Naloxone Market - Opportunities, Challenges Mylan N.V., Novartis AG, Indivior, ADAPT Pharma, Amphastar Pharmaceuticals, INSYS

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.

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).

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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.

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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