Companion Diagnostics Market Research Report - Forecast till 2030

Companion Diagnostics Market: Information By Products & Services (Assays, Kits & Reagents, Software & Services), Technology (Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), In Situ Hybridization (ISH) and Immunohistochemistry (IHC)), Indication (Cancer, Neurological Diseases, Infectious Diseases, Cardiovascular Diseases), End-User (Pharmaceutical & Biopharmaceutical Companies, Contract Research Organizations and Laboratories) - Forecast till 2030

ID: MRFR/MED/2231-CR | May 2020 | Region: Global | 168 Pages         

Companion Diagnostics Market

The companion diagnostics industry is poised to increase at a CAGR of 11.90% to USD 5,471.68 million by 2030

Segmentation

By-Products & Services Assays Kits & Reagents Software & Services
By Technology Polymerase Chain Reaction (PCR) Next-Generation Sequencing (NGS) In Situ Hybridization (ISH) Immunohistochemistry (IHC) Others
By Indication Cancer Neurological Diseases Infectious Diseases Cardiovascular Diseases Others
By End-User Pharmaceutical & Biopharmaceutical Companies Contract Research Organizations Laboratories Others

Key Players

  • Hoffmann-La Roche Ltd (Switzerland)
  • Thermo Fisher Scientific Inc. (US)
  • Agilent Technologies Inc. (US)
  • QIAGEN (Germany)
  • Abbott (US)
  • bioMérieux SA (France)
  • Leica Biosystems Nussloch GmbH (Germany)
  • Illumina Inc. (US)
  • Myriad Genetics Inc. (US)
  • ArcherDX Inc. (US)

Drivers

  • Increasing Prevalence of Chronic Diseases
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Companion Diagnostics Market Overview


The Companion Diagnostics Market is expected to reach USD 5,471.68 million by 2030 at 11.90% CAGR during the forecast period 2022-2030. The companion diagnostics market is expected to grow radically due to an increase in targeted therapy research and development, an upsurge in demand for customized medicine with amplified recognition in developing markets, the advancement of new biomarkers for various diseases, and an upsurge in the number of unmet cancer care needs. With developments in genetic sequencing and genomics, it is now widely assumed that medications can produce varied results in different people.


Companion diagnostic tests based on next-generation sequencing (NGS) attempt to unlock molecular information from each patient's tumor genome to advise cancer therapy treatment decisions. NGS's multiple technological developments also give market companies an immediate competitive advantage over players who offer other technologies like ICH, PCR, and ISH. While immunotherapy has been proven effective in cancer treatment, its high cost has limited patient access. Instead, doctors may decide that combining medicines is the best option, which might extend the treatment from five months to more than three years. In this scenario, the higher the cost, the longer the period. As a result, the market for companion diagnostics is projected to be hampered by the high cost of immuno-oncology medicines.

Avalon GloboCare Corp., a world leader in developing cutting-edge cell-based technologies and therapies, made public its definitive acquisition agreement to purchase a 60% stake in Laboratory Services MSO, LLC, a preeminent reference laboratory. As part of the deal, Avalon will transition its ticker symbol from "AVCO" to "ALBT," reflecting the company's newfound emphasis on laboratory testing and services. STAT blood testing, qualitative drug screening, genetic testing, urine testing, std testing, and many more are all possible. Over the years, Laboratory Services has earned a stellar reputation for its prompt service and low turnaround times.


COVID-19 Analysis


The lockdown and social distancing controls imposed in these COVID-19 countries had a negative effect on the supply chain of these goods.

As a companion diagnostic for Daiichi Sankyo's investigational medicine quizartinib, InVivoScribe Inc. is delighted to announce that they have submitted a supplemental Pre-Market Approval (sPMA) application to the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). Patients with FLT3-ITD mutation in newly diagnosed acute myeloid leukemia (AML) can be identified with this assay.


Market Dynamics


Drivers


Increasing Prevalence of Chronic Diseases Fuels the Market Growth


over the forecast period, the companion diagnostics market is projected to experience substantial growth due to a rise in R&D of targeted therapies, an increase in demand for customised medicine with increased recognition in developing markets, the development of new biomarkers for various diseases, and a higher number of unmet cancer care needs. It is expected that the growing preference for customised medicine, expanded cooperation between businesses and co-development of drug diagnostics would fuel companion diagnostics market growth. The development of the global companion diagnostics industry is motivated by the advantages of companion diagnostics, the growing demand for tailored treatment, the rising global cancer prevalence, and the ever-increasing application fields of companion diagnostics.


Opportunities


Expanding Regulatory Framework  Creates Growth Avenues for Key Players


It is also expected that the growing number of product approvals from global players would fuel demand growth. In the early stages of drug growth, pharmaceutical and biopharmaceutical firms are actively striving to incorporate patient-selection diagnostic frameworks and provide the best applicant for targeted therapies. The development of the companion diagnostics industry is further supported by this. Compared to other sequencing methods, next-generation sequencing discovers several biomarkers for multiple drug treatments in a shorter time span. The use of NGS panels in one test to assess biomarkers has the potential to help treat several different forms of cancers.


