시장
Imbrium Therapeutics, Kinnov Therapeutics, Alkermes, Indivior 등 소수의 주요 기업이 물질사용장애(SUD) 치료제 시장을 주도하고 있습니다. 국가별, 치료법별 시장 규모에 대한 자세한 내용은 다음과 같습니다.
VIVITROL(naltrexone), SUBLOCADE(naltrexone 서방형) 등 오피오이드 수용체를 차단하고 갈망을 억제하여 중독을 치료하는 약물이 승인되면서 SUD 치료 환경은 크게 발전했습니다. 이러한 약물은 회복을 돕는 데 중요한 역할을 하고 있습니다. 기존 치료법에 더해 가바펜틴 나빌론(gabapentin nabilone)과 사이프로헵타딘 프라조신(cyproheptadine prazosin)과 같은 새로운 약물의 조합은 SUD 치료를 더욱 향상시킬 수 있는 유망한 치료법입니다. 이 조합은 중독에 관여하는 다양한 경로를 표적으로 삼아 욕구를 억제하고, 금단 증상을 관리하며, 재발을 예방하는 것을 목표로 하고 있습니다. 연구가 진행됨에 따라 이러한 새로운 치료제는 특히 기존 약수처리에 잘 반응하지 않는 환자들에게 보다 개인화되고 효과적인 치료 옵션을 제공할 수 있으며, SUD 치료 시장은 새로운 분자 및 병용 요법이 개발되어 보다 성공적인 치료법을 위한 길이 열리면서 확대될 것으로 예상됩니다. 확대될 것으로 예상됩니다.
물질 사용 장애(SUD)의 주요 7 시장(미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본)에 대해 조사분석했으며, 각 지역의 시장 규모, 현재 치료법, 미충족 요구, 신약 등의 정보를 제공하고 있습니다.
Report Summary
Market
A few key players are leading the treatment landscape of Substance Use Disorder, such as Imbrium Therapeutics, Kinnov Therapeutics, Alkermes, Indivior and others. The details of the country-wise and therapy-wise market size have been provided below.
The section dedicated to drugs in the Substance Use Disorder report provides an in-depth evaluation of late-stage pipeline drugs (Phase II) related to Substance Use Disorder. The drug chapters section provides valuable information on various aspects related to clinical trials of Substance 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 Substance Use Disorder.
Marketed Drugs
VIVITROL (naltrexone): Alkermes
VIVITROL developed by Alkermes, is a prescription medication used for the treatment of OUD and alcohol dependence. It is an opioid receptor antagonist that works by blocking the effects of opioids in the brain, which helps to reduce cravings and prevent the rewarding effects of opioid use. This action is particularly beneficial in preventing relapse and supporting patients in maintaining abstinence from opioids and alcohol. VIVITROL is administered as an intramuscular injection, providing a convenient once-monthly dosing regimen. VIVITROL was approved in the US in 2006.
In August 2023, Alkermes announced a settlement with Teva regarding patent litigation, granting Teva a license to market a generic version of VIVITROL in the US starting January 15, 2027, or earlier under certain conditions.
BRIXADI (buprenorphine): Braeburn
BRIXADI is an extended-release formulation of buprenorphine developed by Braeburn, approved in May 2023 by US FDA, administered via subcutaneous injection. It functions as a partial agonist at the mu-opioid receptor, providing a controlled modulation of opioid effects, which helps manage cravings and withdrawal symptoms in OUD. As a small molecule, BRIXADI is designed to penetrate cell membranes effectively and offer a long-lasting therapeutic effect. The subcutaneous injection route allows for sustained, steady release of the drug, enhancing patient compliance and supporting consistent treatment outcomes in the management of opioid dependence.
In June 2024, Braeburn, announced the publication of a post hoc analysis in JAMA Network Open, evaluating data from the Phase III trial comparing BRIXADI (buprenorphine) extended-release injection to daily sublingual buprenorphine/naloxone in patients with moderate to severe OUD, including those with fentanyl use.
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.
In May 2024, STALICLA announced the First Patient First Visit (FPFV) for the company's Drug-drug Interaction (DDI) study of STP7 (Mavoglurant), licensed to STALICLA by Novartis. The DDI study is the last regulatory requirement in a comprehensive Phase II program, and completion is expected to trigger the initiation of a Phase III study in the US in 2025.
BPL-003 (Mebufotenin): Atai Life Sciences/ Beckley Psytech
BPL-003, developed by Beckley Psytech, is an innovative therapeutic designed for the treatment of AUD. It belongs to a class of small molecules and is primarily categorized under antidepressants, mood stabilizers, and tryptamines. The product acts as a serotonin receptor modulator, targeting specific receptors in the brain to potentially influence mood regulation and reduce alcohol cravings. Administered intranasally, BPL-003 offers a non-invasive and efficient delivery route, enabling rapid absorption and a quick onset of action. The product is being developed to address AUD, utilizing its mechanism of action to modulate serotonin pathways, which are crucial in regulating mood and behavior, ultimately aiding in alcohol cessation and recovery. Currently, it is in Phase II of development for the treatment of AUD.
