Wake up call

Wake up call

It seems that more and more Indians are finding it difficult to get a good night’s sleep. No wonder then that India’s share of the global market for sleep remedies, which runs into few billions, is increasing with each passing year. Sachin Jagdale analyses the situation

Insomnia, a sleeping disorder characterised by ‘persistent difficulty in falling asleep’, first made its appearance in Western countries like US and UK, but is now keeping Asian populations as well awake till the wee hours of the morning. India, which enjoys the dubious distinction of being the Wworld’s second most populated country, is also expected to join this club in the coming years.

The fact that ‘sleeplessness’ is regarded as an epidemic among the medical community should be the ‘wake up’ call for the Indian population, how did this reach such proportions in the first place?

Insomnia, a global worry

Shakti P Chakraborty, Group President-India Region Formulations, Lupin, opines, “ Insomnia is becoming an increasingly common complaint which currently affects more than a third of all adults worldwide, in varying degrees. Increasing demands in the workplace, extended working hours and the resultant increase in stress experienced by people have all contributed to this epidemic. In the West alone, more than 60 million individuals have insomnia, and the number is growing every day. The US has the largest number of insomniacs anywhere in the world, followed by Germany and the UK.” He adds, “As per a recent survey, Indians are increasingly suffering from sleep disorders. For instance, around 93 percent of Indians have been found to be sleep deprived – getting less than the eight hours of sleep they need per day. This leads to poorer immunity and a host of other health problems.”

“As per a recent survey, Indians are increasingly suffering from sleep disorders. For instance, around 93 per cent of Indians have been found to be sleep deprived – getting less than the eight hours of sleep they need per day”

– Shakti P Chakraborty Group President-India Region Formulations

Lupin

Charlotte Mackey, senior healthcare analyst, Datamonitor, raises another point that patients use non-pharmaceutical solutions and do not raising the issue with doctors because they do not believe it (lack of sleep) is important. “Also doctors are not focused on asking about sleep patterns and do not look out for insomnia as a medical condition.”

Getting comparative figures for insomnia is difficult as he points out thatepidemiology studies assessing the prevalence of insomnia in countries outside of the seven major markets are sparse. For instance, in the BRIC (Brazil, Russia, India and China) region, national surveys exist only for Brazil and China. Published studies report the prevalence of insomnia in Brazil to be 32 percent to 38.9 percent. By comparison, population studies in China report greater breadth of insomnia prevalence rates, ranging from 9.2 percent to 32.9 percent, reveals Mackey.

While echoing some of Mackey’s views Chakraborty also stresses on the necessity of bringing in some of the measures employed by western countries to India to curb insomnia. He informs, “Typically, Indians do not like talking about sleep – related problems. It is considered more of a lifestyle disease such as diabetes is. But things have changed now and, like diabetes, people have been taking sleep deprivation seriously. Many hospitals in the country now have dedicated departments for sleep disorders. But a lot still needs to be done when you consider that western countries have sleep labs and clinics that conduct polysomnography tests and monitor breathing patterns while sleeping to give patients a detailed diagnosis.”

Country

Age group

Overall prevalence (%)

US

13–16 yrs

10.7

US

18 yrs

5.4

Japan

20 yrs

4.5

France

15 yrs

5.6

Germany

18 yrs

4.7

Italy

15 yrs

6.8

Spain

15 yrs

7.9

UK

15 yrs

6.4

Global market for insomnia

Globally the market for insomnia drugs is flourishing like never before. US remains the dominant force here as well but other countries are fast catching up. The market figures available today rightly proves this fact. As per the statistics provided by Mackay, total prescription sales for prescription insomnia drugs across the world stood at $4.3 billion in 2009, with the ex-seven major market region accounting for 22.1 percent (MIDAS sales data, IMS Health, March 2010). Accounting for 48 percent of global sales, the US represents the most dominant region. The rest of the world market was valued at $954 million in 2009, therefore occupying a greater market share than the combined 5EU (France, Germany, Italy, Spain and UK). In terms of total sales volume (IMS standard units prescribed), the rest of the world market accounted for over half (59 percent) of global sales market sales, with the BRIC (Brazil, Russia, India and China) countries constituting 32 percent of sales volume within this region (MIDAS sales data, IMS Health, March 2010).

“However, the launch of several new products over the last few years has helped to increase patient awareness. Particularly among elderly patients, tranquillisers, sleeping pills and anti-depressants alone account for an estimated $75 billion of the $ 300 billion prescription drug market worldwide,” informs Chakraborty.

Brand

2009 sales ($m)

Growth 2008–09 (%)

CAGR 2005–09 (%)

Market share 2009 (%)

Ambien CR (zolpidem controlled release) 923 5.10% 92.40% 27.50%
Lunesta (eszopiclone) 728 -3.40% 24.60% 21.70%
Ambien (zolpidem) 439 4.20% -33.50% 13.10%
Rozerem (ramelteon) 84 -15.80% 63.00% 2.50%
Imovane (zopiclone) 74 -3.30% -2.90% 2.20%
Total of key brands 2248 0.90% -4.60% 66.90%
CAGR = compound annual growth rate

US will face the heat

According to Datamonitor uptake of current pipeline candidates is expected to offset intensifying generic erosion of the insomnia market over 2010–2019. In 2019, the insomnia market is forecast to be a total $3.5 billion, across the seven major markets (compound annual growth rate [CAGR] 2010–19: 0.5 percent). While growth of the US market is set to be inhibited by further generic erosion from 2011 onwards, Japan will represent the key growth region over the next 10 years.

