Europe Molecular Diagnostics Market by Product (Reagents & Kits, Systems, Software), Test Type (Lab, PoC), Technology (PCR, INAAT, Sequencing, Microarray), Application (Infectious Diseases, Oncology), End User (Hospital, Diagnostic Lab) - Forecast to 2030

The Europe Molecular Diagnostics Market is projected to reach $13.25 billion by 2030, at a CAGR of 4% from 2024 to 2030. Molecular diagnostics is a branch of medical and clinical laboratory science that involves the detection, identification, and measurement of specific genetic or molecular markers within a person's biological samples (e.g., blood, tissue, or other bodily fluids) to diagnose and monitor diseases, predict disease risk, and guide treatment decisions. It is a rapidly evolving field that has revolutionized the way various diseases are diagnosed and managed.

The growth of this market is driven by factors such as technological advancements in molecular diagnostics, the increasing use of PoC diagnostic tests, an increase in funding for the R&D of diagnostic products, the rising geriatric population, and the increasing prevalence of target diseases. However, unfavorable regulatory framework and cost of molecular diagnostic tests hamper the growth of this market to a notable extent. Additionally, developments in companion diagnostics are expected to offer significant growth opportunities for the players operating in the molecular diagnostics market. However, the dearth of skilled professionals is a challenging factor for the market.

Technological Advancements in Molecular Diagnostics

The healthcare landscape is constantly changing due to innovations in medical technologies. In recent years, companies have been focused on developing advanced diagnostic kits that can yield faster results than traditional kits. These advanced kits allow healthcare providers and caregivers to make crucial medical decisions promptly. For instance, companies have been developing ultra-fast PCR kits to minimize the time required to generate test results. For instance, in February 2021, Eurofins Technologies (Luxembourg) launched the GSD Nova Prime SARS-CoV-2 Direct RT-PCR kit for the qualitative detection of SARS-CoV-2 from human nasopharyngeal swabs. The GSD Nova Prime SARS-CoV-2 Direct RT-PCR kit shortens the complete turnaround time of the test, providing results in approximately one hour without compromising accuracy, allowing for a higher processing capacity.

Integrating digital technologies in clinical and ambulatory settings helps improve doctors’ and physicians’ ability to reach an initial diagnosis. Also, the digitalization of diagnostic services helps document and analyze patient data and test results, which minimizes human error and makes treatment and care pathways more consistent. Hence, an increasing number of healthcare providers are adopting digitally compatible diagnostic systems and devices to store patient data and view patients’ medical histories instantly. There are advanced digitalized molecular diagnostics products; for instance, in August 2022, F. Hoffmann-La Roche (Switzerland) launched its digital PCR system, Digital LightCycler System. The system accurately quantifies trace amounts of specific DNA and RNA targets that are not typically detected by the conventional PCR method. Hence, technological advancements drive the Europe Molecular Diagnostic Market.

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Increasing Focus on Companion Diagnostics Creates an Opportunity for the Europe Molecular Diagnostics Market

Companion molecular diagnostics measure the levels of proteins, genes, or specific mutations to reveal specific and effective therapies for an individual’s condition. Companion diagnostics (CDx) is a form of personalized, stratified, and precision medicine that individualizes a patient’s treatment. CDx has expanded from oncology drugs to multiple therapeutic areas, and the number of combinations has grown significantly over the years. Also, personalized medicine for infectious diseases helps to orient the molecular management of infections. Molecular microbiology offers technologies that can detect and identify microorganisms rapidly. Determining the pharmacogenetic profiles of patients suffering from infectious diseases provides an additional assessment of the drug metabolizer phenotype and/or of the risk of potential adverse drug interactions. Personalized medicine is thus expected to help develop new therapies and new methods for disease detection.

European companies in this market are collaborating for the development and commercialization of CDx due to the growth potential of companion diagnostics. This will help the companies expand their product portfolios and strengthen their presence across regions. For instance, in April 2022, AstraZeneca plc (U.K.) and Amoy Diagnostics Co., Ltd. (China) signed a collaboration agreement for multiple companion diagnostics programs in China, Japan, and the European Union. Also, in September 2021, Merck KGaA (Germany) and Illumina, Inc. (U.S.) partnered to develop and commercialize companion diagnostic tests to identify genetic mutations in patients with HRD-positive tumors who are eligible for the PARP inhibitor targeted treatment.

Key Findings of the Europe Molecular Diagnostics Study:

In 2024, the Kits & Reagents Segment is Expected to Dominate the Europe Molecular Diagnostics Market

Among the products & services included in the report, in 2024, the reagents & kits segment is expected to account for the largest share of the Europe molecular diagnostics market. Factors such as frequent and repetitive use of molecular diagnostic reagents & kits, availability of disease-specific kits for the early diagnosis of chronic and infectious diseases, and technological advancements in molecular diagnostics contribute to the segment’s largest share.

In 2024, the Laboratory Tests Segment is Expected to Dominate the Europe Molecular Diagnostics Market

Among the test types included in the report, in 2024, the laboratory tests segment is expected to account for the largest share of the Europe molecular diagnostics market. Lab testing is the traditional approach in which the clinician takes a sample from the patient and sends it to the laboratory for processing and testing. The laboratory technicians conduct the processing and testing and create a report for the clinician. The laboratory testing approach for molecular diagnostics has many advantages over other approaches. It has higher accuracy and reliability when compared to point-of-care testing, owing to which the adoption is more compared to PoC tests.

