Cocaine Use Disorder - Market Insight, Epidemiology And Market Forecast - 2032

Key Highlights:

• The 12-month diagnosed prevalence of Cocaine Use Disorder has been increasing due to the increased use of illicit drugs among adults and older adults. This may be attributed to stressful life events or other social problems.
• The current treatment of Cocaine Use Disorder relies on behavioral interventions including contingency management and cognitive-behavioral therapy for substance use disorders.
• One of the major concerns in understanding the market for Cocaine Use Disorder is that there is a paucity of evidence to validate many of the interventions used in the daily management of CUD. No consensus guidelines are available in the US, EU4 and the UK, and Japan for the management of CUD patients.
• Recent advances in understanding the processes involved in cocaine addiction have allowed researchers to identify promising new candidate medications that, shortly, can be effective pharmacological treatments for CUD.
• In 2022, the market size of Cocaine Use Disorder was highest in the US among the 7MM, accounting for approximately USD 35.5 million, which is further expected to increase by 2032.
• Emerging therapies STP7/ mavoglurant and EMB-001, have the potential to create a positive shift in the Cocaine Use Disorder market size.
• Though CUD is currently managed through psychosocial treatment and a few drugs like topiramate and disulfiram, there are no approved pharmacological treatments for CUD. If approved, STALICLA's mavoglurant would be the first FDA-approved treatment indicated for patients with CUD.
• With positive results from Phase II, mavoglurant, a metabotropic glutamate receptor 5 (mGluR5) antagonist, can potentially reduce the craving for cocaine in CUD patients and has the potential to address the unmet need for CUD.
• EMB-001 is being investigated under Phase II trial in moderate-to-severe CUD patients. The two grants from the National Institute on Drug Abuse of the National Institutes of Health (NIDA) and the Rose Research Center (RRC) would support the development of EMB-001.

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

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

Geography Covered

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

Study Period: 2019-2032

Cocaine Use Disorder Understanding and Treatment Algorithm

Cocaine Use Disorder Overview

Cocaine use disorder (CUD) is a pattern of cocaine use leading to clinically significant impairment or distress. Cocaine is a powerfully addictive stimulant made from coca plant leaves native to South America. Its use is associated with cardiovascular and neurologic effects, and chronic repeated exposure leads to tolerance, adverse psychological and behavioral effects, and complications, including infections, stroke, and seizure.

The use of cocaine increases the levels of the natural chemical messenger called dopamine in the brain; dopamine controls pleasure and movement. In normal instances, the brain releases dopamine in response to possible rewards, such as the smell of good food, then cycles back into the released cell and shuts off the signal between nerve cells. However, in cocaine use, dopamine is prevented from re-cycling, which causes extra amounts to build up between nerve cells. Because of this “flood” of dopamine, normal brain communication is interrupted, causing the high that people get from cocaine.

CUD is the compulsive use of cocaine, defined by at least 2 of 11 symptoms during 12 months. Its medical, psychological, and behavioral consequences make it a severe public health problem affecting millions globally. In the United States alone, approximately 2.2 million people use cocaine regularly (compared to 600,000 methamphetamine users), more than 1.0 million of whom meet the diagnostic and statistical manual for mental disorders (DSM-5) criteria for CUD.

The sign and symptoms of CUD can be categorized into four groups: mood symptoms, behavioral symptoms, physical symptoms, and psychological symptoms. Some of the CUD symptoms include anxiety, restlessness, extreme talking, increased energy, decreased need to sleep, headaches, severe paranoia, violent mood swings, and a break from reality.

Cocaine Use Disorder Diagnosis

According to DSM-5, CUD is classified as mild, moderate, or severe, defined by the number of symptoms within 12 months. A minimum of two to three DSM-5 criteria is required for a mild diagnosis of CUD; between four and five of the DSM-5 criteria are necessary for a moderate, and between six and seven of the DSM-5 criteria must be met to be diagnosed with severe CUD.

Key diagnostic factors include drug use by family members, adrenergic arousal, mood change, and agitation. Other diagnostic factors include anxiety, suspicious burns, seizures, drug-induced formication, previous hospitalization for detoxification, and others.

Diagnostic tests such as physical examination, urine toxicology, chest pain, and testing for other complications can help diagnose CUD.

