Keywords: cost; diagnostics; laboratory outcome; ue; valume. vol Laboratory diagnostics is a highly complex and multi-faceted enterprise, which provides a fundamental con-tribution to the clinical decision making by means of minimally invasive testing (1) . Besides this general portrayal, the organization of clinical laboratory services not only is markedly heterogeneous from one country to another, but also varies widely within the same country. Regardless of speculative or logistical considerations on consolidation and laboratory networking (2) , the leading determinants of clinical laboratory services typically include quality and accuracy of testing, turnaround time, the nature of analysis and additional services provided, expenditures, revenues along with certification or accred-itation to reliable standards. Now, with the global economy dramatically affected by an unprecedented and widespread financial crisis (i.e., the most serious recession in postwar history), national healthcare systems – and clinical laboratories as well – are squeezed between a rock and a hard place, wherein the need to maintain a high degree of quality and excel-lence must be balanced against lower funding. The gradu-ally widening gap between economical resources and request of testing placed on laboratory facilities is thereby expected to become the leading driver of the diagnostic market in the very next future. Another important aspect that may seriously influence the future trend of the in vitro diagnostic (IVD) market is the negative impact of the economical crisis on wealth and employment, which will expectedly generate reductions pullback in consumers ’ use of non-essential routine medical care and diagnostic testing, with the tangible threat that the slowdown will soon inflate other areas which are less discretionary (3) . Long payment delays and potential bankruptcy of some countries are additional problems that may dramatically influence future trends. Another good point is the US elec-tion, with its reflection on the Affordable Care Act (ACA) strongly supported by President Obama (4) . It is in fact predictable that the policy consequences of election will be suddenly and persuasively felt in connection with the healthcare reform. If the Democrats hold the White House and Senate in 2013, the ACA will be implemented mostly as constructed. However, if the Republicans win the elec-tions, the ACA will undergo a dramatic deconstruction along with fears that Medicaid expansion may be seriously jeopardized (5) . Before specifically addressing the relationship between testing volumes and expenditure, it seems rea-sonable to give a synthetic picture of the relationship between healthcare and laboratory economics. According to the European Diagnostic Manufacturers Association (EDMA), the 2010 revenues generated by the IVD in Europe approximated € 10.5 billion, thus representing roughly 0.8 % of the total European healthcare expenditure, which has been estimated at approximately € 1312.5 billion (6) . The IVD expenditure per capita has reached € 20.6 in the same year, thus slightly increasing from € 20.1 in 2009. The five leading markets (i.e., Germany, France, Italy, Spain and UK, in decreasing order) accounted for nearly € 7.5 billion, thereby representing more than two thirds of the all IVD market across Europe. Taking the Italian market as an example, the IVD expenditure has reached € 1.760 billion in 2010 (official source: Assobiomedica), which represents a modest 1.6 % of the total national healthcare expenditure (estimated at € 112.889 billion in the same year). It is also noteworthy that the expenditure of the IVD market was nearly half of that recorded for other biomedi-cals (e.g., € 3.628 billion for pacemakers, defibrillators, prosthetic devices, catheters, etc.), and virtually identical to that of medical informatics services and telemedicine (€1.577 billion). According to these figures, which would expectedly mirror those of other western countries, it is reasonable to put forward the concept that the costs of laboratory diagnostics are little more than the tip of the iceberg for the total healthcare expenditure (Figure 1). Essentially, the financial reforms of many governments in Europe and abroad have been insistently focused to control and even restrain IVD expenditure. This policy has been driven by several questionable conjectures.
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Oct 1, 2016
Demian Abrego Almazán + 2
Open Access
