Key Highlights
- In 2023, the total market size of Peripheral Nerve Injuries accounted for ~USD 2.4 billion in the 7MM.
- In 2023, annual number of peripheral number injuries of upper extremities in the 7MM were ~2.9 million and of lower extremities were ~1.1 million.
- Surgical treatment aims to repair the damaged nerve, maximize the number of axons that regenerate through the site of injury, and increase the proportion of axons that grow back to appropriate targets. In 2023, total number of PNI surgeries performed in 7MM were ~1.7 million.
- In January 2024, the USFDA granted Orphan Drug Designation to Neuraptive Therapeutics' NTX-001 for peripheral nerve injury repair. In May 2020, Fast Track Designation was granted for NTX-001 in peripheral nerve injury treatment.
- In February 2020, Orthocell secured patents in Canada and Japan for its CelGro technology, enabling production of a customizable medical device fostering tissue repair and healing across orthopaedic, reconstructive, and surgical applications.
- Avance Nerve Graft received Regenerative Medicine Advanced Therapy (RMAT) designation in October 2019.
The Peripheral Nerve Injuries market report provides current treatment practices, emerging drugs/devices, Peripheral Nerve Injuries market share of individual therapies, and current and forecasted Peripheral Nerve Injuries market size from 2020 to 2034, segmented by seven major markets. The report also covers current Peripheral Nerve Injuries treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
Geography Covered
- The United States
- EU4 (Germany, France, Italy, and Spain) and the United Kingdom
- Japan
Study Period: 2020-2034
Peripheral Nerve Injuries (PNI) Disease Understanding and Treatment Algorithm
Peripheral Nerve Injuries Overview
Peripheral nerve injuries (PNIs) are complex conditions involving damage to the nerves outside the brain and spinal cord, affecting sensation, movement, and organ function. These injuries can occur due to various causes, including traumatic incidents such as motor vehicle accidents, falls, sports injuries, or penetrating wounds. Compression of nerves from conditions like carpal tunnel syndrome or nerve entrapment syndromes, as well as systemic diseases like diabetes or autoimmune disorders, can also lead to PNIs. Symptoms of PNIs depend on the type and location of the affected nerves. Sensory nerve damage often presents with symptoms like pain, tingling, numbness, or altered sensation in the affected area. Motor nerve injuries may result in muscle weakness, paralysis, or muscle wasting, affecting coordination and strength.Peripheral Nerve Injuries Diagnosis
Diagnosing PNIs typically involves a comprehensive evaluation by healthcare professionals, including a detailed medical history, physical examination, and various diagnostic tests. Imaging studies such as magnetic resonance imaging (MRI) or computed tomography (CT) scans may help visualize nerve injuries and associated structures. Electrophysiological tests such as nerve conduction studies and electromyography can assess nerve function and identify the extent and severity of nerve damage.Peripheral Nerve Injuries Treatment
Treatment strategies for PNIs aim to alleviate symptoms, promote nerve healing, and restore function. In mild cases, conservative management may include rest, activity modification, physical therapy, and pain management with medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) or neuropathic pain medications. Orthotic devices, splints, or braces may be used to support and protect affected limbs.Peripheral Nerve Injuries (PNI) Epidemiology
The Peripheral Nerve Injuries epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the annual cases of peripheral nerve injuries, annual number of peripheral nerve injuries by extremities, and total number of PNI surgeries performed in the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.- In the 7MM, the US accounted for the highest number of cases of Peripheral Nerve Injuries, with nearly 1.7 million in 2023.
- Among EU4 and the UK, Italy accounted for the highest number of cases of Peripheral Nerve Injuries, followed by France, whereas Spain occupied the bottom of the ladder.
- The number of Upper extremities injuries are higher than that of Lower extremities injuries. In the US, in 2023, the former accounted for nearly 1.2 million, while the latter accounted for nearly 0.5 million.
- In the 7MM, the US accounted for the highest number surgeries Peripheral Nerve Injuries, with nearly 770 thousand in 2023.
