Biosimilars Market to Observe Utmost CAGR 24.7% by 2031, Demand, Key Drivers, Development Trends and Competitive Outlook

Who are the top players in biosimilars?

Exxon Mobil Corporation
Haihang Industry Co., Ltd.
Kent elastomer products
Kuraray Co.
Shell,Ltd.
SIBUR
Dupont

According to the report, the global biosimilars industry was estimated at $15.9 billion in 2021, and is anticipated to hit $143.6 billion by 2031, registering a CAGR of 24.7% from 2022 to 2031.

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Covid-19 scenario-

The COVID-19 pandemic created difficulties for the pharmaceutical industry to focus on R&D activities including biosimilar development, which impacted the global biosimilars market negatively.

Moreover, there was a delay in product approvals and product launches, owing to the global health crisis, which further restricted the expansion of the market.

Key Takeaways:

Definition and Purpose of Biosimilars: Biosimilars are biologic medical products that are highly similar to an existing approved reference biologic (originator or innovator product). They are designed to have the same mechanism of action, safety, and efficacy as the reference product.

Cost Savings and Accessibility: One of the primary drivers behind the development and adoption of biosimilars is the potential for cost savings. Biosimilars are usually priced lower than their reference biologics, which can lead to increased accessibility for patients and healthcare systems.

Regulatory Framework: The approval process for biosimilars involves demonstrating a high degree of similarity to the reference product through a rigorous comparative analytical and clinical testing process. Regulatory agencies like the FDA in the United States and the EMA in Europe have established guidelines for biosimilar approval.

Market Growth: The biosimilars market has been steadily growing, driven by patent expirations of several high-revenue biologics. As more reference biologics lose exclusivity, biosimilars are expected to capture a significant share of the market.

Therapeutic Areas: Biosimilars are developed across various therapeutic areas, including oncology, immunology, diabetes, and more. They provide alternatives for patients who require expensive biologic treatments for chronic and serious conditions.

Challenges and Barriers: Developing biosimilars is complex and requires substantial investment in research, development, and manufacturing. Regulatory hurdles, intellectual property issues, and the need for robust clinical trials can pose challenges for biosimilar manufacturers.

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Market Segmentation:

By Therapeutic Area:

Oncology
Immunology (rheumatoid arthritis, psoriasis, etc.)
Diabetes
Hematology
Growth Hormone Deficiency
Other therapeutic areas (cardiology, neurology, etc.)

By Product Type:

Monoclonal Antibodies (mAbs)
Insulin Biosimilars
Erythropoietin Biosimilars
Filgrastim Biosimilars
Other biologic product categories

By Region:

North America (United States, Canada)
Europe (Germany, France, UK, etc.)
Asia-Pacific (China, India, Japan, etc.)
Latin America
Middle East and Africa

By Manufacturing Process:

Mammalian Cell Culture-Derived Biosimilars
Microbial Fermentation-Derived Biosimilars

By End User:

Hospitals
Clinics
Specialty Pharmacies
Research Institutes

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Europe garnered the major share in 2022-

Based on region, Europe held the major share in 2021, generating nearly two-fifths of the global biosimilars market. At the same time, the same region would also grow at the fastest CAGR of 25.9% by 2031. This is attributed to rise in the prevalence of cancer and increase in launches of multiple biosimilars in the region.

Table of Content:

CHAPTER 1:INTRODUCTION
1.1.Report description
1.2.Key market segments
1.3.Key benefits to the stakeholders
1.4.Research Methodology
1.4.1.Secondary research
1.4.2.Primary research
1.4.3.Analyst tools and models

CHAPTER 2:EXECUTIVE SUMMARY
2.1.Key findings of the study
2.2.CXO Perspective

CHAPTER 3:MARKET OVERVIEW
3.1.Market definition and scope
3.2.Key findings
3.2.1.Top investment pockets
3.3.Porter's five forces analysis
3.4.Top player positioning
3.5.Market dynamics
3.5.1.Drivers
3.5.2.Restraints
3.5.3.Opportunities
3.6.COVID-19 Impact Analysis on the market

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