US Biosimilars Market Report 2022 to 2030

US Biosimilars Market Analysis

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US Biosimilars 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. Cost-effectiveness, patent expirations of reference biologics, increasing demand for biologic medicines, a supportive regulatory environment, and increased acceptance by healthcare professionals are all main drivers in the biosimilars market. Novartis AG, Pfizer Inc., Amgen Inc., Coherus Biosciences Inc., Mylan NV (Viatris Inc.), and Samsung Bioepis Co., Ltd. are among the top competitors in the studied market.

ID: IN10USPH247 CATEGORY: Pharmaceuticals GEOGRAPHY: US AUTHOR: Riddhi Solanki

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US Biosimilars Market Analysis Summary

US Biosimilars Market is valued at around $12208.4 Mn in 2022 and is projected to reach $52075.2 Mn by 2030, exhibiting a CAGR of 19.88% during the forecast period 2023-2030.

Biosimilars are pharmaceutical medications that are highly similar to an existing biological reference product, known as the originator or reference biologic. Biosimilars are designed to be comparable in quality, safety, and efficacy to the reference product while being less expensive. They are an alternative to costly biologic therapeutics, providing patients with greater access to treatments while potentially saving healthcare systems money. To demonstrate their similarity to the reference product, biosimilars go through a rigorous scientific and regulatory process that includes comparative analytical investigations, and non-clinical and clinical trials. Cost-effectiveness, patent expirations of reference biologics, increasing demand for biologic medicines, a supportive regulatory environment, and increased acceptance by healthcare professionals are all main drivers in the biosimilar market. Novartis AG, Pfizer Inc., Amgen Inc., Coherus Biosciences Inc., Mylan NV (Viatris Inc.), and Samsung Bioepis Co., Ltd. are among the top competitors in the studied market.

Market Dynamics

Market Growth Drivers

Cost-effectiveness: Biosimilars are typically less expensive than reference biologics, making them an appealing option for both healthcare providers and patients. Biosimilars' cost-effectiveness encourages their use and adds to market growth
Expiration of Patents: Many biologic medications have reached or are about to approach the end of their patent protection, allowing biosimilar makers to enter the market. Patent expiration opens the door to biosimilar development and market expansion
Growing Demand for Biologic Therapies: Biologic medications are widely employed in the treatment of a wide range of ailments, including cancer, autoimmune disorders, and chronic problems. The growing demand for biologics necessitates the development of more economical alternatives, resulting in the expansion of the biosimilar market
Healthcare Professionals' Growing Acceptance: Over time, healthcare professionals have acquired confidence in the safety and efficacy of biosimilars. Their increasing acceptability and readiness to prescribe biosimilars contribute to market expansion

Market Restraints

Regulatory Obstacles: Despite advances in regulatory frameworks, obtaining regulatory approval for biosimilars can still be difficult and time-consuming. Market entry might be hampered by stringent regulatory requirements and the necessity for comprehensive comparison studies
Intellectual Property Rights and Patent Litigation: Intellectual property rights and patent litigation present obstacles for biosimilar makers, delaying market access and competitiveness
Patient and physician education: It is critical to educate physicians and patients about biosimilars for them to be accepted and adopted. Lack of awareness, as well as worries about safety and efficacy, may stymie market growth?

Competitive Landscape

Key Players

Novartis AG
Pfizer Inc.
Amgen Inc.
Coherus Biosciences Inc.
Mylan NV (Viatris Inc.)
Samsung Bioepis Co., Ltd.

Development in Biosimilars Market Analysis

In May 2022, Amneal Pharmaceuticals, Inc. received United States Food and Drug Administration ("FDA") approval for a Biologics License Application ("BLA") for pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the proprietary name FYLNETRA
The Phase II study evaluates the efficacy and safety of Hepatic Arterial Infusion Chemotherapy (HAIC) in combination with Sintilimab and Bevacizumab Biosimilar in the treatment of patients with unresectable hepatocellular carcinoma
A Phase II Study of Sintilimab Combined with GEMOX IBI305 (Bevacizumab Biosimilar) Versus GEMOX as First-line Therapy in Patients with Advanced Intrahepatic Cholangiocarcinoma is now underway and is expected to be completed by 2025

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 Biosimilars Market Segmentation

By Product Class

Monoclonal Antibodies
Recombinant Hormones
Immunomodulators
Anti-inflammatory Agents
Other

By Applications

Blood Disorders
Growth Hormonal Deficiency
Chronic and Autoimmune Disorders
Oncology
Other

By Therapeutic Area

Oncology
Autoimmune Diseases
Diabetes
Infectious Diseases
Others

By Distribution Channel

Hospital Pharmacies
Retail Pharmacies
Online Pharmacies

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.