Opioid Use Disorder - Market Insight, Epidemiology and Market Forecast - 2032

Key Highlights:

• Opioid use disorder is the chronic use of opioids that causes clinically significant distress or impairment. It consists of an overpowering desire to use opioids, increased opioid tolerance, and withdrawal syndrome when discontinued.
• In 2022, the highest number of diagnosed prevalent cases of Opioid Use Disorder (OUD) was observed in the United States among the 7MM.
• As per severity-specific cases, it was observed that mild cases of Opioid Use Disorder (OUD) formed the highest number of cases across the 7MM region.
• Opioid Use Disorder (OUD) is treated with buprenorphine or methadone replacement treatment, which reduces morbidity and mortality risk. Naltrexone helps prevent relapse whereas, Naloxone is used to treat opioid overdose.
• In 2022, the market size of Opioid Use Disorder (OUD) was found to be ~1,970 million in the 7MM. The market size is estimated to increase during the forecast period (2023-2032).

The “Opioid Use Disorder (OUD) - Market Insights, Epidemiology, and Market Forecast - 2032” report delivers an in-depth understanding of the Opioid Use Disorder (OUD), historical and forecasted epidemiology as well as the Opioid Use Disorder (OUD) market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Opioid Use Disorder (OUD) market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Opioid Use Disorder (OUD) market size from 2019 to 2032. The report also covers current Opioid Use Disorder (OUD) treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered

• The United States
• The EU4 (Germany, France, Italy, Spain) and the United Kingdom
• Japan

Study Period: 2019-2032

Opioid Use Disorder (OUD) Disease Understanding and Treatment Algorithm

Opioid Use Disorder (OUD) Overview

Repeated substance use that creates problems in a person's home, work, or school life is defined as a Substance Use Disorder (SUD), a treatable mental health condition. The United States loses nearly 185 people every day to substance overdose deaths. Opioids are involved in almost 70% of the lives lost due to substance overdoses, equating to nearly 47,000 opioid-related deaths in 2018 alone. Opioid Use Disorder (OUD) is a type of SUD defined by the repeated use of opioids. The economic burden of OUD and fatal opioid overdose is estimated to be over one billion dollars annually in the US when accounting for healthcare and treatment, criminal justice, lost productivity, reduced quality of life, and value of life lost costs. OUD significantly impacts the lives of individuals who experience OUD, families and loved ones, and communities nationwide.

Opioid Use Disorder (OUD) Diagnosis

A diagnosis is based on specific criteria such as unsuccessful efforts to cut down or control use, as well as use resulting in social problems and a failure to fulfill obligations at work, school, or home. The term opioid use disorder superseded the phrases opioid abuse and opioid dependence in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The DSM-5 assesses the severity of opioid use disorder based on the frequency of recurrent symptoms reported during the previous 12 months.

Note: Further details related to diagnosis are provided in the report.

Opioid Use Disorder (OUD) Treatment

Drug therapy for Opioid Use Disorder (OUD) has been linked to lower overdose and overall fatality rates. Buprenorphine, methadone, and naltrexone are all FDA-approved drugs for the treatment of Opioid Use Disorder (OUD). Clinicians should provide or organize therapy using evidence-based drugs for individuals suffering from Opioid Use Disorder (OUD), especially if the condition is moderate or severe. Clinicians who are unable to treat patients with Opioid Use Disorder (OUD) should refer them to a substance use disorder treatment specialist, such as an office-based buprenorphine or naltrexone treatment provider, or an opioid treatment program certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) to provide methadone or buprenorphine for patients with Opioid Use Disorder (OUD).

Opioid Use Disorder (OUD) Epidemiology

As the market is derived using the patient-based model, the Opioid Use Disorder (OUD) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of Opioid Use Disorder (OUD), Gender-specific Cases of Opioid Use Disorder (OUD), Age-specific Cases of Opioid Use Disorder (OUD), and Severity-specific Cases of Opioid Use Disorder (OUD), in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032.

