By Drug Type:




Global Naloxone Market, By Distribution Channel:



Retail Pharmacies

Online Pharmacies


Key players operating in the naloxone market include, Mylan N.V., Novartis AG, Indivior Plc., ADAPT Pharma, Inc., Amphastar Pharmaceuticals, Inc., INSYS Therapeutics, Inc., Mundipharma International Limited, Kaleo, Inc., and Kern Pharma, S.L.

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