×
Request Free Sample ×

Kindly complete the form below to receive a free sample of this Report

* Please use a valid business email

Leading companies partner with us for data-driven Insights

clients tt-cursor
Hero Background

Italy Biomarker Test Market

ID: MRFR/MED/54581-HCR
200 Pages
Rahul Gotadki
October 2025

Italy Biomarker Test Market Research Report By Application (Oncology, Cardiovascular, Neurology, Infectious Diseases, Metabolic Diseases), By Type of Test (Genetic Tests, Proteomic Tests, Metabolomic Tests, Microbiomic Tests), By Technology (Polymerase Chain Reaction, Mass Spectrometry, Immunoassays, Next-Generation Sequencing) and By End Use (Hospitals, Clinical Laboratories, Research Institutions, Pharmaceutical Companies)-Forecast to 2035

Share:
Download PDF ×

We do not share your information with anyone. However, we may send you emails based on your report interest from time to time. You may contact us at any time to opt-out.

Italy Biomarker Test Market Infographic
Purchase Options

Italy Biomarker Test Market Summary

As per MRFR analysis, the biomarker test market size was estimated at 783.0 USD Million in 2024. The biomarker test market is projected to grow from 812.44 USD Million in 2025 to 1175.0 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 3.76% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The Italy biomarker test market is poised for substantial growth driven by technological advancements and increasing demand for personalized medicine.

  • Technological advancements are enhancing the accuracy and efficiency of biomarker tests in Italy.
  • The largest segment in the market is oncology, while the fastest-growing segment is cardiovascular biomarkers.
  • Regulatory support is fostering innovation and facilitating market entry for new biomarker tests.
  • Increasing demand for personalized medicine and advancements in diagnostic technologies are key drivers propelling market growth.

Market Size & Forecast

2024 Market Size 783.0 (USD Million)
2035 Market Size 1175.0 (USD Million)
CAGR (2025 - 2035) 3.76%

Major Players

Roche Diagnostics (CH), Abbott Laboratories (US), Thermo Fisher Scientific (US), Agilent Technologies (US), Bio-Rad Laboratories (US), Qiagen (DE), Illumina (US), PerkinElmer (US), Merck KGaA (DE)

Italy Biomarker Test Market Trends

The biomarker test market in Italy is currently experiencing notable growth, driven by advancements in personalized medicine and an increasing emphasis on early disease detection. The integration of innovative technologies, such as next-generation sequencing and liquid biopsy, is enhancing the accuracy and efficiency of biomarker tests. This evolution is likely to improve patient outcomes and streamline healthcare processes. Furthermore, the Italian healthcare system is progressively adopting these tests, reflecting a shift towards more tailored treatment approaches. Regulatory frameworks are also evolving to support the development and commercialization of biomarker tests, which may further stimulate market expansion. In addition, the rising prevalence of chronic diseases in Italy is contributing to the demand for biomarker tests. As healthcare providers seek to implement more effective diagnostic tools, the focus on biomarkers is becoming increasingly pronounced. The collaboration between research institutions and the pharmaceutical industry is fostering innovation in this field, potentially leading to the discovery of new biomarkers that could revolutionize disease management. Overall, the biomarker test market appears poised for continued growth, with various factors indicating a robust future.

Technological Advancements

The biomarker test market is witnessing rapid technological advancements, particularly in areas such as genomics and proteomics. These innovations are enhancing the precision of tests, allowing for more accurate disease diagnosis and monitoring. The adoption of advanced technologies is likely to drive the development of novel biomarkers, which could lead to improved patient care.

Regulatory Support

Regulatory bodies in Italy are increasingly recognizing the importance of biomarker tests in clinical practice. This support is manifesting through streamlined approval processes and guidelines that facilitate the introduction of new tests into the market. Such regulatory frameworks may encourage investment and innovation in the biomarker test sector.

Rising Chronic Disease Incidence

The growing incidence of chronic diseases in Italy is significantly influencing the biomarker test market. As healthcare providers aim to enhance diagnostic accuracy and treatment efficacy, the demand for biomarker tests is expected to rise. This trend underscores the critical role of biomarkers in managing complex health conditions.

