Smoking Cessation and Nicotine Addiction - Market Insight, Epidemiology And Market Forecast - 2032

Key Highlights:

• The majority of prevalent cases of smoking cessation were estimated in the US, followed by EU4 and the UK and Japan whereas the highest cases of tobacco use were in EU4 and the UK among these regions.
• In 2022, the market size of smoking cessation and nicotine addiction was highest in the US among the 7MM, accounting for approximately USD 1,470 million, and lowest in Germany with USD 46 million which is further expected to increase by 2032.
• The total market size of the smoking cessation and nicotine addiction treatment market is anticipated to experience growth during the forecast period (2023-2032) due to emerging treatments that includes cytisinicline, AXS-05, and NFL-101.
• Gender-specific prevalent cases of tobacco use were higher in males (around 82,660 thousand cases) as compared to females (around 54,350 thousand) in 2022 in the 7MM.

DelveInsight's "Smoking Cessation and Nicotine Addiction- Market Insights, Epidemiology and Market Forecast- 2032" report delivers an in-depth understanding of the smoking cessation and nicotine addiction, historical and forecasted epidemiology as well as the smoking cessation and nicotine addiction market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Smoking cessation and nicotine addiction market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM smoking cessation and nicotine addiction market size from 2019 to 2032. The report also covers current smoking cessation and nicotine addiction treatment practice/algorithm 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: 2019-2032

Smoking Cessation and Nicotine Addiction Understanding and Treatment Algorithm

Smoking Cessation and Nicotine Addiction Overview

Nicotine/tobacco dependence is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated tobacco use and that typically include a strong desire to use tobacco, difficulties in controlling its use, persistence in tobacco use despite harmful consequences, a higher priority given to tobacco use than other activities and obligations, increased tolerance and sometimes a physical withdrawal state.

Repeated exposure to nicotine develops neuro adaptation of the receptors, resulting in tolerance to many of the effects of nicotine. Withdrawal symptoms appear on stoppage of tobacco use, characterized by irritability, anxiety, increased eating, dysphoria, and hedonic dysregulation, among others. Smoking is also reinforced by conditioning.

Smoking Cessation and Nicotine Addiction Diagnosis

Metabolites of nicotine such as cotinine, nor nicotine, and anabases can be detected in urine and blood; these tests can test compliance with withdrawal therapy or nicotine toxicity. Another method to assess nicotine is COa level; this method is related to cotinine. Some questionnaires can measure nicotine dependence, such as the Fagerstrom Test for Nicotine Dependence, the Wisconsin Inventory of Smoking Dependence and Motives, and the Smokeless Tobacco Dependence Scale.

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

Smoking Cessation and Nicotine Addiction Treatment

Quitting smoking for good and overcoming nicotine dependence requires a multi-faceted approach that may include counseling, support groups, behavioral therapy, and medication. FDA-approved pharmacotherapies include various forms of nicotine replacement therapy as well as bupropion and varenicline.

Many molecules are in the pipeline to treat nicotine addiction patients across the 7MM to cater to their needs. Some major products are anticipated hit the market during 2019-2032, including cytisinicline, AXS-05, and CX-101.

Smoking Cessation and Nicotine Addiction Epidemiology

As the market is derived using patient based model, the smoking cessation and nicotine addiction epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by, Prevalent Cases of Tobacco Use, Gender-specific Prevalent Cases of Tobacco Use, Prevalent Cases of Tobacco Use by Product Type, Age-specific Prevalent Cases of Tobacco Use, Prevalent Nicotine Dependent Cases Among Cigarette Smokers, and Prevalent Cases of Smoking Cessation in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), and the UK, and Japan from 2019 to 2032. The total prevalent cases of tobacco use in the 7MM comprised of approximately 137,010 thousand cases in 2022 and are projected to decrease during the forecasted period (2023-2032).

