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Clinical Diagnostics Industry Overview
By Themedica on April 21, 2009 5:31 AM |
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The medical and clinical diagnostic industry comprises businesses and laboratories that offer analytic or diagnostic services including body fluid analysis and diagnostic imaging that aid the medical profession, and patients following a referral from health care professionals.

worldwide-ivd-market.jpgMedical laboratories are classified based on the type of services they render such as bacteriological laboratories, blood analysis laboratories, medical pathology laboratories, mycology health laboratories, parasitology health laboratories, etc.

The diagnostic imaging industry, on the other hand, is a huge segment by itself and provides services for producing images, via diagnostic equipment, of the patient on referral from health professionals to help with disease diagnoses. Imaging laboratory set-ups include CAT (computerized axial tomography) scanner centers, dental X-ray laboratories, mammogram or breast imaging centers, radiological laboratories, etc.

The world market for diagnostics was valued at $22.47 billion in 2000 and was expected grew at an annual rate of about 6 percent to $28.63 billion by 2005. Around the year 2002, Japan, Western Europe and North America, made up for 85% of the world's in-vitro diagnostics (IVD) market. However, this figure was expected condense to about 75 percent by 2005, due to higher market growth rates within emerging economies such as China, India, Indonesia, and Japan.

The US Diagnostic Equipment Industry Overview

The US diagnostic equipment market is the world's largest, and was valued at $13.5 billion in 2002. Over the years, emergence and growth of managed health care has led to reduced costs in addition to raising the demand for efficient operation within clinical laboratories. Managed care penetration by enrollment for the year 2009 stand at 10.4 million for Medicare, 28.5 million for Medicaid, and 115 million for commercial managed care plans.

As of now, the clinical diagnostic laboratory testing market has a projected value of $98.4 billion in revenue by 2017. The drivers for this growth are expected to be the expanding markets for genetic testing, esoteric testing, in addition to increases in consumer driven health care, and an aging population with an greater access to health care services. Although, the clinical laboratory industry has been affected due to the economic slowdown via declining drugs-of-abuse testing, the effect has been offset to some extent by a modest increase in volumes, a steady pricing environment, and a move towards high-value esoteric testing.

us-medical-and-diagnostic-labs-revenue.jpgThe point-of-care instrument and the medical diagnostic kit (MDK) markets too have emerged as growing segments of the diagnostic laboratory industry.

The US In-vitro Diagnostic (IVD) Tests Market

The in vitro diagnostic (IVD) tests market, in particular, is being seen a highly promising. The national demand for in vitro diagnostic (IVD) products is expected to grow at an annual rate of 5.4 percent to reach $23 billion by 2013. A number of trends forecast to accompany the progression of this segment, some of them are -
The star performers of the IVD industry segment are likely to be the clinical chemistry and immuno-assay systems. While clinical chemistry products will benefit from the sales of personal blood glucose monitoring systems and testing-strips, the growth of immunoassay will be driven by an increased use of value-added chemiluminescent systems into the pharmaceutical drug and infectious disease testing. With the rising volumes of blood glucose monitoring among diabetic patients, endocrine condition testing is expected to be one of the most popular IVD application till 2013 and later.

The IVD products including clinical chemistry reagents and medical instruments, will be in high demand and present ample growth opportunities because of epidemiological trends such as the estimated diabetes burden in the US. The total diabetes burden is forecast to be 11.5% (25.4 million) in 2011, 13.5% (32.6 million) in 2021, and 14.5% (37.7 million) in 2031. The demand will increase on account of the sale of both self-monitoring systems as well as diabetes testing becoming essential to general health screening routines.

  • Hemostasis tests for D-dimer and other cardiac parameters offer bright opportunities among IVD blood testing systems. The reason for this is their ability to quantify heart attack and embolism risk prior to a cardiac emergency.
      • DNA-based forensic, genetic and identity testing through IVD applications is yet another profitable segment as markets of law enforcement and genetic screening begin to generate revenues.
      • Other IVD products with a good potential in the coming years include cellular analysis and anatomical pathology reagents and instruments. The post on the medical instruments industry has more information on clinical instruments.

      The global scenario for in-vitro diagnostics presents similar opportunities -

      During the past couple of years the in-vitro diagnostics market has grown at an annual rate of about 6 percent, and was valued at $36.5 billion in 2007, compared to just $28.7 billion in 2004. By the year, assuming a similar rate of growth, it will reach a figure of $50.0 billion in value. And despite the 2009 financial crisis, the IVD segment is expected to witness growth.
      • Presently the global IVD market is quite consolidated with the top ten market players owning about 80 percent market share.
      • Roche is the largest market share holder with 20 percent, followed by Siemens and Abbott holding 12 percent share each.
      • The global growth drivers for the IVD industry are advancements in molecular diagnostics, health care for diabetes, and emerging markets. In addition Theranostics is also a promising discipline and a number of players are trying to make a headway in the field.

      As soon as the 'glimmers of hope' transform into a full-fledged economic recovery, the opportunities within medical diagnostics will be up for grabs.


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