Italy Biomarker Test Market Drivers

Advancements in Diagnostic Technologies

Technological innovations in diagnostic tools are significantly influencing the biomarker test market. In Italy, the introduction of advanced imaging techniques and high-throughput screening methods has enhanced the accuracy and efficiency of biomarker tests. For instance, the market has seen a surge in the use of next-generation sequencing (NGS) technologies, which facilitate the identification of genetic markers associated with various diseases. This advancement is expected to contribute to a market growth of around 12% over the next few years. As diagnostic capabilities improve, the biomarker test market is likely to expand, providing healthcare professionals with more reliable tools for disease detection and monitoring.

Rising Awareness of Preventive Healthcare

The increasing awareness of preventive healthcare is driving the biomarker test market in Italy. As the population becomes more health-conscious, there is a growing inclination towards early detection and prevention of diseases. This trend is supported by public health campaigns that emphasize the importance of regular health screenings and biomarker testing. Consequently, the biomarker test market is witnessing a surge in demand for tests that can identify risk factors and facilitate timely interventions. It is estimated that the market could experience a growth rate of around 8% as more individuals seek proactive health management solutions.

Increasing Demand for Personalized Medicine

The growing emphasis on personalized medicine is a pivotal driver for the biomarker test market. In Italy, healthcare providers are increasingly adopting biomarker tests to tailor treatments to individual patient profiles. This shift is evidenced by a projected growth rate of approximately 10% annually in the adoption of personalized therapies. As patients seek more effective and targeted treatment options, the demand for biomarker tests is likely to rise. Furthermore, the integration of biomarker testing into clinical practice enhances patient outcomes, thereby reinforcing its importance in the healthcare landscape. The biomarker test market is thus positioned to benefit from this trend, as healthcare systems prioritize precision medicine to improve therapeutic efficacy and reduce adverse effects.

Growing Investment in Research and Development

Investment in research and development (R&D) is a crucial driver for the biomarker test market. In Italy, both public and private sectors are channeling substantial funds into R&D initiatives aimed at discovering new biomarkers and enhancing existing tests. This trend is reflected in the increase of R&D expenditure, which has reached approximately €1 billion in recent years. Such investments not only foster innovation but also facilitate collaborations between academic institutions and industry players. The biomarker test market stands to gain from these developments, as new discoveries can lead to the introduction of novel tests that meet the evolving needs of healthcare providers and patients.

Supportive Government Policies and Initiatives

Supportive government policies and initiatives play a vital role in shaping the biomarker test market. In Italy, the government has implemented various programs aimed at promoting the development and adoption of biomarker tests. These initiatives include funding for research projects and incentives for healthcare providers to integrate biomarker testing into routine practice. Such policies are likely to enhance the accessibility and affordability of biomarker tests, thereby expanding the market. The biomarker test market is expected to benefit from these supportive measures, as they create a conducive environment for innovation and growth.

Market Segment Insights

By Application: Oncology (Largest) vs. Cardiovascular (Fastest-Growing)

In the Italy biomarker test market, Oncology holds a significant share, primarily due to the increasing prevalence of cancer and advancements in targeted therapies. The demand for precise diagnostic tools and personalized medicine in Oncology continues to rise, solidifying its position as the largest segment. Conversely, the Cardiovascular segment is experiencing rapid growth, driven by rising awareness of cardiovascular diseases and the increasing adoption of biomarker tests for early detection and management. The growth trends for these segments illustrate a shift towards more specialized diagnostics. The Oncology segment benefits from continuous innovation in biomarker discovery and validation, while Cardiovascular research focuses on improving patient outcomes and reducing risks associated with heart diseases. Enhanced healthcare policies and the integration of biomarker tests into clinical practice support the expansion of both segments, presenting significant opportunities for market players.

Oncology: Dominant vs. Cardiovascular: Emerging

Oncology is characterized by its established dominance in the Italy biomarker test market, stemming from strong investments in cancer research and a consistent pipeline of groundbreaking diagnostic solutions. The segment is fueled by comprehensive screening programs and a robust framework for regulatory approvals. In contrast, the Cardiovascular segment is emerging rapidly, driven by innovations in non-invasive testing and a better understanding of cardiovascular risks. This segment appeals to patients seeking earlier detection methods and healthcare providers aiming to enhance treatment protocols. Both segments are critical, but Oncology currently leads in market presence, while Cardiovascular is poised for substantial growth due to evolving healthcare demands and increased focus on chronic disease management.

