Enzyme-Linked ImmunoSorbent Assays (ELISA) are tests that use antibodies or enzymes to detect the presence of an antigen or other substance. These tests are generally done with microplates and some level of automation, including liquid handling and robotics. Multiplex and high-throughput ELISA systems are the next generation of ELISA-based automation that takes assay efficiency to another level.

Systems can be categorized into three groups: xMAP, multiplex, and high-throughput or single-plex technologies. The xMAP platform, made popular by Luminex and its strategic partners, is a suspension bead–based technology that multiplexes up to 500 analytes per sample. The system employs color-coded beads that are coated with a reagent specific to a particular bioassay, allowing the capture and detection of specific analytes.

Non-xMAP multiplex technologies, the second category, encompass a range of proprietary techniques and formats that allow multiple-analyte detection from a single sample. These systems generally employ microfluidics or microarray-like technologies that provide higher throughput (e.g., Somalogic’s SOMAscan platform) or increased sensitivity compared to the Luminex xMAP platform.  Some systems, like SOMAscan, can analyze more analytes than Luminex systems.

As for high-throughput and single-plex systems, oftentimes they require significantly less sample volumes and reagent consumption, therefore lowering the cost per assay. Each analyte is typically measured in parallel through multiple channels of a microfluidic device. Single-plex systems also perform parallel analysis but normally with a lower throughput. These systems are typically designed to provide more sensitivity for a focused panel of analytes.

Almost half of the market for automated ELISA platforms belongs to hospitals and clinics, driven by the demand for clinical applications. Companies are investing in developing infectious disease and genetic ELISA-based assays, focusing primarily on oncology, respiratory ailments, diabetes and angiogenesis. Sales of multiple and high-throughput ELISAs, like Meso Scale Discovery’s (MSD) systems, are growing in this diagnostics market, as they require fewer reagents and in some cases less sample than xMAP platforms.

In 2016, the total automated ELISA market was over $560 million. Luminex is the market leader, accounting for more than a third of it. The company offers an open platform, and allows its more than 55 partners to develop assays and sell its instruments. The growth of Luminex and its partners has largely been fueled in recent years by replacement of traditional ELISA assays with their faster multiplexing solutions, as well as the increasing number of new assays related to human health and disease.

MSD and Thermo Fisher Scientific are also prominent suppliers. MSD’s non-xMAP multiplexing technology, called MULTI-ARRAY, is planar based. This technology offers increased dynamic range and improved sensitivity, as well as a decreased need for reagents. Thermo Fisher has over 800 ELISA kits, xMAP multiplex assays and hundreds of Invitrogen assays developed for the Luminex platform, as well as for high-throughput and single-plex systems.

Leading Vendors:

• Luminex
• Meso Scale Discovery
• Thermo Fisher Scientific

Largest Markets:

• Hospital and Clinical
• Pharmaceutical
• Academia

Instrument Cost: 

• $20,000–$300,000