In the past and at present, IVD manufacturers have continuously paid attention to these points

According to statistics, as the world enters an aging era, the rising incidence of chronic diseases, including tumors, diabetes and cardiovascular diseases, is an important factor for the growth of the IVD market. Due to the increasing demand for rapid, reliable and accurate diagnosis as well as timely and personalized treatment, the market demand for various IVD devices has risen.

The increase of infectious diseases

In recent years, the growth of the IVD infectious disease market has been dependent on two factors: improving the diagnostic level of laboratory infrastructure, especially the testing capacity of high-end detection equipment. Past experience has taught us that epidemics are powerful enough to disrupt the global health system, and the market urgently needs the development of better detection methods. The increase in the prevalence of targeted diseases and the improvement of health awareness are another factor that is expected to promote the growth of the global IVD infectious disease market. New products with high sensitivity and user-friendliness will influence the IVD infectious disease market in the coming years.

The operation of automated instrumentsUse more

Under the government's impetus, the high regard for cost control has further driven innovation in the IVD market.

Automation is an important way to control healthcare spending. In IVD applications, fully automated instruments help hospitals and laboratories reduce management expenses and control costs, especially by reducing the demand for professional technicians. Due to the acceleration of the entire process from on-site testing, sample analysis to obtaining results, diagnostic time and related costs are usually reduced.

Manufacturers should not only focus on new, smaller POCT devices, but also on larger ones with faster and higher throughput. If the laboratory regards each test as a separate revenue channel, then choosing to implement more test categories while using a smaller sample size will be the key for enterprises to cater to the market. The clinical laboratory industry collaborates with in vitro diagnostic manufacturers to enhance the level of public health testing, provide accurate test data, and develop new diagnostic technologies. In addition, automation also helps to reduce testing errors, improve efficiency and accuracy, thereby enhancing the treatment process and outcomes.

Overall, technological progress has enabled IVD to go beyond its diagnostic function itself. Nowadays, the demand for IVD is not only about symptom identification and diagnosis, but also plays a crucial role in patient monitoring, personalized medicine, hospital management, and supporting both doctors and patients. The latest generation of IVD medical devices is generating faster, more accurate and more economical diagnoses, improving patient healthcare, enhancing cost-effectiveness and making it easier for patients to access treatment.

It is difficult to achieve the best of both worlds in enhancing sensitivity and specificity. Although the latest technologies such as molecular diagnostics have high specificity and sensitivity, there is still room for improvement in terms of rapid testing and cost for special types, especially for tests used for verification purposes.

There is no fully standardized method for enhancing specificity and sensitivity yet. Currently, enterprises are conducting extensive research and development to analyze, verify and confirm in accordance with international standards, so as to bring good products to the market.

Regulatory environment

New or upgraded devices must undergo strict regulatory reviews to ensure the safety of patients at both personal and public levels. Classify IVD based on the risks it poses to public and individual health, as well as the potential outcomes and impacts if the test is incorrect or unavailable:

Category I: Low to moderate risk tests, where inaccurate results do not cause harm to patients or the public (such as cholesterol tests);

Class II: Medium to high risk, pre-market review is required (such as pregnancy tests);

Class III: High-risk tests that require pre-market review and post-market supervision (such as genetic tests for cancer treatment).

As the regulatory landscape of the IVD market evolves, enterprises that intend to enter foreign markets must keep abreast of the compliance development situation in each country in a timely manner. To avoid delays in entering the market, it is crucial to classify the equipment correctly. If the document is not forward-looking, it may hinder the development of innovative IVD products.

Optimize costs

At present, compared with routine diagnosis, laboratory tests are more expensive, and the market needs to balance the relationship between test costs and test results. IVD manufacturers can consider the following aspects to deal with cost pressure:

The in vitro diagnostic market is highly competitive and fragmented. The entry of many cross-industry players is changing the existing competitive model. In such a complex environment, the successful development, design, production, verification and sale of IVD devices largely depend on the manufacturer's ability to respond to specific, complex and interrelated development requirements.