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  • Published In : Mar 2024
  • Code : CMI1804
  • Pages :199
  • Formats :
      Excel and PDF
  • Industry : Pharmaceutical

Market Size and Trends

The naloxone market is estimated to be valued at USD 1,341.5 Mn in 2024 and is expected to reach USD 2,683.9 Mn by 2031, growing at a compound annual growth rate (CAGR) of 10.4% from 2024 to 2031.

Naloxone Market Key Factors

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The demand for naloxone is expected to rise significantly during the forecast period owing to the increasing prevalence of opioid overdose cases across the world. With rising opioid misuse worldwide due to increased opioid prescriptions for chronic pain management, the cases of opioid overdoses have surged. Naloxone acts as an antidote to reverse opioid overdose and save lives. Favorable government policies and programs aimed at increasing public awareness and availability of naloxone are also expected to boost the market growth during the analysis period.

Increasing dependency on drugs and opioids overdose

For instance, according to the data published by the World Health Organization (WHO) in August 2021, around 0.5 million deaths are caused by drug use, with more than 30% of these deaths attributed to overdose and more than 70% of these deaths caused due to opioids worldwide. Moreover, according to the data published by the Centers for Disease Control and Prevention, in 2021, around 100,306 drug overdose deaths were reported in U.S. during 12-month period ending in April 2021.

Market Concentration and Competitive Landscape

Naloxone Market Concentration By Players

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Increasing Initiatives by Government and Private Organizations

Various naloxone manufacturers, private organizations, and government organizations are focusing on initiatives to reduce the death rate related to opioids overdose by increasing access to products such as naloxone for the population. For instance, on March 3, 2022, the Delaware Department of Health and Social Services’ Division of Substance Abuse and Mental Health (DSAMH) announced about hosting free monthly naloxone access training for all members of the Delaware state, U.S. This training will include learning about recognizing and responding to an opioid overdose.

Naloxone Market Key Takeaways From Lead Analyst

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Market Challenges: Lack of awareness about opioid overdose

One of the key challenges for the naloxone market is the lack of awareness about opioid overdose and the importance of naloxone use. Many people still view addiction as a moral failing rather than a public health issue. This stigma prevents discussions around naloxone and limits its accessibility. Regaining community trust and changing public perception will take significant educational efforts.

Market Opportunities: Supportive government policies

The ongoing opioid epidemic has shone a light on this issue and helped shift discussions into a healthcare framework. Government policies now encourage naloxone distribution and Good Samaritan laws. This policy support can help the market expand distribution beyond first responders. Rising overdose rates also mean more people may witness an event where naloxone could save a life, increasing willingness to carry it.

Naloxone Market By Strength

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Insights, By Strength: Convenience and precision drive the adoption of higher strength formulations

The strength segment includes 2.0 mg/ml, 1 mg/ml, 0.4 mg/ml, and others. The 2.0 mg/ml segment is anticipated to hold 53.5% of the market share in 2024. Many patients experiencing opioid overdose require immediate emergency treatment, making every second critical. The higher concentration of 2.0 mg/ml allows for a smaller volume of drug to be administered through alternate routes like intranasal or intramuscular injections. This is particularly useful when intravenous access may be difficult or delayed. It also reduces the risk of dosing errors as lesser volume needs to be measured accurately. The more concentrated formulation effectively balances the need for swift reversal of overdose against ensuring the right dose is delivered. Additional training for medical professionals and awareness programs on its safe use have further boosted preference and market position of the 2.0 mg/ml variant.

Insights, By Route of Administration: Injectable route drives adoption in emergency response

The route of administration segment includes intranasal and injectable. Injectable contributes the highest share of the naloxone market and is projected to hold 67.8% of the market share in 2024. The injectable segment holds a dominant share in the naloxone market due to its effectiveness in emergency situations like an opioid overdose. Administering naloxone through an injection allows for higher bioavailability and a quicker onset of action compared to other potential routes of administration. Injectable naloxone provides almost instant drug release into the bloodstream, generally bringing someone back from an overdose within 2 to 8 minutes. With every second being critical during an overdose emergency, injectable drugs that get absorbed and circulated immediately are preferred by medical professionals. The ease of use of intramuscular or subcutaneous injections allows bystanders or first responders to rapidly counteract the effects of opioids before it's too late.

