Although Covid-19 is not over yet, the market conditions of nucleic acid and antigen detection reagents are rapidly cooling down, and even "cliff-like" subsidence. These powerful IVD players, including reagent manufacturers and upstream raw material manufacturers, are making plans for sustainable development in the post-epidemic era.
In order to find new business growth points and avoid falling into the inward competition in the "Red Sea" market, new potential inspection projects will inevitably become the focus of powerful players, and many players are already on the way to seize the opportunity. This article will take stock of the hot new markers. The "new" here does not mean that they are at the forefront of academics but are still far from clinical application; it means that there are not many players currently developing, but the market is highly concerned and has great potential in the future. It has been widely used and has become an important project.
① Alzheimer's Disease, AD
Since Roche was approved for listing, the AD marker has received widespread attention, and the development intention of Chinese manufacturers is even higher. After all, there are giants leading the way, and a broad market space is beckoning to everyone. At present, three companies have been certified for human beta amyloid (Aβ1-42) and four companies have been certified for Phospho-Tau (181P).
② Tumor markers
Abnormal prothrombin (PIVKA-II), a marker of liver cancer, also has foreign giants Roche and Abbott Zhuyu ahead, and domestic manufacturers will definitely follow up. Only three have been certified so far.
It is worth mentioning that the thermal scene has a deep background in this field. In addition to PIVKA-II, there are also alpha-fetoprotein heterogenous body (AFP-L3), Golgi protein 73 (GP73), tissue inhibitor of metalloproteinase-1. (TIMP-1) and other three certified exclusive varieties.
The liver fibrosis marker chitinase 3-like protein 1 (CHI3L1) is also a project that many manufacturers want to do. Despite the potential uncertainty of patent infringement, there are currently five certified manufacturers.
In addition, thymidine kinase-1 (TK1), a marker that can monitor abnormal cell proliferation, has been certified by nine companies; vascular endothelial growth factor (VEGF) has been certified by eleven companies.
③ Pre-eclampsia
The market heat triggered by AMH is still fresh in our minds. The preeclampsia markers also led by Roche: soluble fms-like tyrosine kinase-1 (sFlt-1) and placental growth factor PLGF are naturally enough to ignite new enthusiasm for Chinese manufacturers. At present, five sFlt-1 companies have been certified, and there are more PLGF companies, which have reached ten.
④ Bone metabolization
Currently, seven companies have been certified for type I collagen amino-terminal extension peptide (P1NP); more than 20 companies have obtained parathyroid hormone (PTH).
⑤ Interstitial pneumonia
From reagents to raw materials, the project of salivary liquefied sugar chain antigen-6 (KL-6) was first promoted by Japanese companies. It is believed that there will be more and more Chinese upstream and downstream players in the future. Nine have been certified so far.
⑥ Rheumatoid
Matrix metalloproteinase 3 (MMP3), there are currently seven certified.
⑦ Myocardial markers
The cardiac marker market has always been a battleground for military strategists. In order to seize the market share, various manufacturers attach great importance to new cardiac markers. This can be seen from the soluble growth stimulating expression gene 2 protein (sST2), and many Chinese manufacturers spend a lot of money. Purchased patent licenses from American CCD companies, and more than 30 companies have been certified.
Recently, the growth differentiation factor 15 (GDF15) obtained the first domestic registration certificate from Lehe Bio. This project has Roche as the lead brother. In the future, the popularity and ceiling are only higher than sST2. Everyone, roll up sleeves and work hard.
⑧ Autoimmunity
Autoimmunity and allergens have been the focus of many manufacturers in the past two years. There are many projects in this series, and many manufacturers have entered the market. There are not many certified manufacturers for some of these featured projects, and it is believed that they will expand rapidly in the future. For example, seven companies have been certified for anti-phospholipase A2 receptor (PLA2R) antibody, a marker for membranous nephropathy, and anticoagulation, a marker for anticoagulant lipid syndrome. Only two fatty acylserine/ prothrombin (aPS/PT) antibodies have been certified.
⑨ New four items of thrombosis
Four new items of thrombus: thrombin-antithrombin III complex (TAT), plasmin-antiplasmin complex (PIC), thrombomodulin (TM), tissue plasminogen activator-fibrinogen The popularity of lysinogen activator inhibitor-1 (tPAI·C) is no longer needed. At present, the following six companies have been certified, and the number of certified manufacturers will increase rapidly. We will wait and see.
⑩ Free light chain
There are many interested manufacturers in the multiple myeloma markers free light chain kappa and lambda, but only one of them has been certified, which shows that the development of this project is not small, but the market demand is very clear. There are many manufacturers, and the sooner the certificate is obtained, the more conducive it is to seize market share.
In this competitive world, it is like rowing against the current, if you don't advance, you will retreat! Seeking novelty and change is the constant theme.
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