• The total prevalent cases of Opioid Use Disorder (OUD), in the 7MM, were approximately 3,971,300 cases in 2022 and are projected to increase during the forecast period (2023-2032).
• The age-specific cases of Opioid Use Disorder (OUD) were further divided into 12-17 years, 18-25 years, and 26 and above years age segments. It was observed that the 18-25 years age segment comprised the maximum number of cases of Opioid Use Disorder (OUD).
• In 2022, the United Kingdom accounted for ~474,500 prevalent cases of Opioid Use Disorder (OUD).
• In 2022, it was observed that the United States accounted for ~1,184,000 cases in males and ~934,000 cases in females.

Opioid Use Disorder (OUD) Drug Chapters

The drug chapter segment of the Opioid Use Disorder (OUD) report encloses a detailed analysis of Opioid Use Disorder (OUD)-marketed drugs and emerging (Phase III and Phase II and Phase I/II) pipeline drugs. It also helps understand the Opioid Use Disorder (OUD) clinical trial details, expressive pharmacological actions, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Current Therapies

SUBLOCADE: Indivior

SUBLOCADE includes buprenorphine, a partial opioid agonist, and is approved for the treatment of moderate to severe opioid use disorder in patients who have started therapy with a transmucosal buprenorphine product, followed by dosage modification for at least 7 days. SUBLOCADE should be used as part of a comprehensive treatment plan that includes counseling and psychosocial support.

Buprenorphine is now approved for use in the treatment of OUD as a pill, film that dissolves in the mouth, or implant. SUBLOCADE is a novel therapeutic option for people in recovery who may appreciate the advantages of a once-monthly injection over other forms of buprenorphine, such as the ease of taking medicine daily.

VIVITROL (Naltrexone)

VIVITROL is an opioid antagonist. Opioid-dependent individuals, including those being treated for alcoholism, must be opioid-free for the first VIVITROL dose. VIVITROL should be used in conjunction with a complete management program that includes psychological assistance. The drug was approved in October 2010, by the US FDA to prevent relapse to opioid dependence following opioid detoxification.

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

Emerging Drugs

CAM2038: Braeburn Pharmaceuticals

CAM2038 (buprenorphine weekly and monthly depot subcutaneous injection) is an investigational therapy for opioid use disorder used in conjunction with counseling and psychosocial support. The drug is intended for flexible and customized care ranging from commencement and stabilization to long-term maintenance therapy, with once-weekly and once-monthly formulations offering continuous buprenorphine release. Healthcare workers guarantee drug administration and adherence while possibly reducing risks of diversion, abuse, and unintentional pediatric exposure. Seven Phase I-III clinical trials of CAM2038 were completed successfully, including a major Phase III efficacy and long-term safety study.

Except for mild-to-moderate injection-site adverse effects, the safety profile of CAM2038 was essentially comparable with the established safety profile of buprenorphine.

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

Drug Class Insights

The existing Opioid Use Disorder (OUD) treatment is mainly comprised of drugs having the following salts: naltrexone, methadone, and buprenorphine. Several drugs of these salts have been approved in the market.

Buprenorphine is frequently a safe option for persons who have developed an opioid tolerance as a result of OUD. It functions as both a partial mixed opioid agonist and an antagonist at the ?-receptor. It has a stronger affinity for the µ-receptor than other opioids and can cause withdrawal symptoms in those who are currently using other opioids.

Methadone is a long-acting full opioid agonist, and a schedule II controlled medication. It decreases opiate desire and withdrawal, as well as blunting or blocking opioid effects. Naloxone injection belongs to the class of drugs known as opiate antagonists. It relieves hazardous symptoms produced by excessive levels of opiates in the blood by inhibiting the effects of opiates.

Opioid Use Disorder (OUD) Market Outlook

There are effective therapies for Opioid Use Disorder (OUD); however, only roughly one in every four persons with OUD receives specialized care. Medication for opioid use disorder (MOUD), known as the "gold standard" of therapy, is an evidence-based treatment for those suffering from OUD. Counseling and behavioral treatments may be an essential aspect of treatment in addition to drugs, but they are not successful on their own. Medications are also used to treat cravings, alleviate withdrawal symptoms, and prevent opioid euphoria. These drugs do not "cure" the illness; rather, they increase safety and decrease withdrawal symptoms, which might lead to relapse or ongoing drug use. Methadone, buprenorphine, and naltrexone are three FDA-approved drugs often used to treat opioid use disorder (OUD).

