US Biosimilar Monoclonal Antibodies Market Report 2022 to 2030

US Biosimilar Monoclonal Antibodies Market Analysis

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US Biosimilar Monoclonal Antibodies Market is projected to grow from $xx Mn in 2022 to $xx Mn by 2030, registering a CAGR of xx% during the forecast period of 2022 - 2030. Market drivers for biosimilar monoclonal antibodies include rising demand for low-cost biologics, the increasing frequency of chronic diseases, and the need for more economical biologic therapeutics. Among the key global pharmaceutical companies in the Biosimilar Monoclonal Antibodies Market are Samsung Bioepis Co., Celltrion Inc., Biocon Ltd., Pfizer Inc., Amgen Inc., Novartis AG (Sandoz), Mylan N.V., Boehringer Ingelheim International GmbH, Fresenius Kabi AG, and Teva Pharmaceutical Industries Ltd.

ID: IN10USPH246 CATEGORY: Pharmaceuticals GEOGRAPHY: US AUTHOR: Dr. Netal Patel

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US Biosimilar Monoclonal Antibodies Market Analysis Summary

US Biosimilar Monoclonal Antibodies Market is valued at around $2936.9 Mn in 2022 and is projected to reach $12050.6 Mn by 2030, exhibiting a CAGR of 19.3% during the forecast period 2023-2030.

Biosimilar monoclonal antibodies (mAbs) are biological drugs that are highly similar to an approved reference mAb product. Biosimilars are developed to be comparable in terms of safety, efficacy, and quality to the reference product while offering potential cost savings and increased access to treatment options. Monoclonal antibodies are protein-based therapeutics that are designed to target specific antigens involved in various diseases, such as cancer, autoimmune disorders, and inflammatory conditions. They are produced by genetically engineered cells and are known for their high specificity and targeted mechanism of action. The development of biosimilar mAbs involves a complex and rigorous process. Regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established specific guidelines for the approval of biosimilars. Market drivers for biosimilar monoclonal antibodies include rising demand for low-cost biologics, the increasing frequency of chronic diseases, and the need for more economical biologic therapeutics. Samsung Bioepis Co., Celltrion Inc., Biocon Ltd., Pfizer Inc., Amgen Inc., Novartis AG (Sandoz), Mylan N.V., Boehringer Ingelheim International GmbH, Fresenius Kabi AG and Teva Pharmaceutical Industries Ltd. Are among the key global pharmaceutical companies in Biosimilar Monoclonal Antibodies Market.

Market Dynamics

Market Growth Drivers

Cost Reductions: When compared to their originator counterparts, biosimilar monoclonal antibodies offer potential cost savings, making them an appealing option for healthcare systems, payers, and patients
Increasing Biologics Demand: The demand for biosimilar monoclonal antibodies is being driven by the increasing frequency of chronic diseases and the need for effective biologic therapeutics
Strong Biologics Pipeline: The robust pipeline of originator monoclonal antibodies provides biosimilar producers with a significant chance to explore new therapeutic areas

Market Restraints

Complex Manufacturing Process: The creation of biosimilar monoclonal antibodies entails complex manufacturing processes that can provide difficulties in terms of retaining similarity to the originator and guaranteeing consistent quality
Regulatory Obstacles: The primary barriers to biosimilars entering the US market are regulatory exclusivity, regulatory similarity, and interchangeability criteria, and patent exclusivity periods. Even when the core biological molecule patent (primary patent) has expired, the presence of current secondary patents further delays the emergence of affordable biosimilar copies. Secondary patents covered new formulations, manufacturing processes, therapeutic applications of existing active compounds, and innovative combinations of known active components
Patent disputes and intellectual property rights issues can create impediments for biosimilar makers, thereby delaying market access and competitiveness
Physician and patient acceptance: Education and acceptance of biosimilar monoclonal antibodies among physicians and patients may be a barrier, as there may be questions about efficacy, safety, and interchangeability with the originator drugs

Competitive Landscape

Key Players

Samsung Bioepis Co.
Celltrion Inc.
Biocon Ltd.
Pfizer Inc.
Amgen Inc.
Novartis AG (Sandoz)
Mylan N.V.
Boehringer Ingelheim International GmbH
Fresenius Kabi AG
Teva Pharmaceutical Industries Ltd

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

US Biosimilar Monoclonal Antibodies Market Segmentation

By Indication

Oncology
Autoimmune Diseases
Inflammatory Disorders
Others

By Distribution Channel

Hospital Pharmacies
Retail Pharmacies
Online Pharmacies
Specialized Clinics or Treatment Centres

By End-User

Hospitals
Clinics
Ambulatory Surgical Centres
Research Institutions

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.