LONDON, June 7, 2017 /PRNewswire/ -- INTRODUCTION
Cancer is an extremely complex disease and medical science is still struggling to figure out the reasons and factors that influence the disease origin, propagation, spread (metastasis) and relapse. In 2017, a total of 1.7 million new cancer cases are estimated to be diagnosed in the US alone; during the same time period, close to 0.6 million patients are estimated to die due to cancer. The high cancer mortality rate is primarily due to delay in detection of the disease.
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Therefore, in addition to satisfying the unmet market need for advanced and efficient treatment interventions, early cancer diagnosis and screening form an important component of disease prevention and cure. Early diagnosis increases the survival rate that is unlikely to happen if the disease is identified at an advanced stage.
Invasive cancer diagnostic methods such as tissue biopsies have been the gold standard to determine the clinico-pathological characteristics of cancer tissues for many years. The procedure is not only cost-intensive but is also a traumatic experience for the patients. Additionally, endoscopies such as colonoscopy, gastroscopy and laparoscopy are also employed for cancer diagnosis. However, biopsies and endoscopies only offer insights of the disease state at a single point of time. They are unable to measure the disease progression or monitor the effects of the administered therapy over the treatment period. Therefore, the current cancer diagnostics market faces a pressing need for more accurate non-invasive methods of diagnosis to ensure better patient care.
There are several advanced approaches that are not only non-invasive / minimally invasive but also outweigh the limitations posed by invasive diagnostic procedures. Liquid biopsy has emerged as a promising non-invasive cancer diagnostic tool that analyzes biofluids (blood, urine or plasma) to detect rare cells and biomarkers such as circulating tumor cells (CTCs), circulating tumor DNA / RNA (ctNAs) or exosomes.
Moreover, liquid biopsies are capable of not only analyzing the tumor state at the time of sample extraction but can also monitor and track changes in tumor genetics over the course of treatment. In addition to liquid biopsy, the market is gradually witnessing the emergence of several other non-invasive diagnostic technologies that exploit skin lesions, bronchial fluid and exhaled breath as samples to trace signatures of cancer. These tests use gene expression profiles, biomarker analysis, volatile organic compound detection and other advanced techniques of molecular genetics to identify a particular cancer indication.
These non-invasive diagnostic techniques, backed by patient success stories, awareness and the availability of successful clinical validation data for several cancer indications, hold a significant promise and are anticipated to replace the existing invasive diagnostic tools in the coming few years. In fact, social media platforms, such as Twitter, have witnessed an increasing volume of tweets over the years.
Between 2010 and 2016, we were able to identify over 7,000 tweets; this clearly indicates an upsurge in the popularity of these non-invasive tests in the given time period. With liquid biopsy on the forefront, the overall non-invasive cancer diagnostics market is likely to receive a significant boost in the near future.
SCOPE OF THE REPORT
The 'Non-Invasive Cancer Diagnostics Market (2nd Edition), 2017-2030' report provides an extensive study on liquid biopsy kits / assays that are either commercialized or are under development for diagnosis and / or monitoring of different types of cancer. The market is characterized by the presence of several companies that have proprietary technologies / platforms for either isolation / enrichment / enumeration of CTCs or for molecular characterization / 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, and patient and recurrence monitoring of different cancer indications. Such kits are likely to transform the cancer diagnostics market with many commercial success stories in the near future.
The market is primarily led by start-ups / small companies, such as (in alphabetical order) CellMax Life, Celsee Diagnostics, Datar Genetics, DiaDx, EONE-DIAGNOSTICS Genome Center, Exosome Sciences, iCellate Medical, Inivata, IVDiagnostics, LCM Genect and MDNA Life Sciences. It also has presence of mid to large-sized pharma players; notable examples include (in alphabetical order) Biocartis, Counsyl, Foundation Medicine, Genomic Health and NeoGenomic Laboratories.
In addition to the aforementioned players, a number of pharma giants are also developing assets in this field. Prominent players under this category include (in alphabetical order) Affymetrix, Menarini Silicon Biosystems, Myriad Genetics, QIAGEN, Roche, Siemens Healthineers and ThermoFisher Scientific.
As companies continue to initiate and expand their research programs and platforms in this area, one of the key objectives of this report was to understand the future potential of the market.
Amongst other elements, the report provides information on:
- The overall landscape of liquid biopsies and other novel non-invasive diagnostic tests with respect to the stage of development, type of markers (CTCs / ctNA / exosomes), test sample source (blood / urine / others), indications and type of application (early diagnosis / recurrence monitoring / patient monitoring). Additionally, the market overview highlights the geographical distribution and coverage of the tests across the globe, depicting the activity of this domain in different regions of the world.
- Comprehensive profiles of the popular tests and systems highlighting details on development status, specifications and advantages, clinical information, and related collaborations. Additionally, we have provided detailed profiles of the key players involved in the domain.
