DelveInsight’s ‘Peripheral Nerve Injuries (PNI) - Market Insights, Epidemiology, and Market Forecast - 2030’ report delivers an in-depth understanding of the PNI, historical and forecasted epidemiology as well as the PNI market trends in the United States, EU5(Germany, France, Italy, Spain, and the United Kingdom) and Japan.
The PNI market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM PNI market size from 2017 to 2030. The report also covers current PNI treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Geography Covered
• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan
Study Period: 2017–2030
Peripheral Nerve Injuries (PNI) Disease Understanding and Treatment Algorithm
Overview
The peripheral nervous system (PNS) is a vast communications network that transmits information from the brain and spinal cord (the central nervous system) to every other part of the body. Peripheral nerves (PN) also send sensory information back to the brain and spinal cord, such as a message that the feet are cold or a finger is burned. The PNS is comprised of three types of cells: neuronal cells, glial cells, and stromal cells. Nerves are comprised of various combinations of motor, sensory, and autonomic neurons.
PNIs remains a major medical problem worldwide. These lesions are caused mainly by vehicular motor accidents, penetrating trauma after stabbing incidents, gunshot injuries, and stretching or crushing injuries after falls. Fractures of the adjacent bones are commonly associated with PNIs, such as humeral fractures associated with radial neuropathy. Depending on the mechanism of the injury, the PNIs can be sharp or blunt, transected, or lacerated; the nerves may be displaced, contused, stretched, or even partially divided, leading to neuromas or lesions in continuity.
Peripheral Nerve Injuries (PNI) Diagnosis
To fully determine the extent of the damage to the nerve, an electrical conduction test can be used to determine the passage of electrical currents through the nerves. The tests used for diagnosis include electromyography (EMG), nerve conduction velocity (NCV) test, MRI neurography, CT scan, and biopsy. Different tests like blood tests, spinal fluid tests, muscle strength tests, and tests of the ability to detect vibrations can also be performed.
Peripheral Nerve Injuries (PNI) Treatment
Depending on the location and degree of the nerve damage, the doctor may prescribe different courses of therapy. For mild nerve injuries, the following non-surgical treatments may be part of the plan such as acupuncture, massage therapy, medication, orthotics, physical therapy and rehabilitation, and weight loss. More severe injuries may require peripheral nerve surgery, which is performed by a neurosurgeon. These surgical procedures can be highly complicated, and this is why it is essential to select an experienced surgeon and team for peripheral nerve operations which may involve nerve grafting, nerve regeneration, or tendon or muscle transfer.
Medications recommended for chronic neuropathic pain are also used for other medical conditions. Among the most effective are a class of drugs first was marketed to treat depression. Nortriptyline and newer serotonin-norepinephrine reuptake inhibitors such as duloxetine hydrochloride modulate pain by increasing the brain’s ability to inhibit incoming pain signals. Another class of medications that quiets nerve cell electrical signaling is also used for epilepsy. Common drugs include gabapentin, pregabalin, and less often topiramate and lamotrigine. Carbamazepine and oxcarbazepine are particularly effective for trigeminal neuralgia, a focal neuropathy of the face. Local anesthetics and related drugs that block nerve conduction may help when other medications are ineffective or poorly tolerated. Medications put on the skin (topically administered) are generally appealing because they stay near the skin and have fewer unwanted side effects.
Peripheral Nerve Injuries Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Number of Annual Peripheral Nerve Injuries, Total Annual Number of PNI by Extremities and Total Number of PNI Surgeries Performed scenario of PNI in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom), and Japan from 2017 to 2030.
Key Findings
This section provides glimpses of the PNI epidemiology in the 7MM.
• The total number of Annual PNI cases in the 7MM was 3,889,176 in 2017.
• The United States accounted for the highest number of PNI cases among the 7MM. The total number of PNI cases in the US was estimated to be 1,645,218 in 2017.
• Upper extremities and lower extremities PNI cases in the US were 1,151,901 and 493,316, respectively in 2017.
• The total number of surgeries performed for PNI in the US was estimated to be 720,605 in 2017.
