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.