- The impact of venture capital funding in this area. It is important to mention that since the industry has witnessed the emergence of several start-ups, funding is a key enabler that is likely to drive both innovation and product development in the coming years.
- An elaborate valuation analysis of start-ups and small players that are involved in the liquid biopsy domain. We built a multi-variable dependent valuation model to estimate the current valuation of a number of companies focused in this domain.
- The emerging trends and the popularity of liquid biopsy on social media platforms, such as Twitter, over the last few years. The volume of tweets has witnessed an increasing trend in the last six years, influenced by the approval and launch of several liquid biopsy tests in the market.
- The competitive landscape of the players involved in the space. This is represented as an illustrative bubble analysis, which is based on parameters such as the liquid biopsy portfolio of a company, its number of employees and geographical coverage of the tests.
- Contribution of the other non-invasive cancer diagnostics market, taking into account the number of tests and the sales registered by the marketed tests.
In addition, we have provided a comprehensive market estimation to determine the global evolution of the liquid biopsy market. This has been done by evaluating the likely success of key applications of early diagnosis, recurrence monitoring and patient monitoring. We have included insights on the likely regional evolution of the market covering US, EU5 and rest of the world.
In addition, we have estimated the likely contribution of different target patient populations to the global market; this covered key indications including (in alphabetical order) bladder cancer, breast cancer, colorectal cancer, gastric cancer, lung cancer, melanoma, ovarian cancer, pancreatic cancer and prostate cancer. Further, we segmented the market by the type of markers (CTCs, ctNAs, exosomes) and the sample source (blood, urine, saliva) used in different liquid biopsies. In order to account for uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios for the time period 2017-2030.
The conservative, base and optimistic scenarios represent three different tracks of the industry's evolution. The research, analysis and insights presented in this report are backed by the deep understanding of key insights gathered from both secondary and primary research.
Our opinions and insights presented in this study were influenced by discussions that we conducted with several experts in this area. These included contributions from (in alphabetical order of companies) Burkhard Jansen (Chief Medical Officer, DermTech), Christer Ericsson (Chief Scientific Officer, iCellate Medical), Frank Szczepanski (President and CEO, IVDiagnostics), Riccardo Razzini (Sales and Marketing Manager, LCM Genect), Philippe Nore (CEO and Co-founder, MiNDERA Corporation), Nathalie Bernard (Marketing Director, OncoDNA), Abizar Lakdawalla (Founder, ProXeom), Mark Li (CEO, Resolution Bioscience) and Jake Micallef (Chief Scientific Officer, VolitionRx). All actual figures have been sourced and analyzed 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 10-15 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 the global burden of the disease. 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 liquid biopsy market. It lists the liquid biopsy tests, technologies and systems. In addition, the chapter includes a detailed analysis of the liquid biopsy tests based on the development stage (available for patients / RUO / under development), sample type (blood / plasma / urine / multiple), type of markers detected (CTCs / ctNA (DNA) / exosomes / multiple / others), indication and type of application (early detection / patient monitoring / recurrence monitoring).
Chapter 6 offers an illustrative bubble analysis representing the competitive landscape of the players involved in the space, based on their liquid biopsy portfolio, number of employees and geographical coverage. In addition, it presents a Venn diagram depicting the distribution of liquid biopsy products across different application areas. The chapter elucidates the emerging trends and the popularity of liquid biopsy on social media platforms, such as Twitter, over the last few years.
Chapter 7 offers a comprehensive discussion on liquid biopsy. We have talked about the emerging need for liquid biopsy highlighting its advantages, and the related challenges. In addition, we have provided profiles of several liquid biopsy products and technologies. These products belong to those companies that were identified as active players in the bubble analysis presented in Chapter 6. The chapter also mentions the liquid biopsy companion diagnostics, which are being co-developed as part of strategic collaborations.
Chapter 8 presents details on the investments and grants received by companies working in the field of liquid biopsy. The analysis highlights the growing interest of the venture capital community and other strategic investors in this market.
Chapter 9 features a comprehensive valuation analysis of the companies that are developing liquid biopsy tests / technologies / systems / platforms / instruments. The chapter provides insights based on a multi-variable dependent valuation model. The model is based on the future potential of the companies' uniqueness, their current popularity, funding received, year of establishment and the employed workforce.
Chapter 10 provides detailed company profiles of the leading players that are involved in the development of liquid biopsy tests. Amongst other details, each profile includes information such as the company overview, financial performance, product portfolio (technical specifications and clinical information) and recent collaborations.
