U.S. Clinical Chemistry and Immunoassay Reagents Markets

Smaller Reagent Manufacturers Find New Solutions to Match Larger Manufacturers’ Advantage of Holding Reagent Rental Contracts

Clinical laboratories’ enthusiasm for solutions that can help reduce huge initial outlays on new instruments is fostering the culture of reagent rental contracts. Through such contracts, an instrument manufacturer rents out analyzers to hospitals or laboratories in exchange for orders for reagents. This method proved to be so popular that it accounted for nearly 75 to 85 percent of all revenue generated within the clinical chemistry and immunoassay reagents market in 2003. However, it also cut out smaller suppliers from the market. These smaller suppliers have been trying to create niche markets by targeting physicians’ offices and regional reference laboratories. To cater to the lower demand volumes of such sectors, these suppliers have been offering reagents in lower volume packs and using analogs that allow for increased stability of reagents.

This Frost & Sullivan research service examines the U.S. Clinical Chemistry and Immunoassay Reagents Markets and discusses the various market trends and opportunities for the reagents. The research segments the market into that for clinical chemistry and immunoassay reagents. It offers revenue forecasts as well as key drivers and restraints affecting market growth.

Advances in Point-of-Care and Combinatorial Testing Spur Market Growth

The quickness of point-of-care (POC) test results has popularized its use among the medical community, boosting demand for new, lower volume analyzers to conduct these tests. The need for more instruments is, in turn, driving sales of additional reagents. Some of these reagents come in the form of higher margin reagent disks or packs, further enhancing revenue. Continued developments such as increasing tests menus while decreasing the size of the analyzers' footprints are likely to further increase uptake of POC testing, and consequently, that of reagents.

The clinical chemistry and immunoassay reagents market is also capitalizing on the advances made in diagnostics. Although new tests provide more information on medical conditions, many laboratories and hospitals prefer to use a combination of old and new technologies for obtaining a complete picture. For instance, in cardiology, specific myoglobin and troponin tests are conducted in addition to the regular creatine kinase-MB. "These practices augment test volumes and reagent revenues," says the analyst.

Market Growth Expected to Be Mainly Volume Driven

In the total market, clinical chemistry dominates in terms of unit volume with approximately 87.9 percent, while immunoassay reagents lead in revenue with about 67.8 percent share. This is ample evidence of the ‘commodity status’ of most clinical chemistry tests and the growth opportunities for higher margin immunoassay techniques. In future, the markets for both clinical chemistry and immunoassay reagents are expected to be driven by volume demand, especially from an ever-increasing aging population.

"The educated patient group is becoming more aware of the availability of various treatment options and is proactively requesting tests," notes the analyst. This is bolstering the unit sales of reagents, especially high-end ones, since patients have been asking for the latest tests for both early diagnosis as well as more comprehensive disease management. Unexpected epidemiological outbreaks such as SARS are also likely to sporadically increase demand for reagents and drive volume and revenue.

Improvements in Customer Service

Since end users of clinical chemistry and immunoassay reagents––clinical laboratories––face significant challenges due to continued constraints on reimbursement rates, there are many approaches to marketing strategies. The analysis of the market provides details about the most pressing issues facing clinical laboratories and reveals how reagent manufacturers can focus efforts to best provide solutions for those challenges.

Identification of New Market Trends

In a market dominated by many large participants and reagent rental contracts, smaller diagnostics manufacturers need to know where to focus their efforts to increase revenue and growth. The analysis of the reference laboratory market provides strategies and opportunities for competing in the space.

Improvements in Marketing Effectiveness

Since there are varying levels of volume of clinical chemistry and immunoassay reagents available for end users, there are many approaches to marketing strategies. The analysis of the market provides the most important competitive factors by segment so that marketing efforts can be centered around what is important to clients.

Improve Impact of Presentations

Make credible internal and external presentations by having the most recent information about a particular subject. This analysis provides the current trends and challenges within the industry.

Improved Accuracy of Business Planning

When companies decide on where to focus their research and development dollars, it is imperative that they have accurate information depicting the position and direction of the market as well as the challenges that might be encountered. This research service provides insights into the current and expected market conditions at the total and segment levels.

