Oncology Companion Diagnostic Market to Grow with a CAGR of 7.93% through 2028
Ongoing research, technological advancements, and
regulatory support is expected to drive the Global Oncology Companion
Diagnostic Market growth in the forecast period, 2024-2028.
According to TechSci Research report, “Oncology
Companion Diagnostic Market – Global Industry Size, Share,
Trends, Competition Forecast & Opportunities, 2028”, the Global Oncology
Companion Diagnostic Market stood at USD 2.97 billion in 2022 and is
anticipated to grow with a CAGR of 7.93% in the forecast period, 2024-2028.
This can be attributed to patient-centered care. Companion diagnostics
represent a shift towards patient-centered care. By providing physicians with essential
information about a patient's tumor, these tests help avoid unnecessary
treatments and reduce side effects. Patients benefit from a more individualized
approach to their cancer care, which can lead to improved quality of life and
outcomes.
Furthermore, artificial intelligence (AI) and machine
learning are becoming increasingly integrated into the oncology companion
diagnostic market. AI can analyze vast datasets of patient information,
biomarker data, and treatment outcomes to identify patterns that may go
unnoticed by human experts. By leveraging AI, companion diagnostics will become
more sophisticated, allowing for personalized treatment recommendations based
on comprehensive patient profiles.
The ever-evolving landscape of oncology companion
diagnostics in the era of advanced omics technologies is poised to propel the
market forward. Since January 2020, the FDA has granted its approval for ten
new combinations and single-agent regimens, all of which utilize specific CDx
assays. For example, in November 2022, the FDA approved Roche's VENTANA FOLR1
(FOLR1-2.1) RxDx Assay, an IHC-based companion diagnostic designed to identify
ovarian cancer patients eligible for ELAHERE treatment. Furthermore, the
Ventana HER2 Dual ISH DNA Probe Cocktail assay gained FDA approval in July
2020, providing a swift method for detecting the HER2 biomarker in breast
cancer and serving as a companion diagnostic for Herceptin therapy. Similarly,
in August 2020, the FDA also approved the Guardant360 CDx assay, which is an
NGS test leveraging circulating cell-free DNA as a companion diagnostic, and
the FoundationOne Liquid CDx, a pan-tumor liquid biopsy test.
The economic advantages offered by oncology companion
diagnostics (CDx) assays, along with their ability to reduce clinical trial
timelines, have accelerated the adoption of these assays by pharmaceutical
manufacturers. Companion diagnostics can enhance the effectiveness of treatment
across various diseases by equipping clinicians with clear clinical criteria
for diagnosis and treatment. They also contribute to the efficient allocation
of patient resources and national insurance policies by curbing unnecessary and
costly targeted chemotherapy drug treatments.
The co-development of drugs and diagnostics has
markedly improved since the FDA issued the "In Vitro Companion Diagnostic
Devices" guidance in 2016, emphasizing the simultaneous approval of
diagnostic assays and their corresponding therapeutic products. This framework
streamlines collaboration between pharmaceutical and diagnostic companies,
allowing for the selection of a lead compound and a corresponding biomarker.
As a result, major pharmaceutical and diagnostic
developers have entered into partnerships to co-develop drugs and oncology
companion diagnostic assays. For instance, in June 2020, ThermoFisher
Scientific and Agios Pharmaceuticals expanded their collaboration to develop a
companion diagnostic for vorasidenib, an investigational drug for low-grade
glioma. Similarly, in June 2020, Burning Rock Biotech Limited joined forces
with CStone Pharmaceuticals to commercialize and co-develop a CDx for
pralsetinib in China.
Browse over XX market data Figures spread
through XX Pages and an in-depth TOC on "Global Oncology Companion Diagnostic Market.”
The Global Oncology Companion Diagnostic Market is
segmented into product & service, technology, disease type, end use,
regional distribution, and company.
Based on its disease type, the "other
disease-type" category emerged as the dominant segment, capturing the
largest share of revenue. In 2022, the non-small cell lung cancer (NSCLC)
segment held the most significant revenue share, driven by the rising incidence
of NSCLC and the development of multiple oncology companion diagnostic tests
for this disease. For example, in December 2022, the FDA approved Agilent
Resolution ctDx FIRST, a companion diagnostic for NSCLC patients with the KRAS
G12C mutation, to determine their eligibility for adagrasib (Krazati)
treatment. This assay also assists healthcare professionals in profiling EGFR
genes in tumors. In May 2020, the FDA granted approval for the FoundationOne
CDx assay for use with Capmatinib in treating metastatic NSCLC.
