코카인 사용 장애 - 시장 인사이트, 역학, 시장 예측(2034년)

Key Highlights:

• Cocaine Use Disorder is the compulsive use of cocaine despite its medical, psychological, and behavioral consequences. It is a severe public health problem, affecting millions of people globally. The devastating disorder impacts both individuals and society.
• Short-term cocaine use shows signs of mental alertness, extreme happiness, and energy, hypersensitivity to sight, sound, touch, and irritability. Other health effects of cocaine are dilated pupils, constricted blood vessels, nausea, restlessness, and raised body temperature.
• As per the DSM-5, two or three symptoms indicate mild CUD, four or five symptoms indicate moderate CUD and six or more symptoms indicate severe CUD.
• According to leading physicians, psychosocial treatments like contingency management and cognitive-behavioral therapy for substance use disorders (CBT-SUD) have proved gold standards for CUD.
• So far, no medication has met the US Food and Drug Administration's (FDA) criteria for approval or has proven to be effective; current CUD pharmacological treatment includes the use of off-label therapies with antidepressants (citalopram), selective serotonin reuptake inhibitor (SSRI), psychostimulants (methadone and diacetylmorphine), dopamine agonists (amantadine and modafinil), dopamine blockers (CLOZARIL and ketamines), and others.
• The absence of a standard treatment for CUD has hampered clinical development. Without a guiding prototype, developing new treatments has proven challenging. Furthermore, the current understanding of the pathophysiologic characteristics of CUD remains insufficient for developing beneficial pharmacological therapies.
• The National Institute on Drug Abuse of the National Institutes of Health (NIDA) supports the medication development pipeline for treating CUD.
• Though the pipeline is scarce, DelveInsight forecasts that Mavoglurant, EMB-001 and others would prove to be successful labeled therapies for inducing abstinence in CUD with their launch in the 7MM in the forecast period (2024-2034).
• In 2023, the United States accounted for the highest diagnosed prevalent cases of Cocaine Use Disorder followed by the United Kingdom.
• In the 7MM, males reported more cases than females for Cocaine Use Disorder.
• In the United States, individuals of the =26 age group accounted for the highest number of diagnosed CUD cases in 2023.

Report Summary

• The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase II and Phase I) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the Cocaine Use Disorder market, providing an in-depth examination of its historical and projected market size (2020-2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The report includes qualitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM cocaine use disorder market.

Market

A few key players are leading the treatment landscape of Cocaine Use Disorder, such as STALICLA, Embera NeuroTherapeutics, and others. The details of the country-wise and therapy-wise market size have been provided below.

• In the total market size of Cocaine Use Disorder in the 7MM, the United States accounted for the highest market share, i.e. more than 55% in 2023, followed by Germany and the United Kingdom.
• Among EU4 and the UK, Germany accounted for almost 25% of the market size in 2023.
• The United States accounted for approximately USD 30 million in 2023.
• Currently, only Standard of Care (SOC) is being used as the only option of therapy for the treatment of Cocaine Use Disorder.

Cocaine Use Disorder (CUD) Drug Chapters

The section dedicated to drugs in the Cocaine Use Disorder report provides an in-depth evaluation of late-stage pipeline drugs (Phase II) related to Cocaine Use Disorder. The drug chapters section provides valuable information on various aspects related to clinical trials of Cocaine Use Disorder, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting Cocaine Use Disorder.

Emerging Therapies

Mavoglurant (STP7/AFQ056): STALICLA

STP7 (mavoglurant) is a selective nonallosteric 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 the US National Institute on Drug Abuse (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.

EMB-001: Embera NeuroTherapeutics

EMB-001, a patent product, comprises two FDA-approved medications, the cortisol synthesis inhibitor metyrapone (MET) and the benzodiazepine receptor agonist oxazepam, that act as a potential pharmacological treatment for CUD. MET is an 11 B-hydroxylase inhibitor that blocks cortisol synthesis in the brain and adrenal cortex. At the same time, OX is a GABAA-positive allosteric modulator that increases the sensitivity to GABA, the main inhibitory neurotransmitter in the brain. It may also decrease cortisol synthesis in the brain. Through multiple pathways, this combination uniquely targets reducing the cravings and loss of control that drive relapse in addiction, thereby possibly maximizing potential efficacy. EMB-001 acts by mechanisms distinct from those of existing addiction treatments. It is hypothesized to reduce the increased activity in the stress response system induced by drugs, cues, and stressors that contribute to relapse in addiction. The drug has completed the Phase I trial and is currently being investigated under Phase II clinical trial evaluation to treat CUD.

Cocaine Use Disorder (CUD) Market Outlook

Currently, no medications are approved for cocaine dependence or CUD; however, recent advances in understanding the processes involved in cocaine addiction have allowed researchers to identify several promising new candidate medications. 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.

In a nutshell, not many potential therapies are being investigated to manage Cocaine Use Disorder. Even though it is too soon to comment on the above-mentioned promising candidate to enter the market during the forecast period (2024-2034). Eventually, this drug will create a significant difference in the landscape of cocaine use disorder in the coming years. The treatment space is expected to experience a significant positive shift in the coming years owing to the improvement in healthcare spending worldwide.

