Clinical Laboratory Diagnostics
Welcome to the innovative world of Clinical Laboratory Diagnostics. This Leomics Tutorial will offer a primer on this ever-evolving industry, and guide organizations as they begin their decision-making process.
Fast Facts on Clinical Laboratory Diagnostics
The clinical laboratory diagnostics world is divided into two service businesses: Clinical Diagnostics and In-Vitro Diagnostics.
A service business includes all reference laboratories, hospitals, and private laboratories that perform physician-ordered tests.
Typical examples of service businesses include Quest Diagnostics, Lab Corp, Genzyme, Mayo Reference Laboratories, ARUP and many more in the United States.
Europe has smaller reference laboratories in all countries, but the continent’s clinical service business is more concentrated in larger hospitals and academic centers.
There are large service reference laboratories in Japan, Singapore, Korea, Australia, India, Brazil, Argentina, Colombia, Mexico and Canada.
The United States market for this sector is close to $38 billion. We estimate that the global market is $70 billion. Within the service lab market, molecular diagnostics is about $4.2 billion in the U.S. The average annual growth rate is around 15%. The annual growth rate of the core business, not including non molecular diagnostics, is around 5%. The average price of a molecular diagnostics test is around $350 versus $25 for a core laboratory test. Molecular diagnostics includes testing for DNA, RNA, and proteomic/metabolomic panels. Molecular diagnostics testing is comprised of genetic, infectious disease, cancer, and companion diagnotics or pharmacogenomic tests.
The in-vitro diagnostics (IVD) service business produces all manufactured kits and instrument. In the United States, these kits are generally FDA-approved, or have received approval by similar regulatory agencies