Global Companion Diagnostics (CDx) Market: Focus on Technology, Indication, Country-wise Analysis, Regulatory Framework, and Competitive Landscape - Analysis and Forecast, 2018-2025
Global Companion Diagnostics Market to Reach $4.1 Billion by 2025
LONDON, Oct. 2, 2018 /PRNewswire/ -- In the era of precision medicine, the healthcare industry is focused on the development of advanced biomarker-based diagnostics to deliver improved patient care and enhance treatment outcome.The increasing prevalence of chronic disorders and improving regulatory framework for supporting drug-diagnostic co-development models are promoting the growth of the companion diagnostics market.
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Thereby, the advent of precision medicine approach and development of precision diagnostics are improving quality of life of the patients and reducing economic, societal, and clinical burden.
Presently, companion diagnostic (CDx) solutions are developed based on four technologies which include Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next Generation Sequencing (NGS), and Polymerase Chain Reaction (PCR).Till date, the healthcare industry has witnessed a number of successful procedures for parallel development of drug and its companion diagnostic, but mostly for oncology.
However, successful commercialization and approval of companion diagnostics for multiple cancer types, including lung cancer, breast cancer, leukemia, colorectal cancer, gastric cancer, ovarian cancer, and melanoma, have further drawn the attention of several pharmaceutical and diagnostic companies to venture into this lucrative market by developing CDx solutions for non-oncology indications, including neurodegenerative diseases, infectious diseases, metabolic disorders, and cardiovascular diseases. Further, several players are now focusing on the development of multiple biomarker-based CDx development, which is anticipated to enhance the growth of NGS-based companion diagnostics market.
The purpose of this study is to gain a holistic view of the companion diagnostics market in terms of various influencing factors, such as recent trends, regulatory frameworks, and technological advancements in the market.The scope of this report constitutes a detailed study of the technologies associated with the global companion diagnostics market.
The market has been segmented into 'technology', 'indication', and 'region'.The report presents the reader with an opportunity to unlock comprehensive insights with respect to the market and helps in forming well-informed strategic decisions.
The research uncovers some of the substantial parameters that must be taken into consideration before entering into the market.
This research report aims at answering various aspects of the global companion diagnostics market with the help of the key factors driving the market, the restraints, and the challenges that can possibly inhibit the overall market growth, and the current growth opportunities that are going to shape the future trajectory of the market expansion.The report includes an in-depth examination of the key players and recent developments taking place in this market.
Moreover, the report includes chapters on market dynamics (market drivers, opportunities, and challenges) and industry analysis as well.
The research study highlights the factors governing the industry attractiveness with Porter's Five Forces for a comprehensive understanding of the global companion diagnostics market. Moreover, the study includes detailed product mapping, market estimation, and analysis of key trends in multiple geographical regions, growth of companion diagnostics market in each region for different cancer types, and the key strategies and developments by the prominent companion diagnostics manufacturers.
The answers to the following key questions can be derived from this report:
• What are the major market drivers, challenges, and opportunities in the global companion diagnostics market?
• What are the underlying structures resulting in the emerging trends within the companion diagnostics industry?
• What was the market value of the leading segments and sub-segments of the global companion diagnostics systems market in 2017?
• How will each segment of the global companion diagnostics market grow during the forecast period and what will be the revenue generated by each of the segments by the end of 2025?
• What are the influencing factors that may affect the market share of the key players?
• How will the industry evolve during the forecast period 2018- 2025?
• What are the key developmental strategies which are being implemented by the key players to sustain in this competitive market?
• What are the key technologies in companion diagnostics market? What are the major benefits of each technology?
• How has the market been segmented on the basis of indication? Which indication is dominating the global companion diagnostics market and its reason?
• What is the market share of the companies by CDx technologies which include Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next Generation Sequencing (NGS), and Polymerase Chain Reaction (PCR)?
• Who are the key manufacturers in the companion diagnostics market and what are their contributions?
• What is the scope of each companion diagnostic technology in North America, Europe, and Asia-Pacific?
• What are the key regulatory implications in developed and developing regions for companion diagnostics?
• What is the growth potential of companion diagnostics in each region?
• Which companion diagnostic technology is having most promising growth and in which indication type?
The key manufacturers who have been contributing significantly to the companion diagnostics market include Abbott Laboratories, Agilent Technologies, Inc., ARUP Laboratories, bioMérieux S.A., Danaher Corporation, F. Hoffmann-La Roche AG, Illumina, Inc., Invivoscribe Technologies, Inc., MolecularMD Corporation, Myriad Genetics, Inc., QIAGEN N.V., Thermo Fisher Scientific Inc., among others.