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

Cocaine Use Disorder Treatment

No medication has yet been approved to treat CUD; psychosocial treatment is currently the standard. Several psychological treatments, including group counseling, individual drug counseling, cognitive behavioral therapy (CBT), and contingency management, are effective; however, many patients still do not respond to these treatments and are associated with high dropout rates. Despite decades of efforts, CUD has not responded well to pharmacotherapeutic interventions.

Intensive outpatient therapy (IOT) has shown to be as effective as inpatient drug treatment for the initial treatment of CUD. Standard outpatient drug counseling typically consists of one or two sessions per week; an individual counseling session is typically between 30 min and 60 min, while group sessions are 60-90 min in length. IOT treatments typically provide 9 h of treatment contact per week. Participation in mutual help groups (such as 12-step meetings) is generally encouraged.

Many behavioral treatments for cocaine addiction have proven effective in residential and outpatient settings. Indeed, behavioral therapies are often the only available and effective treatments for many drug problems. One form of behavioral therapy showing positive results in people with CUDs is contingency management (CM), also called motivational incentives. Motivational interviewing has shown to be an effective way where using voucher-based reinforcement has worked. In this treatment, patients receive vouchers redeemable for goods and services in the community, contingent upon achieving a predetermined therapeutic goal. CM treatment is especially effective in promoting initial abstinence from cocaine.

Cocaine Use Disorder Epidemiology

As the market is derived using a patient-based model, the Cocaine Use Disorder epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by 12-month diagnosed prevalent cases of Cocaine Use Disorder, Gender-specific cases of Cocaine Use Disorder, Age-specific cases of Cocaine Use Disorder, and Severity-specific cases of Cocaine Use Disorder 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 12-month diagnosed prevalent cases of Cocaine Use Disorder in the 7MM comprised approximately 1,869,555 cases in 2022 and are projected to increase during the forecasted period.

• The total number of 12-month diagnosed prevalent cases of Cocaine Use Disorder in the United States was around 1,152,759 cases in 2022.
• The US contributed to the largest 12-month diagnosed prevalent population of Cocaine Use Disorder, acquiring ~62% of the 7MM in 2022. Whereas EU4 and the UK, and Japan accounted for around 33% and 5% of the total population share, respectively, in 2022.
• In the US, males diagnosed with Cocaine Use Disorder are higher in number than females. In 2022, cases of Cocaine Use Disorder among males were approximately 805,548, while among the female population, there were approximately 347,211 CUD cases. These numbers are expected to rise during the study period.
• According to the publisher's estimates, in EU4 and the UK, the diagnosed prevalence of Cocaine Use Disorder is highest in the =35 age group, while 12-17 years has the least cases. In EU4 and the UK, the =35 age group accounted for the highest number of diagnosed CUD cases 312,774, followed by 281,730 cases in 18-34 years and 20,225 cases in 12-17 years in 2022, which is projected to increase during the forecast period.
• According to the publisher's estimates, in Japan, the diagnosed prevalence of mild cases of Cocaine Use Disorder is more than the moderate-severe cases. In 2022, there were approximately 61,342 mild, and 40,725 moderate-severe cases of Cocaine Use Disorder in Japan which are projected to decrease during the forecast period.

Cocaine Use Disorder Drug Chapters

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

Emerging Drugs

STP7 (mavoglurant): STALICIA

STP7 (mavoglurant) is a selective nonallosteric metabotropic glutamate receptor 5 (mGluR5) antagonist. mGluR5 has been tied to mood disorders, addiction, and rare and common forms of autism. The product is believed to block a certain protein in the brain, which research has shown is related to people's craving to use drugs like cocaine. A clinical Phase II study showed mavoglurant-induced abstinence in CUD patients through inhibition of mGluR5, with no evidence of withdrawal liability.

The company plans to advance mavoglurant into Phase III development to treat CUD which will be covered by NIDA. Also, the company will use its precision neurobiology drug development platform (DEPI) to detect subgroups of high-responder patients with rare and common neurodevelopmental disorders where mavoglurant can be an effective treatment, as guided by earlier clinical studies.

The drug is expected to be a promising agent with its launch anticipated in 2026 in the United States market. Also, with the significant reduction of cocaine use by the patients taking mavoglurant in the Phase II trial, STP7 can potentially reduce the craving for cocaine in CUD patients. If approved, the drug would be the first to enter the market, capturing a notable share of the untapped market.

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

Drug Class Insights

Psychosocial treatments are the treatments of choice for CUD, with standard approaches including contingency management and cognitive behavioral therapy. However, investigators have sought to develop pharmacological agents to augment the efficacy of psychosocial treatments.

