Nerve biologic products include artificial nerve conduit, nerve graft, nerve wraps, or nerve capping devices used for guiding axonal regrowth to facilitate nerve regeneration. These devices are majorly used in clinical treatments for nerve injuries. Nerve biologic products are commonly used for complex suturing, for instance suturing of two ends of a separated nerve that needs rigid process. The scaffold material used for generating nerve biologic products is either from synthetic or biological origin. The nerve biologic products are manufactured from various biocompatible products such as polysialic acid (PSA), collagen type I/III, spider silk fiber, silkworm silk fibroin, chitosan, aragonite, and alginate.
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.
Nerve Biologic Products Market – Regional Analysis
On the basis of region, the global nerve biologic products market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.
Based on region, North America is expected to hold lead position in the global nerve biologic products market during the forecast period, owing to rising number of peripheral nerve injuries in the U.S. For instance, according to Proceedings of the National Academy of Sciences of the U.S. study in June 2017, over 250,000 people from the U.S. suffers from peripheral nerve injury annually.
Asia Pacific and Europe region is also expected to observe significant growth in the nerve biologic products market. This is attributed to rising awareness of central nervous system disorders and therapeutic treatments through organized conferences. For instance, proceeding to 6th International Conference on Central Nervous System (CNS) Disorder and Therapeutics which is to be held in Paris in November 2018, 7th International Conference on Central Nervous System (CNS) Disorder and Therapeutics is to be held in Japan in June 2019. These conferences mainly discusses on topics such as diseases and disorders of the CNS, neuroimmunological disorders, neurometabolic disorders, brain tumors, and neurosurgery.
Key players operating in the global nerve biologic products market include, Stryker, AxoGen, Inc., Integra LifeSciences, Collagen Matrix, Inc., Polyganics, Checkpoint Surgical Inc., and TEXAS PHARMACUETICAL PVT LTD.
Nerve Biologic Products Market – Taxonomy
By Product Type
- Nerve Wraps
- Nerve Grafts
- Nerve Conduit
- Nerve Capping
- Nerve Grafting
- Direct Nerve Repair/ Neurorrhaphy
- Dural Defects
- Peripheral Nerve Injuries
- North America
- Asia Pacific
- Latin America
- Middle East