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시장보고서
상품코드
2082997
통증 동반 당뇨병성 신경병증 관련 만성 통증 : 시장 인사이트, 역학 및 예측(2036년)Chronic Pain associated with Painful Diabetic Neuropathy - Market Insights, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
‘통증 동반 당뇨병성 신경병증 관련 만성 통증 시장 보고서’에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황을 종합적으로 분석했습니다. 본 보고서에서는 PDN에 따른 만성 통증 환자의 부담 동향, 매출액 및 시장 점유율의 추이, 정점 시기의 환자 점유율 및 치료법 보급 현황에 대한 분석을 평가함과 동시에, 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제공합니다. 본 보고서에서는 PDN과 관련된 만성 통증 분야에서 주요 미충족 수요 사항을 부각시키고, 경쟁 구도와 임상 환경을 분석하여 고부가가치 성장 기회를 도출하는 한편, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
당뇨병 및 당뇨병성 신경병증의 유병률 증가
제1형 및 2형 당뇨병 유병률 증가는 PDN 시장의 주요 성장 동력입니다. 고령화와 비만 인구에서 당뇨병 발병률이 증가함에 따라 당뇨병성 말초신경병증 및 만성 신경병증성 통증의 사례가 늘어나고 있으며, 이에 따라 해당 환자층이 확대되고 있습니다.
비오피오이드를 이용한 통증 관리에 대한 관심 증가
오피오이드 의존성 및 부작용에 대한 우려로 인해, 대체적인 통증 관리 방식으로의 전환이 진행되고 있습니다. 임상의 및 의료 시스템에서는 비오피오이드 약물 요법, 외용 요법, 신경 조절 기기, 그리고 다각적인 전략의 도입이 점점 더 확대되고 있습니다.
의료 서비스 접근성 향상 및 당뇨병 관리 프로그램 확충
선진국 및 신흥 시장의 의료 인프라, 보험 적용 범위, 만성 질환 관리 프로그램이 확대됨에 따라 환자들의 진단 및 치료 접근성이 향상되어 시장 성장을 뒷받침하고 있습니다.
PDN에 따른 만성 통증의 개요
PDN에 따른 만성 통증은 장기간 지속되는 고혈당 및 대사 기능 장애로 인한 말초 신경 손상으로 인해 발생하는 당뇨병의 일반적인 합병증입니다. 일반적으로 발이나 종아리에 영향을 미치는 대칭적인 '양말 모양'의 분포를 보이는 지속적인 신경병성 통증으로 나타나며, 그 감각은 작열감, 따끔거림, 찌르는 듯한 통증, 전기 충격과 같은 감각, 또는 촉각 과민증으로 표현됩니다. PDN은 수면, 신체 기능, 삶의 질 및 정신 건강을 현저히 저해합니다. 당뇨병성 말초신경병증(PDN) 환자의 약 20-30%가 만성 통증 증상을 겪고 있으며, 이는 당뇨병 관련 합병증 중에서도 가장 큰 부담을 주는 것 중 하나입니다.
PDN에 따른 만성 통증의 진단
PDN에 따른 만성 통증은 주로 당뇨병 환자의 만성 신경병성 통증 병력을 바탕으로, 감각 상실이나 반사 저하 등의 신경학적 검사 소견을 근거로 하여 임상적으로 진단됩니다. DN4나 painDETECT와 같은 선별 도구는 진단에 도움이 되지만, 신경전도검사나 임상 검사는 일반적으로 비전형적인 증상이 있는 경우나 신경 손상의 다른 원인을 배제하기 위해서만 시행됩니다.
통증을 동반한 당뇨병성 신경병증(PDN)에 따른 만성 통증의 치료
PDN에 따른 만성 통증 관리에는 통증 조절, 기능 개선 및 최적의 당뇨병 관리에 중점을 둔 다학제적 접근이 필요합니다. 엄격한 혈당 관리는 질환의 진행을 늦추는 데 도움이 될 수 있지만, 일반적으로 이미 발생한 신경병성 통증을 호전시키지는 못합니다. 1차 치료법으로 고려되는 약물 요법에는 프레가발린이나 가바펜틴 등의 항경련제, 그리고 두록세틴 등의 SNRI가 포함됩니다. 아미트립틸린과 같은 삼환계 항우울제는 특정 환자에게 처방되는 경우가 있습니다. 캡사이신 패치나 리도카인 제제 등의 국소 요법은 국소적인 통증 완화를 가져올 수 있습니다.
