Substance Use Disorder Market Summary

• According to the Substance Abuse and Mental Health Services Administration (SAMHSA) 2025 National Survey on Drug Use and Health (NSDUH), Substance Use Disorder represents a substantial and heterogeneous treatment market in the US. In 2025, more than 44 million people aged 12 years and older had a past-year Substance Use Disorder, encompassing both alcohol- and drug-related disorders and providing a sizeable underlying population for treatment interventions.
• Data from the 2025 NSDUH further indicate that pharmacotherapy penetration remains uneven across substance-specific disorders, creating opportunities for greater medication adoption. In 2025, only 2.6% of people with alcohol use disorder (AUD) in the US received medication for AUD, compared with 15.7% of people with Opioid Use Disorder (OUD) receiving medication for OUD. The disparity highlights that the presence of approved pharmacotherapies does not translate uniformly into treatment uptake, particularly in AUD.
• Alcohol Use Disorder prevalence shows a pronounced sex disparity in Japan. A 2025 nationwide survey estimated past-year suspected AUD in 5.4% of men versus 0.8% of women, corresponding to approximately 3 million people nationally, highlighting the substantially higher AUD burden among Japanese men.
• Polysubstance use is outpacing opioid-centric treatment. Medications for OUD (MOUD) addresses only the opioid component of co-use, and no approved therapy exists for stimulant use disorder. Patients stabilized on MOUD therefore stay exposed through continued stimulant use, leaving the stimulant component as the main gap in current care.
• Early alcohol initiation is linked to greater polysubstance use among patients with AUD. A 2026 French analysis found that earlier alcohol onset was associated with higher concurrent opioid and stimulant use, particularly among women, highlighting age at alcohol initiation as an important marker of polysubstance-use risk.
• Commercial performance of leading Opioid Use Disorder therapies indicates strong demand for long-acting treatment options. Indivior reported record SUBLOCADE net revenue of USD 253 million in Q2 2026, representing a 21% year-over-year increase, while H1 2026 revenue reached USD 486 million, up 26% year over year. The company subsequently raised its FY2026 SUBLOCADE revenue guidance to USD 1.01–1.05 billion, highlighting continued commercial expansion of long-acting buprenorphine treatment for OUD.

DelveInsight’s “Substance Use Disorder Market Insights, Epidemiology, and Market Forecast – 2036” report delivers an in-depth understanding of Substance Use Disorder, historical and forecasted epidemiology, as well as the Substance Use Disorder therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

The Substance Use Disorder market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, Substance Use Disorder patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment and growth rate projections (Historical & Forecast 2022–2036) across the 7MM regions. The report highlights key unmet medical needs in Substance Use Disorder and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Substance Use Disorder Disease Understanding

Substance Use Disorder Overview

Substance Use Disorder is characterized by impaired control over psychoactive substance use, increasing priority given to substance use over other activities, and continued use despite harmful consequences. It may involve alcohol, opioids, cannabis, stimulants, sedatives, nicotine, or multiple substances, with clinical manifestations including craving, tolerance, withdrawal, and functional impairment varying by substance and severity.

Substance Use Disorder Diagnosis

Diagnosis is primarily clinical and assesses the pattern, consequences, and degree of control over substance use. The DSM-5-TR uses 11 criteria covering impaired control, social impairment, risky use, and pharmacological features, with Substance Use Disorder severity classified as mild, moderate, or severe based on the number of criteria met. Screening tools such as AUDIT for alcohol use and ASSIST for multiple substances can support identification of problematic substance use and inform further clinical assessment.

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

Current Substance Use Disorder Treatment Landscape

Treatment for Substance Use Disorder varies by the substance involved and generally combines behavioral interventions with pharmacotherapy where evidence-based medications are available. For OUD, methadone, buprenorphine, and naltrexone are established medication options, while AUD has pharmacological options including naltrexone, acamprosate, and disulfiram. Behavioral interventions, including cognitive behavioral therapy and motivational approaches, remain important components of treatment across Substance Use Disorder subtypes.

Despite available therapies, substantial treatment gaps remain across individual Substance Use Disorders. Stimulant use disorder has no FDA-approved pharmacotherapy, with contingency management identified as the current standard of care. Treatment is further complicated by polysubstance use and differences in treatment response across individuals, creating continued demand for therapies with novel mechanisms, improved tolerability, and greater applicability across underserved substance-use populations.

