2016 genetic testing industry analysis
November 30, 2016 Source: Jing Yesi Finance
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];If it is a company upstream of the gene sequencing industry, the products are sold to a wide range of target customers, covering the fields of scientific research, medical treatment, and commodity inspection. Products include sequencers, DNA extraction kits, capture kits/multiplex sub-amplification kits, and library kits. The on-machine sequencing kit, in which the sequencer and the on-machine sequencing kit are bound, the DNA extraction kit, the capture kit/multiplex sub-amplification kit, and the library kit can be used by third-party products, domestically. Enterprises can cut in from these three directions, but the most critical tool enzymes and separation materials in the kit are mainly imported products, and the barriers are high. If the import substitution of these two products can be realized, the company has a higher Strong technical strength.
At present, there are more than 200 companies involved in the concept of genetic testing in the country. According to the scope of business, these companies can be divided into:
1 The most upstream genetic testing instrument development company (sequencer, chip scanner, PCR equipment);
2 Provide middle and upper reaches of the sample processing reagents and consumables (building library kit, test kit, tool enzyme, gene chip );
3 Middle-end enterprises that provide third-party genetic testing services;
4 providing downstream enterprises for sequencing data storage, analysis and reporting;
5 There are also commercial companies that integrate these three parts to provide CRO services.
Of course, if the company's research and development strength and economic strength allow, most companies will choose to extend the upstream and downstream industry chain to further enhance their profitability.
According to the services of genetic testing companies, they can be divided into four categories: scientific research services, third-party clinical genetic testing services, direct-to-individual testing services, and non-medical genetic testing services (such as food, environmental, criminal investigation, etc.).
The content we share today focuses on the use of genetic testing in medical diagnosis . This field has a wide audience, high added value and large market space. Including the following aspects:
Provide medical diagnosis services for patients in the name of scientific research : doctors play a leading role in recommending patients who need to do genetic testing. The benefits that doctors get are the guidance of medication, scientific research data, and sales commission. At present, the methods commonly used in tumor gene sequencing are currently adopted. Because at present, only NIPT has been approved for clinical high-throughput detection kits for tumors , and other medical diagnostics that can only be disguised in the form of scientific research can obtain benefits. The pure scientific research genetic testing market is at the level of 10 billion.
Approved third-party independent medical laboratory for testing outsourcing services for hospitals: these institutions can carry out molecular diagnostic services (subject to PCR laboratory certification by the clinical inspection center), such as QPCR, ddPCR, gene chip, etc., but high throughput The application of sequencing in clinical testing is currently limited. Only the institutions on the pilot list can issue formal clinical reports. Currently, the first four pilot areas are listed, namely genetic diagnosis, prenatal screening and diagnosis, preimplantation embryos genetic diagnosis, tumor gene sequencing, the list of pilot unit developed jointly by the health Planning and Maternal and Child Hospital Authority Medical Administration Division. The market for clinical genetic testing is at the level of 100 billion.
Commercialized B2C gene testing: Commercial companies that provide personal genetic testing services generally provide non- diagnostic genetic testing, while China has many direct-to-individual genetic testing commercial organizations, including even disease risk, natural genetics, and personality traits. Such as a series of genetic analysis services, there will be pressure to strengthen supervision and integration in the future. The market space is at the billion level.
Non-medical genetic testing services: including food, environmental microbes, criminal investigation, inspection and quarantine, etc., belonging to the fragmentation market, involving many fields, and the space is at the level of 10 billion.
I. Analysis of the supervision and trend of the genetic testing industry
China's genetic industry is in the early stage of the rise of the market, and the regulatory system is still very imperfect, giving people a very confused feeling. Before 2014, China's gene sequencing industry was in an unregulated state; in February 2014, CFDA and the Health Planning Commission stopped all gene sequencing businesses to focus on the industry; in March 2014, the Health Planning Commission issued “About Qualcomm†The notification of the application of the genetic testing technology clinical application pilot unit, the notice requires that the high-throughput gene sequencing technology has been carried out, and the medical institutions that meet the requirements of the application can apply for the pilot and specify the genetic sequencing project for the pilot application. In December 2014, the Health and Medical Administration of the Health and Family Planning Bureau issued the first batch of clinical sequencing clinical trials for genetic diagnosis, prenatal screening and diagnosis, and preimplantation embryo genetic diagnosis . Subsequently, 2015 month, Maternal and Child health Division of Planning Commission formally approved 108 health care institutions in the clinical trial of high-throughput sequencing technology NIPT, and review the clinical trial conduct genetic diagnosis preimplantation embryos by 13 institutions; in March 2015, medical affairs medical tube The Bureau released the first clinical trial list of high-throughput sequencing for tumor diagnosis and treatment programs. Since then, CFDA has approved several instruments, detection reagents, etc. for high-throughput sequencing.