Indian pharma players are gearing up to benefit from patent expiries, and many are already networked with national wholesalers and pharmacy chains in the US. For instance, Lupin’s US subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for the company’s Eszopiclone tablets, from the US Food and Drug Administration (USFDA). The brand product had annual sales of approximately $761 million for the 12 months ended December 2009, based on IMS Health sales data. “We look forward to bringing Eszopiclone tablets to the US market as an affordable generic alternative post patent expiry (in 2012 )and expect good revenues from the same,” says an optimistic Chakraborty.

Molecule ZolpiMist Mechanism of action Company Phase (country) Formulation
Zolpidem Silenor GABAa receptor agonist Novadel Pharma Inc/ ECR Pharmaceuticals Approved (US) Oral spray
Doxepin hydrochloride NBI34060 5-HT reuptake inhibitor Somaxon Pharmaceuticals Approved (US) Oral tablet
Indiplon Intermezzo GABAa receptor agonist Neurocrine Biosciences Registration (US) Oral capsule
Zolpidem ACT-078573 GABAa receptor agonist Transcept Pharmaceuticals Registration (US) Oral sublingual tablet
Almorexant MK-4305 Orexin receptor antagonist Actelion Pharmaceuticals/ GlaxoSmithKline III (US and EU) Oral tablet
Unknown VEC-162 Orexin receptor antagonist Merck & Co Inc III (US and EU) Oral
Tasimelteon GSK649868 Melatonin MT1 and MT2 receptor agonist Vanda Pharmaceuticals III (US) Oral capsule
Unknown ITI-722 Orexin receptor antagonist GlaxoSmithKline II (Germany) Oral
Unknown MK-6096 5-HT2A receptor agonist Intra-Cellular Therapies, Inc. II (US) Oral
Unknown Orlogin Unknown Merck & Co Inc II (US) Unknown
Unknown LY2624803 Melatonin MT1 receptor agonist Neurim Pharmaceuticals II (Israel, Switzerland) Unknown
Unknown SKP-1041 H1/5HT2a compound Eli Lilly & Co II (US) Oral capsule
Zaleplon AZ-007 GABAa receptor agonist Somnus Therapeutics II (US) Oral tablet
Zaleplon Zaleplon- GR GABAa receptor agonist Alexza Pharmaceuticals I (US) Respiratory inhalation
Zaleplon Neu-P11 GABAa receptor agonist Intec Pharma Ltd I (Israel) Oral
Unknown AB1003 Melatonin MT1 and MT2 receptor agonist Neurim Pharmaceuticals I (Israel, Switzerland) Unknown
Unknown   Unknown Abielle Pharmaceuticals Preclinical (US) Oral controlled release
GABA = gamma-aminobutyric acid; 5-HT2A = 5-hydroxytryptamine (known as serotonin).
Note: ZolpiMist (zolpidem) and Silenor (doxepin hydrochloride) received regulatory approval from the Food and Drug Administration (FDA) in December 2008 and March 2010 respectively. However, as of July 2010, launch of these products had not yet taken place. Therefore, for the purposes of this report, Datamonitor has classified ZolpiMist and Silenor as pipeline drugs.

Misuse of drugs

There is potential misuse/abuse of sleeping pills and its been a prerogative of pharma companies to prevent this throught various strategies like tracking the use and strict control of prescriptions, conducting awareness campaigns, setting up anti-suicide and anti-depression helplines, etc. The availability of medical information online has no doubt led to increased knowledge level of medicines, and also increased awareness levels on situations like insomnia. Unfortunately, better access to such medications overthecounter have led to self-medication and in most cases, over use/misuse of these drugs. Most patients do not realise that medical information gained over the net and from books is superficial at best and in no whay can substitute a medical practitioner’s inputs. Ignorance about the long term effects of such medications could also lead to severe consequences, including loss of life

“The trend of pharma drug abuse is increasing as people have easier access to them now and especially with drug prices coming down. This has become a serious problem in countries like ours where the pharma industry is booming and hence people are spoilt for choice. Inappropriate prescriptions and uninformed use of prescriptions cost health care systems billions of dollars each year and affects the quality of life of millions worldwide and India is no exception. Long term use of medications such as tranquilisers and sleeping pills can result in brain damage which can be permanent. Studies show that close to 40 percent of impaired or dead drivers show prescription drugs in their system and a majority of the time, these are sedatives that greatly affect alertness,” says Chakraborty.

According to Chakraborty, controlling this problem requires a nationwide awareness campaign, strict vigilance and community involvement. In addition, automation and proper prescription control by both doctors and retailers, can be a deterrent for the misuse of insomnia drugs. This calls for cooperative action between doctors, pharma companies, government, pharmacists as well as the consumers. . “We can prevent this ongoing epidemic through education, acceptance of responsibility and accountability within a market-driven system which has unfortunately left a society crippled by the effects of mind-altering drugs,” Chakraborty concludes.

sachin.jagdale@expressindia.com