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Summary and extracts
1 Synthèse du marché
1.1 Introduction
Advanced therapies are a category of innovative medical treatments that exploit advanced technologies to modify or manipulate genetic material, cells, or tissues with the goal of treating or curing complex and often incurable diseases.They represent an advanced frontier of personalized, targeted, and regenerative medicine, offering new treatment options for a wide range of genetic, oncological, degenerative, and autoimmune diseases. In recent years, innovative therapeutic technologies have been developed based on DNA, RNA, cells, and tissues, rather than chemically synthesized molecules. This broad set of therapeutic solutions is classified as Advanced Therapeutic Medicinal Products (ATMPs). ATMPs are true medicines derived from the remarkable advances made over the past 50 years in biotechnology and genetic engineering.
The value of the global market for advanced therapies shows significant growthfrom 2023 to 2030,with a compound annual growth rate (CAGR) of 16.80 percent.Starting from $31.6 billion in 2023, it is expected towill reach $93.7 billion in 2030. This represents an196% increaseover the forecast period.Conventional drug manufacturers, seeking to gain a competitive advantage, are looking at ATMPs as a lucrative source of revenue in future health care systems.
In Europe, 22 Advanced Therapies have been approved-6 of these have since been withdrawn from the market, ihe value of its market was $9.0 billion in 2023, and is expected to reach $27.2 billion in 2032, an increase by 202% in nine years at a CAGR of 13.0%.
As forour country, 8 Atmps are reimbursed and on the market, and another 6 are under evaluation. In the coming years, the market value is estimated to grow by 449% in a full scenario and 250% in a reduced scenario. One of the most interesting data is the national spending trend for ATMPs in Italy, which has grown by 6014% in four years, this reflects a significant increase in the adoption of innovative therapies, highlighting the growing importance of investing in advanced medical solutions to address complex diseases, while underscoring the need to balance access to these therapies with the economic sustainability of the health care system, as the rapid growth in investment presents major challenges in terms of cost management and equity in access to care.
1.2 The global market
In recent years, innovative therapeutic technologies have been developed based on DNA, RNA, cells, and tissues instead of chemically synthesized molecules. This broad set of therapeutic solutions is classified as Advanced Therapeutic Medicinal Products (***). ATMPs are true medicines derived from the remarkable advances made in biotechnology and genetic engineering over the ...
1.3 The European market
To date, ** Advanced Therapies have been approved in Europe - * of which have since been withdrawn from the market - mainly for monogenic diseases, hematologic malignancies, and tissue injury. It is estimated that at least ** Advanced Therapies will be on the way by ****, with nearly ***,*** patients potentially treatable with a gene ...
1.4 The Italian market
Technological innovation in biotechnology is leading to significant developments in advanced therapies, including gene therapies, cell therapies, and regenerative medicine. These advances offer new possibilities for the treatment of previously difficult-to-treat diseases, attracting investment and interest from both the public and private sectors. As for our country, * Atmps are reimbursed and ...
1.5 Inflation suffered by the sector
Inflation has increased production and research costs in advanced therapies, leading companies to review budgets and priorities. Despite rising drug prices and difficulties in accessing funding, the industry has responded by optimizing costs, seeking collaborations, and adopting automation technologies to maintain production efficiency. Companies have also intensified partnerships to share resources ...
2 Analyse de la demande
2.1 Overview of demand
In recent years, innovative technologies based not on chemically synthesized molecules but on DNA, RNA, cells, and tissues have been developed for therapeutic purposes. This broad panel of therapeutic solutions is classified as Advanced Therapeutic Medicinal Products (***)-compatible donor.
ATMPs are a rapidly growing therapeutic category, offering new opportunities for the ...
2.2 Geographical distribution of demand
The geographical distribution of ATMP spending in Italy shows a strong concentration in some regions, with Lombardy leading the way with ** million, followed by Latium with *.* million and Emilia-Romagna with *.* million. Regions such as Piedmont, Veneto, Tuscany and Sicily show moderate spending between *.* and *.* million. Other regions such as Valle d'Aosta, ...
