Therapeutic Areas 2017 As new technologies such as immunotherapy have undergone a landmark change, many treatment concepts are being subverted or redefined!
With the gradual integration of diagnosis and treatment, pan-IVD molecular-based, concomitant and gene-based diagnostic technologies have also developed rapidly and gradually shifted from scientific research to a broader market of clinical hundreds of billions of patients.
The traditional IVD market has entered a stable and mature competition in the Red Sea in the world. Emerging detection technologies and big data must be the commanding height in the future!
Precision Medical opens 100 billion Blue Ocean markets for IVD
At present, the size of the global market for precision medicine has exceeded 60 billion U.S. dollars, of which the area of precision diagnostics is approximately 10 billion U.S. dollars. It is estimated that by 2030, the relevant market scale is expected to exceed the trillion-billion-yuan mark, and precision medicine will provide a multibillion-dollar blue ocean diagnostic market.
Treatment promotes diagnosis, the arrival of 'individualized early diagnosis'
Diagnosis of the emergence of the Blue Ocean market, with the trend of 'integration of diagnosis and treatment', new drug development, immunotherapy and other areas of breakthroughs.
For example, in May 2017, with the approval of the FDA approved Keytruda for MSI-H/dMMR as a positive treatment for MSD-H/dMMR, the first drug to treat nearly all tumors in the history of human cancer was created by the FDA. Sexual approval! Because of repair of MMR-related gene mutations, errors in DNA replication (MSI-H) cannot be repaired in time, which is one of the causes of cancer.
Prior to this, the treatment of cancer was based on the definition of the origin of the cancer in the body. For example, for breast cancer and lung cancer. After this approval, Keytruda can be used for any cancer regardless of the positiveness of MSI-H/dMMR. treatment.
2017 is a watershed, FDA has approved multiple gene detection technologies for clinical use at an unprecedented rate, and second-generation sequencing technologies are gradually maturing.
December 2016: FDA Approves First NGS-Based Companion Diagnostic Protocol to Detect Advanced Ovarian Cancer with BRCA Mutations; This Is a Milestone in the Field of Gene Sequencing.
May 2017: The journal Nature Medicine unveils the world's first million human advanced cancer sequencing results released by the best cancer centers in the United States, the Big Data Cancer Genetic Mutation Project based on GenBank Sequencing Technology, New model
June 2017: The FDA approved the first NGS-based assay from Invitrogen for multiple NGS companion diagnostics of new non-small cell tumors, allowing physicians to find matching therapies for patients within days, whereas in the past This process can take weeks.
December 2017: FDA Milestones Further Rapidly Approves Foundation Medicine's In Vitro Diagnostics Test for FoundationOne CDx Listing Application Also Approved by CMS Coverage, Regulation and Medicare Department of United States Medicare and Medicaid Services for Tumor Immunization Determined treatment of genetic testing market-oriented process can be seen.
However, studies show that more than 55% of cancer-related gene mutations in patients may be missed, the use of new analytical methods to expand the scope of oncogene detection, it is imperative.
The breakthrough of treatment means that the precise medical concept of 'treating different diseases with the same disease and curing diseases with different diseases' is being realized step by step, and the era of 'early diagnosis' of cancer also slowly comes.
Early cancer cure rate is very high, early diagnosis and early treatment of cancer ecological chain has become an urgent need .And this ecological chain, the early diagnosis has become the most important.As the tumor detection is basically a rigid demand, early diagnosis of the market is huge Compared with individualized medicine, precision medicine places more emphasis on the deep features of 'disease' (such as genetics and proteomics) and the high precision of 'medicine', laying a solid foundation for early diagnosis.
Independent laboratories rely on the rapid development of technology to solve the problem of equipment costs
The development of precision medical services brings a large number of diagnostic needs, but the equipment needed for diagnosis is expensive and often requires a corresponding technician, which is a considerable cost to any hospital, which to some extent inhibits the diagnosis application.
Independent Clinical Laboratory (ICL), which is often referred to as a third-party medical testing organization, or with a higher degree of professionalism, relies on the scale-up effect of medical university clinical testing center to purchase high-end and high-end Testing equipment is possible.
After nearly 10 years of development, independent medical laboratories in China have begun to take shape. Domestic independent medical laboratories including DI Diagnostics and Golden Domain Medical Systems have undergone a rapid phase of rapid expansion.
Therapeutic technology has led to more diagnostic needs, and the diagnosis itself has expanded into a larger market. The development of an independent medical laboratory has solved the high problem of diagnostic equipment. Therefore, the core of diagnostic development has returned to the 'technical' level .
IVD clinical diagnostic technology three hot areas of the trend
Technological development promotes the expansion of market demand, and market demand in turn promotes technological change. This positive and positive cycle has been brought into full play in the field of precision medicine.
In the field of detection, the most fiery today is gene sequencing, liquid biopsy and mass spectrometry.
1. Gene sequencing - the fastest growing segment of molecular diagnostics
Genome sequencing is a novel genetic testing technique that analyzes the entire sequence of a gene from bodily fluids and predicts the likelihood of developing a variety of diseases, with individual behavioral traits and behavioral justifications. Gene sequencing technology can lock in individual disease genes and prevent and treat them in advance At the same time with the big data, lock more disease characteristics.
Clinical application:
Gene sequencing is widely used in the field of reproductive health, cancer prevention and control, pathogen analysis, transplantation matching and complex diseases, etc. Currently, NIPT is the most mature gene sequencing application in reproductive health services.
