Global Companion Diagnostic Market is Poised to Witness a Growth at a High Rate of ~13% from 2022 to 2027
Rising need for personalized medicine, continuous advancement in medical technology both for the diagnosis and the treatment of patients, decreased costs of genetic-based CDx tests which allow broader market access, growing cases of adverse drug reactions and side effects, and rising demand for next-generation sequencing are some of the key factors driving the global companion diagnostics market.
Companion diagnostic (CDx) is a diagnostic test used as a companion to a therapeutic drug to discover
its applicability to a person. It requires multiple monitoring methods to
provide extremely valuable data, allowing patients, health practitioners, and payers
to decide with a higher level of certainty on the possible advantages of a
treatment or care pathway.
Growing Demand for NGS-Based Technology
Drives the Companion
Diagnostics
Market
The increasing demand for next-generation
sequencing technology especially its capability to identify rare
variants is crucial to continuing success and the wider distribution of
companion diagnostics solutions in the market. The use of NGS panels in one
test has the potential to help in the treatment of many different types of
cancers. For instance,
§ In July 2022, Almac Diagnostic partnered with AstraZeneca to develop and commercialize a variety of companion diagnostic (CDx) products based on NGS and qPCR-based technologies
Demand
for Companion Diagnostics for Targeted Cancer Drugs Drives the Companion
Diagnostics Market
According to
clinical research, up to 75% of cancer patients do not respond well to the same
cancer treatment. In such cases, companion diagnostic tests help to indicate
the presence of a molecular target and can also reveal the off-target effects
of a therapeutic, predicting toxicities and adverse effects associated with a
drug.
More than 90% of
all globally certified CDx tests are associated with targeted cancer
therapeutics. Some of the FDA-approved oncology drugs available in the market
are:
Indication Type |
Drug Trade Name (Generic) |
Biomarker(s) Details |
Approval Date |
Acute Myeloid Leukemia - Peripheral Blood or Bone
Marrow |
Rezlidhia (olutasidenib) NDA 215814 |
R132 mutations (R132C, R132H, R132G, R132S, and
R132L) |
P170041/S006 |
Non-Small Cell Lung Cancer (NSCLC) - Plasma |
Krazati (adagrasib) NDA 216340 |
KRAS G12C |
P210040 |
Potential Role of Companion Diagnostics in Precision Medicine Drives the Companion Diagnostics Market
Personalized
medicine is the practice of giving the correct dosage of the correct medicines
at the correct time. Companion diagnostics, which are used to identify eligible
patients for a particular therapy, are a significant driver to enable
personalized treatment choices and precision medicine. Companion diagnostics
offers numerous advantages in the advancement of personalized medicine and the
improvement of preclinical and clinically focused drug development.
Major
Challenges in Companion Diagnostics Market
The high cost of drug development therapies,
associated clinical trials, the introduction of new stringent regulations for
scientific validity, and analytical and clinical performance for in-vitro
diagnostics (IVD) are expected to stifle growth in the companion diagnostics market
in the next years.
North America is expected to hold a large
share of the Companion Diagnostics Market
From
a geographical standpoint, North America holds a dominant market share of the
companion diagnostics market. This can be primarily attributed to the rising
prevalence of diseases like cancer & HIV, improvements in regulatory
guidelines, and potential economic beneļ¬ts for drug developers early in drug
development in the region.
Competitive Landscape Analysis of Companion Diagnostics Market
Some of the significant players operating in the market's
include Thermo Fischer
Scientific Inc., Illumina Inc., Bayer AG, Danaher Corporation, Invitae, and
Agilent Technologies, Inc, among others.
Organic and Inorganic
Growth Strategies Deployed by Players for Gaining a Foothold in the Companion
Diagnostics Market
Players
operating in this market are adopting organic and inorganic growth strategies
such as collaborations, acquisitions, and new product launches to gain market
share. For instance,
§ In October 2022, Roche announced they have received approval from the FDA for the first companion diagnostic to identify patients with HER2-low metastatic breast cancer
§ In May 2022, Illumina, Inc. announced the incorporation of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight Oncology (TSO) Comprehensive (EU) test
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