Opioid Withdrawal Syndrome - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• The Opioid Withdrawal Syndrome market is projected to witness consistent growth throughout the forecast period (2023-2034). The market size of Opioid Withdrawal Syndrome in the 7MM is expected to increase, driven by the launch of emerging therapies.
• The analyst's analyst projects that the total number of Opioid withdrawal syndrome cases in 7MM were approximately 8,169,411 in 2022 and these cases are further expected to decrease during the forecasted period (2023-2034).
• Most number of opioid misuse cases were estimated in the US, followed by UK, Italy, and France in 2022.
• In the US, the market mainly consisted of opioid agonist-antagonist, Alpha-2 adrenergic agonists and others, which generated nearly USD 1.17 billion in 2022.
• The total size of the Opioid withdrawal syndrome treatment market is anticipated to experience growth during the forecast period due to the emergence of new and effective treatments, namely DMX-1002 (Ibogaine), and others.

This report delivers an in-depth understanding of the Opioid Withdrawal Syndrome, historical and forecasted epidemiology and the Opioid Withdrawal Syndrome market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Opioid Withdrawal Syndrome market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM, Opioid Withdrawal Syndrome market size from 2020 to 2034. The report also covers current Opioid Withdrawal Syndrome treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

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

Study Period: 2020-2034

Disease Understanding and Treatment Algorithm

Opioid Withdrawal Syndrome Overview

Opioid withdrawal is a constellation of symptoms that occurs after abrupt cessation, therapeutic discontinuation, or dosage reduction of opioids (ie, µ-receptor agonists), or after administration of an opioid antagonist (naltrexone or naloxone) or in some cases partial opioid agonist (buprenorphine) to a person who is physically dependent on opioids as a result of persistent, regular use.

According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, signs and symptoms of opioid withdrawal include lacrimation or rhinorrhea, piloerection "goose flesh," myalgia, diarrhea, nausea/vomiting, pupillary dilation, photophobia, insomnia, autonomic hyperactivity (tachypnea, hyperreflexia, tachycardia, sweating, hypertension, hyperthermia), and yawning.

Opioid Withdrawal Syndrome Diagnosis

Although there is no diagnostic test for opioid withdrawal, urine toxicology must be checked to rule out withdrawal from any other drugs or combination of drugs. Urine toxicology is positive for most opioids such as morphine, heroin, codeine, oxycodone, and propoxyphene) for 12 to 36 hours after use. Methadone, buprenorphine, and LAAM (L-alpha-acetylmethadol) will not be detected in positive urine opiate tests, and they must be specifically tested. Urine toxicology for other drugs (marijuana, cocaine, benzodiazepine, and amphetamines) may also be commonly positive in opiate users. ECG, complete blood count (CBC), blood alcohol level, and basic metabolic panel (BMP) should also be done. COWS (Clinical Opioid Withdrawal Scale) assessment for opioid withdrawal is commonly used to determine the severity of opioid withdrawal.

Opioid Withdrawal Syndrome Treatment

The primary treatment for opioid withdrawal syndrome involves a combination of medications and supportive care. Medications like methadone, buprenorphine, and naltrexone are commonly used to alleviate withdrawal symptoms and manage cravings. These medications work by either mimicking the effects of opioids to a lesser extent or blocking the opioid receptors. Additionally, supportive care may include counseling, behavioral therapies, and psychosocial support to address the psychological aspects of addiction. Symptomatic treatment in opioid withdrawal includes loperamide for diarrhea, promethazine for nausea/vomiting, and ibuprofen for myalgia. Clonidine can be given to reduce blood pressure.

Opioid Withdrawal Syndrome Epidemiology

As the market is derived using the patient-based model, the Opioid Withdrawal Syndrome epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Number of Opioid misuse cases, Number of cases with long-term opioid usage, and Total Opioid Withdrawal Syndrome Cases in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan, from 2020 to 2034.

According to estimations, 9,077,124 Number of cases with long-term opioid usage were found in 2022 in the 7MM.

As per the analyst's estimations, the total number of cases with opioid withdrawal syndrome in the United States were approximately 7,087,561 in 2022 and are projected to decrease during the forecast period.

