HKIG: Seizing Opportunities in the Upstream Segment of the Billion-Dollar IVD Market
Undoubtedly, the IVD market has experienced explosive growth in recent years. According to data from Frost & Sullivan and Northeast Securities, the global IVD market size is projected to reach $91.9 billion in 2022 and rapidly grow to $133.9 billion by 2025, with a compound annual growth rate (CAGR) of approximately 9.9%.
“The booming development of downstream enterprises will inevitably drive improvements in the technical standards of upstream key raw materials, components, reagents, and consumables. Particularly in the current complex international economic environment, the industrial status and attention garnered by companies in critical upstream segments have significantly increased compared to the past,” Dr. Bian Chao, Founder, Chairman, and General Manager of Huakang Immunology Technology (hereinafter referred to as “HKIG”), told VCBeat.
According to data from YaoLianQuan, the global market size for IVD reagent raw materials was estimated at approximately RMB 30.33 billion in 2019 and is projected to reach around RMB 56.53 billion by 2030. Among this,As one of the fastest-growing and largest subsectors within the in vitro diagnostics (IVD) industry, immunodiagnostics currently lacks any globally dominant suppliers of reagent raw materials. Moreover, no Chinese enterprises are among the top global suppliers of immunodiagnostic reagent raw materials, representing a blue ocean market with substantial demand and broad prospects.
From a horizontal perspective, the nearly white-hot market competition and rapid development of the IVD industry in recent years have led to the public perception that there are numerous companies focusing on raw materials for immunodiagnostic reagents. However, from a vertical perspective, when additional criteria such as independent R&D, autonomous large-scale production, and self-owned comprehensive quality control systems are applied on top of the foundation of immunodiagnostic reagent raw materials, the list of relevant companies is reduced by more than half.
“On this basis, the number of independently developed and manufactured products that have gained recognition from mainstream downstream customers in China is even smaller. If we further consider whether these products can be sold overseas and withstand the scrutiny of high-level international customers, the number of companies focused on this field is truly few and far between,” said Dr. Bian Chao to VCBeat.
HKIG is an innovative technology-driven enterprise that integrates all the aforementioned attributes, focusing on the research and development, manufacturing, and sales of antigen and antibody raw materials for clinical immunodiagnostic applications. The company was co-founded in 2020 by Dr. Bian Chao and a close friend he had known for over a decade.
Prior to founding his company, Dr. Bian Chao had approximately fifteen years of experience in scientific research and industrialization in the fields of immunology and antibody engineering.
He conducted his doctoral research at the Graduate University of the Chinese Academy of Sciences. After obtaining his degree, he remained at the institute as an Associate Researcher, focusing on scientific research and innovative product development in the field of antibody engineering. He also serves as Deputy Director of the Antibody Research Center (Shanghai R&D Public Service Platform) under a CAS-affiliated institute, and as General Manager and Technical Director of a CAS-controlled enterprise, where he oversees CRO operations related to antibody engineering.
After approximately ten years of scientific research and industrialization work at the Chinese Academy of Sciences, Dr. Bian Chao joined the Beckman Research Institute at City of Hope National Medical Center in the United States to conduct postdoctoral research. While abroad, inspired by China’s domestic policies on entrepreneurship, innovation, and talent support, Dr. Bian decided to return to China and immerse himself in the wave of entrepreneurial ventures.
Recalling the original intention behind starting his venture, Dr. Bian Chao said, “I have been closely following the development of China’s antibody-based pharmaceutical industry for over a decade. Before launching my startup, I assessed the stage of development of this sector in China and felt that the country had already established a solid foundation and was at a critical juncture in its industrial growth. More importantly, as one of the inheritors of the Chinese Academy of Sciences’ expertise and academic culture in antibody engineering, I feel a responsibility to pass on, optimize, and promote the technologies we have accumulated over decades, enabling them to realize their value in the biopharmaceutical industry.”
Regarding the heritage of domestic antibody engineering technology, Dr. Bian Chao recounted the “old” stories of the older generation.
During his tenure at the Chinese Academy of Sciences, Dr. Bian Chao studied under renowned experts and pioneering figures in China’s antibody engineering technology. In their daily interactions, these senior scientists would share with Dr. Bian stories from the 1970s and 1980s, when monoclonal antibody preparation technology was just emerging in China.
At that time, the foundation of life sciences research in China was extremely weak; many equipment, instruments, reagents, consumables, and technical solutions that now appear readily accessible and commonplace were entirely absent. Yet the research direction targeted domestically was the cutting-edge and highly coveted field of hybridoma technology for monoclonal antibody production—a breakthrough that earned the 1984 Nobel Prize in Physiology or Medicine.
“There appears to be a huge gap between the goal and reality,” remarked Dr. Bian Chao.
Dr. Bian Chao recounted that, for instance, cell culture media were initially developed in China by starting from the formulation stage, achieving complete independent R&D and manufacturing. Similarly, CO₂ cell incubators were innovatively modified by researchers based on outdated bacterial incubators. Enzyme-linked immunosorbent assay (ELISA) plates were also adapted and replaced using soft plastic hemagglutination plates.
“Even the laminar flow hoods and biosafety cabinets that are commonplace today were completely unavailable at that time. Researchers back then would thoroughly clean a laboratory room, install ultraviolet lamps, and perform cell culture procedures on ordinary laboratory benches. By relying on rigorous and robust aseptic techniques, they were able to ensure long-term, continuous cell cultures remained free from contamination.”
