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  • Published On : Mar 2022
  • Code : CMI4953
  • Industry : Pharmaceutical
  • Pages : 198
  • Formats :

Naloxone is an opioid overdose reversal medicine used to treat morphine and heroin overdoses. It is an opioid antagonist that is classified as a prescription medicine by the U.S. Food and Drug Administration (FDA). Some countries, including Italy and Australia, have reclassified it as an over-the-counter (OTC) drug. Naloxone products are available in a variety of strengths such as 0.4 mg/ml, 1 mg/ml, 0.4 mg/0.4 ml, and 4 mg/0.1 ml. Naloxone is administered in a variety of ways including intranasal, intramuscular, subcutaneous, and intravenous. The most recent medicine in the market is intranasal naloxone product, which can be administered by anyone (non-medical professional). Intravenous products, on the other hand, are mostly administered by trained medical experts.

The U.S. naloxone market is estimated to be valued at US$ 1,390.7 million in 2022 and is expected to exhibit a CAGR of 10.2% during the forecast period (2022-2030).

Figure 1. U.S. Naloxone Market Share in Terms of Value (US$ Mn), By Drug Type, 2022

U.S. Naloxone  | Coherent Market Insights

Increasing product launches in the U.S. is expected to drive the market growth over the forecast period.

The increasing product launches by market players in the country is expected to drive the U.S. naloxone market over the forecast period. For instance, on February 20, 2019, Indivior Plc., a pharmaceutical company announced the launch of Suboxone (buprenorphine and naloxone) sublingual film authorized generic by the U.S. Food and Drug Administration (FDA). The authorized generic is being marketed and distributed on Indivior’s as a representative by Sandoz Inc., a Switzerland based healthcare company has introduced suboxone film is a prescribed medicine indicated for the treatment of opioid dependence and as it is prescribed medicine, it should be used as part of a complete treatment plan to include counseling and psychosocial support.

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U.S. Naloxone Market Report Coverage

Report Coverage Details
Base Year: 2021 Market Size in 2022:

US$ 1,390.7 Mn

Historical Data for: 2017 to 2020 Forecast Period: 2022 to 2030
Forecast Period 2022 to 2030 CAGR: 10.2% 2030 Value Projection:

US$ 2,909.1 Mn

Geographies covered:
  • Region: North America: U.S. 
Segments covered:
  • By Drug Type: Branded, Generic
  • By Route of Administration: Intranasal Administration, Intramuscular Administration, Intravenous Administration, Others
  • By Distribution Channel: Hospitals Pharmacies, Retail Pharmacies, Online Pharmacies
Companies covered:

Mylan N.V., Novartis AG, Indivior Plc., ADAPT Pharma, Inc., Amphastar Pharmaceuticals, Inc., INSYS Therapeutics, Inc., Mundipharma International Limited, Kaleo, Inc.,  Kern Pharma, S.L., Samarth Life Sciences Pvt. Ltd., Opiant Pharmaceuticals, Pfizer, Sandoz, and Amneal Pharmaceuticals 

Growth Drivers:
  • Increasing product launches in U.S.
  • Increasing cases of opioid overdose
Restraints & Challenges:
  • Side effects of naloxone

Figure 2. U.S. Naloxone Market Share (%), By Route of Administration, 2022

U.S. Naloxone  | Coherent Market Insights

Increasing cases of opioid overdose in the U.S. is expected to drive demand for its treatment drugs during the forecast period.

Increasing cases of opioid overdose is expected to drive the demand for naloxone products during emergency treatments for treating narcotic overdose, during the forecast period. For instance, according to the data published by the U.S. Department of Health and Human Services (HHS) in 2019, U.S. population around 3.7% i.e. approximately 10.1 million people aged 12 or older misused opioids in the year 2019 and specifically 9.7 million people aged 12 or older misused prescription pain relievers in the year 2019.

U.S. Naloxone Market – Impact of Coronavirus (COVID-19) Pandemic

The COVID-19 pandemic is expected to drive growth of the U.S. naloxone market during the forecast period. According to the Coronavirus Disease (COVID-19), Weekly Epidemiological Update by the World Health Organization, over 5,899,578 cases and 11,946 deaths due to coronavirus disease (COVID-19) were reported till February 23, 2022 across the U.S.

Furthermore, increasing opioid cases in the U.S. during the pandemic is expected to drive the U.S. naloxone market over the forecast period According to the article published in National Center for Biotechnology Information (NCBI) about increases in naloxone administrations by Emergency Medical Services Providers during the COVID-19 Pandemic, in May 2021, the opioid crisis in the U.S. may be exacerbated by the COVID-19 pandemic. Increase in opioid use, emergency medical services (EMS) running for opioid-related overdoses, and opioid overdose deaths have been reported in year 2021.

