Naloxone Market Booming Worldwide Report 2021 | Mylan N.V., Novartis AG, Indivior, ADAPT Pharma

SEATTLE, UNITED STATES, UNITED STATES, December 6, 2021 /EINPresswire.com/ -- Naloxone is the medication mainly used for reversing opioid overdose including heroine and morphine. Naloxone is the opioid antagonist, where the U.S. Food and Drug Administration (FDA) lists it under the prescription drugs, however some countries including Australia and Italy have rescheduled it for an over-the-counter (OTC) medicine. Products of naloxone are accessible in several strengths. Presently, the available naloxone strengths include 1mg/ml, 0.4mg/ml, 4mg/0.1ml, 0.4mg/0.4ml, and others. Naloxone is administrated through several routes including intranasal, intravenous, and intramuscular/subcutaneous. Intranasal products of naloxone are the newest products in market that could be given by any person (non-medical professionals). However, the intravenous product is administrated mainly by medical professionals who are trained properly.

The global naloxone market size accounted for US$ 310.2 Mn in 2020, and is projected to exhibit an 11.4% CAGR from 2021 – 2028.

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Major players functioning in the global naloxone market are Mylan N.V., Indivior Plc., Novartis AG, ADAPT Pharma, Inc., INSYS Therapeutics, Inc., Amphastar Pharmaceuticals, Inc., Mundipharma International Limited, Kern Pharma, S.L., and Kaleo, Inc.

Increasing approvals and launches of novel products of naloxone by several regulatory bodies is a key factor expected to fuel growth of the global naloxone market during the forecast period. For instance, the U.S. Food and Drug Administration (FDA), in January 2017, approved NARCAN Nasal Spray 2 mg formulation by Adapt Pharma Inc. for the emergency treatments of suspected or known opioid overdose. Mylan N.V., in 2016, introduced its injection of naloxone hydrochloride- USP, 0.4 mg/mL packaged in single-dose vials of 1 mL. Its equivalent therapeutically with the of Hospira Inc.’s naloxone hydrochloride injection 0.4 mg/mL. Mundipharma International Limited, in September 2017, received the European Medicines Agency’s (EMA) approval for its intranasal naloxone 1.8 mg product for usage in opioid overdose’s emergency reversal.

Increasing opioid overdose cases is expected to raise demand for products of naloxone through emergency treatments, in turn expected to drive growth in the global naloxone market over the forecast period. For instance, as per the 2016 published data from the U.S. Department of Health and Human Services (HHS), over 11.5 million individuals misuse the prescription drugs, over 948,000 individuals using heroin. As per the 2018 published data by National Institute on Drug Abuse, in the U.S., around 115 individuals die daily owing to overdose of opioid. As per the same source, opioid overdose in the U.S. raised by 30 % between July 2016 and September 2017 within 52 areas of 45 states.

Drug reimbursement scenarios play a key role in adoption of expensive products in developed countries including Europe and North America. Hence, favorable reimbursements for products of naloxone is expected to fuel the adoption for these products. Presently, most insurance cover for naloxone is provided at healthcare facilities.

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Moreover, certain states of the U.S. have begun to cover take-home naloxone. Therefore, take-home naloxone’s adoption is expected to rise in the near future. For instance, within the state of New York since January 2014, the Medicaid program of state began covering the take-home naloxone’s intramuscular formulation.

North America is expected to account for the highest share in the global naloxone market over the forecast period due to presence of unique naloxone products including EVZIO (naloxone hydrochloride injection) and Narcan nasal spray, which is not yet present in any another region. Moreover, initiatives by several organizations and companies for increasing naloxone access is expected to drive growth of the global naloxone market in the near future. For instance, Loyola Medicine along with the Cook County Department of Homeland Security and Emergency Management collaborated in February 2018, where police officials were trained by Loyola Medicine for using Narcan in opioids overdose cases. Adapt Pharma Limited, in 2016, entered a partnership with Smith Medical Partners, LLC to distribute free Narcan (Naloxone HCl) nasal spray within every high school of the U.S.

Europe is expected to witness robust growth in the global naloxone market, owing to rising novel naloxone product approvals in this region. For instance, Indivior Inc., in July 2017, an Indivior Plc.’ subsidiary, received the marketing authorization (MA) by French Regulatory Agency ANSM for the novel Nalscue naloxone hydrochloride nasal spray suggested for suspected or characterized opioid overdose emergency treatment within France.

Regulatory Scenario

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Therapeutic Goods Administration (TGA), in 2016, placed naloxone over Schedule 3 when utilized for the opioid overdose treatment, thus enabling the naloxone purchase over-the-counter (OTC) in Australia.

Within Europe, various countries enable take-home naloxone owing to high opioid overdose rate within this region. Presently, naloxone programs of take-home exists in 7 European nations— Denmark, Germany, Italy, Estonia, Norway, Spain, along with the U.K. (EMCDDA, 2015c).

As per the Regulatory Affairs Professional Society published data, naloxone is yet to receive approval from the U.S. Food and Drug Administration as a drug of over-the-counter (OTC). However, certain organizations including Walgreens pharmacies are offering of products naloxone over-the-counter in around 5,800 of the 8,200 stores for increasing the naloxone access.

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