So who is regulated by the genetic testing industry, how is it regulated, and what is the scope of supervision? We did the following sorting out.
Regulatory authorities: The entire genetic testing industry involves a large number of sub-sectors, including hospitals, clinical inspection centers, instrument reagents, commercial companies, and different technology platforms. Therefore, there are many regulatory authorities involved.
1 Development and Reform Commission, from the macroscopic development of the genetic testing industry development plan: In June 2015, the National Development and Reform Commission issued the "Notification of the National Development and Reform Commission on the implementation of major projects in emerging industries," which mentioned the focus on the development of new medical technologies such as genetic testing, It will build 30 genetic testing technology application demonstration centers within 3 years to rapidly promote the clinical application of genetic testing and the localization of genetic testing equipment reagents; in addition, the local development and reform commission is also involved in the pricing of genetic testing projects, such as the Sichuan Development and Reform Commission pricing non-invasive prenatal 2400 yuan / time.
2 The Health Planning Commission mainly reviews and regulates the qualifications of genetic testing institutions. It is regulated by three parts: the Medical and Medical Reform Bureau, the Women and Children Division, and the Clinical Inspection Center: the Medical and Medical Reform Bureau has successively issued genetic disease diagnosis and production. pre-screening and diagnosis, preimplantation genetic embryo diagnosis, cancer diagnosis and treatment of these four professional first gene sequencing clinical trial list, "drug-metabolizing enzymes and drug targets for genetic testing guidelines (trial)", " Technical Guidelines for Individualized Treatment and Detection of Tumors (Trial)"; the Ministry of Women and Children has added 108 medical service institutions to conduct clinical trials of NIPT high-throughput sequencing technology based on the pilot list of the Medical and Medical Reform Bureau. audit to carry out preimplantation embryos genetic diagnosis of clinical trial by 13 institutions; reference system Center rummage responsibility is to undertake clinical laboratory quality management and control work, running between national clinical laboratory quality evaluation plan, build, test clinical application of Evaluation and acceptance of medical laboratories carrying out genetic testing services.
3 CFDA , supervising instruments, reagents, and analysis software on the gene detection chain , such as EGFR, KRAS, BRAF, C-KIT, CYP2C9, CYP2C19 and other gene detection kits, gene chips, etc.; in high-throughput sequencing, CFDA has approved several sequencers and detection reagents for NIPT, but in the diagnosis of tumors , there are currently no high-throughput sequencers and high-throughput test kits approved. The pilot units can only use self-made reagents (LDTs). ) in the form of testing.
Technical supervision: The technology platforms in gene detection mainly include PCR (qPCR, ddPCR), FISH (fluorescence in situ hybridization), gene chip, sequencing (first-generation sequencing, high-throughput sequencing), and currently, in addition to high-throughput sequencing clinical services A restrictive policy has been formulated. Only the pilot unit can issue a preliminary inspection report. The use of other genetic testing technologies, such as PCR, FISH, and first-generation sequencing, is not limited. The clinical inspection unit can be applied as long as it has passed the PCR laboratory and pathology laboratory certification. These technologies.
Institutional regulation: What kind of institutions can carry out high-throughput sequencing clinical services? In addition to the list of pilot clinical high-throughput gene sequencing technology pilot units issued by the Medical and Medical Reform Bureau and the Women and Children Division, there are also “individualized medical testing pilot units†(often referred to as LDT pilots in the industry) approved by the Health Planning Commission. The units include the three institutions of the Central South University Xiangya Medical Laboratory, Beijing Boao Medical Laboratory and the First Affiliated Hospital of China Medical University. The breadth and scope of individualized medical testing pilots are higher than the high-throughput gene sequencing pilot; There are also inspection institutes approved by local health departments, such as “Nanjing High-tech Precision Medical Laboratoryâ€. But even without these qualifications, sequencing services can provide testing services in the form of scientific reports (to circumvent medical testing restrictions), or establish joint laboratories with pilot hospitals to enjoy profit sharing. These all reflect the immature supervision of China's genetic industry. The US clinical inspection agency adopts the form of CLIA/CAP certification. It is very likely that China will adopt similar certification qualifications in the future.
