Naloxone Market Analysis | CMI

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NALOXONE MARKET ANALYSIS

• 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
• 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).

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• 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.

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Figure 1. Global Naloxone Market Share (), By
Strength, 20182026
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• 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.

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Figure 2. Global Naloxone Market Share (), By
Region, 2026
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• 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 states Medicaid program began
  to cover the intramuscular formulation of
  take?home naloxone.

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Market Segment

• 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.

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• 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

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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.

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Key Players

• 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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