Global Companion Diagnostics
Market Report
2025
Delivery Includes:- Market Timeline 2019 till 2031, Market Size, Revenue/Volume Share, Forecast and CAGR, Competitor Analysis, Regional Analysis, Country Analysis, Segment Analysis, Market Trends, Drivers, Opportunities, Restraints, ESG Analysis, Porters Analysis, PESTEL Analysis, Market Attractiveness, Patent Analysis, Technological Trend, SWOT Analysis, COVID-19 Analysis, Consumer Behavior Analysis, etc.
The base year for the calculation is 2023 and 2019 to 2023 will be historical period. The year 2024 will be estimated one while the forecasted data will be from year 2025 to 2031. When we deliver the report that time we updated report data till the purchase date.
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Base Year | 2023 |
Historical Data Time Period | 2019-2023 |
Forecast Period | 2024-2031 |
Global Market Size | 121212 |
Country Market Size | 121212 |
North Americ Market Size | 121212 |
Europe Market Size | 121212 |
Asia Pacific Market Size | 121212 |
South America Market Size | 121212 |
Middle East and Africa Market Size | 121212 |
Market Split by Technology Type |
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Market Split by End-User |
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Market Split by Indication |
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List of Competitors |
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Regional Analysis |
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Country Analysis |
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Companion Diagnostics Market is Segmented as below. Particular segment of your interest can be provided without any additional cost. Download the Sample Pages!
Companion diagnostics (or CDx) are medical examinations or tools that provide vital information required to use a related treatment product—usually targeted therapy or customized medicine—safely and effectively. By identifying specific characteristics of a patient's illness at the molecular or genetic level, these diagnostics seek to support doctors in making well-informed treatment decisions. The core idea of companion diagnostics is to tailor medical care to each patient's specific characteristics. By identifying particular biomarkers, genetic mutations, or other molecular traits, healthcare providers can determine the probability that a patient will respond to a particular medicine or treatment. Companion diagnostics are usually applied in areas like cancer, where determining specific genetic changes is critical to choosing the best treatment plan.
Furthermore, the market for companion diagnostics is anticipated to grow significantly as a result of an increase in new product launches, the discovery of novel biomarkers for a range of illnesses, a boom in the study and creation of targeted therapies, a rise in the demand for personalized medicine that is becoming more well-known in developing nations, and an increase in the number of unmet needs for cancer care. For example, the AmoyDx Pan Lung Cancer PCR Panel (also known as the "PLC Panel") was introduced in Japan in January 2022 by Amoy Diagnostics Co. Ltd and PREMIA Holdings (HK) Limited as a paid companion diagnostic for certain anti-cancer medications. Additionally, the growing emphasis on customized medicine and the co-development of medication and diagnostic technologies are factors contributing to the growth of the worldwide companion diagnostics market.
The increasing number of cancer cases worldwide is driving up public demand for and awareness of customized medications. For example, figures released by the Australian Institute of Health and Welfare in December 2021 estimated that around 151,000 Australians received a cancer diagnosis (413 per day) and 49,000 Australians lost their lives (135 per day). Many prospects for applications in indications including cancer, cardiovascular, and neurological disorders have arisen as a result of firms increasing their cooperation for better biomarkers and diagnostics to concentrate on cost regulations.Thus, the companion diagnostics market's growth is being influenced by the aspects listed above. However, it is anticipated that the market expansion will be constrained by the high cost of drug development, the related clinical trial costs, and reimbursement challenges across several nations.
In recent years, there has been a notable increase in the occurrence of cancer. Effective CDx are becoming more and more necessary as the number of cancer cases rises. This is because genetic testing gives doctors precise information regarding treatment protocols and a clear picture of patients' malignancies. Consequently, the growing incidence of cancer is driving up sales of CDx products. Statistics on cancer in Canada show that 229,200 new cases of cancer were detected in the country in November 2021. Furthermore, 2.26 million new instances of breast cancer and 2.21 million cases of lung cancer were reported globally in 2022, according to the World Health Organization (WHO).
Additionally, in response to a growing demand, innovative tests are being created to identify particular kinds of mutations. The U.S. FDA approved Guardant360 CDx in August 2020.Using Next-Generation Sequencing (NGS) technology, our first liquid biopsy companion diagnostic identifies patients with particular types of mutations of the Epidermal Growth Factor Receptor (EGFR) gene in metastatic Non-Small Cell Lung Cancer (NSCLC).