Regulatory application areas: current clinical applications of high-throughput sequencing can only be applied to the pilot diagnosis of genetic diseases, prenatal screening and diagnosis, preimplantation genetic diagnosis and embryo diagnosis and treatment of cancer four professional direction. But in the cardiovascular field, the field of infectious diseases, intestinal microbial metagenomics and other second-generation sequencing has good prospects, the current pilot clinical trial of high-throughput sequencing LDT only in the specific application of a professional direction of future applications The field will become wider and wider.
Supervision of instrument reagents: Approved by CFDA . There are sequencers (binding reagents), library kits, test kits, and analysis software that need to be declared in high-throughput sequencing . In terms of NIPT, CFDA has approved the Huada Gene (BGISEQ-100 life-based Ion Torrent technology, BGISEQ-1000 based on the sequencing technology of Complete Genomics acquired by Huada Gene), and DA Proton's life-based Ion Torrent technology. NIPT second-generation gene sequencer and supporting reagents (BioimnSeq 4000 based on life Ion Torrent technology), Berry and Kang (NextSeq CN500 with Illumina) (Triple, 13 and 21 trisomy detection reagents) Box, on-board sequencing reagents; In terms of tumors , there are currently no high-throughput sequencers and high-throughput test kits approved, and the pilot units can only perform testing services in the form of self-made reagents (LDTs). In the long run, multi-target gene panels (tens of hundreds of genes or targets) high-throughput detection kits are basically not approved, because the site mutation rate is very low, it is difficult to find enough patients to carry out clinical trials. And the test results can not be verified, so these kits can only be used in the form of LTDs in the clinical laboratory, can not be sold; and a small number of target genes (several genes, a small number of mutation sites) detection kit may Will be approved by the CFDA , but from the cost of detection, the detection cost of a small number of target genes will not be lower than the detection of multi-target genes, so the terminal price is not much different. When marketing with multi-target gene panels, it does not have Advantage.
Summary: At present, the clinical application of high-throughput sequencing in China is still very immature. The pilot list is a mechanism that has the qualification to issue clinical test reports. It is not a limitation for other organizations to carry out sequencing services (can be carried out in the form of scientific research). Service), the approval of instruments and reagents is not restrictive, and the market is in the stage of shuffling. The genetic testing company needs to actively prepare for both hands. On the one hand, it prepares for the declaration of the qualification of the clinical inspection, and actively arranges the hospital terminal, on the one hand, the instruments and reagents are started. Approval. In the future, China may adopt similar CLIA/CAP approvals as the United States, and it is expected that the preferential distribution of hospital channels will benefit.
Case (US CLIA certification): In the United States, as long as the CLIA (Clinical Laboratory Improvement Amendments) certification is passed, third-party laboratories can develop various new diagnostic reagents or services according to market demand. Self-built projects or homemade reagents (LDTs). This type of testing can only be used in the laboratory and cannot be circulated or sold to any other laboratory or health care facility, thus keeping the risk to a limited extent and thus does not require FDA approval. At the same time, since CLIA is a laboratory, there is no need to apply for approval for each new service or product. The hospital or patient can choose the appropriate diagnosis according to their own needs. This policy gives third-party laboratories great freedom and the prosperity of independent laboratories in the United States. The most unique aspect of CLIA certification is that laboratory self-constructed projects can provide molecular testing services to guide clinical practice within their laboratories, even without FDA approval. As long as they are CLIA-licensed laboratories, their own research and development of preparations, technologies, etc. can also legally enter the clinic, and reasonable charges. The benefit of this is that in the face of huge medical needs and new technologies that are constantly changing, all CLIA labs can quickly develop new diagnostic applications based on market demand. At the same time, the US government does not have to respond to every new application that is unstoppable. And patients can get new diagnostic services instantly according to their needs. At the same time, the FDA can choose the FDA to consider a really good diagnostic method for further certification, and issue certification in the name of the FDA to accelerate the FDA 's application of good diagnostic methods in the market. As long as the applicant company has passed the CLIA certification and can guarantee the quality of the product, it can be directly applied to the clinic.