Cocaine Use Disorder (CUD) Disease Understanding and Treatment

Cocaine Use Disorder (CUD) 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. According to the DSM-5, CUD is classified as mild, moderate, or severe based on the number of symptoms within 12 months. A minimum of two to three DSM-5 criteria is required for a mild diagnosis, between four and five for a moderate diagnosis, and between six and seven for a severe diagnosis.

Cocaine Use Disorder (CUD) Diagnosis

The diagnosis of cocaine use disorder (CUD) involves a combination of physical examination, clinical evaluation, and laboratory testing. Physical examination may reveal external markers of chronic cocaine use, such as cracked lip and thumb caused by heat-related injuries, salmon-colored marks or infected areas from skin sloughing due to subcutaneous injection, and nasal septum perforation from snorting. Common clinical findings include tachycardia, hypertension, diaphoresis, mydriasis, tremulousness, extreme agitation, and mood lability, which may progress to suicidal depression. Urine toxicology screening plays a crucial role when the cause of hyperadrenergic symptoms is unclear; the detection of benzoylecgonine, a long-lasting cocaine metabolite, confirms cocaine use and may be followed by gas chromatography/mass spectrometry for validation. The presence of levamisole, a common cocaine adulterant, can further aid in detection. For patients presenting with chest pain, evaluation begins with ECG and cardiac enzyme analysis, as cocaine use can precipitate acute myocardial infarction, particularly in chronic users with underlying cardiac conditions. Brain imaging and electroencephalograms are warranted for individuals exhibiting seizures, recurrent episodes, or focal neurological symptoms, which may indicate cerebrovascular complications. Comprehensive assessment and targeted testing for associated complications are essential for accurate diagnosis and effective management of CUD.

Cocaine Use Disorder (CUD) Treatment

The treatment of cocaine use disorder (CUD) involves both nonpharmacological and pharmacological approaches. Psychosocial and behavioral interventions are currently the gold standard for managing CUD. Intensive outpatient therapy (IOT), cognitive-behavioral therapy for substance use disorders (CBT-SUD), and contingency management (CM) have proven effective in promoting abstinence and relapse prevention. CM, which uses motivational incentives like vouchers, and CBT-SUD, which focuses on functional analysis and skills training, remain key strategies. However, no pharmacotherapy has been approved for CUD, though promising candidates include dopamine agonists (e.g., modafinil), GABA/glutamate modulators (e.g., topiramate), and novel agents like ketamine, which influences NMDA receptor signaling. Emerging options such as galantamine, a cholinergic agent, are also being explored for their potential role in addressing disruptions in neurotransmitter systems associated with cocaine use. Integrating behavioral and pharmacological approaches remains the most effective strategy for managing CUD.

Cocaine Use Disorder (CUD) Epidemiology

The Cocaine Use Disorder epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total diagnosed prevalent cases, Gender-specific cases, Age-specific cases, Severity-specific cases, and Total treated cases of Cocaine Use Disorder in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.

• Among the 7MM, the United States accounted for the highest number of cases of cocaine use disorder in 2023, with nearly 1,160,000 cases. These cases are anticipated to increase by 2034.
• In the United States, individuals of =26 year age group account for the highest number of cases of cocaine use disorder in 2023.
• In the 7MM, the prevalence of males is more than females in Cocaine Use Disorder.
• Among EU4 and the UK, the United Kingdom accounted for the highest number of diagnosed prevalent cases in 2023, while Italy accounted for the least.

KOL Views

To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects of Cocaine Use Disorder, including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.

Our team of analysts at Delveinsight connected with more than 15 KOLs across the 7MM. We contacted institutions such as the Yale University School of Medicine, Tokyo Institute of Psychiatry, University of Chieti-Pescara, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Cocaine Use Disorder market, which will assist our clients in analyzing the overall epidemiology and market scenario.

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 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, designation, 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 trials for Cocaine Use Disorder, one of the most important primary endpoints was achieving hemolysis control, LDH normalization, etc. Based on these, the overall efficacy is evaluated.

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

Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved 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.

Cocaine Use Disorder (CUD) Report Insights

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

Cocaine Use Disorder (CUD) Report Key Strengths

• Eleven-year Forecast
• The 7MM Coverage
• Cocaine Use Disorder Epidemiology Segmentation
• Key Cross Competition

Cocaine Use Disorder (CUD) Report Assessment

• Current Treatment Practices
• Reimbursements
• Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis, Unmet needs)

Key Questions:

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in Cocaine Use Disorder management recommendations?
• Would research and development advances pave the way for future tests and therapies for Cocaine Use Disorder?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of Cocaine Use Disorder?
• What kind of uptake will the new therapies witness in the coming years in Cocaine Use Disorder patients?

