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.
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.
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.
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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.
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.
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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.
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.
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