Italy Oncology Clinical Trials Market Analysis

Italy Oncology Clinical Trials Market Analysis


$ 3999

Italy's oncology clinical trials market is projected to grow from $303.6 Mn in 2022 to $448.6 Mn by 2030, registering a CAGR of 5% during the forecast period of 2022-30. The market will be driven by the rising incidence of cancer in Italy & well-established research infrastructure and regulatory environment. The market is segmented by phase, by study design & by indication. Some of the major players include Pfizer Inc., Roche Holding AG & MolMed S.p.A.

ID: IN10ITCT006 CATEGORY: Clinical Trials GEOGRAPHY: Italy AUTHOR: Vidhi Upadhyay

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Italy Oncology Clinical Trials Market Executive Summary

Italy's oncology clinical trials market is projected to grow from $303.6 Mn in 2022 to $448.6 Mn by 2030, registering a CAGR of 5% during the forecast period of 2022-30. The Italian public health system is regarded as one of the most advanced worldwide, with almost all patient expenditures covered. The system emphasizes both preventive and curative treatment. According to research on the functioning of the Italian healthcare system, Emilia Romagna had the highest grade in healthcare provision in 2022. According to Globocan 2020, the total incidence of all cancer was found to be 415 269. Out of which 13.3% were breast cancer cases, 11.7% were colorectum cases & 10.1% were lung cancer cases. Prostate cancer was the most common kind of cancer in males, with over 36 thousand new cases expected in 2020, followed by lung and colorectal cancer. Breast cancer was the most frequent kind of cancer in women, accounting for about 55 thousand cases in 2020, followed by colorectal and lung cancer.

According to the EU Clinical Trials Registry, about 4,000 current cancer clinical studies are underway in Italy, accounting for around 30% of all ongoing clinical trials in the nation. These studies include chemotherapy, targeted treatments, immunotherapies, and various cancer kinds and treatment techniques. In Italy, both public and private organizations, such as hospitals, university medical centers, research institutes, and commercial firms, undertake oncology clinical trials. The major institutes in this discipline are;

  • National Cancer Institute, Milan
  • European Institute of Oncology, Milan
  • Regina Elena National Cancer Institute, Rome

italy oncology clinical trials market analysis

Market Dynamics

Market Growth Drivers

The Italian Association of Medical Oncology (AIOM) is a member of the European Organisation for Research and Treatment of Cancer (EORTC) and engages in several of its clinical trials. These partnerships have also aided Italy's status as a leader in the worldwide cancer research environment. With several world-renowned institutes and academic centers participating in cancer research, Italy has a well-developed research infrastructure. This provides a solid framework for the government to undertake clinical trials. The Italian government has shown a significant commitment to research and development in the healthcare industry, especially cancer. This includes clinical trial financing, infrastructural development, and tax exemptions for enterprises participating in R&D.

Market Restraints

The regulatory framework for clinical trials in Italy is extensive, which might be a barrier to entry for certain businesses. Clinical trial permission may be a time-consuming and expensive procedure, thus some organizations may choose to conduct studies in nations with more simplified regulatory systems. Despite the Italian government's commitment to promoting R&D in the healthcare industry, financing for clinical trials remains low. This may make it challenging for academics and firms to undertake clinical trials.

Competitive Landscape

Key Players

  • Pfizer Inc.
  • Roche Holding AG
  • Novartis AG
  • Merck & Co., Inc.
  • Bristol-Myers Squibb Company
  • AstraZeneca PLC
  • Sanofi S.A.
  • Moleculin Biotech
  • Menarini Group (ITA)
  • Chiesi Farmaceutici S.p.A (ITA)
  • Angelini Pharma (ITA)
  • Dompé farmaceutici S.p.A. (ITA)
  • MolMed S.p.A. (ITA)

Notable Deals

  1. December 2022, Pluvicto®, developed by Novartis, was approved by the European Commission as the first targeted radioligand therapy for the treatment of progressing PSMA-positive metastatic castration-resistant prostate cancer
  2. December 2022, Moleculin Biotech has received approval from the Agenzia Italiana del Farmaco (AIFA, the Italian Medicines Agency's competent authority) and the Istituto Superiore di Sanità (ISS, the Italian National Institute of Health) to begin its Phase I/II clinical trial of Annamycin plus Cytarabine (Ara-C) to treat acute myeloid leukaemia (AML)

Healthcare Policies and Regulatory Landscape

Several international cooperation for cancer clinical trials includes Italian universities. The Italian Association of Medical Oncology (AIOM), is a member of the European Organisation for Research and Treatment of Cancer (EORTC) and takes part in several of its clinical trials. The regulatory framework for cancer clinical trials in Italy is comparable to that of other European nations. The Italian Medicines Agency (AIFA) is in charge of approving clinical trials and verifying that they adhere to ethical and scientific requirements in Italy. In general, the regulatory procedure for clinical study authorization is swift and simplified.

