Global next generation cancer diagnostics market size was valued at USD 2,161.2 million in 2014. Key growth drivers of this sector include rising advancements in genomics and proteomics based research coupled with increasing the prevalence of oncology disorders.
Further advancement of diagnostic laboratories and adoption of more integrated and automated lab systems are also factors expected to fuel demand for advanced workflow systems and boost revenue generation through to 2022.
Development and introduction of extensive product offerings from a number of large industry entities are a significant factor expected to provide the lucrative avenues for growth in this market. Companion diagnostics and its associated tandem growth related to the advancement of personalized medicine and advanced genomic medicine have poised this industry to exhibit potentially high-value avenues and opportunities for growth over the forecast period.
The introduction of government reforms targeted towards the tumor eradication by the introduction of novel diagnostic and prognostic methodologies is anticipated to propel substantial progress in this industry in the coming seven years. Rise in the number of projects undertaken by oncologists for gaining insights into tumorigenesis mechanism, consequently leading to enhancement in demand for serial sampling, diagnosis, and therapeutic manipulation is also a growth rendering driver of next generation cancer diagnostics sector.
Active participation of global organizations such as National Cancer Institute, Cancer Research Institute, National Foundation for Cancer Research, and Cancer Research UK are supportive of the projected sector progress.
U.S. Next Generation Cancer Diagnostics Market, By Technology, 2015-2022 (USD Million)
Key technologies analyzed in this study are DNA microarrays, protein microarrays, RT-PCR, NGS sequencing, and lab-on-chips technologies. Advantages such as determination of gene duplications or deletions, melting curve analysis for the identification of mutations, and profiling available with real-time PCR technology for tumor profiling in clinical laboratories are factors supportive of the larger share of this segment.
PCR-based methods are also found to be cost-effective relative to traditional testing procedures and the availability of plethora of procedures for analysis of real-time PCR data are key drivers rendering growth in this segment
DNA and protein microarrays are anticipated to witness a reduction in usage rate as a result of a positive shift in the preference rate of NGS-based technology. Rising maturity in NGS systems and ancillary protocols for library preparation and data analysis tools have certainly contributed to its increasing popularity among the research community. Market sentiments analysis as published by certain major market entities has also mentioned that DNA microarrays are expected to lose a major part of their market share to NGS-based diagnostics over the coming decade.
As per the function, next generation cancer diagnostics industry is broadly classified into risk analysis, tumor screening, prognostic diagnosis, therapeutic monitoring, & companion diagnostics.
Companion diagnostics is projected to register substantial growth over the forecast period because of the introduction of companion tests with therapeutics to diagnose safety and effectiveness of corresponding biological products used.
In July 2015, Roche’s Cobas Mutation Test v2 based on the EGFR mutation was submitted for pre-market approval to the U.S. FDA, as companion diagnostic test for AZD9291 that is an investigational therapy by AstraZeneca for the treatment of non-small cell lung cancer.
In October 2015, Dako, an Agilent Technologies company announced the U.S. FDA approval of a new companion diagnostic assay for non-small cell lung tumor. There are a number of similar companion diagnostic products in the pipelines of major market entities and their expected commercialization over the coming seven years will provide lucrative avenues for growth.
Types of Cancer Insights
Depending on the site of tumor development the cancer types are majorly categorized as breast, cervical, colorectal, unknown primary, leukemia, lung, & prostate cancer among others.
Lung tumor is the dominant segment with respect to revenue in 2014 because of a comparatively higher number of research projects and patent applications filed in this segment. Furthermore, lung cancer also has the highest prevalence at a global level and therefore warrants a larger section of the market dedicated to catering to the huge patient base. However, breast oncology disorders are expected to witness considerable growth over the forecast period owing to rise in its incidence rate that would augment the demands for diagnostic and screening technologies.
Owing to the fact that biomarker tests have exhibited accuracy levels as high as 90% in investigational studies and provide enhanced sensitivity for the screening of tumors, it is expected that through to 2022, this segment will experience a significant growth in demand throughout the forecast period.
Rise in the number of research projects for circulating tumor cell detection for deciphering complex processes leading to tumor metastasis in effective development of oncology therapeutics is anticipated to influence substantial growth in the sector over the forecast period.
North America dominated the next-generation oncology diagnostics industry with a revenue share of over 40%. The launch of favorable initiatives by the government such as the “80% by 2018” movement is expected to boost the market over the forecast period. In this movement, over 170 organizations including government health departments, medical professional societies, cancer coalitions, and health departments have committed to eliminate oncology diseases and are working to achieve shared goal of reaching 80% screening for oncology disorders by 2018.
Asia Pacific is expected to be one of the fastest growing regions of this sector and is projected to grow at a lucrative rate. Factors accounting for faster growth herein include a largely untapped market base which has exhibited technological advancement in healthcare research over the latter half of the past decade. Considerably higher investments in healthcare research and economic enhancement of these regions are further expected to enhance industrial potential through to 2022.
Key market contributors present in the next generation cancer diagnostics industry are Johnson & Johnson, Novartis AG, Cepheid, Roche Holdings AG, Philips Electronics NV, Abbott Laboratories, GE Healthcare, Thermo Fisher Scientific Inc., Agilent Technologies Inc., Perkin Elmer Inc., Illumina Inc., Sysmex Corporation, Qiagen, Hologic Inc., Myriad Genetics Inc., Almac Group Limited, Opko Health Inc., and Genomic Health Inc.
Industry participants are involved in geographic expansion by providing clinical testing facilities in untapped regions of the market. Additionally, participants are involved in gaining reimbursement. For instance, in October 2015, Medicare initiated the coverage of Oncotype Dx for prostate cancer in the U.S.
This study comprises of different tests involved for the diagnosis of cancer which are studied in order to provide validated data on their usage rate and preference by physicians. The variable analysis is carried out keeping into consideration various parameters of the tests such as accuracy, sensitivity, turn-around time, and costs.
Market estimates are based on the availability of the given test of interest along with its application in serving cancer diagnosis and progression monitoring. Revenue and product penetration of the dominant players operating herein are the factors taken into consideration while estimating the market size and segmentation. The rise in the adoption of companion diagnostics in cancer eradication coupled with personalized medicine is factor propelling growth in this market.
Dominant players in the cancer therapeutics market are involved in collaborations with the diagnostic firms in order to monitor disease progression. Thus, next generation of cancer diagnostics which focus less on therapy and concentrate more on early, efficient and rapid early diagnosis is an aspect of the market gaining substantial attention in the field of biotechnology and clinical diagnostics.
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