Peripheral Neuropathic Pain - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• Peripheral neuropathic pain (PNP) results from lesions to the peripheral nervous system caused by mechanical trauma, metabolic diseases, neurotoxic chemicals, infection, or tumor invasion.
• Peripheral neuropathy has various causes, with diabetic peripheral neuropathy (DPN) being the most common subtype in the 7MM. Lumbosacral radiculopathy (LSR) is another significant contributor to peripheral neuropathy, followed by post-operative PNP, post-traumatic PNP, and chemotherapy-induced peripheral neuropathy (CIPN). The least common contributor is postherpetic neuralgia (PHN), which occurs as a complication of herpes zoster (shingles).
• In 2023, the total market size of PNP in the 7MM was ~USD 12.00 billion, which is expected to increase by 2034, with a significant CAGR during the forecast period (2024-2034).
• The United States accounts for the largest market size of PNP in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• PNP is treated using diverse modalities, including anticonvulsants, tricyclic antidepressants, and SNRIs. Topical agents like capsaicin and lidocaine offer localized relief, while nonpharmacological interventions such as physical therapy and TENS are also utilized, ensuring a multifaceted approach for effective management.
• Treatment for Peripheral Neuropathy (PNP) focuses on pain management with drugs like NSAIDs, opioids, topical medications, anticonvulsants, and antidepressants. Approved drugs like QUTENZA, NUCYNTA ER, HORIZANT, ZTlido, and TARLIGE are currently available for certain patient segments.
• The entry of emerging drugs is expected to boost the PNP market significantly, potentially offering novel therapeutic options and influencing treatment dynamics.
• The development pipeline for therapies targeting peripheral neuropathy includes several drugs such as AP-325, QUTENZA, XEOMIN, VX-548, LX9211, HALNEURON, SEMDEXA, adezunap, and others.
• The growth of the PNP disease market is expected to be mainly driven by more targeted and personalized therapies and treatments addressing symptoms and underlying causes.
• Compared to all the emerging therapies, LX9211 and SEMDEXA are expected to become the market leader, having a major influence on the PNP market of the 7MM by 2034.
• Adezunap is expected to have a low uptake in the 7MM due to legal hurdles, public stigma, business constraints from being labeled high-risk, and quality control issues related to cannabidiol in emerging markets. These challenges hinder its market acceptance and manufacturing quality.
• ZTlido has gained meaningful market share in a steadily growing lidocaine patch market in recent years, primarily driven by strong payer coverage. It may face competition from generic lidocaine patch manufacturers.

This report delivers an in-depth understanding of Peripheral Neuropathic Pain (PNP), historical and forecasted epidemiology as well as the Peripheral Neuropathic Pain (PNP) market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Peripheral Neuropathic Pain (PNP) market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Peripheral Neuropathic Pain (PNP) market size from 2020 to 2034. The report also covers current Peripheral Neuropathic Pain (PNP) treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Peripheral Neuropathic Pain (PNP) Understanding and Treatment Algorithm

Peripheral Neuropathic Pain (PNP) Overview, Country-Specific Treatment Guidelines, and Diagnosis

Peripheral neuropathies encompass disorders of peripheral nerve cells and fibers, manifesting secondary to a wide range of pathologies. These nerves include cranial nerves, spinal nerve roots and ganglia, nerve trunks and division, and autonomic nervous system nerves. Several methods are used to classify peripheral neuropathies, including mono-neuropathies, multifocal neuropathies, and polyneuropathies. Some forms of neuropathy involve damage to only one nerve (mononeuropathy). Neuropathy affecting two or more nerves in different areas is called multiple mononeuropathy or mononeuropathy multiplex. Many or most of the nerves are often affected (polyneuropathy).

The variability of symptoms allows distinguishing characteristic clinical phenotypes of peripheral neuropathy that should be recognized in order to stratify the diagnostic workup accordingly. Nerve conduction studies are essential to determine the phenotype (axonal versus demyelinating) and severity. Laboratory tests, including genetic testing, CSF examination, nerve imaging, and nerve biopsy, represent additional clinical tests that can be useful in specific clinical scenarios.

