Author: Ken Rubenstein, PhD
Industry-leading growth rates, expanding applications and innovation characterize the molecular diagnostics sector. This report presents a synthesis of these developments including the increased diversity of assay targets, emergence of new and proposed point of care (POC) products, the appearance of sequencing-based assays that could fundamentally alter the field and automated low-density microarray-based assays.
Discussed in this report:
The technological landscape underlying molecular diagnostics today
Products and systems currently on the market
Products and platforms in development
Market dynamics of competition, regulatory and reimbursement
Applications beyond infectious agents, cancer, and genetic disease
Promising multiplex assays in development
Novel Point-of-Care (POC) formats
Likely impact of regulatory reform
Coverage of over 100 companies
Molecular diagnostics is a vital and dynamic field in which yesterday’s new technologies and platforms are today becoming populated with novel, diverse, and useful content. One might conclude that the molecular diagnostics market is approaching maturity as advances in automation has shifted the market toward the higher volume end of the spectrum, and platform offerings are now largely stabilized, enabling manufacturers to focus on adding platform-specific content.
However, as this report reveals, the molecular diagnostics market remains dynamic in the sense that small companies are continually developing useful new assays in unmet molecular diagnostic sectors. Also, significant technological contributions in the areas of signal amplification, multiplex assays, and DNA sequencing are contributing to the continuing expansion of applications. Tests for Alzheimer’s disease and autism are in development as are additional companion diagnostics, prognostic/prediction tests, genetic disease screens and pharmacogenetic assays.
This report found companies are pursuing sample-to-answer automation for single assays. These point-of-care (POC) approaches appear likely to result in sophisticated test strips, disposable plastic rotors, and other formats for this purpose. The MDx market is currently growing at nearly double the rate of the overall IVD market and the report concludes this growth is likely to continue for several more years. Oncology and critical care infectious disease testing sectors are likely growth leaders. In the current environment, regulatory reform, with reference to LDTs, is likely to advance slowly, but the pace could quicken should political leadership shift back toward the left in 2012. Despite this chance this report finds the previously modest pace of MDx deal-making actually accelerated in late 2010.
Furthermore, if and when significant regulatory reform does adversely affect MDx, it is likely to do so in a phased manner, starting with the highest risk assays and include significant levels of “grandfathering.” Limited funding for small companies and difficulty in achieving adequate reimbursement are issues that the public and private sector must address if personalized medicine and related entities are to continue advancing at healthy growth rates. In any event, point of care applications and next-generation sequencing-based assays are quite likely to provide significant sector growth over the next decade.
New technologies promise to open an extensive point of care market with next-generation sequencing awaiting further refinement before quite possibly having a major impact on the character of the MDx market. Multiplex assays have achieved only modest success in the market to date, but products now in development show great promise. Regulatory reforms now under consideration could slow market growth, although recent political shifts are likely to slow or even prevent much of an impact for 2011.
Even if regulatory reform stalls, the industry still needs improved reimbursement for esoteric and expensive personalized medicine products. The entire reimbursement infrastructure drastically needs updating in order to accommodate advances in MDx. Companies are also faced with growing costs for assay validation Limited automation capability caused by intrinsic protocol complexity of MDx assays relative to other IVD sectors provides another limitation to market growth in high volume test sites. As test menus grow, manufacturers will likely accelerate efforts to advance automation capabilities.
About the Author:
Ken Rubenstein, PhD, a biochemist and molecular biologist, received his PhD at the University of Wisconsin and postdoctoral training at the University of Pennsylvania School of Medicine. He was a key innovator and research manager for Syva Company, the diagnostics branch of Syntex Corporation. During his 13 years with Syva, Dr. Rubenstein became vice president, scientific affairs, a function that included strategic planning. Since 1983, he has served as a technology and marketing consultant to biomedical companies and an industry analyst, with more than 40 published studies to his credit.