Chapter 11 provides an overview of the other non-invasive diagnostics for oncology. It highlights different diagnostics tests, including non-blood based biomarker detection tests (saliva-based biomarker detection, stool-based metabolic biomarker detection, skin-based biomarker detection, semen-based biomarker detection and urine based biomarker detection), DNA methylation detection test, fecal occult blood test and fecal immunochemical test, MicroRNA (miRNA) based test, pigmented lesion assay, stool DNA (sDNA) testing, and Volatile Organic Compound (VOC) detection test. The diagnostic procedures discussed in this chapter are backed up by several examples. In addition, the chapter illustrates a detailed analysis on the survey conducted for gaining a deeper understanding on the nature of products and services offered by the companies.
Chapter 12 highlights the market forecast and sizing of the overall non-invasive cancer diagnostics market. This chapter discusses, in detail, the parameters that are likely to influence the evolution of liquid biopsy market. It features detailed insights on the likely market evolution for across different application areas such as early diagnosis, patient monitoring and recurrence monitoring. Additionally, the chapter presents a detailed market segmentation by the key indications, types of markers (CTCs, ctNAs, exosomes) and types of samples (blood, urine, saliva). The chapter also highlights the likely distribution of the market across the US, EU5 and RoW (including Asia) regions. We have also presented an informed view on the contribution of the other non-invasive tests in the overall non-invasive cancer diagnostics market.
Chapter 13 summarizes the overall report. In this chapter, we have listed the key takeaways and have provided our independent opinion based on the research and analysis described in previous chapters.
Chapter 14 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the insights provided to us by Burkhard Jansen (Chief Medical Officer, DermTech), Christer Ericsson (Chief Scientific Officer, iCellate Medical), Frank Szczepanski (President and CEO, IVDiagnostics), Riccardo Razzini (Sales and Marketing Manager, LCM Genect), Philippe Nore (CEO and Co-founder, MiNDERA Corporation), Nathalie Bernard (Marketing Director, OncoDNA), Abizar Lakdawalla (Founder, ProXeom), Mark Li (CEO, Resolution Bioscience) and Jake Micallef (Chief Scientific Officer, VolitionRx)
Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 16 is an appendix, which provides the list of companies and organizations mentioned in the report.
1. We identified over 110 liquid biopsy tests; of these, 60% of the tests are currently available for patients while the remaining are either available for research use only (RUO) or are under development. Further, of the total tests, 36% detect the presence of ctDNA in the sample, nearly 41% detect CTCs and 4% validate the presence of exosomes. Close to 19% of the liquid biopsy tests identify the presence of multiple / other markers.
2. It is worth highlighting that there are seven liquid biopsy tests that are being explored for use as companion diagnostics. Many partnerships have been inked to co-develop liquid biopsy companion diagnostic products; notable examples include collaborations between BMS and GRAIL (2017), Merck and Sysmex Inostics (2016), Biocept and Baylor College of Medicine (2015), QIAGEN and Tokai Pharmaceuticals (2015), ANGLE and MD Anderson Cancer Center (2015), and AstraZeneca and QIAGEN (2015).
3. Considering the future potential of these diagnostic kits and systems, several investors have made substantial capital commitment to drive future development. We identified approximately 196 funding instances amounting to capital investments (equity / debt / grants) of over USD 3.8 billion between 2011 and 2017; these investments were made either directly or indirectly to support the development of liquid biopsy products. In 2016 alone, driven by increased venture capital activity, amount worth USD 770 million was invested in different companies.
4. It is worth highlighting that with the rising activity in the field of cancer diagnostics, pharmaceutical players have been keen to explore the acquisition opportunities in this domain. In the Roots Analysis proprietary valuation analysis of over 40 start-ups / small companies, we identified nine companies that are likely to achieve valuation of over USD 500 million.
5. The market, primarily driven by the sales generated by liquid biopsy tests, is anticipated to register a growth rate of 19% between 2017 and 2030. The current market is dominated by the tests that offer patient monitoring (63% share). Specifically, catering to the high unmet need for timely treatment, the share of early diagnosis is likely to increase from 20% in 2017 to over 40% by 2030.
6. Among specific indications, we believe that prostate cancer is likely to capture the largest share of the market (~15%). Subsequently, owing to the large target patient population, breast cancer is likely to capture a share of 14% by 2030. In addition, lung cancer is also likely to capture a significant market share of 12% by 2030. It is worth highlighting that, despite the low prevalence of lung cancer, the demand of liquid biopsies is significantly high as tissue biopsy is extremely difficult in case of lungs.
7. With regard to the geographical activity, in 2017, the US is likely to capture the maximum share (43%) followed by EU5 (34%) and Rest of the World (RoW, 23%). The overall trend is unlikely to change significantly in 2030; however, regions in RoW are likely to occupy a larger share in 2030 (29%). It is important to highlight that, within RoW, Asian countries such as China, India, Japan, have several developers and distributors of liquid biopsy tests, demonstrating an elevating activity within these regions.
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