• Among the European 5 countries, Italy had the highest cases of PNI with 412,612 cases, followed by France and the United Kingdom with 292,295 cases, and 276,320 cases, respectively. On the other hand, Spain had the lowest cases, i.e., 142,880 in 2017.
• Japan ranks second highest for numbers of PNI cases among 7MM. In 2017, there were an estimated 848,800 cases of PNI in Japan.
Country Wise-PNI Epidemiology
The epidemiology segment also provides the PNI epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
Peripheral Nerve Injuries Drug Chapters
This segment of the PNI report encloses the detailed analysis of the marketed and pipeline drugs/devices. It also helps to understand the clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug and the latest news and press releases.
Peripheral Nerve Injuries Marketed Products
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. As a part of its global strategy, the company subsequently applied with the FDA to sell Nerbridge in the United States. In June 2016, Toyobo achieved 510(k) clearance with the US Food and Drug Administration (FDA) to sell Nerbridge.
Products detail in the report…
Neurolac and Neurolac Thin Wall (TW): Polyganics
Neurolac and Neurolac Thin Wall (TW) are nerve guides that provide mechanical support to the healing nerve for a period of up to 10 weeks after which they are naturally degraded. These are indicated for reconstruction of peripheral nerve discontinuities of up to 20 mm, typically in the hand and wrist. Neurolac TW features a reduced wall thickness to facilitate handling and needle penetration if required. These conduits are approved in the US, EU, and distributed in various countries.
Products detail in the report…
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Peripheral Nerve Injuries Emerging Technique
CelGro: Orthocell Limited
CelGro is a unique collagen medical device intended for use in tissue regeneration and repair. CelGro enhances nerve regeneration in three different ways. Nerve repair with CelGro does not require the use of sutures to hold the membrane in place. Tensionless repair is highly desirable in nerve reconstruction for several reasons, but primarily because it reduces the risk of additional damage to the nerve, and it reduces the time needed to complete the surgery. Orthocell designed CelGro with handling characteristics to assist surgeons perform complex reconstructive surgical procedures with the tensionless repair. CelGro is proving to increase the strength and quality of the repair and makes surgery easier.
Products detail in the report…
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.
Products detail in the report…
List to be continued in the report…
Peripheral Nerve Injuries Market Outlook
Treatment for PNI depends on the type of nerve injury. The primary goal of the repair is to achieve the reinnervation of the target organs by regenerating sensory, motor, and autonomic axons into the environment of the distal nerve with minimal loss of fibers at the suture line, as the therapeutic options, at present, cannot achieve perfect sensory and motor recovery in all cases. The treatment is mainly based on surgery and the use of nerve conduits, wraps, and nerve grafts.
Since antiepileptics such as gabapentin, oxcarbazepine, and lamotrigine target high-voltage activated Ca channels, they are useful in nerve pain management. Pregabalin has a similar MOA like gabapentin, which does not affect GABA receptors. Gabapentin and pregabalin are particularly useful for neuropathic pain in patients with a history of cardiovascular disorders, glaucoma, or urinary retention.
Nerve grafting remains the “gold standard”; clinical treatment for peripheral nerve defects, regardless of the size of the gap. As per the claims of AxoGen, Avance Nerve Graft has no disadvantages related to immunogenicity due to its decellularized and cleansed extracellular matrix. The FDA or Conformit Europe approved most of the conduits for clinical use that were made of type I collagen, such as NeuraGen, NeuroFlex, and NeuroWrap. Besides, there are available conduits also, which are synthesized of polyglycolic acid and polylactide-caprolactone (Neurotube, Neurolac).
In March 2013, Toyobo received permission from Japan’s Ministry of Health, Labour, and Welfare to manufacture and sell Nerbridge, a new medical treatment device for the regeneration of damaged nerves.
Gene therapy offers another exciting alternative to autologous nerve grafts for enhancing peripheral nerve repair. Despite major progress in understanding peripheral nerve regeneration, the gold standard for repairing a nerve defect remains autografting. Until now, there are no studies to prove better outcomes than nerve grafting.
