Naloxone Market, by Drug Type (Branded and Generic), by Administration (Intranasal Administration, Intramuscular Administration, and Intravenous Administration), by Distribution Channel (Hospitals Pharmacies, Retail Pharmacies, and Online Pharmacies), and By Geography - Size, Share, Outlook, and Opportunity Analysis 2018-2026

  • Published On : Aug 2018 |
  • Pages : 199 Pages |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

Naloxone Market- Insights

Naloxone is a medication which is mainly used to reverse opioid overdose such as morphine and heroine. Naloxone is an opioid antagonist and the U.S. Food and Drug Administration (FDA) list it under prescription drugs, however some countries such as Italy and Australia have rescheduled it as an over-the-counter (OTC) medication. Naloxone products are available in various strengths. Currently, the available strengths of naloxone include 0.4 mg/ml, 1mg/ml, 0.4mg/0.4ml, 4mg/0.1ml, and others. Naloxone are administrated from different routes such as intranasal, intramuscular/subcutaneous, and intravenous. Intranasal naloxone products are the latest product in market which can be administrated by anyone (non-medical professional). However, intravenous products are mainly administrated by medical professional who are properly trained.

Frequent launches and approvals of novel naloxone products is expected to fuel the global naloxone market growth

Increasing launches and approval of novel naloxone products by various regulatory bodies is expected to be a major factor aiding in 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.

The global naloxone market size was valued at US$ 310.2 Mn in 2017, and is expected to witness a CAGR of 11.4% over the forecast period (2018 – 2026).

Figure 1. Global Naloxone Market Share (%), By Strength, 2018–2026

Naloxone  | Coherent Market Insights

Source: Coherent Market Insights Analysis (2018)

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

Increasing cases of opioid overdose is expected to increase demand for naloxone products during emergency treatments which in turn will positively drive the global naloxone market growth. 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.

Figure 2. Global Naloxone Market Share (%), By Region, 2026

Naloxone  | Coherent Market Insights

Source: Coherent Market Insights Analysis (2018)

Favorable reimbursement scenarios for naloxone products is also expected to aid in market growth

Reimbursement scenario for drugs play a major role in adoption of high cost products in developed regions such as North America and Europe. Therefore, favorable reimbursements for naloxone products is expected to support the adoption of these products. Currently, most types of insurance cover and reimburse for naloxone administered directly in a medical setting.

Furthermore, some states in the U.S. have started covering take-home naloxone. Hence, adoption of take-home naloxone is expected to increase in the near future. For instance, in New York State from January 2014, the state’s Medicaid program began to cover the intramuscular formulation of take?home naloxone.

North America naloxone market is expected to a hold dominant position over the forecast period due to the presence of novel naloxone products such as Narcan nasal spray and EVZIO (naloxone hydrochloride injection), which is still not present in any other region. Furthermore, initiatives taken by various companies and organizations to increase access of naloxone is expected to fuel the market growth. For instance, in February 2018, Loyola Medicine and the Cook County Department of Homeland Security and Emergency Management collaborated, where Loyola Medicine trained 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.

Furthermore, Europe naloxone market is expected to show significant growth in the near future, owing to increasing approvals of novel naloxone products in the region. 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. Hence, these products when launched in the European market it will drastically fuel market growth in the near future

Regulatory Scenario

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, many countries allow take-home naloxone due to high rate of opioid overdose in this region. Currently, take-home naloxone programs exists in seven European countries— Denmark, Estonia, Germany, Italy, Norway, Spain, and the U.K. (EMCDDA, 2015c).

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.

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.

Naloxone is an opioid antagonist used to counter the effects of opioid overdose, such as morphine and heroine. Naloxone is indicated for use in opioid overdose to counteract life-threatening depression of the central nervous system and respiratory system, allowing an overdose victim to breathe normally. Naloxone is non-scheduled prescription medication, which in most cases, is administrated by emergency response personnel or minimally trained personnel, and is thus ideal for treating overdose in people who are prescribed opioid pain medication. Naloxone can be administrated through parenteral route, by injecting in the muscle or vein.

Market Dynamics

Increasing launches and approval of new naloxone products in the market is expected to drive the global naloxone market growth over the forecast period. In October, 2016 Health Canada approved Narcan Nasal Spray 4 mg for non-prescription, community use in Canada

Rising prevalence of opioid overdose in key regions such as North America, and Europe is expected to drive demand for naloxone products and drive the naloxone market growth in the near future. For instance, according to the data published by European Monitoring Center for Drugs and Drug Addiction (EMCDDA), in 2016, around 150,943 high-risk opioid users were reported in Germany and around 330,445 were reported in the U.K.

Furthermore, initiatives by various government and private organizations to increase access of naloxone product among the population is also expected to drive market growth. For instance, in 2015, Kaleo, Inc. partnered with the Clinton Foundation and provided bulk discounts on its EVZIO to various college universities and public safety organizations.

