Summary
The global in vitro diagnostics (IVD) market experienced significant growth, driven by demand for COVID-19 testing and the increasing prevalence of various health problems. North America held the largest market share in 2020 at 42.8%, but the Asia-Pacific region is expected to see the most dynamic growth. In Europe, the market jumped to 14.4 billion euros in 2020, and 20.7 billion euros in 2021, a trend paralleling the French market, which grew by 32% in 2020 and 22% in 2021. The market's rapid expansion can be attributed to rising healthcare spending, an ageing population and technological advances in in vitro diagnostics. In particular, the COVID-19 crisis has accelerated IVD consumption, with PCR tests becoming widely used and contributing significantly to market growth.
Dynamism and transformation of the in vitro diagnostics sector in the face of pandemic challenges
In the ever-changing landscape of the country's in vitro diagnostics (IVD) market, recent years have been marked by significant growth and transformation, particularly influenced by the COVID-19 health crisis. Traditionally, the in vitro diagnostics market encompasses a plethora of techniques and devices intended for diagnosis in medical laboratories, using human or animal samples. It is characterized by a diverse range of customers, mainly medical and hospital laboratories. The impact of the global pandemic cannot be ignored, which has particularly accelerated consumption of IVDs, given the critical role played by PCR tests during this period. Laboratories, which play a central role in the response to the pandemic, experienced a substantial increase in demand due to the soaring need for COVID-19 testing.
The market as a whole showed an impressive growth rate. The global IVD market grew by almost 80%, with an estimated value of between $90 and $95 billion by 2022. This robust growth is set to continue, reaching between $150 and $160 billion by 2030, with an average annual growth rate of around 7%. North America has traditionally dominated this landscape, but the winds of change are visible, with Europe and Asia-Pacific not far behind. The latter region in particular has shown an explosive growth trajectory, posting the highest compound annual growth rate (CAGR) forecasts for years to come. This testifies to the dynamic nature of the market and the shift in global economic weight towards Asia-Pacific markets.
In Europe, the French market is particularly important, being the second largest after Germany and accounting for over 10% of the European market. It enjoyed steady but moderate growth until the pandemic, which catalyzed an explosive increase in market value, with estimates reaching over 2.5 billion euros.
Worldwide, the market is segmented along traditional lines, with major international multi-sector groups such as Roche Diagnostics, Abbott and Thermo Fisher Diagnostics generating significant sales, demonstrating their strong presence in the field. Specialists in areas such as haemostasis and thrombosis (e.g. Diagnostica Stago) and rapid diagnostic tests (e.g. Biosynex) have also carved out substantial niches, underlining the diversity of needs and areas of interest in the IVD landscape.
In conclusion, driven primarily by the demand for diagnostic tests triggered by the pandemic, the in vitro diagnostics market has undergone remarkable expansion across the country and beyond.
Key players shaping the in vitro diagnostics landscape
The in vitro diagnostics (IVD) market has undergone remarkable growth and transformation, particularly accentuated by the advent of the COVID-19 pandemic. This era of change has been characterized by the emergence of key players, each making a significant contribution to the IVD ecosystem through their specialized offerings and innovations.
Below, we take a look at some of the most important entities at the forefront of this dynamic sector.
- Roche Diagnostics is a titan of the healthcare industry and a market leader in in vitro diagnostics. With a well-established reputation for continuous innovation, Roche provides a wide range of diagnostic tests and platforms that address a variety of medical conditions, including cancer, metabolic diseases and infectious diseases such as COVID-19. Its portfolio ranges from highly complex laboratory instruments to simple point-of-care tests, embodying its commitment to improving patient care by helping healthcare professionals gain actionable insights.
- Abbott Laboratories, a diversified healthcare conglomerate, offers a wide range of diagnostic solutions. Their expertise spans multiple segments of the IVD market, from basic laboratory diagnostics to molecular diagnostics and point-of-care testing. The company is known for its relentless pursuit of improving healthcare by providing reliable and accessible diagnostic technologies to communities worldwide.
- Thermo Fisher Scientific Thermo Fisher Scientific's role in the IVD market is underlined by its specialization in the supply of laboratory equipment, reagents and consumables. It meets the high demands of research and clinical laboratories, offering tools and services that facilitate the diagnostic process. Thermo Fisher's contributions to life sciences and healthcare are invaluable, with a focus on accelerating research and improving patient outcomes.
- Danaher Corporation is a global innovator in science and technology, and its various operating companies play a key role in the in vitro diagnostics market. The company's portfolio includes advanced diagnostic tests and systems that facilitate the diagnosis, monitoring and treatment of disease. Danaher's commitment to research and development enables it to remain at the forefront of advances in diagnostics.
- bioMérieux Specializing in microbiology, bioMérieux is a key player in providing diagnostic solutions for infectious diseases, cardiovascular emergencies and targeted cancer treatments. BioMérieux's commitment to public health is reflected in a range of systems that simplify and accelerate the testing process. BioMérieux products play a key role in clinical decisions worldwide, where accurate and timely diagnoses can have vital implications for patients.
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- Last update : 18/10/2023
Summary and extracts
1 Market overview
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 Demand analysis
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 Market structure
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 Offer analysis
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 years.es, and the COVID-** health crisis revealed the ...
5 Regulations
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 ...
6 Positioning the players
6. Segmentation
- Roche Groupe
- Diagast
- Abbott Groupe
- Danaher
- Thermo Fisher Diagnostics
- Sebia
- BioMerieux Groupe
- Diagnostica Stago
- Biosynex
- Diagnostic Medical System DMS
List of charts
- The European in vitro diagnostics market
- Breakdown of the global in vitro diagnostics market
- Sales in the in vitro diagnostics market
- Breakdown of IVD market share in Europe
- The French in vitro diagnostics market
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