During a seizure, a person experiences abnormal behavior, symptoms, and sensations, sometimes including loss of consciousness.
There are few symptoms between seizures. Epilepsy is usually treated by medication and in some cases by surgery, devices or dietary changes.
Broad-spectrum anti-epileptic drugs occupy a significant share in the market, as they are preferred in cases where different focal seizures from generalized seizures become difficult.
These include both first and second-generation anti-epileptic drugs, including widely used drugs such as sodium valproate/valproic acid. Narrow-spectrum anti-epileptic drugs, though useful, can be used only under certain specific conditions.
Apart from these, other new drugs have entered the market and occupy considerable shares, but their spectrum of activity is not yet determined. It is expected that upon determination of the range of business, these drugs will fill a significant share, outpacing the existing broad- and narrow-spectrum anti-epileptic drugs
The global epilepsy drugs market is primarily driven by the need for effective medications as the generic or branded drugs available in the market only provide symptomatic treatment.
This has increased investment in the R&D of new drugs for epilepsy by companies such as Marinus Pharmaceuticals, SAGE Therapeutics, H.Lundbeck, and CURx Pharmaceuticals. Medications in the regulatory filing and Phase III stages are expected to enter the market during the forecast period.
Fast track designations are assigned to the drugs used to treat severe conditions with high unmet needs in the market.
For instance, Turing Pharmaceuticals TUR-004, which is in the preclinical stage of development for epilepsy, received fast-track designation by the US FDA in October 2015.
Also, IV ganaxolone by Marinus Pharmaceuticals, for the treatment of status epilepticus received the orphan designation from the FDA in April 2016 ; Epidiolex by GW Pharmaceuticals received the orphan drug designation in April 2016 to treat tuberous sclerosis complex, and Neurelis received orphan drug designation for its drug NRL-1 (intranasal diazepam) in December 2015 to treat acute repetitive seizures.
The global epilepsy drugs market segmentation is done by the generation of drugs, the spectrum of activity and by the type of seizures.
The generation of drugs if further segmented into First generation antiepileptic drugs, Second generation antiepileptic drugs and Third generation antiepileptic drugs.
The global anti-epileptic drugs market is dominated by second-generation anti-epileptic drugs due to their high penetration in developed and developing countries.
However, it has been observed that with the introduction of third-generation drugs, which have better efficacy and safety profiles than second-generation drugs, the market share of the latter is slowly consumed by the former.
Partial-onset seizures, also referred to as focal seizures, starts from one area of the brain. They can be either idiopathic or symptomatic. Idiopathic partial epilepsy, also known as benign focal epilepsy, usually begins at the age of five and eight and is considered the mildest form of epilepsy.
The Americas is the largest market for epilepsy drugs due to the high prevalence of the disorder and the treatment options in the region, especially in the developed markets such as the US and Canada.
Approximately 1% of the population in Canada has epilepsy, and 15,000 new cases are diagnosed each year. Recently, there was a shortage of epilepsy drugs in Canada.
Such instances force people to switch from one drug regimen to another, creating discomfort. Shortages of drugs may lead to worsening of the condition and can result in repetitive seizures.
Thus, regulatory authorities have to take measures to prevent such conditions and provide effective management of the disease.
Only a few Latin American countries such as the Bahamas, Bolivia, Brazil, Chile, Colombia, El Salvador, Guatemala, Mexico, and Venezuela have a program or plan of action for the management of epilepsy.
Lack of access to adequate healthcare services is one of the barriers to epilepsy treatment in low and middle-income countries in this region.
Collaborations among local vendors will help increase the market penetration of epilepsy drugs in Latin America. For instance, BIAL formed an exclusive license agreement with moksha8 in July 2014 to commercialize eslicarbazepine acetate in Brazil and Mexico.
According to CDC, in 2015, it was around 5.1 million individuals have been diagnosed with epilepsy or a seizure disorder in the US, and the total number of individuals with active epilepsy is about 2.9 million. Also, the incidence of epilepsy in the US is approximately 150,000 cases per year. It was also reported that the total direct and indirect cost associated with epilepsy is around 15.5 billion yearly.
The Epilepsy Foundation of Hawaii encouraged its members to dress in purple on March 26, 2014, to create awareness regarding epilepsy.
The PPACA underwent a few changes to provide better patient care in the US. Access to Medicaid has been broadened to cover low-income families. The improved healthcare system along with the increased Medicaid payments led to the coverage of a large number of people in 2014.
In April 2014, the national manager of the TGA announced that TGA and EMA have entered into an agreement to share the assessment reports of orphan drugs.
In March 2016 Fycompa received approval in Japan and was launched in the region in May 2016. Vimpat by UCB is in the stage of a regulatory filing in Japan for the treatment of the disorder. In Australia, approximately 250,000 individuals are living with epilepsy, and 3%-3.5% of individuals will experience epilepsy at some point in their life. The incidence rates are around 12,000 individuals per year. In China, approximately nine million individuals have epilepsy, and roughly half a million are diagnosed with the disorder every year. UCB along with Project HOPE took up the initiative of improving medical care for children with epilepsy in China.
Research studies by the Indian Epilepsy Centre have reported that one out of every 100 or 200 individuals has epilepsy. It is also said that the incidence of the disorder is 20-50 per 100,000 people every year. Purple Day is organized on March 26th every year to create awareness about the disorder
Competitive Analysis
Key players are adopting strategies such as mergers and acquisitions, partnerships, and regional expansion to stand out as strong competitors in the market. New product launches along with increased focus on R&D are other ways the leading players improve their market presence. The emergence of multiple new drugs is expected to provide a competitive edge to key players in the global epilepsy drugs market.
In June 2016, Jubilant Life Sciences received final approval from the US FDA for the generic Levetiracetam injection for the treatment of epilepsy in the US market
In April 2016, Eisai partners with Russias Pharmstandard to manufacture Halaven (oncology), Lenvima (oncology), and Fycompa (epilepsy)
In February 2016, Aprecia Pharmaceuticals completed a 35 million financing to launch its epilepsy drug, Sprite
In May 2016, Acorda Therapeutics discontinued the development of Plumiaz (diazepam) Nasal Spray, a therapy being studied for the treatment of seizure clusters in individuals with epilepsy
December 2015, Eisai signs an agreement worth 78.2 million to acquire Liaoning TianYi Biological Pharmaceutical in China.
December 2015, Bials Portela reports positive results for a pivotal Phase III noninferiority trial for the treatment of individuals with partial-onset seizures
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