Reconstruction of diagnostic market under the wave of domestic substitution

The Chinese in vitro diagnostic market is undergoing an epic power restructuring. The UBS 2025 report reveals that the market share of local enterprises has jumped from 37% in 2019 to 47% in 2023, achieving comprehensive breakthroughs in two strategic highlands: immunoassays (market size accounting for 40%) and clinical chemistry (21%). Behind this transformation is the superposition resonance of triple kinetic energy.

Technological Breakthrough: From Imitation and Innovation to Global Leadership

The COVID-19 pandemic has become a watershed in the industry. Previously, foreign giants monopolized 90% of high-end testing equipment, and local enterprises were trapped in a passive situation of "following reagents and importing equipment". But after 2020, three key variables have overturned the competitive landscape: the emergence of a 40 billion level testing demand due to sudden public health emergencies, the opening of capital transfusion channels through the Science and Technology Innovation Board, and the breakthrough of the 75% threshold for supply chain localization rate.

The R&D investment intensity of local enterprises reached 12.6%, which is two percentage points higher than that of foreign investment. Top enterprises have completed nearly 200 immunization testing project layouts, with 40% more testing menus than international leading enterprises. The localization rate of fully automatic chemiluminescence analyzer has exceeded 75%, and the single machine detection speed has reached 900 tests/hour, which is 50% higher than international competitors. A field survey conducted at a tertiary hospital in Suzhou showed that the daily detection volume of domestic equipment increased by 28%, and operating costs decreased by 35%, completely breaking the cognitive paradox that "imported equipment is more economical".

Policy Engine: Centralized Procurement Reshaping the Logic of Value Distribution

The pilot program of chemiluminescence centralized procurement is like toppling a domino, triggering a nationwide policy resonance. Volume based procurement reconstructs the market through a triple mechanism: price suppression (with an average decrease of 52%), procurement volume binding (with a mandatory increase in the proportion of domestic equipment), and service point system (with localized services included in the scoring). In a bidding case of a tertiary hospital, domestic enterprises achieved a turnaround in the technical scoring stage with the "iron triangle" of fully automated assembly lines, hundred item testing menus, and localized maintenance.

This policy combination has brought structural changes: the proportion of domestic equipment procurement in tertiary hospitals has soared from 18% in 2019 to 70%, and the contribution rate of high-end market sales has exceeded 50%. The more profound impact lies in the transformation of business models - leading enterprises are beginning to evolve towards an ecological competition of "equipment+reagents+data services", and AI assisted diagnostic systems have covered 3000 medical institutions.

Supply chain revolution: from bottleneck to autonomous and controllable

The self-sufficiency rate of key raw materials has jumped from 58% before the epidemic to 89%, and this silent supply chain revolution has reshaped the foundation of industry competition. Domestic leading enterprises have successfully reduced the cost of chemiluminescence reagents by 40% and shortened the research and development cycle of new products to 9 months by controlling core raw material technologies such as monoclonal antibodies through strategic mergers and acquisitions. In a certain IVD industrial park in Hangzhou, the vertical integration system of raw materials, equipment, and reagents forms a 72 hour rapid response capability, which has a crushing advantage compared to the overseas transfer cycle of 3-6 months for foreign-funded enterprises.

The control of the entire industry chain is generating spillover effects: a quality control product research and development center has achieved a consistency of 99.8% in test results, exceeding international certification standards; Microfluidic chip technology has propelled POCT detection into the era of "chip laboratories".

After years of development, Hubei Xindesheng Material Technology will uphold innovative concepts, continuously improve product quality and service levels, and contribute to the development of the IVD industry.