The market for near-patient, decentralized blood diagnostics

A complete blood cell count (CBC) or blood status is the most commonly ordered test used for in vitro diagnostics (IVD). The IVD market was estimated to have sales of approximately SEK 600 billion in 2019, of which hematology accounted for just over SEK 40 billion. The hematology market can, in turn, be divided into two customer segments: a centralized segment, consisting of larger hospitals with their own central and commercial reference laboratories, and a decentralized segment consisting of smaller hospitals, clinics, laboratories, health centers and doctor’s offices. Boule focuses on the decentralized niche, which had sales of just over SEK 6 billion in 2019. Globally, there are over 100,000 small and medium-sized diagnostic laboratories, for which Boule’s instruments are an attractive option.

Market segments

The decentralized hematology market can, in turn, be divided into two product segments: 3-part and 5-part differential. In a 3-part analysis, white blood cells are grouped into three subgroups, while the 5-part analysis groups them into five subgroups. The cost-effective 3-part analysis accounts for approximately 80 percent of the analyses performed and the more advanced 5-part analysis accounts for the rest of the tests. Since both instrument prices and cost per test are significantly higher for 5-part solutions, this segment accounts for about 40 percent of the value on the market. Boule, with its proprietary products, is strongest in the 3-part segment, mainly due to Boule’s investment in growth in developing countries.

Growth factors

Diagnostics is an important and integral part of healthcare that is used both for medical examinations and for planning and monitoring the treatment of sick patients. The growth of the hematology market is driven by several macro factors, the most important of which are:

  • Population growth
  • Rising standards of living
  • Increasing elderly population

The main growth drivers in the fast-growing markets in, for example, Asia, Africa and the Middle East are improving standards of living and improving healthcare. This trend is especially apparent in rural areas and smaller towns. The market for nearpatient diagnostics is still dominated by 3-part instruments, with annual growth of about 5%. The market for 5-part instruments has higher growth and increases by about 8% per year.

Near-patient analysis still forms a fairly small part of the market, but it is growing considerably faster than the decentralized hematology market as a whole. As the shortage of trained staff increases globally, so does the demand for simple rapid tests.

The benefits of near-patient decentralized testing have also been highlighted in connection with the COVID-19 pandemic. With digitalization and artificial intelligence, there is potential with in vitro diagnostics to not only generate test results but also to analyze and interpret data to facilitate clinical decisions.

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