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Summary and extracts

1 Market Summary

1.1 Definition and presentation

The aesthetic medicine and surgery market includes two different segments:

  • Aestheticmedicine: a less invasive branch that does not use surgery to correct a patient's blemishes or defects. Aesthetic medicine treatments are characterized by noninvasive treatments and usually short and painless recovery times.
  • Cosmetic surgery: a branch of plastic surgery that allows a patient's appearance to be improved or physical defects to be permanently eliminated, either totally or partially, through surgeries. Cosmetic surgery procedures are quite invasive, in most cases produce permanent results, and involve longer and more painful recovery times.

This market study focuses mainly on the first segment.

The global cosmetic surgery and medicine market is growing rapidly, and is expected to grow at a CAGR of 11% through 2027. The aesthetic medicine market still remains predominantly dominated by the United States, where a record 5.3 million non-surgical procedures were performed in 2021.

The Italian market is also growing, thanks in particular to the increasing popularity of so-called "non-invasive" methods of aesthetic medicine, placed on the borderline between medical treatment and simple aesthetic procedures. Italy is in fact the country in the world with the highest number of aesthetic medicine procedures in proportion to its population. In recent years, due to covid, this growth has come to a halt from which Italy is recovering more slowly than other countries.

The Italian market is still predominantly driven by women, with 75.8% of procedures, but interest from men has grown in recent years. In fact, it is estimated that requests for non-surgical treatments by men have increased by 25.4 percent since 2008 .

Italians are resorting to aesthetic medicine from an increasingly younger age, as they prefer to prevent the signs of aging, instead of treating them, in the best possible way and with optimal results.

In Italy, the injectables segment dominates the aesthetic medicine market, with 79.8% of all procedures. In fact, Hyaluronic acid fillers and botulinum toxin are the most popular nonsurgical procedures among Italians.

The aesthetic medicine market requires high entry costs and advanced technology , and most manufacturers specialize in manufacturing. The market is constantly renewing, and in recent years there have been major technological advances that have enabled the spread of increasingly less invasive and more effective procedures, such as CoolSculpting and Rhinofiller .

1.2 The global market driven by the United States

The aesthetic medicine and surgery market consists of two segments:

aesthetic medicine (***) cosmetic surgery (***)

The global aesthetic medicine and surgery market was valued at $**.* billion in **** and is expected to grow at a CAGR of **% through ****, reaching a value of $**.* billion at the end of the period.

Market growth is encouraged by growing aesthetic consciousness, greater acceptance of cosmetic surgeries as a means of changing one's appearance, and technological advances in the surgical and nonsurgical fields.

Size of the global aesthetic medicine and surgery market World, ****-*****, in billions of USD Source: ****

Aesthetic medicine is the fastest growing segment. From **** to ****, the cosmetic surgery segment increased "only" *.* percent, while the cosmetic medicine segment increased **.* percent. In contrast, the comparison with the previous year, ****, shows +**.*% and +**.*%, respectively.

The growth in ****, especially regarding surgery, is partly explained by considering that the previous year restrictions caused by the pandemic made many of the procedures impossible.

In ****, the number of surgeries continued to increase. The number of surgeries is

Evolution of the number of surgical and non-surgical interventions World, ****-****, in millions Source: ****

According to the International Society for Plastic and Aesthetic Surgery (***).

Currently, the global market is still largely dominated by the United States. ...

1.3 Domestic market

According to ISAPS, the Italian market represents *.*% of the global aesthetic medicine and surgery market, which gives us an Italian market size of ***.** million euros (***)

In Italy, the aesthetic medicine segment is one of the most developed in the world, accounting for **.* of the total market. Therefore, we can estimate the Italian aesthetic medicine market at *** million euros, which is a sharp increase from **** when the value was estimated at ***.* million euros. (***) and also to the greater willingness to perform this type of surgery after the health crisis grafted by Covid-**

Share of aesthetic surgical and non-surgical interventions Italy, ****, in % Source: ****

The field of aesthetic medicine has also experienced significant growth in Italy. According to theNational Observatory of Aesthetic Medicine, the growing popularity of aesthetic medicine is due to the growing desire of Italians to take care of themselves and their appearance. Moreover, Italians are resorting to aesthetic medicine from an increasingly younger age, as they prefer to prevent the signs of aging, instead of treating them, in the best possible way and with optimal results.

Compared to ****, already in **** the number of non-surgical procedures in Italy had almost doubled, following a positive trend in the broader market of aesthetic medicine ...