Peripheral Neuropathic Pain (PNP) Treatment

Medications such as NSAIDs can relieve mild peripheral neuropathy symptoms, while anti-seizure drugs like gabapentin and pregabalin, as well as topical treatments like lidocaine, can reduce nerve pain. Antidepressants like amitriptyline, nortriptyline, duloxetine, venlafaxine, and desvenlafaxine may also provide relief despite potential side effects. Therapies like scrambler therapy, spinal cord stimulation, plasma exchange, steroids, IV immune globulin, and physical therapy can also help manage symptoms. Surgery may be necessary for neuropathies caused by nerve pressure from tumors.

Peripheral Neuropathic Pain (PNP) Epidemiology

The Peripheral Neuropathic Pain (PNP) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The Peripheral Neuropathic Pain (PNP) epidemiology is segmented with detailed insights into Total Cases, Type-specific Cases, and Treated Cases of Peripheral Neuropathic Pain (PNP).

• In 2023, the United States recorded the highest incidence of PNP among the 7MM, with ~35,200,000 reported cases.
• The 7MM saw the highest number of severe cases in post-operative and post-traumatic PNP, while moderate cases predominated in PHN in terms of severity.
• Estimates indicate that in 2023, the EU4 and the UK collectively reported approximately 19.3 million cases, with Germany representing the largest share at around 35% of the total cases.
• In 2023, diabetic peripheral neuropathy (DPN) accounted for the highest number of cases in the US, comprising approximately 50% of the total cases.

Peripheral Neuropathic Pain (PNP) Drug Chapter

The drug chapter segment of the Peripheral Neuropathic Pain (PNP) report encloses a detailed analysis of Peripheral Neuropathic Pain (PNP) marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the Peripheral Neuropathic Pain (PNP) pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

QUTENZA (capsaicin): Grünenthal and Averitas Pharma

QUTENZA (capsaicin) 8% topical system, a non-systemic, non-opioid pain relief delivered in the form of a patch, indicated for treating neuropathic pain associated with postherpetic neuralgia or associated with diabetic peripheral neuropathy (DPN) of the feet in adults. Capsaicin is an agonist for the transient receptor potential vanilloid 1 receptor (TRPV1), an ion channel-receptor complex expressed on nociceptive nerve fibers in the skin. QUTENZA is marketed and distributed by Averitas. Currently, it is being evaluated under a Phase III trial in post-surgical neuropathic pain. The trial is expected to be completed by October 2024, with an estimated enrollment of 408 participants.

In November 2018, Grünenthal extended its commercial footprint to the US, acquiring Averitas Pharma. Averitas Pharma will commercialize the pain patch QUTENZA for Grünenthal in the US. Grünenthal had recently acquired the remaining global rights from Acorda Therapeutics.

ZTLIDO (lidocaine): Scilex Pharmaceuticals

ZTLIDO is a topical lidocaine system (1.8%) approved for relieving pain associated with postherpetic neuralgia. ZTLIDO is designed as a lighter, thinner product with improved adhesion relative to LIDODERM (lidocaine patch 5%) while providing a bioequivalent delivery of lidocaine in an efficient drug delivery system. Lidocaine is a local amide anesthetic; it blocks sodium ion channels required for initiating and conducting neuronal impulses.

Patients are advised to apply ZTLIDO to intact skin to cover the most painful area and to apply the prescribed number of topical systems (maximum of three) only once for up to 12 h within 24 h (12 h on and 12 h off). Smaller areas of treatment are recommended in patients who are debilitated or have impaired elimination. Achieve this by cutting ZTLIDO with scissors into a smaller size before removing the release liner.

Note: Detailed current therapies assessment will be provided in the full report of Peripheral Neuropathic Pain (PNP)

Emerging Drugs

SEMDEXA (SP-102): Scilex Holding Company

SP-102 is a preservative-free, surfactant-free, and particulate-free, novel epidural steroid injection (ESI) formulation of 10 mg dexamethasone sodium phosphate in a viscous gel solution for subacute lumbosacral radicular pain (Sciatica). Its extended local effect provides durable pain relief and significant improvement in functioning from a single injection with rapid onset.

Recently, the company has completed a pivotal Phase III (NCT03372161) Corticosteroid Lumbar Epidural Analgesia (“CLEAR”) trial, which was designed to evaluate the safety and efficacy of SP-102 in Lumbosacral Radiculopathy (or Sciatica).