Restraints


High Costs of Companion Diagnostics to Impede Market Growth


Despite having guaranteed returns on investment, the high initial cost keeps these tests out of the reach of a large portion of end users, especially those in developed countries. This allows end-users, such as pharmaceutical firms, reference labs, hospitals, and CROs, who see the use of such diagnostic testing as a burden on their budgets, to opt for diagnostic services from third parties.

Through this strategic partnership, I-Mab and Roche Diagnostics will work together to develop companion diagnostics solutions for I-novel Mab's pipeline. Roche is the undisputed world leader in the in vitro diagnostics market, while I-Mab is a Chinese clinical stage biopharmaceutical company dedicated to the research, development, and commercialization of new biologics. The development of companion diagnostics is now an integral aspect of the R&D process for novel biologics. In addition to assisting in the diagnosis of various diseases, they can also be used to detect protein expression levels and altered genes, narrowing down the pool of potential candidates. To assure the efficacy and safety of their products and keep R&D expenses in check, cutting-edge biotech firms can benefit from using companion diagnostics.


Segmental Analysis


Global Companion Diagnostics Market has been segmented by Technology, Indication, Products & Services, and End Users.


By-Products & Services


The companion diagnostics market, based on products & services, has been bifurcated into kits, & reagents, assays, and software & services. Growing demand for kits and reagents during the COVID 19 pandemic is likely to lead the companion diagnostics market.


By Technology


The companion diagnostics market is segmented into polymerase chain reaction (PCR), next-generation sequencing (NGS), in-situ hybridization, immunohistochemistry, and other developments has been bifurcated on the basis of technology. The ease of use and widespread availability of PCR kits & reagents in companion diagnostic research pushes the PCR segment with increasing PCR applications.


By Indication


The indication-based industry has been categorised into cancer, neurological disorders, respiratory diseases, infectious diseases, and others. The cancer market is currently the main revenue generation segment and is expected to rise substantially over the forecast period. 


By End-User


The companion diagnostics industry has been categorised into pharmaceutical & biopharmaceutical firms, hospitals, contract testing organisations, and those focused on end-users. Due to their growing popularity in drug production and the increasing significance of companion diagnostic biomarkers, the large share of the pharma and biopharmaceutical segment can primarily be attributed to the widespread use of companion diagnostics in these sectors.

By working together, SAGA Diagnostics and AstraZeneca hope to create novel assays for analyzing tissue samples and liquid biopsies, with the goal of discovering previously unknown methylated targets. Precision oncology and ultrasensitive noninvasive monitoring of cancer patients are primary focuses at SAGA Diagnostics, a cancer liquid biopsy and genetic testing company. The biopharmaceutical firm AstraZeneca operates on a global scale. The SAGAsafe technology's ultrasensitive performance and the possibility of tailoring very complicated digital PCR (dPCR) assays to match AstraZeneca's desired analytical criteria were cited as reasons for the company's decision to work with SAGA.


Regional Analysis


Global Companion Diagnostics Market, based on region, has been divided into the Americas, Europe, Asia-Pacific, and the Middle East & Africa.


Americas to Lead with Superior Healthcare Facilities


The field of the Americas is likely to lead the global companion diagnostics market. The high incidence rate of cancer and other chronic diseases and increasing healthcare spending in the area can be due to this. In addition, market development is also projected to drive the rising number of healthcare organisations working on generated genomic databases to understand the human genome and growing research activities in this area using companion diagnostic kits.


Presence of Major Players to Lead European Market


During the review period, the European market for companion diagnostics is expected to be the second-highest. The growth of the regional industry is projected to fuel the participation of a significant number of companies and increasing research and development activities to improve personalised drug treatment for cancer patients. In addition, increasing per capita income raises the preference for personalised treatment, further fuelling consumer growth.


APAC to Witness the Fastest Growth


Due to the extreme increasing number of patients with cancer, cardiovascular and neurological disorders, Asia-Pacific is expected to be the fastest growing region. Moreover, business development is also positively influenced by the growing incidence of infectious diseases. The growth of the APAC companion diagnostics market is projected to be driven by the high occurrence of cancer, increasing proteomics & genomics research, rising research funding, increasing investments by pharmaceutical and biotechnology firms, and increasing awareness of customised therapeutics in many APAC countries.

An agreement between Illumina and the Israeli Ministry of Health (MoH) has been revealed, with the goal of sequencing the complete genomes of premature and severely unwell children in NICUs as part of a pilot study (NICU). The Genetics Institute at Tel-Aviv Sourasky Medical Center is in charge of the program, which will assess the feasibility of using whole genome sequencing (WGS) as a first-line diagnostic tool to help with the early detection of disease-causing genetic abnormalities in infants and improve clinical care and management. Newborns hospitalized to a NICU with a clinically suspected genetic abnormality will be enrolled together with their biological parents at one of eighteen institutions. Library preparation of DNA and sequencing reagents for WGS samples utilizing the most up-to-date NovaSeq 6000 S1 v1.5 reagent kit will be provided by Illumina, which will use its Illumina DNA PCR-Free Prep reagents.


