The market for ocular prostheses - France

1.2 The global market

The global market for ocular implants is valued at $**.* billion in ****, and is expected to grow at a CAGR of *.*% over the period ****-****, due to the higher number of eye diseases such as glaucoma and cataracts. According to the WHO (***) in ****, ** million people suffered from cataracts in ****, and *.* million people worldwide were diagnosed with glaucoma.

Evolution of the global market for ocular implants World, ****-****, US$ million Source: ****

North America, like Western Europe, is expected to account for a significant share of the global market for ocular implants, notably due to the aging of the population and associated eye disorders .

However, the above figures do not represent the market for ocular prostheses, but rather the broader market for ocular implants, which includes prostheses.

Global market breakdown for ocular implants (***) World, ****, as % of total Source: ****

In reality, the ocular prosthesis market represents only **% of the total ocular implant market, far behind intraocular lenses (***). This represents a total market size of around * billion euros by ****.

The world's leading manufacturers of ocular implants and ocular prostheses are: Carl Zeiss, Bausch & Lomb, Aurolab, Staar Surgical and Morcher GmbH.

1.3 The French market: market size

In France, by ****, the number of people wearing ocular prostheses is estimated at ***,***, or *.*% of the French population , according to the Social Security. [***] This figure is stable from one year to the next, with as many people entering the loop of prosthesis wearers as leaving it (***).

New prostheses :

To estimate the total market size of the ocular prostheses sector, we can take the number of new prostheses each year and multiply it by the average price of a prosthesis. In ****, the number of new prostheses manufactured was *,***, stable compared to ****, and the average price was €*** (***)[***]. Sales of new ocular prostheses in **** would therefore be *,*** x €*** = €*.* million.

Tolerance tests:

To this sales figure for new prostheses must be added tolerance tests costing €***.** per new prosthesis. This corresponds to annual revenues of €***.** x **** = €*.*** million.

Maintenance:

We must also add the maintenance of ocular prostheses, of €**.** per year (***). This corresponds to a revenue of €**.** x ***,*** = €*.*** million for the year **** .

Estimated market size :

The market size for the ocular prostheses sector is therefore €*.* million + €*.*** million + €*.*** million = €**.* million for ****. (***)

Given that there are ** ocularists / ocular prosthetists in France, divided into ** laboratories, the average turnover of an ocular prosthesis laboratory in France is ***,*** euros per year in ...

2.1 Strong demand

Quantitative aspect of demand: assessment of potential demand

In ****, the number of new ocular prostheses is estimated at *,***. Today, however, waiting and manufacturing times are long, and supply is limited in the face of growing demand. The demand for prostheses is therefore not fully satisfied, and actual demand is therefore greater than the *,*** prostheses mentioned above.

In France, nearly *.* million people suffer from a vision impairment, and a blind person is born every ** hours [***]

In ****, of the ***,*** cases seen in Paris' three ophthalmology emergency centers (***) **% were traumatic emergencies, i.e. nearly **,***. In France, ophthalmological emergencies account for *% of all emergencies. Each year, *.*% of the population consults us for an ocular emergency.

trend in the number of requests for unscheduled care handled by ophthalmology emergency structures in Paris France, ****-**, in numbers

These data date from ****, but are still relevant as they clearly reflect the very high demand for eye care and eye prostheses. The following graph shows the different waiting times according to the type of request.

Median waiting time for an appointment by reason for request France, ****, in days Source: ****

Thus waiting times for ophthalmology, and consequently for obtaining an ocular prosthesis, are very long (***).

Qualitative aspect of demand: who ...

2.2 Glaucoma: one of the leading factors in the demand for ocular prostheses

Glaucoma is a chronic eye disease caused by damage to the optic nerve. It is favored by an increase in the internal pressure of the eye. [***]

Number of people affected :

Glaucoma affects *% to *% of the population over the age of **, and around **% over the age of **. *.* million people are treated for glaucoma in France, but ***,*** have the disease unknowingly, undetected and untreated. This means that if these ***,*** people are not treated in time, the risk of complications and blindness increases [***]

Glaucoma is the second leading cause of blindness in developed countries after AMD. [***]

The WHO estimates that *.* million people worldwide are blind as a result of glaucoma, representing **% of global blindness. Assuming that this **% is also valid for France, this would meanthat **,*** people are blind due to glaucoma in France, knowing that there will be ***,*** blind people in France in ****. [***]

Of these **,*** people, a certain number need an ocular prosthesis following an operation to make their daily lives easier.

2.3 Another reason for wearing a prosthesis: AMD

AMD is age-related macular degeneration. Itis a chronic eye disease that affects the central area of the retina. It develops from the age of ** onwards. Smoking, age and genetic predisposition are the main risk factors. [***]

Number of people affected :

This disease affects around *% of the French population, but its frequency increases with age : *% of people aged **-**, **% of those aged **-** and **-**% of those over **. It is the main cause of blindness and poor vision in the elderly.

