Germany Point-of-Care Sepsis Diagnostics Market Size, Share & Industry Analysis, By Product Type (Instruments and Reagents & Kits), By Technology (Molecular Diagnostics and Immunoassays), By Pathogen (Bacterial Sepsis and Fungal Sepsis), By End User (Hospitals & Clinics and Standalone Laboratories), and Country Forecast, 2024-2032

Germany point-of-care sepsis diagnostics market size was valued at USD 14.6 million in 2023. The market is expected to grow from USD 16.0 million in 2024 to USD 35.2 million by 2032, exhibiting a CAGR of 10.3% during the forecast period.

Sepsis refers to a serious and emergency health condition that occurs when the body responds to an infection in an improper manner that damages the vital organs and often leads to death. Sepsis often progresses into severe sepsis and septic shock, and early treatment can often improve patient outcomes. Several types of infection can cause sepsis. This includes bacteria, viruses, or fungi infections. The increase in the cases of bacteria and fungal sepsis increases the incidence of hospital-acquired infections, and the sepsis mortality rate and the use of medical equipment for early diagnosis in Germany have contributed to the market growth.

• For instance, according to the Robert Koch Institute, a Federal Institute within the portfolio of the Federal Ministry of Health, there are currently 21 National Reference Centers (NRCs) and 39 Consultant Laboratories (CLs), each appointed for three years. These laboratories are considered to be the national centers of excellence in laboratory science for a particular pathogen or group of pathogens.

Additionally, the increasing incidence of chronic cases leading to sepsis and improving healthcare infrastructure in Germany are driving the market expansion. Moreover, leading and regional players are working hard to promote their product portfolio through innovative product launches and strategic initiatives. Such efforts to strengthen access to various sepsis diagnostic products also bolster the market growth. In terms of the global and European point-of-care sepsis diagnostics markets, the Germany market is prominent.

The Germany market witnessed a positive impact during the COVID-19 pandemic. Patients suffering from the disease were prone to developing sepsis, leading to an increase in sepsis cases. This had a positive impact on sales of sepsis diagnostics products in Germany. The company's patient visits and revenues were expected to return to pre-pandemic growth levels in 2021 and fully normalize in 2022 and 2023. Sustained growth is expected to occur between 2024 and 2032.

Germany Point-of-Care Sepsis Diagnostics Market Trends 

Demand for Rapid and Speedy Point of Care Testing is Notable Trend

The Germany point-of-care sepsis diagnostics market has seen a notable trend in recent years in the increasing adoption of rapid diagnostics, including for sepsis. Such rapid or rapid point-of-care diagnostic methods have significantly decreased the turnaround times, standardization, and efficiency of sepsis diagnosis. Thus, the development of rapid POC diagnostic methods for early sepsis diagnosis is gaining momentum in the market. The growing acceptance of point-of-care testing is pushing companies to launch innovative product offerings.

• For instance, in August 2021, Abionic SA's Pancreatic Stone Protein (PSP) test on the abioSCOPE was certified by the BSI certification agency as complying with the European In-vitro Diagnostic Regulation (IVDR), EU 2017/746. Pancreatic Stone Protein (PSP) on the abioSCOPE is the earliest marker of sepsis, allowing for its identification up to 72 hours before the standard of care in 5 minutes. Such advancement in diagnostic technologies is expected to propel the Germany point-of-care sepsis diagnostics market trends in the future.

Germany Point-of-Care Sepsis Diagnostics Market Growth Factors

Escalating Sepsis Cases to Drive Market Growth

The increasing incidence of sepsis across various healthcare settings is the main driver of the sepsis diagnostics market in Germany. The increase in both the number and frequency of sepsis cases often leads to a significant demand for sepsis diagnostic tests in Germany. Additionally, the faster and more accurate sepsis diagnosis offered by point-of-care devices is expected to drive market growth.

• For instance, as per research published by Frontiers Media S.A. in 2022, in a retrospective, single-center observational study, routinely collected data from the patient data management system and the hospital information system were analyzed. The prospective, multicenter German incidence of severe sepsis and septic shock (INSEP) study described that 57.0% of the sepsis cases were nosocomial-associated, and, of these, 50.0% were ICU-acquired. Thus, sepsis is considered a severe infectious disease and a leading cause of death in hospitals. Such factors are expected to propel the market growth during the forecast period.