1. Executive Summary
1.1 Disease Overview
1.2 Global Scenario
1.3 Country Overview
1.4 Healthcare Scenario in Country
1.5 Clinical Trials Regulation in Country
1.6 Recent Developments in the Country

2. Market Size and Forecasting
2.1 Market Size (With Excel and Methodology)
2.2 Market Segmentation (Check all Segments in Segmentation Section)

3. Market Dynamics
3.1 Market Drivers
3.2 Market Restraints

4. Competitive Landscape
4.1 Major Market Share
4.2 Key Company Profile (Check all Companies in the Summary Section)

4.2.1 Company
4.2.1.1 Overview
4.2.1.2 Product Applications and Services
4.2.1.3 Recent Developments
4.2.1.4 Partnerships Ecosystem
4.2.1.5 Financials (Based on Availability)

5. Reimbursement Scenario
5.1 Reimbursement Regulation

6. Methodology and Scope

Oncology Clinical Trials Market Segmentation

By Phase (Revenue, USD Billion):

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

By Study Design Outlook (Revenue, USD Billion):

  • Epilepsy
  • Parkinson's Disease (PD)
  • Huntington's Disease
  • Stroke
  • Traumatic Brain Injury (TBI)
  • Amyotrophic Lateral Sclerosis (ALS)
  • Muscle regeneration
  • Others

By Indication Outlook  (Revenue, USD Billion):

  • Interventional
  • Observational
  • Expanded Access

Insights10 will provide you with the reports within 10 key parameters which are:

  1. Market Overview
  2. Market Growth Drivers & Restraints
  3. Epidemiology of Disease Type
  4. Market Segmentation
  5. Market Share
  6. Competitive Landscape
  7. Key Company Profiles
  8. Healthcare Policies & Regulatory Framework
  9. Reimbursement Scenario
  10. Factors Driving Future Growth

Based on our many years of experience, we believe that these are the parameters that are critical to decision-making for business stakeholders. Our focused approach to developing reports focused on 10 key parameters, enabled us to arrive at the name “Insights10”.

 

Stage I: Market Data Collection

Primary Interviews: We have developed a network of experts, freelancers, and researchers across countries through which we engage with local experts to gather key data points and assumptions about each market. We also engage regularly with some of the best market research agencies such as Atheneum, GuidePoint, GLG, etc. to conduct surveys and interviews, and build intelligence. We have language translators as a part of our team, who between them can cover 30+ languages allowing us to extract better local insights.

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Data Sources: We have access to multiple highly reliable free and subscription data sources. We have many years of experience to understand which sources are more dependable for what and which to prefer for the reliable and latest information. The key sources of information include the following, but are not limited to:

 

 

Stage II: Market Data Analysis and Statistical Model

Market Trends: We generally look at macro parameters and micro indicators. The macro parameters include changes in government policies, demand and supply of the market, government intervention programs, and major market share. The micro indicators are GDP growth, market size, market volume, etc. We also understand nuances specific to each country like the US, Canada, India, Germany, etc., and have worked across 60+ countries and hence not only understand global trends but how these differ by country, how payment models, market structure, cultural parameters, etc. differ in each country.

Market Sizing and Analysis: Our expert data analytics team has created various market forecast models by employing the top-down approach i.e. starting with the large overall market and segmenting different areas and the bottom-up approach i.e. starting with population and epidemiology and rolling up based on spend, etc., estimating the size of the market, and distributing among the geographic and/or product segments.

The top-down approach is mainly used for new product forecasting and the bottom-up approach is used for demand estimation of any product for different countries summed up to form the total market. We are able to round off insights and build stronger forecasts because we always do both these methods and triangulate the final numbers.

The study on the market covers the analysis of the leading geographies such as Asia-Pacific, Africa, Europe, Middle East, North America, and  Latin America for the period of 2022 to 2030. The qualitative analysis covers the industry landscape and trends, market opportunities, competitive landscape, and policy and regulatory scenario, and the quantitative analysis covers different market estimates and forecasts.

Data Triangulation & Validation:

Data triangulation of various sources and results of the research are carried out by benchmarking with reliable sources such as industry statistics, statistical databases, and company-level averages, etc.

We make sure to finalize the numbers in alignment with the market research. Firstly, our internal experts ensure thorough validation and checking to ensure accurate and precise analysis and then validation is also done using a multiple-data analysis model. Two-level validation is done and entails the finalization of the report scope and the way of representation pattern.

 

 

Stage III: Interpretation and Presentation

Analysis & Interpretation: The information gathered is then analyzed and synthesized. The second series of interviews are done if necessary to check and validate. The future opportunities are analyzed by understanding product commercialization and many other factors. It also comprises the analysis of data discrepancies observed across various data sources. Information procured from secondary and primary results is then, interpreted by considering the following parameters: (a partial list)

  • Establishing market drivers and trends
  • Analyzing the regulatory landscape to understand future growth
  • Market Segment based analysis to obtain revenue/volume
  • ​Analyzing current needs and determining penetration to estimate the market

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Data curated from the analysis and interpretation are drawn to portray all in one consolidated report.

Presentation & Reporting: The market research report is presented in different forms such as charts by using a scientific approach for easy understanding. Historic, current, and future analysis is provided for each market in terms of both value and volume. The size of the market is interpreted in the US Dollar value and the respective unit, based on the product, for volume consumption.

The foreign exchange rates are calculated on the respective dates and for the respective regions covered in the study.

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Last updated on: 20 March 2023
Updated by: Riya Doshi

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