Hidradenitis Suppurativa (HS) - Market Insight, Epidemiology And Market Forecast - 2032

Hidradenitis Suppurativa (HS) - Market Insight, Epidemiology And Market Forecast - 2032

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, EU-5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

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.

Geography Covered

• The United States
• The EU-5
• Japan

Study Period: 2019-2032

Hidradenitis Suppurativa Disease Understanding and Treatment Algorithm

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 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 HS, 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.

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 HS involves identification of the disease and assessment of its comorbidities. Fulfillment of three criteria are necessary for the diagnosis of HS:

• Typical lesions: deep-seated, painful nodules
• Characteristic distribution: Typical anatomical predilection (i.e axillae, groins, perineal and perianal regions, buttocks, infra-mammary and inter-mammary folds)
• Recurrence: Chronicity and recurrence of lesions

There are multiple assessment tools or questionnaires used for evaluating HS severity. Some are specifically designed for HS, 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), whereas others, including the Dermatology Quality of Life Index (DLQI), the SF-36 short-form health survey, and the Skindex, are not HS-specific. 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

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. 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.

Hidradenitis Suppurativa Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent population of Hidradenitis Suppurativa, gender-specific prevalent population of Hidradenitis Suppurativa, age-specific prevalent population of Hidradenitis Suppurativa, stage-specific population of Hidradenitis Suppurativa, in the 7MM market covering the United States, EU-5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2019 to 2032.

Key Findings

This section provides glimpse of the Hidradenitis Suppurativa epidemiology in the 7MM

Country Wise- Hidradenitis Suppurativa Epidemiology

• The epidemiology segment also provides the Hidradenitis Suppurativa epidemiology data and findings across the United States, EU-5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
• The total diagnosed prevalent population of Hidradenitis Suppurativa in the 7MM comprised of 1,239,695 cases in 2021 and are projected to increase during the forecast period.
• The total diagnosed prevalent population of Hidradenitis Suppurativa in the United States is 572,057 in 2021.
• The United States contributed to the largest prevalent population of Hidradenitis Suppurativa, in 7MM in 2021.
• Among the EU-5 countries, Germany accounted for the highest number of Hidradenitis Suppurativa cases, whereas Spain accounted for the lowest cases in 2021.
• In Japan, the total diagnosed prevalent population of Hidradenitis Suppurativa was 89,917 in 2021 and is anticipated to rise during the forecast period.
• In 2021, males and females accounted for 143,014 and 429,043 cases respectively in the United States.

Hidradenitis Suppurativa Drug Chapters

Drug chapter segment of the Hidradenitis Suppurativa report encloses the 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. In 2022, the company was expecting regulatory submissions of COSENTYX in Hidradenitis suppurativa. The safety of Cosentyx in Hidradenitis Suppurativa was consistent with the therapy’s known safety profile. Also, the company anticipates positive data-readout for Phase III SUNSHINE in second half of 2022 and SUNRISE trial in 2022. Both the trials met the primary endpoint at Week 16. Another Phase III trial (NCT04179175) currently in recruiting stage is expected to have data readout by 2025.

SKYRIZI (risankizumab): AbbVie

Risankizumab (ABBV-066), under development by AbbVie is a subcutaneously administered anti-interleukin-23 antibody. Currently, the company is investigating this product in the Phase II trial for patients with moderate-to severe-hidradenitis suppurativa.

Risankizumab is already approved for psoriasis in the US and Europe, and the company is also investigating risankizumab for the treatment of multiple inflammatory diseases including Crohn’s disease, ulcerative colitis, atopic dermatitis, and psoriatic arthritis. SKYRIZI is approved in the United States, Canada, Mexico, and the European Union and is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. In Japan, SKYRIZI is approved for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis, and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies.

BIMZELX (bimekizumab): UCB Biopharma SPRL

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. In 2021 the company announced the ongoing Phase III program in moderate-to-severe hidradenitis suppurativa showed an unprecedented, accelerated patient recruitment, and the company anticipates the topline results in the second half of 2022 for BEHEARD I and BE HEARD II trials.

