LONDON--(BUSINESS WIRE)--According to the latest research report released by Technavio, the global epilepsy drugs market is expected to grow steadily at a CAGR of more than 4% until 2020.
This report titled ‘Global Epilepsy Drugs Market 2016-2020‘, provides an in-depth analysis of the market in terms of revenue and emerging trends. The report also considers the revenues to be generated from the sales of drugs that are expected to be launched into the market along with the decline in revenues from the patent expiries of marketed drugs during the forecast period.
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“First-generation anti-epileptic drugs such as phenobarbital, ethosuximide, primidone, phenytoin, carbamazepine, and valproic acid were in use for decades. However, they are associated with side-effects, have narrow therapeutic ranges, and have complicated pharmacokinetics,” said Barath Palada, one of Technavio’s lead industry analysts for healthcare.
“During the 1990s and early 2000s, second-generation anti-epileptic drugs such as levetiracetam, lamotrigine, pregabalin, topiramate, and gabapentin entered the market. Third-generation drugs such as rufinamide, eslicarbazepine, retigabine, and lacosamide have also entered the market. Compared to first-generation anti-epileptic drugs, new-generation drugs have fewer side-effects and wider therapeutic ranges,” added Barath.
Some of the other driving forces behind the growth of the global epilepsy drugs market are as follows:
- Tentative approval of late-stage pipeline molecules
- Special regulatory designations
- Development of novel therapeutics using innovative technologies
Tentative approval of late-stage pipeline molecules
Though a number of branded and generic drugs are available in the market to treat epilepsy, they provide only symptomatic treatment. Hence, the need for effective medications still prevails in the market. 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. Drugs in the regulatory filing and Phase III stages are expected to enter the market during the forecast period. Among these drugs are IV carbamazepine by H. Lundbeck, Captisol-enabled Fosphenytoin by Sedor Pharmaceuticals, NRL-1 (intranasal diazepam) by Neurelis, NPC-04 (Oxcarbazepine) developed by Nobelpharma, in collaboration with Novartis. Similarly, ganaxolone by Marinus Pharmaceuticals, SAGE-547 by SAGE Therapeutics, and Carisbamate (YKP509) by SK Biopharmaceuticals are among the Phase III stage molecules to treat epilepsy. Vimpat (lacosamide) by UCB is filed for approval in China, Japan, and the EU, and is in the Phase III stage of development in other regions. The tentative approval of these molecules will help in the increased uptake of these drugs, thus potentiating the growth of the market.
Special regulatory designations
Special regulatory designations such as orphan drugs designation and fast track designations assigned to the drugs by the FDA and the EMA help in the faster entry of these drugs into the market. Fast track designations are assigned to the drugs used to treat serious conditions with high unmet needs in the market. Similarly, orphan drug designations are assigned for the drugs used to treat rare diseases. These designations help in the faster approval process for the drugs and help in their early entry into 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. Similarly, SAGE-547 by SAGE Therapeutics, midazolam by Upsher-Smith, cannabidiol by GW Pharmaceuticals, and cannabidiol by INSYS Therapeutics received both fast track and orphan drug designations. 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.
Development of novel therapeutics using innovative technologies
The technological advancements in the field of epilepsy drugs have led to the development of novel molecules. For instance, Aprecia Pharmaceuticals develops Spritam (levetiracetam) using the ZipDose technology, which uses a three-dimensional printing (3DP) platform. In this process, a porous, water-soluble matrix is prepared by binding multiple layers of powder using an aqueous fluid. This soluble matrix disintegrates rapidly, which helps in easy administration and precise delivery of high doses of the drug. The drug was approved by the US FDA in August 2015. Similarly, SciFluor develops fluorine-enabled small molecule therapeutics. Using this platform, the company has developed SF0034, which acts as a selective KCNQ2/3 activator. The drug was found to show efficacy in treating epilepsy and tinnitus. The development of such drugs with novel mechanisms or by the use of new technologies, providing potential benefits are expected to increase the uptake of these drugs and help the global epilepsy drugs market grow.
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