Insects (whole body), mite dermatophagoides pteronyssinus - Biologic Drug Details

Summary for insects (whole body), mite dermatophagoides pteronyssinus

Tradenames:	1
High Confidence Patents:	0
Applicants:	5
BLAs:	5
Suppliers: see list	4

Pharmacology for insects (whole body), mite dermatophagoides pteronyssinus

Physiological Effect	Cell-mediated Immunity Increased Histamine Release Increased IgG Production
Established Pharmacologic Class	Standardized Insect Allergenic Extract
Chemical Structure	Allergens Antigens, Dermatophagoides Insect Proteins

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for insects (whole body), mite dermatophagoides pteronyssinus Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insects (whole body), mite dermatophagoides pteronyssinus Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for insects (whole body), mite dermatophagoides pteronyssinus Derived from Patent Text Search

No patents found based on company disclosures

Insects (whole body), mite dermatophagoides pteronyssinus Market Analysis and Financial Projection Experimental

The Biologics Market: Dynamics and Financial Trajectory for Mite-Derived Drugs like Dermatophagoides pteronyssinus

Introduction

The biologics market is on the cusp of a significant expansion, driven by various factors including the increasing prevalence of chronic diseases, advancements in drug delivery systems, and the growing adoption of biosimilars. One of the key segments within this market involves biologic drugs derived from insects, particularly the house dust mite Dermatophagoides pteronyssinus. This article delves into the market dynamics and financial trajectory of these mite-derived biologic drugs.

Market Size and Growth Projections

The biologics market, which includes drugs derived from Dermatophagoides pteronyssinus, is expected to experience substantial growth. By 2032, the biologics market is projected to reach USD 699.5 billion, growing at a Compound Annual Growth Rate (CAGR) of 7.8% from 2024 to 2032[1].

Drivers of Market Growth

Several factors are driving the growth of the biologics market, including:

Increasing Burden of Chronic Diseases

The rising prevalence of chronic diseases such as allergic rhinitis, asthma, and conjunctivitis is a significant driver. Biologic drugs like those derived from Dermatophagoides pteronyssinus are increasingly used to treat these conditions[1].

Technological Advancements

Continuous technological advancements are facilitating the development of more targeted and effective therapies. This includes improvements in drug delivery systems and the production of biologics[1].

Growing Adoption of Biosimilars

Biosimilars, which are biologic products that are highly similar to an already approved biologic drug, are gaining traction due to their cost-effectiveness and similar efficacy. This trend is expected to continue, contributing to market growth[4].

Improved Healthcare Infrastructure

Enhanced healthcare infrastructure and increasing awareness about biologic therapies are also driving the market forward. Regulatory approvals and the strong pipeline of biologic drugs further support this growth[1].

Dermatophagoides pteronyssinus: A Key Player

Background and Use

Dermatophagoides pteronyssinus extracts are used in immunotherapy for house dust mite-induced allergic rhinitis, asthma, and conjunctivitis. These extracts are sterile solutions derived from the whole bodies of the mites and are used for intradermal testing or subcutaneous immunotherapy[2][3].

Clinical Indications

The extracts are indicated for patients aged 12 to 65 years with a clinical history of allergy to dust mite allergens, confirmed by in vitro testing for IgE antibodies or skin testing. They are effective in mitigating symptoms of mite-induced allergic conditions[2][3].

Pharmacology and Immunotherapy

The immunotherapy involves the administration of standardized mite extracts, which lead to significant increases in mite-specific IgG4 antibodies and interleukin-10-positive T cells, while reducing IgE-mediated basophil histamine release. This results in improved clinical parameters and symptom reduction[2].

Production and Growth of Mites

The production of Dermatophagoides pteronyssinus involves growing the mites on a medium of brine shrimp eggs and wheat germ. Studies have shown that these mites exhibit excellent growth rates in semi-synthetic media, reaching maximum values after several weeks. The major allergens Der p 1 and Der p 2 are highly expressed during the later phases of mite growth[5].