Under the aforementioned conditions of extreme scarcity and lack of foundation, several senior scientists published a brief report titled “Establishment of Hybridoma Cell Lines Producing Monoclonal Antibodies Against Peking Duck Red Blood Cells” in Volume 14, Issue 2 of Acta Biologiae Experimentalis Sinica in June 1981. This was the first academic paper on monoclonal antibody research conducted in China.Building from scratch, this paper was published only six years after the seminal work by Nobel laureates C. Milstein and G. Köhler, who invented the hybridoma technology for monoclonal antibody production (the team established this technology in 1975).
“Given that the current environment and conditions are far superior to those of the 20th century, it would be difficult to justify our failure to produce internationally leading technologies and products.” Driven by the original aspiration to inherit and optimize technology, Dr. Bian Chao is dedicated to refining both technology and products.
To date, HKIG has completed the development of three major technology platforms.
First is the high-efficiency, precision antibody development technology platform.Through technological transformation and innovation, HKIG has developed a monoclonal antibody preparation technology platform featuring high-efficiency fusion and high-throughput screening capabilities, with independent intellectual property rights. This platform combines the advantages of hybridoma technology and single B-cell technology, serving as a highly efficient upgrade to traditional hybridoma technology platforms.Its antibody screening efficiency can be increased by more than 10-fold, and the screening time can be reduced by over 50%.
Next is the production technology platform for scaled-up manufacturing of engineered cell products.Established in accordance with biopharmaceutical standards and tailored to the specific characteristics and requirements of immunodiagnostic reagent production, this platform ensures consistent, large-scale supply while maintaining stable product performance, thereby addressing long-standing critical weaknesses in the domestic production of reagent raw materials.
Next is the technical platform for product evaluation and solution development.The platform is established in accordance with medical device registration standards, enabling products to rapidly transition from the kit development phase to the medical device registration phase, thereby maximizing savings in clients’ R&D time and financial investment.
Leveraging the aforementioned three major platforms, HKIG has strategically positioned its product portfolio in high-demand medical testing sectors, such as tumor markers and thyroid function, focusing on antigen and antibody reagent raw materials. Meanwhile, the company has also established R&D roadmaps for emerging diagnostic fields, including thrombosis and Alzheimer’s disease, to gradually introduce innovative products to the market.
Regarding the market introduction and expansion of products, Dr. Bian Chao told VCBeat that this requires addressing two issues. First, the prerequisite for successful commercialization of a product is based on excellent products and services. Second, the market needs to be "educated" when accepting new products and technologies, "but this requires a certain period."
Based on the aforementioned technological platforms, HKIG possesses three differentiated capabilities.First, leveraging years of expertise in antibody engineering and development, HKIG has established rapid production line expansion capabilities that keep pace with the emerging market demands across various fields of immunodiagnostics. Second, HKIG ensures stable product supply; the company has built a large-scale production technology system based on biopharmaceutical standards, enabling scalable supply while maintaining consistent quality of reagent raw materials. Third, HKIG possesses the capability to independently address customer needs; in addition to supplying self-developed products, the company provides comprehensive kit construction solutions to help minimize customers’ R&D costs and time investment.
Excellent technologies and products naturally earn customer recognition. HKIG has currently established a partnership with a world-leading, well-known supplier of IVD raw materials, providing the company with high-quality antibody-based diagnostic reagents developed to address unmet clinical testing needs.
For domestic enterprises, reaching a certain stage of development inevitably entails overcoming critical technological bottlenecks, breaking import monopolies, and expanding into global markets.
In response, Dr. Bian Chao stated that HKIG operates in the upstream segment of the industry chain and has pursued a path of complete originality and independent development. “This is a crucial guarantee that we are not constrained by key technologies or materials. We have conducted thorough assessments of every stage of product R&D and manufacturing, ensuring there are no risks of being bottlenecked in terms of equipment, reagents, or consumables.”
However, critical bottlenecks persist across the biopharmaceutical and medical device industries. Data indicate that a significant proportion of key raw materials such as antigens and antibodies, bioseparation media, and high-end electronic components remain reliant on imports. Addressing these complex bottleneck issues requires collaborative efforts from enterprises, government bodies, research institutions, healthcare providers, and even the general public.
“Conditions have actually improved in recent years, with certain areas shifting from addressing gaps to focusing on quality enhancement. While improving quality is far more challenging than filling gaps, we are already moving in the right direction,” Dr. Bian Chao told VCBeat.
Regarding breaking monopolies and expanding overseas, HKIG offers the public a different perspective.“In today’s globalized economic and social landscape, companies need not confine themselves to being local enterprises focused solely on the Chinese market. HKIG’s product development, manufacturing, operational strategies, and planning are all formulated against the backdrop of the global development of laboratory medicine and the in vitro diagnostics (IVD) industry. Therefore, the focus lies not on so-called breaking monopolies or expanding overseas, but rather on whether our business philosophy, technological innovation, and product quality have gained recognition from mainstream high-level manufacturers and customers worldwide, and whether we stand at the forefront of international advancements in immunodiagnostic technologies and products.”
In line with the aforementioned development objectives, HKIG has established collaborative partnerships with several renowned research institutions, including the University of Chinese Academy of Sciences, as well as with leading international diagnostic reagent companies. These collaborations aim to advance the development of diagnostic raw materials urgently needed by the industry, thereby achieving mutual benefits and win-win outcomes.
In the future, HKIG will adhere to industry-leading standards to integrate the entire value chain of R&D, production, services, and marketing for raw materials used in immunodiagnostic reagents. Rooted in China’s fertile healthcare landscape and guided by a global perspective on innovation, HKIG is committed to delivering high-quality products and services to customers worldwide at an early stage, empowering them to navigate swiftly through the fierce market competition in the in vitro diagnostics (IVD) industry.