In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. In recent years, the popularity of the concept of PCR testing by the epidemic has raised the public's awareness of in vitro diagnostics, and the IVD industry has gained growth opportunities.

After more than 60 years of iterative development, chemiluminescence analysis has become the mainstream of the domestic immunodiagnostic market in recent years, and has developed alongside with other testing techniques. Chinese immunodiagnostics market has maintained stable growth in the past five years. In the future, with the increase of national per capita medical expenditure, the increase of immunodiagnostic special tests, the expansion of testing scenarios driven by new medical infrastructure, and the iterative progress of testing technique the immunodiagnostic market is expected to further expand and grow.

Development of Immunodiagnostic Technique

Since 1960, immunodiagnostic technique in China has been constantly updated and developed, starting from the earliest radioimmunoassay and going through immune colloidal gold, enzyme-linked immunoassay, and chemiluminescence analysis. The continuous technological iterations of products have better met the changing needs of clinical diagnosis. In recent years, the domestic clinical application is mainly based on chemiluminescence, which has the advantages of high sensitivity, high specificity, high throughput, high stability, and easy operation.

Immunodiagnostics has a wide range of application scenarios. Its relevant testing platforms are available in hospital laboratory/clinical departments, medical examination centers and third-party independent laboratories.

Immunoassay platforms in clinical applications can be broadly divided into medium/high-throughput instruments and low-throughput instruments. Medium/high-throughput instruments are mainly based on chemiluminescence and enzyme-linked immunoassay techniques, and are usually large test platforms placed in the central testing departments of 3A/2A hospitals and in third-party independent laboratories. Low-throughput immunodiagnostic instruments mainly meet the needs of hospital emergency departments or smaller and primary hospitals with fewer samples for testing.

Immunodiagnostics Market Status

Chinese immunodiagnostics market has maintained an overall growth rate of approximately 20% over the past five years, and is expected to reach a market size of CNY 52.4 billion in 2022. Among them, the medium and high throughput market dominates with a size of CNY 45.6 billion.

Currently, more than 200 immunodiagnostic programs are carried out at the clinical level in China and are widely available in all-level hospitals. These programs are mainly focused on tumor markers, infectious diseases, thyroid function, etc. and there is still much space for expansion of routine tests. In addition, the strong encourage of medical device innovation in the "14th Five-Year Plan", medical system reform and national health awareness will also drive the growth of the immunodiagnostic market.

In terms of the overall immunodiagnostic market, chemiluminescence has basically replaced enzyme-linked immunoassay in the middle and high throughput market. 2022 market size of chemiluminescence exceeds CNY 40 billion, occupying more than 85% of the immunodiagnostic market share. In the low throughput market, quantitative testing has also significantly surpassed qualitative testing, with single-component quantitative testing occupying about 80% share in 2022.

With the continuous growth of the immunodiagnostic market, the market scale of each brand will be further enhanced, especially chemiluminescence players are expected to seize more market share under the promotion of policy support and medical reform.

The status of the immunodiagnostics segment

For the diagnostic needs of different diseases, the immunodiagnostic market can be further differentiated according to the subdivided tests. Among them, tumor markers, thyroid function and infectious diseases are the three largest segments of the immunodiagnostics market, accounting for more than 60% of the overall immunodiagnostics market.

Each segment of the immunodiagnostic market will grow at different rates in the future, and the three major test segments will gradually enter a mature phase with a slowdown in growth due to external constraints. The fastest-growing cardiac markers and inflammatory factors segments will have greater growth potential due to factors such as medical policy enactment, healthcare system reform, and patient population growth. The importance of these three areas in the immunodiagnostics market will gradually emerge and is worth focusing on.

Trends and Outlook

The immunodiagnostics market is characterized by four major trends, including diversified customer groups and clinical demands, homogeneous product competition, accelerated domestic substitution, and continuous technological innovation.

With the implementation of graded diagnosis and treatment and the government's investment in medical infrastructure, the immunodiagnostic industry has become more diversified in terms of customer groups, which requires more individualized solutions and services in clinical practice, and the customer groups are expanding and the demand for diagnostics will continue to rise.

In addition, the competitive pressure in the immunodiagnostic industry will become more and more intense due to the impact of more domestic manufacturers entering the market, medical insurance cost control and collective purchasing policies. In the absence of significant quality advantages, immunoassay products have formed a homogeneous competition situation.

On the other hand, the improvement of the market requirements for the quality, accuracy, operation and efficiency of the test products will continue to push the update of immunodiagnostic technique to better meet the clinical needs and benefit patient groups.