Italy In Vitro Diagnostics (IVD) Market Overview

The Italy in vitro diagnostics market was valued at USD 4,361.79 million in 2022 and is projected to decline to USD 3.74 billion by 2030, registering a negative CAGR of -1.90% from 2023 to 2030. This decline is primarily attributed to the sharp reduction in demand for IVD products related to COVID-19 detection, which had significantly boosted market size during the pandemic years.

Despite this downturn, several factors are expected to support market activity. The increasing prevalence of chronic diseases in Italy and substantial investments by key industry players in research and development (R&D) are likely to stimulate demand for innovative diagnostic technologies. For example, in April 2021, DiaSorin, an Italian diagnostic test manufacturer, acquired molecular testing firm Luminex for approximately USD 1.8 billion.

The rising incidence of various medical conditions such as cancer, autoimmune disorders, cardiovascular diseases, and inflammatory illnesses further underscores the demand for diagnostic solutions. According to Globocan, Italy recorded around 415,269 new cancer cases and approximately 174,759 deaths in 2020. The most commonly diagnosed cancers include breast, prostate, colorectal, lung, and bladder cancer. Additionally, data from the International Diabetes Federation indicated that around 4.4 million adults in Italy were living with diabetes as of 2022. Contributing factors include unhealthy diets, tobacco and alcohol use, obesity, and sedentary lifestyles.

Regulatory changes are also expected to shape the market's future. In September 2022, Italy updated its national regulatory framework for IVD products to enhance safety standards. Further, in September 2021, Italy partnered with France to distribute the LoopDeeLab device, capable of detecting COVID-19 infections within 45 minutes using RT-LAMP molecular biology techniques.

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Favorable government initiatives, universal healthcare coverage, and a robust pharmaceutical and biotechnology sector are also likely to boost the adoption of advanced IVD solutions. For example, in August 2022, DIESSE Diagnostica Senese entered a distribution agreement with Grifols to offer its Promonitor assay portfolio, enabling biological drug monitoring through ELISA and point-of-care platforms.

Technological advancements focusing on higher accuracy, cost efficiency, and portability are poised to propel market growth. In April 2020, Arrow Diagnostics signed an agreement with the Italian government to supply the Allplex SARS-CoV-2 Assay, capable of detecting five genes including coronavirus genes. Furthermore, in November 2022, the company was selected to supply diagnostic reagents to the Tuscany regional government.

Key Market Trends & Insights

• Product Segment:
  The reagent segment held the largest market share at 64.18% in 2022 and is expected to maintain its dominance. Growth in this segment is driven by the availability of advanced reagents, rising demand for high-tech diagnostics, and strong portfolios from local players like Adaltis S.r.l.
• Technology Segment:
  Molecular diagnostics accounted for 40.39% of market revenue in 2022, bolstered by increasing demand for point-of-care solutions, ongoing product innovations, and widespread interest in infectious disease detection.
• Application Segment:
  The infectious diseases segment led the market in 2022 due to a high burden of diseases such as hepatitis, pneumonia, HIV, and tuberculosis. Strategic partnerships and new product launches continue to strengthen this segment.
• End-use Segment:
  The core lab segment dominated with 27.6% revenue share in 2022, supported by a high volume of testing in hospitals, clinics, and diagnostic centers. Factors like technological integration and cost efficiency are further driving this segment's growth.

Market Size & Forecast

• Market Size (2022): USD 4,361.79 Million
• Projected Market Size (2030): USD 3.74 Billion
• CAGR (2023–2030): -1.90%

Key Players & Strategic Initiatives

Leading companies are pursuing strategies such as partnerships, acquisitions, and product launches to enhance their market presence. Notable examples include:

• MeMed Diagnostics and DiaSorin partnering in September 2020 to commercialize a test differentiating between viral and bacterial infections.
• DiaCarta Inc collaborating with Arrow Diagnostics for the distribution of its ColoScape test in Italy.

Prominent players in the Italian IVD market include:

• F. Hoffmann-La Roche Ltd
• Abbott
• bioMérieux SA
• Danaher
• QIAGEN
• BD
• Sysmex Corporation
• DiaSorin S.p.A.
• The Menarini Group
• SENTINEL CH. SpA
• Quidel Corporation

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Conclusion

While the Italy in vitro diagnostics market is projected to contract due to reduced reliance on COVID-19 testing, the broader landscape remains optimistic. The rising burden of chronic and infectious diseases, coupled with regulatory reforms, government initiatives, and ongoing innovation, is expected to partially offset this decline. Strategic partnerships and technological advancements will play a key role in shaping the market’s future trajectory. Despite a negative CAGR, the IVD sector in Italy will continue to hold strategic importance in the nation’s healthcare ecosystem, particularly in enabling timely and accurate disease diagnosis.