- Alzheimer's
Disease
- Multiple
Sclerosis
- Attention
Deficit Hyperactivity Disorder (ADHD)
- Insomnia
- Depression
- Neuropathic
Pain
Alzheimer's
Disease: Over
the last 3 years, the value of the Alzheimer's disease market has grown
by an average of 19% per year. Growth has been driven by increasing
availability and reimbursement of Alzheimer's drugs. There are
considerable opportunities within these markets due to an ageing
population and the high unmet clinical need, particularly within the
late stage of disease. In addition, research over the last 20 years has
increased our understanding of the underlying mechani
sm
s
of disease progression and provided new targets for drug validation
resulting in a number of novel drugs entering clinical trials.
Nootropic
drugs or anti-Alzheimer's drugs are one of the largest segments of the
neurodegenerative market and accounted for 33% of global sales (US$2.6
billion in 2003 and equivalent to 4% of global CNS drug sales). The
market for drugs to treat Alzheimer's disease has grown steadily since
the launch of Aricept in 1996 and
experienced 21% growth year-on-year in 2003. Whilst the
US
accounts
for approximately 49% of global Alzheimer's drug sales, the majority of
growth occurred outside the
US
with
European sales increasing from 28% of sales in 2002 to 33% in 2003. This
is largely due to the launch of Ebixa, the
new NMDA receptor antagonist from Lundbeck/Forest,
and the recognition by regulatory committees such as the NICE in the
UK
condoning
the use of these agents in moderate-to-severe Alzheimer's disease. The
most frequently prescribed anti-Alzheimer's drug is Aricept
from Eisai/
Pfizer
,
which was launched in the major pharmaceutical markets in 1997. In 2003,
Aricept generated global sales of US$1.5
billion, accounting for approximately 54% of the market by value.
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Multiple
Sclerosis:
It
is estimated that over 350,000 Americans (approximately 1 in 1,000 aged
over 30 years) live with multiple sclerosis (MS) and approximately 3
million live with it worldwide. However, the prevalence may be higher
because of the uncertainty in diagnosing the condition. Women are twice
as susceptible as men and it is more common in people in northern
latitudes over the age of 18 years. In addition, siblings of an
individual with multiple sclerosis have a higher chance of developing
the disease. The incidence of multiple sclerosis varies throughout the
world, although there is a significantly higher incidence of the disease
found in the Northern Hemisphere. Multiple sclerosis is the most common
cause of neurological disability in young adults in the
UK
.
It is variable in presentation and progression. Although there is no
cure, there are many symptomatic treatments available. However, many
patients do not respond to current therapies (30%) and the more chronic
forms (secondary-progressive MS) are poorly treated with existing
therapies.
Approximately
56% of multiple sclerosis global sales were derived from the
US
(US$1.9
billion) in 2003, with the remainder largely derived in
Europe
(43%,
US$1.4 billion). Avonex (Biogen
Idec) is amongst the few CNS drugs that generated blockbuster sales of
over US$1 billion globally in 2003. There has been considerable growth
in sales as more beta-interferon-naive patients receive treatment due to
reimbursement of injectable agents: Betaseron
has benefited from European approval to treat secondary -progressive
multiple sclerosis (around 40% of the patient population). Sales growth
will be driven by current drugs gaining broader indications, MS medicine
being prescribed earlier in treatment in clinically -defined multiple
sclerosis patients and the longer-term use of combination therapies as
more classes of drug become available.
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Attention
Deficit Hyperactivity Disorder (ADHD): The
value of the ADHD market was US$1.7 billion in 2003 and it is now the
11th largest segment of the CNS market by sales and one of the fastest
growing (+33% year-on-year). Global sales of ADHD are forecast to reach
US$3 billion by 2010. This will be due to greater penetration in the
treatment of new patients particularly adult ADHD, improvements in
patient compliance due to the launch of new formulations, new
non-schedule II drugs and the development of novel classes of drugs in
late-stage clinical trials. There has been a significant increase in
ADHD diagnosis and prescription of medicine since the early 1990s due to
wider understanding of the condition in the mental health community,
increased use of medication and healthcare coverage and the launch of
ADHD specific drugs (from 2000 onwards). ADHD is one of the most common
psychiatric disorders of childhood and approximately 50% to 70% of
children with ADHD will continue to experience symptoms into adulthood.
In 2000, it was estimated that 4-5 million individuals (mainly children)
were diagnosed with ADHD of whom, 75-85% were
treated with psychostimulants. Over 8
million adults in the
US
may
exhibit the symptoms of ADHD, while only an estimated 600,000 are being
treated.
Approximately
97% of ADHD global sales were derived from the
US
in
2003, with the remainder from
Europe
.
