Pharmacogenomics Technology/Theranostics/Companion Diagnostics (CDx) Market Report

Pharmacogenomics Technology/Theranostics/Companion Diagnostics (CDx) Market Analysis By Therapeutic Area (Oncology Neurological, Cardiovascular, Immunology Disorders), By Technology, And Segment Forecasts, 2014 - 2025

Published: June 2017  |  150 Pages  |  Format: PDF  |  Report ID: GVR-1-68038-940-1

Industry Insights

The global pharmacogenomics technology/theranostics/ CDx market size was estimated at USD 5.62 billion in 2016. Theranostics, are pioneering personalized medicine by predicting prognosis, and pinpointing diagnoses down to the subtype of chronic conditions. Rising cost of healthcare coupled with new opportunities for improved treatments exerts an ever increasing pressure on healthcare budgets. In particular, the diagnostic industry is observed to be the target for several cost-cutting exercises by payers and government. 

Aforementioned facts pronounce the diagnostic industry to incorporate innovation and product enhancement in order to maintain year-on-year growth. In addition, presence of similar pressures on the pharmaceutical industry with respect to rise in demands from payers is expected to bolster growth in this industry. Pharmacogenomics tests are anticipated to exhibit progress as a consequence of their increasing importance in emerging markets. The demand is driven due to the preference by government bodies in order to ensure value from prescribed drugs and practice cost management.

Germany pharmacogenomics technology market by therapeutic area, 2014 - 2025 (USD Million)

Germany pharmacogenomics technology Market

Application of the theranostic nanoparticles for imaging as well as in therapy has gained significant attention for disease management in recent times. Usage of Magnetic-Based Theranostic Nanoparticles (MBTN) in disease management owing to advantages associated is anticipate to boost revenue generation in this sector. These nanoparticles serve as multifunctional agents for site-specific magnetic targeting and as negative contrast agents in Magnetic Resonance Imaging (MRI). Moreover, the advances in molecular diagnostics aid in identification of novel biomarkers that contribute to the therapeutic value of a given drug.

Theranostics’ role in decreasing the R&D costs and lowering the time involved in clinical trials pushes its adoption by the pharmaceutical companies. Market opportunities are encouraging smaller participants to focus on development of novel tests for already licensed drugs, thus leading to growth in coming years. The market is driven by collaborations and pipelines for upcoming products. Goal of the collaborations between the companies is identification of appropriate tumor targets by expansion of known mutations associated with defective DNA repair. Companies are engaged in development of single comprehensive tests that can capture a large amount of relevant content.

However, issues pertaining to regulatory scenario and reimbursement criteria for the use of companion diagnostic tests are expected to restrict the growth to certain extent. Regulations for these diagnostic solutions are not fully established to meet the developmental requirements. Furthermore, assessment of epigenetic variations, circadian rhythms, environmental and non-genetic factors, on an individual's response need to be assessed for clinical implementation of pharmacogenomic tests. Advanced algorithms and appropriate study designs need to be incorporated for effective usage of theranostics in clinical settings.

Efforts continue to foster collaboration among the pharmaceutical industry, regulators, academic researchers and clinicians, insurers, and policy makers. These entities are working with an objective of streamlining the process to a comprehensive clinical practice.

Therapeutic Area Insights

Oncology accounted for the largest share of the therapeutic areas and is expected to be sustained, propelling a fresh round of robust activity around the world. Theranostics possess the potential to make precision cancer care effective as well as affordable. 

Ever expanding armamentarium of therapies based on molecular diagnostics principle for cancer treatment, is attributed to increase the penetration rates of oncology based tests. Appropriate selection of predictive biomarkers that can provide clinical benefit in a small subset of patients is the crucial step for implementation of companion diagnostics in cancer.

Technology Insights

With the rise in number of proof-of-concept studies and research pertaining to sequencing, especially next generation sequencing, the theranostic tests are anticipated to witness substantial progress. 

Meteoric progress in the aspects of NGS technology, platform, and data analysis solutions is propelling widespread and rapid uptake of the technique in the research settings. Research carried out in order to develop regulated next-generation sequencing-based clinical trial assays and companion diagnostics is expected to fuel growth.

Presence of a strong assay portfolio with respect to polymerase chain reaction is responsible for the larger share of this technology in 2016. Benefits associated with their usage is attributive for the estimated share.

Pharmacogenomics technology (theranostics & CDx) market, by region, 2016 (%)

pharmacogenomics technology Market

Regional Insights

North America dominates in revenue generation owing to the presence of established players operating in this region. These players are engaged in active collaborations in order to gain share in the competitive market. 

Accelerated R&D of integrated medicine in the U.S. as a consequence of active participation of regulatory bodies and government is anticipated to bolster growth over the forecast period. FDA has issued guidance documents for coordination of milestone reviews with the different agencies, expected performance requirements, clarification of appropriate regulatory strategy, defining timeliness to enable a smooth application process, and key deliverables.

Asia Pacific is estimated to witness potential growth in the coming years as a consequence of adoption of advancements in the developing economies of this region. In addition to this demand for the pharmacogenomic testing is attributive for projected growth.

Competitive Insights

Some of the key players in the market are Qiagen NV, GE Healthcare, Agilent Technologies, F Hoffman La Roche, Foundation Medicine, Thermo Fisher Scientific Inc., Leica Biosystems Nussloch GmBH, and Pfizer. Companies are engaged in proactive optimization of business mix and portfolios. These companies are involved in developing theranostics that can target one or two drugs most effective drugs in an individual. The entities are also engaged in developing the assays that aid in increasing understanding of molecular phenotype.

Report Scope 

Attribute

Details

Base year for estimation

2016

Actual estimates/Historical data

2014 - 2016

Forecast period

2017 - 2025

Market representation                                        

 revenue in USD Million and CAGR from 2017 to 2025

Regional scope

North America, Europe, Asia Pacific, Central & South America, Middle East & Africa

Country scope

U.S., Canada, Germany, UK, China, Japan, Brazil, South Africa

Report coverage             

Revenue forecast, company share, competitive landscape, growth factors and trends

15% free customization scope (equivalent to 5 analyst working days)

If you need specific market information, which is not currently within the scope of the report, we will provide it to you as a part of customization


Segments Covered in the Report

This report forecasts revenue growth at regional & country level and provides an analysis on the latest trends and opportunities in each of the sub-segments from 2014 to 2025. For the purpose of this report, Grand View Research has segmented the pharmacogenomics technology/theranostics/ CDx market on the basis of therapeutic area, technology, and regions: 

  • Therapeutic Area Outlook (Revenue, USD Million; 2014 2025)

    • Oncology

      • Lung Cancer

      • Breast Cancer

      • Colorectal Cancer

      • Cervical Cancer

      • Others

    • Neurological Disorders

    • Cardiovascular Disease

    • Immunological Disorders

    • Others

  • Technology Outlook (Revenue, USD Million; 2014 - 2025)

    • PCR

    • In-situ Hybridization

    • Immunohistochemistry

    • Sequencing

    • Others

  • Regional Outlook (Revenue, USD Million; 2014 - 2025)

    • North America

      • U.S.

      • Canada

    • Europe

      • Germany

      • UK

    • Asia Pacific

      • Japan

      • China

    • Latin America

      • Brazil

    • Middle East and Africa (MEA)

      • South Africa

Key questions answered by the report
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