In recent years, the field of
medicine has witnessed a transformative shift towards personalized treatments.
At the forefront of this movement is the companion diagnostics market, which
plays a pivotal role in tailoring medical interventions to individual patients.
This article explores the dynamics, significance, and frequently asked
questions about companion diagnostics.
The report "Companion
Diagnostics Market by Product (Assays, Kits, Software & Services),
Technology (PCR, NGS, ISH, IHC), Indication (Breast, Blood, Lung, Colorectal
Cancer, Neurology Diseases), End User (Pharma Companies, CROs), Region - Global
Forecast to 2026", the global companion diagnostics market is projected to
reach USD 9.9 billion by 2026 from USD 5.5 billion in 2021, at a CAGR of 12.6%.
The policy programs to provide
effective care to patients with cancer, high drug development activity,
structured regulatory framework in the region, and large patient pool
undergoing advanced medical testing. Emerging economies such as China, Japan,
and India are providing lucrative opportunities for the players operating in
the companion diagnostics market.
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The major players operating in
this market are F. Hoffmann-La Roche Ltd. (Switzerland), Agilent Technologies,
Inc. (US), Qiagen N.V. (Germany), Thermo Fisher Scientific, Inc. (US), Abbott
Laboratories, Inc. (US), Almac Group (UK), Danaher Corporation (US), Illumina
Inc. (US), bioMérieux SA (France), Myriad Genetics, Inc. (US), Sysmex
Corporation (Japan), Abnova Corporation (Taiwan), Guardant Health, Inc. (US),
ICON Plc (Ireland), BioGenex Laboratories, Inc. (US), Invivoscribe Technologies
(US), ArcherDX, Inc. (US), NG Biotech (France), Q² Solutions (US), Amoy
Diagnostics Co., Ltd. (China), Abacus Diagnostica Oy (Finland), Asuragen Inc.
(US), SAGA Diagnostics (Sweden), Meso Scale Diagnostics, LLC. (US), and
Creative Biolabs (US).
The assays, kits &
reagents segment accounted for the largest share of the companion diagnostics
market, by product & service segment, in 2020
The companion diagnostics market
is segmented into assays, kits & reagents, and software & services. The
assays, kits & reagents accounted for the largest share of the companion
diagnostics market in 2020, mainly due to the availability of a wide range of
products, and increasing use of assays and kits in different therapeutic areas.
PCR segment to register the
highest growth rate during the forecast period
The companion diagnostics market
is segmented into polymerase chain reaction (PCR), next-generation sequencing
(NGS), in situ hybridization (ISH), immunohistochemistry (IHC), and other
technologies. In 2020, the PCR segment accounted for the largest share of the
companion diagnostics market. Factors such as the ease of use and widespread
availability of PCR kits & reagents in companion diagnostic testing, and
growing applications of PCR in the high-throughput detection of mutants with a
limited or low allele frequency of genes.
Cancer segment to register the
highest growth rate during the forecast period
The companion diagnostics market
is segmented into cancer, cardiovascular diseases (CVDs), neurological
diseases, infectious diseases, and other indications (inflammatory and
inherited diseases, among others). In 2020, the cancer segment accounted for the
largest share of the companion diagnostics market. Factors such as growing role
of companion diagnostics in the personalized medicine treatment for cancer and
increasing utility of biomarkers in the diagnosis of cancer.
The pharmaceutical &
biotechnology companies segment accounted for the largest share of the
companion diagnostics market, by end user segment, in 2020
Based on end user, the companion
diagnostics market is segmented into pharmaceutical & biotechnology
companies, reference laboratories, CROs, and other end users (including
physician & hospital laboratories, and academic medical centers). In 2020,
pharmaceutical & biotechnology companies accounted for a larger share of
the companion diagnostics market. The growing use of companion diagnostics
owing to their increasing prominence in drug development, and the increasing
importance of companion diagnostic biomarkers.
North America is the largest
regional market for companion diagnostics market
The global companion diagnostics
market is segmented into five major regions—North America, Europe, the Asia
Pacific, Latin America, and the Middle East & Africa. In 2020, North
America accounted for the largest share of the companion diagnostics market.
The North American companion diagnostics market growth can be attributed to the
presence of many leading companion diagnostics vendors & national clinical
laboratories, the easy accessibility to technologically advanced devices and
instruments, and the highly developed healthcare system in the US and Canada.
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Companion diagnostics are medical
tests that aid healthcare professionals in making informed decisions about the
most suitable treatments for patients. These tests are specifically designed to
identify biomarkers, genetic mutations, or other molecular characteristics that
are closely associated with a particular medical condition. The information
gleaned from companion diagnostics allows physicians to predict how a patient
is likely to respond to a specific treatment, helping to guide therapeutic
choices and avoid unnecessary interventions.
Personalized Medicine Revolution:
The increasing realization that each patient's genetic makeup influences
treatment responses has propelled the demand for companion diagnostics.
Pharmaceutical companies are now focusing on developing drugs that are effective
for specific patient subsets, and companion diagnostics enable the
identification of these subsets.
Improved Treatment Outcomes: By
tailoring treatments to an individual's unique genetic profile, companion
diagnostics can lead to more effective outcomes. This approach minimizes
trial-and-error prescribing and reduces adverse effects.
Regulatory Support: Regulatory
agencies, such as the U.S. Food and Drug Administration (FDA) and the European
Medicines Agency (EMA), have recognized the importance of companion diagnostics
in guiding precision medicine. They now require comprehensive diagnostic data
before approving certain targeted therapies.
Rise in Chronic Diseases: The
global prevalence of chronic diseases, including cancer and cardiovascular
conditions, has surged. Companion diagnostics enable early detection and
personalized treatment plans for these diseases.
A1: Traditional diagnostics focus
on identifying the presence or absence of a disease. Companion diagnostics go
beyond this by identifying specific molecular markers that indicate the
likelihood of a patient responding positively to a particular treatment.
A2: One notable example is the
HER2/neu gene testing for breast cancer patients. This test helps determine
whether a patient is a suitable candidate for targeted therapies like trastuzumab
(Herceptin).
A3: While companion diagnostics
have gained significant traction in oncology, their applications extend to
other therapeutic areas like cardiovascular diseases, infectious diseases, and
neurological disorders.
A4: Patient data privacy is a
critical concern. Medical data collected for companion diagnostics are subject
to strict privacy regulations, such as the Health Insurance Portability and
Accountability Act (HIPAA) in the U.S. and the General Data Protection
Regulation (GDPR) in the EU.
A5: Initially, companion
diagnostics may seem costlier due to their specialized nature. However, in the
long run, they can reduce healthcare expenses by minimizing ineffective
treatments and adverse events.
A6: The companion diagnostics
market is poised for growth as personalized medicine becomes more prevalent.
Technological advancements, increased collaborations between pharmaceutical and
diagnostic companies, and expanded regulatory support are expected to shape the
future of this field.
In conclusion, companion
diagnostics have emerged as a critical component of personalized medicine,
revolutionizing how healthcare providers approach treatment decisions. As the
field continues to evolve, patients can look forward to more targeted and effective
therapies, resulting in improved outcomes and better quality of life.