Thin-layer rapid use epicutaneous patch test - Biologic Drug Details

Summary for thin-layer rapid use epicutaneous patch test

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

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 thin-layer rapid use epicutaneous patch test Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for thin-layer rapid use epicutaneous patch test Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for thin-layer rapid use epicutaneous patch test Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Biologic Drugs: Focus on Thin-Layer Rapid Use Epicutaneous Patch Test

Introduction

The biologics market, which includes advanced diagnostic tools like the thin-layer rapid use epicutaneous patch test (TRUE test), is experiencing significant growth driven by various factors. This article delves into the market dynamics and financial trajectory of biologic drugs, with a specific focus on the TRUE test.

Biologics Market Overview

The global biologics market is projected to reach USD 699.5 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 7.8% from 2024 to 2032. This growth is fueled by the increasing prevalence of chronic diseases, technological advancements, and the rising adoption of biosimilars[1][4].

Drivers of the Biologics Market

Several key factors are driving the growth of the biologics market:

Increasing Burden of Chronic Diseases

The rising incidence of chronic diseases such as cancer, autoimmune disorders, and inflammatory conditions is a significant driver. Biologic therapies offer targeted and often more effective treatments for these conditions[1][4].

Technological Advancements

Continuous technological advancements in drug delivery systems and diagnostic tools are enhancing the efficacy and safety of biologic treatments. The TRUE test, for example, is a well-standardized technique of patch testing that offers high accuracy and ease of use[5].

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 comparable efficacy. This segment is expected to grow significantly, contributing to the overall market growth[4].

Improved Healthcare Infrastructure

Enhancements in healthcare infrastructure and increasing awareness about biologic therapies are also driving market growth. Better access to healthcare services and education about the benefits of biologic treatments are expanding the market[1].

Thin-Layer Rapid Use Epicutaneous Patch Test (TRUE Test)

What is the TRUE Test?

The TRUE test is an epicutaneous patch test used for diagnosing allergic contact dermatitis (ACD). It is a thin-layer, ready-to-use test that ensures optimal contact with the skin and subsequent permeation of the allergen, leading to high antigen bioavailability[5].

Merits of the TRUE Test

• Ease of Use: The TRUE test is easy to handle and can be applied by paramedical personnel.
• Accurate Dosage: The test ensures an even spread and accurate dosage of the allergen.
• High Bioavailability: The vehicle used in the TRUE test ensures high bioavailability of the antigen.
• Few Side Effects: The test has few side effects and reactions are mostly within the limits of the patch site[5].

Clinical Performance

Studies have shown that the TRUE test is a well-standardized technique with good accuracy. It is particularly valuable in routine clinical practice due to its ease of use and minimal side effects. However, it has limitations such as a limited number of antigens available and questionable predictive value for some antigens[5].

Financial Trajectory of Biologic Drugs

Market Size and Growth

The biologics market, including diagnostic tools like the TRUE test, is expected to reach USD 699.5 billion by 2032. This represents a significant increase from the USD 349.6 billion market size in 2023[1].

Segmental Growth

The monoclonal antibody segment is expected to dominate the market, exhibiting a CAGR of 5.7% during the forecast period. The oncology segment will also register substantial growth, with a CAGR of 6.2% and accounting for a revenue share of 25.9% in 2024[4].

Regional Growth

North America holds a substantial value share of the market, with 43.8% in 2023. Emerging markets like China and India are expected to grow at CAGRs of 8.8% and 8.5%, respectively, from 2024 to 2034[4].

Technological Advancements in Diagnostic Tools

Deep Learning in Patch Testing

Recent advancements in deep learning are enhancing the accuracy and efficiency of patch testing. For instance, a deep learning approach using context-retaining pre-processing techniques can achieve more than 86% recall and 94% specificity in identifying skin reactions, contributing to faster and more accurate diagnoses[3].

Challenges and Limitations

Regulatory Approvals

While the TRUE test has been approved for use in adults and is being considered for use in children and adolescents, regulatory approvals can be a challenge. Ensuring safety and efficacy across different age groups is crucial[2].

Limited Antigen Availability

The TRUE test currently has a limited number of antigens available, which can limit its applicability in certain cases. Expanding the range of antigens is essential for its broader adoption[5].

Key Takeaways

• The biologics market is expected to reach USD 699.5 billion by 2032, driven by chronic diseases, technological advancements, and the adoption of biosimilars.
• The TRUE test is a valuable diagnostic tool for allergic contact dermatitis, offering ease of use, accurate dosage, and high bioavailability.
• Technological advancements, including deep learning, are enhancing the accuracy and efficiency of diagnostic tools.
• Regulatory approvals and expanding the range of available antigens are key challenges for the TRUE test.

FAQs

Q: What is the projected growth rate of the biologics market from 2024 to 2032?

A: The biologics market is expected to grow at a CAGR of 7.8% from 2024 to 2032[1].

Q: What are the main drivers of the biologics market?

A: The main drivers include the increasing burden of chronic diseases, technological advancements, growing adoption of biosimilars, and improved healthcare infrastructure[1][4].

Q: What are the merits of the TRUE test?

A: The TRUE test is easy to use, ensures accurate dosage, has high bioavailability, and has few side effects[5].

Q: How is deep learning impacting patch testing?

A: Deep learning is enhancing the accuracy and efficiency of patch testing by achieving high recall and specificity rates in identifying skin reactions[3].

Q: What are the limitations of the TRUE test?

A: The TRUE test has a limited number of antigens available and questionable predictive value for some antigens. Additionally, regulatory approvals for different age groups are ongoing[5].

Sources

1. Biologics Market Size to Reach USD 699.5 Billion by 2032, Impelled by Emergence of Advanced Drug Delivery Systems. Biospace.
2. Clinical Review - T.R.U.E. TEST. FDA.
3. Detecting Skin Reactions in Epicutaneous Patch Testing with Deep Learning: An Evaluation of Pre-Processing and Modality Performance. MDPI.
4. Biosimilar and Biologics Market Is Expected to Reach USD 1,060.7 Billion by 2034. GlobeNewswire.
5. Thin-layer rapid-use epicutaneous test (TRUE test). Indian Journal of Dermatology, Venereology and Leprology.

Last updated: 2024-12-19