Companion diagnostics (CD) refer to a type of in vitro diagnostic tests or assays that are intended to help physicians in making effective treatment decisions based on the patient’s response to a specific drug targeted toward a specific biomarker, expressed in a particular disease or indication. The patient’s response to an ongoing therapy is mapped with the help of companion diagnostics in terms of changes in gene amplification, nullifying the effect of mutations, changes in protein overexpression and receptor-substrate interaction, and so on. These tests aim at providing insights into the patient’s likely response pattern to a particular therapy, thereby enabling optimization of appropriate dosing concentrations and course of administration. The increasing importance of personalized medicine and commercialization of targeted therapeutics have driven the demand for companion diagnostics, which in turn is projected to observe a rise in trend of adoption by patients as well as health care service providers.

Companion diagnostics help in cost reduction for drug manufacturers by narrowing the target patient population who are likely to benefit from the targeted therapy. These tests enable physicians to rule out therapeutic options which are not likely to be as effective as a particular targeted drug, and thus eliminate the need for use of higher-priced cancer therapeutics and other unnecessary treatments. The consideration of a defined patient population and resultant higher efficacy of targeted therapeutics further increase the chances of the drug’s approval and aid in streamlining of the drug development process (such as fasten the approval process). In addition, companion diagnostics are important to rule out the possibility of side effects and alleviate health care costs related to management of side effects.

The demand for personalized medicine has been on a rise since the significant development in genomics research and biomarkers. This can be attributed to the efficiency and target-specific nature of personalized medicine with better patient outcomes. In addition, the targeted therapies have minimal or no side effects compared to the conventional therapies. With the paradigm shift in the drug discovery and development process, pharmaceutical companies are shifting their focus toward the development of novel targeted therapies (genotype or phenotype specific therapies). The adoption of this paradigm shift marked the gradual termination of traditional blockbuster model. Hence, these factors increase the demand and uptake of personalized medicine which in turn drives the growth of the companion diagnostics market. Increase in the number of cancer incidence, demand for personalized medicine, and reduction in drug development cost have contributed to augment the growth of the digital companion diagnostics market. However, poor reimbursement policies, and longer developmental and approval phase are factors that are restraining the growth of the market.

The market for digital companion diagnostics can be segmented on the basis of technology, disease indication, end-user, and geography. Based on technology, it is segmented into molecular diagnostics and immunohistochemistry. The molecular diagnostics segment is further sub-segmented into PCR, in situ hybridization, and next generation sequencing. This segment is anticipated to be a fast growing market due to advancement in technology, adoption of precise and accurate techniques by users, and reduction of cost and time associated with use of these methods.

Based on disease indication, the market is segmented into breast cancer, melanoma, lung cancer, colorectal cancer, and infectious disease. The breast cancer segment is estimated to hold a large market size during the forecast period. The major factors fueling growth of this market are rise in global incidence rates of breast cancer, shift toward development of targeted therapies, and increase in acceptance level of the test due to the enhanced specificity and efficiency.

Based on end-user, the market is segmented into hospitals, pharmaceutical companies, and laboratories. Based on geography, the market for digital companion diagnostics has been distributed over North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America is estimated to dominate the market due to increase in health care expenditure and rise in demand for personalized treatment.

Key potential players operating in the digital companion diagnostics market are Qiagen N.V., Agilent Technologies, Inc., Agendia N.V., Life Technologies Corporation, GE Healthcare Ltd., Roche Holdings AG, Abbott Laboratories, and Genomic Health, Inc.

This study by TMR is all-encompassing framework of the dynamics of the market. It mainly comprises critical assessment of consumers' or customers' journeys, current and emerging avenues, and strategic framework to enable CXOs take effective decisions.

Our key underpinning is the 4-Quadrant Framework EIRS that offers detailed visualization of four elements:

  • Customer Experience Maps
  • Insights and Tools based on data-driven research
  • Actionable Results to meet all the business priorities
  • Strategic Frameworks to boost the growth journey

The study strives to evaluate the current and future growth prospects, untapped avenues, factors shaping their revenue potential, and demand and consumption patterns in the global market by breaking it into region-wise assessment.

The following regional segments are covered comprehensively:

  • North America
  • Asia Pacific
  • Europe
  • Latin America
  • The Middle East and Africa

The EIRS quadrant framework in the report sums up our wide spectrum of data-driven research and advisory for CXOs to help them make better decisions for their businesses and stay as leaders.

Below is a snapshot of these quadrants.

1. Customer Experience Map

The study offers an in-depth assessment of various customers’ journeys pertinent to the market and its segments. It offers various customer impressions about the products and service use. The analysis takes a closer look at their pain points and fears across various customer touchpoints. The consultation and business intelligence solutions will help interested stakeholders, including CXOs, define customer experience maps tailored to their needs. This will help them aim at boosting customer engagement with their brands.

2. Insights and Tools

The various insights in the study are based on elaborate cycles of primary and secondary research the analysts engage with during the course of research. The analysts and expert advisors at TMR adopt industry-wide, quantitative customer insights tools and market projection methodologies to arrive at results, which makes them reliable. The study not just offers estimations and projections, but also an uncluttered evaluation of these figures on the market dynamics. These insights merge data-driven research framework with qualitative consultations for business owners, CXOs, policy makers, and investors. The insights will also help their customers overcome their fears.

3. Actionable Results

The findings presented in this study by TMR are an indispensable guide for meeting all business priorities, including mission-critical ones. The results when implemented have shown tangible benefits to business stakeholders and industry entities to boost their performance. The results are tailored to fit the individual strategic framework. The study also illustrates some of the recent case studies on solving various problems by companies they faced in their consolidation journey.

4. Strategic Frameworks

The study equips businesses and anyone interested in the market to frame broad strategic frameworks. This has become more important than ever, given the current uncertainty due to COVID-19. The study deliberates on consultations to overcome various such past disruptions and foresees new ones to boost the preparedness. The frameworks help businesses plan their strategic alignments for recovery from such disruptive trends. Further, analysts at TMR helps you break down the complex scenario and bring resiliency in uncertain times.

The report sheds light on various aspects and answers pertinent questions on the market. Some of the important ones are:

1. What can be the best investment choices for venturing into new product and service lines?

2. What value propositions should businesses aim at while making new research and development funding?

3. Which regulations will be most helpful for stakeholders to boost their supply chain network?

4. Which regions might see the demand maturing in certain segments in near future?

5. What are the some of the best cost optimization strategies with vendors that some well-entrenched players have gained success with?

6. Which are the key perspectives that the C-suite are leveraging to move businesses to new growth trajectory?

7. Which government regulations might challenge the status of key regional markets?

8. How will the emerging political and economic scenario affect opportunities in key growth areas?

9. What are some of the value-grab opportunities in various segments?

10. What will be the barrier to entry for new players in the market?

Note: Although care has been taken to maintain the highest levels of accuracy in TMR’s reports, recent market/vendor-specific changes may take time to reflect in the analysis.

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Digital Companion Diagnostics Market

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