The global in-vitro diagnostics (ivd) market is estimated to grow at a CAGR of X% during the forecast period. Several partnerships among biopharmaceutical companies have led the development of IVD technology. For instance, in October 2017, Illumina, Inc. and Pillar Biosciences, Inc. declared an agreement for the development of next-generation sequencing (NGS) based on IVD tests. Pillar Biosciences will work toward the development of several diagnostic tests that will be run on the Illumina MiSeq Dx instrument.

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Pillar Biosciences has developed Stem Loop Inhibition Mediated Amplification (SLIMamp) which is an advanced technology to leverage the performance and efficiency of targeted NGS panels for the clinical user. The integration of MiSeqDx and SLIMamp will make NGS accessible to clinical laboratories and enable affordable precision medicine. Moreover, in May 2017, Seegene, Inc., a developer of molecular diagnostics technologies and assays, entered into a partnership with Thermo Fisher Scientific in which Seegene will file for the US FDA clearance of its Allplex diagnostic assay portfolio.

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The incorporation of Seegene's Allplex assay and Thermo Fisher's PCR System opens a new level of innovation to the market by allowing a comprehensive molecular diagnostics solution. Seegene’s advanced multiplex detection technologies coupled with Thermo Fisher's major position in instrumentation will take a strong foothold in the US market. Furthermore, in March 2018, Abionic SA has raised nearly $20.9 million in Series C financing. This is aimed at widening the Abionic’s portfolio of point-of-care IVD tests for critical care and emergency medicine.

Under this strategy, the company planned to introduce a multinational sepsis impact study of its Pancreatic Stone Protein (PSP) test for sepsis risk assessment and management. This is the only device across the globe that offers results representing an indication of sepsis in 5 minutes. There is a significant need for an accurate and rapid test that will allow treatment faster while reducing the antibiotics use when they are not required. Rising partnerships and funding opportunities for the development of IVD tests is the key trend in the global IVD market.

Furthermore, rapid growth in the IVD market across the countries, such as the US, China, Germany and India has been reported over the years. For instance, Germany is anticipated to hold the largest share in the IVD market in Europe in 2018. Germany is a home to high-tech industry and offers advanced reagents and cutting-edge instruments. The major players that offers IVD reagents in the country include Merck KGaA, Bioanalytic GmbH and Siemens AG.

In IVD products, Reagents segment held the major share in IVD products in 2018. Diagnostic reagents have significant importance in IVD tests as it is the key component that starts the reaction with the patient’s test sample. When the reagent is not of better quality, the IVD test will not provide a reliable and accurate result. Additionally, IVD reagents are major components in the special chemistry and clinical chemistry testing laboratories. Without IVD reagents, such laboratories are not able to produce the information needed for diagnosis, monitoring and treatment of patients.

The companies are expanding their portfolio of IVD reagents. For instance, in April 2019, Beckman Coulter expands the portfolio of standardized ClearLLab IVD reagents for the clinical flow cytometry lab. It is the first 100-color IVD panel of immunophenotyping reagents. It is FDA approved for both, lymphoid and myeloid lineages. It offers better quality results from dry unitized incorporation of the cluster of differentiation (CD) markers with the use of DURA Innovations dry technology of the company. Such pre-formulated antibody combinations enable laboratories to avoid the potential errors of manual antibody cocktail preparation.

By using ClearLLab 10C system, the laboratories will have an immunophenotyping tools portfolio that supports in delivering better patient outcomes for leukaemia and lymphoma (L&L) analysis in a compliant lab setting. It will not require carrying out extensive preparation, manual validation and QC tasks. These advances in IVD reagents are supporting to increase its performance and effectiveness in clinical testing applications. As a result, it can increase the efficiency of the diagnostic testing procedure, and thereby will contribute to the growth of the global IVD market.

Global IVD Market- Segmentation

By Application

Diabetes
Infectious Diseases
Cancer
Drug Testing
Autoimmune Diseases
Others (Nephrology and Cardiology)

By Product

Instruments
Reagents
Software and Services

By Technology

Immunodiagnostics
Molecular Diagnostics
Hematology
Tissue Diagnostics
Others (Clinical Chemistry and Coagulation)

By End-User

Hospitals & Clinics
Diagnostic Laboratories
Others (Academics and Research Institutions)

Global IVD Market– Segment by Region

North America

US
Canada

Europe

Germany
UK
France
Spain
Italy
Rest of Europe

Asia-Pacific

China
Japan
India
Rest of Asia-Pacific

Rest of the World

Middle East & Africa
Latin America

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