PUBLISHER: DelveInsight | PRODUCT CODE: 1259775
PUBLISHER: DelveInsight | PRODUCT CODE: 1259775
DelveInsight's " Hidradenitis Suppurativa - Market Insights, Epidemiology and Market Forecast-2032" report delivers an in-depth understanding of the Hidradenitis Suppurativa, historical and forecasted epidemiology as well as the Hidradenitis Suppurativa market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom and Japan.
The Hidradenitis Suppurativa market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Hidradenitis Suppurativa market size from 2019 to 2032. The report also covers current Hidradenitis Suppurativa treatment practice/algorithm, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Study Period: 2019-2032
Hidradenitis Suppurativa Overview
According to the National Organization of Rare Disorders, Hidradenitis suppurativa is a chronic condition characterized by swollen, painful lesions, occurring in the armpit, groin, anal and breast regions. It is a painful and long-term skin condition causing abscesses and scarring on the skin. Affected patients may present with acute abscesses, but the condition often progresses to a chronic state with persistent pain, sinus tract fistula formation, and scarring. Although foreign body type granulomas are a common finding in Hidradenitis suppurativa, the presence of discrete epithelioid granulomas in the dermis away from the site of active inflammation is unusual and should alert the pathologist to the possibility of a systemic granulomatous disease like Crohn's disease (CD) or sarcoidosis. The longstanding disease can result in fibrosis, dermal contractures, significant scarring, the formation of fistulae, and rarely malignant transformation to squamous cell carcinoma.
It is a difficult condition to face physically as well as mentally the individual can manage the condition by preventing breakouts, draining the lesions, and in some cases, using skin grafts to repair damaged areas.
There is significant inter-individual variability regarding the site of the disease, the type of lesions presents, and the associated systemic response (general malaise, arthralgia, and rise in inflammatory markers) during disease flares. It affects females about three times more often than males. The condition typically becomes apparent during puberty but almost never after the age of about 40 years. Many things can trigger flare-ups of this disease including menstruation for women, weight gain, stress, hormonal changes, heat, and perspiration. In some cases, early symptoms, such as itching or discomfort, may precede the condition's characteristic manifestations.
Hidradenitis Suppurativa Diagnosis
The diagnosis is primarily clinical, based on symptoms reported by the patient and signs observed by the physician. No pathognomonic test exists, and biopsy is rarely required, especially in well-developed lesions.
Primary Diagnosis of Hidradenitis suppurativa involves the identification of the disease and assessment of its comorbidities. Fulfillment of three criteria are necessary for the diagnosis of Hidradenitis suppurativa:
Hidradenitis suppurativa is usually associated with depression and severe overall impairment of quality of life (QoL), exceeding other skin disorders heavily impacting Quality of life such as psoriasis, atopic dermatitis, alopecia, and acne. Hidradenitis suppurativa may restrict simple movements, interfere with routine daily activities, be disfigured because of the wound healing and scarring process, and limit the ability to work. Pain is reported as the most significant factor contributing to the impairment of quality of life in patients with Hidradenitis suppurativa, although malodorous and staining secretions also contribute to poor self-perception, embarrassment, stunted social life, and problems with interpersonal relationships. A plethora of comorbidities including inflammatory bowel diseases, spondyloarthropathies, obesity, and metabolic syndrome, may be associated with Hidradenitis suppurativa, increasing the disease burden. Therefore, the availability of disease severity assessment tools that might accurately evaluate both clinical picture and patients' discomfort is important for the management of patients with Hidradenitis suppurativa and for driving the therapeutic strategy.
There are multiple assessment tools or questionnaires used for evaluating Hidradenitis suppurativa severity. Some are specifically designed for Hidradenitis suppurativa, such as the Hurley staging classification, the modified Sartorius score, the Hidradenitis Suppurativa Clinical Response (HiSCR), the Hidradenitis Suppurativa-Physician Global Assessment (HS-PGA), and the Hidradenitis Suppurativa Severity Index (HSSI). The Hurley staging and the modified Sartorius score are the most commonly used assessment tools in both trial setting and real-life practice.
