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Italy’s Renaissance for Pharma R&D

Posted on: 30 Nov 05


As a major pharmaceutical market, Italy is a key region for the pharmaceutical industry. In terms of value, Italy’s pharmaceutical market is the fourth largest in Europe and represents around 13% of the regional total.

As a major pharmaceutical market, Italy is a key region for the pharmaceutical industry. In terms of value, Italy’s pharmaceutical market is the fourth largest in Europe and represents around 13% of the regional total (1). The continuing demand for pharmaceuticals has put pressure on the government’s overall funding of healthcare, which stands at around 9% of Gross Domestic Product (GDP). As has been observed in many other countries the growth in pharmaceutical spending has begun to outstrip the growth in total healthcare spending (2).


Medicines in demand

As a percentage of total healthcare spending, the current expenditure on pharmaceuticals in Italy stands at around 22%, which is higher than that for France and Germany – and even the US (2). However, such figures must be examined carefully because although new medicines contribute to healthcare spending increases in the short term, they can result in net healthcare savings in the long term because of reduced hospitalization rates, as well as reduced mortality and morbidity (3).


Products in the cardiovascular, alimentary/metabolism, central nervous system, respiratory and anti-infective therapeutic classes represent the majority of sales in the Italian pharmaceutical market. During 2005, these categories represented around 70% of total pharmaceutical sales in Italy, which interestingly paralleled the distribution pattern in the US, which is the leading global market (4). The Italian pharmaceutical industry association Farmindustria has also noted a recent rise in sales of dermatology, analgesic, ophthalmology and cough and anti-influenza products (5).


Dealing with demographics

Demographic factors will have a major impact on the make-up of the Italian pharmaceutical market in the future. Although ageing of the population is affecting healthcare policy in most countries, it is particularly relevant to Italy as the country may have one of the ‘oldest populations’ in the world by 2050 (6). This is because the country could have the highest percentage in the world of the population aged 65 and over (18.1%) and the lowest percentage of population aged 15 and below (14.1%) (6).


This scenario presents the pharmaceutical industry with both opportunities and challenges (7). On the one hand there will be increased demand for medicines to tackle conditions that predominantly affect the elderly and this will benefit companies carrying out R&D in these fields. However, in view of several economic studies that have analyzed the effect of population ageing on healthcare spending the government is likely to expand its cost containment approach to healthcare (7). For example, a 2001 study by the Organisation for Economic Co-operation and Development (OECD) found that the over-65 age group accounted for 40-50% of healthcare spending and that their per capita healthcare costs were three to five times higher than those under 65 (8). What worries policy makers is that even when based on the best data available these predictions may represent an underestimation of the future situation and so the demand from the elderly population may be higher than anticipated (7).


It is the changing nature of the demand for healthcare that has prompted the Italian authorities to develop a more proactive approach to its policies. The recent Italian Sanitary Program (Piano Sanitario Nazionale) has placed a greater emphasis on preventative measures in healthcare (6, 9). This involves educating people so that they understand how changes in their lifestyle can help them avoid serious medical conditions in the future. However, the success of such initiatives depends on the government’s ability to communicate well with the public and to involve those who provide their healthcare.


Implications for research

The leading pharmaceutical markets are also major areas for R&D and Italy is no exception. According to Invest in Italy, the country is ranked fourth in terms of life sciences R&D spending and has a well-organized network of academic and private institutions involved in research projects (10).  As a result of Italy’s National Health Plan, which prioritizes disease areas such as cancer and cardiovascular disease, over 250 research projects were approved in 2004 and these were valued at over €60 million. Italy’s emphasis on an industrial application of this medical research provides an incentive for a range of pharmaceutical and biotech companies to become involved.


Italy is already an important location for clinical trials, with about 600 studies being carried out each year in a variety of therapeutic areas, and its popularity is likely to increase. In particular, as the target population for new medicines in future therapeutic areas will often be the elderly then clinical trials will need to reflect this important part of the population (7). At present, there are a number of reports that highlight how the elderly remain under-represented in clinical trials. In the US, one study found that although patients over the age of 65 accounted for 60% of all cancer cases, only around 36% of this age group participated in clinical trials (11). Cancer Research UK has highlighted similar concerns and believes that this makes it difficult to determine best practice for the growing numbers of elderly patients (12). Thus, the profile of Italy’s population makes the country an ideal location for clinical trials in order to improve this situation. However, much will depend on the industry’s abilities to communicate with the local medical community and patients to encourage their involvement in these types of clinical trials.



Italy represents an attractive market for the pharmaceutical industry, because despite the government’s efforts to slow healthcare spending by targeting pharmaceuticals there will inevitably be an increase in the demand for new medicines. The pharmaceutical industry’s challenge is how best to show that use of their products will help Italy meet its healthcare targets in the long term. The country also represents a vibrant environment for industry research but this will require companies to demonstrate to the medical community and patients that their projects have relevance to the healthcare needs of the population.




1.        Anon (2005). “The Pharmaceutical Industry in Figures”, European Federation of Pharmaceutical Industry Associations (EFPIA).

2.        Anon (2005). Pharma spending drives budgets for OECD countries. Scrip World Pharmaceutical News. 23 November 2005. No. 3109. p18.

3.        Kermani F. (2000). Global Pharmaceutical Pricing: Strategic Issues and Practical Guidelines. Urch Publishing.

4.        Anon (2005). IMS Retail drug Monitor. 12 Months to August 2005.

5.        Anon (2004). Indicatori Farmaceutici. Farmindustria.

6.        Maroni R (2002). Statement by Italy at the Second World Assembly on Ageing; Madrid, Spain. 8th-12th April 2002.

7.        Kermani F (2005). Ageing And Healthcare Demand. Contract Services Europe. 1 June 2005.

8.        Hoxley H. and Jacobzone S. (2001). Healthcare expenditure : a future in question. OECD Observer. December 2001. Organisation for Economic Co-operation and Development (OECD).

9.        Anon (2005). Piano Sanitario Nazionale 2003-2005.

10.     Anon (2005). Life Sciences in Italy. Invest in Italy.

11.     Anon (2004). Elderly Under Represented In Clinical Trials. Elderly cancer patients are significantly under-represented in cancer clinical trials. PSA Rising.

  1. Anon (2004). Symptoms and treatment - Breast cancer. Cancer Research UK.

Dr Faiz Kermani

Last updated on: 27/08/2010 11:40:18

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