2034年までの700万年前後の乾癬市場の展望：乾癬の種類別の包括的分析 | DelveInsight

The psoriasis treatment pipeline features several promising candidates in mid- to late-stage development, poised for approval in the coming years. This evolving landscape offers a variety of innovative therapeutic options, such as Imsidolimab (from AnaptysBio), TAK-279 (developed by Nimbus Lakshmi and Takeda), Sonelokimab (by MoonLake Immunotherapeutics), and additional treatments across different therapeutic lines. The anticipated introduction of these therapies is expected to drive positive growth in the psoriasis market. Notably, several companies are actively contributing to this pipeline through sponsored or co-sponsored clinical trials in psoriasis from Phase 1 to Phase 3. Below is a comprehensive overview of these companies, including their drug candidates, trial phases, mechanisms of action, and key updates:

• Maruho Co., Ltd. : Drug Candidate: Difamilast (OPA-15406); Clinical Trial Phase(s): Phase 3 (completed in Japan; ongoing global Phase 3); Mechanism of Action (MOA): Phosphodiesterase 4 (PDE4) inhibitor, which reduces inflammation by increasing cyclic AMP levels in immune cells, thereby modulating inflammatory responses in psoriasis; Latest News/Developments: In 2023, Maruho completed a Phase 3 trial in Japan showing significant improvement in Psoriasis Area and Severity Index (PASI) scores for plaque psoriasis. The drug received approval in Japan in 2024 for atopic dermatitis and psoriasis. Global Phase 3 trials (e.g., in the US and Europe) are ongoing, with positive interim data reported in 2024 indicating efficacy in moderate-to-severe plaque psoriasis; Clinical Trial Registry ID(s): NCT04058041 (Phase 3, completed); NCT05197270 (ongoing Phase 3).
• Mitsubishi Tanabe Pharma Corporation : Drug Candidate: MT-818 (formerly MT-9929); Clinical Trial Phase(s): Phase 2 (completed); Phase 3 (ongoing); Mechanism of Action (MOA): Janus kinase (JAK) inhibitor, specifically targeting JAK1 and JAK3, which blocks cytokine signaling pathways involved in psoriasis inflammation; Latest News/Developments: Phase 2 trials completed in 2023 showed dose-dependent improvements in PASI scores for moderate-to-severe plaque psoriasis. Phase 3 trials began in 2024, with early data indicating safety and efficacy comparable to existing biologics. No regulatory approvals yet; the company is targeting global markets; Clinical Trial Registry ID(s): NCT04885946 (Phase 2, completed); NCT06154486 (Phase 3, ongoing).
• Takeda Pharmaceutical Company Limited : Drug Candidate: TAK-279 (formerly NDI-034858); Clinical Trial Phase(s): Phase 2b (completed); Phase 3 (ongoing); Mechanism of Action (MOA): Tyrosine kinase 2 (TYK2) inhibitor, which modulates immune responses by blocking TYK2-mediated signaling in inflammatory pathways, reducing psoriasis-related inflammation; Latest News/Developments: Phase 2b trials (2023) demonstrated superior PASI 75 response rates versus placebo in moderate-to-severe plaque psoriasis. Phase 3 trials launched in 2024, with interim data in 2024 showing promising results. Takeda (in collaboration with Nimbus Lakshmi) aims for regulatory submissions in 2025–2026; Clinical Trial Registry ID(s): NCT05488977 (Phase 2b, completed); NCT06136663 (Phase 3, ongoing).
• Meiji Seika Pharma Co., Ltd.: Drug Candidate: ME3183; Clinical Trial Phase(s): Phase 2 (ongoing); Mechanism of Action (MOA): Interleukin-17 (IL-17) inhibitor, targeting the IL-17 pathway to reduce keratinocyte proliferation and inflammation in psoriasis; Latest News/Developments: Phase 2 trials initiated in 2023 for moderate-to-severe plaque psoriasis, with no public data yet. The company is focusing on Asian populations, with potential Phase 3 plans in 2025; Clinical Trial Registry ID(s): NCT05891665 (Phase 2, ongoing).
• Daewoong Pharmaceutical Co., Ltd. : Drug Candidate: DWP05195; Clinical Trial Phase(s): Phase 1 (completed); Phase 2 (ongoing); Mechanism of Action (MOA): Phosphodiesterase 4 (PDE4) inhibitor, increasing cyclic AMP to suppress inflammatory cytokines in psoriasis; Latest News/Developments: Phase 1 trials completed in 2022 with good safety profiles. Phase 2 trials for moderate-to-severe plaque psoriasis started in 2023, showing early efficacy in Korean patients. No approvals yet; the company plans to expand to global trials; Clinical Trial Registry ID(s): NCT05391698 (Phase 1, completed); NCT05691686 (Phase 2, ongoing).
• Celltrion, Inc. : Drug Candidate: CT-P43 (biosimilar to ustekinumab); Clinical Trial Phase(s): Phase 1 (completed); Phase 3 (ongoing); Mechanism of Action (MOA): IL-12/23 inhibitor (biosimilar to ustekinumab), blocking these cytokines to reduce psoriasis inflammation; Latest News/Developments: Phase 1 trials completed in 2022, confirming pharmacokinetic equivalence. Phase 3 trials for moderate-to-severe plaque psoriasis are ongoing, with data expected in 2025. Celltrion received approval for other biosimilars in psoriasis markets but is pursuing this for expanded indications; Clinical Trial Registry ID(s): NCT04994652 (Phase 1, completed); NCT05352854 (Phase 3, ongoing).
• PharmaEngine, Inc.: Drug Candidate: PEP503 (nalmefene) – Note: Primarily for other indications, but has psoriasis-related trials; Clinical Trial Phase(s): Phase 2 (completed); Mechanism of Action (MOA): Opioid receptor modulator, targeting pruritus and inflammation in psoriasis via kappa opioid receptor antagonism; Latest News/Developments: Phase 2 trials for psoriasis-associated pruritus completed in 2023, showing reduced itching but limited overall psoriasis efficacy. No further psoriasis trials announced; the company is pivoting to other dermatological conditions; Clinical Trial Registry ID(s): NCT04149574 (Phase 2, completed).
• TaiMed Biologics, Inc.: Drug Candidate: TMB-365 (ibalizumab) – Primarily for HIV, but has exploratory psoriasis trials; Clinical Trial Phase(s): Phase 1 (completed); Mechanism of Action (MOA): CD4-directed monoclonal antibody, potentially modulating immune responses in psoriasis by blocking CD4+ T-cell activation; Latest News/Developments: Phase 1 trials for psoriasis completed in 2022, with mixed results on safety. No further psoriasis development; the company focuses on HIV treatments; Clinical Trial Registry ID(s): NCT03219632 (Phase 1, completed).