The breast cancer segment is anticipated to exhibit
the most rapid CAGR during the forecast period. Breast cancer ranks among the
most prevalent and deadly forms of cancer, fostering a demand for oncology
companion diagnostics. According to the World Health Organization (WHO), in
2020, 2.3 million women were diagnosed with breast cancer, resulting in 685,000
reported deaths worldwide. Data from the Centers for Disease Control and
Prevention reveals that approximately 264,000 women and 2,400 men are diagnosed
with breast cancer annually in the United States. Moreover, a favorable
reimbursement environment for innovative breast cancer diagnostic solutions in
key regions is expected to facilitate their adoption. In January 2020, the
Centers for Medicare & Medicaid Services (CMS) expanded its coverage to
include Next-Generation Sequencing (NGS) as a diagnostic tool for inherited
breast cancer patients.
The growth of the leukemia segment at a significant
rate can be attributed to increased strategic initiatives by key players in the
development and introduction of novel NGS and companion diagnostic solutions
for leukemia diagnosis.
Based on end use, the hospital sector captured the
largest market share in 2022 and is projected to experience the most rapid CAGR
in the foreseeable future. This growth is driven by the presence of
well-equipped facilities and a substantial number of skilled healthcare professionals
within this segment. Furthermore, the expansion of healthcare coverage and
favorable reimbursement policies for early cancer diagnosis and prevention,
especially in U.S. hospitals, are expected to bolster this segment's market presence.
The pathology/diagnostic laboratory segment is
expected to witness increased revenue generation due to the availability of
precise and sensitive cancer screening and diagnostic tests. Prominent
diagnostic laboratory service providers such as CSI Laboratories, Laboratory
Corporation of America Holdings, Quest Diagnostics, Sonic Healthcare Limited,
and Bio-Reference Laboratories are actively offering testing services in this
market.
Oncology companion diagnostics have relatively low
penetration in academic medical centers, primarily due to lower clinical
oncology testing volumes. However, this segment is projected to experience a
significant CAGR throughout the forecast period in the oncology companion
diagnostics market. This is attributed to the growing partnerships between
academic centers and diagnostic developers. For instance, QIAGEN holds a global
co-exclusive license with Johns Hopkins University for PCR-based oncology companion
diagnostics, specifically for detecting mutations in the PIK3CA gene. This
collaboration led to the CE approval of the therascreen PIK3CA RGQ PCR kit in
February 2020.
In December 2022, the FDA granted approval for
QIAGEN's therascreen KRAS RGQ PCR kit as a companion diagnostic test for Mirati
Therapeutics' drug, KRAZATI, used in the identification of patients with
non-small cell lung cancer (NSCLC) featuring a KRAS G12C mutation.
Major companies operating in Global Oncology
Companion Diagnostic Market are:
- Agilent Technologies Inc
- Illumina Inc
- QIAGEN NV
- Thermo Fisher Scientific Inc
- F Hoffmann-La Roche AG
- ARUP Laboratories Inc
- Abbott Laboratories Inc
- Myriad Genetics Inc
- bioMérieux SA
- Invivoscribe Inc
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“In the coming years, the oncology companion
diagnostic market will continue to shape the future of cancer treatment,
providing tailored therapies that improve the quality of care and offer hope to
patients with a wide array of cancer types. The industry's commitment to
innovation and collaboration will be instrumental in realizing the full
potential of precision medicine in oncology,” said Mr. Karan Chechi, Research
Director with TechSci Research, a research-based management consulting firm.
“Oncology Companion Diagnostic Market By
Product & Service (Product (Instrument,
Consumables, Software), Service), By Technology (Polymerase chain reaction
(PCR), Next-generation sequencing (NGS), Immunohistochemistry (IHC), In situ
hybridization (ISH)/Fluorescence in situ hybridization (FISH), Others), By
Disease Type (Breast cancer, Non-small cell lung cancer, Colorectal cancer,
Leukemia, Melanoma, Prostate cancer, Others), By End Use (Hospitals,
Pathology/Diagnostic laboratory, Academic medical center), By Region, By Competition Forecast &
Opportunities, 2018-2028F”, has evaluated the future growth potential of Global
Oncology Companion Diagnostic Market and provides statistics & information
on market size, structure and future market growth. The report intends to
provide cutting-edge market intelligence and help decision makers take sound investment
decisions. Besides, the report also identifies and analyzes the emerging trends
along with essential drivers, challenges, and opportunities in Global Oncology
Companion Diagnostic Market.
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