Postherpetic Neuralgia - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• In the 7MM, United States accounted for the largest market size in 2023, with approximately 70% of the total market size.
• Postherpetic neuralgia occurs in a subset of the population suffering from an episode of acute herpes zoster. The incidence of herpes zoster increases with age, with most cases occurring in patients over 50.
• FDA-approved options encompass analgesics, anticonvulsants, and topical remedies such as 5% lidocaine and 8% capsaicin patches. Off-label alternatives frequently employed for severe and stubborn PHN involve tricyclic antidepressants, opioids, and interventional approaches like nerve ablation and injection procedures.
• Approximately 40-50% of patients with PHN do not respond to any treatment, and other patients experience limited efficacy.
• Topical therapies, such as the lidocaine patch or the capsaicin patch, can reduce pain in PHN without significant systemic effects, a characteristic that may be beneficial in the elderly population.
• FDA-approved ZTlido, a proprietary 1.8% lidocaine topical system developed by Scilex Holding in 2018. It demonstrated superior qualities compared to the US reference product, Lidoderm 5%, such as enhanced bioavailability, skin adhesion, and efficiency in drug delivery.
• ZTlido may face competition from generic lidocaine patches manufactured by different companies such as Mylan, Teva Pharmaceutical, and others, as well as with LIDODERM.
• The emerging pipeline for postherpetic neuralgia in the 7MM is relatively limited, focusing on drugs being approved for neuropathic pain based on clinical trials involving postherpetic neuralgia and diabetic peripheral neuropathic pain. Key players include Lexicon Pharmaceuticals (LX9211) and Merz Therapeutics (Incobotulinum toxin A).
• The market is expected to change in the coming years, driven by the increasing incidence of shingles and the aging population. One of the major trends in the market is the increasing use of non-opioid pain medications. The opioid epidemic in the United States has led to a greater focus on non-opioid pain management options, which is likely to continue.

Report Summary

• The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of mid-stage (Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the postherpetic neuralgia market, providing an in-depth examination of its historical and projected market size (2020-2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The report includes qualitative insights that provide an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM postherpetic neuralgia market.

Postherpetic Neuralgia Disease Understanding and Treatment Algorithm

Postherpetic Neuralgia Overview

Postherpetic neuralgia is a common complication of shingles caused by varicella-zoster virus (VZV) reactivation, which resides latently in the body after a primary varicella infection. The shingles outbreak causes damage to the sensory nerves, which leads to abnormal signals being sent to the brain, resulting in pain. Postherpetic neuralgia is a neuropathic pain syndrome characterized by pain that persists for more than 90 days after the outbreak of herpes zoster. Common symptoms experienced by patients with postherpetic neuralgia include burning, stabbing, shooting, aching, throbbing, itching, or electric shocks on the affected area. Risk factors for postherpetic neuralgia are increasing age and immunosuppression. People who have acute pain and severe rash during shingles also have a higher risk of developing postherpetic neuralgia.

Postherpetic Neuralgia Diagnosis

The diagnosis of postherpetic neuralgia is clinical. A history of herpes zoster and the nature of the pain are critical parameters of a postherpetic neuralgia diagnosis. Thus, obtaining a detailed medical history, including symptoms and vaccination history, is very important. Pain intensity and quality should be assessed using an appropriate pain scale based on the patient’s ability to communicate - a numerical rating scale (usually an 11-point scale: from 0, no pain, to 10, severe pain), a visual analog scale, or verbal descriptor scale (e.g., McGill Pain Questionnaire). Postherpetic neuralgia diagnosis does not rely on laboratory evaluations. However, laboratory tests and some targeted imaging may provide a degree of utility. Viral culture or immunofluorescent staining may be used to distinguish herpes simplex from herpes zoster.

Postherpetic Neuralgia Treatment

The treatment of postherpetic neuralgia should be directed at pain control and minimizing treatment-related adverse events. Pain relief is challenging and should include drugs, interventionist procedures, and non-pharmacological adjuvant therapy. Guidelines recommend treatment of postherpetic neuralgia with calcium channel a2-d ligands (gabapentin and pregabalin), tricyclic antidepressants (amitriptyline, nortriptyline, or desipramine), or topical lidocaine patches as first-line drugs; opioids and topical capsaicin patch or cream as second-line treatment options or combination therapies with different mechanisms of action. Some patients with postherpetic neuralgia may have persistent pain despite pharmacological, topical, psychological, and physical therapies. Paravertebral and sympathetic nerve blocks may manage these cases of refractory postherpetic neuralgia.

Postherpetic Neuralgia Epidemiology

As the market is derived using a patient-based model, the postherpetic neuralgia epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of herpes zoster, total incident cases of PHN, gender-specific cases of PHN, age-specific cases of PHN, and total treated cases of PHN in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2020 to 2034.

