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

See chart