난치성 증례의 경우, 병용 요법, 신경 조절 요법 또는 통증 전문의에게 의뢰하는 방안이 검토될 수 있습니다. 정기적인 운동, 물리치료, 심리적 지원, 수면 관리, 환자 교육과 같은 비약물적 치료도 전반적인 치료 성과와 삶의 질(QOL)을 향상시키는 데 필수적입니다.
통증 동반 당뇨병성 신경병증 관련 만성 통증과 관련된 역학 분석 및 예측을 통해 도출된 주요 결과
PDN에 따른 만성 통증의 치료 현황은 약물 요법과 비약물 요법을 병행함으로써 발전하고 있습니다. 1차 선택 약물에는 항경련제, SNRI, 삼환계 항우울제가 포함되며, 타펜타돌 등의 오피오이드는 중증 환자에게만 제한적으로 사용됩니다. 물리치료, 경피적 전기신경자극(TENS), 인지행동치료 등의 비약물 요법이 약물 치료를 보완하고 있습니다. 사용 가능한 치료법이 있음에도 불구하고, 많은 환자들이 충분한 통증 완화를 얻지 못하고 있으며, PDN 관리의 유효성, 안전성 및 장기적 예후를 개선하기 위해 특정 통증 경로를 표적으로 하는 새로운 치료법에 대한 연구가 계속되고 있습니다.
PDN에 따른 만성 통증의 약물 치료에는 말초 및 중추 통증 기전 모두를 표적으로 하는 다각적인 접근법이 사용됩니다. 1차 치료제로는 일반적으로 칼슘 채널을 조절하여 신경 세포의 흥분성을 낮추는 프레가발린이나 가바펜틴 등의 항경련제가 꼽힙니다. 또한, 기분과 통증 조절 모두에 작용하는 두록세틴이나 벤라팍신 등의 SNRI도 일반적으로 처방되고 있습니다. 삼환계 항우울제(예 : 아미트립틸린)도 효과가 있을 수 있지만, 특히 고령자의 경우 부작용으로 인해 사용이 제한되는 경우가 많습니다. NUCYNTA를 포함한 오피오이드 진통제는 의존성 및 장기적인 안전성에 대한 우려로 인해 난치성 사례에 한해 사용됩니다. 캡사이신 크림이나 리도카인 패치와 같은 외용제는 전신에 미치는 영향을 최소화하면서 국소적인 통증 완화를 가져다줍니다. 최적의 치료를 위해서는 통증의 중증도, 동반 질환 및 환자의 내성을 고려한 맞춤형 치료 계획이 필요한 경우가 많습니다.
PDN에서 만성 통증 관리에 대한 비약물적 치료는 기능 개선, 통증 지각 완화, 그리고 삶의 질 향상에 중점을 두고 있습니다. 주요 전략으로는 이동성을 개선하고 불편감을 완화하기 위한 물리치료와, 통증 신호를 조절할 가능성이 있는 TENS(경피적 전기 신경 자극) 등이 포함됩니다. 인지행동치료(CBT)는 환자가 만성 통증을 대처하는 방법을 익히는 데 도움이 됩니다.
전압 의존성 나트륨 채널 NaV1.8의 선택적 억제 : 이 치료 접근법은 주로 말초 통각 신경세포에서 발현되는 NaV1.8 나트륨 채널을 선택적으로 차단하여, 당뇨병성 신경병증에 수반되는 비정상적인 통증 신호 전달을 완화합니다. 신경병성 통증의 주요 매개 물질을 표적으로 삼으면서도 다른 나트륨 채널에는 영향을 미치지 않음으로써, 이러한 약물은 중추 신경계에 미치는 부작용을 최소화하면서도 효과적인 진통 효과를 가져올 가능성이 있습니다. 예 : Vertex Pharmaceuticals사의 수제트리긴(VX-548).