Peripheral Nerve Injuries Drug/Device Chapters
The drugs/devices chapter segment of the Peripheral Nerve Injuries report encloses a detailed analysis of the late-stage (Phase III and Phase II/III) and early-stage (Phase I/II) pipeline products. The current key players for emerging drugs/devices and their respective candidates include Neuraptive Therapeutics (NTX-001), KLISBio (SilkBridge), Orthocell Limited (CelGro), and others. The drug/device chapter also helps understand the Peripheral Nerve Injuries clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details, and the latest news and press releases.Marketed Products
Avance Nerve Graft: Axogen Corporation
Avance Nerve Graft is an off-the-shelf processed human nerve allograft intended for the surgical repair of peripheral nerve discontinuities. Through a proprietary cleansing process for recovered human peripheral nerve tissue, the graft preserves the essential inherent structure of the extracellular matrix (ECM) while cleansing away cellular and noncellular debris. It is intended for the surgical repair of peripheral nerve discontinuities to support regeneration across the defect. It is processed and distributed by the US FDA and EU requirements for Human Cellular and Tissue-based Products. It had also received Regenerative Medicine Advanced Therapy (RMAT) Designation in 2018, and the company is also conducting a phase III clinical trial, ECON Study, to support its Biologic License Application (BLA) Submission. With the final subject enrolled in July 2020, the last patient is expected to complete the study no later than October of 2021. The AxoGen portfolio of products is available in the United States, Canada, the United Kingdom, and several other European and international countries.Nerbridge: Toyobo
Nerbridge is a resorbable, artificial nerve conduit with polyglycolic acid tubing and a collagenous interior. It is the only such device currently approved in Japan. Nerbridge is mainly used in clinical practice to bridge peripheral nerves after traumatic nerve injury, but there are few reports on its application in reconstruction and repair of the facial nerve. In a study, the utility of Nerbridge to promote nerve regeneration has been evaluated in a murine model of injury to the buccal branch of the facial nerve. The use of Nerbridge has been reported mainly in orthopedic surgery, and its efficacy in trials was 82.8%. The ccompany reports two cases of lingual nerve reconstruction using Nerbridge. In both cases, the lingual nerve was resected due to submandibular gland cancer. The company evaluated the cases by the Semmes-Weinstein monofilaments test. There are problems with length restriction and price, but it is one of the effective reconstruction methods for the reconstruction of the lingual nerve.Emerging Drugs/Devices
NTX-001: Neuraptive Therapeutics
NTX-001 is a kit used during surgical nerve repairs after trauma or during face and body reconstructive procedures. It is (comprised of previously approved components) provided as sterile solutions. The active pharmaceutical agent is a topically administered product used in conjunction with a delivery device directly to the nerve. The therapy has been extensively studied in preclinical studies, and early clinical cases support advancing into the mid-stage clinical studies.NTX-001 is a potentially transformative adjunctive treatment for peripheral nerve injuries, using a propriety system for the reconnection of severed nerves. Neuraptive Therapeutics is also investigating other therapies for nerve repair. NTX-002 is a device that is under investigation in the preclinical phase as a nerve repair device.
SilkBridge: KLISBio
SilkBridge consists of a silk fibroin (SF) scaffold with a hybrid electrospun-textile structure in which electrospun (ES) layers, in the inner and outer parts of the device, are coupled to the textile (TEX) layer, in the middle. This configuration allows the body’s natural healing process to repair the nerve while its tube shape isolates and protects the injured nerves during the healing process. Silk fibroin is fully biocompatible and promotes cell proliferation by stimulating in vivo tissue regeneration. SilkBridge has an optimized balance of biomechanical and biological properties, can sustain perfect cellular colonization of the conduit and the progressive growth of the regenerating nerve fibers.CelGro: Orthocell Limited
CelGro is a unique collagen medical device intended for use in tissue regeneration and repair. CelGro enhances nerve regeneration in 3 different ways.- CelGro protects the area of injury by preventing other faster-growing cells invading the repair site
- CelGro guides the growth of new nerve fibers and creates a favorable microenvironment of growth factors and nutrients to support the growth of healthy nerve cells
- CelGro is highly biocompatible, and does not cause inflammation at the repair site. CelGro is completely resorbed within 6 months with no scar tissue formation
Peripheral Nerve Injuries Market Outlook
Nerve injuries can result in discomfort and various issues related to muscle innervation or loss of sensation. People of all ages are susceptible to peripheral nerve injuries (PNIs), which can stem from diverse causes such as medical conditions or trauma. PNIs predominantly affect the upper limbs and are often associated with trauma, leading to symptoms like paraesthesia, weakness, paralysis, and pain. Surgical intervention is often necessary for severe nerve damage, with the treatment approach depending on the type of nerve injury. The primary aim of repair is to restore sensory, motor, and autonomic function by regenerating axons, although current therapeutic options may not guarantee complete recovery in all cases.- The US accounted for the largest market size of Peripheral Nerve Injuries in the 7MM, with nearly USD 1.5 billion in 2023.
- Among EU4 and the UK, Italy accounted for the maximum market size in 2023, while Spain occupied the bottom of the ladder.
- Among all the therapies, Autografts are expected to generate the highest revenue followed by NTX-001 in the 7MM by 2034.
Peripheral Nerve Injuries Drugs Uptake
This section focuses on the rate of uptake of the potential drugs/devices expected to be launched in the market during the study period. The analysis covers Peripheral Nerve Injuries market uptake by drugs/devices; patient uptake by therapies; and sales of each product.Peripheral Nerve Injuries Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I/II stage. It also analyzes key players involved in developing targeted therapeutics.Pipeline Development Activities
The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for Peripheral Nerve Injuries emerging therapies.KOL- Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like Neuroscientists, Professor and Vice Chair Department of Critical Care Medicine and Director, PhD, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or Peripheral Nerve Injuries market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.The analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Johns Hopkins University School of Medicine, University of California, etc., were contacted. Their opinion helps understand and validate Peripheral Nerve Injuries epidemiology and market trends.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.