Insights, By Distribution Channel: Accessibility and familiarity boost retail pharmacy dominance

The distribution channel segment includes hospital pharmacies, retail pharmacies, and online pharmacies. Retail pharmacies contribute the highest share of the naloxone market and is projected to hold 39.2% of the market share in 2024. Patients and caregivers frequently choose to fill naloxone prescriptions from retail stores which are widely spread across most communities. This provides them with round-the-clock availability without requiring an appointment or wait time. Retail pharmacies are also where individuals go regularly for other medication needs. Their experience and knowledge of retail outlets instills confidence among consumers for procuring naloxone conveniently. With rising rates of opioid abuse developing into a public health crisis, retail distribution further aids over-the-counter dispensing policies and take-home naloxone programs and training. Wide reimbursement coverage has further cemented retail pharmacies as the most approachable access point for this important rescue medication.

Regional Insights

Naloxone Market Regional Insights

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North America represents the largest market for naloxone globally and is expected to hold 43.8% of the market share in 2024. The growing epidemic of opioid abuse and rising mortality rates has led to increased government focus and policy changes to expand access to naloxone. Several states and municipalities now recommend or require naloxone to be co-prescribed with opioid prescriptions, thus driving up demand. Moreover, most private and public healthcare plans provide coverage for naloxone, making it affordable for users. Leading pharmaceutical manufacturers also have a well-established presence in the U.S. with distribution networks across the supply chain, ensuring wide availability of branded and generic naloxone products.

Europe has emerged as the second major region for naloxone, led by the markets in Germany, France, and the U.K. While the crisis of opioid abuse is not as severe as in North America, many European countries are gradually realizing the therapeutic potential of naloxone in addressing increasing drug overdose cases. Naloxone prescription trends in these countries show faster growth compared to other European markets. Manufacturers have also prioritized these countries and launched localized educational programs to promote off-label use of naloxone by potential first responders like family members. This is positively impacting the accessibility of naloxone nasal sprays and auto-injectors, particularly in community settings. The supportive regulatory environment and nationwide healthcare coverage further support the growth of the naloxone market across major Western European markets.

Market Report Scope

Naloxone Market Report Coverage

Report Coverage Details
Base Year: 2023 Market Size in 2024: US$ 1,341.5 MN
Historical Data for: 2019 To 2023 Forecast Period: 2024 To 2031
Forecast Period 2024 to 2031 CAGR: 10.4% 2031 Value Projection: US$ 2,683.9 MN
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Strength: 2.0 mg/ml, 1 mg/ml, 0.4 mg/ml, Others
  • By Route of Administration: Intranasal, Injectable (Intramuscular, Subcutaneous, Intravenous)
  • By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies 
Companies covered:

EMERGENT, Indivior PLC, Akorn, Inc, Hikma Pharmaceuticals PLC, Viatris Inc., Sandoz, Teva Pharmaceuticals, Amphastar Pharmaceuticals, Inc., Kaleo, Inc., Pfizer Inc., Amneal Pharmaceuticals, Viatris Inc., Somerset Pharma, LLC, Orexo AB, and UCB Pharma

Growth Drivers:
  • Increasing dependency on drugs and opioids overdose
  • Increasing initiatives by government and private organizations
Restraints & Challenges:
  • Lack of awareness about opioid overdose
  • Stringent regulatory approval process

