Opioid Use Disorder Market

• The Opioid Use Disorder Market Size in the 7MM was around USD 2,000 million in 2023. The market is anticipated to witness a substantial positive shift owing to better uptake of existing drugs and raised awareness.
• In 2023, the United States accounted for the largest Opioid Use Disorder Market Size (around USD 1,400 million) of Opioid Use Disorder, in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• Opioid Use Disorder is characterized by chronic opioid use causing distress or impairment, including intense cravings, increased tolerance, and withdrawal symptoms upon cessation. It encompasses dependence and addiction and can lead to severe consequences like disability or death.
• As per DelveInsight’s estimates, the total Opioid Use Disorder prevalent cases were around 4,000,000 in 2023 in the seven major markets (7MM), and more than 50% of these cases were found in the US.
• Currently, the US FDA-approved medications indicated for the Opioid Use Disorder treatment include buprenorphine, methadone, and naltrexone.
• The leading Opioid Use Disorder companies such as Indivior PLC, Alkermes, Orexo AB, Titan Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., Mallinckrodt Pharmaceuticals, BioDelivery Sciences International Inc., Viatris Inc., Pfizer, Inc., Hikma Pharmaceuticals PLC, Camurus, and others are developing therapies for Opioid Use Disorder treatment.
• In March 2023, the FDA approved BRIXADI for treating moderate to severe opioid use disorder. It comes in weekly and monthly injections, suitable for patients already on buprenorphine treatment.
• Epidemiological and clinical studies have shown that opioid use disorders are highly comorbid with psychiatric disorders, including anxiety, depression, bipolar disorder, attention-deficit hyperactivity disorder, borderline personality disorder, antisocial personality disorder, and schizophrenia. Therefore, there is a need of looking at patients with substance use disorders from a more holistic perspective and address any mental illnesses they may suffer from.
• In February 2025, Indivior announced that the FDA approved label changes for SUBLOCADE® injection, a treatment for moderate to severe Opioid Use Disorder. The updates include a rapid initiation protocol reducing treatment time from one week to one hour and alternative injection sites to improve flexibility and patient adherence.
• In November 2024, SOLVD Health, a patient intelligence company focused on precision solutions for better health outcomes, announced that it has received U.S. Food and Drug Administration (FDA) PMA supplement approval for its INFINITI High Throughput System (HTS) to be used with AvertD®.

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DelveInsight's “Opioid Use Disorder Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of Opioid Use Disorder, historical and forecasted epidemiology as well as the Opioid Use Disorder therapeutics market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Opioid Use Disorder Treatment Market Report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Opioid Use Disorder market size from 2020 to 2034. The report also covers current Opioid Use Disorder treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Opioid Use Disorder Treatment Market

Opioid Use Disorder Overview, Country-Specific Treatment Guidelines and Diagnosis

Opioid addiction involves a mix of genetic and environmental factors. Non-genetic influences like substance abuse history, psychiatric disorders, childhood trauma, and certain personality traits (like impulsivity) significantly contribute to addiction risk.

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) introduced the term "opioid use disorder" to replace "opioid abuse" and "opioid dependence." It lists 11 main symptoms to diagnose the disorder and assesses its severity based on the number of recurring symptoms within a year.

Further details related to country-based variations in diagnosis are provided in the report...

Opioid Use Disorder Treatment

Medication treatment of Opioid Use Disorder has been associated with reduced overdose and overall mortality. FDA-approved medications indicated for the treatment of Opioid Use Disorder include buprenorphine, methadone, and naltrexone. Clinicians should offer or arrange treatment with evidence-based medications to treat patients with Opioid Use Disorder, particularly if moderate or severe. Clinicians unable to provide treatment themselves should arrange for patients with Opioid Use Disorder to receive care from a substance use disorder treatment specialist, such as an office-based buprenorphine or naltrexone treatment provider, or from an opioid treatment program certified by Substance Abuse and Mental Health Services Administration (SAMHSA) to provide methadone or buprenorphine for patients with Opioid Use Disorder. Ongoing opioid use disorder clinical trials are exploring innovative treatments aimed at reducing dependence, improving patient outcomes, and preventing relapse, offering hope for more effective long-term recovery strategies.

