The in vitro diagnostics market - France (2024)

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 sales World, ****-****, in billions of dollars Source: ****

The global market in **** was dominated byNorth America with **.*% market share, followed by Europe and Asia Pacific. Asia Pacific, however, was experiencing the most dynamic growth, with a CAGR of *.*% forecast to ****. [***]

In ****, the North American market is valued at $**.** billion. Europe, on the other hand, maintains its *nd place in the market , thanks in particular to the following factors: growing healthcare expenditure, well-established infrastructures, and a high number of patients suffering from infectious diseases and cancer. Finally, forecasts once again assign Asia-Pacific the record for growth over the period ****-****. [***]

Breakdown of the global in vitro diagnostics market World, ****-****, in billions of dollars and as a percentage Source: PwC The European market

The European in vitro diagnostics market has been growing rapidly since ****. Its value rose from €**.* billion in **** to €**.* billion in ****, and exploded in **** and ****, reaching €**.* billion and €**. * billion ...

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 increase in value. While it showed continuous growth between **** and **** (***), **** saw an increase of **% on ****, and **** an increase of **% on ****. Thus, in ****, the French market is valued at *.** billion euros.

France, **** - ****, in M€ MedTech

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 in ****. Its cost, set at €**, is reimbursed by the French health insurance system (***). Serological tests cost €*.** and €**.** respectively. [***]

The crisis will nevertheless have generated tensions in terms of supplies. Laboratory supplies are of two types:

Reagents: products required for analyses. Consumables: masks, gloves, test tubes, etc.

French laboratories had to contend with high price inflation and delivery delays throughout the first half of ****, before showing considerable resilience in the second half.

In reality, laboratories are still dependent on foreign suppliers for their reagent supplies (***), as France does not yet have sufficient production capacity. As a result, laboratories that are part of large networks are the most successful in managing tensions in the value chain. Independent laboratories were more likely to experience supply difficulties. However, all benefited from the crisis. [***]

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 in EU countries Europe, ****, as % of country GDP Source: ****

The highest-spending countries are France and Germany, devoting **.*% and **.**% of GDP respectively to their healthcare systems in February ****. France's and Germany's figures are the highest in the EU as a whole. In ****, France will spend around *** billion euros, while Germany takes first place with *** billion euros.

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 power [***]. In fact, as we saw in the previous section, health-related spending will account for **.*% of national GDP in ****.

These figures are the result of a sharp increase in demand for healthcare and medical goods in France. Indeed,their consumption is growing steadily. From ***.* billion euros in **** to ***.* billion euros in ****, we can conclude that the French are increasingly concerned about their health.

Consumption of healthcare and medical goods France, ****-****, in billions of euros DREES - Vie Publique

*.*% of total expenditure on healthcare and medical goods in ****, or *.* billion euros

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

Finally, spending by analysis laboratories had reached a record level of *.* billion euros in **** before exploding in **** with the health crisis, with growth of around *%. By ****, spending has recovered to around *.* billion euros. evolution of CSBM for analysis laboratories France, ****-****, in billions of euros Source: ****

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 over France, ****-****, in % Source : INSEE ...which will continue to be a growth driver for the future of the sector Population projections to **** in millions of inhabitants, France, ****-****, % Source: CNSA (***) Source: CNSA (***) based on INSEE The aging of the French population is real, as this graph shows. While those aged ** and over willrepresent only *.*% of the population in ****, their weight in the French population will double to **.*% in ****. This aging is linked to longer life expectancy and the arrival of the baby-boom generation at retirement age: * factors favoring the number of potential consumers for dental implants and prostheses. However, younger populations may also have growing IVD needs, due to increasingly demanding and sometimes harmful lifestyles. Stress phenomena and cases, which are increasingly prevalent among young people, have a direct influence on the number of illnesses that may require special monitoring, including IVDs.

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-** screening tests France, ****-****, in millions of units Source: ****

breaks down into antigenic and PCR

The following graph illustrates this trend, showing the rate of antigenic testing by age group. It can be seen that, while the use of antigenic testing has risen sharply since the second half of ****, it remains more widespread among the youngest population categories (***).

Proportion of antigenic tests among total PCR and antigenic tests by age group France, ****-****, in Source: ****

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 ** years, the profession has restructured. Faced with the challenges of cost control imposed by public authorities, the medical biology sector has rationalized. Today's landscape is made up of multi-site structures, the result of numerous mergers between private-sector laboratories.

number of laboratories (***) with at least one employee France, **** - ****, in units Source: ****

The main laboratory groups and their structure According to an article on viedebio. com published in July ****, in France today, three players - Biogroup, Cerba and Inovie - hold **% of the market share. Generalist laboratories such as Synlab, Unilabs and Eurofins follow, with human health activities accounting for only part of their sales.