2.3 Online interest in advanced therapies
Online searches for CAR-T and gene therapies in Italy from July **** to June **** show divergent trends and interesting dynamics. Searches on CAR-T therapies start from an index of **.* in July **** and increase significantly to **.* in June ****, an increase of ***%. The largest peaks are observed in June **** and January ****, showing increasing interest ...
2.4 Trends of major diseases treated by advanced therapies
Between **** and **** in Italy, the leading causes of death for which advanced therapies are indicated show different trends. Malignancies are the predominant cause, with the number declining from ***,*** in **** to ***,*** in ****, a * percent decrease. Ischemic diseases of the heart also show a significant reduction, from **,*** to **,***, a decrease of **%. Chronic lower ...
2.5 New trends in demand
New trends in the demand for advanced therapies, such as gene therapies, cell therapies, and RNA therapies, are influenced by various technological, regulatory, and market factors. Here is an overview of the main current trends:
*. Exponential Growth in Demand
Rare Disease Rise: There is a growing awareness and diagnosis of ...
3 Structure du marché
3.1 Italian market structure
From **** to ****, the number of companies active in the field of biotechnology for health in Italy increased steadily from *** to ***. This represents an increase of **.* percent over the period. **** saw a significant increase, with a jump from *** to ***, while in **** there was a slight decline to ***, followed by continued recovery and ...
3.2 Value Chain
*. Research and Development (***)
Discovery and Innovation:
Identification of diseases and unmet clinical needs. Development of advanced technologies and methodologies such as viral vectors, CRISPR, and scaffolds for tissue-based therapies.
*. Preclinical Experimentation
Preliminary Testing:
Conducting in vitro and in vivo studies to evaluate safety and initial efficacy. Optimization of doses and ...
3.3 The main players in the market
The Italian companies that have advanced therapies approved in Europe and in Italy, that is, that hold the AIC, marketing authorization, are as follows for gene therapy:
Telethon Foundation: Related to the product Strimvelis, is an organization dedicated to scientific research on rare genetic diseases. Established in May ****, it collaborated on ...
3.4 Innovative start-ups
In the field of advanced therapies, technological and scientific innovations are revolutionizing the treatment of many diseases, particularly cancer diseases. Cell and gene therapies, biologics, and antibody-drug conjugates are some of the areas that are seeing significant developments. These advanced therapies aim not only to improve the efficacy of treatments, but ...
4 Analyse de l'offre
4.1 Supply analysis
Below is a detailed description of the main types of advanced therapy offerings:
table { width: ***%; border-collapse: collapse; } th, td { border: *px solid black; padding: *px; text-align: left; } th { background-color: #f*f*f*; }
Source: ****
4.2 Market prices
Data from the Consumer Price Index for Pharmaceuticals in Italy show a general downward trend from **** to ****. The index fell from **.* in **** to **.* in ****, an overall decrease of about *.* percent. However, the trend has been uneven: the index hit its lowest point in **** at **.*, and then rose slightly in subsequent years, ...
4.3 New supply trends
The market for advanced therapies is evolving rapidly with several emerging trends. Here are the main ones:
Personalization of Treatments: Personalized medicine continues to grow, especially in the context of gene and cell therapies. For example, CRISPR gene editing has seen significant approval in the United Kingdom for the treatment of ...
5 Règlementation
5.1 Regulation of advanced therapies
In Italy, the regulation of advanced therapies is a complex system involving numerous laws and regulations to ensure the safety, efficacy and quality of products. Advanced therapies include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue engineering products. This regulatory process follows guidelines established by the European Union, ...
6 Positionnement des acteurs
6.1 Market segmentation
- Takeda Pharma
- BioMarin Pharmaceutical
- Kite Pharma
- Novartis
- Bristol Myers Squibb
- PTC Therapeutics
- Orchard Therapeutics
- CO.DON AG
- Fondazione Telethon
- Holostem
List of charts presented in this market study
- Global advanced therapies market value
- Market shares of advanced therapies
- European market value of advanced therapies
- Value of investment R&D Biotech
- Market shares of biotech R&D investment by firm size
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The advanced therapies market | Italy
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