According to DelveInsight, the PNI market is expected to change in the study period 2017–2030.
Key Findings
This section includes a glimpse of the PNI 7MM market.
• The market size of PNI in the seven major markets was USD 2,182.82 million in 2017.
• The market size of Peripheral Nerve Injuries (PNI) in the US was USD 1,396.92 million in 2017.
• Among the EU-5 countries, Italy has the highest market size followed by France and the UK. The lowest market size was estimated in Spain with USD 54.03 million in 2017.
• The current management of PNI includes the use of sutures, nerve conduits & processed nerve allograft, and autograft. For small injured nerves in which small area of nerve is damaged, sutures are performed that joins the broken and affected nerve. There are many Food and Drug Administration (FDA) and EMA approved collagen-based conduits such as NeuraGen, NeuroFlex, NeuroMatrix, NeuroWrap, NeuroMend, and several others. Apart from these, an allograft, i.e., Avance Nerve Graft is also present in the market.
• The market size of Autograft, and nerve conduits & processed nerve allografts was estimated to be USD 1,560.95 million, and USD 583.81 million, respectively in 2017, in the 7MM.
• CelGro and NTX-001 are expected to enter the US market in 2021 and 2023, and EU-5 and Japan market in 2022, and 2024, respectively.
Market Outlook for Seven Major Markets
This section provides the total PNI market size and market size by therapies in the United States, Germany, France, Italy, Spain, the United Kingdom, and Japan.
Peripheral Nerve Injuries Drugs Uptake
This section focusses on the rate of uptake of the potential drugs that are expected to get launched in the market during the study period 2017–2030. The analysis covers PNI market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Peripheral Nerve Injuries Development Activities
The report provides insights into different therapeutic candidates in the clinical and premarket clinical studies. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for PNI emerging therapies.
Competitive Intelligence Analysis
We perform competitive and market intelligence analysis of the PNI market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
• The report covers the descriptive overview of PNI, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the PNI epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for PNI is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the PNI market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM PNI market.
Report Highlights
• PNI market is anticipated to increase for the study period 2017–2030.
• Among the emerging products, NTX-001 is projected to lead the market with the largest market share in 2030.
• In the coming years, the PNI market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence PNI R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for PNI. Launch of emerging therapies will significantly impact the PNI market.
• Our in-depth analysis of the pipeline assets across different stages of development, different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key competitors, and launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.
PNI Report Insights
• Patient Population
• Therapeutic Approaches
• PNI Pipeline Analysis
• PNI Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies
PNI Report Key Strengths
• 11-Years Forecast
• 7MMCoverage
• PNI Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake
PNI Report Assessment
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT Analysis
Key Questions
Market Insights:
• What was the PNI market share (%) distribution in 2017 and how it would look like in 2030?
• What would be the PNI total market size as well as market size by therapies across the 7MM during the forecast period (2020–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest PNI market size during the forecast period (2020–2030)?
• At what CAGR, the PNI market is expected to grow at the 7MM level during the forecast period (2020–2030)?
• What would be the PNI market outlook across the 7MM during the forecast period (2020–2030)?
• What would be the PNI market growth until 2030, and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights:
• What is the disease risk, burden, and unmet needs of PNI?
• What is the historical PNI patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
• What would be the forecasted patient pool of PNI at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to PNI?
• Out of the countries mentioned above, which country would have the highest number of PNI cases during the forecast period (2020–2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2020–2030)?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
• What are the current options for the treatment of PNI along with the approved therapy?
• What are the PNI marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of PNI?
• How many therapies are developed by each company for the treatment of PNI?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of PNI?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the PNI therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for PNI and their status?
• What are the key designations that have been granted for the emerging therapies for PNI?
• What are the 7MM historical and forecasted market of PNI?
Reasons to buy
• The report will help in developing business strategies by understanding trends shaping and driving the PNI.
• To understand the future market competition in the PNI market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for PNI in the US, Europe (Germany, Spain, Italy, France, and 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 PNI market.
• To understand the future market competition in the PNI market.