By Type of Test: Genetic Tests (Largest) vs. Microbiome Tests (Fastest-Growing)

In the Italy biomarker test market, the distribution of market share among the types of tests reveals that genetic tests dominate significantly, commanding a majority share due to their well-established applications in personalized medicine and disease management. Following behind are proteomic tests, which account for a moderate portion of the market, while metabolomic and microbiome tests are gaining traction, with the latter experiencing a surge in interest driven by advancements in gut health research. Growth trends in this segment are largely influenced by technological innovations and increased awareness regarding the role of biomarkers in disease diagnosis and treatment. Genetic tests continue to lead due to their precision and reliability, attracting significant investment. Conversely, microbiome tests are emerging rapidly, fueled by a growing understanding of the microbiome's impact on health, making them the fastest-growing segment.

Genetic Tests (Dominant) vs. Microbiome Tests (Emerging)

Genetic tests have firmly established their position in the Italy biomarker test market as the dominant choice for clinicians and researchers alike. Their utility in tailoring patient-specific treatment plans and identifying genetic predispositions to diseases underlines their importance. On the other hand, microbiome tests are emerging as a pivotal area of focus, driven by increasing research into the gut microbiome's influence on metabolic and immune health. While genetic tests benefit from robust clinical validation and regulatory approval, microbiome tests are still in the innovative stages but show immense potential for expansion as scientific evidence supporting their relevance continues to grow.

By Technology: Polymerase Chain Reaction (Largest) vs. Next-Generation Sequencing (Fastest-Growing)

In the Italy biomarker test market, Polymerase Chain Reaction (PCR) technology holds a significant market share, attributed to its robust application in genetic testing and infectious disease diagnostics. Mass Spectrometry and Immunoassays follow, showcasing their essential roles in protein analysis and hormone level detection respectively. Next-Generation Sequencing (NGS) is emerging rapidly, driven by its comprehensive genomic mapping capabilities, although currently, its share is lesser than PCR but growing swiftly. The growth trends within the technology segment are significantly influenced by advancements in diagnostic capabilities and an increasing focus on personalized medicine. The demand for quicker and more accurate testing methods is propelling innovations in NGS, enhancing its presence in the market. Factors such as rising healthcare investments, increasing awareness regarding early disease detection, and the expansion of applications in cancer diagnostics are driving the adoption of these technologies in the Italy biomarker test market.

Technology: PCR (Dominant) vs. NGS (Emerging)

PCR is a dominant technology in the Italy biomarker test market due to its speed, efficiency, and accuracy in amplifying DNA sequences for various diagnostics. It serves as a cornerstone in the detection of pathogens and genetic disorders, making it a preferred choice among laboratories. On the other hand, Next-Generation Sequencing is emerging as a transformative force. Although it lags behind PCR in market share, its capacity for high-throughput genomic analysis places it at the forefront of personalized medicine. The expanding applications of NGS in oncology and hereditary disease are expected to drive its growth, making it a focal point for future investments in the sector.

By End-Use: Hospitals (Largest) vs. Clinical Laboratories (Fastest-Growing)

In the Italy biomarker test market, the end-use segment is primarily dominated by hospitals, which hold a substantial share thanks to their comprehensive diagnostic services and the increasing number of patients requiring biomarker testing. Clinical laboratories follow closely, benefiting from their pivotal role in providing specialized testing and supporting hospital operations. Research institutions and pharmaceutical companies constitute smaller portions of the market but are essential for driving innovation and development in biomarker applications and therapies. Growth trends in this segment are significantly influenced by advancements in healthcare technology, increasing disease prevalence, and a growing emphasis on personalized medicine. Hospitals are expanding their biomarker test offerings to improve patient outcomes, while clinical laboratories are rapidly adapting to meet rising demand. Research institutions are increasingly collaborating with pharmaceutical companies to develop new biomarker tests, contributing to the market's dynamic nature and fostering innovative solutions that address emerging healthcare needs.

Hospitals (Dominant) vs. Clinical Laboratories (Emerging)

Hospitals represent the dominant force in the end-use segment of the Italy biomarker test market, characterized by their extensive infrastructure, access to diverse patient populations, and comprehensive diagnostic capabilities. They typically offer a wide range of biomarker tests that cater to various medical conditions, thereby ensuring a steady demand for these tests. In contrast, clinical laboratories are emerging as vital players, specializing in biomarker testing and delivering rapid results to support clinical decisions. Their ability to provide services to multiple healthcare facilities makes them increasingly important, particularly as the demand for diagnostic accuracy and speed in patient care grows. The collaboration between hospitals and clinical laboratories further enhances the efficiency and effectiveness of biomarker testing services.

