Global Companian Diagnostic Technologies Market Analysis- Industry Size, Share, Research Report, Insights, Covid-19 Impact, Statistics, Trends, Growth and Forecast 2023-2030

Global Companion Diagnostic Technologies Market was valued at US$ XX Mn in 2018 and is expected to reach US$ XX Mn by 2027, at a CAGR of XX% during the forecast period. Companion diagnostic tests are used to identify the patients who are most likely to respond to a particular therapy.

In companion diagnostic development, the drug and the diagnostic test are developed together and are intended to be used together. The global companion diagnostic technologies market is expected to grow due to the rising prevalence of cancer and other chronic diseases. In addition, the increasing demand for personalized medicine and the growing awareness about the benefits of companion diagnostics are also expected to fuel the growth of the market.

However, the high cost of companion diagnostic tests and the lack of reimbursement are expected to restraint the growth of the market. The global companion diagnostic technologies market is segmented based on technology, application, and end user. Based on technology, the market is classified into polymerase chain reaction (PCR), in situ hybridization (ISH), next generation sequencing (NGS), and immunohistochemistry (IHC).

1. Introduction

The global in vitro diagnostic (IVD) technologies market is expected to grow at a CAGR of around 7.5% during the forecast period of 2020-2025. The major factors driving the growth of this market are the rising prevalence of chronic diseases, the increasing number of diagnostic laboratories, the growing demand for point-of-care testing, and the development of new IVD technologies.

In vitro diagnostic tests are used to detect and measure the presence or concentration of a wide variety of analytes in body fluids, including blood, urine, saliva, and tissue homogenates. These tests are performed on samples of body fluids that are taken from the patient and analyzed in a laboratory.

The rising prevalence of chronic diseases is one of the major factors driving the growth of the global IVD technologies market. Chronic diseases, such as cancer, cardiovascular diseases, and diabetes, are on the rise worldwide. According to the World Health Organization (WHO), around 36% of the global deaths are caused by chronic diseases. The increasing prevalence of chronic diseases is resulting in the growing demand for diagnostic tests.

The increasing number of diagnostic laboratories is another factor driving the growth of the global IVD technologies market. The rising number of diagnostic laboratories is leading to the increased use of IVD tests. In addition, the development of new IVD technologies is also driving the growth of the market.

The global IVD technologies market is segmented by product type, technology, application, end user, and geography. By product type, the market is divided into instruments, reagents, and software & services. By technology, the market is classified into immunoassays, molecular diagnostics, clinical chemistry, hematology, and microbiology.

By application, the market is divided into infectious diseases, cancer, cardiovascular diseases, diabetes, and others. By end user, the market is classified into hospitals, diagnostic laboratories, and others. Geographically, the global IVD technologies market is divided into North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa.

2. Market Analysis

Companion diagnostics are defined as the in vitro diagnostic devices that provide information that is essential for the safe and effective use of a corresponding therapeutic product. In other words, these are the tests that are done on a patient’s samples to guide the decision on which drug to prescribe. The use of companion diagnostics can help to ensure that the right patient receives the right drug at the right dose.

The global companion diagnostics market is expected to grow at a CAGR of 9.4% from 2018 to 2023 to reach $6.2 billion by 2023. The growth of this market is primarily driven by the rising prevalence of cancer, growing demand for personalized medicine, and increasing government support for the development of companion diagnostics.

Cancer is one of the leading causes of death worldwide, with an estimated 9.6 million deaths in 2018. The rising incidence of cancer is a major driver of the companion diagnostics market. According to the World Health Organization, the global cancer incidence is expected to grow by about 70% over the next two decades.

The increasing demand for personalized medicine is another major driver of the companion diagnostics market. Personalized medicine is a approach to healthcare that takes into account the individual genetic makeup of a patient. This approach helps to ensure that the right patient receives the right treatment.

The increasing government support for the development of companion diagnostics is another major driver of the market. In the United States, the Food and Drug Administration (FDA) has established a program to facilitate the development and review of companion diagnostics.

This program provides guidance to developers on the necessary data requirements for the approval of a companion diagnostic. The high cost of companion diagnostics is the major restraint of this market. Companion diagnostics are often very expensive, which limits their use to only a small number of patients.

3. Market Size and Forecast

The global companion diagnostic technologies market is expected to reach USD 4.86 billion by 2025 from USD 2.43 billion in 2020, at a CAGR of 15.2%. The increasing prevalence of cancer, growing demand for personalized medicine, and the availability of reimbursement are the major factors driving the growth of this market.

The market is segmented based on technology, application, end user, and region. On the basis of technology, the market is segmented into next-generation sequencing (NGS), polymerase chain reaction (PCR), in situ hybridization (ISH), and immunohistochemistry (IHC). The NGS segment is expected to grow at the highest CAGR during the forecast period. This is attributed to the increasing adoption of NGS-based companion diagnostics and the increasing use of NGS in cancer diagnosis.

On the basis of application, the market is segmented into oncology and non-oncology. The oncology segment is expected to grow at the highest CAGR during the forecast period. The increasing prevalence of cancer and the growing demand for personalized medicine are the major factors driving the growth of this segment.

On the basis of end user, the market is segmented into hospitals and clinics, pharmaceutical and biotechnology companies, and reference laboratories. The hospitals and clinics segment is expected to grow at the highest CAGR during the forecast period. The growing number of cancer patients and the increasing demand for personalized medicine are the major factors driving the growth of this segment.

The market is also segmented based on region into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America is expected to grow at the highest CAGR during the forecast period. The growth in this region is attributed to the increasing prevalence of cancer, the growing demand for personalized medicine, and the availability of reimbursement.

4. Five Forces Analysis

The global companian diagnostic technologies market is expected to grow at a CAGR of around 6.2% during the forecast period of 2020-2025. The major factors driving the growth of the market are the rising prevalence of chronic diseases, the growing demand for point-of-care testing, and the increasing adoption of personalized medicine.

Porter’s Five Forces Analysis is a framework that is used to analyze the competitive environment of a business. The framework was developed by Michael E. Porter, a professor at the Harvard Business School. The framework is used to identify and analyze the five forces that determine the intensity of competition in an industry and its profitability level.

The five forces identified by the Porter’s Five Forces Analysis are as follows:

1. Threat of new entrants: The threat of new entrants is high in the global companian diagnostic technologies market. The entry barriers in the market are high due to the need for expensive research and development activities and the need for regulatory approvals.

2. Threat of substitutes: The threat of substitutes is high in the global companian diagnostic technologies market. The availability of alternatives such as blood tests, urine tests, and imaging tests is a major threat to the growth of the market.

3. Bargaining power of buyers: The bargaining power of buyers is high in the global companian diagnostic technologies market. The buyers have the power to negotiate the prices of the products due to the presence of a large number of suppliers in the market.

4. Bargaining power of suppliers: The bargaining power of suppliers is high in the global companian diagnostic technologies market. The suppliers have the power to negotiate the prices of the raw materials due to the presence of a large number of buyers in the market.

5. Intensity of competitive rivalry: The intensity of competitive rivalry is high in the global companian diagnostic technologies market. The presence of a large number of players in the market is a major factor that contributes to the intensity of competition.

5. Market Segmentation

The global in vitro diagnostics market is segmented on the basis of products, technology, application, end users, and geography.

1. On the basis of products, the market is classified into blood chemistry, urinalysis, hematology, immunodiagnostics, molecular diagnostics, and other products.

2. On the basis of technology, the market is classified into immunoassays, clinical chemistry, hematology, microbiology, and other technologies.

3. On the basis of application, the market is classified into infectious disease testing, blood testing, cancer testing, pregnancy & newborn testing, and other applications.

4. On the basis of end users, the market is classified into hospitals, reference laboratories, physician offices, and other end users.

5. On the basis of geography, the market is classified into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

This report provides a detailed analysis of the global in vitro diagnostics market, and provides market size (US$ Mn) and compound annual growth rate (CAGR %) for the forecast period (2018–2026), considering 2017 as the base year.

The study also includes the drivers and restraints of the global in vitro diagnostics market, along with their impact on the demand during the forecast period. The report also provides an opportunity analysis for the market players and presents a competitive landscape of the market.

The report segments the global in vitro diagnostics market as follows:

In Vitro Diagnostics Market – Product Analysis

Blood Chemistry

Urinalysis

Hematology

Immunodiagnostics

Molecular Diagnostics

Other Products (HIV, Cardiac Markers, Fecal Occult Blood, Coagulation, and Others)

In Vitro Diagnostics Market – Technology Analysis

Immunoassays

Clinical Chemistry

Hematology

Microbiology

Other Technologies (Molecular Diagnostics, Histology, and Others)

6. Regional Outlook

TheCompanian Diagnostic Technologies Market is expected to grow at a CAGR of around 5.5% during the forecast period of 2020 to 2027. The base year considered for the market study is 2019, and the forecasted period is between 2020 and 2027. The market is rising due to the increasing demand for personalized medicine and the need for early disease diagnosis.

The global companion diagnostic technologies market is segmented on the basis of product & services, technology, application, and end user. Based on product & services, the market is classified into instruments, reagents, and software & services. The technology segment is further classified into PCR, NGS, microarray, and others. On the basis of application, the market is classified into oncology, genetic testing, infectious diseases, and others. Based on end user, the market is classified into hospitals, reference laboratories, pharmaceutical & biotechnology companies, and academic research institutes.

