LONDON, Nov. 10, 2016 /PRNewswire/ -- INTRODUCTION
Cancer is an extremely complex disease and medical science is still struggling to figure out the factors influencing the disease origin, propagation, spread (metastasis) and relapse. In addition to satisfying the unmet market need for advanced and efficient treatment interventions, cancer prevention, early detection and management is extremely important. The high cancer mortality rate is primarily due to delay in detection of the disease. Early diagnosis and screening makes it possible to cure the disease completely and/or increase survival rates. Over the years, various technological advances have helped medical professionals understand cancer better. Recent research in cancer biology has led to a lot of innovation in the development of a number of new diagnostic tools. These modern diagnostic techniques can help detect and classify cancer with increased accuracy and sensitivity.
It is also important to highlight that the cost of management and treatment of cancer is a growing concern considering its highly progressive and fatal nature. Performing a biopsy includes costs associated with the equipment, cost of the procedure itself, consultation fees, hospital fees, costs of analytical tests and those associated with post-operative care. To manage this financial burden, the introduction of novel non-invasive techniques, which are cost-effective and more accurate, has become an indispensable necessity.
There are several advanced approaches, which are non-invasive or minimally invasive in nature, and these outweigh the limitations posed by invasive diagnostic procedures. Specifically, liquid biopsy has emerged as a promising non-invasive cancer diagnostic tool for early detection as well as monitoring the disease's progress. This technique of tracing the presence of circulating biomarkers in blood and other biological fluids of cancer patients is becoming increasingly popular in the medical fraternity. In addition to liquid biopsy, the market is gradually witnessing the emergence of several other non-invasive diagnostic technologies. These include techniques based on molecular imaging, advanced genomic and transcriptomic methods of detection of clinically significant biomarkers and identification of nucleosomal levels. All such non-invasive tests hold a significant promise to enhance the quality of patient care.
SCOPE OF THE REPORT
The 'Non-Invasive Cancer Diagnostics Market, 2015-2030' report provides an extensive study on liquid biopsy kits/assays that are either commercialised or under development for the diagnosis of different types of cancer. Liquid biopsy primarily focuses on the detection, isolation and characterisation of biomarkers from circulating tumour cells (CTCs), circulating tumour DNA (ctDNA) or exosomes present in biological fluids, which can be collected in a single blood draw. The market is characterised by the presence of several companies that have proprietary technologies/platforms for either isolation/enrichment/enumeration of CTCs or molecular characterisation/sequencing of the genetic material extracted from the CTCs/exosomes. Based on these platforms, a number of liquid biopsy kits and systems are being developed for non-invasive diagnosis, prognosis, patient and recurrence monitoring. It is important to stress that even though liquid biopsy has still not made a strong foothold in the field of oncology, it is likely to transform the cancer diagnostics market with many commercial success stories in the near future.
In addition to liquid biopsy, there are several other novel and promising non-invasive diagnostics being developed for the diagnosis and prognosis of cancer. However, these tests are only indicative of the disease and may require further validation through more robust diagnostic methods such as biopsy. These tests retrieve the test sample non-invasively and use innovative techniques to screen for the desired parameters indicative of the disease with a moderate level of accuracy. Some of these are designed to be used at home by the patient itself.
As companies continue to initiate and expand their research programs and platforms in this area, one of the key objectives outlined for this report is to understand the future potential of the market. This is done by analysing:
- The global burden of cancer in terms of incidence and prevalence of different cancer indications across different geographies.
- The overall landscape of liquid biopsies and other novel diagnostic tests with respect to the type of analysis (CTCs/ctNA/exosomes), test sample source (blood/urine/others) and indications.
- The likely global evolution of the liquid biopsy market taking into account initial diagnosis, recurrence monitoring and patient monitoring.
- Contribution of other novel diagnostic tests in the non-invasive cancer diagnostics market and the market opportunity of the key indications influencing the overall growth.
We have provided three market forecast scenarios for the time period 2015-2030. The conservative, base and optimistic scenarios represent three different tracks of industry evolution. Our opinions and insights, presented in this study, were influenced by discussions that we conducted with experts in this area. All actual figures have been sourced and analysed from publicly available information and discussions with industry experts. The figures mentioned in this report are in USD, unless otherwise specified.
