Spain Biosimilars Market Analysis

Spain Biosimilars Market Analysis


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Spain'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 21.1% from 2022 to 2030 and will reach $1.7 Bn in 2030. The market is segmented by product type and indication type. The Spainn Biosimilars market will grow as there is a shortage of qualified radiologists and imaging technologists in some areas, leading to longer wait times and delays in diagnosis and treatment. The key market players are Pfizer (USA), Roche (CHE), Novartis (CHE), Merck (USA), Sanofi (FRA), GlaxoSmithKline (GBR), AstraZeneca (GBR), and others.

ID: IN10ESPH027 CATEGORY: Pharmaceuticals GEOGRAPHY: Spain AUTHOR: Chandani Patel

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Spain Biosimilars Market Executive Summary

Spain'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 21.1% from 2022 to 2030 and will reach $1.7 Bn in 2030. Spain has been a leader in the use of biosimilars, with a robust regulatory framework and policies in place to promote the use of these drugs. Biosimilars are an important part of the pharmaceutical industry in Spain, offering a more affordable and accessible alternative to biological drugs. Currently, there are a number of biosimilars available in Spain, including versions of drugs used to treat cancer, autoimmune diseases, and other conditions. These drugs are approved by the Spanish Agency for Medicines and Medical Devices (AEMPS), which follows the European Medicines Agency (EMA) guidelines for the approval and use of biosimilars.

It is anticipated that the Spanish biosimilar market would expand over the coming years, propelled by reasons including the desire to lower healthcare costs and the rise in demand for low-cost, efficient treatments for chronic illnesses. The Spanish government's initiatives to encourage the use of biosimilars are anticipated to be a major factor in the market's expansion.

spain biosimilars market analysis

Market Dynamics

Market Growth Drivers

Many of the original biologic drugs that are used to treat diseases in Spain are coming off patent, making way for biosimilars to enter the market. Biosimilars are typically priced lower than their reference biologics, providing significant cost savings to patients and healthcare systems. Moreover, with lower prices and increased availability, biosimilars can provide wider access to essential treatments for patients.

The Spanish government has taken several measures to promote the use of biosimilars, such as encouraging the prescription of biosimilars over reference biologics and promoting the development of a biosimilar industry in Spain.

Market Restraints

Physicians and patients in Spain may not be familiar with biosimilars or may have concerns about their safety and efficacy. The approval process for biosimilars in Spain can be complex and time-consuming, leading to delays in market entry. Moreover, physicians and patients may have strong brand loyalty to reference biologics, making it difficult for biosimilars to gain market share.

Competitive Landscape

Key Players

  • Pfizer (USA)
  • Roche (CHE)
  • Novartis (CHE)
  • Merck (USA)
  • Sanofi (FRA)
  • GlaxoSmithKline (GBR)
  • AstraZeneca (GBR)
  • Johnson & Johnson (USA)
  • AbbVie (USA)
  • Bristol Myers Squibb (USA)

Healthcare Policies and Regulatory Landscape

The Spanish regulatory agency responsible for approving biosimilars is the Spanish Agency of Medicines and Medical Devices (AEMPS). Biosimilars are required to undergo a rigorous approval process that includes comprehensive preclinical and clinical testing.

In Spain, biosimilars are reimbursed through the National Health System (SNS) in the same way as reference biologics. Biosimilars are subject to the same pricing and reimbursement regulations as reference biologics, which includes a reference price system and negotiated prices between the Spanish government and manufacturers. Biosimilars are also included in the Spanish Biosimilars Plan, which aims to promote the use of biosimilars in the Spanish healthcare system.

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

Spain 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

Our database offers a comprehensive list of healthcare centers, meticulously curated to provide detailed information on a wide range of specialties and services. It includes top-tier hospitals, clinics, and diagnostic facilities across 30 countries and 24 specialties, ensuring users can find the healthcare services they need.​

Additionally, we provide a comprehensive list of Key Opinion Leaders (KOLs) based on your requirements. Our curated list captures various crucial aspects of the KOLs, offering more than just general information. Whether you're looking to boost brand awareness, drive engagement, or launch a new product, our extensive list of KOLs ensures you have the right experts by your side. Covering 30 countries and 36 specialties, our database guarantees access to the best KOLs in the healthcare industry, supporting strategic decisions and enhancing your initiatives.

How Do We Get It?

Our database is created and maintained through a combination of secondary and primary research methodologies.

1. Secondary Research

With many years of experience in the healthcare field, we have our own rich proprietary data from various past projects. This historical data serves as the foundation for our database. Our continuous process of gathering data involves:

  • Analyzing historical proprietary data collected from multiple projects.
  • Regularly updating our existing data sets with new findings and trends.
  • Ensuring data consistency and accuracy through rigorous validation processes.

With extensive experience in the field, we have developed a proprietary GenAI-based technology that is uniquely tailored to our organization. This advanced technology enables us to scan a wide array of relevant information sources across the internet. Our data-gathering process includes:

  • Searching through academic conferences, published research, citations, and social media platforms
  • Collecting and compiling diverse data to build a comprehensive and detailed database
  • Continuously updating our database with new information to ensure its relevance and accuracy

2. Primary Research

To complement and validate our secondary data, we engage in primary research through local tie-ups and partnerships. This process involves:

  • Collaborating with local healthcare providers, hospitals, and clinics to gather real-time data.
  • Conducting surveys, interviews, and field studies to collect fresh data directly from the source.
  • Continuously refreshing our database to ensure that the information remains current and reliable.
  • Validating secondary data through cross-referencing with primary data to ensure accuracy and relevance.

Combining Secondary and Primary Research

By integrating both secondary and primary research methodologies, we ensure that our database is comprehensive, accurate, and up-to-date. The combined process involves:

  • Merging historical data from secondary research with real-time data from primary research.
  • Conducting thorough data validation and cleansing to remove inconsistencies and errors.
  • Organizing data into a structured format that is easily accessible and usable for various applications.
  • Continuously monitoring and updating the database to reflect the latest developments and trends in the healthcare field.

Through this meticulous process, we create a final database tailored to each region and domain within the healthcare industry. This approach ensures that our clients receive reliable and relevant data, empowering them to make informed decisions and drive innovation in their respective fields.

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Last updated on: 17 May 2023
Updated by: Dhruv Joshi

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