Bermekimab: Janssen Pharmaceuticals

Bermekimab previously known as (MABp1) is a recombinant human IgG1 monoclonal antibody specific for human interleukin-1α, initially developed by XBiotech and acqired by Janssen (a subsidiary of Johnson & Johnson) to treat patients with hidradenitis suppurativa. It is the only antibody targeting IL-1a currently in clinical development and has the potential for superior efficacy and safety compared to the current standard of care. The mechanism of action is thought to be the inhibition of neovascularization and modulation of the production of IL-8 and human β-defensin-2.

OTEZLA (Apremilast): Amgen

Apremilast is a novel, orally available, small molecule, phosphodiesterase (PDE-4) inhibitor developed by Celgene Corporation for treating patients with hidradenitis suppurativa. By inhibiting PDE-4, this molecule increases intracellular levels of cAMP and thereby inhibits the production of multiple pro-inflammatory mediators, including PDE-4, TNF-alpha, and interleukin-2 (IL-2) interferon-gamma, leukotrienes, and nitric oxide synthase. The company has completed its Phase II clinical study for the treatment of moderate hidradenitis suppurativa.

In 2019, Amgen announced that it had entered into an agreement with Celgene Corporation in connection with its previously announced merger with Bristol Myers Squibb Company to acquire worldwide rights of OTEZLA (apremilast). In 2021, Amgen announced that the FDA has approved OTEZLA (apremilast) for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

Note: Detailed emerging therapies assessment will be provided in the final report.

Hidradenitis Suppurativa Market Outlook

There is no cure for HS, 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 HS) 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 HS 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 HS 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 HS 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-α) monoclonal antibody (IgG1) that has a high affinity and specificity for TNF-α.

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 Low-grade glioma7MM market.

• The total market size of Hidradenitis Suppurativa in the US is USD 899 million in 2021 and is projected to grow during the forecast period (2022-2032).
• Among the EU-5 countries, Germany has the maximum revenue share in 2021 while Spain has the lowest market share.
• The market size of Hidradenitis Suppurativa in Japan is USD 13 million in 2021 which is expected to rise during the forecast period (2022-2032).

The United States Market Outlook

The total market size of Hidradenitis Suppurativa in the United States is expected to increase with a CAGR of 11% during the study period (2019–2032).

The EU-5 Market Outlook

The total market size of Hidradenitis Suppurativa in EU-5 is expected to increase with a CAGR of 7% during the study period (2019–2032).

Japan Market Outlook

The total market size of Hidradenitis Suppurativa in Japan is expected to increase with a CAGR of 9% during the study period (2019–2032).

Analyst Commentary

• Hidradenitis Suppurativa market has diverse pipeline targeting Interleukins (i.e. IL-17, IL-1), anti-TNF, JAKi and anti-complement factor.
• Pipeline therapies are coming with patient convenient RoA and also expected to increase the treatment duration.
• Precedent of HUMIRA orphan designation and potential benefits related to orphan categories.
• Emerging therapies with better clinical profile compared to HUMIRA expected to dominate the market.
• Currently only HUMIRA is approved for the treatment of moderate to severe HS with modest efficacy and thus providing the potential lucrative market opportunities.
• No treatment options available in relapsed/ refractory patients to HUMIRA.
• Now companies are also focusing on the development of biomarkers which will further increase the prevalent pool owing to diagnosis in early stages for better diagnosis.
• Rising prevalence of HS will provide the larger window of opportunity for new treatment.

Hidradenitis Suppurativa Drugs Uptake

This section focusses on the rate of uptake of the potential drugs expected to get launched in the market during the study period 2019-2032. 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 Phase III results of the BEHEARD I and BEHEARD II trials at the end of 2022.The drug uptake is medium to fast at 75% probability of success and the peak share is estimated to be 6% in the US.

