1.1 Presentation and definition of the in vitro diagnostics market

In-vitro diagnostics (IVD) includes all techniques, devices or equipment used on human or animal tissue samples or biological fluids for the purpose of diagnosing pathologies in medical laboratories. In vitro diagnostics differ from in vivo diagnostics, which are performed directly on living organisms, not on samples.

The european Union Regulation 2017/746 defines an in vitro diagnostic device (IVD) as "any medical device that consists of a reagent, reagent product, calibration material, control material, kit, instrument, apparatus, equipment, software or system, used alone or in combination, which is intended by the manufacturer to be used in vitro in the examination of specimens from the human body, including donated blood and tissue, solely or primarily for the purpose of providing information about one or more of the following:

(a) a physiological or pathological process or condition
(b) physical or mental congenital defects
(c) a predisposition to a condition or disease
(d) to determine whether a particular treatment is safe for and compatible with potential recipients
(e) predicting the response or reactions to a treatment
(f) to define or monitor therapeutic measures.

The main customers of in vitro diagnostics manufacturers are medical laboratories and hospital laboratories.

The global in vitro diagnostics market is growing and is expected to continue to do so in the coming years. The IVD instrument sales market is largely dominated by the United States.

The French market is the second largest in Europe. While it showed moderate growth until 2019 after a period of consolidation and concentration of the sector through numerous takeovers and mergers between laboratories, the year 2020 has seen significant growth in the market with the explosion in demand for Covid-19 screening tests.

1.2 A growing global market

The global in vitro diagnostics market is growing rapidly, with the market currently worth more than $** billion worldwide in ****. This growth is expected to continue in the years to come, notably due to structural changes in socio-demographic parameters such as the global aging of the population and changes in lifestyles. By ...

1.3 A strong French market

The European in vitro diagnostics market has been growing rapidly since ****. Indeed, while the value of this market on a European scale was nearly €**.* billion, it was worth nearly €**.* billion in ****, with continuous growth over the period (***). This growth on a European scale is driven by structural changes: on the one ...

1.4 Effetct of the COVID-19 crisis

PCR tests meet the definition of in vitro diagnostics. Analytical laboratories were at the heart of the global pandemic. They were able to benefit from the continuity of activity even during containment but also from the increased demand for Covid-** testing.

The PCR test has been widely consumed during the year ...

2.1 Health expenditure in the EU

Europe presents a rather large panorama of medical biology laboratories. There are many differences between countries. These differences are reflected in the health care systems and the divergence in health care spending by European country.

An article from EM Consulte provides a typology of health systems in Europe:

The Bismarckian wage-based ...

2.2 Medical laboratories in health care and medical goods consumption

Each year, the Institut d'Informations et de Conjonctures professionnelles (***) and DREES data are used to obtain the evolution of the consumption of care and medical goods in France.

Changes in the consumption of medical care and goods France, ****-****, billion euros Source: ****

Breakdown of the CSBM by expenditure category France, ****, in Source: ...

2.3 Demographic changes and changes in consumption patterns

IVD market activity is largely influenced by the demographic situation of the country concerned. The greater the number of elderly people, the greater the risk of disease. Among the diseases that develop with age are cardiovascular diseases, neurodegenerative diseases and even cancers.

France is concerned by this trend, since according to ...

2.4 Strong demand linked to Covid-19

Global demand for Covid-** screening tests explodes

Covid-** screening tests have been the main issue in the in-vitro diagnostics market in recent years. Indeed, the demand for them has obviously risen sharply with the health crisis.

The following graph shows the evolution of the number of Covid-** screening tests performed in ...

3.1 A national market in consolidation

While IVD is involved in nearly **% of medical decisions, its weight in the healthcare market remains minor, accounting for no more than *% of healthcare industry revenues. [***]

Number of laboratories

The I+C industry report attests to this decline in the number of laboratories employing at least one employee. Over the past ...

3.2 Reagent manufacturing at the heart of the in vitro diagnostics market

The French IVD market is dominated by the reagents sub-segment, which accounts for **% of sales in the market, with the remaining **% corresponding to the sale of instruments, excluding self-tests sold to the general public. These reagents are mainly used for the diagnosis of allergies, blood sugar and cholesterol levels, and also ...

3.3 Distribution of IVD devices: financial risks borne by suppliers

The IVD market has recently seen a major evolution in the relationship between the product supplier and the laboratories. Historically, this relationship was based on the classic principle of ordering/billing units of reagents to the supplier, and has been transformed in favor of billing a fixed, global price per "patient" ...

4.1 In vitro diagnostics offer, by pathology

Today, the promising segment of self-tests, in the case of diabetes control for instance, is developing very strongly, as are rapid and delocalized tests, taking advantage of the widespread practice of outpatient medicine. Specific instruments and consumables exist for the different types of diagnostics:

Immunochemistry (***), Biochemistry (***), Immunology (***), Hematology (***), Microbiology (***), Genetic Diagnostics ...

4.2 Breakdown of medical biology expenditure by pathology: a range of diagnostics

The French In Vitro Diagnostics industry, from startups to global groups, has all the assets to become a high-performance sector at the service of public health. Driven by technological, scientific and biological advances and digital transformation, innovation in diagnostics has accelerated in recent years. The Covid-** health crisis has revealed the ...

5.1 A national market subject to changing European regulations

In order to be marketed in the European Union (***), established to protect the safety and health of users [***].

This Directive is currently being progressively replaced by IVD Regulation ****/***, which entered into force on May **, ****. Manufacturers have a transition period of * years to modify their manufacturing process and technical documentation to meet ...