Increasing Awareness Regarding Sepsis to Boost Market Expansion

In Germany, the various national governments and private activities are actively working on spreading the knowledge of sepsis between populations. Initiatives include sepsis screening, sepsis training, evaluation of sepsis beams, and increased patient results. Rising awareness regarding sepsis is driving the market growth.

• Furthermore, in August 2020, the Sepsis Wissen (Sepsis Knowledge) project was initiated in Germany to increase the awareness of sepsis. Therefore, increasing awareness and support efforts by various government agencies and foundations are expected to boost the overall market growth.

Other Drivers:

Government Initiatives Promoting Early Detection and Treatment

Sepsis is a critical condition which can lead to death. Lack of awareness is a major reason for such incidences. For instance, according to an article published by Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB in 2019, approximately 60,000 deaths occur every year in Germany due to sepsis. Thus, such factors promoted to launch of government initiatives for early diagnosis and treatment of sepsis.

Rising Healthcare Expenditure and Infrastructure Development

Germany’s healthcare expenditure is among the highest in the European Union (EU). The increasing healthcare expenditure and investments by the government are propelling the Germany point-of-care sepsis diagnostics market growth.

Demand for Personalized Medicine:

Various bacteria and fungi strains are responsible for detecting sepsis. Detecting such strains is important for precise treatment. Such concern enhances the need for personalized medicine approaches for patients. This factor may be a lucrative growth opportunity for the market.

RESTRAINING FACTORS

Limited Number of Healthcare Professionals to Pose Limitations to Market Growth

The growing need for sepsis diagnostics is facing several critical challenges that may hinder the growth of the point-of-care sepsis diagnostics market in the coming years. In the case of sepsis, early detection and prompt treatment are essential for the patient's survival. Still, limitations such as inadequate equipment and a shortage of skilled medical professionals may adversely affect the expansion of the market.

• In October 2024, as per a recent survey conducted by the Marburger Bund North Rhine-Westphalia/Rhineland-Palatinate region, a shortage of physicians was noted. An estimated 28% of the senior physicians reported vacancies in their departments.

However, growing concerns over sepsis diagnosis and treatment are expected to drive the demand for diagnostic devices. The shortage of qualified medical professionals to perform these sepsis diagnostic protocols is restricting the market’s growth.

Other Restraints:

High Costs of POC Diagnostic Devices

Robust advances in technologies also increase the cost of diagnostic products. The high cost associated with point-of-care diagnostic analyzers restricts the market growth.

Regulatory Hurdles and Approval Processes

The European Union manages the medical device approvals in Germany. There is a long and stringent protocol for product launches in the market. Such factors restrict the market growth during the forecast period.

Competition from Traditional Laboratory-based Diagnostics

Despite the growing technological advancements, certain competition due to demand for traditional laboratory testing methods is hindering market growth. The general population commonly relies on traditional methodologies for sepsis detection. This creates huge competition among the key players providing conventional and advanced point-of-care devices.

Germany Point-of-Care Sepsis Diagnostics Market Segmentation Analysis

By Product Type Analysis

Robust Number of Sepsis Diagnostic Procedures Promotes the Reagents & Kits Segment Dominance

The Germany point-of-care sepsis diagnostics market is divided into instruments and reagents & kits, on the basis of product type.

The reagents & kits segment held the highest share due to the increasing number of sepsis cases and growing awareness of early diagnosis among the German public. The growth of this segment is also due to the large number of reagents and kits used in different techniques.

The instruments segment accounted for a prominent portion of the market. The increasing adoption of point-of-care devices boosts the growth of the segment in the market. In addition, the major players in the market cooperate with various organizations to expand their diagnostic instruments business in Germany.

• For instance, according to an article published by Frontiers Media S.A. in 2022, in a retrospective, single-center observational study, routinely collected data from the patient data management system and the hospital information system were analyzed. The prospective, multicenter German Incidence of severe sepsis and septic shock (INSEP) study described that 57.0% of the sepsis cases were nosocomial-associated, and, of these, 50.0% were ICU-acquired.

