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Summary and extracts

1 Market Overview

1.1 Definition and presentation

Medical biology laboratories (LBMs), formerly known as medical analysis laboratories (MLAs), are places whose function is to perform medical diagnosis and monitoring based on samples of various human biological fluids. They are run by biologists.

The market for medical biology laboratories can be segmented according to the presence or absence of certification, inspection, testing and accreditation of the laboratories themselves.

In 2024 the world market for clinical testing laboratories is estimated at 277.$96 billion. Moderate growth in the industry is expected in the near future. For the period 2024-2029 a compound annual growth rate is estimated (CAGR) of 6.49 percent, under which the market could reach a total value of more than 380 billion dollars.

In Italy there are about 37,870 people working within the nearly 10,000 laboratories in the territory.

The difference between accredited and non-accredited laboratories also falls in turnover. The growth rate of turnover is much higher in accredited entities. In addition, accredited laboratories are considered much more efficient and with higher labor productivity.

it is important to consider the positive contribution that the medical biology laboratory industry makes to the development of the National Health Service. This industry has significant rates of investment in research and innovation, which are fundamental to the development of Italy's healthcare and economy.

The largest biomedical center can be found in Mirandola (Emilia Romagna). Northern Italy is in general the area where companies and turnover in this market are most concentrated. In Central Italy, most of the laboratories are concentrated in Lazio and Tuscany, while as far as Southern Italy is concerned we notice a smaller presence in general except for Campania, Puglia and Sicily.

This type of industry is extremely important at the healthcare level, and this was also demonstrated by the recent Covid-19 pandemic, which exposed all the flaws in the system and reiterated how necessary it is to invest in research and scientific innovation in order to increase the speed and accuracy of the medical tests that these laboratories perform.

1.2 The Global Market

In ****, the world market for clinical testing laboratories is estimated at $***.** billion. Moderate growth in the industry is expected in the near future. A compound annual growth rate (***) of *.**% is estimated for the period ****-****, under which the market could reach a total value of more than $*** billion by the end of the period.

Clinical testing laboratory market World, ****-****, in billions of dollars MordorIntelligence

The European Market

Europe presents a rather broad landscape of medical biology laboratories. There are many differences between countries. These differences are reflected in health care systems and the divergence in health care spending by European country.

An EM consulte article provides a typology of health care systems in Europe:

The Bismarckian system based on wages; The Beveridgian system financed by taxes; Mixed models Private and legalized systems.

Health spending as a percentage of GDP

In ****, the average expenditure of EU member countries was **.* percent of GDP. In particular, the highest values are in Germany, France and Austria, with expenditure shares of **.*%, **.*% and **.*% of GDP, respectively. Italy's spending as a ratio of GDP is lower than the European average, standing at *.* percent in ****.

Dépenses de santé des pays de l'UE Europe, ****, en % du PIB du ...

1.3 The Italian Market

A total of *,*** outpatient/laboratory type health facilities were surveyed in Italy in ****: *,*** facilities are public while *,*** are private facilities accredited to the National Health System. As a result, there are an estimated *.* public laboratories per ***,*** inhabitants and *.* accredited private laboratories per ***,*** inhabitants. In terms of laboratories alone, in **** there are an estimated *,*** public laboratories and *,*** private laboratories and accredited to the National Health System. Breakdown of Clinical Laboratories between Private and Public Italy, ****, in number of laboratories Source: ****

As for healthcare spending, this has been growing strongly for years in Italy with an increase of **.* percent between **** and ****, and an expected growth, also accomplice to new public funding projects, of * percent in * years. of the total national healthcare spending, only *.*% is allocated to laboratory medicine, which has been continuously shrinking over the years. A total of *.** billion was allocated to this type of service in ****.

Trend in National Health System Financing Italy, **** - *****, in billions of euros Source: ****

1.4 Impact of Covid

Testing laboratories have been at the center of the global pandemic. it is clear that they have not been overly affected by the crisis, benefiting from both the continuity of business even during containment and the increased demand for Covid-** testing.