MEA to witness Gradual Growth


Due to rising cancer cases and increasing tastes for customised drugs, the Middle East & Africa market is expected to experience steady growth. Thanks to the rising number of hospitals, research labs, increasing investment by healthcare firms, a growing number of cancer cases, and increasing drug discovery, the Middle East & Africa market is expected to experience steady growth.


Competitive Landscape


Growing R&D Projects to Boost Market Growth


Acquisitions, alliances, growth, and product releases were some of the main tactics adopted by players operating in the global companion diagnostics industry.


June 2020: A strategic collaboration was formed between Thermo Fisher Science Inc. and Agios Pharmaceuticals to co-develop a second companion oncology diagnostic tool.



  • Hoffmann-La Roche Ltd (Switzerland)

  • Thermo Fisher Scientific Inc. (US)

  • Agilent Technologies, Inc. (US)

  • QIAGEN (Germany)

  • Abbott (US)

  • bioMérieux SA (France)

  • Leica Biosystems Nussloch GmbH (Germany)

  • Illumina, Inc. (US)

  • Myriad Genetics, Inc. (US)

  • ArcherDX, Inc. (US)

  • Foundation Medicine, Inc. (US)

  • NG Biotech (France)

  • ICON plc (Ireland)

  • Invivoscribe, Inc. (US)

  • Abnova Corporation (Taiwan)

  • Guardant Health (US)


Recent Development



  • Feb 2022 Foundation Medicine, Inc. and Eli Lilly and Company (Lilly) have announced a collaboration to develop Foundation Medicine's tissue- and blood-based tests as companion diagnostics for RETEVMO® and additional Loxo Oncology treatments in Lilly's pipeline. The collaboration will first look at using FoundationOne®CDx for adult patients with metastatic rearranged transfection fusion across tumor types who might be candidates for Lilly's RET inhibitor, RETEVMO, in the US and EU.

  • Jan 2022 Leica Biosystems, a cancer diagnostics company, has partnered with Leap Therapeutics, a biotechnology firm, to create a companion diagnostic for Dickkopf-related protein 1 detection (DKK1). The assay will aid in the clinical development of Leap Therapeutics' anti-DKK1 cancer treatment, DKN-01, which is now undergoing clinical trials. DKK1 is a cancer-related protein that allows tumor cells to inhibit the immune system and develop uncontrollably. DKK1 overexpression has been linked to a worse chance of survival in cancer patients.


Report Overview


By-Products & Services



  • Assays, Kits, & Reagents

  • Software & Services


By Technology



  • Polymerase Chain Reaction (PCR)

  • Next-Generation Sequencing (NGS)

  • In Situ Hybridization (ISH)

  • Immunohistochemistry (IHC)

  • Others


By Indication



  • Cancer

  • Neurological Diseases

  • Infectious Diseases

  • Cardiovascular Diseases

  • Others


By End-User



  • Pharmaceutical & Biopharmaceutical Companies

  • Contract Research Organizations

  • Laboratories

  • Others



Report Scope:

Report Attribute/Metric Details
  Market Size   USD 5,471.68 million
  CAGR   11.90%
  Base Year   2021
  Forecast Period   2022-2030
  Historical Data   2020
  Forecast Units   Value (USD Billion)
  Report Coverage   Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
  Segments Covered   Products & Services, Technology, Indication, End User
  Geographies Covered   North America, Europe, Asia-Pacific, and Rest of the World (RoW)
  Key Vendors   Hoffmann-La Roche Ltd (Switzerland), Thermo Fisher Scientific Inc. (US), Agilent Technologies, Inc. (US), QIAGEN (Germany), Abbott (US), bioMérieux SA (France), Leica Biosystems Nussloch GmbH (Germany), Illumina, Inc. (US), Myriad Genetics, Inc. (US), ArcherDX, Inc. (US), Foundation Medicine, Inc. (US), NG Biotech (France), ICON plc (Ireland), Invivoscribe, Inc. (US), Abnova Corporation (Taiwan), Guardant Health (US)
  Key Market Opportunities   Expanding Regulatory Framework Creates Growth Avenues for Key Players
  Key Market Drivers   Increasing Prevalence of Chronic Diseases


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Frequently Asked Questions (FAQ) :

The companion diagnostics market would enjoy a valuation of USD 5,471.68 million by 2030

The companion diagnostics market would have companies like Agilent Technologies (US), Abbott Laboratories (US), F. Hoffmann-La Roche AG (Switzerland), ARUP Laboratories (US), Qiagen N.V. (The Netherlands), Myriad Genetics, Inc. (US), and Thermo Fisher Scientific Inc. (US).

The companion diagnostics market report has contract research organizations, clinical laboratories, pharma & biotech companies, and others as end users.

Major segments of the companion diagnostics market report are infectious diseases, cancer, central nervous system disorders, cardiovascular diseases, and others.

Inaccuracy in test results can hold back the companion diagnostics market growth.