IVD market set to explode in Europe

Discoveries and innovations in molecular diagnostics are propelling the advancement of personalised medicine and theranostics and creating new growth opportunities for IVDs.

As manufacturers concentrate on providing greater benefits such as early diagnosis, improved decision-making, and better monitoring of treatment, the market will maintain its strong growth trajectory.

The rising insurance coverage in countries such as France, Spain, and Germany will also contribute largely to positive trends in the market.

According to the latest Frost and Sullivan report the move by healthcare institutions to minimise errors and control costs is expected to boost the uptake of in vitro diagnostic (IVD) technology on a global scale.

Industry drivers within the IVD market include the expansion of the aged population as well as the technological advances in molecular diagnostics

The current market, especially the European, has been predicted to grow further as a result of these influences. Global revenues in this industry, which totalled $28.68 billion (€23.8 million) in 2004, are expected to reach $43.10 billion in 2011.

Other markets, such as the developing nations in Asia, Latin America, and Africa are likely to encounter more problems such as cost containment efforts and fluctuating economic conditions, which are interrupting the transition into these new IVD technologies.

"In developing countries, poor healthcare infrastructures and struggling economies greatly impede modernisation and create extremely price sensitive environments,"​ said Frost & Sullivan research analyst Silvia Cerqueira

"Distribution and logistical issues, local supplier presence, and minimal healthcare expenditure also present considerable hurdles to achieving market growth,"​ she added.

The report acknowledges that these countries have recognised these obstacles and have set in place healthcare awareness programs and government initiatives to increase spending and create opportunities for growth.

This is certain to have a knock-on effect in Europe with governments in nations such as Germany and France working toward raising healthcare standards, the market will continue to expand rapidly.

Low prices, consolidating multiple tests on a single platform, and customer service also take on renewed importance as markets become highly competitive and consumers raise their demands.

"Understanding individual markets and clinical needs is becoming increasingly important to overcome obstacles and promote the adoption of new technologies,"​ said Cerqueira.

"New IVD systems must also address unmet needs and provide substantial added value."​

One other obstacle that has the potential to upset predictions are the stringent regulatory policies. Regulations such as those imposed by the Food and Drug Administration (FDA) have added to the difficulties in introducing these innovations quickly.

In the United States, all clinical diagnostic tools must gain FDA approval and comply with the Clinical Laboratory Improvements Amendments of 1988 (CLIA) regulations.

The report recommended companies must be forward thinking in the development of new technologies and ensure proper quality control and quality assurance.

Several smaller companies combat this challenge by collaborating with larger companies and thereby benefit from the latter's experience and economic resources.

"In Europe, regulations such as the IVD Directive and CE marking also impede potential market entry of new competitors,"​ said Cerqueira.

"Due to the substantial cost of a CE mark, companies may have to abandon older generation devices and low-volume region-specific products."​

However, the report concludes that the reforms to boost the healthcare market, especially in the United Kingdom, counterbalance this move toward regularisation.

The report: "Global In Vitro Diagnostics Market Outlook (F365)," is now available to buy from Frost and Sullivan.​