Market Size (2022)
USD 5.63 Billion
Fastest Growing Segment
Global Companion Diagnostic Market has valued at USD 5.63 Billion in
2022 and is anticipated to project impressive growth in the forecast period
with a CAGR of 11.76% through 2028. Companion diagnostics are medical devices
used in conjunction with therapeutic drugs to assess the impact and suitability
of drugs for specific individuals. These diagnostics are developed alongside
drugs to identify patient groups that respond to or are not suitable for the
therapy based on their characteristics. Healthcare professionals utilize this
device to evaluate the effectiveness of a particular treatment for a patient.
In 2020, Roche obtained FDA approval for the Cobas EGFR Mutation Test v2
companion diagnostic, which assists in determining the appropriate use of EGFR
tyrosine kinase inhibitors for lung cancer treatment. Companion Diagnostic
(CDx) is a clinical test co-developed with a therapeutic drug to identify
patients who will respond or not respond to the drug. It enables the
identification of patient groups that can or cannot be treated with the
corresponding drug. CDx helps practitioners evaluate the benefits, side
effects, and associated risks of therapeutic drugs, ensuring patient safety.
The global Companion Diagnostics Market is driven by factors such as
increasing patient demand for tailored therapy, expanded applications of
personalized medications, higher prevalence of chronic diseases, and growing
incidence of medication-related allergies. These factors contribute to the
development of customized CDx, promoting market growth. Additionally, CDx tests
offer advantages such as cost-effectiveness, high sensitivity, and rapid and
accurate results within shorter time frames, further fueling the growth of the
Companion Diagnostics Market.
Key Market Drivers
Increasing Demand for NGS-Based Technology
The growing demand for next-generation sequencing (NGS) technology, with
its exceptional capability to identify rare variants, plays a critical role in
the continued success and wider distribution of companion diagnostics solutions
in the companion diagnostics market. By utilizing NGS panels, a single test has
the potential to aid in the treatment of numerous types of cancers, offering a
more comprehensive approach to personalized medicine.
For instance, in July 2022, Almac Diagnostic forged a strategic
partnership with AstraZeneca, a leading pharmaceutical company, to
collaboratively develop and commercialize multiple companion diagnostic (CDx)
products. These innovative CDx solutions will be based on cutting-edge NGS
(next-generation sequencing) and qPCR-based (quantitative polymerase chain
reaction) technologies, further advancing the field of precision medicine and
enhancing patient care. Through this collaboration, Almac Diagnostic and AstraZeneca
aim to improve the accuracy and effectiveness of diagnostics, enabling targeted
therapies and personalized treatment plans for patients. This partnership
demonstrates the commitment of both companies to drive innovation in the field
of companion diagnostics and contribute to the advancement of precision
By leveraging the power of NGS and qPCR technologies, Almac Diagnostic
and AstraZeneca envision a future where companion diagnostics play a pivotal
role in guiding treatment decisions and improving patient outcomes across
various therapeutic areas. This collaboration represents a significant step
forward in the development of advanced diagnostic solutions that will
revolutionize the way diseases are diagnosed and treated. With the combination
of cutting-edge technologies and strategic partnerships, the field of precision
medicine is poised to make significant strides in improving patient care and
transforming healthcare on a global scale.
Companion Diagnostics for the Targeted Cancer Drugs
Clinical studies have shown that a significant percentage, up to 75%, of
cancer patients do not respond favorably to the same prescribed cancer drug.
This highlights the pressing need for companion diagnostic tests, which play a
crucial role in identifying the presence of a molecular target and also
uncovering any off-target effects of a therapeutic. By doing so, these tests
can predict toxicities and adverse effects associated with a drug, ultimately
aiding in personalized treatment approaches.
It is worth noting that over 90% of globally approved companion
diagnostic (CDx) tests are specifically associated with targeted cancer
therapeutics. This CDx approach to cancer genomic characterization not only
helps physicians identify the specific alterations driving the growth of a
patient’s cancer but also enables them to explore targeted treatment options
that may not have been previously considered. This comprehensive and tailored
approach to cancer treatment holds immense potential in improving patient
outcomes and revolutionizing the field of oncology.
Advancements in The Latest Technologies
Next-generation sequencing (NGS) based companion indicative tests aim to
unlock nuclear information from the genome of each individual to guide
treatment decisions for various diseases. By utilizing advanced sequencing
techniques, NGS can identify multiple biomarkers in a shorter timeframe
compared to other sequencing methods. This comprehensive approach allows for
the assessment of biomarkers in a single test, potentially benefiting the
treatment of a wide range of illnesses. Furthermore, the continuous advancements
in NGS technology provide market players with a competitive edge over those
offering alternative technologies such as PCR, ICH, and ISH. As a result, key
industry players are actively engaged in the development of companion
diagnostic products based on NGS, capitalizing on the opportunities presented
by this innovative field.