Hidradenitis Suppurativa Treatment
A clinically relevant staging and disease severity assessment is essential for the development of evidence-based treatments. There are several scoring systems for the assessment of disease severity of Hidradenitis suppurativa, including Hurley staging, Physician's Global Assessment (PGA), the modified Sartorius score (MSS), and Hidradenitis suppurativa Severity Index (HSSI).
In 1989, a severity classification was first proposed by Hurley. Fortunately, Stage I disease is the most common, while Stage II occurs in more than one-fourth of patients, and few cases of Hidradenitis suppurativa patients have Stage III. The Hurley staging system is the most widely used Hidradenitis suppurativa classification scale in routine clinical practice in three severity groups, but the classification has limitations. The Hurley classification is a not very quantitative one, consisting of only three stages and based on rather static disease characteristics such as scarring and fistulas.
Hence, it is not suitable for monitoring the efficacy of interventions in clinical trials. A more detailed and dynamic Hidradenitis suppurativa severity score was created by Sartorius et al. and was later modified and validated. The main parameter in the modified Sartorius score is the counting of individual nodules and fistulas. This modified Sartorius score is difficult to use and its usability is limited especially in severe cases in which lesions become confluent.
Based upon the published guidelines for hidradenitis suppurativa developed by the Guidelines Subcommittee of the European Dermatology Forum, a detailed review of all therapies was conducted. All therapeutic aspects of the treatment included in the guidelines were reviewed. A category of evidence and strength of recommendation was developed for the first line of therapy, including topical clindamycin, oral clindamycin/rifampicin, tetracycline, and subcutaneous adalimumab. A similar approach was taken for the second-line therapies, including zinc gluconate, resorcinol, intralesional corticosteroids, infliximab, acitretin, and etretinate. Third-line therapies included colchicine, botulinum toxin, isotretinoin, dapsone, cyclosporine, and hormones.
Surgical evaluated therapies included individual lesions excision, total excision of lesions surrounding hair-bearing skin, secondary intention healing, and primary closure, reconstructive with skin grafting and NPWT reconstruction with flap, deroofing, carbon dioxide laser therapy, laser therapy, and intense pulsed light.
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total diagnosed prevalent cases of Hidradenitis suppurativa, Gender-specific prevalent cases of Hidradenitis suppurativa, Age-specific prevalent cases of Hidradenitis suppurativa, Stage-specific cases of Hidradenitis suppurativa, in the 7MM market covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032.
Key Findings
This section provides glimpse of the Hidradenitis Suppurativa epidemiology in the 7MM
The drug chapter segment of the Hidradenitis Suppurativa report encloses a detailed analysis of Hidradenitis Suppurativa marketed drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Hidradenitis Suppurativa clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Marketed Drugs
HUMIRA (adalimumab): AbbVie
HUMIRA (adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). This drug was created using phage display technology resulting in an antibody with human-derived heavy and light chain variable regions and human IgG1: kappa constant regions. It is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps.
Note: Detailed Current therapies assessment will be provided in the full report of Hidradenitis suppurativa
Emerging Drugs
COSENTYX (secukinumab): Novartis Pharmaceuticals
COSENTYX (secukinumab), marketed by Novartis is an IL-17A monoclonal antibody that selectively binds to IL-17A and inhibits Interleukin-17A, and IL-17 promotes neutrophil activities. These cytokines act on many different cell types and defend against different extracellular pathogens causing fungal or bacterial infections. This product is approved for several indications, such as plaque psoriasis, ankylosing spondylitis, and psoriatic arthritis. However, the company is investigating this product in Phase III for the treatment of hidradenitis suppurativa patients. This therapeutic molecule is administered by the subcutaneous route. Data from SUNSHINE and SUNRISE trials were submitted to health authorities as part of regulatory applications. The company expects a regulatory decision in the first half of 2023 in Europe and the second half in 2023 in the US for COSENTYX in hidradenitis suppurativa.