Key features of the study:

  • This report provides in-depth analysis of naloxone market and provides market size (US$ Million) and Compound Annual Growth Rate (CAGR %) for the forecast period (2018 – 2026), considering 2017, as the base year
  • It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, regional outlook, and competitive strategy adopted by leading players
  • It profiles leading players in the global naloxone market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments, and strategies, and future plans
  • Key companies covered as a part of this study 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.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decision regarding their future product launches, technology up-gradation, market expansion, and marketing tactics
  • The global naloxone market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through the various strategy matrices used in analyzing the naloxone market

Detailed Segmentation:

  • Global Naloxone Market, By Strength:
    • 0.4 mg/ml
    • 1mg/ml
    • 0.4mg/0.4ml
    • 4mg/0.1ml and Others
  • Global Naloxone Market, By Drug Type:
    • Intranasal
    • Intramuscular/Subcutaneous
    • Intravenous
  • Global Naloxone Market, By Distribution Channel:
    • Hospitals
    • Clinics
    • Retail Pharmacies
    • Online Pharmacies
    • Others
  • Global Naloxone Market, By Geography:
    • North America
      • By Strength:
        • 0.4 mg/ml
        • 1mg/ml
        • 0.4mg/0.4ml
        • 4mg/0.1ml and Others
      • By Drug Type:
        • Intranasal
        • Intramuscular/Subcutaneous
        • Intravenous
      • By Distribution Channel:
        • Hospitals
        • Clinics
        • Retail Pharmacies
        • Online Pharmacies
        • Others
      • By Country:
        • U.S.
        • Canada
    • Europe
      • By Strength:
        • 0.4 mg/ml
        • 1mg/ml
        • 0.4mg/0.4ml
        • 4mg/0.1ml and Others
      • By Drug Type:
        • Intranasal
        • Intramuscular/Subcutaneous
        • Intravenous
      • By Distribution Channel:
        • Hospitals
        • Clinics
        • Retail Pharmacies
        • Online Pharmacies
        • Others
      • By Country:
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Strength:
        • 0.4 mg/ml
        • 1mg/ml
        • 0.4mg/0.4ml
        • 4mg/0.1ml and Others
      • By Drug Type:
        • Intranasal
        • Intramuscular/Subcutaneous
        • Intravenous
      • By Distribution Channel:
        • Hospitals
        • Clinics
        • Retail Pharmacies
        • Online Pharmacies
        • Others
      • By Country:
        • China
        • India
        • Japan
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • By Strength:
        • 0.4 mg/ml
        • 1mg/ml
        • 0.4mg/0.4ml
        • 4mg/0.1ml and Others
      • By Drug Type:
        • Intranasal
        • Intramuscular/Subcutaneous
        • Intravenous
      • By Distribution Channel:
        • Hospitals
        • Clinics
        • Retail Pharmacies
        • Online Pharmacies
        • Others
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Middle East
      • By Strength:
        • 0.4 mg/ml
        • 1mg/ml
        • 0.4mg/0.4ml
        • 4mg/0.1ml and Others
      • By Drug Type:
        • Intranasal
        • Intramuscular/Subcutaneous
        • Intravenous
      • By Distribution Channel:
        • Hospitals
        • Clinics
        • Retail Pharmacies
        • Online Pharmacies
        • Others
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Strength:
        • 0.4 mg/ml
        • 1mg/ml
        • 0.4mg/0.4ml
        • 4mg/0.1ml and Others
      • By Drug Type:
        • Intranasal
        • Intramuscular/Subcutaneous
        • Intravenous
      • By Distribution Channel:
        • Hospitals
        • Clinics
        • Retail Pharmacies
        • Online Pharmacies
        • Others
      • By Country:
        • Central Africa
        • South Africa
        • North Africa
  • Company Profiles
    • Mylan N.V.*
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Key Strategies
      • Recent Developments
    • Novartis AG
    • Indivior Plc.
    • Adapt Pharma, Inc.
    • Amphastar Pharmaceuticals, Inc.
    • INSYS Therapeutics, Inc.
    • Mundipharma International Limited
    • Kaleo, Inc.
    • Kern Pharma, S.L.

 “*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objective and Assumption
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Strength
      • Market Snippet, By Route of Administration
      • Market Snippet, By Distribution Channel
      • Market Snippet, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Product Approvals/Launch
    • Pipeline Analysis
    • Regulatory Scenario
    • Reimbursement Scenario
    • Dosage Variation
    • Pricing Analysis
    • Supply Chain Analysis
  4. Global Naloxone Market, By Strength, 2016 – 2026 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017–2026
      • Segment Trends
    • 0.4 mg/ml
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • 1mg/ml
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • 0.4mg/0.4ml
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • 4mg/0.1ml and Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
  5. Global Naloxone Market, By Route of Administration, 2016 – 2026 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017–2026
      • Segment Trends
    • Intranasal
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Intramuscular/Subcutaneous
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Intravenous
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
  6. Global Naloxone Market, By Distribution Channel, 2016 – 2026 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017–2026
      • Segment Trends
    • Hospitals
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Clinics
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Retail Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Online Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Mn)
  7. Global Naloxone Market, By Region, 2016 – 2026 (US$ Mn)
    • Introduction
      • Market Share Analysis, By Region, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, For Regions, 2017–2026
    • North America
      • Market Size and Forecast, By Strength, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Route of Administration, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026 (US$ Mn)
        • U.S.
        • Canada
    • Europe
      • Market Size and Forecast, By Strength, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Route of Administration, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026 (US$ Mn)
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Strength, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Route of Administration, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026 (US$ Mn)
        • China
        • India
        • Japan
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • Market Size and Forecast, By Strength, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Route of Administration, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026 (US$ Mn)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Africa
      • Market Size and Forecast, By Strength, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Route of Administration, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026 (US$ Mn)
        • Central Africa
        • South Africa
        • North Africa
    • Middle East
      • Market Size and Forecast, By Strength, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Route of Administration, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Distribution Channel, 2016 – 2026 (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2026 (US$ Mn)
        • GCC
        • Israel
        • Rest of Middle East
  8. Competitive Landscape
    • Heat Map Analysis
    • Company Profiles
      • Mylan N.V.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Novartis AG
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Indivior Plc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Adapt Pharma, Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Amphastar Pharmaceuticals, Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • INSYS Therapeutics, Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Mundipharma International Limited
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Kaleo, Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Kern Pharma, S.L.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
  9. Section
    • References
    • Research Methodology
    • About us and Sales Contact

*Browse 47 market data tables and 33 figures on “Naloxone Market - Global forecast to 2025”.

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