Most of the data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Industry analysts' views
While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
Chapter 2 presents an executive summary of the report. It offers a high level view on where the market for liquid biopsy and other novel non-invasive diagnostics is headed in the mid to long term.
Chapter 3 provides a general introduction to cancer statistics and burden of the disease worldwide. In this section, we have also highlighted the importance of early detection of the disease through diagnosis and asymptomatic screening. The chapter outlines the conventional invasive diagnostic tests, which are widely used for cancer diagnosis and prognosis.
Chapter 4 discusses in detail the need for non-invasive cancer diagnostics and their importance. We have highlighted the underlying concept of liquid biopsy and other non-invasive tests. In addition, we have mentioned the principle behind common imaging tests that are deployed in cancer diagnosis.
Chapter 5 provides a holistic view of the non-invasive cancer diagnostics landscape. It enlists the liquid biopsy tests, technologies and systems. In addition, it offers a list of other non-invasive tests. These lists include information on the developer, technology used by the product, test sample source and indication. We have also mapped the geographical presence of the enlisted non-invasive cancer diagnostics developers.
Chapter 6 offers a comprehensive discussion on liquid biopsy. We have talked about the emerging need for liquid biopsy highlighting its advantages and challenges. In addition, we have provided technology profiles and product profiles of several liquid biopsy products. The chapter also mentions the liquid biopsy companion diagnostics, which are being co-developed as part of strategic collaborations.
Chapter 7 provides an overview of the other novel non-invasive diagnostics used in oncology. It highlights the different imaging based diagnostic procedures, biomarker and nucleosome based diagnostics, skin lesion and breath based diagnostics. The diagnostic procedures discussed in this chapter are backed up by several examples.
Chapter 8 highlights the market forecast and sizing of the overall non-invasive cancer diagnostics market. This chapter discusses, in detail, the parameters likely to influence the evolution of liquid biopsy market. In addition, we have also presented the market share of other non-invasive diagnostic tests and an opportunity analysis for the key indications likely to have the maximum impact on the overall market.
Chapter 9 provides detailed company profiles of the leading players in the market involved in the development of liquid biopsy as well as other non-invasive tests. Amongst other details, each profile includes information such as the company overview, financial performance, product portfolio and recent collaborations.
Chapter 10 summarises the overall report. In this chapter, we list the key takeaways and provide our independent opinion based on the research and analysis described in previous chapters.
Chapter 11 is a collection of interview transcripts of the discussions that were held during the course of this study.
Chapter 12 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 13 is an appendix, which provides the list of companies and organisations mentioned in the report.
1. We have identified over 50 liquid biopsy tests; some of these are commercialised and the rest are currently under development. Of these, 50% tests are based on the identification of disease biomarkers in ctDNA of the test sample. Nearly 37% of the tests are based on the enumeration/analysis of CTCs in the sample and the remaining 13% validate the presence of the disease from the information obtained from exosomes.
2. Several companies are developing systems and instruments to support the detection, isolation and characterisation of rare cells. Examples include (in no specific order) the Parsortix System by ANGLE, ScreenCell® Isolation Devices by ScreenCell, ApoStream™ System by ApoCell, ClearCell FX® System by Clearbridge BioMedics and iCellate® Instrument by iCellate Medical.
3. Firms have also taken initiatives and entered into collaborations to co-develop liquid biopsy companion diagnostic products; notable examples include collaborations between Tokai Pharmaceuticals and Qiagen, AstraZeneca and Qiagen, Sysmex Inostics and Bayer HealthCare.
4. In addition to liquid biopsy, we have identified close to 40 other non-invasive cancer diagnostics that are used for screening, diagnosis, prognosis and patient monitoring; these include techniques based on molecular imaging, advanced methods of detecting clinically significant biomarkers and identification of nucleosomal levels.
5. Primarily driven by liquid biopsy, the non-invasive cancer diagnostics market is anticipated to grow aggressively at a healthy annual growth rate of 44% between 2015 and 2030. Prostate cancer, breast cancer, colorectal cancer and lung cancer are likely to be the key indications which will drive the market; combined, these are expected to account for over 70% of the total liquid biopsy market in 2030.
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