Moreover, compared to conventional chemotherapy and radiation, targeted medicines offer cancer patients more effective and less hazardous therapeutic options. It is crucial to remember that not all patients respond well to the same targeted medicine, and some may develop resistance over time. To determine which patients will benefit most from a particular targeted medication, companion diagnostics can be used to locate resistance mutations. The increasing prevalence of cancer and the expanding use of targeted therapies are anticipated to fuel the companion diagnostics market's expansion during the forecast period.
Personalized medicine is the practice of adjusting medical care to each patient's unique characteristics. Personalized medications are accurate and specially designed for each patient to provide better therapy depending on the body's reaction and susceptibility to illness. Personalized medicine can reduce side effects and costs associated with therapy while simultaneously improving patient outcomes and quality of life. In personalized medicine, companion diagnostics are essential because they help determine the best course of action and dose for each patient based on their genetic profile or expression of biomarkers.
Personalized medicine is not a new idea—it has been used in medical therapy for many years. In fact, its application has grown with time. In recent years, customized medicine has grown at an accelerated rate due to the introduction of new technology. Nonetheless, a long history of scientific study and medical practice forms the basis of these advancements. Therefore, rather than representing a sudden, radical shift in medical practice, customized medicine can be understood as an evolution of it. As new technologies and discoveries are made, the field of customized medicine will continue to advance, building on its foundation of knowledge and technology. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10058568)
As to the most recent estimates provided by the Personalized Medicine Coalition, individuals with various cancer types, hereditary rare diseases, and a variety of infectious and chronic illnesses can access over 75,000 genetic testing kits and 300 customized medications available in the market.Additionally, companion diagnostics can help monitor response to and resistance to treatment, allowing for any necessary therapy adjustments.
The companion diagnostics market is seeing a notable increase in the number of newly approved products. A lot of tests are being adopted as a result of the growing number of approved new products, which is fuelling market expansion. Important producers also concentrate on creating new tests that fuel the expansion of the companion diagnostics market. For example, in May 2022, Illumina's TruSight oncology (TSO) complete test was approved by the CE. This test analyses several tumour indicators to pinpoint a cancer patient's unique molecular profile. Additionally, Agilent Technologies Inc. was approved in May 2022 for their qualitative immunohistochemistry assay, PD-L1 IHC 22C3 pharmDx.
Many regulatory agencies, such as the U.S. Food and Drug Administration (FDA), require companion diagnostic tests for the approval of certain targeted therapies. It is necessary to understand companion diagnostic values in order to get regulatory approval for these treatments.
Utilizing the body's own immune system, immunotherapy is a treatment strategy that fights cancer. Although immunotherapy has demonstrated significant promise as a cancer treatment, patient access to it has been hampered by its high cost. As an alternative, doctors may combine several therapies, extending the duration of treatment beyond three years, from five months. In this instance, the price rises in direct proportion to the length of time.
Moreover, the cost of customized immunotherapies is expensive. For example, the cost of YESCARTA (produced by Gilead Sciences) and KYMRIAH (developed by Novartis), the approved CAR T-cell therapy, varies from USD 373,000 to USD 475,000 per patient depending on the type of cancer being treated. When considering cancer treatment options, immunotherapies can be far more expensive than chemotherapy or radiation therapy. Therefore, it is anticipated that the enormous costs linked to immuno-oncology treatments will hinder the global market's expansion.
To help advise treatment choices for cancer therapy, NGS-based companion diagnostic tests seek to extract molecular information from each patient's tumour genome. Compared to other sequencing approaches, next-generation sequencing finds many biomarkers for multiple pharmacological treatments faster. Treatment for a wide variety of malignancies may benefit from the use of NGS panels for biomarker measurement in a single test. The different technological developments in NGS also give market participants an instant competitive advantage over those offering other technologies, such PCR, ICH, and ISH. Major industry participants are concentrating on creating companion diagnostic solutions based on NGS as a result.
