현재 손발바닥 농포증에 특화된 FDA 승인 약물은 없지만, 여러 가지 치료 옵션에 대한 전망이 있습니다. 국소 치료는 병변이 제한적인 환자에게는 효과적이지만, 장기적으로 효과가 지속되지 않는 경우가 많습니다. 생물학적 제제, JAK 억제제, DMARDs, 레티노이드와 같은 전신 요법은 PPP를 제거할 수 있지만 부작용이 있을 수 있습니다. 광선요법도 효과적이지만, 접근성과 비용에 대한 문제가 있습니다.
현재 일본에서는 3종류의 약물이 손발바닥 농포증(PPP) 치료제로 승인되어 있는데, 2018년 승인된 IL-23 p19 서브유닛 억제제인 TREMFYA(Guselkumab), 2023년 PPP에 대해 최초로 승인된 IL-17 경로 억제제인 LUMICEF(브로달루맙), 2023년 5월 PPP에 대해 승인된 IL-23 억제제 SKYRIZI(리산키주맙)가 있습니다. 이들 치료제는 중요한 염증성 사이토카인을 표적으로 삼아 기존 치료에 반응하지 않는 환자의 PPP를 관리합니다. 그러나 새로운 PPP 치료제 파이프라인은 아직 제한적이며, 암젠의 오테즐라(OTEZLA, 성분명: 아프레밀라스트)가 가장 주목할 만한 후보로 꼽히고 있습니다.
한 마디로 PPP를 치료하기 위해 연구되고 있는 잠재적 치료법은 많지 않습니다. 예측 기간(2024-2034년)에 미국과 유럽 시장에 진입하는 위의 유망한 후보에 대해 언급하기에는 너무 이릅니다. 어쨌든 이 약물은 향후 몇 년 동안 PPP에 큰 변화를 가져올 것으로 보입니다. 이 치료 영역은 전 세계적으로 의료비 상승으로 인해 향후 몇 년 동안 큰 폭의 플러스 전환을 보일 것으로 예상됩니다.
이 보고서는 주요 7개국(미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본)의 손발바닥 농포증(PPP) 시장을 조사 분석하여 각 지역의 시장 규모, 현재 치료법, 미충족 수요, 신약 등에 대한 정보를 제공합니다.
Report Summary
Market
A few key players are leading the treatment landscape of PPP, such as Janssen, Kyowa Kirin, and others. The details of the country-wise and therapy-wise market size have been provided below.
The section dedicated to drugs in the PPP report provides an in-depth evaluation of late-stage pipeline drugs (Phase III and Phase II) related to PPP. The drug chapters section provides valuable information on various aspects related to clinical trials of PPP, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting PPP.
Marketed Therapies
LUMICEF (brodalumab): Kyowa Kirin
Kyowa Kirin received approval from the Ministry of Health, Labour, and Welfare (MHLW) in Japan in August 2023, for a partial change in the approved indication of LUMICEF (brodalumab) to include the treatment of PPP in patients who have had an inadequate response to existing therapies. LUMICEF is a fully human anti-interleukin-17 (IL-17) receptor. An antibody that selectively inhibits inflammatory cytokines like IL-17A, IL-17A/F, IL-17F, and IL-17C by binding to the IL-17A receptor. This makes it the first IL-17 pathway inhibitor approved for PPP. The approval is based on positive results from a Phase III clinical trial in Japan, which showed that LUMICEF met its primary endpoint, confirming its efficacy and safety for PPP patients.
LUMICEF was first approved in Japan in 2016 for psoriasis and has since been approved for other indications, including ankylosing spondylitis. The approval of LUMICEF for PPP provides a new treatment option for patients suffering from this painful and debilitating condition.
SKYRIZI (risankizumab): AbbVie/ Boehringer Ingelheim
SKYRIZI (risankizumab) is a monoclonal antibody that works by binding to the p19 subunit of interleukin-23 (IL-23), a cytokine involved in the inflammatory process. By binding to this subunit, risankizumab effectively prevents IL-23 from interacting with its receptor on immune cells. This mechanism of action helps to reduce the inflammatory responses that are associated with certain autoimmune conditions, including PPP. By inhibiting the IL-23/IL-23 receptor interaction, risankizumab can modulate the immune system and reduce the overactive immune response that drives the symptoms of PPP. Currently, risankizumab is approved in Japan for the treatment of PPP, providing a targeted therapeutic option for patients with this chronic and challenging condition.