Key Developments

  • In August 2023, Emergent BioSolutions Inc., a multinational specialty biopharmaceutical company, announced that NARCAN Naloxone HCl Nasal Spray 4 mg will be available statewide and online starting in September 2023. The manufacturer's suggested retail price for NARCAN Nasal Spray is USD 44.99 per carton, which equates to around USD 22.50 per dose.
  • On August 30, 2023, Walgreens, a pharmacy store chain in the U.S., announced that over-the-counter (OTC) NARCAN Nasal Spray will be available in Walgreens locations and online beginning September 5, with statewide availability on September 7, 2023.
  • In March 2023, Amneal Pharmaceuticals, Inc., a generics and specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg, a generic version of Narcan used to treat a known or suspected opioid overdose emergency.
  • In December 2021, Sandoz, a global leader in generic and biosimilar medicines, today announced the US launch of its authorized generic version of Narcan (naloxone hydrochloride) Nasal Spray 4mg, which is used to treat opioid overdoses. It is readily available to consumers in the U.S. through retail pharmacies and institutions, including hospitals.
  • *Definition:The naloxone market consists of pharmaceutical products containing naloxone, which is an opioid antagonist used for the complete or partial reversal of opioid overdose. Naloxone products in this market are primarily delivered via injection or nasal spray to rapidly reverse the effects of opioids like heroin, morphine, and oxycodone in case of overdose. Key products in the naloxone market include EVZIO, Narcan Nasal Spray, and various generic naloxone injection formulations.

Market Segmentation

  • Strength Insights (Revenue, USD MN, 2019 - 2031)
    • 2.0 mg/ml
    • 1 mg/ml
    • 0.4 mg/ml
    • Others
  •  Route of Administration Insights (Revenue, USD MN, 2019 - 2031)
    • Intranasal
    • Injectable
      • Intramuscular
      • Subcutaneous
      • Intravenous
  •  Distribution Channel Insights (Revenue, USD MN, 2019 - 2031)
    • Hospital Pharmacies
    • Retail Pharmacies
    • Online Pharmacies
  • Regional Insights (Revenue, USD MN, 2019 - 2031)
    • North America
      • U.S.
      • Canada
    • Latin America
      • Brazil
      • Argentina
      • Mexico
      • Rest of Latin America
    • Europe
      • Germany
      • U.K.
      • Spain
      • France
      • Italy
      • Russia
      • Rest of Europe
    • Asia Pacific
      • China
      • India
      • Japan
      • Australia
      • South Korea
      • ASEAN
      • Rest of Asia Pacific
    • Middle East
      • GCC Countries
      • Israel
      • Rest of Middle East
    • Africa
      • South Africa
      • North Africa
      • Central Africa
  • Key Players Insights
    • Indivior PLC
    • Akorn, Inc
    • Hikma Pharmaceuticals PLC
    • Viatris Inc.
    • Sandoz
    • Teva Pharmaceuticals
    • Amphastar Pharmaceuticals, Inc.
    • Kaleo, Inc.
    • Pfizer Inc.
    • Amneal Pharmaceuticals
    • Viatris Inc.
    • Somerset Pharma, LLC
    • Orexo AB
    • UCB Pharma

Frequently Asked Questions

The CAGR of the naloxone market is projected to be 10.4% from 2024 to 2031.

Increasing dependency on drugs and opioids overdose and increasing initiatives by government and private organizations are the major factors driving the growth of the naloxone market.

Lack of awareness about opioid overdose and stringent regulatory approval process are the major factors hampering the growth of the naloxone market.

In terms of strength, 2.0 mg/ml is estimated to dominate the market revenue share in 2024.

EMERGENT, Indivior PLC, Akorn, Inc, Hikma Pharmaceuticals PLC, Viatris Inc., Sandoz, Teva Pharmaceuticals, Amphastar Pharmaceuticals, Inc., Kaleo, Inc., Pfizer Inc., Amneal Pharmaceuticals, Viatris Inc., Somerset Pharma, LLC, Orexo AB, and UCB Pharma are the major players.

North America is expected to lead the naloxone market.

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