Innovations in The Management of Diabetes-Next generation treatments and market dynamics
Introduction
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Type 1 diabetes
occurs most often in children or young adults and accounts for 5 -10% of the
diagnosed diabetes patient population. Type 2 diabetes, accounts for 90–95% of
diagnosed diabetes cases worldwide, typically developing in middle aged adults.
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Approximately 246
million individuals worldwide have diabetes in 2007. As such, diabetes is now
slotted as the fifth leading cause of death across most developed markets, with
increasing incidence and prevalence rates being detected across several
developing and emerging markets. By 2030, the WHO estimates that the number of
cases of diabetes is expected to increase by 7.1% globally, driven by the
growing prevalence of Type 2 diabetes, primarily in developing markets such as
India and China.
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While prevalence rates of diabetes continue to
increase globally, low diagnosis rates across the majority of countries remains
a pressing issue. It is estimated that among Type 2 diabetes patients across
the seven major markets, only 50% have been diagnosed, with only 80% of these
patients receiving treatment.
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The treatment of
diabetes and related long-term complications is predicted to place increasing
pressing on healthcare systems across the majority of countries. It is
estimated that total costs associated with diabetes could reach an estimated
$396bn in 2025.
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Outside of the
current unmet needs in marketed diabetes treatments, the expanding patient
population and heightening healthcare costs present immense market potential
for drugs that demonstrate not only an improved overall drug profile, but
assist in reducing the cost burden associated with this disease.
Currently marketed innovatives
·
The global diabetes
market was valued at $24,275m in 2007, having registered a growth rate of
13.8%. Growth in this market has remained strong during the period of analysis,
with a CAGR of 13.2% over 2003-07.
·
While several
innovative introductions within new drugs classes, such GLP-1 agonists and
DDP-IV inhibitors, have fuelled growth, there still exists considerable breadth
for market expansion, particularly within the OAD class of drugs as well as
non-invasive insulin drug delivery technologies.
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The availability of
different forms of insulin has partially succeeded in addressing the various
range of treatment needs in diabetes patients, such as Sanofi-Aventis’ Lantus.
The success of insulins has also been catalyzed by the introduction of drug
delivery devices such as pre-filled pens, which has eased the burden of
administration among diabetes patients requiring multiple daily insulin
injections.
·
Despite the strong
levels of growth among human insulins, this has been countered with low levels
of innovation compared to other major classes within the diabetes market,
particularly that of OADs.
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While a new market
entrant, it appears that DPP-IV inhibitor drugs have blockbuster potential as
both adjunctive therapy (primarily with metformin) and possibly as first-line
therapy owing to a combination of factors including an improved
gastrointestinal side-effect profile, low rates of hypoglycemia and no
titration.
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As the first GLP-1
agonist to enter the market, Amylin/Lilly’s Byetta (exenatide) also promises
significant market potential in the treatment of Type II diabetes.
Future drivers of growth and
innovation
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Despite the strong
growth experienced by the diabetes market over the period of analysis driven by
the presence of well-established treatments such as insulin and metformin, as
well as the introduction of new classes of drugs, high levels of unmet need
continue to exist.
·
Several impediments
in the development and launch of novel drugs within the diabetes market, such
as inhaled insulin and dual PPAR agonists, have resulted in increased
speculation about the future potential of innovative diabetes products that effectively
address the unmet needs within the market.
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Attention is
increasingly being turned to Metabolic Syndrome. This syndrome refers to a
clustering of cardiovascular disease risk factors whose underlying
pathophysiology is thought to be related to insulin resistance.
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In light of the
recent safety concerns that are associated with leading antidiabetic
treatments, particularly the TZD’s Actos and Avandia, novel drugs in
development must possess a comparable, if not superior, side-effect profile.
Coupled with the unmet need of convenience of administration, which is
inherently tied to compliance, there remains a substantial market for agents
that offer adequate glycemic control in conjunction with an alternative to
injectable insulins.
·
With the controversy
over Avandia, the FDA is considering stricter standards for how and when
diabetes drugs will be tested for related cardiovascular risks. Recently, it
has been suggested that the FDA is considering implementing stricter rules over
the development of diabetes drugs, which may prove to be a difficult barrier
for several agents in development to overcome.
·
While still in
early stages of development, cell transplantation has emerged as a novel
technique for the treatment for diabetes that appears to offer improvements in
the short-to-medium-term.
Key companies and pipelines
·
While the current
diabetes market features continued growth, the introduction of innovative
products onto the market has progressed somewhat slowly over the past several
years.
·
The majority of
leading players in the diabetes market have witnessed strong growth over
2006-07. The diabetes market is dominated by five companies – Novo Nordisk,
Takeda, Sanofi-Aventis, GSK and Lilly, collectively accounting for 74.1% or
$17,997m of global diabetes sales in 2007. Merck’s diabetes portfolio, while
limited, features the strongest growth of 2,370.5% among the leading companies
due to the launch of Januvia (sitagliptin), the first-in-class DDP-IV inhibitor
to enter the US market in October 2006.
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The leading players
in the innovative diabetes market are employing a range of diverse strategies
to secure future sales growth. These strategies include lifecycle management,
diversification, franchise development and new market entry.
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While lifecycle
management has been key in sustaining momentum within the global diabetes
market, there is increasing pressure on companies to develop and launch
innovative diabetes treatments across a wide range of new drug classes.
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Given the strong
association of diabetes with co-morbidities such as hypertension, dyslipidemia
and obesity, several pharmaceutical companies are re-focusing the development
of innovative products to address several of these issues. Sanofi- Aventis’
marketed Acomplia (rimonabant) is the first-in-class CB-1 antagonist indicated
for the treatment of obese or overweight patients with associated Type 2
diabetes or dyslipidemia risk factors. Sanofi-Aventis is currently conducting
an extensive phase III clinical program is currently underway to assess Acomplia’s
efficacy and safety in the treatment of Type II diabetes.
Future trends and implications
·
The future of the
global innovative diabetes market is forecast to grow significantly over the
next fiver years. This growth will be spearheaded by the continued launch of
novel drugs from new classes of drugs that cater to the unmet needs of the market.
In addition to these expected launches, the forecast increase in diabetes prevalence
globally assisted by increasing levels of diagnosis will also provide an expanded
patient population requiring treatment.
·
The innovative
diabetes market is forecast to expand at a CAGR of 14.1% over the next five
years. This growth is sales will be mostly attributable to the increasing use of
GLP-1 agonists and DDP-IV inhibitors. Growth toward the end of the forecast period
and beyond is believed to be driven by a series of launches across several new
categories of drugs that offer convenience, but more importantly, will serve to
address the unmet needs of prolonged efficacy and disease modification.
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Ongoing concerns
regarding the safety profiles of currently marketed anti-diabetic drugs,
particularly the TZDs, may lead to the possible implementation of stricter FDA
guidelines around the development programs of novel diabetes drugs. As such,
pipeline drugs may suffer delays in launch, negatively impacting the overall market
growth.
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Much of the
predicted growth of the innovative diabetes market in the short-terms appears
to be driven by the extended life cycle management for existing anti-diabetic therapies.
In the long-to-medium term, however, it is believed that pharmaceutical companies
will continue to place increasing efforts on the diversification of their diabetes
portfolio through the development and launch of new drugs from novel classes.