Incidence of AMD according to age France, ****, in % Source: ****

Increased demand for prostheses:

As thenumber of elderly people in France increases, so willthe number of cases of AMD and the demand for prostheses.

Growth in the number of elderly people (***) France, ****-****, % Source: ****

In ****, the proportion of the population aged over ** is estimated at *.*%. According to Insee projections,this figure will rise to **% by ****, or **.* million people.

So, even if vision care improves, the aging of the population will lead to an overall increase in demand for ocular prostheses.

2.4 Other diseases and causes of demand for ocular prostheses

Accidents:

Diseases such as glaucoma are increasingly well treated, and prevention is increasingly effective, but the number of accidents and traumas remains very high (***), sometimes necessitating the fitting of ocular prostheses.

The leading accidental cause of blindness in France is a champagne cork in the eye. [***] There are no figures available in France to quantify this phenomenon. However, a famous study has appeared in the British Journal of Ophthalmology which, out of **.*** injuries recorded (***), ** were due to champagne corks in the eye.

Finally, one in six of all cases seen in ophthalmological emergency departments is due to trauma. [***]

Eye cancer:

Eye cancer is rare. The most common is uveal melanoma in adults , with *** to *** new cases in France each year. Retinoblastoma is the most common eye cancer in children, with around ** cases per year in France. [***]

Diabetes :

Diabetes can lead to retinal damage: diabetic retinopathy , which affects **% of type * diabetics. Diabetic retinopathy is the leading cause of blindness in France for people under **. [***]

Cataracts and glaucoma are more common in diabetics. Diabetes is therefore one of the main causes of vision loss among people of working age in developed countries. [***]

In ****, diabetes affected more than *.* million people in France, and is ...

3.1 Value chain

Source: ****

Before the ocular prosthesis is fitted, the ophthalmologist must validate the tolerance test. The ophthalmologist is involved throughout the process, in collaboration with the ocularist who manufactures the prosthesis. It is the ophthalmologist who issues the prescription for the ocular prosthesis to the patient, which is compulsory. Social Security covers ***% of the cost of the ocular lenses, and reimburses maintenance and polishing every six months, and prosthesis renewal every six years.

3.2 Ocularists

Ocularists can be either self-employed or employed by a laboratory: in ****, there were ** ocularists, including ** laboratories. The majority of ocularists are therefore employed by laboratories.

The ocularist's main tasks :

Take impressions and measurements of the patient's eye Identify particularities of iris color, brilliance, shape and size of the eyeball Design the ocular prosthesis Paint the iris, veins and white of the eye Advise on changes in vision and perception Provide information on prosthesis maintenance measures

Ocularist remuneration:

The average gross annual salary for an entry-level ocularist is €*,***. They may start their career in a laboratory or directly in a hospital, before becoming self-employed. [***]

Training required to become an ocularist:

The UDOF has asked theUniversité Pierre et Marie Curie Paris VI to create a university diploma in ocular prosthetics.

The profession of ocularist can be practiced by people who hold a university diploma in applied ocular prosthetics and have three years' experience in the field. rience of three years' continuous practice with one or more ocularists or in one or more departments of a health care establishment in which prostheses are manufactured. [***]

Syndicat des ocularistes :

UDOF, the ocularists' union, oversees the profession, looks after training and works on legislation for ocular prostheses. ...

3.3 The manufacture of ocular prostheses

Ocular prostheses are made from PMMA (***), a biocompatible, lightweight and resistant material. They are made up of several layers. The first is the shade of the white of the eye that the professional seeks to reproduce. The second corresponds to the make-up: the vessels are reconstituted from wool threads to restore a lifelike appearance. The hand-colored iris is then incorporated during the firing process, before the third layer of transparent resin is applied to the surface. [***]

The work is carried out by hand, using tools similar to those used by dentists and jewellers: magnifying loupes, impression trays, prosthesis presses...

The average production time for an ocular prosthesis is estimated at ** hours.

The world leader in PMMA is Altuglas International, a former subsidiary of Arkema (***), followed by Evonik and Mitsubishi Rayon. Altuglas was acquired in **** by the American group Trinseo

PMMA price index trend Europe, ****-****, in $ Source: ****

This curve shows the evolution of the PMMA price index between **** and ****. There is an overall price increase of **% over the period June **** - December ****. This price rise has a strong impact on the cost of ocular prostheses.

3.4 Steps involved in fitting an ocular prosthesis

Each ocular prosthesis is entirely made-to-measure. A total of three appointments are required with the wearer before the final fitting. A follow-up visit is recommended every * months on average, for polishing. Another important aspect of the treatment is the time spent with the patient, explaining, informing, reassuring and comforting him or her, who may have many questions before the procedure. [***]

The steps[***]:

*st session: selection of a preform for molding the cavity, recording of dimensions, iris and scleral tints and vascularization, and an administrative part (***) *nd session: fitting and successive touch-ups, verification of the iris produced by the laboratory, production of the ocular prosthesis if everything is in order (***) *rd session: delivery (***)

3.5 Financing eye prostheses

The law regulates the prices (***). [***]

Link to the decree of October **, **** relating to ocular prostheses in chapter * of title II of the list of reimbursable products and services provided for in article L. ***-* of the social security code.