Hidradenitis Suppurativa Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase II, Phase III and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, 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 MD, professor of dermatology at Baylor College of Medicine in Houston, Texas MD, MPH, of the University of Southern California, Founder and Chief Scientific Officer at MoonLake, Chief Scientific Officer and President for Worldwide Research, Development, and Medical at Pfizer, President, and CEO of Aclaris. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Hidradenitis Suppurativa market trend. This will support the clients in potential upcoming novel treatment 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.

Scope of the Report

• The report covers the descriptive overview of Hidradenitis Suppurativa, explaining its causes, signs and symptoms, pathogenesis and currently available therapies.
• Comprehensive insight has been provided into the Hidradenitis Suppurativa epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Hidradenitis Suppurativa are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of Hidradenitis Suppurativa market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Hidradenitis Suppurativa market.

Report Highlights

• In the coming years, Hidradenitis Suppurativa market is set to change due emerging therapies in the pipeline, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Hidradenitis Suppurativa R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• The report also encompasses other major segments, i.e., total diagnosed prevalent population of Hidradenitis Suppurativa, gender-specific prevalent population of Hidradenitis Suppurativa, age-specific prevalent population of Hidradenitis Suppurativa, stage-specific population of Hidradenitis Suppurativa.
• Expected Launch of potential therapies, COSENTYX (Novartis Pharmaceuticals), SKYRIZI (AbbVie), BIMZELX (UCB Biopharma SPRL), Bermekimab (Janssen Pharmaceuticals), OTEZLA (Amgen), and others might change the landscape in treatment of Hidradenitis Suppurativa.
• The US FDA-approved drugs which is currently available include HUMIRA (adalimumab) (AbbVie).

Hidradenitis Suppurativa Report Insights

Hidradenitis Suppurativa Report Insights

• Patient Population
• Therapeutic Approaches
• Hidradenitis Suppurativa Pipeline Analysis
• Hidradenitis Suppurativa Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Hidradenitis Suppurativa Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage
• Hidradenitis Suppurativa Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Hidradenitis Suppurativa Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• SWOT
• Attribute Analysis

Key Questions

Market Insights:

• What was the Hidradenitis Suppurativa market share (%) distribution in 2019 and how it would look like in 2032?
• What would be the Hidradenitis Suppurativa total market size as well as market size by therapies across the 7MM during the study period (2019–2032)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Hidradenitis Suppurativa market size during the study period (2019–2032)?
• At what CAGR, the Hidradenitis Suppurativa market is expected to grow at the 7MM level during the study period (2019–2032)?
• What would be the Hidradenitis Suppurativa market outlook across the 7MM during the study period (2019–2032)?
• What would be the Hidradenitis Suppurativa market growth till 2032 and what will be the resultant market size in the year 2032?
• How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What is the disease risk, burden and unmet needs of Hidradenitis Suppurativa?
• What is the historical Hidradenitis Suppurativa patient pool in the United States, EU-5 (Germany, France, Italy, Spain, and the UK) and Japan?
• What would be the forecasted patient pool of Hidradenitis Suppurativa at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Hidradenitis Suppurativa?
• Out of the above-mentioned countries, which country would have the highest prevalent population of Hidradenitis Suppurativa during the study period (2019–2032)?
• At what CAGR the population is expected to grow across the 7MM during the study period (2019–2032)?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

• What are the current options for the treatment of Hidradenitis Suppurativa? What are the current treatment guidelines for the treatment of Hidradenitis Suppurativa in the US and Europe?
• What are the Hidradenitis Suppurativa marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
• How many companies are developing therapies for the treatment of Hidradenitis Suppurativa?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Hidradenitis Suppurativa?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Hidradenitis Suppurativa therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Hidradenitis Suppurativa and their status?
• What are the key designations that have been granted for the emerging therapies for Hidradenitis Suppurativa?
• What are the 7MM historical and forecasted market of Hidradenitis Suppurativa?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the Hidradenitis Suppurativa.
• To understand the future market competition in the Hidradenitis Suppurativa market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Hidradenitis Suppurativa in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for Hidradenitis Suppurativa market.
• To understand the future market competition in the Hidradenitis Suppurativa market.