Second, the industry focus of gene sequencing: focus on service
Focusing gene sequencing service, it is difficult to rely on goods (detection kits, chips) to establish a separate advantage, that the immunodiagnostic, chemiluminescent different, are ultimately detected as a genetic testing the DNA sequence, and two, The tertiary structure is irrelevant, and the detection principle is relatively simple. The DNA primers are used to target the sequence to be tested, and then the primers are used to extend the sequence. On the contrary, the extraction, storage and capture of the sample DNA is rather cumbersome and requires professional The technician went to the operation. Upstream instruments have been monopolized by a few companies, and the upstream and downstream kit products do not have high technical barriers (of course, if you can form obvious technical advantages in the construction and capture links, or develop more efficient tools) Enzymes are also promising), and there is a large uncertainty in the approval of high-throughput genetic testing kits (in the future, it may refer to the US CLIA-certified method, and qualified testing institutions will use them in the form of LTDs homemade reagents. However, it cannot be sold without the approval of the Food and Drug Administration. The sample size of the hospital is limited. The first entry will definitely occupy many advantages. The NIPT market is close to saturation, and the competition for cancer hospitals is becoming increasingly hot. Therefore, it is the first to seize the market through services. This may be a safer choice.
Will the hospital purchase a sequencer for high-throughput sequencing? If the hospital sorts itself, then the pre-detection organization is bound to be difficult to compete, so it is necessary to think about this factor. This problem should be considered separately. On the one hand, consider the number and needs of users, on the one hand, consider the cost of sequencing. The most widely used high-throughput sequencing is the analysis of NIPT and tumor diagnosis:
In the field of non-invasive prenatal diagnosis, the number of newborns in China is about 15 million per year, and the potential customer base is large. NIPT can give clear diagnosis results and corresponding prevention measures, and the results are related to the health of the next generation. The detection price is 2400. In addition, the accuracy requirements of sequencing for NIPT are not particularly high (currently mainly for the three-body examination of chromosomes 13, 18, and 21), detection is a quantitative process, usually using the life ion torrent platform (currently Among the five approved instruments, three are reported as ion torrents, and some organizations in the United States have adopted gene chips for NIPT. Many large hospitals are able to carry out NIPT services on their own. The target market for third-party sequencing organizations should be in small and medium-sized hospitals.
However, the application of high-throughput sequencing in the field of tumors is not the same. In China, there are about 4.5 million new tumor patients per year, and the price of tumor panel sequencing is between 8,000 and 20,000, and now patients who do tumor panel sequencing are mainly The purpose is to obtain targeted drug medication guidance, targeted drugs are more expensive (monthly medication costs around 50,000), so the target population is even more narrow; in addition, tumor detection requires higher sequencing accuracy, mainly for the point Mutation or micro-deletion micro-repetition, high requirements for the technology platform, usually using Illumina Hiseq/next Seq sequencer, expensive equipment, and high cost of starting reagent supplies (about 150,000 at a time), if there is not enough sample size Basically, every time you turn on your computer, you are losing money; and the analysis of tumor data is complicated, and you need specialized bioinformatics talents and databases, so in the field of cancer (especially in other areas where there are fewer patients), we think Qualcomm The amount of sequencing is still based on third-party clinical inspection agencies, and the target market is in large hospitals.
Third, the development direction of the gene sequencing company (NGS): sequencing is the starting point rather than the end point
If it is a company upstream of the gene sequencing industry, the products are sold to a wide range of target customers, covering the fields of scientific research, medical treatment, and commodity inspection. Products include sequencers, DNA extraction kits, capture kits/multiplex sub-amplification kits, and library kits. The on-machine sequencing kit, in which the sequencer and the on-machine sequencing kit are bound, the DNA extraction kit, the capture kit/multiplex sub-amplification kit, and the library kit can be used by third-party products, domestically. Enterprises can cut in from these three directions, but the most critical tool enzymes and separation materials in the kit are mainly imported products, and the barriers are high. If the import substitution of these two products can be realized, the company has a higher Strong technical strength. In the field of scientific research and commodity inspection, the approval threshold for kits is low, but customized services are required; in the field of medical diagnosis , multi-gene capture kits/multi-sub-amplification kits are unlikely to be approved by CFDA (the reasons have been explained above) Only the certified clinical laboratory can use the self-made reagents. Therefore, this part of the enterprise (individuals, the world and the genes, the burning of the stone, etc.) need to prepare for the construction of the clinical inspection center and layout to the server.
