in vitro and companion diagnostics industry 2010 yearbook l.
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Global In-Vitro Diagnostics (IVD) and Companion Diagnostics (CDx) market set to boom in the next seven years

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Global In-Vitro Diagnostics (IVD) and Companion Diagnostics (CDx) market set to boom in the next seven years

The global IVD and CDx market was valued at $30.4 billion in 2009 and is forecast to grow to $42.2 billion by 2016 at the rate of 4.8% over the next seven years. Immunochemistry and Clinical chemistry markets will be the largest IVD categories, accounting for nearly 60% of the total revenues. These markets are expected to grow at 5.2% and 4.1% CAGR (Compounded Annual Growth Rate) between 2009–2016, to reach $15,477.4m and $9,506.7m respectively. The genetic testing market will be the fastest growing market, at a CAGR of 6% during 2009–2016, to become an over the billion dollar market. The global IVD and CDx market will be driven by new technological advancements, a shift towards more complex immunochemistry tests to Point of Care (POC), and the adoption of cost cutting measures such as increased automation and self testing. Major technological advancements such as next generation DNA sequencing, molecular imaging, and microfluidics-based diagnostic devices are expected to drive growth in categories such as immunochemistry and genetic testing.

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Need to control costs at laboratories to drive adoption of new processes and instruments

Cost reduction has become the primary theme of healthcare reforms globally. To survive and succeed in these challenging conditions, it is imperative for laboratories to look for ways to adapt and implement new strategies to help them

save on costs. In today’s competitive environment, revenues per test are continually falling, requiring testing centers to increase their productivity for survival. The paradigm shift towards improved quality, error free services, and the need to ensure patient satisfaction to retain their allegiance has prompted laboratories to adopt novel technologies such as automation and point of care, in order to reduce their expenses. The acceptance of new technologies is expected to drastically improve among those who are currently reluctant to invest to achieve long term cost reduction goals. Companion diagnostics, in particular, hold great potential to reduce healthcare costs.

Roche, Siemens, Abbott and Beckman Coulter Dominate the Global IVD Market

F. Hoffmann-La Roche Ltd (Roche), Siemens Medical Solutions (Siemens), Abbott Laboratories (Abbott) and Beckman Coulter were the leading companies in the global IVD market in 2009. These top four companies accounted for 36% of the total market share. Roche was the market leader and accounted for 12%


of the market in 2009. Siemens, Abbott, and Beckman Coulter accounted for 10%, 8%, and 6% respectively. The global market for IVD is quite fragmented due to the presence of a number of small local players. However, a large number of acquisitions of the smaller players by the market leaders are resulting in consolidation of the market. For instance, during 2005-2007, Siemens acquired

Diagnostic Products Corporation, Dade Behring, and Bayer Diagnostics Division. Another leading trend is the entry of diagnostic imaging companies such as Siemens and Philips into the IVD market.

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Rising Emphasis on Patient Centric, Personalized Medicine to Accelerate Development of Companion Diagnostics

Companion diagnostics involves utilization of biomarkers for new diagnostic tools and to identify a patient population for a particular drug. It can provide information that is more dynamic, sensitive, and specific for disease progression in a patient and prescribe drugs which are tailored to the person’s genetic make-up.


Across the globe, healthcare providers are turning their attention to spiraling healthcare costs due to the increasing prescriptions of expensive drugs which may or may not work for all individuals. Moreover, the rise in the mortality due to the adverse drug reactions from inappropriate prescription drugs has gained interest in the face of tightening budgets. Pharmacogenomics is increasingly being seen as a solution for administering drugs which work, by assessing the

patient’s genetic disposition for drug metabolism, hence avoiding costs associated with adverse drug reactions.

Many IVD companies are evaluating business models based on molecular diagnostics by collaborating with pharmaceutical companies for pharmacogenomic testing as the driving force behind the shift toward personalized medicine.

Companion Diagnostics hold tremendous potential in personalizing medicine: Oncology will remain the prime focus

The application of advanced technologies for the development of personalized medicine, be it diagnostics or therapeutics, in the drug discovery process is becoming increasingly evident. The integration of pharmacogenomic data in clinical trials and drug development process helps in selecting patients that are more likely to respond or least likely to suffer any side effects. This considerably reduces the time, size and expense of clinical trials and also helps


pharmaceutical companies to overcome the challenges posed by conventional processes which are time consuming and expensive. Thus, many pharmaceutical companies are turning towards drug and diagnostic co-development.

Development of companion diagnostics in oncology is gaining momentum, owing to genetic variations and Single Nucleotide Polymorphisms (SNPs) involved in cancers and the resulting genetically defined patient subtypes. A number of therapeutics and biomarkers are focused on cancer research to allow better understanding of the disease. Within oncology, the major indications are breast cancer, lung cancer and colorectal cancer. The other major therapeutic areas of interest to pharmaceutical companies include infectious diseases, immunology and cardiovascular diseases.

GBI Research's new report “In-vitro and Companion Diagnostics Industry – 2010 Yearbook” provides an in-depth analysis on the potential applications of in-vitro and companion diagnostics in pharmaceutical drug discovery and clinical services. The report suggests investment decisions in in-vitro and companion diagnostics market by providing information on major segments of in-vitro diagnostics, namely Immunochemistry, Clinical chemistry, Infectious immunology, Hematology, Microbiology, Histology and Cytology, Genetic testing


and Companion diagnostics markets, market forecasts and analysis, pipelines, competitive landscape, research trends and mergers and acquisitions. In addition to this, the report also covers market drivers and restraints for the global in-vitro and companion diagnostics market.

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