NERVE BIOLOGIC PRODUCTS MARKET ANALYSIS

Market Challenges And Opportunities

Nerve Biologic Products Market Drivers

Advancements in research and development for developing innovative technology for nerve biologic products are expected to drive growth of the nerve biologic product market. For instance, in February 2015, researchers from the University of Sheffield developed a device, 3D-printed nerve guidance conduit (NGC). NGC is a network of miniature tubes, which guide injured nerve ends towards each other, thereby enabling them to repair naturally. The device uses computer-aided design (CAD), which can be modified for any type of nerve damage or even adapted for joint specific nerves of patient.

Furthermore, in June 2016, Polyganics, a medical device manufacturing company, received the CE mark for Neurocap, its nerve capping device. Neurocap is an absorbable implant for treatment and reduction of symptomatic neuroma in peripheral nerves. The device was cleared for sales in the U.S. in January 2016.

Moreover, U.S. Food and Drug Administration’s (USFDA) clearances for nerve biologic products is projected to increase growth of the market. For instance, in June 2014, Collagen Matrix Inc. received USFDA clearance for its Flexible Collagen Nerve Conduit. Flexible Collagen Nerve Conduit is a resorbable and flexible type I collagen tubular matrix that offers encasement for peripheral nerve injuries as well as shielding of the neural environment.

Furthermore, in May 2015, AxoGen, Inc. received USFDA clearance to proceed for Investigational New Drug (IND) application for Avance Nerve Graft. The product is commercially available while it is transitioned to a biologic product due to USFDA’s enforcement discretion grant. It has porcine submucosa extracellular matrix used to wrap and protect injured peripheral nerves and strengthen the nerve reconstruction while preventing soft tissue attachments.

Nerve Biologic Products Market Restraint

Product recall by the USFDA due to contaminations and sterility issues is expected to restrain growth of the nerve biologic products market. For instance, in June 2015, USFDA recalled NeuraWrap Nerve Protector and Dural Graft Matrix, manufactured by Integra LifeSciences, due to process deviation in manufacturing, and higher levels of pyrogens than acceptable by the specifications for the products. NeuraWrap Nerve Protector was specified for management of peripheral nerve injuries while Dural Graft Matrix was an absorbable implant for repair of dural defects.