Such growing cases in various settings are expected to boost the utilization of instruments and propel segmental growth.

By Technology Analysis

Significant Product Launches by Key Players Enabled Immunoassay Segment Attained Dominant Share in 2023

The market for point-of-care sepsis diagnostics can be divided into immunoassays and molecular diagnostics, in terms of technology.

The immunoassays segment held the dominant market share in point-of-care sepsis diagnostics in Germany in 2023. Advances in research and development of immunological tests are expected to contribute to the expansion of this segment. Strategic partnerships between key players drive the market growth to launch advanced immunoassay products.

• For instance, SphingoTec GmbH launched the IB10 sphingotest bio-ADM, a CE-IVD-marked point-of-care test to regulate blood levels of Bioactive Adrenomedullin (bio-ADM) quantitatively. It is a rapid point-of-care (POC) immunoassay. The test is made available on the company`s platform Nexus IB10. It uses whole blood samples without any pre-processing, requires less than three minutes of hands-on time, and delivers results after 20 mins. Nexus IB10 can be flexibly deployed in labs or near-patient settings such as intensive care units and Emergency Departments.

The field of molecular diagnostics is expected to see an increase in activity during the specified period. These diagnostic tests offer higher accuracy, precision, and efficiency, playing a significant role in the expansion of this sector. There is a development of point-of-care molecular solutions for various bacterial and viral diseases. These factors are anticipated to support the market's expansion throughout the forecast period.

By Pathogen Analysis

Huge number of Bacterial Sepsis Cases Contributed to its Highest Share in Market

Based on pathogen, the market can be bifurcated into fungal and bacterial sepsis.

The sepsis bacterial segment owned a dominant share in 2023. The growth of the segment is attributed to the increasing incidence of bacterial sepsis and increasing awareness initiatives for the detection of bacteria responsible for sepsis.

The fungal sepsis segment holds a suitable share in the Germany point-of-care sepsis diagnostics market and is expected to expand during the forecast period. Many patients suffer from sepsis caused by fungal infections. The increasing incidence of sepsis due to fungal infections is driving the expansion of this segment. Moreover, significant number of product launches for fungal sepsis diagnosis propels the segment’s growth.

• For instance, The T2 Biosystems’s T2Candida Panel is the first and only FDA-cleared and CE-marked diagnostic test for the detection of sepsis-causing fungal pathogens directly from whole blood.

By End User Analysis

Incidence of Sepsis Among Hospitalized Patients Enabled Hospitals & Clinics Segment to Dominate Market

In terms of end user, the market can be segmented into hospitals & clinics and standalone laboratories.

The hospitals & clinics segment accounted for the maximum share of the German market in 2023. The dominance of this segment is explained by the notable prevalence of sepsis in hospitalized patients. Improved hospital infrastructure and increasing penetration of point-of-care devices are driving the development of this segment of the market.

• For instance, according to a published article by JAMA Network in 2022, a retrospective cohort study based on health claims data of AOK, a statutory health insurance provider in Germany, identified 159,684 sepsis patients and 116,507 patients who survived hospitalization. Among them, 66.8% of survivors were re-hospitalized, and 45.0% were re-hospitalized with infection (67.4% of all re-hospitalizations). Such a rising number of hospital cases is contributing to the segmental growth.

Meanwhile, independent laboratories hold the second position in the German point-of-care sepsis diagnostics market. The increase in the number of laboratories and growing demand for cost-effective sepsis treatment are expected to drive the growth of the segment.

KEY INDUSTRY PLAYERS

Strategic Partnerships and Strong Brand Presence to Foster Company’s Market Growth

In terms of a competitive landscape, the market is semi-consolidated in nature. The company bioMérieux, Inc. held a significant Germany point-of-care sepsis diagnostics market share. The robust distribution network, product offerings such as VIDAS B·R·A·H·M·S PCT, and strategic initiatives such as mergers, acquisitions, and partnerships are contributing to the company’s dominance in the Germany market.

Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd., Abbott, and Radiometer Medical ApS are also some of the other prominent players in the Germany market. Moreover, some of the emerging players have been staggering with product approvals to boost their presence in the market. These players are focusing on competitive strategies such as pricing, technology, and product distribution.

• In December 2019, Nanomix received CE Mark for its S1 Assay for the rapid, simultaneous detection and quantification of lactate (LAC), procalcitonin (PCT), and C-reactive protein (CRP) from human plasma specimens.

Case Studies

Impact of Specific Diagnostic Tools on Patient Outcomes

In Germany, a substantial number of sepsis cases has been staggering. This has led to increased efforts by key players and healthcare settings to promote specific diagnostic tools for improving patient outcomes.

• In May 2024, Bosch and Randox invest heavily in the Vivalytic analysis platform. One goal is the development of a sepsis IVD1 grade test that will be the first to feature highly innovative and novel BioMEMS technology.

Future Outlook

Potential Technological Breakthroughs to Foster Future Market Growth

The growing demand for early diagnosis has augmented various technological advancements in the market. Due to such factors, numerous startup companies are emerging with new technologies that may also include rapid sepsis diagnostics in the near future.

• For instance, according to an article published by the European Commission in 2019, Dimitris Tsiokos, a researcher at the Aristotle University of Thessaloniki and founder and CEO of Bialoom, has a Cypriot startup. This company uses optical chips that combine silicon photonic circuits, plasmonic waveguides, and microfluidics to simultaneously measure a panel of key disease indicators from just a small volume of blood.

Such advancements are expected to boost more growth opportunities during the forecast period.

List of Top Germany Point-of-Care Sepsis Diagnostics Companies:

• Abbott (U.S.)


• Thermo Fisher Scientific Inc. (U.S.)


• Radiometer Medical ApS (Danaher) (U.S.)


• bioMérieux, Inc. (France)


• DiaSorin S.p.A. (Italy)


• F. Hoffmann-La Roche Ltd. (Switzerland)


• Siemens Healthineers AG (Germany)


• Boditech Med Inc. (South Korea)


• T2 Biosystems, Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• April 2024: Deepull, a company with a presence in Germany, debuted its point of care diagnostic UIICORE system for the detection of sepsis. The UIICORE system uses a polymerase chain reaction to extract microbial DNA from a human blood sample.


• November 2023: Nagarro and Radiometer announced a partnership in the healthcare sector.


• June 2023: DiaSorin launched LIAISON B·R·A·H·M·S MR-proADM immunodiagnostic assay in all countries accepting the CE Mark. The assay improves patients’ management by providing a more precise assessment of disease severity and related risks for unfavorable outcomes.


• December 2022: bioMérieux received the CE-marking of VIDAS KUBE, the next-generation system in the VIDAS immunoassay portfolio.


• May 2022: Thermo Fisher Scientific and DiaSorin entered into a new and long-term agreement on Thermo Fisher’s biomarker testing mid-regional adrenomedullin (B·R·A·H·M·S MR-proADM).


• April 2021: PixCell Medical signed an exclusive distribution agreement with Axonlab to distribute the HemoScreen, PixCell's hematology analyzer, in key European geographies.

REPORT COVERAGE

Germany point-of-care sepsis diagnostics market report emphasizes market analysis and predictions. It focuses on major aspects such as major companies, products, technologies, pathogens, and end users. Additionally, it offers insights into market dynamics in Germany, the prevalence of sepsis, regulatory scenarios, product launches, industrial developments, and technological advancements. Additionally, the impact of COVID-19 has also been highlighted in the report.

Report Scope & Segmentation

ATTRIBUTE	DETAILS
Study Period	2019-2032
Base Year	2023
Estimated Year	2024
Forecast Period	2024-2032
Historical Period	2019-2022
Unit	Value (USD million)
Growth Rate	CAGR of 10.3% from 2024-2032
Segmentation	By  Product Type Instruments Reagents & Kits
By  Technology Molecular Diagnostics Immunoassays
By  Pathogen Bacterial Sepsis Fungal Sepsis
By End User Hospitals & Clinics Standalone Laboratories