The current promising pharmacological classes for CUD treatment include psychostimulants, anticonvulsants, antipsychotics, antidepressants, dopamine agonists, and psychiatric agents.

Dopamine agonists have been successfully used to treat several forms of SUD, including opioid and tobacco use disorders, as pharmacotherapy at opioid and nicotine receptors is much simpler; however, cocaine treatment remains challenging due to its diverse effects in the brain, involving multiple kinds of neurotransmitters.

Methamphetamine has also been investigated in trials with stringent retention criteria but did not show significant results. Mostly in all trials except a few, long-acting amphetamine or methamphetamine, retention has been poor. In at least one trial, the poor retention rate was due not to the poor tolerability of the medication but rather to the stringent retention criteria used in the preliminary proof-of-concept trials. Before long-acting amphetamine or methamphetamine is used clinically, the preliminary trials are needed to be replicated in larger trials using a more standard patient population. However, based on the promise of these trials, other dopamine agonists, including modafinil, have been evaluated for CUD.

Modafinil is another well-known cognitive enhancer with the potential to treat CUD. It is a psychostimulant shown to increase dopaminergic neurotransmission by blocking the dopamine transporter. It also enhances glutamate neurotransmission and may be efficacious for CUD by increasing dopamine transmission or ameliorating the glutamate depletion seen in chronic cocaine users. In a trial wherein cocaine-dependent subjects were given modafinil in 200 mg or 400 mg doses or a placebo for several days and then challenged with 30 mg of IV cocaine in an inpatient research ward, the pretreatment with modafinil significantly blunted cocaine-induced euphoria as measured by scores on the Addiction Research Center Inventory Amphetamine Scale. Modafinil was evaluated in many other trials with mixed results which do not suggest the significant efficacy of this drug in cocaine users as a whole. However, modafinil has shown efficacy in certain subpopulations of cocaine users, particularly those without comorbid alcohol use. The efficacy of modafinil may also be sensitive to the degree of treatment adherence. In most trials, modafinil is well tolerated and has low abuse liability, making it a potentially safer choice of dopamine agonist for treating CUD.

Topiramate potential has been tested in many clinical trials; among them, few showed positive results; one trial reported that topiramate-treated subjects showed a significantly higher rate of abstinence during the last 5 weeks of the trial compared to placebo-treated patients. Among patients who returned for at least one visit after receiving medications, topiramate-treated subjects were also significantly more likely to achieve at least 3 weeks of continuous abstinence from cocaine compared to placebo-treated patients (59% vs. 26%), and topiramate-treated subjects were significantly more likely than placebo-treated subjects to be rated very much improved at their last visit (71% vs. 32%). However, many other trials also reported negative results.

Many of these treatment classes have shown promise in double-blind, placebo-controlled clinical trials and are undergoing confirmatory testing in one or more trials. With continuous research and development activities soon, there might be an effective pharmacological treatment for cocaine dependence.

Cocaine Use Disorder Market Outlook

Cocaine is among the major illicit stimulants used worldwide. There is an increased risk of dependence with heavier use and when cocaine is smoked or injected. Additionally, cocaine abuse is associated with significant mortality and morbidity with cardiovascular and neurologic effects, and chronic repeated exposure leads to tolerance, adverse psychological and behavioral effects, and complications, including infections, stroke, and seizure. However, no medication has yet been approved to treat CUD; psychosocial treatment is currently the standard.

Several psychological treatments, including group counseling, individual drug counseling, cognitive behavioral therapy (CBT), and contingency management, are effective; however, many patients still do not respond to these treatments and are associated with high dropout rates. Despite decades of efforts, CUD has not responded well to pharmacotherapeutic interventions. Nevertheless, a significant understanding of neurobiology has led to the discovery of potential medications like dopamine agonists, including long-acting amphetamine, modafinil, and ?-aminobutyric acid (GABA)/glutamatergic medications, including topiramate. A few combination medications, such as topiramate and mixed amphetamine salts, also appear promising.

The current market has been segmented into different commonly used therapeutic classes based on the prevailing treatment pattern across the 7MM, which presents minor variations in the overall prescription pattern. Disulfiram, topiramate, and modafinil are the major drugs covered in the forecast model.

Key players STALICLA (mavoglurant) and Embera NeuroTherapeutics (EMB-001) are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products for the treatment of Cocaine Use Disorder.