Expert Frost & Sullivan analysts thoroughly examine the following market sectors in this research:

• Clinical Chemistry Reagents
• Immunoassay Reagents

The following technologies are covered in this research:

Clinical Chemistry Reagents: Clinical chemistry reagents are used to perform specific diagnostic tests on automated and semi-automated clinical chemistry analyzers, generally using photometric, potentiometry, and turbidimetric methods in clinical laboratory settings. Clinical chemistry tests are most commonly ordered by doctors to assess the overall functioning of the body by measuring the levels of general metabolites and electrolytes within body fluids. Other types of testing performed using these methods include therapeutic drug monitoring (TDM) of specific pharmaceutical formulations, drugs-of-abuse testing (DAT) for certain illegal drugs, and special chemistry testing.

Immunoassay Reagents: Immunoassay reagents are used to complete immunodiagnostic testing on automated and semi-automated immunoassay analyzers, generally using enzyme immunoassay (EIA), coated microplate, chemiluminescence, and fluorescence methods among others, in clinical laboratory settings. Immunoassays are diagnostic tests that involve antigen to antibody reactions. Immunoassay testing and reagents include those used to measure the functioning of the thyroid and reproductive systems. This type of testing is also used in the diagnosis of anemia, allergies, some TDM, and some DAT.

Reagent Rental Contract: A reagent rental contract is a written agreement between the manufacturer of a particular instrument and a laboratory offering testing facilities. Generally, the contract outlines that the manufacturer of the instrument or instruments will place the analyzer in a laboratory for a specified period. In exchange for this placement, the laboratory agrees to purchase reagents from the manufacturer of the instrument for the life of the contract. In essence, the rental fee is paid through the purchase of reagents for the instrument.

Point-of-Care Testing: Point-of-Care (POC) testing is traditionally performed at hospitals and physician offices either for convenience or to meet a need for immediate diagnosis in critical situations. Most POC tests employ rapid immunoassay techniques or diagnostics that use automated analyzers.

Chapter 2

• Clinical Chemistry and Immunoassay Reagents Market: Impact of Top Industry Challenges (U.S.), 2004-2010
• Clinical Chemistry and Immunoassay Reagents Market: Challenges and Corresponding Strategies (U.S.), 2004-2010
• Clinical Chemistry and Immunoassay Reagents Market: Market Drivers Ranked in Order of Impact (U.S.), 2004-2010
• Clinical Chemistry and Immunoassay Reagents Market: Market Restraints Ranked in Order of Impact (U.S.), 2004-2010
• Clinical Chemistry and Immunoassay Reagents Market: Unit Forecasts (U.S.), 2000-2010
• Clinical Chemistry and Immunoassay Reagents Market: Total Population and 55+ (Years) Population Growth (U.S.), 2000-2010
• Clinical Chemistry and Immunoassay Reagents Market: Reagent-only Price Per Test Forecasts (U.S.), 2000-2010
• Clinical Chemistry and Immunoassay Reagents Market: Revenue Forecasts (U.S.), 2000-2010
• Clinical Chemistry and Immunoassay Reagents Market: Competitive Structure (U.S.), 2003
• Clinical Chemistry and Immunoassay Reagents Market: Market Shares of Select Market Participants (U.S.), 2003
• Clinical Chemistry and Immunoassay Reagents Market: Market Share by Segment for Unit Volumes and Revenues (U.S.), 2000-2010
• Clinical Chemistry and Immunoassay Reagents Market: Database of Key Industry Participants by Reagent Type (U.S.), 2003

Chapter 3

• Clinical Chemistry Reagents Market: Market Share by Segment for Unit Volumes and Revenues (U.S.), 2000-2010
• Clinical Chemistry Reagents Market: Unit Forecasts (U.S.), 2000-2010
• Clinical Chemistry Reagents Market: Reagent-only Price per Test Forecasts (U.S.), 2000-2010
• Clinical Chemistry Reagents Market: Revenue Forecasts (U.S.), 2000-2010
• Clinical Chemistry Reagents Market: Competitive Structure (U.S.), 2003
• Clinical Chemistry Reagents Market: Market Shares of Select Market Participants (U.S.), 2003

Chapter 4

• Immunoassay Reagents Market: Market Share by Segment for Unit Volumes and Revenues (U.S.), 2000-2010
• Immunoassay Reagents Market: Unit Forecasts (U.S.), 2000-2010
• Immunoassay Reagents Market: Reagent-only Price per Test Forecasts (U.S.), 2000-2010
• Immunoassay Reagents Market: Revenue Forecasts (U.S.), 2000-2010
• Immunoassay Reagents Market: Competitive Structure (U.S.), 2003
• Immunoassay Reagents Market: Market Shares of Select Market Participants (U.S.), 2003