Ranking of the main medical biology laboratory groups by sales France, ****, in billions of euros Source: Buisinesscoot The sales of these groups are substantial, all exceeding one billion euros. The capital ownership structure of these groups is highly diverse, with different configurations sharing the market: Capital ...

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 blood groups, or detecting viruses or genetic anomalies. [***]

Among manufacturers, there are two main categories of players : the large, more or less specialized healthcare manufacturers, including Abbott, Siemens Healthcare, bioMérieux and Becton Dickinson; and the smaller, developing players specializing in biotechnologies (***).

There are several stages in the production of IVD medical devices, as summarized by French reagent manufacturer Indicia:

First, the manufacturer carries out a formulation, which corresponds to the dosing and mixing of the raw materials required to prepare the product, accompanied by physico-chemical tests; Formulation is followed by the distribution stage (***), during which liquid reagents are divided into batches according to size, volume or type of container; The products are then sterilized using filters; Next comes secondary packaging, during which the product is inspected (***), labeled, and packed into boxes and then pallets.

Throughout the process, quality controls are carried out according to product type. These include physico-chemical ...

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 led to a transfer of risk to the supplier, who is obliged to pay in advance for all equipment, and only receives payment once the patient has been invoiced by the laboratory. Generally speaking, the manufacturer of these products has a distribution center alongside its R&D and production centers. However, some companies, such as Thermo Fisher Scientific and Diasys Distribution France, specialize in the distribution of laboratory equipment and scientific instruments.

With therise of personalized medicine and the use of self-tests, supermarkets, pharmacies and parapharmacies are playing an increasingly important role in these distribution channels. Today, the main customers of in vitro diagnostics manufacturers are medical biology laboratories, hospital laboratories and blood transfusion recipients for containers. In the case of self-tests, pharmacies are the main customers in France, but supermarketssupermarkets could become future sales outlets for these self-tests, some of which are also sold online.

Overview and ****-**** trends ...

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 pathology.

Nearly **% of laboratory expenditure was rather generalist, not linked to a particular pathology. These include routine care, analgesic treatments, occasional hospitalizations, etc. For the remainder, cardio-eurovascular diseases and cancers are the most important items, accounting for *.*% and *.*% of total expenditure respectively.

These observations are logical, given that the heart of the business is the establishment of diagnoses. It is therefore normal that the majority of analyses are not linked to a particular pathology.

The Covid-** pandemic saw the recent development of a new range of screening tests, starting with PCR and antigenic tests. Self-tests have been added to this offering, notably in the first half of **** with the purchase by Santé Publique France fromthe AAZ and Biosynex groups of *.* million self-tests each. The difference with the antigenic tests already on the market lies in the way the sample is taken . In the case of an autostest, the nasal swab ...

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 years.es, and the COVID-** health crisis revealed the role and importance of in vitro diagnostics in optimizing patient care and deploying appropriate health measures.

The **** edition of the health accounts (***) reports on price index trends in the consumption of medical care and goods for analysis laboratories, particularly IVDs.

annual change in the CSBM price index for analysis laboratories France, ****-****, index *** in **** and % Source: ****

This index has therefore been falling steadily for over ** years, with the restructuring of the sector and policies to harmonize supply on a European scale factors that may explain this decline. This decline is also a factor in the fall in household out-of-pocket expenses observed in ****.

The classic business model is to combine an instrument, a reagent and software, which only work together, making the consumer a captive buyer of consumables. According to Novacyt, the average price of analysis instruments ranges from €**,*** to €***,***. But business models are evolving as laboratories see their budgets squeezed, ...

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 the new requirements of the Regulation. This new regulation includes, among other things, a new classification system based on a risk classification matrix, improved traceability of devices through the supply chain and more demanding monitoring of technical documentation[***].

In France, the agency responsible for overseeing this market is theAgence Nationale de Sécurité du Médicament et des Produits de Santé (***).

6. Segmentation

• Roche Groupe
• Diagast
• Abbott Groupe
• Danaher
• Thermo Fisher Diagnostics
• Sebia
• BioMerieux Groupe
• Diagnostica Stago
• Biosynex
• Diagnostic Medical System DMS Groupe