Alzheimer's disease (AD), widely regarded as the most common cause of dementia, is a progressive neurological disorder. It can result in symptoms like memory loss, personality alterations and difficulty in communicating and performing routine tasks. AD is associated with a complete deterioration in the quality of life and exposes the sufferer to a number of other co-morbidities like depression, anxiety, sleep disorders and perhaps even injury.

A mounting burden
AD has an enormous financial and emotional toll on the society; According to the Alzheimer’s association associates, in the United States alone, the costs of caring for the 4.5 million estimated patients are atleast $100 billion annually. Going by what the prevalence forecasts suggest, Europe is expected to face a similar crunch which could have a devastating effect on its countries in the coming years. It is estimated that more than 70% of the people with Alzheimer’s disease live at home, where family and friends provide the majority of care placing intense physical and emotional stress on caregivers.

Market dynamics
The European AD therapeutics market is one that is characterized by a large patient base, few effective drugs and disproportionately low prescribing volumes. It was worth $1.39 billion in 2005, and is forecast to reach a market value of $3.75 billion growing at a cumulative annual growth rate (CAGR) of 15.2 per cent. Aided by a number of factors such as an a burgeoning elderly population, a sharp increase in diagnosis rates etc., Europe is a very attractive market for AD drug manufacturers around the world. The market consists of two main classes of drugs, the Acetyl cholinesterase inhibitors (AChEIs), and the N-methyl D-aspartate receptor antagonists (NMDARA). AChEIs account for about 80.0 per cent of the market, and literally monopolised the market until the entry of the NMDARA in late 2003. NMDARA drugs have been growing at a phenomenal rate ever since.

The competitive dynamics of the AD market are such that following treatment failure with the one class of drugs, there is a high probability of physicians shifting from one class to the other. Although the AChEIs are firmly established in the market, they are expected to gradually decline following the entry of generics from 2008 onwards. As far as the competitive framework is concerned, the features a variety of participants ranging from big pharmaceutical corporations with end to end functions from R&D to marketing; as well as several smaller biotechnology and specialty pharmaceutical companies with niche capabilities.

Hindrances to market growth
The biggest challenge facing the AD therapeutics market is the lack of genuine disease modifying drugs. All the existing products provide at best, only a modest symptomatic relief, and the new class of drugs are yet to prove their efficacy in the long-term. Yet another challenge is the lack of reliable and effective diagnostic techniques to positively confirm the presence of AD. In addition, the lack of head-to-head studies between existing products in the market, leaves physicians in a dilemma as to what drug to prescribe.

The overall level of reimbursement for AD therapeutics is very low, and is expected to be a big restraint to market expansion. A case in point could be the National Institute of Clinical Excellence (NICE)’s recent ruling which has been the subject of much debate in healthcare circles. Market penetration will also be difficult due to competition from parallel imports, lower-priced generics, and other government sponsored cost-containment initiatives.

What needs to be done
To avoid bearing the brunt of regulators, new drugs have to support reimbursement claims with robust clinical data and cost-benefit studies. Factors such as clinical trial design are expected to play a crucial role in this regard. Market education in the form of AD education, promotional efforts such as physician detailing, continuous medical education (CME) camps, direct to consumer (DTC) campaigns is a key factor for success in such a competitive environment. Yet another strategy that several participants are following in Europe is market expansion by means of securing approval for related indications such as mild cognitive impairment (MCI). In addition, R&D efforts to understand new pathologies and identify novel drug targets are expected to go a long way in discovering drugs which can slow or halt the progression of AD considerably and significantly improve the quality of life.

Emerging Alzheimer’s therapies
In spite of their modest symptomatic effect, AChEIs,and NMDARA will continue to form the backbone of AD treatment in the short to medium term. However, none of the currently approved drugs stop the underlying degeneration of brain cells or reverses disease progression. Thus, several leading hypotheses on the underlying causes of the disorders are being used for the development of new molecules and processes as targets of potential new therapies. Some of the most promising approaches include amyloid plaque deposition, formation of neurofibrillary tangles and neuroinflammation. The variety of therapeutic approaches being researched may foretell a market in which individuals are treated optimally with drug combination therapy.

A promising future ahead
As the burden of elderly individuals in Europe swells, the challenge to develop targeted, effective treatments and our ability to recognise early symptoms and intervene to prevent disease progression will become very critical. Although the existing drugs in the market continue to witness phenomenal sales growth, much of their success can be attributed to the acute unmet need associated with Alzheimer’s disease. Over the last decade or so, research has increased our understanding of the underlying mechanisms of disease progression, and provided new targets for drug validation, generating new hope for the future. Despite a plethora of problems plaguing Alzheimer’s research, given the severe unmet need, there are considerable market opportunities within the European AD therapeutics market, and the quest for the proverbial holy grail of AD therapeutics continues.

Author: Sumanth Kambhammettu, Research Trainee, Pharmaceutcals & Biotechnology, Healthcare Practice (EMEA)

This article was originates from Frost and Sullivan

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