The ophthalmologist's prescription:

An ocular prosthesis requires a medical prescription from an ophthalmologist. The prescription is valid for one year. The fitting of an ocular prosthesis also requires a medical prescription. The ophthalmologist decides whether or not to renew an ocular prosthesis. A prescription from a general practitioner is not valid. [***]

4.1 The different types of ocular prostheses

There are three main types of ocular prosthesis: the sceral lens, implant-supported mobility prostheses and orbital epitheses . [***]

Sceral lenses:

Sceral lenses are long-diameter contact lenses that pass over the cornea without touching it, covering the sclera (***). The lens can be rigid or flexible, with or without optical correction. The aesthetic result is very good, when the patient's eye is not too sensitive; it is discreet and very natural. These lenses also reduce conjunctival discharge.

Implant-supported prostheses :

These ocular prostheses are used after enucleation, and can be fitted one month after surgery. They are positioned inside Tenon's capsule, and are rarely used for evisceration? These prostheses are very difficult to mold.

Orbit epitheses :

These prostheses are used to complete a badly damaged orbit. They replace the eye and orbit, and include eyelids, ocular prosthesis, eyelashes and eyebrows. They can be used after trauma or tumor removal.

4.2 The price of an ocular prosthesis

Table of prices for ocular prostheses by type :

Source: ****

The above prices are regulated by the French Social Security system . the most expensive prosthesis is the definitive ocular prosthesis after mutilating surgery (***) costs €**.**.

4.3 A limited and unevenly distributed offering

Source: ****

The map above shows the results of the search "ocular prosthesis" on Google Maps. The search returned ** results for eye prosthesis laboratories (***), which represents a good sample.

Eye prosthesis laboratories are unevenly distributed across France. There is a very high concentration of practices/labs in Paris (***). The Brittany and Centre regions and the South of France have few or no laboratories. The number of laboratories is very low. The offer is therefore limited.

Opinions reveal the largest laboratories: Dencott, SARL Michel Durand and Prothelem.

4.4 Innovation: towards the democratization of ocular prostheses?

First *D-printed eye prosthesis:

In ****, an English patient received the first artificial eye prosthesis designed entirely by a printer. By manufacturing the prosthesis using a *D printer, the valid eye can be reproduced almost identically.

Thanks to this innovation, the time taken to take charge, design, take impressions and obtain the prosthesis has been halved. [***]

At present, patients wait an average of * weeks for a temporary prosthesis and more than four months for a personalized prosthesis , so thanks to prosthesis printing, the manufacturing process is reduced to two or three weeks, and the initial appointment to half an hour.

This *D-printed prosthesis meets the three main expectations of eye prosthesis applicants:

the precision of the new eye rapid treatment reduced molding time

One of the major advantages of these ocular prostheses is their realistic appearance: they are made entirely of acrylic and reproduce the iris and depth of the natural eye with a certain realism.

This new technology could make up for lost time during the health crisis and reduce long waiting lists.

Link to the website of the German company that makes these *D prints: Fit AG

Towards the democratization of ocular prostheses?

This new technology could give more people ...

5.1 French regulations

Legal definition of the activity:

"Healthcare professional specializing in the fitting of ocular prostheses : he/she fits the non-functional eyeball or orbital cavity following enucleation or evisceration, with a custom-made external ocular prosthesis, to a sick or disabled person. He/she designs, measures and molds the prosthesis, manufactures it, has it tested and delivers it. He checks its tolerance and immediate functional effectiveness, and provides follow-up care, including re-polishing and adaptation."

The APE code for ocular prostheses is ****A. [***]

Professional qualifications:

The ocularist profession can be exercised by people holding the French state diploma of ocularist.

Certain professionals may exercise the activity by dispensation. These include :

holders of a university diploma in applied ocular prosthetics who have * years' continuous experience working for one or more ocularists, or in one or more departments of a health care establishment where prostheses are manufactured professionals whose competence has been recognized by the Ministry of Veterans and Victims of War and health insurance organizations professionals whose competence has been recognized by the national commission

Doctors specializing in stomatology, maxillofacial surgery, ophthalmology and dental surgeons may also practice as ocularists if they meet one of these conditions.

Articles L****-* , D****-* and D****-**-* ...

6.1 Player segmentation

• Altuglas international France
• Dencott
• Cambrillat
• Villanova
• Prothelem
• Michel Durand sarl
• Pascal Oustalet
• Hôpital des Quinze-Vingts
• Hôpital fondation Adolphe de Rothschild