Smoking Cessation and Nicotine Addiction Market

Emerging therapies for smoking cessation and nicotine addiction, including Cytisinicline (cytisine), NFL-101, EMB-001, and others, are expected to drive growth in the market over the coming years.

DelveInsight has published a new report, “Smoking Cessation and Nicotine Addiction – Market Insights, Epidemiology, and Market Forecast–2034”, offering comprehensive insights into the disease, historical and projected epidemiology, and market trends across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

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Some of the key facts of the Smoking cessation and nicotine addiction Market Report:

• In 2023, the United States recorded the highest number of prevalent smoking cessation cases, followed by the EU4, the UK, and Japan, whereas tobacco use was most widespread in the EU4 and the UK. That year, the US led the 7MM (seven major markets) in market size for smoking cessation and nicotine addiction, reaching approximately USD 1,472 million, while Germany reported the smallest market at USD 46 million, though this is expected to increase by 2034.

• The global smoking cessation and nicotine addiction market is projected to grow over the 2024–2034 forecast period, driven by the introduction of novel therapies such as cytisinicline, AXS-05, and NFL-101. According to DelveInsight estimates, in 2023, the EU4 and the UK had the highest number of tobacco users at roughly 63.95 million, followed by the US with 50.89 million and Japan with 20.19 million. These numbers are expected to decline across these regions by 2034.

• In the US, tobacco use in 2023 was more common among males (~31.04 million cases) compared to females (~19.85 million cases). In January 2025, the FDA proposed a landmark rule to limit nicotine levels in cigarettes and other combustible tobacco products to 0.7 mg per gram, aiming to make them minimally or non-addictive. This measure could potentially help 19.5 million people quit smoking within five years and prevent over 48 million young people from initiating use. The rule is open for public comment and would take effect two years after finalization.

• Additionally, in early 2025, the FDA approved Zyn, a tobacco-free nicotine pouch by Philip Morris International, available in 10 flavors including mint and coffee. This approval was based on evidence suggesting lower health risks compared to traditional cigarettes and smokeless tobacco, although concerns remain about flavored products appealing to youth.

• Key companies developing treatments in this space include Achieve Life Sciences, NFL Biosciences SAS, and others. Promising therapies comprise CHANTIX/CHAMTIX (varenicline), ZYBAN (bupropion), Cytisinicline (cytisine), NFL-101, EMB-001, and additional investigational drugs aimed at improving the smoking cessation and nicotine addiction treatment landscape.

Smoking cessation and nicotine addiction Overview

Nicotine dependence is a complex condition involving behavioral, cognitive, and physical responses that develop from repeated tobacco use. It is marked by strong cravings, difficulty controlling intake, continued use despite harmful effects, prioritization of tobacco over other activities, increased tolerance, and withdrawal symptoms. Tobacco, most commonly consumed through smoking, chewing, or snorting, is the primary source of nicotine, with cigarette smoking being the most prevalent and harmful method.

Several factors contribute to nicotine addiction, including weak enforcement of smoking regulations, low awareness, limited motivation to quit, inadequate training for healthcare professionals, and insufficient treatment options, particularly in developing countries. Regular tobacco use leads to neuroadaptation and tolerance, while quitting often triggers withdrawal symptoms such as anxiety, irritability, increased appetite, and mood disturbances, which are further reinforced by conditioned behaviors. Together, these factors underscore the substantial global health burden associated with tobacco dependence.

Smoking cessation and nicotine addiction Market Outlook

Effective tobacco cessation strategies combine behavioral interventions with FDA-approved medications. A variety of products and services are available to support quitting smoking, alongside alternative nicotine products not specifically designed for cessation. Approved pharmacological options include nicotine replacement therapies (NRTs) such as transdermal patches, gums, nasal sprays, oral inhalers, and lozenges.

Additionally, the U.S. FDA has approved two non-nicotine prescription medications for smoking cessation: CHANTIX (varenicline tartrate) and ZYBAN (bupropion hydrochloride), both administered as tablets. Generic versions of these drugs are now widely available in the U.S. and European markets. In Japan, cessation strategies include varenicline (CHAMPIX), NRTs, and some off-label treatments, although bupropion-SR is not approved for this purpose.

Key companies developing new therapies include Achieve Life Sciences (Cytisinicline), Axsome Therapeutics (AXS-05), and NFL Biosciences (NFL-101). Their investigational treatments are at various stages of clinical development, targeting both smoking cessation and nicotine addiction.

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Smoking cessation and nicotine addiction Marketed Drugs

• CHANTIX/ CHAMTIX (varenicline): Pfizer

• ZYBAN (bupropion): GlaxoSmithKline

Smoking cessation and nicotine addiction Emerging Drugs

• Cytisinicline (cytisine): Achieve Life Sciences

• NFL-101: NFL Biosciences SAS

• EMB-001: Embera NeuroTherapeutics, Inc.

Scope of the Smoking cessation and nicotine addiction Market Report

• Study Period: 2020-2034

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key Smoking cessation and nicotine addiction Companies: Achieve Life Sciences, NFL Biosciences SAS, and others

• Key Smoking cessation and nicotine addiction Therapies: CHANTIX/ CHAMTIX (varenicline), ZYBAN (bupropion), Cytisinicline (cytisine), NFL-101, EMB-001, and others

• Smoking cessation and nicotine addiction Therapeutic Assessment: Smoking cessation and nicotine addiction current marketed and Smoking cessation and nicotine addiction emerging therapies

• Smoking cessation and nicotine addiction Market Dynamics: Smoking cessation and nicotine addiction market drivers and Smoking cessation and nicotine addiction market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Smoking cessation and nicotine addiction Unmet Needs, KOL’s views, Analyst’s views, Smoking cessation and nicotine addiction Market Access and Reimbursement

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Key benefits of the Smoking cessation and nicotine addiction Market Report:

1. Smoking cessation and nicotine addiction market report covers a descriptive overview and comprehensive insight of the Smoking cessation and nicotine addiction Epidemiology and Smoking cessation and nicotine addiction market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).

2. The Smoking cessation and nicotine addiction market report provides insights into the current and emerging therapies.

3. The Smoking cessation and nicotine addiction market report provides a global historical and forecasted market covering drug outreach in 7MM.

4. The Smoking cessation and nicotine addiction market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Smoking cessation and nicotine addiction market.

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Table of Contents

1. Report Introduction

2. Executive Summary

3. SWOT analysis

4. Smoking cessation and nicotine addiction Patient Share (%) Overview at a Glance

5. Smoking cessation and nicotine addiction Market Overview at a Glance

6. Smoking cessation and nicotine addiction Disease Background and Overview

7. Smoking cessation and nicotine addiction Epidemiology and Patient Population

8. Country-Specific Patient Population of Smoking cessation and nicotine addiction

9. Smoking cessation and nicotine addiction Current Treatment and Medical Practices

10. Unmet Needs

11. Smoking cessation and nicotine addiction Emerging Therapies

12. Smoking cessation and nicotine addiction Market Outlook

13. Country-Wise Smoking cessation and nicotine addiction Market Analysis (2020–2034)

14. Market Access and Reimbursement of Therapies

15. Market drivers

16. Market barriers

17. Appendix

18. Smoking cessation and nicotine addiction Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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Smoking cessation and nicotine addiction Pipeline Insights, DelveInsight

“Smoking cessation and nicotine addiction Pipeline Insight, 2024” report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Smoking cessation and nicotine addiction market. A detailed picture of the Smoking cessation and nicotine addiction pipeline landscape is provided, which includes the disease overview and Smoking cessation and nicotine addiction treatment guidelines.

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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