The market for companion diagnostics has been hindered by the development of COVID-19. Due to a drop in testing volume and other variables, major participants in the industry also reported a large loss in revenues as a result of the COVID-19 pandemic. The money generated by the big players decreased significantly in 2020. However, the revocation of lockdown regulations, the issuance of stay-at-home directives in numerous nations, the introduction of cutting-edge diagnostic tests, and the reconstruction of the supply chain network were crucial elements in the testing rebound in 2021. Thus, the demand in 2021 was positively impacted by the start of cancer diagnostic testing again and the introduction of new diagnostic tests.
Early COVID-19 diagnosis has become crucial in the market since it can help people with the disease receive the right care. The polymerase chain reaction (PCR) test, which uses nasopharyngeal swabs or other upper respiratory tract specimens, such as throat swabs, was the most widely used and trustworthy method for diagnosing COVID-19. Polymerase chain reaction (PCR) diagnosis thereafter became a primary focus for disease management. At that point in the study, SARS-CoV-2 vaccination companion diagnostics provided many important advantages, such as long-term, dependable immune protection through its monitoring with a particular test combination and, as a result, medical security against COVID-19. Consequently, driving market expansion.
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Large market companies are heavily investing in R&D to expand their product lines, which will spur further growth in the companion diagnostics market. In order to expand their global reach, market players are also pursuing a variety of strategic measures, such as joint ventures, product launches, contracts, mergers and acquisitions, higher investments, and cooperation with other institutions. To grow and thrive in a more competitive and developing market, rivals in the companion diagnostics sector need to provide affordable products. In terms of revenues, Abbott, F. Hoffmann-La Roche Ltd., and Agilent Technologies, Inc. account for a dominant share. Abbott, F. Hoffmann-La Roche Ltd., and Agilent Technologies, Inc. are the market leaders thanks to the introduction of new products and the purchase of rival companies. Additionally, the company's ability to maintain a leadership position in the industry is a result of strong investment in research activities to produce a portfolio of superior treatment options.
For example, one of the top companies in next-generation sequencing-based oncology treatments, Resolution Bioscience, Inc., was purchased by Agilent Technologies, Inc. in April 2021. The company's skills in NGS-based cancer diagnostics were accelerated and enhanced by this acquisition, which also gave it access to cutting-edge technology that will help it compete in the rapidly expanding customized medicine sector.
October 2022: The U.S. FDA approved F. Hoffmann-La Roche Ltd.'s companion diagnostic—PATHWAY—to identify patients with HER2 low metastatic breast cancer eligible for the treatment known as ENHERTU (HER2-directed antibody-drug conjugate).
Top Companies Market Share in Companion Diagnostics Industry: (In no particular order of Rank)
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North America holds the largest share of the global companion diagnostics market and is anticipated to grow significantly during the course of the forecast period. Because of the high rate of cancer and other chronic illnesses, the presence of large market players, the sophisticated healthcare system, the strong support of reimbursement policies and regulatory bodies, and the general acceptance of companion diagnostics and personalized medicine in the region, the North American market is expected to lead the world in this regard.
In terms of global market growth rate, the Asia-Pacific area is anticipated to have the biggest increase. This is due to a sizable and underutilized patient population, improvements in the local healthcare system, and rising disposable income. The market is expected to grow as a result of increased financing for research and diagnostics, rising cancer incidence rates, a boom in proteomics and genomics research, and increased awareness of personalized treatments.
The current report Scope analyzes Companion Diagnostics Market on 5 major region Split (In case you wish to acquire a specific region edition (more granular data) or any country Edition data then please write us on info@cognitivemarketresearch.com
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Global Companion Diagnostics Market Report 2024 Edition talks about crucial market insights with the help of segments and sub-segments analysis. In this section, we reveal an in-depth analysis of the key factors influencing Companion Diagnostics Industry growth. Companion Diagnostics market has been segmented with the help of its Technology Type, End-User Indication , and others. Companion Diagnostics market analysis helps to understand key industry segments, and their global, regional, and country-level insights. Furthermore, this analysis also provides information pertaining to segments that are going to be most lucrative in the near future and their expected growth rate and future market opportunities. The report also provides detailed insights into factors responsible for the positive or negative growth of each industry segment.
Based on technology,
The market is divided into five segments - Polymerase Chain Reaction (PCR), Next-generation Sequencing (NGS), Immunohistochemistry, In Situ Hybridization, and Others.