According to the analyst's estimates, the number of opioid misuse cases in EU4 and the UK were found to be approximately 1,365,293 in 2022.

Opioid Withdrawal Syndrome Drug Chapters

The drug chapter segment of the Opioid Withdrawal Syndrome report encloses a detailed analysis of Opioid Withdrawal Syndrome marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also understands Opioid Withdrawal Syndrome 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.

Marketed Drugs

LUCEMYRA (lofexidine hydrochloride): US World Meds LLC

LUCEMYRA is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine. LUCEMYRA is not an opioid drug. While LUCEMYRA may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days. LUCEMYRA is not a treatment for OUD but can be used as part of a broader, long-term treatment plan for managing OUD.

LUCEMYRA is under license from Britannia Pharmaceuticals, Ltd. USWM, LLC is the exclusive licensee and distributor of LUCEMYRA in the United States and Its territories.

Emerging Drugs

DMX-1002 (Ibogaine HCl): DemeRx IB, Inc. /atai Life Sciences

DMX-1002 is an oral formulation of ibogaine, an oneirogenic indole alkaloid with cholinergic, glutamatergic, and monoaminergic receptor modulatory activity.

Ibogaine is a natural indole alkaloid derived from the West African iboga plant and has previously been marketed as a stimulant and antidepressant in France under the brand name Lambarène. Known for its oneirophrenic and hallucinogenic properties, uncontrolled data from hundreds of patients suggest that Ibogaine is effective as both an acute detoxifier and treatment for opioid addiction.

At present, DMX-1002 is in Phase I/II of clinical development for the treatment of Opiate Withdrawal Syndrome. As per the DemeRx pipeline, the drug is being developed for opioid withdrawal management and relapse prevention, whereas as per atai Life Sciences pipeline, the drug is being developed for OUD treatment.

MN-166: Medicinova

MN-166 is a first in class, orally bioavailable, small molecule glial attenuator that suppresses pro-inflammatory cytokines IL-1ß, TNF-a, and IL-6 and may upregulate the anti-inflammatory cytokine IL-10. It has additionally been shown to be a toll-like receptor 4 (TLR4) functional antagonist that may contribute to its attenuation of neuroinflammation. While considered a New Molecular Entity, or NME, in the United States and Europe, it involves redirection of an approved drug, ibudilast, which was first approved in Japan more than 20 years ago.

Opioid Withdrawal Syndrome Market Outlook

The treatment approach for Opioid Withdrawal Syndrome depends on the severity of the symptoms experienced by the individual. In cases of mild withdrawal, patients are encouraged to prioritize hydration by consuming at least 2-3 L of water daily and may benefit from supplementation with vitamins B and C to support overall health. Typically, symptomatic treatment and supportive care suffice for managing mild symptoms, focusing on alleviating discomfort and ensuring the patient's well-being during this phase.

For individuals experiencing moderate to severe opioid withdrawal, pharmacotherapy becomes a crucial component of treatment. Medications such as clonidine, an alpha-2 adrenergic agonist, are commonly used to alleviate physical symptoms such as sweating, diarrhea, and abdominal cramps. However, it is important to monitor for potential side effects such as drowsiness and low blood pressure. Buprenorphine is often preferred for moderate to severe withdrawal due to its efficacy in symptom relief and craving reduction. Nevertheless, caution is warranted, especially in patients with respiratory issues or diabetes.

The market for Opioid Withdrawal Syndrome is expected to experience positive growth with the approval of potential drugs like DMX-1002 (Ibogaine), BXCL501 and others.

• The total market size of Opioid Withdrawal Syndrome in the 7MM was around USD 1.30 billion in 2022. This is estimated to increase by 2034 at a significant CAGR.
• In the 7MM, most of the market share was accommodated by Opioid agonist-antagonist generating nearly USD 1.10 billion in 2022.
• Among the 7MM, the US captured the highest market in 2022, covering a total of 90% market, followed by the UK, which is anticipated to grow during the forecast period (2023-2034).
• In 2022, EU4 and the UK captured nearly 9% of the total market in the 7MM.
• Among the forecasted emerging therapies, DMX-1002 (Ibogaine) is expected to capture the highest market in the 7MM by 2034.