Opioid Use Disorder Epidemiology

The Opioid Use Disorder epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The Opioid Use Disorder epidemiology is segmented with detailed insights into Total Prevalent Cases, Gender-specific Cases, Age-specific Cases, and Severity-specific Cases of Opioid Use Disorder.

• As per DelveInsight’s estimates, the total Opioid Use Disorder prevalent population in the US was more than 2,100,000 in 2023.
• Opioid Use Disorder was more common in males compared to females across the 7MM.
• Most cases of Opioid Use Disorder are found in the age group of 18 to 25 years, followed by 26 or older years.
• The Opioid Use Disorder prevalent population in EU4 and the UK was ~1,440,000 cases in 2023 and the highest prevalent population was accounted by Germany.

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Opioid Use Disorder Recent Developments

• In February 2025, Indivior announced that the FDA approved label changes for SUBLOCADE® injection, a treatment for moderate to severe Opioid Use Disorder. The updates include a rapid initiation protocol reducing treatment time from one week to one hour and alternative injection sites to improve flexibility and patient adherence.
• On November 12, 2024, SOLVD Health, a patient intelligence company focused on precision solutions for better health outcomes, announced that it has received U.S. Food and Drug Administration (FDA) PMA supplement approval for its INFINITI High Throughput System (HTS) to be used with AvertD®.

Opioid Use Disorder Drugs Chapters

The drug chapter segment of the Opioid Use Disorder Drugs Market Report encloses a detailed analysis of Opioid Use Disorder marketed drugs and late-stage (Phase III and Phase II) Opioid Use Disorder pipeline drugs analysis. It also deep dives into the Opioid Use Disorder pivotal clinical trials details, recent and expected market approvals, patent details, the latest Opioid Use Disorder news, and recent deals and collaborations. The Opioid Use Disorder drugs market is witnessing significant growth due to rising addiction rates, increasing awareness, and the development of innovative therapies aimed at improving long-term recovery outcomes.

Opioid Use Disorder Marketed Drugs

• BRIXADI (buprenorphine): Braeburn Pharmaceuticals

BRIXADI contains buprenorphine, a partial opioid agonist. It is prescribed for moderate to severe opioid addiction in individuals who have initiated treatment with buprenorphine or are already undergoing buprenorphine therapy. It's an integral part of a comprehensive treatment plan that includes counseling and behavioral therapy.

BRIXADI is approved in both weekly and monthly subcutaneous injectable formulations at varying doses, including lower doses that may be appropriate for those who do not tolerate higher doses of extended-release buprenorphine that are currently available. The weekly doses are 8 milligrams (mg), 16 mg, 24 mg, 32 mg; and the monthly doses are 64 mg, 96 mg, and 128 mg.

• SUBLOCADE (buprenorphine): Indivior

SUBLOCADE, a partial opioid agonist, and is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine‐containing product, followed by dose adjustment for a minimum of 7 days. SUBLOCADE should be part of a complete treatment program that includes counseling and psychosocial support.

Note: Detailed current therapies assessment will be provided in the full report of Opioid Use Disorder...

Opioid Use Disorder Emerging Drugs

• BXCL501: BioXcel Therapeutics

BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of agitation and opioid withdrawal symptoms. BioXcel believes that BXCL501 potentially targets a causal agitation mechanism, and the company has observed anti-agitation results in multiple clinical studies across several neuropsychiatric disorders.

The drug is in Phase Ib/II trial assessing safety, pharmacokinetics, tolerability, and efficacy by administering it twice daily for seven days to patients with opioid withdrawal symptoms.

Opioid Use Disorder Market Outlook

Key players, such as Braeburn Pharmaceuticals, Alkermes, Camurus and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Opioid Use Disorder.

• The highest market revenue was generated by the Buprenorphine in 7MM ~84% of total in 2023.
• Among the 7MM, the United States had the highest market share of Opioid Use Disorder in 2023, which accounted for approximately 67% of the total 7MM market.
• Among the 7MM, EU4 and the UK, France had the highest market share of Opioid Use Disorder in 2023.
• The total market size of Opioid Use Disorder in EU4 and the UK was more than USD 500 million in 2023.

