Italy Biosimilars Market Analysis Report 2022 to 2030

Italy Biosimilars Market Analysis

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Italy's biosimilars market size was valued at $0.4 Bn in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 2.17% from 2022 to 2030 and will reach $2.2 Mn in 2030. The market is segmented by product type and indication type. This market will grow as Italy's biosimilar market is driven by its cost-effective manufacturing capabilities. The key market players are Sandoz (CHE), Celltrion Healthcare Co., Ltd. (KOR), Accord Healthcare (GBR), Teva Italia S.r.l. (ISR), and others.

ID: IN10ITPH027 CATEGORY: Pharmaceuticals GEOGRAPHY: Italy AUTHOR: Chandani Patel

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Italy Biosimilars Market Executive Summary

Italy's biosimilar market size was valued at $0.4 Bn in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 2.17% from 2022 to 2030 and will reach $2.2 Mn in 2030. Italian pharmaceutical companies are relying more and more on biosimilars, which provide a less expensive and more widely available alternative to biological medications. Italy has taken the lead in the creation and marketing of biosimilars and has put laws and initiatives in place to promote their usage.

Several biosimilars, including copies of medications used to treat cancer, autoimmune illnesses, and other ailments, are now offered in Italy. The Italian Medicines Agency (AIFA), which follows the European Medicines Agency (EMA) rules for the approval and use of biosimilars, has authorized these medications.

The desire for inexpensive, efficient therapies for chronic illnesses and the need to lower healthcare costs are two reasons that are predicted to drive the growth of the biosimilar market in Italy during the next years. The market's expansion is also anticipated to be significantly influenced by the Italian government's initiatives to encourage the use of biosimilars.

italy biosimilars market analysis

Market Dynamics

Market Growth Drivers

The desire to lower healthcare costs is one of the key factors driving the Italian biosimilar industry. Because biologic medications may be quite expensive, many patients cannot afford them. Biosimilars provide a less expensive option to these medications, which might lower the cost of healthcare.

Another factor is the rise in chronic illnesses like cancer and autoimmune disorders in Italy. There is an increasing demand for accessible and efficient therapies for these disorders, which biosimilars can offer as more individuals seek therapy for these conditions.

Market Restraints

The lack of knowledge and comprehension among healthcare professionals and patients is one of the major issues the Italian biosimilar sector is now experiencing. Due to worries about their effectiveness and safety, many healthcare professionals may be reluctant to recommend biosimilars, and patients may be reluctant to move from their reference product.

The complicated regulatory requirements for biosimilars provide another difficulty since they might greatly extend the time and expense required to develop and market these goods.

Competitive Landscape

Key Players

Sandoz (CHE)
Celltrion Healthcare Co., Ltd. (KOR)
Accord Healthcare (GBR)
Teva Italia S.r.l. (ISR)
Amgen Italia Srl (USA)
Fresenius Kabi Italia S.r.l. (DEU)
Hospira Italia S.r.l. (USA)
Pfizer Italia S.r.l. (USA)
Hexal AG (DEU)
Biogen Italy Srl (USA)

Healthcare Policies and Regulatory Landscape

The Italian Medicines Agency (AIFA), which follows the European Medicines Agency (EMA) rules for the licensing and use of biosimilars, is in charge of overseeing the use of biosimilars in Italy. Biosimilars must exhibit comparable safety and efficacy and must adhere to the same strict regulatory standards as their reference products.

The National Health Service (SSN), which offers coverage for these medications under the same terms as their reference medicines, decides how much biosimilars are reimbursed in Italy. However, biosimilars' pricing and reimbursement regulations differ from those of their reference products, with biosimilars frequently having lower prices and being reimbursed at different rates.

1. Executive Summary
1.1 Disease Overview
1.2 Global Scenario
1.3 Country Overview
1.4 Healthcare Scenario in Country
1.5 Patient Journey
1.6 Health Insurance Coverage in Country
1.7 Active Pharmaceutical Ingredient (API)
1.8 Recent Developments in the Country

2. Market Size and Forecasting
2.1 Epidemiology of Disease
2.2 Market Size (With Excel & Methodology)
2.3 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
5.2 Reimbursement Process for Diagnosis
5.3 Reimbursement Process for Treatment

6. Methodology and Scope

Italy Biosimilars Market Segmentation

By Product

The monoclonal antibodies, insulin, granulocyte colony-stimulating factor, erythropoietin, recombinant human growth hormone, etanercept, follitropin, teriparatide, interferons, enoxaparin sodium, glucagon, and calcitonin are among the product categories that make up the biosimilars market. Monoclonal antibodies held a sizable portion of the market in 2020. The market is being driven by elements including the widespread use of monoclonal antibodies in the treatment of autoimmune diseases, cancer, and osteoporosis, as well as the affordability of such treatments.

Monoclonal Antibodies
- Infliximab
- Trastuzumab
- Rituximab
- Adalimumab
- Other monoclonal antibodies (bevacizumab, cetuximab, ranibizumab, denosumab, and eculizumab)
Insulin
Granulocyte Colony-Stimulating Factor
Erythropoietin
Recombinant Human Growth Hormone
Etanercept
Follitropin
Teriparatide
Interferons
Enoxaparin Sodium
Glucagon
Calcitonin

By Indication

The biosimilars market is divided into oncology, autoimmune and inflammatory diseases, chronic illnesses, blood disorders, growth hormone insufficiency, infectious diseases, and other indications based on the indication (infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases). The market's largest sector in 2020 will be oncology. This market is expanding as a result of elements like the reduced cost of biosimilars compared to novel biologics and the increased incidence and prevalence of cancer.

Oncology
Inflammatory & Autoimmune Disorders
Chronic Diseases
Blood Disorders
Growth Hormone Deficiency
Infectious Diseases
Other Indications (infertility, hypoglycemia, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases)

Methodology for Database Creation

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Analyzing historical proprietary data collected from multiple projects.
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Combining Secondary and Primary Research

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Merging historical data from secondary research with real-time data from primary research.
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