• The incident cases of herpes zoster in the 7MM comprised approximately 4 million cases in 2023 and are projected to increase during the forecast period due to aging population and widespread use of immunosuppressive therapies.
• The total incident cases of PHN in the 7MM were approximately 600,000 in 2023. These cases are expected to increase by 2034.
• Among the 7MM, the United States accounted for the highest number of incident cases of PHN, i.e., ~300,000 cases in 2023.
• According to estimates, PHN is slightly more common in females than males, accounting for ~60% of the total cases, while males accounted for ~40% of the total population share.
• Among EU4 and the UK, Germany accounted for the largest number of PHN cases, followed by France, whereas Spain accounted for the lowest number of cases in 2023.

Postherpetic Neuralgia Drug Chapters

The drug chapter segment of the postherpetic neuralgia report encloses a detailed analysis of postherpetic neuralgia marketed drugs and emerging pipeline drugs. It also helps understand the postherpetic neuralgia pivotal clinical trial details, recent and expected market approvals, patent details, each drug's advantages and disadvantages, the latest news, and recent deals and collaborations.

Marketed Drug

ZTLIDO (topical lidocaine system): 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. The drug received FDA approval in February 2018 for relieving pain associated with postherpetic neuralgia.

TARLIGE (mirogabalin besilate): Daiichi Sankyo

TARLIGE is an analgesic proprietarily discovered by Daiichi Sankyo that works by inhibiting the excessive release of pain-related neurotransmitters in the presynaptic nerve terminal. Mirogabalin exerts an analgesic effect by suppressing calcium current through binding to the a2d subunit, which plays an auxiliary role in the function of voltage-gated calcium channels in the nervous system. Generally, for adults, the initial dose of mirogabalin is 5 mg orally twice daily, and then the dose is gradually increased by 5 mg at intervals of 1 week or longer to 15 mg orally twice daily. The drug was approved for marketing in Japan in January 2019 based on the results of Phase III clinical trials conducted in Asia, including Japan, in patients with diabetic peripheral neuropathic pain (DPNP) and postherpetic neuralgia for peripheral neuropathic pain (PNP).

Emerging Drug

LX9211: Lexicon Pharmaceuticals

LX9211 is a potent, orally delivered, selective small molecule inhibitor of adaptor-associated kinase 1 (AAK1). It was discovered using Lexicon’s unique approach to gene science. Preclinical studies of LX9211 demonstrated that mice lacking AAK1 exhibited increased resistance to induced neuropathic pain. LX9211 was identified in a neuroscience drug discovery alliance with Bristol-Myers Squibb, from which Lexicon holds exclusive development and commercialization rights.

The company has completed a Phase II clinical trial (NCT04662281; RELIEF-PHN1) of LX9211 in adults associated with postherpetic neuralgia and has shown clear evidence of an effect. Topline results were announced in December 2022.

IncobotulinumtoxinA (NT 201): Merz Therapeutics

IncobotulinumtoxinA, marketed as XEOMIN, is approved in over 75 countries worldwide to treat patients with upper and lower limb spasticity, cervical dystonia, blepharospasm, glabellar lines, and sialorrhea. The drug effectively treats peripheral cholinergic nerve endings by weakening the contraction of voluntary muscles. It also relieves muscle tone by inhibiting the release of a neurotransmitter called acetylcholine. It is free from complex proteins and has a low risk of neutralizing antibody formation.

Currently, the company is conducting a Phase II (NCT06091020) PaiNT trial to investigate the efficacy and safety of subcutaneous NT 201 injections compared with placebo injections in decreasing pain intensity in adults with moderate to severe chronic peripheral neuropathic pain due to postherpetic neuralgia or peripheral nerve injury.

Drug Class Insights

FDA-approved treatments for postherpetic neuralgia (PHN) include analgesics, anticonvulsants, and topical solutions. Antiiconvulsants such as Gabapentin, Pregabalin are commonly used to treat neuropathic pain that work by stabilizing electrical activity in the nerves and reducing abnormal signalling. Tricyclic Antidepressants like Amitriptyline, Nortriptyline modulate pain signals in the central nervous system. Opioids (e.g., oxycodone, morphine), strong pain relievers may be prescribed for severe postherpetic neuralgia pain. However, due to the risk of dependence and other side effects, they are typically used cautiously and for short durations. Topical therapies, such as the lidocaine patch or the capsaicin patch, can reduce pain in PHN without significant systemic effects, a characteristic that may be beneficial in the elderly population. The lidocaine medicated plaster represents a simple and safe therapy that can be used since the onset of the first PHN symptoms.

Postherpetic Neuralgia Market Outlook

Postherpetic neuralgia is associated with significant loss of function and reduced quality of life, particularly in the elderly, and is highly resistant to treatment. Since postherpetic neuralgia is often resistant to pharmacologic treatments, a multimodal analgesic treatment strategy is often used to balance the efficacy and tolerability of the medication regimen, the side effects of which can be limiting and compromise the quality of life and patient compliance. Postherpetic neuralgia has no cure, and patients rely on palliative treatments to reduce pain duration and severity. The market for postherpetic neuralgia treatments has undergone significant changes in recent years, driven by advances in the understanding of neuropathic pain and the development of new treatment options. Previously, the treatment options were limited and were based mainly on oral medications such as NSAIDs, opioids, tricyclic antidepressants, and anticonvulsants. These medications had limited efficacy in treating postherpetic neuralgia and were associated with significant side effects. In recent years, there has been a shift toward using topical medications to treat postherpetic neuralgia. Current treatment of postherpetic neuralgia most often consists of oral gabapentin and prescription lidocaine patches (first-line), and refractory cases may be prescribed opioids to address persistent pain.