BIMZELX (bimekizumab): UCB Biopharma
Bimekizumab is the first humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-17A and IL-17F, two key cytokines driving inflammatory processes. IL-17A and IL-17F are the most closely related members of the IL-17 family of cytokines, and they are both co-expressed at sites of inflammation and have overlapping pro-inflammatory functions. Both IL-17A and IL-17F can independently cooperate with other inflammatory mediators to drive chronic inflammation and tissue destruction. UCB Biopharma has completed the Phase II trial for moderate-to-severe hidradenitis suppurativa. In May 2022, UCB announced that the US FDA has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate-to-severe plaque psoriasis. As per the company, results from two Phase III (BE HEARD I and BE HEARD II) studies will form the basis of global regulatory applications for bimekizumab in hidradenitis suppurativa starting in Q3 2023.
Note: Detailed emerging therapies assessment will be provided in the final report.
Hidradenitis Suppurativa (HS) is a complex dermatological disease characterized by recurrent painful nodules and suppuration in areas, such as the axilla and groin. The disease is poorly understood, and treatment is not satisfactory.
As there is no cure for Hidradenitis suppurativa, early diagnosis and treatment help prevent the disease from getting worse and forming additional scars, and the current treatment approaches depend on the severity and clinical staging of the disease.
There are a number of lifestyle modifications recommended, such as smoking cessation, weight loss, and stress management, but there is little evidence regarding their efficacy. In terms of pharmacological treatment market options, the following therapies are available like topical and systemic antibiotics, corticosteroids, hormonal therapy, systemic retinoid, zinc supplements, and immunosuppressive agents including biologics (HUMIRA, Infliximab). Other pharmacological therapies like birth control pills (to address the hormonal cause of Hidradenitis suppurativa) can also be used.
The mainstay of medical treatment of mild disease involves anti-bacterial washes and topical antibiotics. Acute flares may be managed by intralesional corticosteroids and/or minor surgical procedures. Oral therapies for mild to moderate Hidradenitis suppurativa include extended courses of broad-spectrum antibiotics and systemic retinoid. Currently, the market is mainly driven by off-label therapies and HUMIRA, as it is the only approved therapy for Hidradenitis suppurativa until now.
In severe cases, the oral combo of clindamycin and rifampicin is effective and is used as a first-line treatment. Other first-line treatments like topical Clindamycin, tetracycline, and subcutaneous Adalimumab (HUMIRA) are also there.
However, HUMIRA is the only officially approved treatment for the management of moderate-to-severe Hidradenitis suppurativa by both the European Medicines Agency (EMA) in June 2015 and the US FDA in September 2015. It is a recombinant, fully humanized, anti-tumor necrosis factor-alpha (anti-TNF-a) monoclonal antibody (IgG1) that has a high affinity and specificity for TNF-a.
Moving forward, in off-label therapies, the commonly used antibiotics are clindamycin, rifampicin, and tetracycline as these antibiotics have shown their efficacy in the studies, and these antibiotics are used when more severe or widely spread lesions are present.
On the other hand, corticosteroids like triamcinolone acetonide have been used for the rapid reduction in inflammation associated with acute flares and for the management of recalcitrant nodules and sinus tracts. Additionally, corticosteroids, such as prednisone, are also used to reduce pain and swelling.
Key Findings
This section includes a glimpse of the Hidradenitis suppurativa in the 7MM market.
Analyst Commentary
This section focusses on the rate of uptake of the potential drugs expected to get launched in the market during the forecast period 2023-2032. The analysis covers Hidradenitis suppurativa market uptake by drugs; patient uptake by therapies; and sales of each drug. For example- Bimekizumab is the first humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-17A and IL-17F, two key cytokines driving inflammatory processes. We expect the launch of Bimekizumab in 2024, as the company anticipates starting filings from Q3 2023.
Hidradenitis Suppurativa Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for Hidradenitis Suppurativa emerging therapies.
KOL- Views
To keep up with current market trends, we take KOLs and SME's opinion working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders are professors of dermatology, the University of Pennsylvania, Head of the Dermatology Department, Saint Louis Hospital, Paris, Chief Medical Officers. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Hidradenitis Suppurativa market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
We perform competitive and market Intelligence analysis of the Hidradenitis Suppurativa market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Key Questions
Market Insights:
Epidemiology Insights:
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies: