- The market size for house dust mite disease was found to be USD 9.2 billion in the leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, Japan, and China] in 2024.
- China accounts for the largest market size for HDMD, compared with the United States, EU4, the UK, and Japan, i.e., ~35% of the 7MM + China.
- In 2024, the prevalent population of HDMD was estimated at 40 million cases. This prevalence is influenced by widespread exposure to HDM in indoor environments, increasing rates of atopy, urbanization, and changing lifestyles that favour prolonged indoor activities.
- Leading house dust mite disease companies, such as HAL Allergy, Probelte Pharma, Inmunotek, T-Balance Therapeutics, and others, are developing new house dust mite disease treatment drugs that can be available in the house dust mite disease market in the coming years.
- The promising house dust mite disease therapies in clinical trials include House dust mite allergy vaccine (PURETHAL Mites), Alternaria allergy immunotherapy (BELTAVAC), MM09, Tregalizumab, and others.
- Rising Asthma Burden: In 2024, the diagnosed prevalent population of asthma in the 7MM was approximately 113 million. This number is expected to rise through 2034, driven by advances in complement biology, improved diagnostics, and wider use of genetic testing, complement assays, and multidisciplinary biopsy evaluation.
- Current Sublingual Immunotherapy Options for Allergic Rhinitis: Currently, ODACTRA (ALK-Abelló) and ACTAIR (Stallergenes Greer) are the only available treatments that use a similar way of administration. Both products are well-established options for sublingual allergen immunotherapy in patients with allergic rhinitis.
- Mid- to Late-Stage HDM Therapies: Few late- and mid-stage therapies, such as PURETHAL Mites, BELTAVAC, MM09, and tregalizumab, are being evaluated for HDM-induced allergic rhinitis; however, the absence of recent clinical progress, limited efficacy and safety data, and a lack of advanced-stage results make their therapeutic potential and regulatory prospects uncertain relative to established products.
- Tregalizumab: A Differentiated Treg-Targeted Asset: Tregalizumab, developed by T-Balance Therapeutics, uniquely activates Tregs with high specificity and a well-defined pharmacokinetic profile, underscoring its innovative therapeutic potential.
- Management of HDMD is largely centered on symptomatic relief using off-label and supportive therapies, reflecting the lack of approved disease-modifying treatments.
- Common treatment options include antihistamines, intranasal corticosteroids, leukotriene receptor antagonists, and allergen immunotherapy (AIT).
- While AIT remains a cornerstone of care, its clinical efficacy varies significantly among patients.
- Long treatment durations, suboptimal adherence, and safety concerns, such as the risk of systemic allergic reactions, often limit the real-world utility of AIT.
- The HDMD therapeutic landscape is gradually evolving with the development of targeted immunotherapies and peptide-based vaccines designed to induce immune tolerance while minimizing adverse effects.
- The approval of ODACTRA marked a key milestone as the first sublingual immunotherapy tablet for HDM-induced allergic rhinitis; however, its black-box warning and limited pediatric safety data highlight ongoing challenges in long-term disease control.
- Several late-stage candidates, including PURETHAL Mites, BELTAVAC, and MM09, are in development, though publicly available updates are limited, indicating modest recent developmental momentum.
- None of these assets has advanced to regulatory submission or commercialization, leaving timelines to market uncertain.
- Tregalizumab, currently in mid-stage development, represents a differentiated approach by selectively activating regulatory T cells (Tregs) and is supported by well-characterized pharmacokinetic data, positioning it as a potentially innovative therapy in HDMD.
- In September 2025, Stallergenes Greer and Nuance Pharma entered into an exclusive long-term partnership to develop and commercialize ACTAIR, Stallergenes Greer’s sublingual allergen immunotherapy tablet for the treatment of HDM-induced allergic rhinitis.
- In July 2025, Stallergenes Greer and CEOLIA Pharma announced the transition of promotional activities for ACTAIR in Japan. After ending the 2010 license agreement with Shionogi, which had been responsible for developing, registering, and commercializing ACTAIR in Japan, Stallergenes Greer has appointed CEOLIA as its new promotional partner in the country, effective July 3.
- In February 2025, the US FDA approved ALK’s ODACTRA tablet for use in young children with HDM allergy. ODACTRA is now indicated to treat HDM-induced allergic rhinitis, with or without conjunctivitis, in children aged 5–11 years, in addition to patients aged 12 through 65.
- Total Prevalent Population of HDMD
- Total Diagnosed Prevalent Population of HDMD
- Gender-specific Diagnosed Prevalent Population of HDMD
- Allergen-specific Diagnosed Prevalent Population of HDMD
- Total Treated Cases of HDMD
|
House Dust Mite Disease Market Report Metrics |
Details |
|
Study Period |
2020–2034 |
|
Coverage |
8MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, Japan, and China]. |
|
House Dust Mite Disease Market CAGR |
3.5 % |
|
House Dust Mite Disease Market Size in 2024 |
USD 9.2 Billion |
|
Key House Dust Mite Disease Companies |
HAL Allergy, Probelte Pharma, Inmunotek, T-Balance Therapeutics, ALK-Abello, Stallergenes Greer, and others |
|
Key House Dust Mite Disease Therapies |
House dust mite allergy vaccine (PURETHAL Mites), Alternaria allergy immunotherapy (BELTAVAC), MM09, Tregalizumab, ODACTRA/ACARIZAX/MITICURE, ACTAIR/ORYLMYTE/AITMYTE, and others |
- Therapeutic Assessment: House Dust Mite Disease current marketed and emerging therapies
- House Dust Mite Disease Market Dynamics: Key Market Forecast Assumptions of Emerging House Dust Mite Disease Drugs and Market Outlook
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, House Dust Mite Disease Market Access and Reimbursement
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1 |
House Dust Mite Disease Market Key Insights |
|
2 |
House Dust Mite Disease Market Report Introduction |
|
3 |
Executive Summary of HDMD |
|
4 |
Key Events |
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5 |
Epidemiology and Market Forecast Methodology |
|
6 |
HDMD Market Overview at a Glance |
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6.1 |
Clinical Landscape (Analysis by Molecule Type, Phase, and Route of Administration [RoA]) |
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6.2 |
Market Share of HDMD by Therapies (%) in the 7MM + China in 2024 |
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6.3 |
Market Share of HDMD by Therapies (%) in the 7MM + China in 2034 |
|
7 |
Disease Background and Overview |
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7.1 |
Introduction |
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7.2 |
House Dust Mite Allergic Disorders |
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7.2.1 |
Allergic Asthma |
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7.2.2 |
Allergic Rhinitis |
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7.2.3 |
Atopic Dermatitis |
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7.3 |
Symptoms |
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7.4 |
Diagnosis |
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8 |
House Dust Mite Disease Treatment |
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9 |
Epidemiology and Patient Population |
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9.1 |
Key Findings |
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9.2 |
Assumptions and Rationales |
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9.3 |
Total Diagnosed Prevalent Population of Asthma in the 7MM + China |
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9.4 |
Total Diagnosed Prevalent Population of Allergic Rhinitis in the 7MM + China |
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9.5 |
Total Diagnosed Prevalent Population of Atopic Dermatitis in the 7MM + China |
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9.6 |
Total Diagnosed Prevalent Population of HDMD in the 7MM + China |
|
9.7 |
The United States |
|
9.7.1 |
Total Prevalent Population of HDMD in the United States |
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9.7.2 |
Total Diagnosed Prevalent Population of HDMD in the United States |
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9.7.3 |
Gender-specific Diagnosed Prevalent Population of HDMD in the United States |
|
9.7.4 |
Allergen-specific Diagnosed Prevalent Population of HDMD in the United States |
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9.7.5 |
Total Treated Cases of HDMD in the United States |
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9.8 |
EU4 and the UK |
|
9.9 |
Japan |
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9.10 |
China |
|
10 |
House Dust Mite Disease Patient Journey |
|
11 |
Marketed House Dust Mite Disease Drugs |
|
11.1 |
Key Cross Competition |
|
11.2 |
Dermatophagoides farinae and Dermatophagoides pteronyssinus (ODACTRA/ACARIZAX/MITICURE): ALK-Abello |
|
11.2.1 |
Product Description |
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11.2.2 |
Regulatory Milestones |
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11.2.3 |
Other Developmental Activities |
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11.2.4 |
Summary of Pivotal Trials |
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11.2.5 |
Clinical Development |
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11.2.6 |
Analyst Views |
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11.3 |
House dust mite allergen extract (ACTAIR/ORYLMYTE/AITMYTE): Stallergenes Greer |
|
12 |
Emerging House Dust Mite Disease Drugs |
|
12.1 |
Key Cross Competition |
|
12.2 |
House Dust Mite Allergy Vaccine (PURETHAL Mites): HAL Allergy |
|
12.2.1 |
Product Description |
|
12.2.2 |
Clinical Development |
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12.3 |
Alternaria Allergy Immunotherapy (BELTAVAC): Probelte Pharma |
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12.4 |
MM09: Inmunotek |
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12.5 |
Tregalizumab: T-Balance Therapeutics |
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13 |
HDMD Market: 7MM + China Analysis |
|
13.1 |
Key Findings |
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13.2 |
Total Market Size of HDM in the 7MM + China |
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13.3 |
House Dust Mite Disease Market Outlook |
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13.4 |
Conjoint Analysis |
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13.5 |
Key House Dust Mite Disease Market Forecast Assumptions |
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13.6 |
The United States House Dust Mite Disease Market Size |
|
13.6.1 |
Total Market Size of HDMD in the United States |
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13.6.2 |
Total Market Size of HDMD by Therapies in the United States |
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13.7 |
EU4 and the UK House Dust Mite Disease Market Size |
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13.8 |
Japan House Dust Mite Disease Market Size |
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13.9 |
China House Dust Mite Disease Market Size |
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14 |
House Dust Mite Disease Market Unmet Needs |
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15 |
House Dust Mite Disease Market SWOT Analysis |
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16 |
KOL Views on House Dust Mite Disease |
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17 |
House Dust Mite Disease Market Access and Reimbursement |
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17.1 |
The United States |
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17.2 |
In EU4 and the UK |
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17.3 |
Japan |
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17.4 |
Summary and Comparison of Market Access and Pricing Policy Developments in 2025 |
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17.5 |
Market Access and Reimbursement of HDMD Therapies |
|
18 |
Bibliography |
|
19 |
House Dust Mite Disease Market Report Methodology |
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www.delveinsight.com Logo: https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpg SOURCE DelveInsight Business Research, LLP
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