Summary

The global in vitro diagnostics (IVD) market, estimated at $97.12 billion in 2023, is on a trajectory of sustained growth with a projected compound annual growth rate (CAGR) of 7.1% from 2024 to 2030, potentially reaching over $156 billion. The European market, valued at $25.36 billion in 2022, is also expected to grow, albeit at a slower CAGR of 2.2% through 2028, potentially reaching $28.90 billion. The COVID-19 pandemic significantly impacted the market, with a spike in spending on diagnostic medical devices, and without COVID-19 diagnostic tools, the market would have seen a decline.

Analysis of the In Vitro Diagnostics Market Demand in Italy

The demand for in vitro diagnostic (IVD) devices in Italy has been experiencing significant growth, a trend that's projected to continue for the coming years. This rise in demand is reflected by the numbers, with the Italian IVD market valued at approximately $3.19 billion in 2022 and expected to see an increase to around $5.05 billion by 2030. The annual growth rate (CAGR) is estimated at nearly 6% during the period from 2023 to 2030. A major driver of this upsurge in demand was the Covid-19 pandemic, which led to a remarkable boost in the market due to the need for diagnostic tests. However, it is worth noting that if Covid-19 diagnostic tools were excluded, the market would have shown a decline of approximately 5%. The Italian demographics play a crucial role in shaping the IVD market with an aging population where around 24% are aged 65 or older as of 2023. This indicates a higher propensity for diseases associated with old age, increasing the need for diagnostics. Furthermore, the most common ailments in this demographic, including hypertension, arthrosis, and heart disease, are typically monitored and diagnosed using IVD technology. Preventive health measures are also gaining traction among Italians, with most of the population actively seeking information on health and prevention—a number that has nearly doubled since 2016. This rise in health awareness is expected to result in continued demand for diagnostic services and devices. From the supply side, Italy's IVD market is complemented by a robust manufacturing sector with over 4,500 companies, employing more than 110,000 people. The industry demonstrates an innovative and specialized profile with ongoing growth in the number of enterprises, particularly in the manufacturing of medical devices for IVD. The distribution channels for IVD in Italy include hospitals, analysis laboratories, and pharmacies. The hospitals show a declining trend in number, yet the laboratories and private pharmacies reflect growth, suggesting a shifting landscape in diagnostic service provision. The regulatory landscape in Italy and the broader European Union has undergone substantial changes with the introduction of the In Vitro Diagnostic Medical Devices Regulation (IVDR). This new framework is expected to influence market dynamics by restructuring the classification of IVD devices based on risk and impacting the processes for conformity assessments and market placement. In terms of market segmentation, the IVD market comprises various offerings which include devices intended for high individual and public health risks to self-diagnostic tests.

the in vitro diagnostics market - Italy

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Number of pages : 30 pages
Format : Digital and PDF versions
Last update : 14/03/2024

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Summary and extracts

1 Market Overview

1.1 Definition and presentation

In vitro diagnostics are an essential part of health care, which can provide critical information at every stage of the patient's journey, from prognosis, screening, diagnosis, monitoring disease progression, and predicting treatment responses, contributing to the available medical information regarding a patient, enabling early and targeted treatments, and helping to reduce hospital stays and convalescence, and improving the well-being of the general public.
it has been estimated that the results of in vitro diagnostic tests influence up to 70 percent of clinical decisions, while accounting for only 0.8 percent of total health care expenditures.
In vitro diagnostic medical devices (IVDs) can consist of devices (e.g., reagent equipment kits) that are simple or of sophisticated technology to perform assays on samples taken from the human body (e.g., blood, urine, saliva, and tissues taken by biopsy). They can be used in different settings ranging from Testing Laboratories, to the home environment for self-tests (e.g., glucose meters) that can be used directly by the patient (lay user).

In 2023 the global in vitro diagnostic (IVD) market is estimated at 97.$12 billion. Sustained growth of the industry is expected in the near future. For the period 2024-2030 a compound annual growth rate is estimated (CAGR) of 7.1 percent under which the global market could reach a total value of more than 156 billion dollars.As for the European market, this reached a value of $25.36 billion in 2022.

This study focuses on the specific in vitro diagnostic (IVD) market in Italy, analyzing consumption trends, competitive dynamics, and growth prospects for the sector. For information on related markets, such as medical biology laboratories, see the specific studies available in the Businesscoot catalog.

2 Demand analysis

3 Market structure

4 Supply analysis

5 Regulations

6 Positioning of actors

List of charts

In vitro diagnostic (IVD) market
In vitro diagnostic (IVD) market
Medical device sector, breakdown by type of activity
Detected expenditure on in vitro diagnostic medical devices
In vitro diagnostic (IVD) market
Italian market growth between 2019 and 2020 with and without Covid diagnostic tools
Sectors that suffered the most damage during the Covid pandemic
Health Expenditure of EU Countries
SSN Expenditure
Public vs. private spending on health care
Evolution Population aged 65 and older, percent of total population
Most prevalent diseases in Italy, by age group
Percentage of Italians doing prevention
Where Italians search for medical information
Preventive examinations carried out voluntarily by Italians
Medical device manufacturing firms by type
IVD diagnostic device manufacturing enterprises
Medical device manufacturing clerks
Evolution of number of hospitals in Italy
Private pharmacies in Italy
Medical testing laboratory enterprises and employees
Producer price index for the manufacture of medical instruments and supplies
Consumer price index for laboratory investigations
Import - export products under HS Code 3822 "Diagnostic or laboratory reagents on any medium, prepared diagnostic or laboratory reagents, whether or not presented in kit form"
Main countries of export destination of products under HS Code "Diagnostic or laboratory reagents on any medium, prepared diagnostic or laboratory reagents, including those presented in kit form"
Main countries of origin of import of products under HS Code "Diagnostic or laboratory reagents on any medium, prepared diagnostic or laboratory reagents, whether or not presented in kit form"

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Companies quoted in this study

This study contains a complete overview of the companies in the market, with the latest figures and news for each company. :

Diasorin s.p.a

Instrumentation Laboratory s.p.a

A. Menarini Diagnostics s.r.l

Ortho-Clinical Diagnostics Italy s.r.l

Cepheid s.r.l

DIESSE Diagnostica Senese s.p.a

D.I.D Diagnostic International Distribution s.p.a

Euroimmun Italia s.r.l

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