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

Substance Use Disorder Epidemiology

The Substance Use Disorder epidemiology section of the Substance Use Disorder market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader (KOL) views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the prevalence of Substance Use Disorder. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings from Substance Use Disorder Epidemiological Analysis and Forecast

• As per DelveInsight’s estimates, within EU4 and the UK, France recorded the highest diagnosed prevalent Substance Use Disorder population in 2025, with more than 16 million cases, while the UK had the lowest, at approximately 8 million cases.
• According to a 2020 US population-based study, approximately 27.5 million adults reported ever having a substance use problem, with prevalence highest among individuals aged 35–49 years (12.8%), followed by those aged 26–34 years (12.7%), and lowest among those aged 18–25 years (7.2%).
• According to the 2021 German Epidemiological Survey of Substance Abuse, problematic cannabis use affected approximately 1.3 million adults aged 18–64 years in Germany, with prevalence of 3.4% among men versus 1.6% among women, indicating a higher burden of problematic cannabis use among males.
• In 2025, the substance type-specific distribution of diagnosed prevalent Substance Use Disorder cases in Japan was highest for tobacco use disorder (~85%) and lowest for cannabis use disorder (<1%).

Substance Use Disorder Epidemiology Segmentation

• Total Diagnosed Prevalent Cases of SUD
• Substance Type-specific Cases of SUD
• Age-specific Diagnosed Prevalent Cases of SUD
• Gender-specific Diagnosed Prevalent Cases of SUD
• Total Treated Cases of SUD

Substance Use Disorder Drug Analysis & Competitive Landscape

The Substance Use Disorder drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III Substance Use Disorder clinical trials. It covers mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships upcoming key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the Substance Use Disorder treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the Substance Use Disorder therapeutics market.

Approved Therapies for Substance Use Disorder

BRIXADI/BUVIDAL (buprenorphine): Braeburn/Camurus

BRIXADI/BUVIDAL (buprenorphine) is a long-acting injectable formulation of buprenorphine, a partial µ-opioid receptor agonist, designed for the treatment of OUD. By providing sustained buprenorphine exposure through a subcutaneous depot, it helps prevent opioid withdrawal symptoms and reduce the urge to misuse opioids. Its weekly or monthly dosing offers an alternative to daily transmucosal buprenorphine, potentially reducing the burden associated with frequent dosing.

• In May 2023, the US FDA approved BRIXADI (buprenorphine) extended-release injection for the treatment of moderate-to-severe OUD in adults, offering weekly and monthly subcutaneous dosing options.
• In November 2018, the European Commission granted marketing authorization to BUVIDAL (buprenorphine) for the treatment of opioid dependence in adults and adolescents aged 16 years and older, introducing weekly and monthly prolonged-release subcutaneous formulations across the EU.

Note: Detailed marketed therapies assessment will be provided in the final report...

Substance Use Disorder Pipeline Analysis

IGALMI (Dexmedetomidine): BioXcel Therapeutics

BXCL501 (dexmedetomidine) is an investigational, orally dissolving film formulation of the selective a2-adrenergic receptor agonist dexmedetomidine being evaluated for opioid withdrawal in patients with OUD. Its non-opioid mechanism targets a2-adrenergic signaling involved in opioid withdrawal symptoms.

• In March 2026, BioXcel Therapeutics reported positive Phase II results for BXCL501 (dexmedetomidine) in opioid withdrawal among patients with OUD, with the 240 µg twice-daily dose reducing withdrawal symptoms by more than 30% and numerically outperforming lofexidine.

Note: Detailed emerging therapies assessment will be provided in the final report...

Substance Use Disorder Market Outlook

The Substance Use Disorder therapeutics market is further expected to increase by the major drivers, such as the rising prevalence population, technological advancements, and upcoming therapies in the forecast period (2026–2036).

With ongoing research and continued dedication, the future holds hope for effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the Substance Use Disorder market in the 7MM is expected to change significantly during the forecast period 2026-2036.

