Market Space Analysis of IVD Raw Materials
IVD raw materials are upstream of the entire industry chain, and their quality determines the quality of in vitro diagnostic reagents and the accuracy of the final diagnosis results, which is one of the core links of the industry chain.
1. Overview of IVD raw materials
In a broad sense, IVD raw materials include biologically active/non-biologically active materials used to prepare in vitro diagnostic reagents and components required to develop in vitro diagnostic equipment. In a narrow sense, IVD raw materials refer to the reaction systems used for biochemical, immunological, or molecular diagnostic reagents. Raw materials include four parts: the core reaction system, the signal system, the reaction system carrier, and the reaction environment. The core reaction system raw materials such as antigens, antibodies, and diagnostic enzymes play an essential role in the quality of in vitro diagnostic reagents. They are the key to in vitro diagnostic reagents.
2. The market space for IVD raw materials
Benefiting from the increase in diagnostic testing and the discovery of new markers, the global market for in vitro diagnostic reagent raw materials has maintained steady growth in recent years. In 2019, the global in-vitro diagnostic reagent raw material market was expected to be approximately RMB 30.33 billion. It is estimated that by 2030, the global in-vitro diagnostic reagent raw material market scale will reach about RMB 56.53 billion.
The global in-vitro diagnostic reagent raw material market is prominently characterized by many participants, a small individual scale, and a highly fragmented industry. In contrast, many small and medium-sized laboratories occupy a place in the industry by supplying several characteristic projects.
With China's in vitro diagnostic industry's rapid development, the upstream raw materials market has rapidly expanded. According to the report, China's IVD raw materials market has grown from 3.3 billion in 2015 to 8.2 billion in 2019, with a compound annual growth rate of 25.8%. The market size in 2024 will reach 20 billion yuan, and the compound annual growth rate from 2019 to 2024 will be 19.4%.
From the perspective of market competition, imported products still occupy the dominant position in the IVD raw material market. In 2019, the market size of imported products was 7.3 billion yuan, accounting for 88% of the IVD raw material market. The market size of Chinese products was 1 billion yuan, accounting for a small proportion, but the development speed was fast. The compound growth rate from 2015 to 2019 reached 30.6%, higher than that of imported products.
With the continuous improvement of the technical level of Chinese enterprises and the increasing emphasis on the localization of the biotechnology industry supply chain, the market size of domestic in vitro diagnostic reagent raw materials is expected to grow at a compound annual growth rate of 23.3%. It will reach 2.7 billion yuan by 2024 and gradually realizes import substitution.
- Cardiac Troponin I (cTnI)
- Myoglobin (Myo)
- Creatine Kinase-MB (CKMB)
Heart-type Fatty Acid Binding Protein (H-FABP)
- N-terminal Pro B Type Natriuretic Peptide (NT-proBNP)
Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Cardiac Troponin T (cTnT)
Pepsinogens I (PGI)
Human Epididymis 4 (HE4)
- Prostate-Specific Antigen (PSA)
- Squamous Cell Carcinoma (SCC)
- Neuron-Specific Enolase (NSE)
- Cytokeratin 19 Fragment (CYFRA21-1)
- Human Progastrin-releasing Peptide (ProGRP Tumor Marker)
- Protein Induced by Vitamin K Absence or Antagonist-II (PIVKA II Tumor Marker)
- Inflammatory Marker
- Influenza (Flu)
- Estradiol (E2)
Anti-human Mullerian Hormone (AMH)
Placental Growth Factor (PLGF)
- Soluble Fms-like Tyrosine Kinase-1 (sFlt-1)
Follicle Stimulating Hormone(FSH)
Human Chorionic Gonadotropin (Total HCG β)
- Progesterone (Prog)
- Thyroid Function
- Glucose Metabolism
- Bone Marker
Heterophilic Blocking Reagent
- Animal Diagnostics