The global companion diagnostics market is projected to witness growth at
a CAGR of 20.0% during the forecast period of 2022-2030.
Companion diagnostic refers to an in vitro medical device used along with a
therapeutic drug to analyze the effect & applicability of the drug on
patients. It utilizes a combination of tests and therapies to provide critical
information about corresponding therapeutic drugs or biological products to
deliver safe and effective medical treatment. These diagnostics also provide an
in-depth understanding of disease biology and the mechanism of action (MOA),
which aid medical professionals in determining the potential side effects or
risks of a therapeutic product on specific human bodies.
Factors such as the ever-expanding application areas of companion
diagnostics due to a variety of advantages offered by them; the rising
significance of companion diagnostics in drug development; the soaring demand
for in-vitro diagnostics and targeted therapies; the escalating demand for
next-generation sequencing; the increasing number of clinical trials, the growing
development of new biomarkers for various diseases, the burgeoning cases of
adverse drug reactions related to drugs due to lack of efficacy and the rapidly
surging number of technological advancements in healthcare are primarily
driving the global companion diagnostics market.
Additionally, the incidence of cancer cases of different types has been
surging at an unprecedented pace around the globe since the last few decades.
According to a new report, the global cancer burden is projected to rise and
reach up to about 22.0 million new cancer cases (with approximately 13.0
million cancer deaths) by the end of 2030. Companion diagnostics is extensively
utilized to enhance the predictability of oncology drug development process.
Thus, the proliferating incidences of cancer is expected to propel the adoption
of companion diagnostics for the rapid development of drugs in cancer
treatment. Alongside, the number of FDA approvals for cancer diagnostic tests
is also rising, providing impetus to the global companion diagnostics market.
Moreover, the number of partnerships and collaborations between leading
companies in the market for the development of novel companion diagnostics
products is witnessing a swift increase. Such collaborations between companies
for the development of better biomarkers and diagnostics are anticipated to create
ample opportunities for the growth of the global companion diagnostics market
in the upcoming years.
Furthermore, other factors such as the burgeoning significance and demand
of personalized medicine, the existence of higher number of unfulfilled needs
for the treatment of cancer, the increasing critical healthcare needs of aging
population, the improvements in regulatory guidelines, the surging emphasis on
the co-development of drugs and diagnostic technologies, the escalating R&D
activities in the development of novel diagnostic tests for various chronic
diseases, swift expansion in genomics and proteomics research and the growing
number of government-based initiatives & spending are expected to further
bolster the growth of the global companion diagnostics market during the
However, factors such as the dearth of trained professionals, the high
costs associated with companion diagnostics, and the presence of stringent
government policies for product approvals are predicted to hinder the growth of
the market to a certain extent during the forecast period.
COMPANION DIAGNOSTICS MARKET SEGMENTATION:
By Product & Services:
Assay Kits & Reagents
Software & Services
Polymerase Chain Reaction (PCR)
In Situ Hybridization (ISH)
Next-Generation Sequencing (NGS)
By End User:
Pharmaceutical & Biopharmaceutical Companies
Contract Research Organizations
Middle East & Africa
Based on products and services, the
assay kits & reagents segment is projected to account for the largest
market share in the companion diagnostics market during forecast period. The
segment’s growth can be attributed to the rapidly surging demand for high-performance
diagnostics kits in clinical trials and commercial application and the growing
developments in sample processing. However, the software & services segment
is expected to attain the highest CAGR of 17.5% in the market during the
Based on technology, the polymerase
chain reaction (PCR) segment held the largest share in the global companion
diagnostics market in 2020. The segment is anticipated to retain its dominance
in the market over the forecast period. The segment’s growth can be attributed
to factors such as the widespread availability, ease of use and cost
effectiveness of PCR; the growing applications of PCR in the high-throughput
detection of mutants with a limited or low allele frequency of genes and the
high turnaround time of PCR as compared to other technologies. However, the
next-generation sequencing (NGS) segment is predicted to register the highest
CAGR in the market during the forecast period.
Based on indication, the cancer segment
captured the largest share of the global companion diagnostics market in 2020
and is expected to continue doing the same over the forecast period. Factors such as the rapidly increasing
prevalence of cancer cases across the globe; the existence of higher number of
unfulfilled needs for treatment of cancer; the escalating number of R&D
activities for cancer and the growing number of FDA approved companion
diagnostics are among the predominant factors contributing to the segment’s
Based on end-user, the pharmaceutical
& biopharmaceutical companies segment held the largest share in the
companion diagnostics market in 2020. The trend is poised to continue over the
The massively increasing application of
companion diagnostics in these companies due to their growing prominence in
drug development is the major factor attributed to the segment’s growth.
The North American region dominated the
global companion diagnostics market in 2020 and is expected to further retain
its position in the market during the forecast period. The growth of the market
in the region can be attributed to various factors such as the surging
prevalence of cancer cases in the region, the increasing number of
technological advancements and adoption rate in the region, the high presence
of leading market players in the region, the rising number of initiatives in
genomics and precision medicines and the rapid development in healthcare
infrastructure in the region. Furthermore, the escalating demand for
personalized medicine, the increasing number of product launches, and the
rising government spending are also anticipated to significantly contribute to
the growth of the market in the region during the forecast period. Countries
such as the U.S. and Canada are the major contributors to the growth of the
market in the region.
The Asia Pacific region is projected to
emerge as the fastest growing regional market for companion diagnostics during
the forecast period of 2021-2030. The growth of the market in the region can be
attributed to the soaring investments & research funding by pharmaceutical and
biotechnology companies in the region, the rising awareness regarding personalized
therapeutics & companion diagnostics in the region and the rapidly
expanding healthcare infrastructure in the region. Moreover, the high
population and patient base, the growing demand for advanced therapies, and the
rising prevalence of cancer and neurology disease cases in the region are
expected to further create tremendous growth opportunities for the companion
diagnostics market in the region during the forecast period. Countries such as
India, China and Japan are among the major contributors to the growth of the
market in the region.
KEY COMPANIES IN COMPANION DIAGNOSTICS
Hoffmann-La Roche AG
Agilent Technologies Inc.
Biogenex Laboratories Inc.
Abbott Laboratories Molecular Inc.
ARUP Laboratories Inc.
Foundation Medicine Inc.
Thermo Fisher Scientific Inc.
Guardant Health Inc.
Myriad Genetics Inc.