There are several testing laboratories that, indeed, saw their revenues increase during the emergency and until, partially, the introduction of do-it-yourself Covid tests. One example is the Italian companyCopan. The company had begun developing flocked swabs, used during the pandemic to trace Covid, in ****. However, the pandemic greatly increased the company's turnover, *** million in ****, more than double that of ****. After increasing production, Copan now has the capacity to produce * billion per year. Net income nearly quintupled in ****, to $** million, on sales of $*** million. It surpassed that figure in ****, with sales growing to $*** million.** percent of Copan'ssales come from flocked swabs, which have been used in at least one billion molecular tests conducted in doctors' offices and clinics around the world since the pandemic began. A figure that does not include swabs for rapid testing or home kits, which are a small fraction of Copan's business.

Still, the crisis has generated tensions over supplies. There are two types of laboratory ...

2 Demand analysis

2.1 The main drivers of demand

Several drivers can drive the demand for private clinics in Italy. We can find two main categories, demographic characteristics of the Italian population and income characteristics .

The age distribution andmedian age of the Italian population are also important factors to consider in order to better understand this market and its customers.

The Italian population is composed of about ** million people, distributed in ** regions (***), under the significant effect of declining birth rates and increasing life expectancy, which has led to an increase in the percentage life expectancy of people aged ** or older to **.*%.

Italian population distribution Italy, ****-****, as a percentage of population Source: ****

At the income level, Italian households have an average income between ** and ** thousand euros, depending on the number of members. The income one is an important aspect, given the high costs of private health care. Despite this, more and more people are deciding to allocate part of their resources to private healthcare. In ****, **% of total spending on healthcare went to private facilities, a figure that for the first time decreased from the previous year due to the blocks imposed by Covid. (***). In total, in ****, spending on healthcare accounted for *.* percent of total Italian household spending on consumeri.

Evolution ...

2.2 Geographic Distribution of Demand

In total, the number of laboratory tests in Italy in **** was *.** billion, up **.*% from ****. Compared with the pre-pandemic period, the number of laboratory analyses performed increased by **.*% (***).

Number of clinical biological and chemical analyses, by year Italy, **** - ****, in millions of analyses Source: ****

Regarding the geographical distribution of analyses performed in ****, Lombardy tops the national ranking with ***.* million analyses (***).

3 Market structure

3.1 Market Structure

In order to analyze the structure of the laboratory market, active enterprises under Ateco Code **.**.* "Clinical analysis laboratories, X-ray laboratories and other diagnostic imaging centers" are analyzed. In particular, trends in the number of active enterprises and the number of employees as well as the legal form of different activities are analyzed.

Number of enterprises

Between **** and ****, the total number of active enterprises under Ateco Code **.**.* increased. During the period analyzed, the total number of enterprises increased from *,*** to *,***, marking an increase of *.* percent. However, while between **** and **** the trend is negative (***).

Active enterprises under Ateco Code **.**.* "Clinical analysis laboratories, radiographic laboratories and other diagnostic imaging centers" Italy, ****-****, in number Istat

Employees The total number of employees also shows a positive trend between **** and ****. During the period analyzed, the total number of employees increased from **,*** to **,***, representing an increase of **.* percent. In contrast to the previous case, between **** and ****, the trend in the number of employees is stagnant between **** and **** and rising sharply between **** and **** (***). Employment in enterprises active under Ateco Code **.**.* "Clinical analysis laboratories, radiographic laboratories and other diagnostic imaging centers" Italy, ****-****, in thousands Istat Legal form Finally, regarding the legal form of different businesses, **.*% are sole proprietorships ...

3.2 The main actors

A list of the main players active in the medical biology laboratory sector is proposed below:

Synlab Italia s.r.l: founded in ****, represents one of the main players in the medical testing and diagnostic services sector in Italy. Part of the Synlab Group, a European leader in medical diagnostics, the company offers a wide range of laboratory tests and advanced diagnostic services, ranging from laboratory medicine to diagnostic imaging. With an unwavering commitment to innovation and quality, Synlab Italia stands out for the efficiency of its services, guaranteeing reliable and timely results to both patients and healthcare professionals. The network of laboratories and diagnostic centers scattered throughout the country allows Synlab Italia to be close to the needs of the population, contributing significantly to the progress of public health in the country.

