What types of diagnostics tests does Agappe Diagnostics offer?

TJ: Agappe Diagnostics is an Indian in vitro diagnostic (IVD) manufacturer. Our reagents range includes clinical chemistry, immunoturbidimetry, coagulation, hematology, urinalysis, and most recently molecular biology reagents. We have the biggest reagent manufacturing facility in India at approximately 200,000 square feet, where we employ over 400 people. We also have a separate facility for equipment manufacturing where we manufacture semi-automatic and entry level automatic analyzers. In the molecular diagnostics space, we have a specialized line of LAMP equipment, and are the first to introduce the LAMP test in India. Agappe Diagnostics already manufactures 45% of our equipment lines in India, with the strategy being to manufacture 80% of equipment in-country within the next four years.

The company also has a global presence, with our international business managed from our Swiss entity. From there, we serve customers in countries including Indonesia, the Philippines, and Egypt. We have a strong presence in the Asia Pacific and see great opportunity to expand further into Latin America, Europe, and Africa.

Why did the company decide to expand into immunology?

TJ: In India and globally, the most promising segment is immunology. Agappe Diagnostics only recently grew its presence in this segment but has become the first Indian company to attain the manufacturing license for chemiluminescence immunoassay (CLIA) based reagents. The Indian IVD industry is approximately US$2 billion, with immunology representing about US$450 million.

How is point of care testing helping India’s healthcare systems reach rural populations?

BM: The point of care (POC) segment in India is approximately US$400 million. Technology in IVD and POC testing is evolving very fast, especially in the wake of the pandemic, and I believe the POC game is going to be very exciting for the next decade. India’s current government is working to bring health care to rural populations, and it is towards this goal that POC plays a crucial role. POC testing used to be expensive, but with the rapid evolution of the technology, it has become more affordable and competitive in the marketplace. For example, diagnostics for sickle cell anemia previously required extremely high cost, high performance liquid chromatography (HPLC) testing, which requires expert staff and centralized lab testing. Today, POC technology allows for testing at approximately US$1,000 less, at only US$2 to US$3 per test, while providing the same quality of results. In India, sickle cell anemia trait is prevalent in approximately 10% of the tribal communities, and there is a significant number of carriers of this blood disorder across the country. POC technology provides a cost-effective way to screen the population.

How does India compare to other countries in terms of legislative involvement within the industry?

BM: India’s regulatory system is evolving and becoming more aligned towards the new IVD regulations that are going to be in place. The country has a very fair system both for multinational and local companies where the same regulatory controls apply.

TJ: Indian regulatory systems are in complete harmony with international regulatory systems. With this in mind, the government is currently focusing on localization and has offered PLI schemes to local manufacturers. The PLI scheme not only encourages foreign companies to find a workforce in India and thereby generate employment, but also encourages domestic and local production to localize supply chains. Depending on the products you are developing and manufacturing, you get a percentage of your R&D investment back from the government. Approximately 75% of medical devices are currently imported, and the goal is to significantly reduce this percentage.

What are Agappe Diagnostics’ goals for the next few years?

BM: Agappe Diagnostics’ strategic objective is to build a strong IVD organization that develops and delivers affordable solutions. Diagnostics is still only a small component of the overall Indian healthcare sector, meaning there is ample opportunity for growth.

TJ: Agappe Diagnostics has made revolutionary steps in immunochemistry systems, which led to us receiving a national award. These instruments play a vital role in India, especially post-Covid, in managing infections and diseases. Another exciting space is the hematology segment, and Agappe Diagnostics is the first hematology reagent and equipment manufacturer in India. We are significantly investing in R&D for 5-part hematology systems, which we will introduce to the Indian diagnostics space.