1.4 The rise of medical tourism

Medical tourism refers to the phenomenon whereby patients travel abroad to undergo medical treatment. In the past, this term usually referred to those who traveled from developing countries to major medical centers in more developed countries to undergo treatment to which they would not have access in their own country. However, in recent years, the term has also begun to be used to refer to those who travel from more developed countries to developing countries to undergo medical treatment at lower prices.

According toISAPS, *.* percent of cosmetic surgeries in Italy in **** were performed on foreign patients. The foreign patients were mainly from Switzerland, France and Romania.

According to Health Tourism Industry, after the adoption of an agreement by the EU in ****, which allowed European citizens to receive treatment in all other EU countries, a health tourism boom began. Italian hospitals have benefited from this boom, and the phenomenon of medical tourism in Italy continues to have a promising outlook both in terms of the country's global positioning and in terms of support from public funding.

In Italy, medical tourism is a fast-growing sector. In **** it had reached a value of * billion euros, up ** percent from ****. Covid has had a strong impact ...

2 Demand analysis

2.1 Demand remains confined to a small part of the population

Demographics of demand

In Italy, demand for aesthetic medicine treatments has been growing steadily for several decades, thanks to several socio-demographic factors such as an aging population, the increasing importance of physical appearance, the normalization of aesthetic treatments, and the expansion of the male market. As we have seen, the sector has been deeply affected by the pandemic, but given the vigorous recovery of the world market, the Italian market is expected to follow, albeit more slowly, the same trend.

The percentage distribution of people undergoing aesthetic medicine procedures in Italy is mainly concentrated in the middle age groups. The **-** age group accounts for the majority of people undergoing such procedures, with **.** percent. This figure suggests that young adults are particularly interested in improving their appearance through aesthetic medicine, probably for reasons related to their own image and self-esteem. The **-** age group also has a significant percentage, at **.**%. This group might turn to aesthetic medicine to counteract the signs of aging or to maintain a younger, fresher appearance.

Aesthetic medicine procedures by age group Italy, ****, in % Source: ****

Demand is still heavily concentrated on a small portion of the population. According toISAPS, the Italian market is still predominantly dominated by ...

2.2 The reasons why Italians turn to cosmetic medicine

The main reason why men and women decide to undergo aesthetic medicine surgery is the need to feel good about themselves: almost * out of ** patients (***) stated this. An interesting fact that reflects the change in our society in recent years is the one related to the importance of image on social networks: about **% of patients say that among their motivations for undergoing aesthetic medicine is the desire to look their best on social networks, such as Facebook.

Just like women, men decide to go to the doctor not only to improve the condition of their skin, but especially to prevent aging after the age of **. Today, more than **% of men between the ages of ** and ** want to improve their physical appearance. Men undergo cosmetic treatments driven by a desire to look younger and more competitive at work and to improve their self-esteem. [***]

In addition, it seems that the goal of most patients in the higher age group is to look a little younger, without excess to maintain a natural appearance. In fact, **.* percent only need a facial rejuvenation of about * years, while ** percent would like to turn back the hands of the clock by ** years or more [***].

Reasons why to resort ...

2.3 Demand trends

The needs and demands of Italians have changed profoundly in recent years, redefining the existing dynamics within the world of aesthetic medicine and surgery.

There are three main trends in demand: the influence of social media on young people who choose to resort to aesthetic medicine, the growing focus on the prevention of the causes of aging, and the increasing use of noninvasive procedures to correct aesthetic imperfections previously corrected with plastic surgery.

An increasingly younger target audience

Younger patients have also increasingly begun to approach the world of aesthetic medicine. **.* percent of girls and *.* percent of boys have already used aesthetic medicine to treat acne, reduce hair and stretch marks, correct their nose, ears, or breasts.[***]

According to the Italian Society of Aesthetic Medicine, this trend is partly caused by the self-esteem issues, dissatisfaction and fear of not being beautiful enough generated by social media. Young patients are constantly exposed to images of ideal perfection online, which they hope to achieve by resorting to cosmetic surgery. According to the Italian Society of Reconstructive and Aesthetic Plastic Surgery, in recent years there has been a ** percent increase in the number of cosmetic surgeries performed with the goal of looking better in ...

2.4 The impact of the Covid-19 emergency on demand

The lockdown caused by the Covid-** pandemic has generated a renewed interest in self-care among Italians. After months of carbohydrate-rich diets, lack of exposure to the sun and outdoors, accumulated stress and the effect of blue light from screens, Italians began to see the effects of the pandemic on their skin. As a result, once out of lockdown, Italians began to look for solutions to feel regenerated. This was not only a physical need, related to the fact that they may have neglected their appearance and skin for several months, but more importantly a psychological need. After the lockdown, Italians felt the need for a fresh start, and aesthetic medicine can help them achieve this goal [***]

Furthermore, a study conducted by Renaissance Trend Lab found that taking care of themselves was one of the things Italians missed most during the lockdown. Once out, Italians thought they would satisfy this need by going to the hairdresser (***).

