Diagnostic reagents and certified reference materials market in Italy

Earlier Report Observations

The Italian market for diagnostic reagents expanded in physical volume from 13 847 t in 2018 to 21 677 t in 2020. This growth was supported by the EU regulatory framework governing in-vitro diagnostic quality and safety, which provided market stability. The presence of major multinational players like Thermo Fisher Scientific and Abbott Laboratories fostered innovation and investment. In 2020, domestic production capacity was directly strengthened by Diesse Diagnostica's investments in automation 4.0, workforce expansion, and new high-containment biological research laboratories, contributing to a significant surge in market volume.

Market volume experienced fluctuations between 2021 and 2023, reaching a peak of 29 756 t in 2022 before declining to 19 561 t in 2023. Underlying this volatility was a structural shift in demand towards molecular diagnostics and immunodiagnostics for infectious diseases, cancer, and autoimmune conditions, which sustained market value. The adoption of reagent and instrument leasing models altered cost structures for laboratories. Simultaneously, the increased uptake of Point-of-Care Testing (POCT) systems and the integration of digital AI solutions began transforming testing distribution and efficiency, influencing volume patterns.

In 2024, the market volume stabilized at 20 495 t. A key development was the start of construction on Diesse Diagnostica's largest Italian diagnostic laboratory in Monteriggioni, representing a major infrastructure investment exceeding €20 million with advanced automation. Continued stringent regulation on product quality and traceability, coupled with persistent demand for autoimmune and molecular diagnostic reagents, formed the core market context. A growing preference for sustainable consumables also aligned with environmental norms.

Production diagnostic reagents and certified reference materials in Italy

In value, 2017-2020, M $ US

Italy's production of diagnostic reagents and certified reference materials has increased for the third consecutive year. In 2020, output was valued at 396.8 million US dollars, marking a sharp rise of 40.8% compared to 2019. Over the period from 2017 to 2020, production grew by 67%, with a compound annual growth rate of 18.6%.

Annual dynamics of production in Italy in value, 2017-2020, M $ US

In kind, 2017-2020, t

Italy's production of diagnostic reagents and certified reference materials has increased for the third consecutive year. In 2020, 10 656 tonnes were produced, up by 29.7% year-on-year. From 2017 to 2020, production rose by 76.8%, with a compound annual growth rate of 20.9%.

Annual dynamics of production in Italy in kind, 2017-2020, t

Exports diagnostic reagents and certified reference materials from Italy

Exports in kind, t

In 2020, shipments of diagnostic reagents and certified reference materials from Italy to abroad totalled 7 916 tonnes, showing a moderate drop of 3.9% year-on-year. Between 2017 and 2020, exports decreased by 8.5%, equating to an annualized rate of 2.9%. The lowest volume was recorded in 2018 at 7 915 tonnes, with the largest decline of 8.5% occurring that year. In contrast, the largest increase of 4.0% was seen in 2019.

Annual dynamics of product's exports from Italy in kind, 2017-2020, t

From 2017 to 2020, exports in kind of diagnostic reagents and certified reference materials from Italy were distributed across numerous markets. Russia accounted for 11.2% of exports, Germany for 11.1%, and Spain for 8.2%, with these three countries together representing only 30.5% of total flows.

Structure of product's exports in kind by countries, 2017-2020

World map of product's exports from Italy in kind, 2017-2020

Exports in value, M $ US

Exports of diagnostic reagents and certified reference materials from Italy have increased for the third consecutive year. In 2020, exports reached 709 million US dollars, a sharp improvement of 39.6% compared to 2019. Over the period from 2017 to 2020, exports grew by 53.6%, with a compound annual growth rate of 15.4%.

Annual dynamics of product's exports from Italy in value, 2017-2020, M $ US

During 2017–2020, exports in value terms of diagnostic reagents and certified reference materials from Italy were spread across many markets. Germany accounted for 15.6% of exports, Spain for 11.5%, and the United Kingdom for 8.6%, with these three countries jointly making up only 35.7% of total flows.

Structure of product's exports in value by countries, 2017-2020

World map of product's exports from Italy in value, 2017-2020

Imports diagnostic reagents and certified reference materials to Italy

Imports in kind, t

The volume of diagnostic reagents and certified reference materials imported by Italy has increased for the second consecutive year. In 2020, imports amounted to 18 937 tonnes, which is 18.7% higher than the previous year. Between 2017 and 2020, imports decreased by 3.4%, equating to an annualized rate of 1.2%. The lowest volume was recorded in 2018 at 15 265 tonnes, with the largest decline of 22.2% occurring that year.

Annual dynamics of product's imports to Italy in kind, 2017-2020, t

Throughout 2017–2020, Germany, the United States, and France formed the key group of partners for imports in kind of diagnostic reagents and certified reference materials to Italy. Germany accounted for 43.4% of imports, the United States for 14.5%, and France for 8.2%, with these three countries together representing 66.2% of total flows.

Structure of product's imports in kind by countries, 2017-2020

World map of product's imports to Italy in kind, 2017-2020

Imports in value, M $ US

Italy imported 1 946 million US dollars worth of diagnostic reagents and certified reference materials in 2020, representing a sharp increase of 62.2% from the previous year. Between 2017 and 2020, imports increased by 67.3%, equating to an annualized rate of 18.7%. The largest decline was recorded in 2019 at 2.8%.

Annual dynamics of product's imports to Italy in value, 2017-2020, M $ US

From 2017 to 2020, Germany, the United States, and the Netherlands formed the main group of destinations for imports in value terms of diagnostic reagents and certified reference materials to Italy. Germany accounted for 26.9% of imports, the United States for 17.4%, and the Netherlands for 10.1%, with these three countries together accounting for 54.4% of total flows.

Structure of product's imports in value by countries, 2017-2020

World map of product's imports to Italy in value, 2017-2020