Get more detailed insights about Italy Biomarker Test Market

Key Players and Competitive Insights

The biomarker test market in Italy is characterized by a dynamic competitive landscape, driven by advancements in precision medicine and an increasing emphasis on personalized healthcare. Key players such as Roche Diagnostics (CH), Abbott Laboratories (US), and Thermo Fisher Scientific (US) are at the forefront, leveraging their extensive research capabilities and innovative product portfolios. Roche Diagnostics (CH) focuses on integrating digital health solutions into its biomarker testing, enhancing diagnostic accuracy and patient management. Abbott Laboratories (US) emphasizes strategic partnerships to expand its reach in the Italian market, while Thermo Fisher Scientific (US) is investing heavily in R&D to develop next-generation biomarker assays. Collectively, these strategies foster a competitive environment that prioritizes innovation and technological advancement.

In terms of business tactics, companies are increasingly localizing manufacturing and optimizing supply chains to enhance operational efficiency. The market structure appears moderately fragmented, with several players vying for market share. However, the influence of major companies is substantial, as they set industry standards and drive technological advancements. This competitive structure encourages smaller firms to innovate and differentiate their offerings, thereby contributing to a vibrant market ecosystem.

In October 2025, Roche Diagnostics (CH) announced a collaboration with a leading Italian university to develop novel biomarker tests for early cancer detection. This partnership is strategically significant as it not only enhances Roche's research capabilities but also positions the company as a leader in the burgeoning field of oncology diagnostics. The collaboration is expected to yield innovative solutions that could redefine patient care in Italy.

In September 2025, Abbott Laboratories (US) launched a new biomarker test aimed at improving cardiovascular disease diagnosis. This introduction is crucial as it addresses a pressing healthcare need in Italy, where cardiovascular diseases remain a leading cause of mortality. Abbott's focus on this area reflects its commitment to enhancing patient outcomes through targeted diagnostics, potentially increasing its market share in the region.

In August 2025, Thermo Fisher Scientific (US) expanded its Italian operations by opening a new facility dedicated to biomarker research and development. This expansion is indicative of the company's long-term strategy to bolster its presence in Europe and underscores its commitment to innovation. The facility is expected to accelerate the development of cutting-edge biomarker tests, further solidifying Thermo Fisher's competitive position in the market.

As of November 2025, current trends in the biomarker test market include a pronounced shift towards digitalization, sustainability, and the integration of artificial intelligence (AI) in diagnostic processes. Strategic alliances are increasingly shaping the competitive landscape, enabling companies to pool resources and expertise. Looking ahead, competitive differentiation is likely to evolve, with a greater emphasis on innovation and technology rather than price-based competition. Companies that can reliably deliver advanced solutions while optimizing their supply chains will likely emerge as leaders in this rapidly evolving market.

Key Companies in the Italy Biomarker Test Market market include

Industry Developments

Recent developments in the Italy Biomarker Test Market have highlighted significant advancements and collaborations among major companies. In August 2023, Roche announced a partnership with the European Diagnostics Group to expand its biomarker testing portfolio in Italy, improving precision medicine capabilities in oncology. Additionally, in July 2023, Thermo Fisher Scientific revealed plans to enhance its genomic testing capacity in Italy by investing in state-of-the-art facilities, reflecting the growing demand for advanced diagnostic solutions.

The market is witnessing strong growth, with companies like Agilent Technologies and Siemens Healthineers pushing for innovative solutions to meet healthcare needs.Furthermore, in May 2023, QIAGEN acquired a local diagnostics firm aimed at boosting its offering in liquid biopsy technologies, showcasing a trend of consolidation among key players in the market.

The growth in market valuation has been supported by regulatory approval of various biomarker tests, aligning with the Italian government's focus on expanding precision medicine initiatives. In recent years, milestones such as the launch of several new biomarker tests by Illumina and BioRad Laboratories have also contributed to the dynamic landscape, driving advancements in diagnostic accuracy and patient outcomes.