• The total market size of Cocaine Use Disorder in the 7MM is approximately USD 48.3 million in 2022 and is projected to increase during the forecast period (2023-2032).
• The market size in the 7MM will increase at a CAGR of 18.1% due to increasing awareness of the disease and the launch of the emerging therapy.
• In 2022, topiramate and disulfiram were among the most prescribed medication across the US. Though the revenue of the current standard of care will decline owing to the launch of emerging therapies.
• Among EU4 and the UK countries, the UK accounts for the maximum market size in 2022, while Italy occupies the bottom of the ladder in 2022.
• Japan accounted for the fifth largest market among the 7MM with approximately USD 2.0 million in 2022, which is expected to increase during the forecast period (2023-2032).
• In the US, among the emerging therapies, STALICLA's STP7/ mavoglurant, the first to enter, is expected to attain a peak in its 7th year accounting for approximately USD 178 million.

Cocaine Use Disorder Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2019-2032. For example, STP7/ mavoglurant, a metabotropic glutamate receptor 5 (mGluR5) antagonist for the treatment of Cocaine Use Disorder, with an anticipated entry by 2026 in the US is predicted to have a medium-fast uptake during the forecast period.

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

Cocaine Use Disorder Pipeline Development Activities

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

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Cocaine Use Disorder emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SME's opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on Cocaine Use Disorder evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as the Mount Sinai School of Medicine Center, Friedman Brain Institute, Max Planck Institute of Psychiatry, Munich; the hospitals of the AP-HP University Hospital Group, Paris; Sapienza University of Rome; National Institute of Mental Health, Tokyo, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Cocaine Use Disorder 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 analysis 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 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 Cocaine Use Disorder trials, one of the most important primary outcome measures is the proportion of cocaine use days.

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 route of administration, order of entry and designation, 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.

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 drugs usually has a limited impact 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 the past few 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.

In the case of drug abuse, when it is medically necessary for a patient to receive detoxification and/or rehabilitation for drug substance abuse as a hospital inpatient, care coverage is available. Coverage is also available for treatment services that are provided in the outpatient department of a hospital to patients who, for example, if a patient has been discharged from an inpatient stay for the treatment of drug substance abuse or who require treatment but do not require the availability and intensity of services found only in the inpatient hospital setting.

While Medicare covers a broad array of treatment services, the coverage of services for mental health, behavioral health, and substance abuse disorders is not as extensive as its coverage for other services.

Medicare pays for treating alcoholism and substance use disorders in both inpatient and outpatient settings. Medicare Part A pays for inpatient substance abuse treatment; individuals pay the same copays as for any other type of inpatient hospitalization. Likewise, Medicare Part B pays for outpatient substance abuse treatment services from a clinic or hospital outpatient department.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, 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 Report

• The report covers a segment of key events, an executive summary, descriptive overview of Cocaine Use Disorder, 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, disease progression along with 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 treatment landscape.
• A detailed review of the Cocaine Use Disorder 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 in shaping and driving the 7MM Cocaine Use Disorder market.

Cocaine Use Disorder Report Insights

• Patient Population
• Therapeutic Approaches
• Cocaine Use Disorder Pipeline Analysis
• Cocaine Use Disorder Market Size and Trends
• Existing and future Market Opportunity

Cocaine Use Disorder Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage
• Cocaine Use Disorder Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Cocaine Use Disorder 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 Cocaine Use Disorder total market size, the market size by therapies, market share (%) distribution in 2019, and what would it look like in 2032? What are the contributing factors for this growth?
• How will psychostimulants as a class affect the treatment paradigm of Cocaine Use Disorder?
• How will disulfiram compete with topiramate and modafinil?
• Which class is going to be the largest contributor in 2032?
• What are the pricing variations among different geographies of off-label therapies?
• How would 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 Cocaine Use Disorder? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Cocaine Use Disorder?
• What is the historical and forecasted Cocaine Use Disorder patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Out of the above-mentioned countries, which country would have the highest diagnosed prevalent population of Cocaine Use Disorder during the forecast period (2023-2032)?
• What factors are factors contributing to the growth of Cocaine Use Disorder cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Cocaine Use Disorder? What are the current treatment guidelines for the treatment of Cocaine Use Disorder in the US and Europe?
• How many companies are developing therapies for the treatment of Cocaine Use Disorder?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Cocaine Use Disorder?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive therapies?
• What is the 7MM historical and forecasted market of Cocaine Use Disorder?

Reasons to Buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Cocaine 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
• 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 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 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 for substance use disorder, barriers to accessibility of expensive 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.