Table of Contents

1. Key Insights

2. Report Introduction

3. CUD Market Overview at a Glance

• 3.1. Market Share (%) Distribution of CUD in 2023 in the 7MM
• 3.2. Market Share (%) Distribution of CUD in 2034 in the 7MM

4. Methodology

5. Executive Summary of CUD

6. Key Events

7. Disease Background and Overview of CUD

• 7.1. Introduction to CUD
• 7.2. Signs and Symptoms
• 7.3. DSM 5 Criteria for Cocaine Use Disorder: Signs and Symptoms of CUD
• 7.4. Classification of CUD
• 7.5. Etiology
• 7.6. Risk Factors
• 7.7. Pathophysiology
  • 7.7.1. Dopamine Brain Rewarding Mechanism
  • 7.7.2. Disruption of Serotonin Levels at the Ventral Pallidum
  • 7.7.3. Cholinergic Pathway
• 7.8. Complications of Cocaine Use
• 7.9. Diagnosis
  • 7.9.1 . Key Diagnostic Factors
  • 7.9.2. Other Diagnostic Factors
  • 7.9.3. Diagnostic Tests
  • 7.9.4. DSM-5 Diagnostic Criteria for CUD
  • 7.9.5. DSM-5 Diagnostic Criteria for Diagnosing and Classifying Substance Use Disorders

8. Management and Treatment

• 8.1. Nonpharmacological Treatment
• 8.2. Pharmacological Treatment
• 8.3. Treatment Guidelines
  • 8.3.1. Substance Abuse and Mental Health Services Administration (SAMHSA) Recommendations
  • 8.3.2. American Addiction Center (AAC) Treatment Recommendation
  • 8.3.3. The German National Strategy on Drug and Addiction Policy
  • 8.3.4. International Society of Substance Use Professionals
  • 8.3.5. Drug Misuse and Dependence: UK Guidelines on Clinical Management
  • 8.3.6. Evidence on Pharmacotherapies for Cocaine Use Disorder, Stratified by Drug Class

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale: The 7MM
  • 9.2.1 . Diagnosed Prevalent Cases of CUD
  • 9.2.2 . Gender-specific Cases of CUD
  • 9.2.3 . Age-specific Cases of CUD
  • 9.2.4. Severity-specific Cases of CUD
• 9.3. Total diagnosed prevalent cases of CUD in the 7MM
• 9.4. Total Treated cases of CUD in the 7MM
• 9.5. The United States
  • 9.5.1. Total diagnosed prevalent cases of CUD in the US
  • 9.5.2. Gender-specific cases of CUD in the US
  • 9.5.3. Age-specific cases of CUD in the US
  • 9.5.4. Severity-specific cases of CUD in the US
  • 9.5.5. Total Treated cases of CUD in the US
• 9.6. EU4 and the UK
  • 9.6.1. Total diagnosed prevalent cases of CUD in EU4 and the UK
  • 9.6.2. Gender-specific cases of CUD in EU4 and the UK
  • 9.6.3. Age-specific cases of CUD in EU4 and the UK
  • 9.6.4. Severity-specific cases of CUD in EU4 and the UK
  • 9.6.5. Total Treated cases of CUD in EU4 and the UK
• 9.7. Japan
  • 9.7.1. Total diagnosed prevalent cases of CUD in Japan
  • 9.7.2. Gender-specific cases of CUD in Japan
  • 9.7.3. Age-specific cases of CUD in Japan
  • 9.7.4. Severity-specific cases of CUD in Japan
  • 9.7.5. Total Treated cases of CUD in Japan

10. Patient Journey

11. Emerging Therapies

• 11.1. Key Cross Competition
• 11.2. Mavoglurant (STP7/AFQ056): STALICLA
  • 11.2.1. Product Description
  • 11.2.2. Other Developmental Activities
  • 11.2.3. Clinical Developmental Activities
  • 11.2.4. Safety and Efficacy
  • 11.2.5. Analyst View

12. Market Analysis

• 12.1. Key Findings
• 12.2. Market Outlook
• 12.3. Conjoint Analysis
• 12.4. Key Market Forecast Assumptions
  • 12.4.1. Cost Assumptions and Rebates
  • 12.4.2. Pricing Trends
  • 12.4.3. Analogue Assessment
  • 12.4.4. Launch Year and Therapy Uptake
• 12.5. Total Market Size of CUD in the 7MM
• 12.6. United States Market Size
  • 12.6.1. Total Market Size of CUD in the United States
  • 12.6.2. Market Size of CUD by Therapies in the United States
• 12.7. EU4 and the UK Market Size
  • 12.7.1. Total Market Size of CUD in EU4 and the UK
  • 12.7.2. Market Size of CUD by Therapies in EU4 and the UK
• 12.8. Japan Market Size
  • 12.8.1. Total Market Size of CUD in Japan
  • 12.8.2. Market Size of CUD by Therapies in Japan

13. KOL Views

14. SWOT Analysis

15. Unmet Needs

16. Appendix

• 16.1. Bibliography
• 16.2. Report Methodology

17. DelveInsight Capabilities

18. Disclaimer