Summary

The Germany In-Vitro Diagnostic Market was valued at USD 3,709.12 million in 2020, and it is expected to reach USD 5,264.97 million by 2026, registering a CAGR of 5.63%, during the period of 2020-2026.

In Germany, due to the COVID-19 pandemic, the demand for in-vitro diagnostic products is increasing such as a sharp rise in demand for polymerase chain reaction (PCR), and next-generation sequencing (NGS), serology based rapid-test products, the supportive regulatory landscape for product development and commercialization, and a rapid rise in target patient population which is expected to boost the market growth. Moreover, these factors have allowed the market players to improve and strengthen their current manufacturing and distribution capabilities as well as to focus on product commercialization and upgrades.

For instance, in February 2020, Altona Diagnostics GmbH (Germany) also launched the RealStar SARS-CoV-2 RT-PCR Kit 1.0 for detecting the coronavirus using PCR. Thus, this increase in newer diagnostic kits will boost the adoption of in-vitro diagnostics, thereby providing lucrative opportunities for the growth of the in-vitro diagnostics market in the upcoming years.

In addition, in June 2020, CENTOGENE partnered exclusively with Lufthansa and with Fraport to offer First Walk-In COVID-19 Testing Facility to passengers flying to and from Frankfurt Airport (FRA) in Germany.

Some of the factors that are driving the market growth in Germany inlcude increasing number of private hospitals and independent testing laboratories and increasing demand for point-of-care testing and personalized medicine. Moreover, Germany is the biotechnology hub due to presence of many pharmaceutical and biotechnology companies which will be the major contributing factor for the market growth in the Germany.

Also, the factors such as the rising number of cases of chronic diseases, increasing aging population, increasing demand for accurate diagnosis, and favorable government initiatives will also the driving factor for the growth of in-vitro diagnostics market in Germany. For instance, according to the GLOBOCAN report of 2020, about 628,519 new cases of cancer were diagnosed in 2020 in Germany. The breast and colorectum cancer were more prevalent in females while in male prostate and lung cancer were more prevalent in the country.

In addition, as per the report published by International Diabetes Federation in 2020, the prevalence rate of diabetes in adults of Germany was 15.3% and the total number of diabetes (both type 1 and type 2) diagnosed in adults was 9,510,500.

Innovative developments in the IVD field are currently driven by four major trends: point-of-care testing, automation, digitalization, and the concept of personalize medicine. Also, factors contributing to the growth of market include rapid increase in the infectious disease population, technological advances, rapidly aging population, and advent of point of care diagnostics. For instance, as per the report published in 2019, HIV outcomes: Beyond Viral Suppression, there were around 86,000 people in Germany were living with HIV whereas around 20% of the diseased population were living in Berlin. The high burden of these infectious diseases are expected to boost the demand for in-vitro diagnostics tests in this region.

The market players are adopting various strategies such as product launches, developments, collaborations and expansions to increase market share. For instance, In January 2019, Qiagen, a German company, announced the development of a range of next-generation systems for digital polymerase chain reaction (digital PCR or dPCR), one of the fastest-growing molecular testing applications, in the life sciences industry. However, factors limiting the growth of the market are a lack of proper reimbursement policies and cumbersome regulatory framework.

Key Market Trends

Molecular diagnostic segment dominates the Germany In-Vitro Diagnostics Market

Molecular diagnostics are used to analyze biological markers in the genome and proteome to detect pathogens or mutations.

The article “Mass Spectrometric Identification of SARS-CoV-2 Proteins from Gargle Solution Samples of COVID-19 Patients, published by Christian Ihling, Charles Tanford Center, Halle, Germany, published in 2020, stated that Mass spectrometry delivered valuable diagnostic data that complement genomic information and allow to increase the current knowledge of the COVID-19 disease caused by the SARS-CoV-2 virus. Such studies in the region using mass spectrometer increase the awareness and demand for these devices.