Methadone, an oral µ-agonist, has been widely used and extensively researched around the world. Methadone is exclusively available in the United States through licensed and tightly regulated clinics that initially need practically daily patient involvement to acquire the medicine, however, occasional take-home doses are normally permitted for patients who follow program criteria.

Patients must have a current opioid-use disorder with physiologic characteristics or be at high risk of relapse to be eligible for methadone maintenance. Furthermore, individuals are not already enrolled in another maintenance program and are not particularly prone to methadone-related medical issues.

The limitation of methadone to specialized clinics in the United States has led to the hunt for an alternative oral, long-acting opioid. This search has led to the discovery of buprenorphine maintenance treatment. Although oral buprenorphine is rapidly degraded in the liver, it is efficiently absorbed when administered as a sublingual tablet or buccal film. Buprenorphine's effects extend for 24 to >36 h. It alleviates opioid withdrawal symptoms and somewhat inhibits other opioid intoxication. Overdoses are a concern with buprenorphine, especially when used with depressant medications, and drug diversion is a possibility. However, mortality with buprenorphine induction is lower than during methadone induction.

Naltrexone is a µ-opioid receptor antagonist that inhibits opioid effects and aids in the maintenance of opioid abstinence in highly motivated patients. Medication therapy is most successful when combined with patient engagement in a self-help group as part of a cognitive behavioral approach (to increase motivation, work towards behavioral improvements, and prevent relapse). At larger dosages, these drugs might cause gastrointestinal discomfort, tiredness, sleeplessness, and abnormal levels of liver function tests. However, naltrexone is reasonably safe for those who drink a lot of alcohol and those who have hepatitis C or HIV.

The treatment of Opioid Use Disorder (OUD) differs as per geography. In contrast to other nations that have established harm reduction measures for OUD, treatment of OUD has not been licensed in Japan, making opioid maintenance therapy challenging, and detoxification is only provided at a few mental facilities.

The 'Narcotics and Psychotropics Control Act' in Japan severely regulates opioid analgesics. Furthermore, because Japanese physicians prescribe fewer opioids, Japan has not seen the huge surge in opioid usage seen in other nations. As a result, many Japanese physicians believe that opioid analgesic overuse or addiction is uncommon in Japan.

Because few viable medicines are being studied to control OUD, it is fair to assume that the therapeutic space will undergo considerable reconfiguration between 2023 and 2032.

A few players like Braeburn Pharmaceuticals (CAM2038), BioXcel Therapeutics (BXCL501), and others are evaluating their lead candidates for the treatment of Opioid Use Disorder (OUD). These therapies are expected to change the Opioid Use Disorder (OUD) treatment landscape.

• The total market size of Opioid Use Disorder (OUD) in the United States was approximately USD 1,370 million in 2022 and is projected to grow during the forecast period (2023-2032).
• According to the estimates, Spain recorded the least market share, i.e., around 2% of the total market size of Opioid Use Disorder (OUD) in the 7MM in 2022.
• Among the EU4 (Germany, France, Italy, and Spain) and the UK, France had the largest revenue share in 2022.
• In 2022, buprenorphine captured the largest market size of Opioid Use Disorder (OUD) in the 7MM.

Opioid Use Disorder (OUD) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during the forecast period (2023-2032). For example, for CAM2038, we expect the drug uptake in the US to be medium with a probability-adjusted peak share of approximately 13.5%, and years to the peak is expected to be 8 years from the year of launch.