Most requested aesthetic procedures after lockdown Italy, ****, in % Source: ****

Not surprisingly, among the injectables segment, the most requested procedures are those involving the upper part of the face, due to the use of masks covering the nose and mouth. TheItalian Association for Aesthetic Botulinum Therapy (***) reported ...

2.5

3 Market structure

3.1 A market structured around equipment manufacturers and medical professionals

The value chain of aesthetic medicine includes several stages. First, raw materials are supplied to manufacturers, who process them to produce medical equipment. The latter is then purchased by independent medical practices, hospitals, and aesthetic medicine centers, and is finally used to perform nonsurgical procedures on final patients.

We can distinguish two main types of players in the aesthetic medicine market: medical equipment manufacturers and physicians or medical facilities.

Equipment manufacturers

The Italian manufacturer market is characterized by a strong specialization given the complexity of technology and the high cost of medical equipment. There are three main segments of the market: injectables, energy-based equipment, and cosmeceuticals .

Injectables are chemicals inserted into the skin through a needle that support muscles or plump the skin, decreasing the appearance of wrinkles. The two main types of injectables are neuromodulators, such as botulinum toxin, which are used to weaken and paralyze facial muscles, and dermal fillers, such as hyaluronic acid, which are inserted under the skin to provide volume and support in multiple areas of the face. Energy-based devices are the devices used by physicians to perform aesthetic medicine treatment. Based on technology, they are classified into laser, pulsed light, electromagnetic energy, ultrasound, cryolipolysis, and ...

3.2 Production of aesthetic medicine equipment

Aesthetic equipment manufacturing includes the production of injectables, energy-based machinery, and cosmeceuticals. The aesthetics market requires high entry costs and advanced technology , and most manufacturers specialize in producing one of these segments.

The main players in the market international companies, and most production sites are located abroad with the exception of a few tricolor groups specializing in cosmeceuticals and injectables (***), such as Fidia Farmaceutici. These companies have their production sites in Italy. For foreign manufacturers, if they do not have a production site in Italy, they mostly have commercial subsidiaries that provide logistics and distribution of equipment to hospitals, centers, and physicians.

If these groups do not have subsidiaries, distribution in Italy is entrusted to specialized wholesalers.

Each product requires its own production line :

The production of botulinum toxin for aesthetic purposes is strictly regulated in Italy as only three groups are authorized to market it in the territory. Allergan markets its product in the aesthetic market under the name Vistabel/Vistabex, derived from botulinum toxin type A, dosed at ** units, and received marketing authorization in ****. Ipsen has been marketing Azzalure since ****, and finally, the Merz laboratory has been marketing its product called Bocouture since ****. Machinery production concerns energy-based equipment, such ...

3.3

4 Supply analysis

4.1 Overview of the offer

The supply in the aesthetic medicine market can be summarized as follows:

*. Injectables

Botulinum toxin : Botulinum toxin works by inhibiting the release of the neurotransmitter acetylcholine: by blocking its release in the muscles, it reduces excessive facial expressions and thus stops skin sagging, the primary cause of wrinkles and stretch marks. This facelift does not require any anesthesia, is performed without hospitalization, and leaves no obvious marks on the face such as ecchymosis (***).

There are three botulinum formulations for cosmetic use authorized by the Italian Drug Agency in **** (***).

Calcium hydroxyapatite: is a mineral salt found in the human body. Calcium hydroxyapatite microspheres, bound with a methylcellulose gel, are injected with a needle into the skin. The filler has a dual effect: it fills in wrinkles and forms a structure that stimulates fibroblasts to create new collagen and elastin. Once injected into the skin, it is ***% reabsorbable within a year.

Hyaluronic acid: exists naturally in all living organisms and is a component of the extracellular space. it is essential for the formation of collagen and elastic fiber matrix and for maintaining skin hydration. Hyaluronic acid is injected in very small doses into the affected regions using a syringe equipped with a ...

4.2 Injectables segment leading the market

In Italy, the injectables segment dominates the aesthetic medicine market, accounting for **.*% of all procedures. In contrast, facial rejuvenation and other procedures account for only a marginal share of the market, *.*% and **.*%, respectively.

