시장
STALICLA, Embera NeuroTherapeutics 등 소수의 주요 기업들이 코카인 사용 장애 치료 시장을 주도하고 있습니다. 국가별, 치료법별 시장 규모는 다음과 같습니다.
현재 코카인 중독 및 CUD 치료제로 승인된 약물은 없지만, 최근 몇 년 동안 코카인 중독에 관여하는 과정에 대한 이해가 진전되면서 연구자들은 몇 가지 유망한 신약 후보를 확인했습니다. 집단 상담, 개별 약물 상담, 인지행동치료(CBT), 컨틴전시 관리 등 다양한 심리치료가 효과적이지만, 많은 환자들이 여전히 이러한 치료에 반응하지 않고 높은 중도탈락률과 관련이 있습니다. 수십 년간의 활동에도 불구하고 CUD는 약물 치료적 개입에 잘 반응하지 않습니다. 그럼에도 불구하고, 신경생물학적 이해는 장시간 작용하는 암페타민과 modafinil을 포함한 도파민 작용제, topiramate를 포함한 아미노부티르산(GABA)/글루타메이트 작용제와 같은 잠재적 약물의 발견으로 이어지고 있습니다. topiramate와 혼합암페타민염과 같은 일부 약물 병용요법도 유망한 것으로 보입니다.
한 마디로 말해서, 코카인 사용 장애 치료제로 고려되고 있는 것은 그리 많지 않습니다. 예측 기간(2024-2034년)에 시장에 진입하는 위의 유망한 후보에 대해 언급하기에는 너무 이릅니다. 궁극적으로, 이 약물은 향후 몇 년 동안 코카인 사용 장애의 상황에 큰 변화를 가져올 것으로 보입니다. 이 치료 영역은 전 세계적으로 의료비 증가로 인해 향후 몇 년 동안 크게 성장할 것으로 예상됩니다.
이 보고서는 미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본 등 7개 주요 코카인 사용 장애(CUD) 시장을 조사 분석하여 각 지역의 시장 규모, 현재 치료법, 미충족 수요, 신약 등에 대한 정보를 제공합니다.
Report Summary
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.
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.
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.
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.
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.