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Global Market Entry for an In Vitro Diagnostics


Global Market Entry for an In Vitro Diagnostic:

In vitro diagnostics or shortly IVD, are basic, non-invasive and rigorous tests, which are performed on various biological samples in order to diagnose a disease. Specifically, our company deals with production of CRC IVD products in the EU. The products we manufacture are useful for screening and therapy.

The worldwide demand for vitro diagnostic products has gone up and it is projected that by 2015’ it will have increased by 7.1%. The European Union is the region worst hit by colorectal cancer, a condition that is highly malignant. Statistics reveal that men are worst hit by this disease. Overall, according to the detailed and comprehensive statement, 12.9 % of the European population account for 12.2 % malignancy related mortality.

It is also shocking that almost 410000 cases were reported in 2007 concerning the spread of this disease. Out of these, 210000 succumbed to the disease.

The European Union market for in vitro diagnostics devices stood at 30 % of the global market share. The EU demand, according to this projection will increase by almost 7.1 % p.a. through 2015.Therfore, its very important that we increase our product production by 20% in order to match the ever-growing demand. Though Japan and USA still make the world’s largest in vitro products markets, the developing world is growing fastest.

The EU IVD market demand was roughly $1.2 billion in 2008.According to the analysis from our market research data, sales estimates for the IVD products in the same market niche will reach $ 2.2 billion by 2015. This indicates that the demand is outdoing the supply, which will eventually result in shortages.

As an industry, we need to understand that the demand for these IVD products is as a result of increasing cases of CRC malignancy infections all over the EU. It is outstanding to note that this region has the highest number of CRC victims than elsewhere, meaning that urgent measures and policy formulations have to be brought into immediate attention in order to increase the production of newer and more advanced IVD products.

We need also to realize that the increasing demand for our product is because of the ageing population, informed patients and other macroeconomic dynamics. In EU member countries like Germany, the IVD sales have not been good because of market-based restrictions, which are categorically placed on critical reimbursement of blood test devices and other new tests on CRC patients and highly consolidated market.

Due to few numbers of laboratories in Italy, our company won’t be able to increase IVD products sales in this region. Besides, most public hospitals have been subjected to various restrictions on volumes of testing and budgets. Another issue, which will affect IVD product market in Italy, is late payments. The average is almost 300-day sales outstanding-it’s almost 5 times greater than the recommended period of 60 days in the EU.

Spain, UK. Portugal and Switzerland have experienced a rapid increase in the demand for our IVD products due to large number of hospitals and increased penetration of international laboratory chains to these regions. However, though Portugal experienced an increase of 2.85 % of total IVD market, laboratory market was adversely affected by government’s stringent market restrictions.

Stringent competition is one of the key factors that will adversely affect our market scope. As at now there are many companies spreading across Europe, which are dealing with manufacture and sale of IVD products. These companies are-Abbott Diagnostics, Celera Corporation, Cepheid, Gen-Probe Inc, bioMerieux Inc, Beckman Coulter and many others. The stiff competition will result to reduction in prices and hence poor company performance. This implies that our products should be developed in a way that it will guarantee market success-that is, using advanced technology in production, regulatory approval by EDMA and constant reimbursement. Health care deficits have caused a great challenge to our product performance because of recession effects.

The IVD product performance in EU is, however, secured by the fact that most ageing people require these products. Our target group consists of approximately 140 million people who are aged above 50 years. A greater percentage of these people come from countries where CRC screening is performed at regional hospitals. We need, therefore to increase the production of colonoscopy devices, Fecal Occult Blood Test machines, and Immune Fecal Occult Test Devices.

Despite the challenges due to budgetary restrictions for most IVD suppliers, we can be able to be sure of future market growth. This is because molecular biology, hematology, and coagulation still rank as one of the best markets for our IVD testing devices.

The CRC screening tools to be taken into consideration are fecal occult blood testing which will be vital in the diagnosis of CRC and will also act as a screening tool on invisible blood traces. The cost of this equipment currently in Sweden, for example, is almost 22000 kronor. This indicates that government has to subsidize the clients in order to be able to purchase these drugs. However, we need to understand that our marketing strategy will be based upon the demand of these facilities in Europe.

There will be increased demand for our product by 2014. However, we need to increase the umber of trained workforce, modify the working hour’s schedule, and reformulate the retirement rates for our older staff members who could still be useful in the productivity of our productivity. The actual demand by 2014 could increase because almost 60% of the European population aged above 60 years and above is periodically screened for CRC. These rates are projected to increase by 10%.

This increase will eventually increase the screening rate to almost 70%, hence requiring us to supply 500 FTEs by 2014 in order to gather for increased in colonoscopy demand.

The CRC facilities market for Europe will be approximately14.5 billion Euros against 2008’s 10.2 billion, which represented a paltry 0.8% of the total health care budget. Revenue growth will be projected to increase by3.0percentage. The demand is increasing because of ever-growing awareness from patients that it is also a cost effective way in providing vital information for quick diagnosis of the disease.

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