There's a light at the end of the tunnel - but it's not a light up

January is a time when many smokers strengthen their resolve to kick their habit, with 1.2 million estimated to have embarked on this journey this New Year's Day in the UK alone(1). However, as smokers who have attempted and failed to quit will agree, will power by itself is often not sufficient and smoking cessation aids are often needed. Estimated to be worth just $213 million 2006**, according to a new report* from independent market analyst Datamonitor, the prescription nicotine dependence market is set to grow strongly at a compound annual growth rate (CAGR) of 16% to reach $4.6 billion by 2016**. It will be driven by the launch of two promising pipeline nicotine vaccines and the continued uptake of Pfizer's popular nicotine receptor agonist Chantix (varenicline).

Few smokers seek help with quitting from their doctor

Although the dangers of tobacco use have been recognized for over half a century, and in an increasing number of countries have resulted in the banning of smoking in enclosed spaces (this law was enforced in the UK last July), nicotine dependence continues to represent a serious public health problem. Indeed, smoking is a major contributor to illnesses such as lung cancer, emphysema, heart disease and stroke, and is one of the world's leading causes of preventable death.

Datamonitor estimates that nicotine dependence affects almost 116 million individuals across the seven major markets (7MM) – France, Germany, Italy, Japan, Spain, UK and US – in 2007, says Datamonitor central nervous system (CNS) analyst Charlotte Mackey. “Despite the currently high prevalence of nicotine dependence, evidence suggests that only a small proportion of individuals actively seek help from their primary care physician (PCP).”

Key opinion leaders interviewed by Datamonitor concur that only between 3 and 5% of potential patients seek help from their PCP.

Currently limited range of prescription treatments

A plausible reason for the low presentation rate to PCPs is that until recently, there was not an efficacious prescription drug available to patients. At present, the nicotine dependence market consists of a wide range of over-the-counter (OTC) products, such as a multitude of nicotine replacement gums and patches, with sales exceeding $2 billion across the 7MM in 2006. By comparison, the prescription nicotine-dependence market is considerably under-developed, with just two marketed products: GlaxoSmithKline's Zyban (bupropion) and Chantix, which garnered combined sales of $213m across the US and five major European markets in 2006. There are currently no prescription nicotine-dependence drugs available in Japan, says Mackey.

“Although the convenient access of OTC products to smokers intending to quit but not willing to see a physician and the sheer size of this market represents considerable competition to prescription products, the success of Chantix demonstrates that an efficacious drug, combined with a strong direct-to-consumer (DTC) advertising campaign in the US can lead to an increase in presentation to PCPs,” she says.

Since its August 2006 launch, Chantix has experienced a strong uptake, particularly in the US, with sales exceeding $87m across the six major markets (6MM) in 2006. As such, Datamonitor believes that the under-developed prescription market has enormous potential for growth.

Drugs that reduce relapse rates can expect strong uptake

Despite the availability of two prescription drugs and a wide range of OTC products, nicotine dependence remains a chronically relapsing condition with only a minority of individuals achieving permanent abstinence in an initial attempt to quit. According to the National Institute for Health and Clinical Excellence (NICE) (2) in the UK, it is estimated that about four million smokers a year attempt to quit but that only 3 to 6% of these succeed. Therefore, Datamonitor believes that the development of a drug that demonstrates a lower relapse rate than Chantix can expect to gain substantial revenue, Mackey says.

“In view of the size of the patient potential of nicotine dependence, the opportunity for a drug offering an improvement on current treatments is huge,” she says.

A key advantage to companies entering the nicotine dependence market is that compared to several other markets, achieving reimbursement for a new drug is unlikely to be difficult. Healthcare payers and governmental bodies (such as the UK's NICE), should be willing to approve such drugs owing to the long-term savings accrued from reducing the incidence of smoking-related illnesses.

Nicotine vaccines set to make substantial impact on market

Datamonitor believes that the most promising candidates in the current pipeline for the potential treatment of nicotine dependence are the nicotine vaccines, which are designed to prevent nicotine from entering the brain, thereby reducing the pleasurable effects of smoking.

Nicotine vaccines are the largest drug class in late-stage development for the treatment of nicotine dependence, representing a move away from nicotine replacement and nicotine agonist therapies that have historically dominated the market. Datamonitor predicts the launch of two nicotine vaccines in 2010 and 2012 respectively: Nabi Biopharmaceuticals' NicVAX and Novartis' NIC-002.

The novel mechanism of action of NicVAX is expected to generate strong interest among physicians and Datamonitor forecasts the drug to garner 7MM combined sales of $706m by 2016. Despite the second-to-market status of NIC-002, it is predicted that the compound's strong efficacy, combined with Novartis' strong sales and marketing experience will lead to a strong uptake, achieving sales of $1.3 billion in 2016.

Despite yielding promising clinical trial results, neither of the nicotine vaccines is likely to be able to reduce an individual's craving for nicotine. Therefore, in theory, use of a nicotine vaccine in conjunction with an anti-craving drug has the potential to bolster long-term quit rates.

The injectable formulations of the vaccines and the need to take time off work in order to be administered the vaccine by a healthcare professional may deter some from using NIC-002 and NicVAX. However, opinion leaders interviewed by Datamonitor were unanimously optimistic about the potential of vaccines in the treatment of nicotine dependence and reported that there would be a sufficiently strong uptake among patients with a strong motivation to quit smoking.

“The utility of vaccines in nicotine dependence lies in their convenient dosing regimen and long-term irreversibility which has the potential to improve patient compliance and reduce relapse rates, a key obstacle in the successful treatment of nicotine dependence,” Mackey says.

“Due to these advantages, Datamonitor believes nicotine vaccines will become important players in the nicotine dependence market in the future, potentially allowing millions of smokers to kick the habit and playing a key role in the market growing strongly to reach $4.6 billion across the 7MM by 2016.”

* Pipeline Insight: Substance Dependence – Part I: Nicotine
** Seven major markets: UK, US, France, Germany, Italy, Japan and Spain, MIDAS Sales Data, IMS Health, July 2007.

References

1. Office for National Statistics.
2. NICE Guidelines 2002, http://guidance.nice.org.uk.
Datamonitor's report Pipeline Insight: Substance Dependence – Part I: Nicotine provides analysis of drugs in late-stage clinical development for use in treating nicotine dependence, including important clinical trial results, patient potential, and drug revenue forecasts to 2016; supported by key opinion leader comments.