Executive Summary
The global healthcare expenditure was valued approximately $7 trillion in 2015 and is expected to reach over $8.5 trillion by 2020, owing to the increasing prevalence of chronic diseases, such as cancer, diabetes, cardiovascular diseases, and respiratory diseases, among others. In addition, the rise in global geriatric population and the increase in incidence of communicable diseases, neurodegenerative diseases, and infectious diseases, among others are escalating the economic, social, and clinical burden, across the globe, thereby increasing pricing pressure on the pharmaceutical as well as diagnostic companies. Acknowledging the criticality of the situation, government bodies of several nations have been restructuring their regulatory framework and norms to help companies in reducing treatment costs and expand accessibility to advance healthcare solutions. On the other hand, the healthcare companies are trying to reduce the unnecessary healthcare expenditure by enabling novel treatment approaches and developing cost-effective products based on advanced technologies. Advent of precision medicine, a patient-centric treatment approach based on biomarker study, is perceived to be promising in driving a paradigm shift in the healthcare industry. This biomarker-based, targeted medication would not only facilitate in eliminating the uncertainty of trial and error method of medications, but also eliminate unnecessary healthcare expenditure.
In the era of precision medicine, the number of commercialized predictive biomarker assays has increased tremendously, especially in case of chronic diseases, to facilitate the development of targeted therapeutics.These biomarker-based assays, known as companion diagnostics (CDx), not only aid in parallel development of targeted drugs, but also provide essential information for patient stratification to enable effective and safe use of corresponding treatment.
Till date, healthcare industry has witnessed several successful drug-diagnostic co-developments mostly for oncology.However, successful commercialization and approval of CDx for multiple cancer types, including lung cancer, breast cancer, leukemia, colorectal cancer, gastric cancer, ovarian cancer, and melanoma, have further drawn attention of several pharmaceutical and diagnostic companies to venture into this lucrative market by developing non-oncology CDx solutions, especially for indications such as neurodegenerative diseases, infectious diseases, metabolic disorders, and cardiovascular diseases, thereby enhancing the growth of global CDx market.
The global companion diagnostics market is expected to reach $4.1 billion by 2025. With increasing demand for NGS-based companion diagnostics, the global CDx market is expected to witness double digit growth rate during the forecast period 2018-2025. In addition, PCR-based companion diagnostics is expected to be dominating among the other technology-based products, in 2025. In 2017, companion diagnostics for lung cancer was responsible for a 27.20% share of the global market value.
The purpose of the study is to gain a holistic view of the global companion diagnostics market in terms of various factors such as recent trends and technological advancements, influencing the market.The scope of this report is centered upon conducting a detailed study of the products allied with the companion diagnostics market, which includes various technology-based products such as Immunohistochemistry (IHC), In Situ Hybridization (ISH), Next Generation Sequencing (NGS), and Polymerase Chain Reaction (PCR).
However, the market estimation only comprises manufacturers of companion diagnostics.The companion diagnostics market is segmented into three different parts namely technology, indication, and region.
The global market value was estimated using these three different approaches and was validated with one another. These segments are further segmented into several sub-segments to ease the market estimation and to gain a holistic view of the market.
Based on the region, the global companion diagnostics market is segmented into North America, Europe, Asia-Pacific, and Rest-of-the-World (RoW). North America is the leading contributor to the global companion diagnostics market and was responsible for a 52.53% share of the global market values in 2017. However, Asia-Pacific is expected to grow at a CAGR of 32.06% during the forecast period 2018-2025.
The key companion diagnostics manufacturers who have been contributing significantly to the companion diagnostics market include Abbott Laboratories, Agilent Technologies, Inc., ARUP Laboratories, bioMérieux S.A., Danaher Corporation, F. Hoffmann-La Roche AG, Illumina, Inc., Invivoscribe Technologies, Inc., MolecularMD Corporation, Myriad Genetics, Inc., QIAGEN N.V., and Thermo Fisher Scientific Inc., among others.
Countries Covered
• North America
• The U.S.
• Canada
• Europe
• The U.K.
• Germany
• France
• Italy
• Spain
• Rest-of-Europe
• Asia-Pacific
• China
• Japan
• India
• Australia
• Singapore
• Rest-of-APAC
• Rest-of-the-World
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