This is largely due to a higher diagnosis rate in paediatrics
and availability of drugs for medical reimbursement. Over the last 3
years the value of the ADHD market has grown by an average of 37% per
year. Growth has been driven by the launch of new non-stimulant drugs,
new patients and the development of new formulations providing
flexibility in dosing and higher patient compliance. The ADHD market is
still in its infancy and is a classic example where a niche market has
been exploited by biotechnological companies and pharmaceutical
companies, having recognised its potential,
are launching new agents to capitalise on
future growth.
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Focusing
on Insomnia:
The
insomnia market is on the verge of considerable growth due to the launch
of new formulations of leading drugs, new classes of drugs with improved
side-effect profiles and patient dynamics - an ageing patient
population.
New formulations are reaching the market and leading brand products face
competition from generics and from the new GABA-A receptor agonists: Estorra
(Sepracor) to be launched in late 2004, Indiplon
(
Pfizer
/Neurocrine)
and Gaboxadol (Lundbeck/Merck)
in mid-2005 and early 2007, respectively. Sleep disorders cover a range
of problems, the best known types being insomnia, sleep apnoea
and restless legs syndrome. Insomnia is the most prevalent sleep
disorder and it is estimated that it affects over 37 million
US
citizens
and over 100 million people worldwide with approximately 25% of elderly
people and 15% of the general population suffering from the condition.
Studies suggest that less than 20% of insomniacs seek help and less than
20% of sufferers are prescribed medication.
Approximately
US$2.5 billion is currently spent on hypnotics and sedatives in the
treatment of insomnia the 8th largest segment of CNS drug sales. The
global market for insomnia drug sales is unevenly distributed. In 2003,
the
US
insomnia
market accounted for 57% of the global market compared to 32% in
Europe
and
11% in the rest of world (largely
Japan
).
This is largely due to the pricing differential between the European and
the
US
market.
GABA-A receptor agonists (non-benzodiazepines) will continue to remain
the cornerstone for the treatment of both acute and chronic insomnia.
However, the launch of several new products over the next 3 years will
help to increase patient awareness, particularly in the elderly, and
help the market to grow to US$4.9 billion by 2010.
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Depression:
The
depression market is the largest segment of the CNS market with global
sales of US$15.5 billion in 2003, and has grown by 12% year-on-year.
This is a mature market with a number of the leading brands facing
patent expiration in the next 6 years. The dynamics of the marketplace
are changing as new classes of drugs such as the selective noradrenaline
reuptake inhibitor, Cymbalta (Eli Lilly),
and new formulations of drugs such as the 5-HT1A antagonist, Wellbutrin
XL (GSK), are launched. It is estimated that depression affects over
18.8 million
US
citizens
and over 121 million people worldwide, with approximately 20% of the
global population at risk of developing major depression at some point
in their lives. Women are twice as likely to suffer from depression as
men (9.5% versus 5.8%), but prevalence figures vary from country to
country. Depression costs the
US
an
estimated US$44 billion each year. The WHO predicts depression will
become the leading cause of disability by the year 2020.
The
global market for antidepressants is unevenly distributed. In 2003, the
US
antidepressant
market accounted for 71% of the global market compared to 24% in
Europe
and
5% rest of world (largely
Japan
).
We believe the depression market has matured and there are now 5 key
areas of unmet clinical need that will need to be addressed in order to
drive further growth of the market. These include improvements in the
efficacy, speed of onset, safety/tolerability of drugs and a reduction
in remission rates and relapse/recurrence.
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Focusing
on Neuropathic Pain: Pain
products generated global sales of nearly US$40 billion in 2003
(including anaesthetics and antimigraine
agents) and this is expected to double by 2010.
Pain is associated with a broad range of diseases and is often poorly
diagnosed and treated. There has been tremendous research activity into
the treatment of pain and many types of pain remain relatively
unexplored. Approximately 26 million patients worldwide (10 million in
the
US
,
3 million in
Europe
and
1.5 million in
Japan
)
suffer from some form of neuropathic pain, spending an estimated US$2.5
billion globally in 2003. There remains a high unmet clinical need
within neuropathic pain as current therapies such as antidepressants are
under-utilised and many patients in
Europe
have
inadequate pain management programmes and
limited access to opioids.
It
is difficult to determine the exact amount spent on the management of
pain as several classes of drug are used "off-label" in the
treatment of pain such as antidepressants and anti-epileptics. We
anticipate that by 2010, sales of neuropathic pain drugs will double to
US$5.5 billion. Sales will be driven by the launch of novel therapeutic
drugs that specifically target subsets of neuropathic pain associated
with: HIV infection, shingles, diabetes, immune disorders and toxic
neuropathies (for example following treatment with chemotherapeutics).
These include the development of antidepressants (Cymbalta),
antiepileptic agents (Lyrica and Prialt)
glutamate antagonists (Namenda, Lamictal
and CNS 5161) and the cannabinoid agonist (Sativex).
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