
Companion Diagnostics Market is Expected to Reach US$5.58 bn by 2019; Global Industry Segmentation
Due to the dominance of the top
three players in the global companion diagnostics market, the nature of the
market is highly oligopolistic, says Transparency Market Research in a new
study. The leading companies operating in the market are focusing on protecting
their patent rights to retain exclusivity. The top three companies in the
companion diagnostics market are Roche Holdings followed by Qiagen N.V., and
Agilent Technologies. Together they comprise approximately 80.4% of the overall
global market in 2012.
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In order to rake in a greater
share of revenues, many small and large players are competing to co-develop
companion diagnostics by collaborating with pharmaceutical manufacturers. In
this regard, companies are also seeking defensive patents for their technology,
products, and tests to restrain other companies from the usage of their
exclusive tests.
Regulatory
Changes to Ensure Adoption of Companion Diagnostics
Companion diagnostics include two
types of tests namely tests which are developed along with target drugs and the
other developed after the commercialization of drugs. Companion diagnostics
combined with targeted therapeutics are being seen as a major breakthrough in
the personalized medicine field. Companies operating in the companion
diagnostics market are seeking an effective growth strategy in the development
of this concept drug-diagnostic interaction as the healthcare sector is
shifting its focus towards personalized medicine.
According to TMR analyst, the
implementation of well-structured regulatory policies will help in the
development of effective companion diagnostics leading to a growth in the
market. As a result of the FDA guideline in the U.S. regarding the approval of
targeted therapeutic along with its companion drug, two targeted therapeutics,
one of Abbott Laboratories and the other of Roche Holdings, were approve along
the line. Currently, various regulatory agencies around the world are in
support for the use of companion diagnostics for the development and
commercialization of prescription drugs used in targeted therapeutics. Thus,
the change in regulatory policies is expected to boost the adoption of
companion diagnostics globally.
Rising Influence
of Advocacy Groups and Clinical Societies to Negatively Affect Demand for
Companion Diagnostics
As the companion diagnostics
field is still in its infancy, the opinions of various institutions,
organizations, societies, and groups have a deep impact on the acceptance of
these diagnostics.
The opinions and reviews of
clinical societies and advocacy groups are likely to influence the end users
leading to hampering the sales and acceptance of companion diagnostics.
However, many clinical societies and advocacy groups also promote the use and
acceptance of these tests.
Demand for
Companion Diagnostics in Treating Wide Range of Diseases to Help Vendors Expand
Business
The expansion of companion
diagnostics into new areas such as oncology, CNS disorders, infectious
diseases, and metabolism disorders has provided the companies of companion diagnostics
with new growth opportunities. Different pharmaceutical and diagnostics
companies are investing in the development of companion drugs and due to the
expansion in the application scope, these companies are expected to gain
substantial growth opportunities.
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The
global companion drugs market is expected to grow at 18.1% CAGR from 2013 to
2019 to reach US$5.58 bn by 2019. The market was worth US$2.80 bn in 2015.
North America is projected to dominate the market until 2019 with a market
worth US$2.18 bn, followed by Europe. The breast cancer companion diagnostic
segment is estimated to lead the global market in terms of indication by 2019
with a market worth US$2,531.4 mn.