The polymerase chain reaction sector will lead supported by new product launch and regulatory approvals. Because major competitors including QIAGEN N.V. and Thermo Fisher Scientific Inc. introduced new PCR kits, polymerase chain reaction technology held a dominant market share in 2021. QIAGEN N.V. announced the release of the Terascreen KRAS RGQ PCR Kit in May 2021. This test kit helps determine which individuals with non-small cell lung cancer (NSCLC) are eligible to receive LUMAKRAS, a novel medication created by Amgen Inc.
Furthermore, it is employed in many genetic analyses to identify and investigate specific DNA sequences associated with genetic disorders or diseases. Because of its wide application and well-established reputation as a companion diagnostics technology—particularly in the identification of gene mutations and amplifications—the PCR segment is expected to dominate the market.
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Based on End-User,
The market is divided into 4 segments: Pharmaceutical & Biopharmaceutical Companies, Reference Laboratories, Contract Research Organizations, Others. Partnerships with manufacturers that contributed to the pharmaceutical & biopharmaceutical companies segment's significant share.
Companies in the pharmaceutical and biopharmaceutical industries brought in the most money in the market in 2021. The leading position in this market was achieved through partnerships with companion diagnostic manufacturers.
For example, in November 2021, Burning Rock Biotech Limited and Merck KGaA worked together to create tepotinib, an inhibitor of the MET. The OncoCompass Target panel, an in-house designed next-generation sequencing liquid biopsy solution, serves as the foundation for this companion diagnostic test. Burning Rock Biotech Limited and IMPACT Therapeutics signed a global strategic cooperation agreement in August 2021.The partnership wants to create a companion diagnostic (CDX) test for the therapeutic pipeline related to synthetic lethality.()
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Based on indication the market is divided into 4 segments: Cancer,Neurological Diseases, Infectious Diseases, Others.
Given the rising incidence of cancer and the attention major players are paying to developing cutting-edge testing for cancer medications, it is projected that the cancer segment will have a commanding market share for companion diagnostics. Additionally, there is a growing number of biomarker assays being employed for targeted cancer medications.
The World Health Organization (WHO) released statistics in February 2022 indicating that about 400,000 youngsters worldwide are diagnosed with cancer each year. Furthermore, the World Cancer Research Fund International released statistics showing that 18,094,716 million cancer cases were diagnosed worldwide in 2020.
Senior Research Associate at Cognitive Market Research
Manjiri Kanhere is an experienced market researcher focused on the Pharma & Healthcare industry. With over 3+ years of experience, She has worked with major pharmaceutical companies and healthcare providers, helping them to understand market trends, identify new business opportunities, and develop effective sales & marketing strategies. Her expertise lies in the ability to analyze complex data sets and deliver insights that drive business decisions. At Cognitive Market Research, she handles the market research related to Pharma and healthcare industry.
Manjiri Kanhere is an experienced market researcher focused on the Pharma & Healthcare industry. With over three years of experience, She has worked with major pharmaceutical companies and healthcare providers, helping them to understand market trends, identify new business opportunities, and develop effective sales & marketing strategies.
In her current role, Manjiri handles the market research related to Pharma and healthcare industry. Her passion lies in utilizing innovative approaches to distill complex information into strategic insights that empower organizations to make informed decisions.Manjiri remains an invaluable asset in the dynamic landscape of market research.
Numerous factors are driving the huge expansion of the companion diagnostics market. Rising cancer rates, the development of targeted medicines, and the growing need for individualized medicine are all factors contributing to this trend. When it comes to determining which patients will benefit most from a certain medication, companion diagnostics is essential since it can increase treatment efficacy and minimize side effects. Furthermore, the market is expanding due to the increased emphasis on precision medicine and the growing use of companion diagnostic tests in medication development.
Please note, we have not disclose, all the sources consulted/referred during a market study due to confidentiality and paid service concern. However, rest assured that upon purchasing the service or paid report version, we will release the comprehensive list of sources along with the complete report and we also provide the data support where you can intract with the team of analysts who worked on the report.