칸나비노이드 CB1 수용체 작용제 : 이러한 약물은 통각 처리에 관여하는 칸나비노이드 수용체를 활성화함으로써 통증 신호 전달 경로를 조절합니다. 신경 세포의 흥분성을 낮추고 통증 지각을 변화시킴으로써, CB1 수용체 작용제는 만성 신경병성 통증의 증상을 완화하고 환자의 삶의 질(QOL)을 개선하는 데 도움이 될 수 있습니다. 이러한 작용기전은 PDN 및 기타 만성 통증 질환을 관리하기 위한 새로운 비오피오이드 전략이 될 것입니다. 예 : 인벡스 테라퓨틱스(Invex Therapeutics)의 VSN16R(ELPA001로도 알려져 있음).
DelveInsight's 'Chronic Pain Associated with Painful Diabetic Neuropathy (PDN) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the chronic pain associated with PDN, historical and forecasted epidemiology, as well as the chronic pain associated with PDN market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The Chronic Pain associated with PDN market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates Chronic Pain associated with PND patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in Chronic Pain associated with PND and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.
Key Factors Driving the Chronic Pain Associated With Painful Diabetic Neuropathy (PDN) Market
Rising Prevalence of Diabetes and Diabetic Neuropathy
The rising prevalence of type 1 and type 2 diabetes is a key driver of the PDN market. Increasing rates of diabetes-among aging and obese populations-are leading to more cases of diabetic peripheral neuropathy and chronic neuropathic pain, thereby expanding the addressable patient population.
Growing Focus on Non-Opioid Pain Management
Concerns about opioid dependence and adverse effects are driving a shift toward alternative pain management approaches. Clinicians and healthcare systems are increasingly adopting non-opioid pharmacologic therapies, topical treatments, neuromodulation devices, and multimodal strategies.
Improved Access to Healthcare and Diabetes Management Programs
Expansion of healthcare infrastructure, reimbursement coverage, and chronic disease management programs in both developed and emerging markets has enhanced patient access to diagnosis and treatment, supporting market growth.
Chronic Pain Associated with PDN Overview
Chronic pain associated with PDN is a common complication of diabetes mellitus caused by peripheral nerve damage from prolonged hyperglycemia and metabolic dysfunction. It typically presents as persistent neuropathic pain in a symmetrical "stocking" distribution affecting the feet and lower legs, with sensations described as burning, tingling, stabbing, electric shocks, or increased sensitivity to touch. PDN significantly impairs sleep, physical functioning, quality of life, and mental health. Around 20-30% of patients with diabetic peripheral neuropathy develop chronic painful symptoms, making it one of the most burdensome diabetes-related complications.
Chronic Pain Associated with PDN Diagnosis
Chronic Pain associated with PDN is mainly diagnosed clinically based on a history of chronic neuropathic pain in patients with diabetes, supported by neurological examination findings such as sensory loss and reduced reflexes. Screening tools like DN4 or painDETECT can aid diagnosis, while nerve conduction studies and laboratory investigations are typically reserved for atypical presentations or to rule out other causes of neuropathy.
Chronic Pain Associated with Painful Diabetic Neuropathy (PDN) Treatment
Management of chronic pain associated with PDN requires a multidisciplinary approach focused on pain control, functional improvement, and optimal diabetes management. Tight glycemic control may help slow disease progression, but typically does not reverse established neuropathic pain. First-line pharmacologic options include anticonvulsants such as Pregabalin and Gabapentin, as well as SNRIs like Duloxetine. Tricyclic antidepressants such as Amitriptyline may be used in selected patients. Topical therapies, including capsaicin patches and lidocaine preparations, can provide localized relief.
In refractory cases, combination therapy, neuromodulation techniques, or referral to a pain specialist may be considered. Non-pharmacological strategies-such as regular exercise, physical therapy, psychological support, sleep optimization, and patient education-are also essential for improving overall outcomes and quality of life.
Chronic Pain Associated with Painful Diabetic Neuropathy (PDN) Unmet Needs
The section "unmet needs of chronic pain associated with PDN" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.
Comprehensive unmet needs insights in chronic pain associated with PDN and their strategic implications are provided in the full report.
