Diagnostic reagents and certified reference materials market in Czechia

Earlier Report Observations

The Czech market for diagnostic reagents and certified reference materials saw its value rise from 142.1 million US dollars in 2018 to 234.1 million in 2021. This expansion was primarily driven by regulatory preparations at the EU level. The implementation of the Medical Devices Regulation (MDR, Regulation (EU) 2017/745) in May 2020 introduced stricter requirements for manufacturers, including those for in vitro diagnostics, initiating a transition period. Market activity further intensified in 2021 as companies prepared for the upcoming In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746), scheduled to take full effect in May 2022.

A pivotal shift occurred in 2022 when the IVDR entered into force on 26 May, replacing the previous directive. The new framework imposed a stricter risk-based classification system, unique device identification (UDI), and enhanced post-market surveillance requirements. This regulatory tightening caused temporary market disruption, contributing to a contraction in the market's value to 167.9 million dollars that year. Concurrently, Czech authorities enacted Law No. 375/2022 to transpose the IVDR and prepared price control measures, capping annual price increases for medical devices at 8% from the start of 2023.

In the subsequent years of 2023 and 2024, the market adapted to the new regulatory environment. The full implementation of Czech legislation, including Price Decree No. 1/2023/OLZP, took effect in January 2023. Despite the regulatory adjustments, the market's value recovered to 221.0 million dollars by 2024. In physical terms, market volume stabilized at approximately 3 700 t after a peak in 2022. Further legislative fine-tuning continued with Amendment No. 241/2024, reflecting the ongoing evolution of the regulatory landscape for in vitro diagnostics in the Czech Republic.

Production diagnostic reagents and certified reference materials in Czechia

In value, 2018-2021, K $ US

Production of diagnostic reagents and certified reference materials in Czechia has grown for the third year in a row. In 2021, the output was valued at 50 137 thousand US dollars, marking a 32.9% increase compared to the previous year. From 2018 to 2021, production rose by 72.1%, which translates to an average annual growth rate of 19.8%.

Annual dynamics of production in Czechia in value, 2018-2021, K $ US

In kind, 2018-2021, t

In 2021, Czechia produced 2 125 tonnes of diagnostic reagents and certified reference materials, showing little change from the year before. Over the period from 2018 to 2021, production increased by 88.1%, with a compound annual growth rate of 23.4%.

Annual dynamics of production in Czechia in kind, 2018-2021, t

Exports diagnostic reagents and certified reference materials from Czechia

Exports in kind, t

In 2021, Czechia exported 3 495 tonnes of diagnostic reagents and certified reference materials, a 58.6% increase compared to the previous year. Between 2018 and 2021, exports grew by 68.5%, averaging an annual rate of 19.0%. The largest decline occurred in 2020, at 3.3%.

Annual dynamics of product's exports from Czechia in kind, 2018-2021, t

From 2018 to 2021, exports of diagnostic reagents and certified reference materials from Czechia were widely distributed across partner countries. Poland accounted for 14.1% of exports in kind, Slovakia for 12.4%, and Russia for 9.8%, together making up only 36.4% of total flows.

Structure of product's exports in kind by countries, 2018-2021

World map of product's exports from Czechia in kind, 2018-2021

Exports in value, M $ US

Czechia's exports of diagnostic reagents and certified reference materials have increased for the third consecutive year. In 2021, exports reached 174.2 million US dollars, a sharp rise of 69.1% from the previous year. Between 2018 and 2021, exports surged by 136.9%, with an average annual growth rate of 33.3%.

Annual dynamics of product's exports from Czechia in value, 2018-2021, M $ US

Data from 2018 to 2021 show that exports in value terms of diagnostic reagents and certified reference materials from Czechia were not heavily concentrated on a few key destinations. Slovakia represented 21.9% of exports in value terms, Germany 14.7%, and Poland 13.1%, jointly accounting for 49.7% of total flows.

Structure of product's exports in value by countries, 2018-2021

World map of product's exports from Czechia in value, 2018-2021

Imports diagnostic reagents and certified reference materials to Czechia

Imports in kind, t

In 2021, imports of diagnostic reagents and certified reference materials into Czechia totalled 4 936 tonnes, a sharp increase of 45.2% compared to 2020. Over the period from 2018 to 2021, imports grew by 33.4%, with a compound annual growth rate of 10.1%. The lowest volume was recorded in 2020 at 3 398 tonnes, which also saw the largest decline of 9.5%.

Annual dynamics of product's imports to Czechia in kind, 2018-2021, t

From 2018 to 2021, Germany was the main source of imports in kind for Czechia, accounting for 45.6%, followed by Hungary at 10.9% and China at 8.7%. Together, these three countries made up 65.2% of total imports in kind.

Structure of product's imports in kind by countries, 2018-2021

World map of product's imports to Czechia in kind, 2018-2021

Imports in value, M $ US

Imports of diagnostic reagents and certified reference materials into Czechia have risen for the second year in a row. In 2021, imports amounted to 358.1 million US dollars, up by 50.5% from the previous year. Between 2018 and 2021, imports increased by 92%, averaging an annual growth rate of 24.3%. The lowest value was in 2019 at 185.1 million US dollars, which also experienced the largest decline of 0.7%.

Annual dynamics of product's imports to Czechia in value, 2018-2021, M $ US

From 2018 to 2021, the United States accounted for the largest share of imports in value terms at 22.1%, followed by Germany at 21.2% and China at 10.0%. Together, these three countries comprised 53.3% of total import flows.

Structure of product's imports in value by countries, 2018-2021

World map of product's imports to Czechia in value, 2018-2021