• According to DelveInsight estimates, EU4 and the UK accounted for approximately 64,670 thousand cases, which was the highest prevalent cases of tobacco use, followed by the US with around 51,500 thousand cases, and Japan with around 20,840 thousand cases in 2022. These cases are expected to decrease in the US, EU4 and the UK, and Japan by 2032
• Among the EU4 and the UK, Germany had the highest prevalent cases of tobacco use (approximately 18,350 thousand cases), followed by France (approximately 16,410 thousand cases) in 2022. On the other hand, the UK (9,000 thousand cases) had the lowest prevalent cases of tobacco use in EU4 and the UK countries and the 7MM.
• Tobacco use has been identified as male-dominant; in our analysis, the number of males suffering was higher than females. In 2022, 60% prevalent cases tobacco use of were of males, while 40% cases were of females in the 7MM.

Smoking Cessation and Nicotine Addiction Drug Chapters

Drug chapter segment of the smoking cessation and nicotine addiction report encloses the detailed analysis of smoking cessation and nicotine addiction marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the smoking cessation and nicotine addiction 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

Cytisinicline (cytisine): Achieve Life Sciences

Cytisinicline (cytisine) is an oral, plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is an established smoking cessation treatment approved and marketed in Central and Eastern Europe for over 20 years.

Cytisinicline has completed a Phase III study, evaluating the efficacy and safety of 3 mg cytisinicline thrice a day for a treatment duration of 42 days/6 weeks in adult smokers cytisinicline. In addition to this trial, the company is conducting another Phase III study, ORCA-3, and topline data results are expected to be reported in the second quarter of 2023 to empower their findings. Achieve Life Sciences is also evaluating cytisinicline in Phase II for the e-cigarette user population and expects to announce the results by the second quarter of 2023.

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

Drug Class Insights

The treatment for nicotine addiction and smoking cessation includes various options such as nicotine replacement therapy (NRT), non-nicotinic pharmacological therapies, behavioral therapies, and counseling.

Pharmacotherapy acts synergistically with behavioral counseling to increase quit rates and should be encouraged for virtually all daily smokers and considered on a case-by-case basis for nondaily smokers. The US FDA has approved five nicotine replacement therapy (NRT) products as well as bupropion and varenicline for smoking cessation.

Smoking Cessation and Nicotine Addiction Market Outlook

There are effective treatments that support tobacco cessation, including both behavioral therapies and FDA-approved medications. Several distinct products and services are available today for smoking cessation, alongside smoking alternatives that are not specifically indicated for cessation. FDA-approved pharmacotherapies include various forms of nicotine replacement therapies (NRTs) in the form of transdermal patches, gums, nasal sprays, oral inhalers, and lozenges.

The US FDA has approved two smoking cessation products that do not contain nicotine. They are CHANTIX (varenicline tartrate), and ZYBAN (bupropion hydrochloride). Both products are available in tablet form and by prescription only. In the past years, the generic of both the approved drug has entered the market. Both are widely available in the US and the European market. In Japan, varenicline (CHAMPIX), NRT, and some off-label therapies are used for smoking cessation. Bupropion-SR is not licensed in Japan for smoking cessation.

Key players such as Achieve Life Sciences (Cytisinicline), Axsome Therapeutics (AXS-05), and NFL Biosciences (NFL-101) and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of smoking cessation and nicotine addiction.

• The total market size of smoking cessation and nicotine addiction in the 7MM was approximately USD 2,310 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 2.6% due to increasing prevalent cases of the disease and launch of the emerging therapy
• Among EU4 and the UK, France accounts for the maximum market size in 2022 while Germany occupies the bottom of the ladder in 2022

Smoking Cessation and Nicotine Addiction Drugs Uptake

This section focuses on the rate of uptake of the potential drugs expected to get launched in the market during the study period 2019-2032. For example, for cytisinicline, we expect the drug uptake to be slow medium with a probability-adjusted peak share of 18%, years to peak is expected to be 7 years from the year of launch.

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

Smoking Cessation and Nicotine Addiction 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 the detailed information of collaborations, acquisition and merger, licensing and patent details for smoking cessation and nicotine addiction emerging therapies.