Psoriasis Market Outlook in the 7MM Through 2034: Comprehensive Analysis by Psoriasis Type | DelveInsight

The psoriasis treatment pipeline includes several drugs in mid- and late-stage development, with approvals expected soon. The emerging treatment environment provides a broad array of therapeutic choices, featuring Imsidolimab (AnaptysBio), TAK-279 (Nimbus Lakshmi/Takeda), Sonelokimab (MoonLake Immunotherapeutics), and others across various treatment categories. The projected launches of these therapies are anticipated to enhance the market positively.

Psoriasis is a chronic, immune-mediated inflammatory skin disorder characterized by elevated, reddish papules and plaques. It stems from an excessive immune reaction that speeds up skin cell production and induces inflammation. Worldwide, psoriasis impacts roughly 1% to 8% of people, with around one-third of cases beginning in childhood.

In 2023, the United States reported approximately 8 million diagnosed cases of psoriasis. Although no cure exists, effective treatments are available. Topical therapies are the primary approach for mild to moderate cases, often involving glucocorticoids, vitamin D analogs, and phototherapy. For moderate to severe psoriasis, systemic treatments are typically necessary.

Topical options are commonly the initial treatment for psoriasis, as they reduce rapid skin cell growth and inflammation. The advent of biologic therapies has revolutionized plaque psoriasis management.

In the future, the psoriasis treatment field is set to broaden with new therapies from major players like AnaptysBio, MoonLake Immunotherapeutics, Takeda, Evelo Biosciences, UNION Therapeutics, and others, potentially fueling market expansion.

Learn more about the psoriasis market in detail @ Psoriasis Market Report

DelveInsight specializes in the autoimmune diseases market and has a skilled team adept at handling neurological disorders. The firm has recently published epidemiology-driven market reports on various psoriasis forms, including Plaque Psoriasis, Generalized Pustular Psoriasis, Mild to Moderate Plaque Psoriasis, and Moderate to Severe Psoriasis. These reports offer a thorough overview of current treatment methods, emerging drugs, individual therapy market shares, and market size projections from 2020 to 2034, segmented across the 7MM (United States, EU4—Germany, France, Italy, Spain—the United Kingdom, and Japan).

The reports also analyze key companies and their leading candidates at different clinical stages. Let's explore the market evaluations for each psoriasis type in depth.

Plaque Psoriasis Market

Plaque psoriasis is the most prevalent type of psoriasis. Plaques often appear on the scalp, elbows, knees, and lower back, but can occur anywhere. It arises from an accelerated skin cell cycle due to immune system issues, involving T-cell activation and cytokine production. While not infectious, it severely affects quality of life through itching, pain, and emotional strain. Its causes are unclear but likely involve genetics and environmental triggers.

