What are Neurodegenerative Diseases?
According to the EU JPND, neurodegenerative diseases are a group of disorders that cause progressive degeneration of the neurons in the brain. These incurable disorders are genetically inherited or of unknown etiology and have severe debilitating effects causing ataxia and dementia in people and having a serious impact on their mental health. These diseases also restrict several bodily activities, such as balance, movement, speaking, breathing, and heart function.
Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, multiple sclerosis, amyotrophic lateral sclerosis, and epilepsy are some of the neurodegenerative diseases. Huntington’s disease and amyotrophic lateral sclerosis are rare disorders, accounting for a minor share of the market. Alzheimer’s and Parkinson’s diseases are more prevalent and account for a major share of the market.
Neurodegenerative Disease Market Trends
Reformulation of Marketed Drugs
Drug delivery systems such as transdermal patches, ER formulations, and orally disintegrating tablets have increased drug efficacy because of the growing patient compliance and bioavailability of a drug. The reformulation of marketed drugs also provides an opportunity to obtain patent term extensions, which can delay the entry of generics in the market.
In September 2014, the FDA approved single loading dose administration alternatives for all formulations of Vimpat for the treatment of partial-onset seizures in patients with epilepsy aged 17 or above. Single loading doses provide an alternative to the standard titration schedule. The reformulation of solid dosage forms such as tablets can provide a window for titrating the dose according to individual requirements. ER formulations such as Keppra XR reduce the dosing frequency, thereby increasing patient compliance.
Currently, Acorda Therapeutics is developing Plumiaz, a diazepam nasal spray. The intranasal formulation was developed as an alternative for patients who do not wish to use diazepam rectal gel and cannot receive intramuscular or intravenous diazepam. In an attempt to enhance the bioavailability of the drug and thereby reduce these side effects, Levodopa reformulations such as Duopa, Rytary, and OS-320 are being developed. Exelon patches can reduce certain side effects associated with oral formulations while maintaining consistent blood levels of the drug.
Reduction in side effects increases drug acceptance among patients and drives revenue growth. The dry syrup formulation of Aricept allows the adjustment of individual dose along with reducing the bulk of the drug, making it easier to swallow. ER formulations such as Namenda XR reduce the dosing frequency thereby increasing patient compliance.
Emerging Treatment Options
Newer-generation anti-epileptics such as lacosamide are being introduced in the market to replace older-generation epilepsy drugs as they offer various advantages over older-generation drugs, such as the presence of simpler pharmacokinetic profiles. Japan is expected to experience a major shift toward second-generation drugs because of the recent launch of these drugs in the market in the country. However, various countries in APAC are still dominated by first-generation drugs.
The market strategy of major vendors to penetrate the region and increase healthcare reforms is expected to change the treatment regimen for epilepsy. Third-generation epilepsy drugs such as lacosamide also propel market growth in various territories. Oral drugs for multiple sclerosis are in high demand as they have increased patient compliance.
Isis Pharmaceuticals is developing ISIS-HTTRx in collaboration with Roche to treat patients with Huntington’s disease. The mutation of the HTT gene in the affected person produces mutant HTT protein, which is toxic in nature and damages neurons. ISIS-HTTRx is based on antisense technology and blocks the production of all forms of HTT protein. During preclinical studies, a significant reduction in HTT mRNA and protein was obtained by using this technology.
In addition, it delayed the progression of the disease in the mouse model, thereby prolonging the survival of the model. Sangamo BioSciences is developing drug candidate ZFP Therapeutic in collaboration with Shire, which is designed to specifically target the disease-causing HTT gene copy while preserving the activity of the normal gene copy. Safinamide, adenosine A2A antagonist istradefylline and sNN0031, and PRX002 are some of the drugs with novel mechanisms of action used to treat Parkinson’s disease.
Increase in Public Awareness
The acceptability of amyotrophic lateral sclerosis drugs is expected to increase during the forecast period because of the growing public awareness of the disease and associated disorders resulting in a rise in drug penetration. The growing awareness has also led to an increase in research funding and support for clinical and associated services.
For instance, the month of May is celebrated as Amyotrophic Lateral Sclerosis Awareness Month in the US. The ALSA strives to involve and engage patients and families in the process of awareness, such as conducting the ice bucket challenge in 2014 to raise awareness of the disease, and advocating legislative changes. Similarly, the CDMRP organizes the ALSRP Program to help increase the number of scientists researching the disease, advanced new discoveries and treatments, and shed light on the complex genetic and environmental factors.
The CDC oversees a MEW network to improve the care of epileptic patients. The network conducts various programs such as PEARLS, WebEase, and UPLIFT. PEARLS is a team-based approach mediated through supervising psychiatrists, counsellors, and medical providers designed to reduce depression and improve quality of life of adult patients suffering from epilepsy.
Project UPLIFT uses cognitive therapy and mindfulness techniques to treat depression in epileptics. WebEase is based on interactive modules designed to gain confidence in managing epilepsy. March 26 is internationally celebrated as Purple Day to increase awareness of epilepsy. In the US, the month of November is celebrated as national epilepsy awareness month. These types of initiative are expected to increase awareness regarding epilepsy and its available treatments during the forecast period.
Similarly, the MSIF has been observing May 28 as World Multiple Sclerosis Day since 2009 with the intention of raising awareness among the public. In the UK, the Multiple Sclerosis Trust observed Multiple Sclerosis Week from April 28 to May 4, 2014. The organization arranged a Bold in Blue fundraising campaign to aid its information services. In the US, the National Multiple Sclerosis Society organized Multiple Sclerosis Awareness Week during March 2-8, 2015. These organizations also invite multiple sclerosis survivors to share their stories to increase the level of awareness.
April 11 is celebrated as World Parkinson’s Day in an attempt to increase awareness regarding the disease and to encourage various causes which support patients. It is intended to explore and support novel therapeutic and research options. In a similar attempt to share, learn, increase awareness, and support Parkinson’s patients, the month of April is celebrated as Parkinson’s Awareness Month. The Parkinson’s Unity Walk event was organized on April 26, 2014 to increase awareness and raise funds which are used to support Parkinson’s disease organizations. The National Parkinson Foundation in the US, the Michael J. Fox Foundation for Parkinson’s Research, Parkinson’s Disease Foundation, Parkinson Alliance, and the Parkinson’s Institute and Clinical Center benefited from the 2014 walk.
In addition, September 21 is celebrated as World Alzheimer’s Day in an attempt to increase awareness regarding dementia and Alzheimer’s disease. In September 2014, World Alzheimer’s Month was celebrated with the theme “Dementia: Can we reduce the risk?” September 2015 will be marked as the beginning of World Alzheimer’s Month and will be celebrated with the theme “Remember Me.” Media support in terms of films such as “Love, Loss and Laughter”, online talk shows, and fundraising campaigns contributed significantly to the success of this campaign. World Alzheimer’s Month in 2013 marked an increase in queries and interest regarding Alzheimer’s disease.
Workshops such as Healing Camp along with musical events and street plays were organized to increase awareness among the general public. In the past, several national-level campaigns have been organized to disseminate information to the public. For instance, in Hungary, the Hungarian Alzheimer Society and the Red Cross co-ordinated in 2009 to turn off the lights on Budapest’s Chain Bridge to mark World Alzheimer’s Day. Campaigns such as Alzheimer’s Australia’s 2011 Fight Dementia campaign promote the spread of key messages through the general public.