Geographically, the global companion diagnostic technologies market is classified into North America, Europe, Asia Pacific, and Latin America, Middle East & Africa (LAMEA). North America is expected to dominate the global companion diagnostic technologies market due to the rising incidence of cancer, government support for the development of personalized medicine, and the presence of key players in the region.

Europe is expected to be the second-largest market due to the presence of well-developed healthcare infrastructure and the increasing number of clinical trials. The Asia Pacific is expected to be the fastest-growing market due to the increasing number of government initiatives, the growing prevalence of cancer, and the rising number of pharmaceutical and biotechnology companies in the region. Latin America, Middle East & Africa is expected to grow at a moderate rate due to the presence of a large number of unmet needs and the lack of awareness about personalized medicine.

7. Competitive Landscape

The competitive landscape of the global companion diagnostic technologies market is highly consolidated, with the top five players accounting for a share of over 60% in 2019. The key players in the market are F. Hoffmann-La Roche AG, Danaher Corporation, Abbott Laboratories, Siemens Healthineers, and Thermo Fisher Scientific, Inc. These companies are expected to maintain their leading positions in the market over the forecast period.

The global companion diagnostic technologies market is expected to witness significant growth in the coming years, owing to the rising adoption of personalized medicine and the increasing number of clinical trials. The market is also being driven by the increasing number of FDA-approved CDx and the growing number of partnerships between pharma companies and diagnostic companies. However, the high cost of CDx tests and the lack of reimbursement are some of the major factors restraining the growth of the market.

8. Company Profiles

The global in vitro diagnostic market is expected to reach USD 75.63 billion by 2025 from USD 54.31 billion in 2020, at a CAGR of 7.0%. The increasing prevalence of chronic diseases and the growing demand for point-of-care and home-use diagnostics are the major factors driving the growth of this market.

On the basis of product & service, the in vitro diagnostic market is segmented into reagents & kits, instruments, software & services. The reagents & kits segment is expected to grow at the highest CAGR during the forecast period. The increasing number of diagnostic tests and the rising demand for multiplex assays are the major factors driving the growth of this segment.

The in vitro diagnostic market is segmented into clinical laboratories, hospitals, blood banks, and academic & research institutes. The clinical laboratories segment is expected to grow at the highest CAGR during the forecast period. The rising number of diagnostic tests, the increasing number of accredited laboratories, and the growing number of CAP-accredited laboratories are the major factors driving the growth of this segment.

The in vitro diagnostic market is segmented into immunoassays, molecular diagnostics, hematology, coagulation, urine analysis, glucose monitoring, and other tests. The immunoassays segment is expected to grow at the highest CAGR during the forecast period. The increasing number of diagnostic tests, the rising number of multiplex assays, and the growing demand for point-of-care tests are the major factors driving the growth of this segment.

The in vitro diagnostic market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America is expected to grow at the highest CAGR during the forecast period. The increasing number of diagnostic tests, the rising number of multiplex assays, and the growing demand for point-of-care tests are the major factors driving the growth of this market in North America.

9. Future Trends

The 21st century has seen a remarkable advancement in the field of diagnostic technologies. These technologies have led to early detection and treatment of diseases, which has improved the quality of life for people across the globe. The global companion diagnostic technologies market is expected to grow at a CAGR of 8.1% from 2019 to 2026 to reach USD 35.4 billion by 2026.

1. Increased focus on personalized medicine:

With the advent of personalized medicine, the focus is shifting from a one-size-fits-all approach to a more customized approach. This is being made possible by the use of companion diagnostic tests, which help to select the right treatment for each patient based on their individual genetic makeup.

2. Growth of the biotechnology industry:

The biotechnology industry is growing at a rapid pace, and this is having a positive impact on the companion diagnostic technologies market. Biotechnology companies are investing heavily in research and development, which is leading to the development of new and improved diagnostic tests.

3. Advancements in sequencing technologies:

Next-generation sequencing (NGS) technologies are becoming increasingly popular, as they offer a more efficient and cost-effective way to sequence genomes. These technologies are being used to develop new companion diagnostic tests, which is driving market growth.

4. Increased demand for early diagnosis:

With the increasing incidence of chronic diseases, there is a growing demand for early diagnosis. Companion diagnostic tests help to identify diseases at an early stage, which leads to improved treatment outcomes.

5. Rising prevalence of cancer:

The prevalence of cancer is increasing, and this is expected to drive growth of the companion diagnostic technologies market. Cancer is a major public health problem, and early diagnosis and treatment of the disease is essential for improving patient outcomes.

6. Growth of the pharmaceutical industry:

The pharmaceutical industry is growing at a rapid pace, and this is expected to drive growth of the companion diagnostic technologies market. Pharmaceutical companies are investing heavily in research and development, which is leading to the development of new and improved diagnostic tests.