Substance Use Disorder Market Insights

DelveInsight’s ‘Substance Use Disorder Market Insights, Epidemiology, and Market Forecast – 2036’ report provides a detailed outlook of the current and future Substance Use Disorder market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Substance Use Disorder Market Size by Countries

The Substance Use Disorder market size is assessed separately for various countries, including the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2025, the US accounted for a significant share of the overall 7MM Substance Use Disorder market, driven by its large Substance Use Disorder population, substantial unmet treatment need, established medication-based treatment segments, and comparatively high healthcare and treatment costs. This dominance is projected to persist, especially with the potential early introduction of new products. 

Substance Use Disorder Market Size by Therapies

Substance Use Disorder market size by therapies is categorized into current and emerging markets for the study period 2022–2036.

Note: Detailed market segment assessment will be provided in the final report...

Substance Use Disorder Drug Uptake

This section focuses on the sales uptake of potential of Substance Use Disorder drugs that have recently been launched or are anticipated to be launched in the Substance Use Disorder market between 2022 and 2036. It estimates the market penetration of Substance Use Disorder drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the Substance Use Disorder market.

The emerging Substance Use Disorder therapies are analysed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfil in the Substance Use Disorder market.

Note: Detailed assessment of drug uptake and attribute analysis will be provided in the full report on Substance Use Disorder...

Substance Use Disorder Market Access and Reimbursement

DelveInsight’s ‘Substance Use Disorder Market Insights, Epidemiology, and Market Forecast – 2036’ report provides a descriptive overview of the market access and reimbursement scenario of Substance Use Disorder.

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

Substance Use Disorder Market Report KOL Views

To keep up with current Substance Use Disorder market trends and fill gaps in secondary findings, we interview KOLs and SMEs’ working in the Substance Use Disorder domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns of Substance Use Disorder market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the Substance Use Disorder unmet needs.

Substance Use Disorder: KOL Insights

DelveInsight’s analysts connected with 40+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as Johns Hopkins University/Hospital, Yale School of Medicine, King’s College London, South London and Maudsley NHS Foundation Trust, Charité – Universitätsmedizin Berlin, National Center of Neurology and Psychiatry (NCNP), Kurihama Medical and Addiction Center, among others.

Note: Detailed assessment of KOL Views will be provided in the full report on Substance Use Disorder...

Substance Use Disorder Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the Substance Use Disorder Market, utilizing various competitive intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Substance Use Disorder Pipeline Development Activities

The Substance Use Disorder pipeline report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for Substance Use Disorder. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Substance Use Disorder Clinical Trials Development Activities

The Substance Use Disorder clinical trial analysis report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging Substance Use Disorder therapies.

Substance Use Disorder Market Report Insights

• Substance Use Disorder Patient Population
• Substance Use Disorder Therapeutic Approaches
• Substance Use Disorder Pipeline Analysis
• Substance Use Disorder Market Size and Trends
• Substance Use Disorder Market Opportunities
• Impact of Upcoming Substance Use Disorder Therapies

Substance Use Disorder Market Key Strengths

• 11 Years Forecast
• The 7MM Coverage
• Substance Use Disorder Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Substance Use Disorder Market
• Substance Use Disorder Drugs Uptake

Substance Use Disorder Market Report Assessment

• Substance Use Disorder Current Treatment Practices
• Substance Use Disorder Unmet Needs
• Substance Use Disorder Pipeline Product Profiles
• Substance Use Disorder Market Attractiveness
• Substance Use Disorder Market Drivers
• Substance Use Disorder Market Barrriers

Key Questions Answered in the Substance Use Disorder Market Report:

• How common is Substance Use Disorder?
• What are the key findings of Substance Use Disorder epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2022–2036)?
• What are the currently available treatments for Substance Use Disorder?
• What are the disease risk, burden, and unmet needs of Substance Use Disorder?
• At what CAGR is the Substance Use Disorder market and its epidemiology is expected to grow in the 7MM during the forecast period (2026–2036)?
• How would the unmet needs impact the Substance Use Disorder market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of Substance Use Disorder in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• Among EU4 and the UK, which country will have the highest number of Substance Use Disorder patients during the forecast period (2026–2036)?
• How many companies are currently developing therapies for the treatment of Substance Use Disorder?

Reasons to buy Substance Use Disorder Market Forecast Report

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Substance Use Disorder market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity 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 current treatment in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the attribute analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of key opinion leaders 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 market so that the upcoming players can strengthen their development and launch strategy.