Opioid Use Disorder Drugs Uptake

This section focuses on the uptake rate of potential Opioid Use Disorder drugs analysis expected to be launched in the Opioid Use Disorder drugs market during 2024–2034, which depends on the Opioid Use Disorder competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Further detailed analysis of emerging therapies drug uptake in the report...

Opioid Use Disorder Pipeline Development Activities

The Opioid Use Disorder pipeline report provides insights into different Opioid Use Disorder clinical trials within Phase III and Phase II stages. It also analyzes key Opioid Use Disorder Companies involved in developing targeted therapeutics.

Opioid Use Disorder Pipeline Development Activities

The Opioid Use Disorder clinical trilas analysis report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Opioid Use Disorder emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.

DelveInsight’s analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as Dokkyo Medical University, New York University School of Medicine, Boston University School of Medicine, etc., were contacted. Their opinion helps understand and validate current and emerging treatment patterns of Opioid Use Disorder. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the Opioid Use Disorder therapeutics market and the Opioid Use Disorder unmet needs.

Opioid Use Disorder Therapeutics Market: Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in Opioid Use Disorder, one of the most important primary outcome measures is Treatment-emergent adverse events (TEAEs).

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Opioid Use Disorder Therapeutics Market Access and Reimbursement

Reimbursement of rare disease therapies can be limited due to lack of supporting policies and funding, challenges of high prices, lack of specific approaches to evaluating rare disease drugs given limited evidence, and payers’ concerns about budget impact. The high cost of rare disease Opioid Use Disorder drugs usually has a limited effect on the budget due to the small number of eligible patients being prescribed the drug. The US FDA has approved several rare disease therapies in recent years. From a patient perspective, health insurance and payer coverage guidelines surrounding rare disease treatments restrict broad access to these treatments, leaving only a small number of patients who can bypass insurance and pay for products independently.

The Opioid Use Disorder therapeutics market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Opioid Use Disorder Treatment Market Report 

• The Opioid Use Disorder treatment market report covers a segment of key events, an executive summary, descriptive overview, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country specific treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current Opioid Use Disorder treatment market landscape.
• A detailed review of the Opioid Use Disorder treatment market, historical and forecasted Opioid Use Disorder treatment market size, Opioid Use Disorder market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The Opioid Use Disorder treatment market report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Opioid Use Disorder drugs market.

Opioid Use Disorder Treatment Market Report Insights

• Patient-based Opioid Use Disorder Market Forecasting
• Opioid Use Disorder Therapeutic Approaches
• Opioid Use Disorder Pipeline Drugs Analysis
• Opioid Use Disorder Market Size and Trends
• Existing and future Opioid Use Disorder Drugs Market Opportunity

Opioid Use Disorder Treatment Market Report Key Strengths

• 11 Years Opioid Use Disorder Market Forecast
• 7MM Coverage
• Opioid Use Disorder Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL’s feedback on approved and emerging therapies
• Key Cross Competition
• Conjoint analysis
• Opioid Use Disorder Drugs Uptake
• Key Opioid Use Disorder Market Forecast Assumptions

Opioid Use Disorder Treatment Market Report Assessment

• Current Opioid Use Disorder Treatment Market Practices
• Opioid Use Disorder Unmet Needs
• Opioid Use Disorder Pipeline Product Profiles
• Opioid Use Disorder Drugs Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)
• Opioid Use Disorder Market Drivers
• Opioid Use Disorder Market Barriers

FAQs

• What is the growth rate of the 7MM Opioid Use Disorder treatment market?
• What was the Opioid Use Disorder treatment market size, the Opioid Use Disorder market size by therapies, Opioid Use Disorder market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the Opioid Use Disorder market dynamics and subsequent analysis of the associated trends? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
• What are the current and emerging options for the treatment of Opioid Use Disorder?
• How many Opioid Use Disorder Companies are developing therapies for the Opioid Use Disorder treatment?
• What are the recent novel therapies, targets, Opioid Use Disorder mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to Buy Opioid Use Disorder Market Forecast Report

• The Opioid Use Disorder Therapeutics Market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Opioid Use Disorder Drugs Market.
• Insights on patient burden/disease Opioid Use Disorder Prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing Opioid Use Disorder Drugs Market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the Opioid Use Disorder Market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing Opioid Use Disorder Drugs Market so that the upcoming players can strengthen their development and launch strategy.

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