1.1 Definition and scope of the study
A medical device ("MD", also referred to as medical equipment) is defined as "An instrument, apparatus, equipment or software intended by its manufacturer to be used in humans for the diagnosis, prevention, control, treatment, mitigation of disease, injury, or other purposes". [ANSM]
MDs are a heterogeneous, meaning a wide range of products are included under the scope of this product category. Indeed, in France there are between 800,000 and 2,000,000 product references according to HAS Health. Broadly speaking, medical devices can be segmented in the following manner, based on their usage [Financière d'Uzès ] :
- Medical Devices for individual use (hospital equipment, anaesthetic and respiratory devices, etc.) ;
- Equipment (non-active implants, dental material, etc.) ;
- In vitro diagnostics (pregnancy tests, glucometers, etc.) ;
- E-Health (Monitoring of physiological parameters at home in real time).
The market for medical devices is heavily impacted by European and French regulation, which, going forward, will also contribute to a suppression of growth as compliance will continue to be a large cost for companies in the sector.
Nevertheless, the market in France is growing amid an ageing population and longer life expectancies, and is expected to continue doing so going forward. The market is highly fragmented, with a large amount of players included in this industry. M&A activity remains important to thrive in the sector and overcome cost barriers.
Finally, we dedicate a section of analysis with regards to COVID-19. Although it is still early to draw inferences and look at how the industry as a whole has been impacted, it is possible to quantify certain effects in light of the global pandemic.
1.2 A dynamic global market dominated by American companies
World market size medical devices World, **** - ****, US$ billion Source: ****
In ****, the global market value for medical devices and equipment was $***.* billion; this number is expected to grow at CAGR *.*% to reach $***.* billion in ****. Several factors contribute to this growth, including a rising geriatric (***) population and an increase in chronic conditions. ...
1.3 The domestic market signals strength
Evolution of the medical device manufacturing market France, ****-****, € billion Source: SNITEM , INSEE
The French market for medical equipment was worth €** billion in ****, and was expected to reach €**.* billion in ****. This represents around *.**% of the world market (***). The market size in **** is calculated by using the turnover index given by INSEE ...
1.4 The rise of renting medical equipment
Presentation of the market
Medical equipment is rented in order to bring down costs. The main types of equipment leased to health structures is durable equipment, or in other words items such as hospital beds, patient lifts, wheelchairs, respiratory assistance equipment, etc.. However, other equipment including electronic diagnostic equipment, equipment for ...
1.5 Global Trade
In this section, we use data from UN Comtrade to determine France’s trade of medical equipment. The code used is « **** Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments».
The fact that this code encompasses more products than medical ...
2.1 France's growth in health care spending
In ****, health care expenditures amounted to €*,*** per year per habitant in France. This amount includes €*,*** on average for hospital care. Of the total healthcare expenditures, Social Security accounts for **.*% of financing, complementary bodies (***) was carried by households in ****. [***]
By further breaking the healthcare expenditure down, we see that of €***.* billion spent ...
2.2 Demographic factors pointing to increased demand
Ageing population and longer life expectancies
In ****, France will have a population of approximately ** million people according to INSEE. Similar to many other European nations, France is facing a reversed demographic pyramid, with a population that continues to age. In ****, the share of seniors over the age of ** years old represented ...
2.3 The government: a key client
According to Ladocumentationfrancaise, the success of medical devices and the companies behind them is strongly dependant on the rebate (***) rate, which is linked to the government in France.
Despite the high costs of production for medtechs, prices are not following accordingly, and are instead experiencing downward pressure, hurting profit margins in ...
2.4 Innovation is crucial in order to survive
As previously mentioned, renting equipment is integral to the medical device industry. Proffessionals from radiology to orthopaedics, thoracic surgery to cardiology, irrespective of whether they are employed publicly or privately, do not always own their equipment, and indeed are in need of such services. Again, this is a matter of keeping ...
2.5 COVID-19's impact on the industry
The global pandemic's impact is extremely tangible, and touches upon every sector in the economy. Due to the nature of the crisis, healthcare is particularly involved. In this section we aim to look at what disruption the virus has caused for the medical devices industry, and will continue doing going forward. ...
3.1 Market Overview & Sector Analysis
There is a wide geographical disparity between medical equipment companies in France when measured through distribution. Most companies are located in the Île-de-France (***), and together these two regions account for between **% and **% of the market. [***]
In relation to this, an important factor to consider in the medicinal equipment market are merger ...
In France, the sales process of a medical device is often timely and complex. From research to market launch takes between * and * years minimum. [***] Below is a breakdown of how the value chain for medical equipment often looks:
Research and technological innovation is the first step: at this level ...
The production of medical devices is heavily regulated and controlled on both regional (***) also carries out regular inspections of the product's distribution and manufacturing establishments.
According to Lille University there are several channels through which a medical device can be made available for sale:
Specialized service providers; Home health ...
4.1 Product Analysis
We can distinguish four classes of medical devices in Europe. Each class has different compliance requirements to be followed to be able to market and retail their product.
Class III (***) - Examples: breast implants, coated stent, intervertebral cage, hip prostheses ; Class IIb (***) - Examples: condoms, lens disinfectants, blood bags, implantable plates; ...
4.2 Price Analysis
In France, medical equipment prices vary greatly depending on the type of product. Some are said to be non-refundable, and that pricing is free. Others are said to be reimbursed, their price is then set by the Economic Committee for Health Products (***) which sets out different pricing points, ...
5.1 Increasingly strict regulation
Despite strong growth and a promising future, the medical device industry continues to struggle with barriers to growth founded in regulation.
In ****, the regulation of medical devices was modified in the European Union, and is planned to be phased out until the end of **** (***). [***] As mentioned earlier, the former is currently ...
5.2 Nomenclature and Harmonized System of World Customs
The Harmonized System is an international nomenclature for the classification of products. It allows participating countries to classify traded goods on a common basis for customs purposes. At the international level, the Harmonized System (***) for classifying goods is a six-digit code system. [***]
The HS comprises approximately *,*** article/product descriptions that appear ...
The aim of this section is to give an overview of market players by dividing them into different segments, presented below:
- La vitrine médicale
- Distri club Medical
- Bastide le confort médical
- Harmonie medical service
- Vitaléa Médical
- Beaulieu Médical
- BVS Medical
- Laboratoires Chemineau
- Johnson & Johnson Medical
- Medtronic France
- General Electric Healthcare
- Baxter International France
- Siemens Healthineers
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