Hidradenitis Suppurativa Market

Key Highlights

• HUMIRA is completely dominating the market and is expected to dominate until another potential therapy and biosimilars are launched for hidradenitis suppurativa in the US. However, the market value of HUMIRA in Europe has already started declining since 2018, and the sales value decline is expected to be much faster in future years.
• The potential emerging treatment option may open new doors for hidradenitis suppurativa patients who may not respond to currently available therapeutics. The Hidradenitis Suppurativa market is entering an unprecedented era of rapid growth, with a surge in pipeline therapeutics. The Hidradenitis suppurativa market has a diverse pipeline targeting Interleukins (i.e., IL-17, IL-36), anti-TNF, JAKi, and PDE4 inhibitors.
• Dual and tri-specific agents are present in the emerging pipeline, such as BIMZELX, Sonelokimab, Izokibep, and others which could improve patient outcomes.
• Current hidradenitis suppurativa clinical research still suffers from severe shortcomings like, the lack of a uniform outcome measurement since most studies use a type of global physician assessment as the primary outcome measurement
• Access to dermatologists and biologic treatments among commercially and federally insured patients is still low overall, and disparities in hidradenitis suppurativa care exist between insurance types
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed Hidradenitis Suppurativa clinical trials profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Request for unlocking the CAGR of Hidradenitis Suppurativa Market

DelveInsight’s “Hidradenitis Suppurativa – Market Insights, Epidemiology, and Market Forecast – 2032” report delivers an in-depth understanding of 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, market share of individual therapies, and current and forecasted 7MM Hidradenitis Suppurativa market size from 2019 to 2032. The report also covers current Hidradenitis Suppurativa treatment practices/algorithms and Hidradenitis Suppurativa unmet needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2019–2032

Hidradenitis Suppurativa Market Disease: Understanding

Hidradenitis Suppurativa Overview

Hidradenitis Suppurativa is a complex dermatological disease characterized by recurrent painful nodules and suppuration in areas such as the axilla and groin. It is also known as Acne inversa, and there is no biological or pathological test to facilitate diagnosis; its clinical features and chronicity can define it.

Low disease awareness and associated misdiagnoses and under-reporting by patients because of shame and embarrassment have contributed to substantial delays in diagnosis, reported to be between 7 and 10 years on average. The course of the disease is often unpredictable, which can be challenging for patients and healthcare professionals (HCPs) in managing hidradenitis suppurativa.

Systemic therapies, mainly antibiotics and retinoids, are the mainstay of treatment. Topical therapies are mainly used for mild to moderate disease conditions. Adalimumab (HUMIRA) is the only approved drug for treating moderate-to-severe hidradenitis suppurativa.

Hidradenitis Suppurativa Epidemiology

As the market is derived using a patient-based model, the Hidradenitis Suppurativa epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases of Hidradenitis Suppurativa, total diagnosed prevalent cases of Hidradenitis Suppurativa, gender-specific prevalent cases of hidradenitis suppurativa, age-specific prevalent cases of hidradenitis suppurativa, stage-specific prevalent cases of hidradenitis suppurativa and treated prevalent cases of hidradenitis suppurativa in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032. The total prevalent cases of Hidradenitis Suppurativa in the 7MM comprised approximately 6.2 million cases in 2022 and are projected to increase during the forecast period.

• In 2019, the total prevalent cases of Hidradenitis Suppurativa were approximately 2.8 million cases in the US, which is expected to grow during the study period, i.e., 2019–2032.
• Among EU4 and the UK, Germany accounted for the highest number of Hidradenitis Suppurativa prevalent cases, while Spain accounted for the least prevalent cases.
• In the US and EU, Hidradenitis Suppurativa is more common in females than males, but in Japan, it is the opposite, as, in Japan, males are more commonly affected than females.
• The highest proportion of Hidradenitis Suppurativa prevalent pool was observed in the 30–39 years age group among all the countries

Hidradenitis Suppurativa Drug Chapters

The drug chapter segment of Hidradenitis Suppurativa encloses a detailed analysis of marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the Hidradenitis Suppurativa clinical trials details, expressive pharmacological action, agreements and collaborations, approval and patent details, each drug’s advantages and disadvantages, and the latest news and press releases.

Marketed Drugs

HUMIRA: 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.

In September 2015, the US Food and Drug Administration (FDA) approved HUMIRA for treating Moderate-to-severe hidradenitis suppurativa in adults. Later in October 2018, HUMIRA got approved for patients =12 years of age.

AMJEVITA was the first biosimilar to Humira approved by the US FDA in 2016, but all of the adalimumab biosimilars had reached settlement agreements with AbbVie that kept the biosimilars off the US market until 2023. In January 2023, Amgen launched AMJEVITA in the US market, which will lead to the erosion of HUMIRA sales in the US. In Europe, HUMIRA biosimilars entered earlier than the US; in October 2018, Novartis and Amgen launched the first biosimilar of HUMIRA in the EU.

Note: Detailed Current therapies assessment will be provided in the full report of Hidradenitis Suppurativa Emerging Drugs

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 to treat hidradenitis suppurativa patients.

Data from two Phase III Hidradenitis Suppurativa clinical trials, SUNSHINE and SUNRISE, 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 of 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 co-expressed at sites of inflammation and have overlapping pro-inflammatory functions. Both IL-17A and IL-17F can independently cooperate with other mediators to drive chronic inflammation and tissue destruction. UCB Biopharma has completed the Phase II trial for moderate-to-severe hidradenitis suppurativa.

UCB presented eight bimekizumab abstracts at AAD 2023 with results from studies in psoriasis, psoriatic arthritis, and hidradenitis suppurativa. Based on the results from two Phase III (BE HEARD I and BE HEARD II) studies, UCB is planning to file BLA by the end of 2023.

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

Hidradenitis Suppurativa Market Outlook

The mainstay of medical treatment of mild disease involves antibacterial 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 retinoids. Currently, the market is mainly driven by off-label therapies and HUMIRA, as it is the only approved therapy for hidradenitis suppurativa until now.

HUMIRA is completely dominating the market and is expected to dominate the market until the launch of another potential therapy and biosimilars for hidradenitis suppurativa in the US; however, the response of HUMIRA is moderate in hidradenitis suppurativa patients. The US market is set to remain AbbVie’s until 2023 even though its composition-of-matter patent expired in December 2016 in the US; AbbVie has stronger surrounding patents stateside than in Europe, giving them more layers of defense on the biologic’s exclusivity. The scenario of HUMIRA is different in Europe as the biosimilar, i.e., Amgevita, Imraldi, Hyrimoz, and Hulio of HUMIRA, entered the European market in October 2018. They have eroded the market of HUMIRA in Europe, wherein the market of HUMIRA is still declining from the last quarter of 2018 after the patent exclusivity expiration in 2018 in Europe, as per the company. In January 2023, Amgevita launched in the US as the first biosimilar of HUMIRA. But it was not approved for the treatment of hidradenitis suppurativa due to 10-year exclusivity in the US. By requesting distinct, staggered market approvals for specific subsets of hidradenitis suppurativa-affected patients, AbbVie could also obtain extended exclusivity periods under the Orphan Drug Act (ODA). HUMIRA was given an orphan classification by the FDA for treating moderate-to-severe hidradenitis suppurativa on May 13, 2015. By dividing the patient population into two groups—the general population and patients 12 years of age and older—AbbVie could leverage this designation into two distinct orphan exclusivity periods. The hidradenitis suppurativa orphan monopoly granted to AbbVie is valid for patients 12 years of age and older from October 16, 2018, to October 16, 2025, and for the general population from September 9, 2015, to September 9, 2022.

Hidradenitis Suppurativa Companies like Novartis, UCB Biopharma, ACELYRIN, AbbVie, Incyte Corporation, Moonlake Therapeutics, and others are evaluating their lead candidates in different stages of clinical development.

• The market size in the 7MM will increase at a CAGR of 13.5% due to increasing awareness of the disease and the launch of the emerging therapy.
• The total market size of Hidradenitis Suppurativa in the United States was approximately USD 600 million in 2019 and is projected to increase during the forecast period (2023–2032).
• Among EU4 countries, Germany accounted for the maximum market size in 2022, while Spain occupied the bottom of the ladder.
• In 2032, among all the emerging therapies, BIMZELX is expected to generate the highest revenue in the 7MM.

Hidradenitis Suppurativa Drugs Uptake

This section focuses on the uptake rate of potential hidradenitis suppurativa drugs expected to be launched in the market during 2023–2032. Many therapies have failed in clinical trials due to efficacy or safety issues, such as bermekimab, imsidolimab, Zunsemetinib, etc. But many other potential therapies are in the advanced stage; for example, COSENTYX (Secukinumab) is currently filed in the US and Europe. Other medications currently under investigation in Hidradenitis Suppurativa clinical trials include JAK1 inhibitors, i.e., INCB054707. So, launching novel emerging therapies will change the dynamics of the future therapeutic market of hidradenitis suppurativa.

Further detailed analysis of emerging therapies drug uptake in the report…

Hidradenitis Suppurativa Pipeline Development Activities

The report provides insights into therapeutic candidates across the selected therapy areas based on factors like the highest pipeline activity, early-stage assets where trial results are available, mid or late-stage assets, and already available products.

Pipeline Development Activities

The report covers 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 ’ 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 Hidradenitis suppurativa evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along with challenges related to accessibility.

DelveInsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers include the University of California, San Francisco, School of Medicine; CHA Bundang Medical Center, CHA University School of Medicine, and other organizations. Their opinion helps understand and validate current and emerging therapies or market trends in Hidradenitis suppurativa. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the Hidradenitis Suppurativa unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT 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, administration frequency, administration route, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

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.

Hidradenitis Suppurativa Market Access and Reimbursement

Most insurance plans cover HUMIRA, but individual plans may vary in the coverage range. Insurance can lower the out-of-pocket price of HUMIRA from about USD 7,389 to approximately USD 5,000 per month. Some people who receive employer/retiree commercial prescription coverage will be eligible for a HUMIRA Complete Savings Card. The HUMIRA Complete Savings card is only available to people with private insurance coverage from their employer or those who have purchased insurance coverage directly from insurance companies. Copay assistance is unavailable for people who receive prescription reimbursement through federal, state, or government-funded insurance programs.

People without private insurance coverage may get HUMIRA at a reduced cost through Medicare or Medicaid. Medicare is a federal health insurance program for adults older than 65 and individuals with certain disabilities. Prescription coverage is available through Medicare Advantage Plans (Part C) and Supplemental Plans (Part D)

Hidradenitis Suppurativa Market Report Scope

• The report covers the descriptive overview of Hidradenitis Suppurativa, explaining its causes, signs and symptoms, pathophysiology, diagnosis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology of Hidradenitis Suppurativa and its treatment in the 7MM.
• Additionally, a complete account of the current and emerging therapies for Hidradenitis Suppurativa is provided, along with the assessment of new therapies, which is likely to impact the current treatment landscape.
• A detailed review of the global historical and forecasted Hidradenitis Suppurativa market is included in the report, covering drug outreach in the 7MM.
• The report provides an edge while developing business strategies by understanding trends shaping and driving the global Hidradenitis Suppurativa market.

Hidradenitis Suppurativa Market Report Insights

• Patient-Based Hidradenitis Suppurativa Market Forecasting
• Hidradenitis Suppurativa Therapeutic Approaches
• Hidradenitis Suppurativa Pipeline Analysis
• Hidradenitis Suppurativa Market Size and Trends
• Existing and Future Market Opportunities

Hidradenitis Suppurativa Report Key Strengths

• 10 Years Forecast
• 7MM Coverage
• Hidradenitis Suppurativa Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Hidradenitis Suppurativa Report Assessment

• Hidradenitis Suppurativa Unmet Needs
• Hidradenitis Suppurativa Pipeline Product Profiles
• Hidradenitis Suppurativa Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

Market Insights

• What was the Hidradenitis Suppurativa Market share (%) distribution in 2019, and what would it look like in 2032?
• What would be the total Hidradenitis Suppurativa market size and 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 is the Hidradenitis Suppurativa market expected to grow in the 7MM during the study period (2019–2032)?
• What would be the Hidradenitis Suppurativa market outlook across the 7MM during the study period (2019–2032)?
• Hidradenitis Suppurativa patient types/pool where unmet need is more and whether emerging therapies can address the residual unmet need?
• How are emerging therapies performing on the parameters like efficacy, safety, route of administration (RoA), treatment duration, and frequencies based on their clinical trial results?
• Among the emerging therapies, what potential therapies are expected to disrupt the Hidradenitis Suppurativa market?

Epidemiology Insights

• What is the historical Hidradenitis Suppurativa patient pool in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• What would be the forecasted patient pool of Hidradenitis Suppurativa in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• What will be the growth opportunities in the 7MM with respect to the patient population pertaining to Hidradenitis Suppurativa?
• Out of all the 7MM countries, which country would have the highest prevalent population of Hidradenitis Suppurativa during the study period (2019–2032)?
• At what CAGR is the population expected to grow in the 7MM during the study period (2019–2032)?
• What are the various recent and upcoming events expected to improve the uptake of Hidradenitis Suppurativa?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• How many companies are developing therapies for Hidradenitis Suppurativa?
• How many therapies for Hidradenitis Suppurativa are developed by each company?
• How many emerging therapies are in mid-and late-stage of development?
• What are the key collaborations (Industry–Industry, Industry–Academia), mergers and acquisitions, and licensing activities related to Hidradenitis Suppurativa?
• 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 for Hidradenitis Suppurativa and their status?
• What key designations have been granted for the emerging therapies for Hidradenitis Suppurativa?
• What is the global historical and forecasted market of Hidradenitis Suppurativa?

Reasons to buy

• The patient-based hidradenitis suppurative market forecasting report will help develop business strategies by understanding trends shaping and driving the Hidradenitis Suppurativa market.
• To understand the future market competition in the Hidradenitis Suppurativa market and an 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, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying strong upcoming Hidradenitis Suppurativa companies in the market will help in devising strategies to help get ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Hidradenitis Suppurativa market.
• To understand the future market competition in the Hidradenitis Suppurativa market.