Table of Contents
This study aims to cover the regulatory outlook and the diagnostics and drug approval process in the US, Europe, India, China, Japan and Brazil. Comparative analysis enables competitors to understand various regulatory hurdles and to position their products in pipeline better and plan for costs. Comparative analysis also enables an understanding of which geographies are hard to penetrate. Understanding regional barriers and the timeline taken for the evaluation process will help IVD and pharmaceutical companies choose an appropriate partner for their companion diagnostic product development.
With the advent of personalized medicine and more patient-based care, there has been an
increase in the activity of partnerships between pharmaceutical companies and in vitro
For a companion diagnostic manufacturer, it becomes necessary to understand the
reimbursement landscape and the regulatory landscape in order to plan its costs based on
the expected timeline of product release.
The United States follows the most organized regulatory pathway for companion
diagnostics, and many countries are trying to replicate the same regulatory pathway. The
United States has been enforcing the co-development of drugs and diagnostic devices in
an effort to cut down overall healthcare costs relating to the biomarker development itself.
Frost & Sullivan expects that many in vitro diagnostics (IVD) companies will evolve and
reorganize their goals (better planning for R&D biomarker development costs) in Europe
given the recent change in the IVD directive that will govern the companion diagnostic
landscape from 2014 onwards.
A comparative analysis of various regulatory pathways for companion diagnostic tests
reveal that, the United States, China, Japan, and Australia are well regulated markets with
established pathways. As of 2013, Europe was the least regulated and Russia, India, and
Brazil exhibit a similarity for moderately regulated markets.
Certain countries had a well established health authority to review products before their
acceptance in the market, while other countries did not have a proper mechanism in place.
This variation was because of the classification of companion diagnostic tests into a risk-based classification.
A thorough understanding of various regulatory pathways reveal that every system has its
own pros and cons; understanding this to the utmost detail will help manufacturers to
allocate costs in a much more reasonable manner.
Qiagen, Dako, Roche, and bioMérieux have been successful with many products. They
also have a strong pipeline of tests for oncology and other emerging areas such as
infectious disease, central nervous system (CNS), and cardiovascular disease areas.
These companies have a broad understanding of various regulatory hurdles that challenge
market entry strategies. Understanding regional barriers is also important to be able to
choose an appropriate commercialization/biomarker development partner.
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