U.S. Naloxone Market: Restraint

The side effects of naloxone is expected to hinder the U.S. naloxone market growth in the near future. For instance, according to Drug.com, naloxone has some adverse effects that include nausea, vomiting, stomach discomfort, fever, sweating, and body aches.

Key Players

Major players operating in the U.S. naloxone include Mylan N.V., Novartis AG, Indivior Plc., ADAPT Pharma, Inc., Amphastar Pharmaceuticals, Inc., INSYS Therapeutics, Inc., Mundipharma International Limited, Kaleo, Inc., Kern Pharma, S.L., Samarth Life Sciences Pvt. Ltd., Opiant Pharmaceuticals, Pfizer, Sandoz, and Amneal Pharmaceuticals.

Naloxone is an opioid overdose reversal drug that has been licenced by the U.S. Food and Drug Administration (FDA). It is an opioid antagonist, which means it attaches to opioid receptors and can counteract and prevent the effects of opioids such as heroin, morphine, and oxycodone. Intranasal spray (into the nose), intramuscular (into the muscle), subcutaneous (under the skin), and intravenous injection are all options for administering the medicine. Naloxone is widely available over the counter at pharmacies in the U.S. as it is not prescribed medicine. Naloxone can also be obtained for free from community-based distribution initiatives, local public health groups, or local health departments.

Market Dynamics

Key players in the market are focused on adopting strategies such as partnerships, acquisitions, and programs to expand their product portfolio which is expected to drive the market growth. For instance, on October 22, 2021, Hikma Pharmaceuticals PLC, a multinational pharmaceutical company, announced the donation of 50,000 vials of Naloxone HCl Injection, USP – a treatment for reversing opioid overdoses to members of the Opioid Safety and Naloxone Network (OSNN) Buyers Club to help ease an acute shortage of the medicine currently facing non-profit harm-reduction programs which includes treatments for HIV, hepatitis C virus (HCV), HBV counseling and testing, and naloxone for overdose in the U.S. the Opioid Safety and Naloxone Network (OSNN) is a network of over 100 harm-reduction programs in the U.S that distribute naloxone to drug users and their families. Some of its member programs have been participating in community naloxone distribution for over 20 years. Hikma's donation will come from its state-of-the-art sterile injectable manufacturing facility in Cherry Hill, New Jersey, and will be made in collaboration with Hikma Community Health, a new division of Hikma dedicated to providing a variety of treatment options for substance use disorder and opioid overdose in the U.S.

Key features of the study:

  • This report provides an in-depth analysis of the U.S. Naloxone market, and provides market size (US$ Mn) and compound annual growth rate (CAGR%) for the forecast period (2022–2030), considering 2021 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends,  regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the U.S. Naloxone market based on the following parameters – company highlights, products portfolio, key highlights, financial performance, strategies
  • 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.,  Kern Pharma, S.L., Samarth Life Sciences Pvt. Ltd., Opiant Pharmaceuticals, Pfizer, Sandoz, and Amneal Pharmaceuticals
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
  • The U.S. Naloxone market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have an ease in decision-making through various strategy matrices used in analyzing the U.S. Naloxone market

Detailed Segmentation:

  • U.S. Naloxone Market, By Drug Type:
    • Branded
    • Generic
  • U.S. Naloxone Market, By Route of Administration:
    • Intranasal Administration
    • Intramuscular Administration
    • Intravenous Administration
    • Others
  • U.S. Naloxone Market, By Distribution Channel:
    • Hospitals Pharmacies
    • Retail Pharmacies
    • Online Pharmacies  
  • Company Profiles
    • Mylan N.V. *
      • Company Highlights
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Novartis AG
    • Indivior Plc.
    • ADAPT Pharma, Inc.
    • Amphastar Pharmaceuticals, Inc.
    • INSYS Therapeutics, Inc.
    • Mundipharma International Limited
    • Kaleo, Inc.
    • Kern Pharma, S.L
    • Samarth Life Sciences Pvt. Ltd.
    • Opiant Pharmaceuticals
    • Pfizer
    • Sandoz
    • Amneal Pharmaceuticals

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

Frequently Asked Questions

The U.S. naloxone is estimated to be valued at US$ 1,390.7 million in 2022 and is expected to exhibit a CAGR of 10.2 % between 2022 and 2030.
Increasing product launches in U.S. is expected to drive the market growth during the forecast period.
Generic drug segment is expected to hold a major market share during the forecast period in the drug type segment.
The major factor hampering growth of the market include side effects of naloxone.
Major players operating in the market include Mylan N.V., Novartis AG, Indivior Plc., ADAPT Pharma, Inc., Amphastar Pharmaceuticals, Inc., INSYS Therapeutics, Inc., Mundipharma International Limited, Kaleo, Inc., Kern Pharma, S.L., Samarth Life Sciences Pvt. Ltd., Opiant Pharmaceuticals, Pfizer, Sandoz, and Amneal Pharmaceuticals.

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