In 2024, the Polymerase Chain Reaction (PCR) Segment is Expected to Dominate the Europe Molecular Diagnostics Market

Among the technologies included in the report, in 2024, the polymerase chain reaction (PCR) segment is expected to account for the largest share of the Europe molecular diagnostics market. PCR allows rapid amplification of a specific segment of DNA. This technology is sensitive and thus helps in the diagnosis of diseases. It is effective for low-number targets and less expensive than other technologies, such as sequencing. Hence, the huge demand for PCR devices further contributes to the segment’s largest share.

In 2024, the Infectious Diseases Segment is Expected to Dominate the Europe Molecular Diagnostics Market

Among the applications included in the report, in 2024, the infectious diseases segment is expected to account for the largest share of the Europe molecular diagnostics market. The large market share of this segment is attributed to the rising incidence rates of infectious diseases and the increase in initiatives by government organizations toward their prevention by early diagnosis. In the U.K., the number of people diagnosed with sexually transmitted infections (STIs) reached 490.1 thousand in 2020 from 468.3 thousand in 2019. Thus, the growing burden of infectious diseases drives the demand for molecular diagnostics for infectious diseases.

In 2024, the Hospitals & Clinics Segment is Expected to Dominate the Europe Molecular Diagnostics Market

Among the end users included in the report, in 2024, the hospitals & clinics segment is expected to account for the largest share of the Europe molecular diagnostics market. The high number of hospitals and clinics, the high prevalence of healthcare-associated infections (HAIs), and the increasing healthcare expenditure worldwide are driving the demand for molecular diagnostics products in the region. In Europe, several factors driving the growth in the genomic sector increase the adoption of molecular diagnostic products. For instance, the establishment of national programs or pan-European programs, such as the “1+ Million Genomes” initiative, which involves 23 countries across Europe and aims to improve the uptake of genomics by healthcare systems and in personalized healthcare.

Germany: Fastest-growing Country-level Market

Based on geography, Germany is slated to record the highest growth rate during the forecast period. The market growth in Germany is attributed to the well-established healthcare system, the rise in healthcare spending, the rising incidence of chronic diseases, the aging population, efforts by the German Government to further improve the quality of healthcare, research for the development of new technologies, and a high number of patients suffering from hospital-acquired infections. According to GLOBOCAN, in 2020, 628,519 new cancer cases and 252,065 cancer deaths were reported in Germany. The cancer incidence rate is estimated to increase to 749,559 by 2040. Additionally, according to the Robert Koch Institute (Germany), an estimated 400,000–600,000 patients get hospital-acquired infections every year, of which 10,000–15,000 succumb to these infections. Thus, the high burden of chronic and infectious diseases is driving the demand for molecular diagnostics in Germany.

Key Players

The key players profiled in this market study are F. Hoffmann-La Roche Ltd (Switzerland), Hologic, Inc. (U.S.), QIAGEN N.V. (Netherlands), Danaher Corporation (U.S.), bioMérieux S.A. (France), Becton, Dickinson and Company (BD) (U.S.), Siemens Healthineers AG (Germany), DiaSorin S.p.A. (Italy), Abbott Laboratories (U.S.), Thermo Fisher Scientific Inc. (U.S.), Agilent Technologies, Inc. (U.S.), and Illumina, Inc. (U.S.).

Scope of the Report:

Europe Molecular Diagnostics Market Assessment, by Product & Service

• Kits & Reagents
• Instruments/Systems
• Software & Services

Europe Molecular Diagnostics Market Assessment, by Test Type

• Laboratory Tests
• PoC Tests

Europe Molecular Diagnostics Market Assessment, by Technology

• Polymerase Chain Reaction (PCR)
• In Situ Hybridization (ISH)
• Isothermal Nucleic Acid Amplification Technology (INAAT)
• Microarrays
• Mass Spectrometry
• Sequencing
• Other Technologies
  (Note: Other Technologies include electrophoresis, southern blotting, northern blotting, and ligase chain reaction (LCR))

Europe Molecular Diagnostics Market Assessment, by Application

• Infectious Diseases
  • COVID-19
  • Hepatitis
  • HIV
  • Healthcare-associated Infections (HAIs)
  • Chlamydia trachomatis/ Neisseria gonorrhoeae (CT/NG)
  • Human papillomavirus (HPV)
  • Tuberculosis
  • Influenza
  • Other Infectious Diseases
    (Note: Other infectious diseases include meningococcal disease; norovirus (stomach flu); tropical diseases; hand, foot, and mouth disease (HFMD); and pertussis)
• Oncology
  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Prostate Cancer
  • Lymphoma
  • Leukemia
  • Cervical Cancer
  • Other Cancer Types
    (Note: Other cancer types include bladder cancer, melanoma, kidney cancer, stomach cancer, ovarian cancer, thyroid cancer, and chest cancer)
• Genetic Testing
• Neurological Diseases
• Cardiovascular Diseases
• Other Applications
  (Note: Other applications include pharmacogenomics, forensic testing, environmental studies, educational study purposes, human & microorganism genomic research studies, and food & beverages testing.)

Europe Molecular Diagnostics Market Assessment, by End User

• Hospitals & Clinics
• Diagnostic Laboratories
• Academic & Research Institutes
• Other End Users
  (Note: Other end users include blood banks, ambulatory care centers, nursing homes, home care facilities, self-testing, the food & beverage industry, and forensic and environmental testing laboratories.)

Europe Molecular Diagnostics Market Assessment, by Geography

• Germany
• France
• U.K.
• Switzerland
• Ireland
• Belgium
• Italy
• Spain
• Rest of Europe (RoE)

Key questions answered in the report: