Aug 28, 2013
The global in vitro diagnostic (IVD) market will grow from $49.2 billion in 2012 to $69.1 billion in 2017, fueled primarily by increasing demand for self-test IVD products.
According to a report by Research and Markets, issues including laboratory automation, more rapid point-of-care testing capabilities and emerging market opportunities will also drive IVD market growth. Although North America and Europe make up the largest share of the IVD market, report authors expect fastest growth rates in Brazil, Russia, India and China.
Challenges that will likely keep global IVD market CAGR in the single digits over the next four years mirror those often cited by other IVD and medical device industry observers and participants: complex regulatory frameworks in some countries, saturation in bigger IVD markets such as the US and Europe, and labor and budget shortages. How closely the global IVD market develops alongside the medical device market, however, depends significantly on how individual market regulators treat such products. Some market regulators apply the same or similar requirements to IVDs and medical devices, while other regulators maintain distinct frameworks for IVDs.
A new report examining European in vitro diagnostic (IVD) market performance in 2010 sees flat or negative growth across most major EU member states due to cost containment measures and worsening economic conditions.
According to the European Diagnostic Manufacturers Association’s (EDMA) study, the European IVD market totaled €10.5 billion last year, with revenue growth of only two percent from 2009. Cardiology testing and diabetes-related IVD sectors as well as products for managing hospital-acquired infections showed the strongest growth rates in 2010, but all other testing areas showed flat or negative growth.
Comments following European Union regulators’ public consultation on proposed revision to Directive 98/79/EC indicate
The new regulation will change the classifications of Class I, II, III and IIIa IVD devices to Class I, II, III and IV. IVD reclassifications will be more aligned with Global Harmonization Task Force risk-based classification criteria.
Mexican medical device regulators plan to establish simplified registration for in vitro diagnostics and other low-risk products, and to exempt another 1,700 health products from medical device reg