Roadblocks In The Peripheral Nerve Injury Market Require A Multi-faceted Approach

Each year, approximately 1.35 million people die due to vehicular or road accidents. Road crashes are also the most common cause of peripheral nerve injury (PNI), affecting the brachial BP or the radial, fibular, or sciatic nerves, typically in young motorcycle riders. These fragile and delicate nerves can be easily damaged. Other causes contributing to the PNI patient pool are penetrating injuries, falls, serious complications related to regional anesthesia, chemotherapies, gunshot wounds, car accidents involving pedestrians, closed traction injury, sports injuries, and other muddled injuries.

DelveInsight Peripheral Nerve Injury (PNI) epidemiological analysis estimated PNI incidence in 2017 in the 7MM (the US. EU5 (the UK, Spain, Germany. Italy, and France) and Japan) to be 3,889,176. Further, the PNI incidence rate for the US was reported to be the highest in the 7MM, with over 1.5 million cases in 2017. The incidence is additionally expected to increase by each passing year for the forecasted period 2017-30, owing to an anticipated increase in road crashes.

Peripheral nerve injuries are a concerning health issue. Depending on the position of the nerve injury (upper extremity or lower extremity), and degree of nerve damage, a multidisciplinary treatment regimen including acupuncture, massage therapy, medication, orthotics, physical therapy, and rehabilitation is prescribed to the PNI patients. PNI also shares strong ties of kindred with neuropathic pain, which is the most difficult of all the pains to treat and impacts the quality of lives of patients. To cope up with the neuropathic pain, patients are prescribed with medications (Gabapentin, Oxcarbazepine, and Lamotrigine). For severe nerve injury cases, surgical intervention is preferred. These surgical procedures can be highly complicated (maintenance by stitches) and may involve nerve repair, nerve grafting, nerve transfer, fibrin glue, or nerve conduits. DelveInsight estimated more than 1.7 million cases underwent surgeries, and around 8-12% of these cases required surgical revision of former surgery. The approved or marketed options available in the PNI market comprise conduits (NeuraGen, NeuroFlex, Neurotube, Neurolac, Nerbridge, and NeuroWrap) and nerve grafts ( Avance Nerve Graft), which remains the gold standard of the clinical treatment for peripheral nerve defects, regardless of the size of the gap. 

However, the surgical option has several limitations. First and foremost, the process is time-intensive as peripheral nerve regeneration is a slow process. According to a study by Pfister BJ, et al., axonal regeneration rate is as slow as 1-2 mm/day. Surgeons often advocate months for primary and secondary repair and advise weeks of immobilization after the surgery. This often leads to atrophy of motor neurons and nerves. Then, there is always a chance of misalignment of the motor and sensory axons. The availability of donors remains another major hurdle. Even if the donor is available, the impending risk of immunosuppression looms. Lastly, if the patient does manage to cross all of these obstacles, paying a great deal of money, there is no guarantee of 100% recovery. 

Although medical science, regenerative medicine, and tissue engineering have advanced over the years, and a lot has been done in microsurgical research, improvement in peripheral nerve repair remains a challenge. Peripheral nerve injury still continues to be associated with poor patient outcome and significant morbidity. Even prompt diagnosis that can increase the chances of nerve repair by multiple folds remains a far-fetched dream. In the case of acute trauma, peripheral nerve repair is oftentimes neglected. Also, no diagnostic kit procured in the Peripheral nerve injury market is advanced to differentiate between sunderland grades II and IV except histological examination, when most of the injuries are of mixed grade. A better understanding of the pathophysiology of the nerve injury will further augment the efficacy of the diagnosis. There is a paucity of better selective therapy in the Peripheral nerve injury market. No biologics or drugs have yet been recommended potential enough to accelerate nerve regeneration, and there are only a few drugs in the pipeline anticipated to get launched in the PNI market during the forecast period 2020-30.

Key companies working in the Peripheral nerve injury market are  Neuraptive Therapeutics, Silk Biomaterials, and Orthocell Limited. The companies are dedicatedly working to advance the PNI pipeline with their potential drugs in mid-stage developments to be launched in the near future.

DelveInsight estimates an increase in the Peripheral nerve injury market from USD 2,182.82 Million in 2017 in the coming next decade owing to increasing PNI patient pool, extensive R&D, increased funding in the domain, advances in bioengineering techniques, and a lack of approved standard of treatment for nerve repair.

Neuraptive Therapeutics, a few months back, announced clearance of the US FDA Fast Track designation for its NTX-001 for peripheral nerve injuries. The company is optimistic about the potential its franchise therapeutic product possesses in expediting speedy nerve repair and plans to move forward with the Phase II trial. While on the other hand, Orthocell does not shy away from bragging about its product CelGro, which is augured as a promoter of the avant-garde, innovative technology. The results from the interim clinical trials came out to be impressively well with the enhanced repair of peripheral nerves, regained muscle mobilization following surgery, and reduced pain in the affected limbs. 

No wonder, extensive research and funding invested in the neurological field have opened new frontiers in the Peripheral nerve injury market. The scientific community has registered several preclinical trials during the past many years, and the fact that innovation can profoundly influence, a scarce of effective treatment PNI market, can not be overlooked.  Moreover, molecular and bioengineering tactics shall scaffold the development of treatment options in the Peripheral nerve injury market to overcome biological roadblocks. Looking at the current treatment landscape and the pipeline activities, there is a growing consensus that peripheral nerve injuries require a multi-faceted or multi-combinatorial approach of treatment that is a mix of innovation and processes mimicking natural nerve repair.