Key Findings from Chronic Pain Associated with Painful Diabetic Neuropathy (PDN) Epidemiological Analysis and Forecast
Chronic Pain Associated with Painful Diabetic Neuropathy (PDN) Drug Chapters & Competitive Analysis
The Chronic Pain associated with PDN drug chapter provides a detailed, market-focused review of approved and emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the Chronic Pain associated with PDN treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the Chronic Pain associated with PDN therapeutics market.
Approved Therapies for Chronic Pain Associated with Painful Diabetic Neuropathy (PDN)
Tapentadol ER (NUCYNTA): Collegium Pharmaceutical
NUCYNTA is a centrally acting synthetic analgesic approved for managing severe, chronic pain requiring long-term opioid therapy when other treatments are inadequate. Although its exact mechanism is not fully understood, preclinical studies indicate that it functions as both a mu-opioid receptor (MOR) agonist and a norepinephrine reuptake inhibitor (NRI).
QUTENZA (capsaicin 8%): Grunenthal
QUTENZA, developed by Grunenthal, is a high-concentration capsaicin 8% patch, a transient receptor potential vanilloid 1 (TRPV1) receptor agonist approved for the treatment of neuropathic pain associated with diabetic peripheral neuropathy of the feet in adults.
In Europe, it is approved for the treatment of peripheral neuropathic pain. In the US (2020), it had also received approval for the treatment of neuropathic pain associated with DPN of the feet in adults.
Chronic Pain Associated with Painful Diabetic Neuropathy (PDN) Pipeline Analysis
JOURNAVX (Suzetrigine): Vertex Pharmaceuticals
Suzetrigine (VX-548) is an oral, non-opioid medication developed for the treatment of pain, including painful diabetic neuropathy. Its mechanism of action is the selective inhibition of the voltage-gated sodium channel NaV1.8, which plays a key role in pain signal transmission in peripheral nerves.
Vertex Pharmaceuticals advanced its pipeline by initiating three pivotal Phase III trials (NCT07231419, NCT06696443, and NCT06628908) for suzetrigine, targeting the treatment of PDPN, marking a significant milestone in the therapeutic development of novel analgesics for neuropathic pain.
Pilavapadin: Lexicon Pharmaceuticals
Pilavapadin has promising clinical outcomes that have been reported in diabetic neuropathic pain, with a notably favorable safety profile. A non-opioid small-molecule AAK1 inhibitor represents a novel therapeutic approach for neuropathic pain, designed to inhibit the reuptake and recycling of neurotransmitters involved in pain signaling without affecting opioid pathways, with painful DPN as a Phase III-ready lead indication and additional indications prepared for Phase II development.
Chronic Pain Associated with Painful Diabetic Neuropathy (PDN) Key Players, Market Leaders, and Emerging Companies
Chronic Pain Associated with Painful Diabetic Neuropathy (PDN) Drug Updates
The treatment landscape for Chronic Pain associated with PDN is evolving, combining pharmacological and non-pharmacological strategies. First-line medications include anticonvulsants, SNRIs, and tricyclic antidepressants, while opioids like tapentadol are reserved for severe cases. Non-drug approaches such as physical therapy, transcutaneous electrical nerve stimulation, and cognitive-behavioral therapy complement medical treatment. Despite available options, many patients experience inadequate relief, driving ongoing research into novel therapies targeting specific pain pathways to improve efficacy, safety, and long-term outcomes in PDN management.
Pharmacological management of Chronic Pain associated with PDN involves a multimodal approach targeting both peripheral and central pain mechanisms. First-line therapies typically include anticonvulsants such as pregabalin and gabapentin, which modulate calcium channels to reduce neuronal excitability. SNRIs like duloxetine and venlafaxine are also commonly prescribed for their dual action on mood and pain modulation. Tricyclic antidepressants (e.g., amitriptyline) may be effective but are often limited by side effects, especially in older adults. Opioid analgesics, including NUCYNTA, are reserved for refractory cases due to concerns over dependency and long-term safety. Topical agents such as capsaicin cream and lidocaine patches offer localized relief with minimal systemic effects. Optimal treatment often requires individualized regimens based on pain severity, comorbidities, and patient tolerance.