In April 2024, atai Life Sciences announced the publication of Beckley Psytech's Phase I study of BPL-003 in the Journal of Psychopharmacology. This publication highlights key findings on the safety, tolerability, and pharmacokinetic profile of BPL-003, an investigational treatment for AUD.
The treatment landscape for SUD has advanced significantly with the approval of several medications, including VIVITROL (naltrexone), SUBLOCADE (extended-release formulation of naltrexone), and others, which help manage addiction by blocking opioid receptors and reducing cravings. These drugs play a critical role in supporting recovery. In addition to established therapies, emerging drug combinations such as gabapentin + nabilone and cyproheptadine + prazosin show promise for further improving SUD treatment. These combinations target various pathways involved in addiction, aiming to reduce cravings, manage withdrawal symptoms, and prevent relapse. As research progresses, these novel therapies may offer more personalized and effective treatment options, particularly for patients who have not responded well to traditional pharmacotherapies. The market for SUD treatment is expected to grow as new molecules and combination therapies are developed, paving the way for more successful interventions.
In summary, numerous therapies have already been approved for the management of SUD, with several effective medications currently available. While ongoing research continues to explore new treatments, many approved therapies are already making a significant impact in the SUD treatment landscape. The forecast period (2024-2034) is expected to bring further advancements, with emerging therapies enhancing existing treatment options. As healthcare spending continues to increase worldwide, the SUD treatment space is anticipated to see a positive shift, with more accessible and effective therapies becoming available to patients in need.
Substance Use Disorder (SUD) Disease Understanding and Treatment
Substance Use Disorder (SUD) Overview
Substance Use Disorder (SUD) is a complex condition marked by the uncontrolled use of substances, such as alcohol, tobacco, or other psychoactive drugs, despite harmful consequences. Individuals with SUD often become addicted, developing an intense focus on using these substances to the point where their daily functioning is impaired. Continued use leads to changes in brain function, particularly in areas related to judgment, decision-making, and behavioral control. These changes can cause cravings, distorted thinking, and behavioral shifts, even long after the immediate effects of intoxication wear off. Tolerance can develop, requiring larger amounts of the substance to achieve the desired effect, and withdrawal symptoms, including anxiety, may occur when use is discontinued.
Substance Use Disorder (SUD) Diagnosis
The diagnosis of Substance Use Disorder (SUD) begins with a comprehensive evaluation by a healthcare professional, often initiated by concerns raised by family members, friends, or the individual themselves. The process typically involves an intake assessment, which may occur at a drug rehab facility or through a physician or addiction specialist. The clinician will ask about the frequency of substance use, its impact on the person's life, and whether it has caused problems in social, occupational, or educational functioning. They will also assess whether physical dependence, withdrawal symptoms, and tolerance are present. Using the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), the physician evaluates whether the individual meets at least two of the 11 diagnostic criteria for SUD within a one-year period. Based on the number of criteria met, the severity of the disorder is classified as mild (2-3 criteria), moderate (4-5), or severe (6 or more). This diagnostic evaluation helps determine the extent of the disorder and guides the treatment recommendations.
Substance Use Disorder (SUD) Treatment
Treatment for substance use disorder typically involves a combination of individual, group, and family therapy to develop skills for sobriety and navigate situations without turning to substances. Common therapeutic approaches include Cognitive Behavioral Therapy (CBT) to address negative thought patterns, Contingency Management (CM) to encourage sobriety with rewards, Motivational Interviewing (MI) to resolve ambivalence, and Dialectical Behavioral Therapy (DBT) to regulate emotions and reduce cravings. Other methods like Eye Movement Desensitization and Reprocessing (EMDR) for trauma, Rational Emotive Behavior Therapy (REBT) for healthier thinking, and Seeking Safety for trauma and substance misuse are also used. The Matrix Model, 12-Step Facilitation, and the Gottman Method for couples are additional strategies to promote recovery and prevent relapse. In addition to these therapies, medications such as buprenorphine, naltrexone and others are commonly used to treat substance use disorders, especially in managing opioid dependence.
Further details related to treatment and management are provided in the report...
The Substance Use Disorder epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of SUD, Substance type-specific Cases of SUD, Total Treated Cases of SUD 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 Substance 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. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Substance 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 Substance Use Disorder, one of the most important primary endpoints was achieving Change in anxiety as measured by heart rate, Change in blood pressure and anxiety, and others. 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.