Italy Biosimilars Market (2025-2031) Outlook | Analysis, Value, Companies, Revenue, Share, Trends, Size, Growth, Forecast & Industry

Market Forecast By Product (Insulin, Follitropin, Calcitonin, Glucagon, Teriparatide, Others), By Indication (Oncology, Offsite Treatment, Chronic Disorders, Blood Disorders, Infectious Diseases, Others), By Manufacturing (Outsourced, In-house) And Competitive Landscape
Product Code: ETC069932 Publication Date: Jun 2021 Updated Date: Aug 2025 Product Type: Report
Publisher: 6Wresearch Author: Ravi Bhandari No. of Pages: 70 No. of Figures: 35 No. of Tables: 5

Italy Biosimilars Market Overview

The Italy biosimilars market is experiencing steady growth driven by factors such as the increasing prevalence of chronic diseases, rising healthcare costs, and government initiatives to promote the use of biosimilars. The market is highly competitive with both domestic and international players vying for market share. Key players in the Italy biosimilars market include Sandoz, Celltrion, Pfizer, and Samsung Bioepis. The market is characterized by a growing number of approved biosimilar products across various therapeutic areas such as oncology, autoimmune diseases, and diabetes. However, challenges such as regulatory hurdles, concerns about safety and efficacy, and intellectual property issues continue to impact market growth. Overall, the Italy biosimilars market presents opportunities for companies to expand their product portfolios and increase access to affordable biologic treatments for patients in the country.

Italy Biosimilars Market Trends

In the Italy biosimilars market, there is a growing trend towards increased competition as more companies are entering the market with biosimilar products. This is driven by the expiration of patents on several biologic drugs, creating opportunities for biosimilar manufacturers to offer more affordable alternatives. The Italian government has been implementing policies to encourage the uptake of biosimilars, including measures to increase awareness among healthcare professionals and patients. Additionally, collaborations between biosimilar developers and healthcare providers are on the rise to ensure access and adoption of these products. Overall, the Italy biosimilars market is witnessing a shift towards greater market penetration and acceptance of biosimilar products as viable alternatives to expensive biologics.

Italy Biosimilars Market Challenges

In the Italy biosimilars market, several challenges are faced, including limited physician and patient awareness about biosimilars, concerns about the safety and efficacy of biosimilars compared to reference biologics, regulatory hurdles in the approval process, and resistance from originator companies protecting their market share. Pricing and reimbursement policies also play a significant role in hindering the uptake of biosimilars in Italy, as the complex and fragmented healthcare system may create barriers for biosimilar manufacturers to compete effectively. Additionally, the lack of consistent guidelines and interchangeability policies further complicate the market landscape. Overcoming these challenges will require education campaigns, regulatory reforms, and collaboration among stakeholders to increase confidence in biosimilars and promote their adoption in Italy.

Italy Biosimilars Market Investment Opportunities

The Italy Biosimilars Market presents promising investment opportunities due to several factors. With a growing aging population and increasing prevalence of chronic diseases, there is a rising demand for cost-effective biologic drugs, driving the adoption of biosimilars. The Italian government`s initiatives to promote biosimilar uptake through incentives and policies further support market growth. Additionally, patent expiries of major biologic drugs create opportunities for biosimilar manufacturers to enter the market. Collaborations between domestic and international pharmaceutical companies also enhance the competitive landscape. Overall, the Italy Biosimilars Market offers potential for investors to capitalize on the expanding market size and favorable regulatory environment, making it an attractive investment opportunity in the healthcare sector.

Italy Biosimilars Market Government Policy

In Italy, government policies related to the biosimilars market aim to promote the adoption of these cost-effective alternatives to biologic drugs. The Italian Medicines Agency (AIFA) has implemented measures to encourage the use of biosimilars, such as creating a dedicated biosimilars registry and establishing pricing and reimbursement policies to incentivize their uptake. Additionally, the Italian government has introduced initiatives to raise awareness among healthcare professionals and patients about the safety and efficacy of biosimilars, ultimately aiming to increase competition in the market and drive down healthcare costs while maintaining quality standards. Overall, Italy`s policies regarding biosimilars emphasize the importance of fostering a competitive market environment and ensuring access to affordable and high-quality biological medicines for patients.

Italy Biosimilars Market Future Outlook

The future outlook for the Italy Biosimilars Market is promising, with strong growth expected in the coming years. Factors driving this growth include the increasing prevalence of chronic diseases, rising healthcare costs, and the need for more affordable treatment options. Italy`s supportive regulatory environment, with a clear pathway for biosimilar approval and reimbursement, is also contributing to market expansion. Additionally, collaborations between pharmaceutical companies and government initiatives to promote biosimilar usage are further boosting market prospects. With a growing demand for cost-effective biologic therapies, the Italy Biosimilars Market is anticipated to witness significant growth and present opportunities for both domestic and international biopharmaceutical companies.