Chronic plaque psoriasis affects about 90% of psoriasis patients, with 20–30% experiencing moderate to severe forms. In 2024, the United States had around 6.8 million prevalent cases of plaque psoriasis, expected to rise through 2034.

Treatment varies by severity, encompassing topical agents, phototherapy, and systemic options. Mild cases often use corticosteroids, vitamin D analogs, and calcineurin inhibitors. Biologics have transformed plaque psoriasis care by targeting immune components, providing symptom control for many. Key drugs include adalimumab, etanercept, ustekinumab, secukinumab, and ixekizumab.

Pipeline candidates like ME3183 (Meiji Seika Pharma), SGX302 (Soligenix), TAK-279 (Takeda), and others are advancing. DelveInsight's experts predict strong growth in the chronic plaque psoriasis market, driven by rising prevalence, recent approvals, and upcoming novel therapies from 2024–2034.

For an in-depth look at the plaque psoriasis market, visit the Plaque Psoriasis Market Assessment

Generalized Pustular Psoriasis Market

Generalized pustular psoriasis (GPP) is a rare, severe pustular variant, featuring sudden, recurrent episodes with high fever, widespread red pustular rashes, and painful, disfiguring skin changes, sometimes mimicking sepsis.

It typically emerges between ages 40 and 59, though cases in infants and children occur. In 2023, the United States had about 240,000 people with pustular psoriasis, with numbers likely to grow through 2034. SPEVIGO (spesolimab) was the first FDA-approved GPP treatment in the US in 2022, and BIMZELX (bimekizumab) received approval in Japan that year.

The GPP pipeline is sparse, with only Imsidolimab (AnaptysBio) in Phase III trials for this condition. It blocks the interleukin-36 receptor (IL-36R), a key inflammatory pathway in GPP. Market dynamics for generalized pustular psoriasis are expected to evolve due to global healthcare spending increases and rising GPP prevalence.

Explore more on generalized pustular psoriasis drugs in development @ Generalized Pustular Psoriasis Clinical Trials

Mild to Moderate Plaque Psoriasis Market

Plaque psoriasis often presents as large, oval or circular plaques on the scalp, trunk, and body extremities, covered in thick scales from rapid skin cell turnover.

About 15% of plaque psoriasis patients may develop psoriatic arthritis. Diagnosis involves skin exams, medical history, and sometimes biopsies or blood tests to rule out other issues.

OTEZLA (apremilast) is the sole approved drug for mild to moderate plaque psoriasis. It's an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), which breaks down cyclic adenosine monophosphate (cAMP). By inhibiting PDE4, it raises cAMP levels, potentially regulating inflammatory mediators. Its exact mechanisms are not fully understood, but it aids in managing inflammatory conditions.

In December 2021, the FDA extended OTEZLA's approval to adults with mild to moderate plaque psoriasis eligible for phototherapy or systemic therapy, expanding beyond moderate to severe cases.

Late-stage candidates like IRX4204 and SGX302 are in development. Their market entry from 2025–2034 is projected to boost the mild to moderate plaque psoriasis market in the US.

For deeper insights into the mild to moderate plaque psoriasis market, check the Mild to Moderate Plaque Psoriasis Market Outlook

Moderate to Severe Psoriasis Market

Moderate to severe psoriasis is an extensive chronic autoimmune skin disorder with plaques covering over 3–10% of the body or causing significant impairment. Inflammation extends beyond appearance, often with systemic effects and risks of psoriatic arthritis, cardiovascular issues, metabolic syndrome, and mental health problems like anxiety and depression. These patients need systemic therapies.

Global prevalence of moderate to severe psoriasis is about 0.3–1%, higher in North America and Europe. While mild cases dominate, 20–30% are moderate to severe, treated with phototherapy, traditional systemics like methotrexate, cyclosporine, and acitretin, or biologics targeting cytokines such as TNF-alpha (adalimumab, etanercept), IL-12/23 (ustekinumab), IL-17 (secukinumab, ixekizumab, brodalumab), and IL-23 (guselkumab, risankizumab, tildrakizumab). Oral options like deucravacitinib, a TYK2 inhibitor, offer convenience and efficacy.

Major players include AbbVie, Novartis, Eli Lilly, Janssen (J&J), Amgen, and Bristol Myers Squibb, focusing on biologics and targeted orals. The moderate to severe psoriasis market is anticipated to grow, fueled by biologic adoption, new TYK2 and JAK inhibitors, and personalized care.

Dive deeper for a full view of Moderate to Severe Clinical Trials

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