Naloxone Market 2019 | Emerging Growth by Top Players Mylan N.V., Novartis AG, Indivior Plc., ADAPT Pharma, Inc., Amphastar Pharmaceuticals, Inc., INSYS Therapeutics, Inc., Mundipharma International Limited, Kaleo, Inc., and Kern Pharma

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.

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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.

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.

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.

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).

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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.

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