Market Segmentation and Distribution

By Drug Class

Monoclonal antibodies, which are a type of biologic drug, are expected to dominate the market, exhibiting a CAGR of 5.7% during the forecast period. However, the segment involving allergenics, such as those derived from Dermatophagoides pteronyssinus, also plays a crucial role[4].

By Application

The oncology segment is not the primary focus for mite-derived biologics, but the allergy and immunology segment is significant. These drugs are used to treat allergic conditions, which are becoming increasingly prevalent[4].

By Distribution Channel

Pharmacies are expected to hold a substantial market share, with 37.5% of the distribution channel market in 2024. This indicates that biologic drugs, including those derived from mites, are widely available through pharmacy channels[4].

Regional Market Analysis

North America

North America accounted for a significant value share of 43.8% in 2023, indicating a strong market presence for biologic drugs in this region[4].

Asia-Pacific

Countries like China and India are expected to show high growth rates, with China predicted to rise at a CAGR of 8.8% and India at 8.5% from 2024 to 2034. This growth is driven by increasing healthcare access and awareness about biologic therapies[4].

Financial Trajectory

The financial trajectory for biologic drugs, including those derived from Dermatophagoides pteronyssinus, is promising. The overall biologics market is expected to reach USD 1,060.7 billion by 2034, growing at a CAGR of 7.6% from 2024 to 2034[4].

Challenges and Opportunities

Regulatory Approvals

Regulatory approvals are crucial for the growth of biologic drugs. The escalating approvals of biologics by regulatory agencies are a positive indicator for the market[1].

Safety Concerns

Biologic drugs, including those derived from mites, can cause anaphylaxis, a severe and potentially life-threatening allergic reaction. This necessitates careful administration and monitoring[3].

Competitive Landscape

Manufacturers with long-standing experience in biologics production possess valuable expertise in process development, optimization, and quality assurance. This expertise is essential for improving the production of biologics and biosimilars[4].

Key Takeaways

• The biologics market, including drugs derived from Dermatophagoides pteronyssinus, is expected to reach USD 699.5 billion by 2032.
• The market is driven by the increasing prevalence of chronic diseases, technological advancements, and the growing adoption of biosimilars.
• Dermatophagoides pteronyssinus extracts are used in immunotherapy for dust mite allergies and show significant clinical benefits.
• The production of these mites involves semi-synthetic media, and the major allergens are highly expressed during later growth phases.
• The market is segmented by drug class, application, and distribution channel, with pharmacies holding a significant share.
• North America and Asia-Pacific regions are key markets, with high growth rates predicted for China and India.

FAQs

What is the projected market size for biologics by 2032?

The biologics market is expected to reach USD 699.5 billion by 2032, growing at a CAGR of 7.8% from 2024 to 2032[1].

What are the primary drivers of the biologics market growth?

The primary drivers include the increasing prevalence of chronic diseases, technological advancements, growing adoption of biosimilars, improved healthcare infrastructure, and increasing awareness about biologic therapies[1].

What is the clinical indication for Dermatophagoides pteronyssinus extracts?

Dermatophagoides pteronyssinus extracts are indicated for immunotherapy in patients with house dust mite-induced allergic rhinitis, asthma, and conjunctivitis, confirmed by in vitro testing or skin testing[2][3].

How are Dermatophagoides pteronyssinus mites grown for biologic drug production?

The mites are grown on a medium of brine shrimp eggs and wheat germ, showing excellent growth rates in semi-synthetic media[5].

What are the potential safety concerns associated with biologic drugs derived from mites?

These drugs can cause anaphylaxis, including anaphylactic shock and death, especially in individuals with a history of allergen-induced anaphylaxis[3].

Sources

1. Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems. Biospace.
2. Dermatophagoides pteronyssinus. DrugBank.
3. Standardized Mite Extract (Dermatophagoides farinae) - FDA. FDA.
4. Biosimilar and Biologics Market Is Expected to Reach USD 1,060.7 Billion by 2034 and Grow at a Compound Annual Growth Rate of 7.6% - FMI Inc.. GlobeNewswire.
5. Kinetics of Dermatophagoides pteronyssinus and Dermatophagoides farinae growth in a semi-synthetic medium without animal-derived proteins. INRAE.