Germany Biosimilars Market Analysis

Germany Biosimilars Market Analysis


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Germany's biosimilar market size was valued at $0.7 Bn in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 20.4% from 2022 to 2030 and will reach $3.1 Bn in 2030. The market is segmented by product type and indication type. The German biosimilar market will grow with the rising prevalence of chronic diseases in Germany, including cancer, diabetes, and autoimmune disorders. The key market players are Sandoz GmbH (AUT), Fresenius Kabi Deutschland GmbH (DEU), Hexal AG (DEU), STADA Arzneimittel AG (DEU), Sanofi-Aventis Deutschland GmbH (FRA), Teva GmbH (ISR), and others.

ID: IN10DEPH027 CATEGORY: Pharmaceuticals GEOGRAPHY: Germany AUTHOR: Chandani Patel

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Germany Biosimilars Market Executive Summary

Germany's biosimilars market size was valued at $0.7 Bn in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 20.4% from 2022 to 2030 and will reach $3.1 Bn in 2030. Since 2006, biosimilars have been accessible in Germany, where they have one of the largest markets on the continent. Biosimilars are biological drugs that are extremely similar to a reference drug, a biological drug that has already received approval. They are designed to be equally safe and effective as the reference drug. The European Medicines Agency (EMA), which establishes standards for their research and approval, oversees the approval of biosimilars in Germany. With additional criteria to prove comparability with the reference biologic, the approval procedure for biosimilars in Germany is identical to that for biologics.

The cost reductions that biosimilars provide in comparison to reference biologics are one of the major factors driving the market for them in Germany. Biosimilars are an appealing choice for healthcare payers looking to save costs since they are often less expensive than the reference biologics they are based on. The emergence of biosimilars has additionally aided in boosting market competition for biologics, which may result in cheaper costs for patients. It is anticipated that the German biosimilar business would expand as additional biologics lose their patent protection and as physician and patient knowledge rise.

germany biosimilars market analysis

Market Dynamics

Market Growth Drivers

The demand for biosimilars is being driven by the rising prevalence of chronic diseases in Germany, including cancer, diabetes, and autoimmune disorders. Because they are less expensive than biologics, biosimilars are a desirable choice for patients, doctors, and healthcare payers looking for affordable medicines.

Biosimilars are now available on the market as a result of the patents on numerous biologics in Germany expiring. The use of biosimilars to lower healthcare costs has been aggressively encouraged by the German government, which has contributed to the expansion of the biosimilar industry.

Market Restraints

Despite the advantages of biosimilars, their use is resisted by doctors and patients due to a lack of knowledge regarding their safety and effectiveness. Costly Development: Research and development expenditures are high when creating a biosimilar, which might be prohibitive for small and medium-sized businesses.

Additionally, the production of biosimilars requires a sophisticated manufacturing process, and it can be difficult for firms to prove that their medicines are substantially comparable to the reference biologic.

Competitive Landscape

Key Players

  • Sandoz GmbH (AUT)
  • Fresenius Kabi Deutschland GmbH (DEU)
  • Hexal AG (DEU)
  • STADA Arzneimittel AG (DEU)
  • Sanofi-Aventis Deutschland GmbH (FRA)
  • Teva GmbH (ISR)
  • Pfizer Deutschland GmbH (USA)
  • Mylan Healthcare GmbH (USA)
  • Biogen GmbH (USA)
  • Amgen GmbH (USA)

Healthcare Policies and Regulatory Landscape

The European Medicines Agency (EMA) is in charge of biosimilar regulations in Germany, which are identical to those that apply to reference biologics. Biosimilars must, according to the EMA, show that they are comparable to the reference biologic in terms of quality, safety, and effectiveness. To prove their resemblance to the reference biologic, biosimilars must go through a rigorous clinical development program that includes comparison studies. Because part of the data may be inferred from the reference biologic, the approval procedure for biosimilars in Germany is often quicker than that for reference biologics. Due to the intricacy of the manufacturing process and the requirement to show comparability, the approval procedure might yet take many years.

The G-BA (Gemeinsamer Bundesausschuss), the joint committee of the Federal Joint Committee (G-BA), oversees reimbursement for biosimilars in Germany. The G-BA is in charge of deciding whether medical goods and services are reimbursed in Germany. The same regulations governing reference biologic reimbursement apply to biosimilars, and their reimbursement rate is determined by the cost of the reference biologic. To lower healthcare costs, the German healthcare system has been actively encouraging the use of biosimilars. In addition to being less expensive than reference biologics, biosimilars also face price rivalry from other producers, which may result in additional price drops.

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

Germany 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)

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”.

 

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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.

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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

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  • Establishing market drivers and trends
  • Analyzing the regulatory landscape to understand future growth
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Last updated on: 08 December 2023
Updated by: Dhruv Joshi

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