Global Alzheimer’s disease (AD)market was valued at $3.1bn in2015 and isforecast to grow at a modest 5.3% CAGR between 2015 and 2024, culminating in 2024 global sales of $5.2bn.AD is an irreversible, progressive brain disease that slowly destroys memory and, eventually even the ability to carry out the simplest tasks of daily living.
AD afflicts over 15 millionpeople worldwide with roughly 5 million people in the U.S. areliving with this disease. It is estimated that 10% of people aged 65 and older, and about 50% of people over 85, suffer from AD. Direct medical and indirect costs associated with AD are high. In the U.S. alone, the health care expenses and lost wages due to AD is estimated at $100bn annually. With life expectancy increasing throughout the world, AD is expected to become a global health care challenge.
Alzheimer’s disease (AD) remains an unmet need and a multi-billion dollar opportunity for the pharmaceutical industry. The amyloid-beta (Aß) hypothesis remains they key target for pharmacological intervention that seek to slow down disease progression. Plaques and tangles in the brain are two of the main features of Alzheimer’s disease. This is followed by the loss of connections between neurons in the brain. Recent clinical trials demonstrated that development of new anti-Aβ antibodies is necessary to provide clinical benefits to AD patients.
Currently only symptomatic treatments exist, Acetylcholinesterase inhibitors remain the mainstay treatment option in the AD market and are expected to dominate the market for the next few years, despite limited therapeutic benefits. Pfizer’s Aricept continue to be the acetylcholinesterase inhibitor of choice in the treatment of AD. Novartis and Allergan have leading market share positions in branded products in this category. Glutaminergicmodulators also play a role in memory and cognition, signaling through the NMDA receptor. This class is led by Allergan’s Namenda XR. Glutaminergic modulators and acetylcholinesterase inhibitors are often used in combination with one another.
Generics of the cholinesterase inhibitors will likely to capture significant share of the Alzheimer’s treatment market through 2024.
“Product innovations in AD treatment”
The exact cause of AD is unknown, but genetics and environmental factors appear to play a role. Researchers continue to work on the biological mechanisms of AD, leading the way for the development of novel therapies.
Agents with potential disease-modifying characteristics areadvancing to Phase III programs using the latest PET imaging technology and biomarkers. Late-stage trials continue to target slowing the disease progression in patients with mild or moderate AD. Experts continue to believe that beta-amyloid targeting agents in AD with the earliest forms of the disease may ultimately yield the greatest efficacy benefit.
Candidates entering Phase III studies are learning from the series of prior Phase III failures in the field. Key clinical trial failures of the recent past include among others
Eli Lilly’s semagacestat, Pfizer/J&J/Elan’s bapineuzumab, Myriad’s Flurizan,andPfizer/Medivation’sDimebon.
Next-Generation treatments are primarily focused on beta-amyloid field. Researchers believe that the build-up of beta-amyloid in the brain may be the cause of Alzheimer’s disease. The treatment strategies targeting beta-amyloid include immunotherapy, monoclonal antibodies, therapeutic vaccines, secretase inhibitors (gamma and beta), and aggregation inhibitors.
Tau-based therapies and a number of novel mechanisms of actions including 5-HT6 receptor approach are also being evaluated in the treatment of AD.
Approved Treatments in AD
“Optimal Price Point (OPP) for Alzheimer Disease Treatment Products”
Estimated Average product cost – $ xx globally. However, with improve in access and availability of options, OPP and range of acceptable Prices (RAP) are going to change. We at Ameri Research continuously track these prices with our proprietary pricing model.
“Pfizer, Eisai, J&J,Shire, Allergan, and Novartis are some of the key players for AD Treatment market”
Key players in the AD treatment include Pfizer, Eisai, J&J, Allergan, and Novartis among others.
Currently available AD treatments from these companies provide only symptomatic relief, temporarilyimproving brain function in patients with mild-to-moderate disease. These treatments include acetylcholinesterase inhibitorsfrom Pfizer/Eisai’s Aricept, J&J/Shire’s Razadyne ER, Novartis’ Exelon and Allergan’s Nemenda.
There is a rangeof disease modifying next generation treatments being developed in AD. For example, Eli Lilly is clinically testing solanezumab in EXPEDITION 3 and if approved in by 2017, it will capture a substantial portion of the AD market by 2024, offering substantial growth to its top line.
Merck’s verubecestat, a beta secretase inhibitor is in two phase III trials EPOCH and APECS. EPOCH investigates the efficacy of verubecestat in mild-to-moderate AD patients and has a primary completion date in 2017.Biogen has advanced aducanumab into a Phase III program (EMERGE and ENGAGE) with expected data from these trials to be available in 2019.AstraZeneca is also advancing products in beta secretase Inhibitor through clinical trials.