C.D.C s.p.a: founded in **** in Milan, Italy, is positioned as one of the most prestigious companies in the field of medical diagnostics in Italy. The company has built its reputation on the excellence of its services, which include a wide range of state-of-the-art laboratory tests and diagnostic services. Specializing in clinical biochemistry, microbiology, genetics and diagnostic imaging, C.D.C. S.p.A. has ...

3.3 Geographic Distribution

Regarding the geographic distribution of medical biology laboratories, in **** Campania, Lazio, and Sicily top the national ranking with a total of ***, ***, and *** laboratories, respectively. They are followed by Puglia (***).

4 Supply analysis

4.1 Breakdown of medical biology expenses by pathology

Nearly **% of laboratory expenses are general expenses not related to a specific disease. These are routine care, analgesic treatments, occasional hospitalizations, etc. As for the rest of the expenditures, cardiovascular disease and cancer are the largest items with *.*% and *.*% of total expenditures, respectively.

These observations are logical, since the focus of the activity is on establishing diagnoses, so it is normal that most of the analyses are not related to a particular disease

Répartition des dépenses de biologie médicale selon la pathologie France, ****, en % * : ou traitement antalgique ou anti-inflammatoire ** : avec ou sans pathologies, traitements ou maternité *** : maladies respiratoires chroniques (***). Source: ****

4.2 The different types of Laboratories

Two types of laboratories can be distinguished in the market:

Routine biology laboratories

Nonspecialized laboratories are the most prevalent in the area. Their role is to meet the classic demand for medical analysis. These laboratories are often clustered around technical platforms. A place that collects equipment shared by different health institutions, they carry out diagnostic investigations of clinical biochemistry, hematology and microbiology on samples from human excreta, secretions and samples according to the list attached to these regulations, and no methods using radioisotopes are to be employed. The minimum staffing of basic general laboratories consists of:

*) a director; *) an employee with a degree in medicine, biology or chemistry; *) a laboratory technician who meets the requirements of current regulations including the transitional rules provided for in Article **, Regional Law No. */**** or a graduate in biological sciences; *) an auxiliary and/or outside firm for cleaning; *) an administrative worker.

The basic general laboratories must possess the following technical equipment and with the following characteristics :

workbenches suitable for the type and workload; chemical fume hood with extractor fan if staining is performed or irritating products are used; - cabinets for suitable storage of glassware and reagents; two centrifuges; deionizer/distiller or availability of a ...

5 Regulations

5.1 Regulation

In Paragraph ***, Article * of Law No. ***/****, Finance Act ****, laboratory medicine activities are defined as follows : The activity of laboratory medicine provides information obtained by chemical, physical or biological methods on tissues or fluids of human origin or on materials related to human pathology, for the purpose of prevention, diagnosis, monitoring of therapy and the course of disease and for the purpose of research. The types of services performed in the different laboratories and the instrumental equipment have a different degree of complexity commensurate with the health reality and the type of diagnostic questions posed to the laboratory. Therefore, the following types of laboratories are identified: *. Laboratory with territorial value: in the event that there are Territorial Hospital Presidiums with inpatient activities within the Health Authority and that the transport time to the reference facility is incompatible with the care needs, an emergency laboratory activity must be guaranteed, in which diagnostic activities are carried out for defined and shared panels of examinations. These peripheral nodes of the "Network Laboratories," need light and integrated technologies, on which the largest number of tests performed is consolidated, and technical personnel, with telematic connection within a corporate "Single Logical Laboratory." These laboratories carry out the work ...

6 Positioning of actors

6.1 Segmentation

  • Synlab Italia s.r.l
  • C.D.C s.p.a
  • Bianalisi s.p.a
  • Unione Sanitaria Internazionale s.p.a
  • Eurofins Genoma Group s.r.l
  • Synlab Sdn s.r.l

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