1. Market Research
  2. > Healthcare
  3. > General Medicine and Specialty Medicine Market Trends
  4. > Global Regulatory Overview For Companion Diagnostics Market

Global Regulatory Overview For Companion Diagnostics Market

  • April 2014
  • -
  • Frost & Sullivan
  • -
  • 51 pages

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.

Executive Summary

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
diagnostic companies.

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.

Table Of Contents

Global Regulatory Overview For Companion Diagnostics Market
Table of Contents

Executive Summary 4
Global Regulatory Overview 6
US Regulatory Landscape 7
Europe Regulatory Landscape 13
China Regulatory Landscape 18
Japan Regulatory Landscape 24
Brazil Regulatory Landscape 28
India Regulatory Landscape 32
Comparative Analysis of Regulatory Landscape 36

View This Report »

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 24 Million searchable statistics with tables, figures & datasets
  • More than 10,000 trusted sources
24/7 Customer Support

Talk to Amrita

+1 718 303 2019

Purchase Reports From Reputable Market Research Publishers
Contact Lenses: Technologies and Global Markets

Contact Lenses: Technologies and Global Markets

  • $ 6 650
  • Industry report
  • June 2016
  • by BCC Research

This BCC Research report explores present and future strategies within the contact lens market, which includes soft contact lenses, rigid gas permeable lenses and other lenses such as hybrid lenses, advanced ...

Cardiovascular Surgical Devices: Technologies and Global Markets

Cardiovascular Surgical Devices: Technologies and Global Markets

  • $ 6 650
  • Industry report
  • September 2016
  • by BCC Research

Use this report to: - Learn about the trends and developments affecting each type of cardiovascular surgical technology - Analyze trends and opportunities in major regions: North America, Europe, Asia ...

Adhesion Barrier Market by Product, Product Form, Application - Global Forecast to 2021

Adhesion Barrier Market by Product, Product Form, Application - Global Forecast to 2021

  • $ 5 650
  • Industry report
  • August 2016
  • by MarketsandMarkets

The global adhesion barriers market is expected to grow at a CAGR of 8.4% during the forecast period of 2016 to 2021. This market is projected to reach USD 1,216.8 million by 2021 from USD 812.5 million ...


Reportlinker.com © Copyright 2016. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.