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Technology Type | Polymerase Chain Reaction (PCR), Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next Generation Sequencing (NGS) |
End-User | Pharmaceutical & Biopharmaceutical Companies, Reference Laboratories, Contract Research Organizations, Other |
Indication | Cancer, Neurological Diseases, Infectious Diseases, Others. |
List of Competitors | Roche Holdings, Abbott Laboratories, Thermo Fisher Scientific, Agilent Technologies, Life Technologies, GE Healthcare, Agendia, Qiagen, Genomic Health, Myriad Genetics, Advanced Cell Diagnostics, Danaher, Applied Proteomics |
This chapter will help you gain GLOBAL Market Analysis of Companion Diagnostics. Further deep in this chapter, you will be able to review Global Companion Diagnostics Market Split by various segments and Geographical Split.
Chapter 1 Global Market Analysis
Global Market has been segmented on the basis 5 major regions such as North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America.
You can purchase only the Executive Summary of Global Market (2019 vs 2024 vs 2031)
Global Market Dynamics, Trends, Drivers, Restraints, Opportunities, Only Pointers will be deliverable
This chapter will help you gain North America Market Analysis of Companion Diagnostics. Further deep in this chapter, you will be able to review North America Companion Diagnostics Market Split by various segments and Country Split.
Chapter 2 North America Market Analysis
This chapter will help you gain Europe Market Analysis of Companion Diagnostics. Further deep in this chapter, you will be able to review Europe Companion Diagnostics Market Split by various segments and Country Split.
Chapter 3 Europe Market Analysis
This chapter will help you gain Asia Pacific Market Analysis of Companion Diagnostics. Further deep in this chapter, you will be able to review Asia Pacific Companion Diagnostics Market Split by various segments and Country Split.
Chapter 4 Asia Pacific Market Analysis
This chapter will help you gain South America Market Analysis of Companion Diagnostics. Further deep in this chapter, you will be able to review South America Companion Diagnostics Market Split by various segments and Country Split.
Chapter 5 South America Market Analysis
This chapter will help you gain Middle East and Africa Market Analysis of Companion Diagnostics. Further deep in this chapter, you will be able to review Middle East and Africa Companion Diagnostics Market Split by various segments and Country Split.
Chapter 6 Middle East and Africa Market Analysis
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Chapter 7 Top 10 Countries Analysis (Only Available with Corporate User License)
This chapter provides an in-depth analysis of the market share among key competitors of Companion Diagnostics. The analysis highlights each competitor's position in the market, growth trends, and financial performance, offering insights into competitive dynamics, and emerging players.
Chapter 8 Competitor Analysis (Subject to Data Availability (Private Players))
(Subject to Data Availability (Private Players))
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
Data Subject to Availability as we consider Top competitors and their market share will be delivered.
This chapter would comprehensively cover market drivers, trends, restraints, opportunities, and various in-depth analyses like industrial chain, PESTEL, Porter’s Five Forces, and ESG, among others. It would also include product life cycle, technological advancements, and patent insights.
Chapter 9 Qualitative Analysis (Subject to Data Availability)
Segmentation Technology Type Analysis 2019 -2031, will provide market size split by Technology Type. This Information is provided at Global Level, Regional Level and Top Countries Level The report with the segmentation perspective mentioned under this chapters will be delivered to you On Demand. So please let us know if you would like to receive this additional data as well. No additional cost will be applicable for the same.
Chapter 10 Market Split by Technology Type Analysis 2019 -2031
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Chapter 11 Market Split by End-User Analysis 2019 -2031
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Chapter 12 Market Split by Indication Analysis 2019 -2031
This chapter helps you understand the Key Takeaways and Analyst Point of View of the global Companion Diagnostics market
Chapter 13 Research Findings
Here the analyst will summarize the content of entire report and will share his view point on the current industry scenario and how the market is expected to perform in the near future. The points shared by the analyst are based on his/her detailed in-depth understanding of the market during the course of this report study. You will be provided exclusive rights to interact with the concerned analyst for unlimited time pre purchase as well as post purchase of the report.
Why Polymerase Chain Reaction (PCR) have a significant impact on Companion Diagnostics market? |
What are the key factors affecting the Polymerase Chain Reaction (PCR) and Immunohistochemistry (IHC) of Companion Diagnostics Market? |
What is the CAGR/Growth Rate of Pharmaceutical & Biopharmaceutical Companies during the forecast period? |
By type, which segment accounted for largest share of the global Companion Diagnostics Market? |
Which region is expected to dominate the global Companion Diagnostics Market within the forecast period? |
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