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

Opioid Use Disorder (OUD) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I/II stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisition and merger, licensing, and patent details for Opioid Use Disorder (OUD) emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the Opioid Use Disorder (OUD) evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, drug uptake along with challenges related to accessibility, including Medical/scientific writers and Professors at the New York University School of Medicine, Dokkyo Medical University, Japan, etc.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as New York University School of Medicine, Dokkyo Medical University, Japan, and Rutgers School of Public Health, US, etc., were contacted. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Opioid Use Disorder (OUD) market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

The publisher performs Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

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. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Opioid Reimbursement

Opioid use disorder is characterized by an overwhelming urge to consume opioids, increasing opioid tolerance, and withdrawal symptoms when the drugs are stopped. The most severe form of the condition is opioid use disorder, which involves dependency and addiction.

A rising percentage of people with opioid use disorder (OUD) are Medicare enrollees. The standard of care for opioid use disorder (OUD) comprises therapy with one of three FDA-approved drugs for treating opioid use disorder (buprenorphine, naltrexone, and methadone), as well as counseling and other support services as needed. However, only about 20% of those with OUD receive MOUD.

Opioid Treatment Programs

Medicare and all state Medicaid programs cover opioid use disorder (OUD) treatment services furnished by Opioid Treatment Programs (OTPs). State Medicaid programs typically pay for OTP services in daily or weekly bundles, including methadone dosing, toxicology testing, nursing services, and counseling using code H0020 (Alcohol and/or drug services; methadone administration and/ or service (provision of the drug by a licensed program).

Nearly 40% of all non-elderly persons with opioid use disorder (OUD) are covered by Medicaid. All state Medicaid programs must cover "Medication Assisted Treatment (MAT)" services and medications beginning in October 2020 and continuing until 2025 under a new mandated benefit enacted by the SUPPORT Act of 2018. States must include in the new MAT required to benefit all medicines and biologicals authorized or licensed by the FDA for MAT treatment of OUD. medicine utilization control strategies such as preferred medicine lists and prior authorization are still used in state Medicaid programs.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of Opioid Use Disorder (OUD), explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Opioid Use Disorder (OUD) market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The 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 shape and drive the 7MM Opioid Use Disorder (OUD) market.

Opioid Use Disorder (OUD) Report Insights

• Patient Population
• Therapeutic Approaches
• Opioid Use Disorder (OUD) Pipeline Analysis
• Opioid Use Disorder (OUD) Market Size and Trends
• Existing and Future Market Opportunity

Opioid Use Disorder (OUD) Report Key Strengths

• Ten-Year Forecast
• The 7MM Coverage
• Opioid Use Disorder (OUD) Epidemiology Segmentation
• Key Cross Competition
• Attribute Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Opioid Use Disorder (OUD) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions Answered

Market Insights

• What was the Opioid Use Disorder (OUD) market share (%) distribution in 2019, and what would it look like in 2032? What are the contributing factors for this growth?
• How will the drug CAM2038, affect the treatment paradigm of Opioid Use Disorder (OUD)?
• How will CAM2038 compete with already approved drugs in the Opioid Use Disorder (OUD) market?
• 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 market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risk, burdens, and unmet needs of Opioid Use Disorder (OUD)? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Opioid Use Disorder (OUD)?
• What is the historical and forecasted Opioid Use Disorder (OUD) patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Which type of Opioid Use Disorder (OUD), as per severity, is the largest contributor to the Opioid Use Disorder (OUD) patient pool?
• Which age group account for the major share of the Opioid Use Disorder (OUD) patient population? Or which age group is more susceptible to Opioid Use Disorder (OUD) in the 7MM?

Current Treatment Scenario and Emerging Therapies

• What are the current options for the treatment of Opioid Use Disorder (OUD)? What are the current guidelines for treating Opioid Use Disorder (OUD) in the US, Europe and Japan?
• How many companies are developing therapies for treating Opioid Use Disorder (OUD)?
• How many emerging therapies are in the mid-stage and late stage of development for treating Opioid Use Disorder (OUD)?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the key designations that have been granted for emerging therapies for Opioid Use Disorder (OUD)?
• What is the cost burden of approved therapies on the patient?
• What is the patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?
• What is the 7MM historical and forecasted market of Opioid Use Disorder (OUD)?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Opioid Use Disorder (OUD) smarket.
• 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 approved products in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies that will 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 need of the existing market so that the upcoming players can strengthen their development and launch strategy