Rising Use of Personalized Medicine
The increasing utilization of personalized medicine is a key driver
behind the growth of the companion diagnostic market. Personalized medicine
encompasses a multifaceted approach to patient care, enhancing not only the
ability to diagnose and treat diseases but also enabling the identification of
diseases at earlier stages, facilitating more effective treatment. The growing
popularity of personalized medical care stems from its targeted approach based
on individuals' genetic characteristics. In the United States, a considerable
number of individuals seeking medical care experience misdiagnosis, which can
result in delayed and inaccurate diagnoses.
Furthermore, companion diagnostics are gaining prominence in the
development of personalized medicines for early disease detection and the
selection of precise treatment methods, ultimately contributing to reduced
mortality rates. Accurate assessment of an individual's genetic composition
plays a vital role in determining their health status and susceptibility to
severe diseases. Increasing awareness about genetic diseases will further
facilitate the development and commercialization of personalized medicines,
specifically tailored to address these conditions. Moreover, the demand for
companion diagnostic tests is anticipated to rise throughout the forecast
period, driven by the need for accurate patient diagnosis and the advancement
of personalized medicine.
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Key Market Challenges
Lack of Awareness and High Cost of Companion Diagnostics Techniques
While immunotherapy has shown significant promise in the treatment of cancer,
its high cost has limited widespread patient access. As a result, physicians
may opt to combine treatments, which can extend the duration of treatment from
five months to over three years. With longer treatment duration comes a greater
financial burden, as the cost of personalized immunotherapies is also
substantial. In fact, the cost of cancer immunotherapies can far exceed that of
other treatment options such as chemotherapy or radiation therapy.
Consequently, the high cost of immuno-oncology treatments is believed to impede
the growth of the companion diagnostics market. This financial barrier
highlights the need for continued research and innovation to develop more
affordable and accessible immunotherapies for cancer patients.
Lack of Resources in Underdeveloped Nations
Companion diagnostic tests require meticulous attention at every step to
ensure successful execution and reproducible results. One of the significant
challenges in these scientific fields is the scarcity of technically skilled
and trained personnel. The complexity of companion diagnostic tests often
demands sophisticated techniques and instruments, such as image processing, in
certain analytical procedures. The presence of proficient and experienced staff
with strong technical capabilities is paramount for biopharma companies,
academic institutions, R&D laboratories, and organizations.
However, there is a decline in comprehensive training programs for
laboratory professionals as they face undue pressure to deliver faster
turnaround times. Consequently, the focus on training laboratory managers or
preparing them to become experts is insufficient. Moreover, the compensation
package offered is not competitive, leading to a high turnover rate. These
factors, combined with the lack of recognition and understanding of the
importance of laboratory professionals, contribute to the diminishing number of
professionals in this field. This trend is expected to continue during the
forecast period, potentially offsetting the market growth in focus.
Key Market Trends
Growing Importance of Promotional Activities
The increasing significance of promotional activities represents a key
trend in the companion diagnostics market. Companion diagnostics, due to their
specificity in being applicable only to particular drugs, are not as
extensively marketed as other available test kits and devices in the market.
Therefore, it is crucial to give greater attention to improving the
distribution network and enhancing the availability of products to end users.
In terms of advertising sources, internet channels and search engines are among
the most vital, considering their higher visibility and the limited return on
investment and visibility of other media.
Furthermore, besides boosting sales, emphasis is placed on product
functionality, accuracy, and vendors' after-sales services, while marketing
communication takes a back seat. Limited promotion activities pose challenges
in reaching the target market and understanding a company's competitive
position. To attract customers to a company website, the publication of
multiple blogs and newsletters can be beneficial. This approach allows
businesses to sustain their marketing campaigns over an extended period and attract
repeat visitors. As the market continues to witness product enhancements,
vendors are increasingly recognizing the importance of promotional activities,
and this trend is expected to gain momentum, thereby supporting the growth of
the global companion diagnostics market throughout the forecast period.
Growing advancements in biologics
The companion diagnostics market is highly consolidated, with key
players such as F. Hoffmann-La Roche Ltd. (Switzerland), Agilent Technologies,
Inc. (the US), Qiagen N.V. (Germany), Thermo Fisher Scientific, Inc. (the US),
and Abbott Laboratories, Inc. (the US) collectively holding a significant
market share in 2020. Intense competition exists among market players, and only
major corporations can afford the substantial investment in capital, research
and development, and manufacturing. Consequently, this market poses significant
barriers to entry for new competitors.
The Polymerase Chain
Reaction (PCR) segment is currently dominating the market share and is expected
to experience significant growth throughout the forecast period. This can be
attributed to its cost-effectiveness, high sensitivity, and specificity, which
are crucial factors driving the expansion of the market. Moreover, PCR can be
employed on simple automated platforms, further enhancing its appeal. Furthermore,
PCR plays a vital role in determining the sequencing of unknown etiologies for
various diseases, making it an indispensable driver of this segment. Its
ability to accurately identify the genetic makeup of pathogens contributes to
better understanding and diagnosis of diseases.