Nucleic acid amplification technology for molecular diagnostics is the gold standard method for the detection of viruses and has been increasingly adopted. The market players are constantly focusing on the product launches based on nucleic acid amplification and product development strategies for COVID-19. For instance, in May 2021, XPhyto Therapeutics Corp. has announce that its distribution, storage and logistics partner, Max Pharma GmbH, launched the sale of its 25-minute SARS-CoV-2 (COVID-19) RT-PCR test system (“Covid-ID Lab”) in Germany.

In May 2021, in Germany, Seegene Germany GmbH is taking part in the government's Back-to-School program called the "Lolli-Test," a starting point in returning our daily lives back to normalcy. Under the program, Seegene Germany GmbH will be supplying COVID-19 diagnostic tests to laboratories, in business with the federal government, worth up to 19.3 million Euros.

On the basis of technology used, molecular diagnostic devices can be segmented into chips and microarrays, mass spectroscopy, next-generation sequencing (NGS), polymerase chain reaction (PCR)-based methods, cytogenetics, and molecular imaging. Molecular diagnostics has emerged as one of the largest and fastest growing sectors of the in-vitro diagnostics industry in Germany. This development is fueled by the introduction of powerful techniques, such as real-time polymerase chain reaction (PCR) and next generation sequencing (NGS), which allow the amplification and decoding of genetic and epigenetic information.

Initiatives in strategies such as new product development, collaborations, acquisitions and funding in research and development are adopted by key players to secure their positions in Germany market. For instance, in March 2021, German company ZytoVision GmbH entered into distribution agreement with Bio SB for the distribution of line ZytoVision of CE-approved chromogenic in situ hybridization and fluorescent in situ hybridization probes targeted for use in lung carcinomas. Hence, owing to above mentioned factors it is expected to drive the segment growth over the forecast period.

Competitive Landscape

The Germany In-Vitro Diagnostics market is fragmented competitive. The market has rapidly evolved over the last few years. Industry observed significant changes in adoting market strategies such as product developments, mergers and acquisitions in recent years. Thus, the Germany In-Vitro Diagnostics market has become a very competitive industry. Major companies in the market are Qiagen N.V., Siemens Healthcare GmbH, Epigenomics Inc., Abbott Laboratories, F. Hoffmann-La Roche Ltd, among others.

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Table of Contents

1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rapid Increase in Chronic Diseases Coupled with Increasing Demand for Point-of-Care Testing and Personalized Medicine
4.2.2 Increasing Number of Private Hospitals and Independent Testing Laboratories
4.3 Market Restraints
4.3.1 Stringent Regulations Coupled with Cumbersome Reimbursement Procedures
4.4 Porter's Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION
5.1 By Test Type
5.1.1 Clinical Chemistry
5.1.2 Molecular Diagnostics
5.1.3 Immuno Diagnostics
5.1.4 Hematology
5.1.5 Other Test Types
5.2 By Product
5.2.1 Instruments
5.2.2 Reagents
5.2.3 Other Products
5.3 By Usability
5.3.1 Disposable IVD Devices
5.3.2 Reusable IVD Devices
5.4 By Application
5.4.1 Infectious Disease
5.4.2 Diabetes
5.4.3 Cancer/Oncology
5.4.4 Cardiology
5.4.5 Autoimmune Disease
5.4.6 Nephrology
5.4.7 Other Applications
5.5 By End Users
5.5.1 Diagnostic Laboratories
5.5.2 Hospitals and Clinics
5.5.3 Other End Users

6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Abbott Laboratories
6.1.2 Becton, Dickinson and Company
6.1.3 Bio-Rad Laboratories Inc.
6.1.4 bioMerieux SA
6.1.5 Danaher Corporation
6.1.6 Epigenomics Inc.
6.1.7 F. Hoffmann-La Roche Ltd
6.1.8 Johnson & Johnson
6.1.9 Qiagen N.V.
6.1.10 Siemens Healthcare GmbH

7 MARKET OPPORTUNITIES AND FUTURE TRENDS