The first-line use of opioids in treating neuropathic pain (including postherpetic neuralgia) remains controversial. The CDC in the United States advises healthcare professionals to limit opioid prescriptions strictly to cancer-related conditions and a select few other severe health issues. Regarding topical lidocaine therapy for postherpetic neuralgia, a patch version has been approved in the United States, Europe, and Australia, and its use is recommended in the treatment guidelines of the International Association for the Study of Pain. ZTlido, a proprietary 1.8% lidocaine topical system developed by Scilex Holding, gained FDA approval in 2018. In Japan, topical lidocaine therapy for postherpetic neuralgia has not been approved, but lidocaine topical preparations containing gels are being prepared as in-hospital preparations for postherpetic neuralgia.

The market is expected to change in the coming years, driven by the increasing incidence of shingles and the aging population. One of the major trends in the market is the increasing use of non-opioid pain medications. The emerging pipeline for postherpetic neuralgia in the 7MM is relatively limited, focusing on drugs being approved for neuropathic pain based on clinical trials involving postherpetic neuralgia and diabetic peripheral neuropathic pain.

Key Findings

As per the analyst's estimates, the potential drugs that can mark a significant change in the forecast period include ZTLIDO (lidocaine topical system), TARLIGE (mirogabalin besilate), LX9211, and others.

• Current PHN market is largely dominated by low-cost generics, and OTC products.
• The total market size of postherpetic neuralgia in the 7MM is approximately USD 100 million in 2023 and is projected to increase during the forecast period (2024-2034).
• Among EU4 and the UK, Germany accounted for the maximum market size in 2023, while Spain occupies the bottom of the ladder.
• The current pipeline for postherpetic neuralgia in the seven major markets is relatively limited, consisting of a few drugs. Among these, LX9211 is anticipated to achieve the most significant market share during the forecast period.

Postherpetic Neuralgia Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. A fast acceptance can be seen with ZTlido, being designed as a lighter, thinner product with superior adhesion relative to LIDODERM (lidocaine patch 5%) while providing a bioequivalent delivery of lidocaine in an efficient drug delivery system. The product lowers doses while raising efficacy with expected increase in sales in the coming years.

Postherpetic Neuralgia Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II. 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 postherpetic neuralgia emerging therapy.

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. Industry experts contacted for insights on postherpetic neuralgia evolving treatment landscape, patient reliance on conventional therapies, patient’s therapy switching acceptability, and drug uptake, along with challenges related to accessibility, include Medical/scientific writers; Neurologist; Dermatologists; and Professors; MD, FACS, Chair of the Department of The Pain Relief Foundation, Universities, and others.

The analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the Pain Relief Foundation, Nihon University School of Medicine, the Royal Marsden Hospital, Keck Hospital of USC, etc. were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or postherpetic neuralgia market trends. 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 Analyst views. 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

Reimbursement is a crucial factor affecting the drug’s market access. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, payers and other industry insiders are considering many payment models. Currently, ZTlido is covered for more than 200 million lives in the United States, with ongoing efforts to expand coverage. As of January 2023, the company has successfully secured coverage for ZTlido with major entities such as CVS Caremark/Aetna Commercial, Cigna HealthCare (commercial and Medicare plans), Express Scripts (commercial and most Medicare plans), United Healthcare Commercial, Optum Rx Select Commercial, Anthem BCBS, BCBS Louisiana and Kansas, Lifetime/Excellus BCBS, MedImpact, CareFirst, Elixir Commercial, and Medicaid in California, Florida, Idaho, and North Dakota.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved 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 postherpetic neuralgia, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the postherpetic neuralgia 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 shape and drive the 7MM postherpetic neuralgia market.

Postherpetic Neuralgia Report Insights

• Patient Population
• Therapeutic Approaches
• Postherpetic Neuralgia Pipeline Analysis
• Postherpetic Neuralgia Market Size and Trends
• Existing and future Market Opportunity

Postherpetic Neuralgia Report Key Strengths

• Eleven-Year Forecast
• The 7MM Coverage
• Postherpetic Neuralgia Epidemiology Segmentation
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Postherpetic Neuralgia Report Assessment

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

FAQs

• What was the postherpetic neuralgia total market size, the market size by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• Which class is going to be the largest contributor by 2034?
• When is LX9211 expected to be launched?
• 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?
• Who are the generic competitors of ZTlido?
• What are the disease risks, burdens, and unmet needs of postherpetic neuralgia? What will be the growth opportunities across the 7MM concerning the patient population of postherpetic neuralgia?
• What is the historical and forecasted postherpetic neuralgia patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• What are the current options for the treatment of postherpetic neuralgia? What are the current guidelines for treating postherpetic neuralgia in the US and Europe?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?
• What key designations have been granted for the emerging therapies for postherpetic neuralgia?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the postherpetic neuralgia market.
• Insights on patient burden/disease incidence, 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 Analyst view section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of current 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.