Naloxone Market By Route of Administration (Injectables, Nasal, Oral) By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies)By Extraction Process (Solvent-Extracted, Cold-Pressed) By Sa By Formulation (Parenteral, Intranasal, Sublingual), By Dosage (4mg/0.1 ml, 2mg/0.1 ml, 0.4 mg/0.4 ml, 2mg/0.4 ml, Others), By Sales Channel (Hospitals Pharmacy, Outpatient Retail Pharmacy, Online Pharmacy, Wholesaler) - Growth, Share, Opportunities & Competitive Analysis, 2018 – 2026

What is the Regulatory followed by Naloxone?

In 2019, the Therapeutic Goods Administration (TGA) classified Naloxone as Schedule 3 when used to treat opioid overdoses, allowing it to be purchased over-the-counter (OTC) in Australia. In addition, because of the high rate of opioid overdose in this region, many European countries allow take-home naloxone. Take-home naloxone programs are available in seven European countries: Spain, Denmark, Germany, Italy, Norway, Estonia, and the United Kingdom.


What is the Market Size of Naloxone in terms of value?

Global Naloxone Market is predicted to rise at a substantial CAGR of 5.3 percent in the future years. The global market for Naloxone was estimated to be worth USD 3415.2 million in 2021 and is anticipated to grow to USD 5887.09 million by 2028. The leading market participants anticipate that the demand for Naloxone will rise significantly over the next few years, creating revenue opportunities totaling USD 2471.89 million between 2022 and 2028.

What is the Recent Development for Naloxone?

Government and non-governmental organizations in developed and developing countries are launching awareness campaigns to educate people about Naloxone overdose and treatment options. For example, in the United States's 40 states, Good Samaritan laws protect people who report overdoses in good faith. In addition, the range of offenses is protected by immunity provisions that vary by state. According to Regulatory Affairs Professional Society data, Naloxone is still not approved as an over-the-counter (OTC) drug by the US FDA. However, some organizations, such as Walgreens pharmacies, make naloxone products available over-the-counter in over 5,800 of its 8,200 locations to increase naloxone access. 

Interesting Facts about Naloxone Industry

  • The top 5 countries for Naloxone exports are The U.S., The U.K, Germany, France, and Canada.
  • The top 5 importers of Naloxone are Mexico, India, Brazil, Russia, and Japan.
  • Rising Awareness of Opioid Overdose and Effective Treatment in Developed and Developing Countries and others are the major factors driving market growth.
  • The market is expected to be hindered by the negative effects of using Naloxone Spray, and others are projected to restrain the growth of the Naloxone market over the forecast period. 
  • North America region had a major share in terms of volume and value in the global Naloxone market in 2021.
  • Nasal Naloxone to witness high growth during the forecast period.

Who are the Top 10 companies in Naloxone market in terms of value?

The key players in the global Naloxone market include SG Pharma Pvt. Ltd., ADAPT Pharma, Inc., Kaleo, Inc., Pfizer Inc., Amphastar Pharmaceuticals, Inc., Sandoz, Troikaa Pharmaceuticals Ltd., Samarth Life Sciences Pvt. Ltd., Somerset Therapeutics LLC. To increase their Naloxone production and capture a competitive market share on a global scale, these main companies are concentrating on new product development as well as technological innovation. In addition, certain regional and national players are making significant investments to diversify their product lines and boost sales. For instance, in November 2021, Hikma Pharmaceuticals PLC (Hikma), a pharmaceutical company, donated 50,000 vials of Naloxone Injection.

Who are the Top 10 Countries in the Naloxone Market?

The major countries in the global Naloxone market are China, India, the U.S., Canada, the U.K., Germany, France, Russia, Japan, and Mexico. In 2021, the United States will dominate the global market for Naloxone both as a manufacturer and consumer. Additionally, the market in industrialized nations is being pushed primarily by rising consumer health consciousness and increased demand for organic Naloxone. For instance, the 40 states in the United States have Good Samaritan statutes that protect those who report overdoses in good faith. In addition, the range of offenses is shielded by immunity clauses that vary by state.

Which is the Key Route of Administration in the Naloxone Market?

The key Distribution Channels of Naloxone include injectable, nasal, and oral. Naloxone Spray is used to reverse the effects of opioid medications temporarily. The most popular route of administration for all products is a nasal spray. People who have never used opioid narcotics are not affected by the medication in this nasal spray. After the initial nasal spray dose is administered, the patient needs to see a doctor immediately. The Centers for Disease Control and Prevention estimate that 400,000 individuals would die from an opioid overdose between 1999 and 2021. Additionally, around 130 individuals every day in the United States pass away from opioid overdoses, which include illegal drugs like heroin or medications sold as heroin, as well as prescription drugs like oxycodone, fentanyl, morphine, and hydrocodone.

