The Global Full Product Development CMO in the IVD Industry, 2020

A Benchmarking System to Spark Companies to Action—Innovation That Fuels New Deal Flow and Growth Pipelines

Full product development IVD CMO comprises companies that partner with OEMs and support them in the development of IVD devices, ranging from concept to commercialization. IVD companies are continuously looking at new ways to optimize resources due to rising cost pressures and regulatory complexities, prompting industry participants to adopt innovative, integrated business models. CMOS are positioning themselves as one-stop-shop solution providers as opposed to the traditional functional service provider model, creating a mutually beneficial symbiotic relationship between OEMs and CMOs in the IVD industry. The IVD contract manufacturing market is highly fragmented and witnessed a growth rate of 8.5% in 2019. The publisher expects this segment to change significantly over the next few years since the majority of large IVD OEMs are focused on assay development, which is facing competition and capacity constraints due to stringent quality and regulatory requirements, strict delivery timelines, the need for good manufacturing practices, and delivery scale. OEMs are also increasingly outsourcing the design and manufacturing of instruments that perform diagnostics tests, heightening the competition among IVD CMOs to provide holistic services.

OEMs face challenges in meeting the rising demand for assays, reagents, and kits for COVID-19 testing, in turn, placing pressure on CMOs to scale up production of automated instruments with high throughput. The key strategic imperative for IVD instrument CMOs is to develop capabilities to manufacture simple, rapid, miniature, easy to use, automated, decentralized, and connected next-generation IVD devices with higher throughput rates to meet the ever-rising test demand. This is expected to boost competition among IVD CMOs to provide holistic services and become strategic partners to OEMs.

The report reveals the market positioning of companies in an industry using their Growth and Innovation scores, as highlighted in the report methodology. The document presents competitive profiles on each of the companies in the report based on their strengths, opportunities, and a small discussion on their positioning. The publisher analyzes hundreds of companies in the industry and benchmarks them across 10 criteria on the report, where the leading companies in the industry are then positioned. Industry leaders on both the Growth and Innovation indices are recognized as best practice recipients.