Content of the study:
The in vitro diagnostics market - France

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1.1 Overview and definition of the in vitro diagnostics market

In-vitro diagnostics ( IVD) covers all the techniques, devices and equipment used on human or animal tissue samples or biological fluids to diagnose pathologies in medical laboratories. In vitro din vitro diagnostics therefore differs from in vivo diagnostics, which are performed directly on living organisms and not on samples taken from them.and not on samples taken from them.

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

  • concerning a physiological or pathological process or state;
  • concerning congenital physical or mental deficiencies;
  • concerning the predisposition to a condition or disease;
  • to determine whether a given treatment is safe for and compatible with potential recipients;
  • to predict response or reactions to a treatment;
  • to define or control 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 set to continue to do so in the years ahead. In fact, it is estimated to reach $94.7 billion in 2022, after increasing by 80% since 2018, and should reach $157 billion in 2030. The CAGR (average annual growth rate) over the period 2023-2030 would be 7. 1%[pwc]

This market is largely dominated by North America(42.8% share in 2020), followed by Europe and Asia-Pacific[pwc]. The latter region, however, is experiencing the most dynamic growth, with a record CAGR forecast for the period 2023-2030 [Fortune Business Insights], while it was already estimated at 8.6% between 2020 and 2024. [pwc]

The French IVD market is Europe's second-largest (12.6% share in 2021) , behind Germany. While showed moderate growth until 2019, following a period of consolidation and concentration in the sector through numerous takeovers and mergers between laboratories, the explosion in demand for Covid-19 screening tests has boosted the market in 2020 and 2021. Indeed, sales in 2020 and 2021 grew by 32% and 22% respectively, with the French IVD market reaching a value of €2.61 billion in 2021 . [Medtech]

1.2 A fast-growing global market

The global in vitro diagnostics market is growing fast. It is valued at $**.* billion in ****, having grown by almost **% since ****. This momentum is set to continue in the years ahead, as the market is expected to reach $*** billion in ****, recording a CAGR (***) of *.*% over the period ****-****.

In vitro diagnostics market ...

1.3 A major French market

The French IVD market is the second largest in Europe, behind Germany. It will account for **.*% of the European market in ****, as shown in the graph below. IVD market share in Europe Europe, ****, % of total Source: ****

Like the European market, the French market has taken advantage of the health crisis to ...

1.4 The COVID-19 crisis accelerated IVD consumption

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 business continuity even during containment, but also from theincreased demand for Covid-** screening tests.

The PCR test was widely consumed in ****, and continues to be so ...


2.1 Healthcare expenditure in the EU

Europe offers a broad spectrum of medical laboratories. There are many differences between countries, which are reflected in healthcare systems and spending.

An article in EM consulte has produced a typology of healthcare systems in Europe:

The Bismarckian wage-based system; The tax-financed Beveridgian system; Mixed models; Private, legalized systems.

Healthcare expenditure ...

2.2 Medical biology laboratories in the consumption of healthcare and medical goods

Each year, DREES publishes the results of the French health accounts. Below, we use data from the **** edition of Les dépenses de santé en ****.

At the heart of the **** presidential campaign, **% of French people ranked healthcare as one of the priorities to be addressed by politicians, second only to purchasing ...

2.3 Demographic trends and changing consumption patterns

IVD market activity is largely influenced by the demographic situation of the country concerned. The greater the proportion of elderly people, the greater the risk of disease. These include cardiovascular disease, neurodegenerative disease and even cancer.

The ageing population: already a reality in France...

Proportion of the French population aged ** or ...

2.4 Strong demand for Covid-19

Global demand for Covid-** screening tests soars

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

The following graph shows the evolution of the number of Covid-** screening tests (***).

Covid-** ...


3.1 A consolidating domestic market

Although IVD is involved in almost **% of medical decisions, its weight in the healthcare market remains minor, representing no more than *% of healthcare industry sales(***).

Number of laboratories

The I+C industry report bears witness 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 on the market, with the remaining **% corresponding to instrument sales, excluding self-tests marketed to the general public. These reagents are mainly used for allergy diagnostics, blood sugar and cholesterol testing, and also include products for determining ...

3.3 Distribution of IVD devices: financial risks borne by suppliers

The IVD market has recently seen a major change in the relationship between product suppliers and laboratories. Historically, this 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" result.this has ...


4.1 The in vitro diagnostics offering, by pathology

Today, the promising segment of self-tests, such as for diabetes control, is developing strongly, as are rapid and off-site tests, benefiting from the widespread practice of outpatient medicine. Specific instruments and consumables are available for different types of diagnostics: Immunochemistry (***).

Points de repère - issue ** (***) presents medical biology expenditure by ...

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

France's In Vitro Diagnostics industry, from start-ups to global groups, has everything it takes to create a high-performance sector serving public health. Boosted by technological, scientific and biological advances, as well as digital transformation, innovation in diagnostics has particularly accelerated in recent, and the COVID-** health crisis revealed the ...


5.1 A national market subject to evolving European regulations

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

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


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Reviews (1)

Reviews (1)

The in vitro diagnostics market - France

Publicado en 19/05/2022 by Pascale Blangarin

Very good exhaustive and synthetic study

Customer cases and references

Customer cases and references
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Boston Consulting Group

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