Research and Markets has announced the addition of Frost & Sullivan’s new report "U.S. Companion Diagnostics Markets" to their offering.

This analysis provides a detailed view of the US companion diagnostics market. This segments present an executive summary highlighting key analysis and findings pertaining to the market. In addition, industry challenges and strategies for growth are in depth for the US companion diagnostics market. Key developing business models in the market are also discussed.

This Frost & Sullivan research service on US companion diagnostics markets provides the challenges facing companion diagnostic test providers and recommendations for overcoming growing competition and other limitations. It provides the current trends in companion diagnostics, companion diagnostics reimbursement policies, business model analysis, and economics of companion diagnostics. In this research, Frost & Sullivan’s expert analysts thoroughly examine the following markets: companion diagnostics by pharmaceutical/biotechnology as well as companion diagnostics development by pure-play diagnostic companies.

Market Overview

Companion Diagnostics Adoption Goes Hand-in-hand with Cost Savings for Reimbursement Agencies

Being a new market, companion diagnostics is curtailed by the lack of products that are designated as required tests, but this situation is set to change with the introduction of more products. The market started off offering human epidermal growth factor (EGF) receptor 2 (HER2) testing, and has now diversified into infectious disease, cardiovascular, metabolic disorders, and immune system disorders. The most rapidly growing area is oncology, with many new products in the market falling into the cancer companion diagnostics segment. The market can make considerable headway by leveraging companion diagnostics ability to aid clear decision making and provide clinical utility.

Reimbursement agencies will welcome combination diagnostics, as they are losing hundreds of millions of dollars with the current practice of prescribing drugs based solely on a disease diagnosis. This non-personalized approach to therapeutic selections results in considerable wastage of healthcare costs on ineffective treatments. In this scenario, companion diagnostic tests hold an edge by helping to reduce or eliminate adverse events associated with certain treatments.

A companion diagnostic that can help determine whether it is best to proceed or halt a particular medical procedure enables immediate cost/benefits analyses, which can be determined with relatively straightforward calculations. Although data on costs and benefits serve to support the reimbursement of the companion diagnostic test, the reimbursement rates are based solely on the method of test {immunoassay, polymerase chain reaction (PCR)} and not on its value.

With the newly available tests based on advanced technology platforms, companion diagnostics can revolutionize medicine by reducing costs and effectively targeting therapies, says the analyst of this research. However, pharmaceutical companies’ slow adoption of companion diagnostics is a potential restraint to this paradigm shift in personalized medicine. Pharmaceutical companies will need robust economic models to encourage drug diagnostic co-development before they can justify an investment in the market. While various market stakeholders concur that it is beneficial to combine drug development and diagnostics, there is a lack of clarity regarding the risk sharing and return on investment (ROI).

One of the ways biopharmaceutical and diagnostic companies can work together to share risks is through cursory service-level relationships. Another simple solution is large acquisitions. However, there is a growing number of middle ground strategies, wherein two companies co-develop a diagnostic for a therapeutic product by the means of an arms length market transaction.

Larger biopharmaceutical companies established multiple partnerships with small, medium, and large diagnostic companies, which might last several years and the valuation of which can range from a few million dollars a year to a $50-to-$100 million over a stipulated period, notes the analyst. These partnerships are growing in complexity, represented by the multiple ways in which drug developers are working with biomarker discovery service providers and diagnostic developers.

Source: Research and Markets