Key Highlights of the Report:

  • Italy Biosimilars Market Outlook
  • Market Size of Italy Biosimilars Market, 2021
  • Forecast of Italy Biosimilars Market, 2031
  • Historical Data and Forecast of Italy Biosimilars Revenues & Volume for the Period 2021 - 2031
  • Italy Biosimilars Market Trend Evolution
  • Italy Biosimilars Market Drivers and Challenges
  • Italy Biosimilars Price Trends
  • Italy Biosimilars Porter's Five Forces
  • Italy Biosimilars Industry Life Cycle
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Product for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Insulin for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Follitropin for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Calcitonin for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Glucagon for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Teriparatide for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Others for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Indication for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Oncology for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Offsite Treatment for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Chronic Disorders for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Blood Disorders for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Infectious Diseases for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Others for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Manufacturing for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By Outsourced for the Period 2021 - 2031
  • Historical Data and Forecast of Italy Biosimilars Market Revenues & Volume By In-house for the Period 2021 - 2031
  • Italy Biosimilars Import Export Trade Statistics
  • Market Opportunity Assessment By Product
  • Market Opportunity Assessment By Indication
  • Market Opportunity Assessment By Manufacturing
  • Italy Biosimilars Top Companies Market Share
  • Italy Biosimilars Competitive Benchmarking By Technical and Operational Parameters
  • Italy Biosimilars Company Profiles
  • Italy Biosimilars Key Strategic Recommendations

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1 Executive Summary

2 Introduction

2.1 Key Highlights of the Report

2.2 Report Description

2.3 Market Scope & Segmentation

2.4 Research Methodology

2.5 Assumptions

3 Italy Biosimilars Market Overview

3.1 Italy Country Macro Economic Indicators

3.2 Italy Biosimilars Market Revenues & Volume, 2021 & 2031F

3.3 Italy Biosimilars Market - Industry Life Cycle

3.4 Italy Biosimilars Market - Porter's Five Forces

3.5 Italy Biosimilars Market Revenues & Volume Share, By Form, 2021 & 2031F

3.6 Italy Biosimilars Market Revenues & Volume Share, By Indication, 2021 & 2031F

3.7 Italy Biosimilars Market Revenues & Volume Share, By Manufacturing, 2021 & 2031F

4 Italy Biosimilars Market Dynamics

4.1 Impact Analysis

4.2 Market Drivers

4.2.1 Increasing prevalence of chronic diseases in Italy

4.2.2 Cost-saving benefits associated with biosimilars compared to biologics

4.2.3 Favorable government regulations promoting the use of biosimilars

4.3 Market Restraints

4.3.1 Lack of awareness and acceptance among healthcare professionals and patients

4.3.2 Stringent regulatory requirements for biosimilars approval in Italy

5 Italy Biosimilars Market Trends

6 Italy Biosimilars Market, By Types

6.1 Italy Biosimilars Market, By Product

6.1.1 Overview and Analysis

6.1.2 Italy Biosimilars Market Revenues & Volume, By Product, 2018 - 2027F

6.1.3 Italy Biosimilars Market Revenues & Volume, By Insulin, 2018 - 2027F

6.1.4 Italy Biosimilars Market Revenues & Volume, By Follitropin, 2018 - 2027F

6.1.5 Italy Biosimilars Market Revenues & Volume, By Calcitonin, 2018 - 2027F

6.1.6 Italy Biosimilars Market Revenues & Volume, By Glucagon, 2018 - 2027F

6.1.7 Italy Biosimilars Market Revenues & Volume, By Teriparatide, 2018 - 2027F

6.1.8 Italy Biosimilars Market Revenues & Volume, By Others, 2018 - 2027F

6.2 Italy Biosimilars Market, By Indication

6.2.1 Overview and Analysis

6.2.2 Italy Biosimilars Market Revenues & Volume, By Oncology, 2018 - 2027F

6.2.3 Italy Biosimilars Market Revenues & Volume, By Offsite Treatment, 2018 - 2027F

6.2.4 Italy Biosimilars Market Revenues & Volume, By Chronic Disorders, 2018 - 2027F

6.2.5 Italy Biosimilars Market Revenues & Volume, By Blood Disorders, 2018 - 2027F

6.2.6 Italy Biosimilars Market Revenues & Volume, By Infectious Diseases, 2018 - 2027F

6.2.7 Italy Biosimilars Market Revenues & Volume, By Others, 2018 - 2027F

6.3 Italy Biosimilars Market, By Manufacturing

6.3.1 Overview and Analysis

6.3.2 Italy Biosimilars Market Revenues & Volume, By Outsourced, 2018 - 2027F

6.3.3 Italy Biosimilars Market Revenues & Volume, By In-house, 2018 - 2027F

7 Italy Biosimilars Market Import-Export Trade Statistics

7.1 Italy Biosimilars Market Export to Major Countries

7.2 Italy Biosimilars Market Imports from Major Countries

8 Italy Biosimilars Market Key Performance Indicators

8.1 Percentage increase in the number of biosimilar prescriptions

8.2 Time taken for biosimilars to reach the market after patent expiration of reference biologics

8.3 Number of clinical trials conducted for biosimilars in Italy

9 Italy Biosimilars Market - Opportunity Assessment

9.1 Italy Biosimilars Market Opportunity Assessment, By Product, 2021 & 2031F

9.2 Italy Biosimilars Market Opportunity Assessment, By Indication, 2021 & 2031F

9.3 Italy Biosimilars Market Opportunity Assessment, By Manufacturing, 2021 & 2031F

10 Italy Biosimilars Market - Competitive Landscape

10.1 Italy Biosimilars Market Revenue Share, By Companies, 2021

10.2 Italy Biosimilars Market Competitive Benchmarking, By Operating and Technical Parameters

11 Company Profiles

12 Recommendations

13 Disclaimer

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