What are the Major Driving Factors for Naloxone Market?

Increased Awareness of Opioid Overdose and Effective Treatment in Developed and Developing Nations The Penington Institute estimates that drugs are responsible for 0.19 million premature deaths annually, with opioids being the primary cause of these deaths and largely preventable. In January 2020, the Centers for Disease Control and Prevention (CDC) predicted that 64,070 persons would have died from overdoses between 2019 and 2020. These figures thus provide a clear picture of the effects of opioid overdose on a worldwide scale. The increased frequency of opioid drug usage in both developed and developing nations is another element fueling market expansion. This trend is anticipated to boost demand for Naloxone. Globally, the use of opioids for managing chronic pain is rising, and as a result, non-medical opioid usage is rising. This is anticipated to fuel the expansion of the naloxone market.

What are the Major Restraints for Naloxone Market?

The use of Naloxone Spray has some negative effects that are expected to impede the market, which is the main restraint of the global Naloxone market and is projected to hinder market expansion. Some of the symptoms include body aches, sneezing, fever, perspiration, runny nose, yawning, goose bumps, weakness, anxiety, restlessness or irritability, diarrhea, shaking or trembling, nausea or vomiting, stomach cramps, a rapid heartbeat, and elevated blood pressure. Therefore, this drug should be given immediately if an opioid overdose is suspected or confirmed. This will assist in avoiding severe respiratory issues and excessive tiredness, which might cause death.

Which Region Dominated the World Naloxone Market?

Due to the presence of pharmaceutical behemoths, a sizable manufacturing base, and a supportive government commitment to tackle the region's opioid overdose issue, North America owned the highest share of the worldwide naloxone market in 2021. The United States is the world's largest market for Naloxone due to the dramatic rise in the use of prescription medicines, which has led to over 10 million high-risk opioid users in the country. Unfortunately, only 16 percent of this demographic, who make up an estimated 50 percent, are receiving therapy. The naloxone market has been stimulated by rising government initiatives to raise awareness of opioid addiction and its dangers. In addition, the Affordable Care Act's effective reimbursement system and reduced drug costs have led to a rise in naloxone demand.

Due to a surge in opioid dependence, better awareness, and improved access to treatment, Europe has the highest growth. Europe is anticipated to be the second most lucrative naloxone market due to growing knowledge of the therapy for opioid overdose. Because Naloxone is being used more frequently for opioid overdose management in the region, the naloxone market in Latin America is anticipated to rise steadily.

Asia-Pacific is a developing market in the worldwide naloxone market due to greater availability and local manufacturers. Due to the poor market penetration of the product in these regions, the Middle East and Africa are the least profitable areas. Naloxone availability expanding globally and growing awareness of opioid overdose are anticipated to be important market drivers.

Segmentation of Global Naloxone Market-

Global Naloxone Market – By Route of Administration  

  • Injectables
  • Nasal
  • Oral

Global Naloxone Market – By Distribution Channel  

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

Global Naloxone Market – By Extraction Process

  • Solvent-Extracted
  • Cold-Pressed

Global Naloxone Market – By Sales Channel

  • Direct Sales
  • Hypermarkets/Supermarkets
  • Convenience Stores
  • Specialty Retail Stores
  • Traditional Grocery Stores
  • Online Retailers

Frequently asked questions about the global Naloxone industry

North America accounted for the highest share in the global Naloxone market in terms of value as well as volume.

Globally, the use of opioids for chronic pain management is increasing, and as a result, non-medical opioid use is rising are the major factors driving the market growth.

Nasal Naloxone had a major share in 2021 with more than 40% of the market revenue share.

Hospital Pharmacies had a major share in the global market in 2021 and is projected to continue its growth over the forecast period.

Naloxone Market Scope

Report Attribute Details
Market Value in 2021 USD 3415.2 MN
Market Value in 2028 USD 5887.09 MN
CAGR 5.3 %
Benchmarking Year 2021
Past data 2016 – 2021
Forecast period 2022 – 2028
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Published Date:  Jul 2022
Category:  Pharmaceuticals
Report ID:   59436
Report Format:   PDF
Pages:   190
Rating:    4.8 (65)
Delivery Time: 24 Hours to 48 Hours   
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