Emerging Therapies
OTEZLA (apremilast): Amgen
OTEZLA (apremilast) is an oral medication used to treat certain types of psoriasis and psoriatic arthritis. It works as a selective inhibitor of phosphodiesterase 4 (PDE4), which helps to reduce inflammation. In the United States, OTEZLA is approved for the treatment of adults with active psoriatic arthritis, plaque psoriasis in patients who are candidates for phototherapy or systemic therapy, and oral ulcers associated with Behcet's disease. In the European Union, OTEZLA is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response to or have been intolerant of prior disease-modifying antirheumatic drug (DMARD) therapy. It is also approved for moderate to severe chronic plaque psoriasis in adults who have not responded to, are contraindicated for, or are intolerant of other systemic therapies such as cyclosporine, methotrexate, or psoralen and ultraviolet-A light.
While no medications are currently FDA-approved specifically for PPP, several therapeutic options show promise. Topical treatments can be effective for patients with limited disease, though long-term responses are often not sustained. Systemic therapies, including biologics, JAK inhibitors, DMARDs, and retinoids, may achieve PPP clearance, but come with potential side effects. Phototherapy is also effective, though it can present challenges related to accessibility and cost.
In Japan, three drugs are currently approved for the treatment of Palmoplantar Pustulosis (PPP): TREMFYA (Guselkumab), an IL-23 p19 subunit inhibitor approved in 2018; LUMICEF (Brodalumab), the first IL-17 pathway inhibitor approved for PPP in 2023; and SKYRIZI (Risankizumab), an IL-23 inhibitor approved for PPP in May 2023. These therapies target key inflammatory cytokines to manage PPP in patients who do not respond to existing treatments. However, the pipeline for new PPP treatments remains limited, with OTEZLA (apremilast) by Amgen being the most notable candidate.
In a nutshell, not many potential therapies are being investigated to manage PPP. Even though it is too soon to comment on the above-mentioned promising candidate to enter the market of the US and Europe during the forecast period (2024-2034). Eventually, this drug will create a significant difference in the landscape of PPP in the coming years. The treatment space is expected to experience a significant positive shift in the coming years owing to the improvement in healthcare spending worldwide.
Palmoplantar Pustulosis (PPP) Disease Understanding and Treatment
Palmoplantar Pustulosis (PPP) Overview
PPP is a chronic skin condition characterized by the appearance of yellow-brown pustules on the palms of the hands and the soles of the feet. Once considered a type of psoriasis, PPP is now classified separately, though 10-25% of individuals with PPP may also have chronic plaque psoriasis. The exact cause of PPP is not fully understood, but contributing factors may include smoking, bacterial infections, contact allergies (especially to metals), and certain medications. Common symptoms of PPP include red, tender skin, blisters, pustules, itchiness, pain, and thick, scaly skin. While there is no cure for PPP, various treatments can help manage the symptoms and improve the quality of life for those affected.
Palmoplantar Pustulosis (PPP) Diagnosis
The diagnosis of PPP involves examining the affected skin and may include skin swabs to confirm the pustules are sterile, without bacteria or fungi. In some cases, a skin biopsy is needed, where a sample of the affected skin is taken and examined under a microscope to identify specific features of the disease. This helps differentiate PPP from other similar skin conditions, such as psoriasis. A thorough patient history, including potential triggers like smoking and infections, also aids in the diagnostic process.
Palmoplantar Pustulosis (PPP) Treatment
The main strategies for treating patients with PPP include topical agents, phototherapy, systemic therapies (such as acitretin and biologics), and emerging treatments targeting the IL-36 or IL-1 pathways. The treatment approach should be individualized, taking into account disease severity, patient preferences, and contraindications to certain therapies. These strategies aim to provide symptom relief and control inflammation while exploring new therapeutic targets such as monoclonal antibodies blocking IL-36.
The PPP epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases, Gender-specific cases, Age-specific cases, Severity-specific cases, and total treated cases of PPP in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.
In 2023, the age group of 40-64 years accounted for the highest number of cases, with approximately 160,000 cases across the 7MM. This was followed by the 20-39 years age group, which had the second highest number of cases.
KOL Views
To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.
We have reached out to industry experts to gather insights on various aspects of PPP, including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.
Our team of analysts at Delveinsight connected with more than 15 KOLs across the 7MM. We contacted institutions such as the Harvard Medical School, Skin Centre for Dermatology, GISED Study Center, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the PPP market, which will assist our clients in analyzing the overall epidemiology and market scenario.
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 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.
Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, 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, in trials for PPP, One of the most important primary endpoints was achieving at least a 50% reduction from baseline in the PPP Area and Severity Index (PPPASI-50) at week 16. Based on these, the overall efficacy is 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. In addition, the scoring is also based on the route of administration, order of entry and designation, 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
Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.
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.