In efficacy, the trial’s primary and secondary outcome measures are evaluated.
Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.
Market Access and Reimbursement
The treatment of peripheral nerve injuries is complicated by the disparate mechanisms of trauma, patient presentation, and any secondary bone or soft-tissue damages. To provide uniform-successful reconstructive outcomes in these settings, the goals of a tension-free and timely repair are paramount. A tension-free primary repair is typically regarded as the optimal solution for a functional outcome, though this is not often possible as the mechanism of injury frequently requires debridement of crush or traction injury damage. Small biomechanical accommodations can be performed to decrease the tension at the repair site, such as extended external neurolysis or a slight flexion/extension posture of a proximal joint; but, these maneuvers can further compromise the repair if postoperative contractures occur.Scope of the Report
- The report covers a descriptive overview of Peripheral Nerve Injuries, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
- Comprehensive insight has been provided into Peripheral Nerve Injuries epidemiology and treatment.
- Additionally, an all-inclusive account of both the current and emerging therapies for Peripheral Nerve Injuries is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
- A detailed review of the Peripheral Nerve Injuries market; historical and forecasted is included in the report, covering the 7MM drug/devices outreach.
- The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Peripheral Nerve Injuries market.
Peripheral Nerve Injuries Report Insights
Peripheral Nerve Injuries Report Insights
- Patient Population
- Therapeutic Approaches
- Peripheral Nerve Injuries Pipeline Analysis
- Peripheral Nerve Injuries Market Size and Trends
- Market Opportunities
- Impact of Upcoming Therapies
Peripheral Nerve Injuries Report Key Strengths
- Eleven Years Forecast
- 7MM Coverage
- Peripheral Nerve Injuries Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
Peripheral Nerve Injuries Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Qualitative Analysis (SWOT and Conjoint Analysis)
FAQs
- What was the Peripheral Nerve Injuries market share (%) distribution in 2020 and what it would look like in 2034?
- What would be the Peripheral Nerve Injuries total market size as well as market size by therapies across the 7MM during the study period (2020-2034)?
- What are the key findings about the market across the 7MM and which country will have the largest Peripheral Nerve Injuries market size during the study period (2020-2034)?
- At what CAGR, the Peripheral Nerve Injuries market is expected to grow at the 7MM level during the study period (2020-2034)?
- What would be the Peripheral Nerve Injuries market outlook across the 7MM during the study period (2020-2034)?
- What would be the Peripheral Nerve Injuries market growth till 2034 and what will be the resultant market size in the year 2034?
- What are the disease risks, burdens, and unmet needs of Peripheral Nerve Injuries?
- What is the historical Peripheral Nerve Injuries patient pool in the United States, EU4 (Germany, France, Italy, and Spain), and the UK, and Japan?
- What would be the forecasted patient pool of Peripheral Nerve Injuries at the 7MM level?
- What will be the growth opportunities across the 7MM concerning the patient population of Peripheral Nerve Injuries?
- Out of the above-mentioned countries, which country would have the incident population of Peripheral Nerve Injuries during the study period (2020-2034)?
- At what CAGR the population is expected to grow across the 7MM during the study period (2020-2034)?
- How many companies are developing therapies for the treatment of Peripheral Nerve Injuries?
- How many emerging therapies are in the mid-stage and late stage of development for the treatment of Peripheral Nerve Injuries?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to Peripheral Nerve Injuries therapies?
- What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
- What are the clinical studies going on for Peripheral Nerve Injuries and their status?
- What are the key designations that have been granted for the emerging therapies for Peripheral Nerve Injuries?
- What are the 7MM historical and forecasted market of Peripheral Nerve Injuries?
Reasons to buy
- The report will help in developing business strategies by understanding trends shaping and driving Peripheral Nerve Injuries.
- To understand the future market competition in the Peripheral Nerve Injuries market and Insightful review of the SWOT analysis of Peripheral Nerve Injuries.
- Organize sales and marketing efforts by identifying the best opportunities for Peripheral Nerve Injuries in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
- Organize sales and marketing efforts by identifying the best opportunities for the Peripheral Nerve Injuries market.
- To understand the future market competition in the Peripheral Nerve Injuries market.
Table of Contents
1. Key Insights2. Report Introduction3. Executive Summary of Peripheral Nerve Injuries5. Key Events6. Epidemiology and Market Forecast Methodology9. Patient Journey13. Unmet Needs14. SWOT Analysis16. Kol Views18. Publisher Capabilities19. Disclaimer20. About the Publisher
4. Peripheral Nerve Injuries Market Overview at a Glance
7. Peripheral Nerve Injuries: Disease Background and Overview
8. Epidemiology and Patient Population
10. Marketed Drugs
11. Emerging Treatment
12. Peripheral Nerve Injuries: Market Analysis
15. Market Access and Reimbursement
17. Appendix
List of Tables
List of Figures
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- NEURAPTIVE THERAPEUTICS
- KLISBIO
- ORTHOCELL LIMITED
- ONO PHARMACEUTICAL