KOL- Views

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

DelveInsight's analysts connected with 50+ KOLs to gather insights, however interviews were conducted with 15+ KOLs in the 7MM. Centers such as Washington University School of Medicine, Spanish Society of Family and Community Medicine, University Hospital Heidelberg, etc. were contacted. Their opinion helps to understand and validate current and emerging therapies treatment patterns or smoking cessation and nicotine addiction market trend. This will support the clients in potential upcoming novel treatment 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 analysis, and Conjoint Analysis. In SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, and patient burden, and competitive landscape, cost-effectiveness and geographical accessibility of therapies are provided. These pointers are based on Analyst's discretion and assessment of the patient burden, cost analysis and existing and evolving treatment landscape.

Conjoint Analysis is done to analyze multiple approved and emerging therapies on the basis of relevant attributes such as safety, efficacy, and frequency of administration, route of administration and order of entry. Scoring is given based on these parameters to analyze the effectiveness of a therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated, for instance, in smoking cessation and nicotine addiction trials, one of the most important primary outcome measure is the proportion of participants with smoking abstinence.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability and the 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

In the US, treatments for tobacco use and dependence can be covered through health insurance, which includes coverage through private insurance (both the individual market and the employer markets), Medicaid, or Medicare, or coverage provided to active-duty military and veterans; and/or employer-based wellness programs that may be offered in conjunction with health insurance. Comprehensive coverage of tobacco cessation treatments includes coverage of evidence-based cessation treatments (individual, group, and telephone counseling) and FDA-approved cessation medications.

The report further provides the 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.

Scope of the Report:

• The report covers a segment of key events, executive summary, descriptive overview of smoking cessation and nicotine addiction , explaining its causes, signs and symptoms, pathogenesis and currently available therapies
• Comprehensive insight has been provided into the epidemiology segments and forecasts, 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, which will have an impact on at the current treatment landscape
• A detailed review of smoking cessation and nicotine addiction 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 preference that help in shaping and driving the 7MM smoking cessation and nicotine addiction market

Smoking Cessation and Nicotine Addiction Report Insights

• Patient Population
• Therapeutic Approaches
• Smoking Cessation and Nicotine Addiction Pipeline Analysis
• Smoking Cessation and Nicotine Addiction Market Size and Trends
• Existing and future Market Opportunity

Smoking Cessation and Nicotine Addiction Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage
• Smoking Cessation and Nicotine Addiction Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Smoking Cessation and Nicotine Addiction 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 smoking cessation and nicotine addiction total market size, market size by therapies, market share (%) distribution in 2019 and how it would all look like in 2032? What are the contributing factors for this growth?
• How are different therapies going to affect the treatment paradigm of smoking cessation and nicotine addiction?
• What kind of uptake cytisinicline, AXS-05 and NFL-101 is going to witness in the coming 10 years?
• Which drug is going to be the largest contributor in 2032?
• What are the pricing variations among different geographies for approved and 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 is the disease risk, burden and unmet needs of smoking cessation and nicotine addiction? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to smoking cessation and nicotine addiction?
• What is the historical and forecasted smoking cessation and nicotine addiction patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• What is the prevalence rate of smoking cessation and nicotine addiction within tobacco use and what are the evidence from literature or primary market research related to this?
• What factors are affecting the decrease in prevalent cases of smoking cessation and nicotine addiction?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

• What are the current options for the treatment of smoking cessation and nicotine addiction? What are the current treatment guidelines for the treatment of smoking cessation and nicotine addiction in the US and Europe?
• How many companies are developing therapies for the treatment of smoking cessation and nicotine addiction?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of smoking cessation and nicotine addiction?
• 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 smoking cessation and nicotine addiction?
• What will be the impact of approved therapies expected patent expiry?
• What is the cost burden of approved therapies on patient?
• Patient acceptability in terms of preferred treatment options as per real world scenario?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
• What are the 7MM historical and forecasted market of smoking cessation and nicotine addiction?

Reasons to buy:

• The report will help in developing business strategies by understanding latest trends and changing treatment dynamics driving the Smoking Cessation And Nicotine Addiction Market Insights on patient burden/disease prevalence, evolution in diagnosis and factors contributing to the change in 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.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under 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 future
• Detailed insights on the unmet need of existing market so that the upcoming players can strengthen their development and launch strategy