Is it too difficult to develop raw materials independently? How IVD enterprises can leverage their strengths to break through

Release time:

2025-11-21


In the in vitro diagnostics (IVD) industry, raw materials are the core element that determines the performance of diagnostic reagents. With the continuous iteration of technology, the performance requirements of raw materials are also increasing, and independent research and development of raw materials has become an important path for many enterprises to enhance product competitiveness. However, for small and medium-sized enterprises, the development of IVD raw materials is not as simple as "buying equipment", as there are many technical risks and cost pressures hidden within it.

 

Acridine ester NSP-SA-NHS

 

1、 Self developed raw materials: coexistence of high threshold and high risk

 

The development of IVD raw materials not only requires profound technical accumulation, but also a large amount of experimental verification and data support. From molecular design and synthesis processes to stability testing and batch consistency control, every step can become a technical bottleneck. Especially for small and medium-sized enterprises, the lack of professional R&D teams, experimental equipment, and data accumulation leads to a high failure rate of self-developed raw materials.

 

In addition, the performance of raw materials directly affects the sensitivity, specificity, and stability of diagnostic reagents. Once deviations occur, they may affect the market performance of the entire product. Therefore, the trial and error cost of raw material development is very high, and a slight mistake may lead to the dilemma of "large input, low output".

 

2、 High throughput screening: the key path for enterprises to break through bottlenecks

 

Faced with the high threshold of raw material development, many enterprises have begun to explore the technological path of "high-throughput screening". High throughput screening can significantly improve the efficiency of raw material screening, reduce trial and error costs, and accelerate the research and development process. However, establishing a high-throughput screening platform is not an easy task, as it requires not only advanced equipment and software support, but also a professional technical team for data modeling and analysis.

 

For small and medium-sized enterprises with limited funds and resources, building a high-throughput screening system is not only costly, but also time-consuming and risky, making it difficult to see results in the short term.

 

3、 Collaborative development: a path to reduce risks and improve efficiency

 

In this context, cooperating with raw material suppliers with technical strength and rich experience has become a wise choice for many enterprises. By collaborating with professional raw material manufacturers, enterprises can leverage their mature R&D system and production experience to quickly obtain high-quality raw materials, reduce self-developed risks, and improve overall R&D efficiency.

 

4、 Conclusion: Choosing a major, reducing risks, and accelerating innovation

 

The risks brought by technological iteration in the development process of IVD raw materials cannot be ignored. If small and medium-sized enterprises want to stand out in the fierce market competition, they not only need to accumulate technology, but also need to rely on external resources, reduce research and development costs, and improve efficiency.

 

Chromogenic substrate - HDAOS reagent

 

As a professional manufacturer of diagnostic reagent raw materials, Desheng New Materials focuses on the research and production of key raw materials such as color reagents, chemiluminescence reagents, enzyme preparations, etc. We have a comprehensive research and development system and mature production processes, which can provide customers with stable and efficient raw material support. Choose Desheng to make your raw material development path safer and more efficient.