全球无创癌症检测市场大调研(2nd Edition), 2017-2030

导语

爱尔兰市场研究与市场数据网站 Research and Markets 对全球癌症无创检测行业做了一次详细的调研报告。

近年来出现了许多新的癌症检测手段，可以达到微创甚至无创的的效果。目前用的比较多的应该是液体活检，可以利用血液，尿液或者唾液等体液去检测癌症生物标记物，如循环肿瘤细胞(CTCs)，循环肿瘤DNA(ctDNA)和外泌体等。它可以在CT检测之前探测到癌症的存在，并且在治疗过程中监控肿瘤变化。现在市场上也开始逐渐涌现出可以采样皮肤，支气管液和呼出气体的癌症检测技术。

市面上不少公司拥有癌症生物标记物检测平台，开发用于无创癌症检测，预测和病人复发检测等的液体活检试剂盒将为癌症检测市场创造更大的商业价值。新兴的小公司目前作为行业的领头羊，一些中型公司甚至制药巨头公司也开始涉足这个行业，比如我们生物狗常常听见的Affymetrix，QIAGEN, Roche和Thermo Fisher Scientific。

报告包括16个章节，还详细介绍了不同种类的液体活检及其在全球应用的地理分布，常用的检测系统，风险投资的影响，对新兴小型公司的估值，社交平台上的液体活检和行业竞争以及其他无创癌症检测市场的贡献等。

调研涉及到全球500多家公司，对癌症无创检测行业未来10-15年的发展做了一个预测。全书链接在这里，不过售价2499刀，感兴趣的可以购买。

(PS:这么贵，你后台回复"调研"我也不会给你全文PDF的啦~)

购买链接：https://www.researchandmarkets.com/research/83b3cb/noninvasive

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. 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.

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 NeoGenomics 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 Thermo Fisher 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.

Example Highlights

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. Seven liquid biopsy tests 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. 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 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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