On the other hand,
the next-generation sequencing segment is projected to grow rapidly in the
forecast period. This is primarily due to its key advantages, such as higher
sensitivity in detecting low-frequency variants, shorter turnaround time for
analyzing large sample volumes, and the ability to simultaneously sequence
hundreds to thousands of genes or gene regions. These advantages make next
generation sequencing a promising technology with immense potential for various
applications in the field of genomics and personalized medicine.
End User Insights
diagnostics market is fragmented into various segments, including
Pharmaceutical & Biotechnology Companies, Research Laboratories, Contract
Research Organizations, and Others. Among these, the Pharmaceutical &
Biotechnology Companies segment holds the largest market share. This can be
attributed to the growing utilization of companion diagnostics in drug
development and the increasing significance of companion diagnostic biomarkers.
Companion diagnostics play a crucial role in personalized medicine, helping to
identify patients who are most likely to benefit from a specific treatment.
This not only improves patient outcomes but also enhances the efficiency and
effectiveness of the drug development process. With advancements in technology
and the increasing focus on precision medicine, the demand for companion
diagnostics is expected to further rise in the coming years.
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In terms of revenue share, North America is projected to dominate the
market during the forecast period. This can be attributed to several factors,
including the high prevalence of chronic diseases, the presence of
well-established clinical laboratories and companion diagnostic vendors, and
the availability of advanced instruments and devices. Moreover, the region
benefits from a growing geriatric population, high disposable income,
increasing awareness about companion diagnostics, and a rising number of research
and development activities. These additional factors are expected to further
fuel the revenue growth of the North America market in the coming years. North
America accounted for the largest share of the companion diagnostics market.
The growth of the companion diagnostics market in North America can be
attributed to the presence of numerous leading companion diagnostics vendors
and public clinical research centers, the easy availability of technologically
advanced devices and instruments, and the highly developed healthcare system in
the US and Canada.
The utilization of companion diagnostics is considered a significant
treatment option tool for various oncology drugs, a classification reflected in
the FDA's assessment of these tests in terms of risk.
- In August 2022, the
U.S. FDA granted premarket approval for Thermo Fisher Scientific's Oncomine Dx
Target Test as a companion diagnostic (CDx) to identify patients with HER2
(ERBB2) activating mutations (SNVs & Exon 20 Insertion) in non-small-cell
lung cancer (NSCLC), who may be suitable candidates for ENHERTU
- In February 2022,
Genetron Holdings Limited, a prominent precision oncology platform company in
China specializing in molecular profiling tests, early cancer screening
products, and companion diagnostics development, entered into a collaboration
agreement with HUTCHMED (China) Limited to develop a companion diagnostic
- In January 2022,
Amoy Diagnostics Co. Ltd and PREMIA Holdings (HK) Limited launched the AmoyDx
Pan Lung Cancer PCR Panel (the "PLC Panel") in Japan as a reimbursed
companion diagnostic for multiple anti-cancer agents.
Key Market Players
- Abbott Laboratories Inc.
- Agilent Technologies Inc.
- F.Hoffmann-La Roche Ltd
- Biomerieux SA
- Qiagen NV
- Siemens Healthcare
- Thermo Fisher Scientific Inc.
- Danaher Corporation (Beckman Coulter Inc.)
- Myriad Genetics Inc.
- Illumina Inc.
By Product and Services
By Disease Indication
By End User
- Kits and Reagents
- In-Situ Hybridization
- Infectious Diseases
- In-Vitro Diagnostics
- Drug Discovery
- Pharmaceutical &
- Research Laboratories
- Contract Research Organization
- North America
- Asia Pacific
- South America
- Middle East & Africa
In this report, the Global Companion Diagnostic Market has been
segmented into the following categories, in addition to the industry trends
which have also been detailed below:
- Companion Diagnostic Market, By Product and Services:
Kits and Reagents
- Companion Diagnostic Market, By Technology:
- Companion Diagnostic Market, By Disease Indication:
- Companion Diagnostic Market, By Application:
- Companion Diagnostic Market, By End User:
Pharmaceutical & Biotechnology Companies
Contract Research Organization Others
- Companion Diagnostic Market, By Region:
o North America
§ United States
§ United Kingdom
§ South Korea
o South America
o Middle East & Africa
§ South Africa
§ Saudi Arabia
Company Profiles: Detailed
analysis of the major companies present in the Global Companion Diagnostic Market.
Global Companion Diagnostic market report with the given market
data, Tech Sci Research offers customizations according to a company's specific
needs. The following customization options are available for the report:
- Detailed analysis and profiling of
additional market players (up to five).
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