The market for high-throughput and multiplex immunoassay systems consists of a variety of proprietary technologies that miniaturize and automate ELISA-based assays. These systems have become important tools in research and bioprocessing applications. Over the past decade, their use has increased, particularly in the areas of biomarker discovery and development, pharmacokinetics, immunogenicity and bioprocessing.

Nonetheless, there are headwinds that impede the switch from conventional ELISA to high-throughput and multiplex systems. Most of the systems currently on the market are proprietary or closed, which require users to purchase consumables from a single source. This can be a risk if the supplier goes out of business. However, the prices of systems have come down significantly, particularly with the introduction of entry-level systems that allow users to learn more about the technology before investing in advanced systems.

High-throughput systems are generally parallel-processing systems, in which the sample is separated into multiple channels in which individual assays are performed. High-throughput systems incorporate automated sample preparation systems for faster processing. In contrast, multiplex systems typically measure multiple analytes in a single sample. While multiplex systems offer lower throughput, they have the advantage of increased flexibility.

Meso Scale Discovery’s technology consists of patterned microplates and electrochemiluminescence detection. MULTI-ARRY plates offer single-analyte analysis. MULTI-SPOT plates offer multiplex analysis, with each well holding up to 100 spots. The plates are read using the SECTOR and QuickPlex imagers.

Gyros offers a high-throughput system that employs a compact disc that moves nanoliter volumes through a network of microfluidic channels. Centrifugal and capillary forces are used to steer samples and reagents through different regions on the disc. While the initial cost of the GyroLab is at the upper end for such systems, the cost per assay is lower than other products, with a lower overall cost of ownership.

There are several other established players in the market, such as Luminex and ForteBio, a Pall company. There also are many newcomers. Quanterix offers a multiplexing platform utilizing magnetic beads. BioScale’s system is based on acoustic membrane microparticle technology. Genalyte’s Maverick Detection System employs an array of Microring Sensors constructed using silicon-photonics technology. CyPlex provides a system that analyzes multiple proteins from a single sample without multiplexing.

The market for these “next-generation” ELISA systems has become significant, carving out an important niche in the $2 billion standard ELISA market. Overall, the market is still burgeoning, offering considerable growth potential as users migrate to high-throughput and multiplex systems.

HT and Multiplex Immunoassay Systems at a Glance:

Leading Suppliers

• Luminex

• Meso Scale Discovery

• Gyros

Largest Markets

• Pharmaceutical

• CROs

• Biotechnology

Instrument Cost

• $75,000–$300,000