In November 2023, Scilex Holding Company announced a positive Type C meeting with the US FDA. The company has reached an agreement with the FDA on the path forward to advance the clinical development of SP-102 and on the requirements to file a New Drug Application.

Adezunap (AP707): Apurano Pharmaceuticals

Apurano Pharmaceuticals’ investigational drug AP707, featuring the THC-focused active ingredient adezunap, has received EMA approval for DISCOVER approval studies. Utilizing the patented PuranoTec manufacturing process, cannabis flower undergoes processing to create an aqueous nanodispersion of cannabinoids, primarily ?-9-THC. Administered as a sublingual mouth spray, this dispersion allows for rapid and efficient absorption through the oral mucosa, facilitated by a water-soluble shell termed the smart coating. These SmartLipids, encapsulating lipophilic cannabinoids, remain stable in aqueous environments and can directly enter the bloodstream due to their small particle size (< 250 nm).

Currently, two Phase III clinical trials, NCT06072573 and NCT06071975, to evaluate the efficacy and tolerability of AP707 in patients with chronic pain due to diabetic polyneuropathy are recruiting participants. Additionally, two other Phase III trials, NCT06071936 and NCT06071988, are recruiting participants to evaluate the efficacy and tolerability of AP707 in patients with chronic pain due to traumatic or post-operative peripheral neuropathy.

Peripheral Neuropathic Pain (PNP) Market Outlook

• Key players, such as Scilex Holding Company, Grünenthal and Averitas Pharma, Eli Lilly and Company, Mitsubishi Tanabe Pharma Corporation, AstraZeneca, Asahi Kasei Pharma, Veloxis Pharmaceuticals, and others, are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Peripheral Neuropathic Pain (PNP).
• Compared to all the emerging therapies, LX9211 and SEMDEXA are expected to become the market leader, having a major influence on the PNP market of the 7MM by 2034.
• In 2023, opioids led the US market with ~USD 2.40 billion in revenue, closely followed by NSAIDs at ~USD 2.30 billion.

Adezunap is expected to have a low uptake in the 7MM due to legal hurdles, public stigma, business constraints from being labeled high-risk, and quality control issues related to cannabidiol in emerging markets. These challenges hinder its market acceptance and manufacturing quality.

Among EU4 and the UK, the highest revenue was generated by NSAIDs, ~USD 600 million in 2023.

Peripheral Neuropathic Pain (PNP) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024-2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Peripheral Neuropathic Pain (PNP) Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Peripheral Neuropathic Pain (PNP) emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.

The analysts connected with 40+ KOLs to gather insights; however, interviews were conducted with 25+ KOLs in the 7MM. Centers such as Keck Hospital of USC, Harvard Medical School, Robert Koch Institute, Rouen University Hospital, University Hospital Münster, etc., were contacted. Their opinion helps understand and validate current and emerging treatment patterns of Peripheral Neuropathic Pain (PNP). This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, Change in Average Daily Pain Score (ADPS), one of the most important primary outcome measures Change in API on 11-point Numerical Rating Scale (NRS) and ADPS.

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. In addition, the scoring is also based on the probability of success and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of Peripheral Neuropathic Pain (PNP), explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression, along with country-specific treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the Peripheral Neuropathic Pain (PNP) market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Peripheral Neuropathic Pain (PNP) market.

Peripheral Neuropathic Pain (PNP) Report Insights

• Patient Population
• Therapeutic Approaches
• Peripheral Neuropathic Pain (PNP) Pipeline Analysis
• Peripheral Neuropathic Pain (PNP) Market Size and Trends
• Existing and future Market Opportunity

Peripheral Neuropathic Pain (PNP) Report Key Strengths

• Eleven Years Forecast
• The 7MM Coverage
• Peripheral Neuropathic Pain (PNP) Epidemiology Segmentation
• Inclusion of country-specific treatment guidelines
• KOL’s feedback on approved and emerging therapies
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Peripheral Neuropathic Pain (PNP) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What is the growth rate of the 7MM Peripheral Neuropathic Pain (PNP) treatment market?
• What was the Peripheral Neuropathic Pain (PNP) total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
• What are the current and emerging options for the treatment of Peripheral Neuropathic Pain (PNP)?
• How many companies are developing therapies for the treatment of Peripheral Neuropathic Pain (PNP)?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Peripheral Neuropathic Pain (PNP) Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.