Distribution of the aesthetic medicine market by macro segment Italy, ****, in % Source: ****

Analyzing the distribution of the injectables segment, we can see that more than half of the procedures are represented by hyaluronic acid (***) was granted only for its use on the glabella, and more recently, in ****, its therapeutic indications were extended to the temporary improvement of so-called crow's feet, that is, wrinkles on the sides of the eyes. [***]

Share of injectables by type Italy, ****, in % Source: ****

The facial rejuvenation segment is more fragmented than the injectables segment, as the total is divided between chemical peels (***).

Share of facial rejuvenation procedures by type Italy, ****, in % Source: ****

Permanent hair removal accounts for most of the "other" procedures segment, with **.*% of procedures. This is followed by anti-cellulite treatments (***), which has gained increasing popularity in recent years.

Share of "other" procedures by type Italy, ****, in % Source: ****

The most common procedures in Italy, across all segments, are hyaluronic acid (***).

it is interesting to compare the Italian data with the world average. On ...

4.3 Characteristics and prices of procedures

The following table summarizes the characteristics of commercially available nonsurgical aesthetic procedures:

Source: ****

it is important to note that prices vary widely depending on the medical facility, physician, or region.

4.4 Supply trends

The aesthetic medicine market has undergone profound changes in recent years that have been driven by changing customer demand. The supply has adapted to these trends by developing new techniques or advanced machines. Thanks to the continuous technological research conducted by market players, procedures are increasingly dynamic and allow for effective, natural and long-lasting results [***]

In particular

Cryolipolysis , also known as "fat freezing" or by the product name CoolSculpting, is a new procedure that involves noninvasive cooling of body fat to eliminate fat cells, resulting in reduction of body fat without damage to other tissues. The effect of these procedures takes several weeks to be seen.

This procedure is increasingly used as a substitute for liposuction, which is more suitable for more severe cases, but also requires a longer and more painful procedure [***]

Rhinofiller: In recent years, nonsurgical rhinoplasty has become the preferred option for most patients and aesthetic physicians. This minimally invasive technique already produces high satisfaction rates. In addition, patients do not need anesthesia and there is no postoperative recovery period. Ninety percent of patients perform the treatment for cosmetic purposes while in ** percent of cases a functional correction is performed by injecting NASHA fillers at the level of ...

5 Rules and regulations

5.1 Italian regulations

Title required to perform aesthetic medicine treatments

The aesthetic physician has a degree in Medicine and Surgery , but it is not essential that he or she have any other type of specialization. There is not yet an EEC-compliant University Postgraduate School for aesthetic medicine, and therefore there is not yet a recognized title. Aesthetic physicians, after graduating from medical school, may decide to optionally attend a four-year training school, such as The Agora Post-University School of Aesthetic Medicine, or the Academy School of Practical Aesthetic Medicin (***).

Regulations regarding fillers

Among the most widely used Medical Devices (***) carries out constant supervision and surveillance of their use.

In Italy, more aesthetic procedures using fillers are estimated every year. The list of DMs marketed in Italy is registered in a National Database [***]

"Fillers"-are medical devices regulated in general by Legislative Decree No. ** of February **, ****, as amended by Legislative Decree **/**** (***), which indicates the general and essential requirements that a medical device must possess. Fillers, therefore, are medical devices regulated uniformly within the European Union.

Arrangements for placing on the market

Medical devices, including fillers for aesthetic medicine, are not subject to any prior authorization by the Competent Authority (***), as there is a European ...

5.2 Off-label prescribing

Any pharmaceutical company that introduces a new drug to the market must have approval from its relevant ministry. The drug is authorized for the particular clinical indication required, calling it "on label." A physician who uses a drug outside of its usual use, uses it out of indication or "off label." "Off label" use is recognized but regulated in different countries according to national regulations. In Italy, for example, this particular use is accepted provided there is already significant scientific literature on the subject and the patient is informed.[***]

Off-label prescribing occurs when a drug is administered (***):

Other than the intended therapeutic indication. Other than the intended route and mode of administration. According to doses different from those provided in the RCP dosage schedule. Exceeding the contraindications contemplated in the RCP. Other than the uses authorized by the Ministry of Health. Unlike the list prepared by the Single Drug Commission.

Off-label prescribing, beyond compliance with the laws that regulate it, is also an ethical problem, because it goes to decisively affect clinical practice, i.e., the behavior that the doctor assumes towards the therapy to which he subjects his patient.

In fact, while off-label prescription of a drug, in selected clinical ...

6 Positioning of actors

6.1 Segmentation

  • Fidia Farmaceutici
  • Decomedical
  • ITS Group
  • BTL
  • EME Estetica
  • Ipsen
  • Merz Pharmaceuticals
  • Allergan plc (Abbvie)

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