Opioid Withdrawal Syndrome Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2023-2034. For example, DMX-1002 (Ibogaine) in the US is expected to be launched by 2028.

Opioid Withdrawal Syndrome 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 Opioid Withdrawal Syndrome 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 the secondary research. Industry Experts were contacted for insights on Opioid Withdrawal Syndrome evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from Texas A and M University, College Station, TX, USA, Baylor College of Medicine, Houston, Texas, University of Southern California, USA, Bremen Institute of Drug Research, University of Bremen, Germany, Meiji Pharmaceutical University, Tokyo and others.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or Opioid Withdrawal Syndrome 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

We perform 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.

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

The high cost of therapies for the treatment is a major factor restraining the growth of the drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The report further provides detailed insights on the country 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.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of Opioid Withdrawal Syndrome, explaining its causes, signs and symptoms, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will affect the current treatment landscape.
• A detailed review of the Opioid Withdrawal Syndrome market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the 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 preference that help shape and drive the 7MM Opioid Withdrawal Syndrome market.

Opioid Withdrawal Syndrome Report Insights

• Patient Population
• Therapeutic Approaches
• Opioid Withdrawal Syndrome Pipeline Analysis
• Opioid Withdrawal Syndrome Market Size and Trends
• Existing and Future Market Opportunity

Opioid Withdrawal Syndrome Report Key Strengths

• 12 years Forecast
• The 7MM Coverage
• Opioid Withdrawal Syndrome Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Opioid Withdrawal Syndrome Report Assessment

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

Key Questions

Market Insights

• What was the Opioid Withdrawal Syndrome total market size, the market size by therapies, and market share (%) distribution in 2020, and how would it all look in 2034? What are the contributing factors for this growth?
• What unmet needs are associated with the current treatment market of Opioid Withdrawal Syndrome?
• What are the patents of emerging therapies for Opioid Withdrawal Syndrome?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for 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 Withdrawal Syndrome? What will be the growth opportunities across the 7MM concerning the patient population of Opioid Withdrawal Syndrome?
• What is the historical and forecasted Opioid Withdrawal Syndrome patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• What factors are affecting the diagnosis of the indication?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for treating Opioid Withdrawal Syndrome? What are the current guidelines for treating Opioid Withdrawal Syndrome in the US and Europe?
• How many companies are developing therapies for treating Opioid Withdrawal Syndrome?
• How many emerging therapies are in the mid-stage and late stage of development for treating Opioid Withdrawal Syndrome?
• 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 the emerging therapies for Opioid Withdrawal Syndrome?
• What is the cost burden of approved therapies 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, recently approved therapies? Focus on reimbursement policies.
• What are the 7MM historical and forecasted markets of Opioid Withdrawal Syndrome?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Opioid Withdrawal Syndrome 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.
• 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), 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, 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 off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders 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.

Frequently Asked Questions

1. What is the forecast period covered in the report?

The Opioid Withdrawal Syndrome Epidemiology and Market Insight report for the 7MM covers the forecast period from 2023 to 2034, providing a projection of market dynamics and trends during this timeframe.

2. Who are the key players in the Opioid Withdrawal Syndrome market?

The Opioid Withdrawal Syndrome emerging market has many drugs. The major key players developing therapies for Opioid Withdrawal Syndrome are atai Life Sciences, Medicinova, BioXcel Therapeutics Inc., and others.

3. How is the market size estimated in the forecast report?

The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as prevalent cases, treatment costs; revenue generated, and market trends.

4. What is the key driver of the Opioid Withdrawal Syndrome market?

The launch of emerging therapies is attributed to be the key driver for increasing Opioid Withdrawal Syndrome market.

5. What is the expected impact of emerging therapies or advancements in Opioid Withdrawal Syndrome treatment on the market?

Introducing new therapies, advancements in disease understanding and diagnostic techniques, and innovations in treatment approaches can significantly affect the Opioid Withdrawal Syndrome treatment market. Market forecast reports might provide analysis and predictions regarding the potential impact of these developments.

6. Does the report provide insights into the competitive landscape of the market?

The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive dynamics of the Opioid Withdrawal Syndrome market.