Medical Diagnostics
Medical Diagnostics
Introduction
Professional and over the counter (OTC) applications of lateral flow technologies remain the largest area of application for these tests. Market penetration relative to other technologies is high, and there are a large and growing number of applications for the test.
| World LF Test Revenues (US$ millions) | |||||
|---|---|---|---|---|---|
| Sales 2005 |
% Mkt |
Sales 2010 |
% Mkt |
% CAGR |
|
| Clinical | 1,880 | 90 | 2,725 | 89 | 8 |
| Veterinary | 175 | 8 | 270 | 9 | 9 |
| Food & Beverage | 25 | 1 | 50 | 1 | 15 |
| Pharma/Biologics | 10 | 0.4 | 20 | 1 | 15 |
| Environment | 5 | 0.2 | 6 | 0.2 | 4 |
| Water Utilities | 5 | 0.2 | 6 | 0.2 | 4 |
| 2,100 | 100 | 3,077 | 100 | 8 | |
| Source: DCN Market and Technical Report: (Pushing Lateral Flow to the Limits) | |||||
LF tests have had considerable success in penetrating the market for POC immunoassays. In 2005, LF-POC tests have captured 32% of the market for which a lab-based immunoassay is available – $1.9 billion versus $5.8 billion (lab-based).
Primary areas of development in this market segment in recent years have included:
- OTC/Self Tests
- pregnancy/ovulation
- infectious diseases
- cholesterol
- drugs of abuse
- other (FSH, TSH, HbA1c, etc.)
OTC/Self Total
- Professional POC
- Pregnancy
- Infectious Diseases
- Cardiac Markers
- Cholesterol/Lipids
- Drugs of Abuse
- Other
Numerous opportunities are available in this market, taking advantage of the sensitivity, specificity, ease of use and the growing ability for quantification with these assay formats.
DCN’s broad experience in the development of assays in this area, coupled with our ability to design devices specifically for these applications and integrate readers as appropriate, make DCN your ideal partner for the development or manufacture of assays for this segment.
For a detailed discussion of market opportunities and appropriate technologies for lateral flow and flow through market segments, see DCN’s Technology and Market Report on the point of need diagnostics market, entitled Pushing Lateral Flow to the Limits. Contact us for information on how to order this report.
Advantages of lateral flow and flow through assays in this market segment
- Ability to handle multiple sample types, including whole blood, serum, plasma, urine, fecal samples, sweat, tears, spinal fluid
- Ability to perform serology and antigen detection effectively
- High sensitivity
- Quantification ability
- Ease of use
- Low cost
- Speed
DCN has developed numerous assays in this market area. Examples include:
- anti-HIV 1 / 2 (serum / whole blood / saliva)
- hCG (urine)
- Drugs of abuse assays (urine), including Morphine, Opiates, Amphetamine, Methamphetamine, Cocaine, PCP, MDMA
- THC (saliva)
- Dengue (serum/whole blood)
- Malaria (falciparum) (whole blood)
- Hepatitis B surface antigen (serum / whole blood)
- Influenza A (swab)
- anti- HBsAg (serum/plasma/whole blood)
- Progesterone (tears)
- Quantitative Estronediol (human urine)
- Quantitative PdG (Progesterone precursor) (human urine)
- Semi-quantitative caffeine in beverages (coffee/tea/soft drinks)
- Quantitative Troponin I (serum/plasma)
- Quantitative Myoglobin (serum/plasma)
- Quantitative Pro-BNP (serum/plasma)
Developing or manufacturing assays for Medical Diagnostic or Over the Counter uses?
DCN offers a variety of products and services specifically designed to meet your needs, including:
Services
- Education and Training Course in Point of Care assay development
- Contract Assay Development
- Contract Manufacturing
- Custom Conjugation
- Consulting: Market evaluation, technology evaluation, regulatory affairs, manufacturing process development
- Cassette or device design
Platforms for development:
- DiagnostIQ™
- ZAP
Reader Systems for lateral flow and flow through tests:
- Quantitative Handheld Reader
- Quantitative Benchtop Reader
- Qualitative Handheld Reader (The Visualizer)
- Quantitative Handheld Limited Use Reader
High Sensitivity Labels for Development
- Fluorescent particles
- Paramagnetic particles
- Colloidal gold
Sample Collection and Handling Devices
- Urine collection devices (Link to Whiz)
- Sample Homogenizers