Sequencing is the starting point rather than the end point. The largest market for mid-stream sequencing services is in the field of medical diagnosis . In addition to gaining revenue through the provision of services, the biggest potential advantage of sequencing organizations is the ability to obtain tissue samples of specific patients and obtain genetic data. The accumulation of this is a very convenient condition for drug development. For example, cancer patients develop drug resistance after using a targeted drug, and sequencing organizations have discovered new drug resistance sites by gene sequencing (this is a technique for PCR, gene chip detection of known mutation sites). The advantage), then this site is the development direction of the next targeted drug, and the sequencing organization can also obtain the tumor tissue of the patient , thereby cultivating the primary cell strain as a cell model for drug development, which is better than other Drug development organizations have more first-mover advantages. I personally optimistic about the development model of Idea Di, using its own sequencing services as a bridge to open up patients, hospitals, CRO companies, sequencing results to provide medication guidance, while in turn linking downstream drug development and clinical trials , forming a good feedback mechanism.
Case (Foundation Medicine, USA): Foundation Medicine is a commercial company focused on high-throughput sequencing of tumors . The company's proprietary platform generates genomic information that is operable on individual cancers of patients, enabling physicians to practice in clinical practice. Optimizing treatments makes biopharmaceutical companies more effective in developing targeted cancer therapies.
Based on second-generation gene sequencing technology, the company provides cancer patients with accurate medication guidelines based on cancer gene sequencing results . The company's gene sequencing technology can detect genetic mutations that lead to cancer in patients, allowing " individualized medicine " to enter new areas, allowing doctors to conduct targeted cancer treatment based on patient genetic information.
Foundation Medicine's services require a doctor to order, and patients only need to provide more than 10 cases of tissue sections or a few milliliters of blood. From the extraction of tumor cell DNA to the final report, the duration of 14-21 days, including the detection of cancer gene mutations, as well as medication guidance recommendations for each mutant gene.
Foundation Medicine offers two products, FoundationOne and FoundationOne Heme. Both products are based on second-generation gene sequencing, using the Illumina HiSeq 2000 system and Life Technologies' Ion Torrent. The FoundationOne test is applicable to all solid tumors, detecting the coding region of 315 cancer-associated genes and the intron rearrangement of 28 genes at a cost of $5,800. The FoundationOne Heme test detects the coding region of 405 genes and the intron rearrangement of 31 genes for hematological malignancies, lymphoma, leukemia, etc., and the RNA sequence of 265 genes to detect gene fusion at a cost of $7200. The FoundationOne test method was published in Nature Biotechnology in October 2013.
The database of cancer genes was required for cancer gene sequencing detection, and the company established the database FoundationCORE. The company launched the browser ICE 2 in December 2014. One of the features of the browser is the "patient matching" feature. The clinician can search through the existing knowledge base FoundationCORE to find information about other patients similar to the patient's tumor genome. A new component of ICE 2 is PatientMatch, a technology tool that leverages FoundationCORE to increase the usage of FoundationOne and FoundationOne Heme. With PatientMatch, doctors using the ICE 2 network can connect with doctors who treat patients with similar genetic information and share diagnostic results with treatment options. According to the company's third quarter 2015 report, FoundationCORE has 60,000 clinical case information.
One area where Foundation Medicine has been working hard is health care. In 2014, the Key Health Department in Tahiti, Michigan, announced the inclusion of Foundation Medicine's cancer genomic analysis service in healthcare coverage; Google said Google Corp.'s DNA testing service for its cancer genes is part of its employee benefit program. Foundation Medicine is also recognized by the McKesson Diagnostic Exchange and the National Comprehensive Cancer Network for genome-wide detection of non-small cell lung cancer and has received a unique Z-code identifier. In addition, Foundation Medicine Chief Financial Officer Jason Ryan said that the scope of medical insurance will not only gradually expand in lung cancer, but will also gradually involve other disease services.
Foundation Medicine's revenues come from two main sources, one from biopharmaceutical companies and the other from clinical diagnosis. In the third quarter of 2015, revenue from biopharmaceutical companies was $11.7 million, a 75% increase from the same period last year; revenue from clinical diagnosis was $13.7 million, a 40% increase from the same period last year, and revenue growth was significant .
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