The global nerve repair and regeneration market size was valued to be USD 5,900 million in 2015. The factors that contribute to the market growth are the high incidence rateof neurological disorders, a varied product pipeline attributed to the presence ofkey market players, andthe improved treatment efficiency for neurological disorders. Furthermore,the emerging applications and therapies in treating the vigorously growing CNS disorders, such as Parkinson’s disease and Alzheimer’s, arefurther expected to drive the market growth over the forecast period
For instance, according to the CDC data overview, Alzheimer’s is the sixth most dreadful disease in the US and the fifth leading factor for mortality in people above 65 years. In 2014, as per the CDC reports 5.3 million Americans were detected with Alzheimer’s disease and it is estimated to grow to its double count by 2050 as a result of the rising aging population.
U.S. Nerve Repair and Regeneration Market, by Product, 2013 - 2024 (USD Million)
In 2015, a report presented at the American Society for Surgery of Hand, in its annual meeting, stated that the processed nerve allograph used in the treatmentof patients with upper extremity nerve impairmentsmay lead to the restoration of motor and sensory nerve functions. Patients treated with a PNA allograft (Avance Nerve Graft, AxoGen) exhibited recovery of motor functionand sensory nerve function in 75% and85%of the patients, respectively.
The product segment for nerve repair and regeneration market is broadly classified into biomaterials and neurostimulation and neuromodulation devices. The latter segment is further sub-segmented into Spinal Cord Stimulation Devices (SCS), Deep Brain Stimulation Devices (DBS), Sacral Nerve Stimulation Devices (SNS), Vagus Nerve Stimulation Devices (VNS), Gastric Electric Stimulation Devices (GES).
The spinal cord stimulation segment was one of the largest with a market share of over 50% in 2015. The large number of commercially available spinal cord products and the larger number of applicationswere the factors responsible for the resultant,huge market share.
In May 2015, the FDA approved the Senza Spinal cord Stimulation System. The Senza Spinal Cord Stimulator includes a rechargeable implantable stimulator, which is linked to one or two implant leads with external handheld patient controllers; this system is used for the treatment of chronic pain in the limbs or the trunk that is not as effectively minimized with conventional medicine.
In December 2013, the FDA approved the marketing of the very first device, the Cerena Transcranial Magnetic Stimulator (TMS), which alleviates migraine headaches that aretypically antecededby a visual, motor, and a sensory disturbance.
Thissurgery segment consists of direct nerve repair or neurorrhaphy, nerve grafting, stem cell therapy, and neurostimulation and neuromodulation surgery. The stem cell therapy is one of the fastest growing application segments.
In 2013, the FDA approved the newly launched Investigational New Drug (IND), the autologous, mesenchymal stem cell-derived neural progenitor cells (MSC-NPs),developed by the Tisch MS Research Centre in New York, which is used in the treatment of multiple sclerosis for phase I clinical trial.
MSC-NPs have numerous advantages, the treatment is administered in several rounds instead of a single one, these cells have the capacity to differentiate and develop into mature neural tissues with decreased risk of abnormal differentiation. Also, MSC-NPs is administered directly into the cerebrospinal fluid with an aim to target the regenerative mechanisms in the central nervous system.
In 2015, North America dominated the market owing to the increasing incidence rate of neural disorders and health insurance coverage in the region.
In 2015, the Patient Protection and Affordable Care Act (PPACA) stated that 1 of 6 American was delivered a Health Insurance Market place Plan and the people who had opted for the market place plan, 87% of received financial assistance. Moreover, in 2014, the PPACA had taken an initiative to reduce the number of people without healthcare insurance coverage by about 14 million.
Asia Pacific is the fastest growing regional segment due to the increasing aging population, rising awareness in the patients, increasing expenditure towards healthcare and innovative technologies entering into the developing economies, such as India and China.
Key industry contributors are AxoGen, Inc., Stryker Corporation, St. Jude Medical, Inc., Baxter International, Inc., Polyganics B.V., Boston Scientific, Inc., Integra Lifesciences Corporation, Cyberonics, Inc., and Medtronic plc. The industry contributors have a broad product pipeline for neurological disorders. Also, there are innovative new products and therapies to improve the treatment efficiency as well as patient convenience.
For instance, in April 2016, St. Jude Medical, Inc. announced the launch of the first commercial implant for Dorsal Root Ganglion (DRG) therapy to treat chronic intractable pain conditions for patients suffering with complex regional pain syndromes. The U.S. launched implants of St. Jude Medical, Axium Neurostimulator System, treated patients effectively for the pain, which could not be otherwise alleviated with the traditional Spinal Cord Stimulation (SCS) therapy.
Also, in March 2016, AxoGen, Inc. launched the AcroVal Neurosensory & Motor Testing System, which serves as a nerve functionassessment tool in electronically measuring, mapping, and monitoring patients suffering with peripheral nerve injuries.
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