Future Outlook

Italy Biomarker Test Market Future Outlook

The Biomarker Test Market in Italy is projected to grow at a 3.76% CAGR from 2024 to 2035, driven by advancements in precision medicine, increased R&D investments, and rising demand for personalized healthcare solutions.

New opportunities lie in:

  • Development of point-of-care biomarker testing devices for rapid diagnostics.
  • Expansion of biomarker-based companion diagnostics partnerships with pharmaceutical companies.
  • Implementation of AI-driven data analytics platforms for biomarker discovery and validation.

By 2035, the biomarker test market is expected to achieve substantial growth, reflecting evolving healthcare needs.

Market Segmentation

Italy Biomarker Test Market End-Use Outlook

  • Hospitals
  • Clinical Laboratories
  • Research Institutions
  • Pharmaceutical Companies

Italy Biomarker Test Market Technology Outlook

  • Polymerase Chain Reaction
  • Mass Spectrometry
  • Immunoassays
  • Next-Generation Sequencing

Italy Biomarker Test Market Application Outlook

  • Oncology
  • Cardiovascular
  • Neurology
  • Infectious Diseases
  • Metabolic Diseases

Italy Biomarker Test Market Type of Test Outlook

  • Genetic Tests
  • Proteomic Tests
  • Metabolomic Tests
  • Microbiome Tests

Report Scope

MARKET SIZE 2024 783.0(USD Million)
MARKET SIZE 2025 812.44(USD Million)
MARKET SIZE 2035 1175.0(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR) 3.76% (2024 - 2035)
REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR 2024
Market Forecast Period 2025 - 2035
Historical Data 2019 - 2024
Market Forecast Units USD Million
Key Companies Profiled Roche Diagnostics (CH), Abbott Laboratories (US), Thermo Fisher Scientific (US), Agilent Technologies (US), Bio-Rad Laboratories (US), Qiagen (DE), Illumina (US), PerkinElmer (US), Merck KGaA (DE)
Segments Covered Application, Type of Test, Technology, End-Use
Key Market Opportunities Advancements in personalized medicine drive demand for innovative biomarker test solutions in the healthcare sector.
Key Market Dynamics Rising demand for personalized medicine drives innovation and competition in the biomarker test market.
Countries Covered Italy

Leave a Comment

FAQs

What is the projected market size of the Italy Biomarker Test Market in 2024?

The Italy Biomarker Test Market is expected to be valued at 783.0 million USD in 2024.

What is the anticipated market value of the Italy Biomarker Test Market by 2035?

By 2035, the market is projected to reach 1304.0 million USD.

What is the expected CAGR for the Italy Biomarker Test Market from 2025 to 2035?

The CAGR for the Italy Biomarker Test Market during the period from 2025 to 2035 is anticipated to be 4.746%.

Which application is expected to dominate the Italy Biomarker Test Market in 2024?

Oncology is expected to dominate the market with a value of 350.0 million USD in 2024.

What is the expected market size for the Cardiovascular segment in 2035?

The Cardiovascular segment is projected to reach a market size of 250.0 million USD by 2035.

How much is the Neurology segment of the Italy Biomarker Test Market valued at in 2024?

The Neurology segment is valued at 100.0 million USD in the year 2024.

What are the major players in the Italy Biomarker Test Market?

Key players include Beckman Coulter, Agilent Technologies, Siemens Healthineers, and Roche among others.

What is the market value for the Infectious Diseases segment in the year 2035?

The Infectious Diseases segment is expected to be valued at 130.0 million USD in 2035.

What is the projected market size for Metabolic Diseases in 2024?

The Metabolic Diseases segment is projected to be valued at 103.0 million USD in 2024.

What significant market trends can be anticipated in the Italy Biomarker Test Market?

Key trends include increasing adoption of biomarker tests in oncology and cardiovascular applications driven by advancements in technology.

Download Free Sample

Kindly complete the form below to receive a free sample of this Report

Compare Licence

×
Features License Type
Single User Multiuser License Enterprise User
Price $4,950 $5,950 $7,250
Maximum User Access Limit 1 User Upto 10 Users Unrestricted Access Throughout the Organization
Free Customization
Direct Access to Analyst
Deliverable Format
Platform Access
Discount on Next Purchase 10% 15% 15%
Printable Versions