Non-pharmacological approaches to managing chronic pain in PDN focus on improving function, reducing pain perception, and enhancing quality of life. Key strategies include physical therapy to improve mobility and reduce discomfort, and TENS, which may modulate pain signals. Cognitive-behavioral therapy (CBT) helps patients develop coping mechanisms for chronic pain.
Drug Class/Insights into Leading Emerging and Marketed Therapies in Chronic Pain Associated with Painful Diabetic Neuropathy (PDN) (2022-2036 Forecast)
The Chronic Pain Associated with PDN treatment landscape includes established symptomatic therapies such as anticonvulsants, antidepressants, topical agents, and non-pharmacological interventions, alongside a growing pipeline of targeted therapies designed to address the underlying mechanisms of neuropathic pain. Among emerging pharmacological approaches, selective voltage-gated sodium channel inhibitors, cannabinoid receptor agonists, and AAK1 inhibitors have gained significant attention due to their potential to provide effective, non-opioid pain relief with improved tolerability profiles.
Selective Inhibition of the Voltage-Gated Sodium Channel NaV1.8: This therapeutic approach selectively blocks the NaV1.8 sodium channel expressed predominantly in peripheral nociceptive neurons, reducing abnormal pain signal transmission associated with diabetic neuropathy. By targeting a key mediator of neuropathic pain while sparing other sodium channels, these agents may offer effective analgesia with fewer central nervous system adverse effects. E.g., Suzetrigine (VX-548) by Vertex Pharmaceuticals.
Cannabinoid CB1 Receptor Agonists: These agents modulate pain signaling pathways through activation of cannabinoid receptors involved in nociceptive processing. By reducing neuronal excitability and altering pain perception, CB1 receptor agonists may help alleviate chronic neuropathic pain symptoms and improve patients' quality of life. This mechanism represents a novel non-opioid strategy for managing PDN and other chronic pain conditions. E.g., VSN16R (also known as ELPA001) by Invex Therapeutics.
Chronic Pain Associated with Painful Diabetic Neuropathy (PDN) Drug Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the Chronic Pain associated with the PDN market's uptake by drugs, patient uptake by therapy, and sales of each drug.
Currently, the treatment of Chronic Pain associated with PDN is primarily driven by established therapies such as Pregabalin, Gabapentin, and Duloxetine. However, their use is often limited by suboptimal efficacy, tolerability concerns, and persistent residual pain.
Over the coming years, uptake of emerging therapies is expected to increase, led by Suzetrigine due to its promising profile and potential to address unmet needs in neuropathic pain management. This is expected to be followed by investigational agents such as VSN16R and LX9211, supported by advancing clinical evidence and growing demand for novel non-opioid treatment options.
Market Access and Reimbursement of Chronic Pain Associated with Painful Diabetic Neuropathy (PDN)
Reimbursement is a crucial factor that affects the drug's access to the market. 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, many payment models are being considered by payers and other industry insiders.
Further details are provided in the final report....
Chronic Pain Associated with Painful Diabetic Neuropathy (PDN) Therapies Price Scenario & Trends
Pricing and analogue assessment of chronic pain associated with PDN therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, the closest and most appropriate analogue selection for emerging therapies, and the understanding of how pricing influences market access, adherence, and long-term uptake.
Further details are provided in the final report....
Industry Experts and Physician Views for Chronic Pain Associated with Painful Diabetic Neuropathy (PDN)
To keep up with Chronic Pain associated with PDN market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions 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 Chronic Pain associated with PDN emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in Chronic Pain associated with PDN, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as Stanford University, University College London, Joslin Diabetes Center, and Hospital Clinic de Barcelona, etc. were contacted. Their opinion helps understand and validate current and emerging Chronic Pain associated with PDN therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in Chronic Pain associated with PDN.
Qualitative Analysis: SWOT and Conjoint Analysis
We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.
In the SWOT analysis of Chronic Pain associated with PDN, 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.
Conjoint analysis analyzes 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.
The team of analysts analyzes promising 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, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are mainly observed. In addition, the scoring is also based on the route of administration, order of entry, 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.
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