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Biosimilars Market Analysis With The Market Scenario, Distinguishing Regions, And Global Key Players - 2031 | Novartis AG, Pfizer, Inc., Teva Pharmaceutical Industries Ltd.

02-02-2024 02:55 PM CET | Health & Medicine

Press release from: Coherent Market Insights

Biosimilars Market

Biosimilars Market

Market Overview:

Biosimilars are biological products that are developed to be similar to an original biologic medicine known as reference product. Biosimilars provide affordable treatment options for diseases such as cancer, autoimmune disorders etc.

Market Dynamics:

The global biosimilars market is expected to witness significant growth over the forecast period. This is majorly attributed to increasing demand for affordable drugs for treating chronic diseases and patent expiry of biologics. Additionally, favorable regulatory framework and government initiatives to promote biosimilars are also supporting the market growth. For instance, high cost of branded biologics have burdened healthcare budgets globally. Biosimilars provide a more affordable alternative without compromising on efficacy and safety. Moreover, emergence of new players in biosimilars development coupled with increasing clinical pipeline is anticipated to offer growth opportunities in the coming years.

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Major Government Support and Policies for Biosimilar Development Is Driving the Biosimilars Market

Many governments are introducing new policies and offering incentives to develop and manufacture biosimilars in order to expand patient access to affordable treatment options. Some key examples of government support include providing funding for research and development of biosimilars, expediting regulatory pathways to accelerate market approval timelines, and establishing reimbursement schemes. Significant price discounts for biosimilars versus originator biologics also encourage their adoption. For instance, European regulators have approved over 80 biosimilars to date through the European Medicines Agency due to its streamlined authorization process. The U.S. FDA similarly utilizes an abbreviated approval pathway catered for biosimilars.

Growing Patent Expiries of Blockbuster Biologics Is Fueling Market Uptake of Biosimilars

As major biologic drugs tracing billions in annual sales begin losing patent protection in the coming years, an increasing number of potentially lucrative biosimilar development opportunities are emerging. Most prominent among these are anti-TNF inhibitors to treat diseases like rheumatoid arthritis and inflammatory bowel disease. The expiry of Humira's patent protection in 2023 alone is projected to open a $20 billion biosimilar market. Other blockbuster biologics such as Avastin, Herceptin, and Rituxan will face expiration during 2023-2026. This glut of impending exclusivity losses is incentivizing numerous pharmaceutical companies to develop biosimilar versions and capture a share of the huge post-patent markets.

High Manufacturing and Process Complexity Pose Significant Challenges to Biosimilar Development

Unlike generic drugs, biosimilars cannot be readily synthesized due to the intricacies of biological production in living systems. They must be manufactured through complex, capital-intensive bioprocesses and are subject to batch-to-batch variations. Extensive physicochemical and functional characterization as well as clinical testing are also required to demonstrate biosimilarity versus the reference product. Further complicating development is the lack of international consensus on exactly how similar a biosimilar needs to be in its quality attributes and clinical performance. Resolving analytical and clinical uncertainty delays market entry. Significant R&D investments are hence needed to overcome this market restrain.

Established Distribution Networks of Originator Companies Could Impede Biosimilar Uptake

Major biopharmaceutical firms with approved origins biologics have built sophisticated global supply chains and relationships with suppliers, healthcare providers, and payers over many years. This established market positioning and web of connections may favor the originators by slowing substitution with biosimilars. Clinicians may be hesitant in switching treatment if familiar with reference drugs. Furthermore, originator companies often resort to strategies like authorized biosimilar licencing deals, exclusive distribution contracts, patient and provider loyalty programs, and intensive marketing efforts to retain market share post-patent expiry. Biosimilars need to devise effective distribution and promotion plans and generate substantial cost savings to successfully compete against such incumbent advantages.

Consolidation Among Biosimilars Developers Is a Growing Trend in the Industry

In the face of huge developmental costs and complexities and desire to expand commercial capabilities, merger and acquisition activity is on the rise within the biosimilars industry. Large pharmaceutical corporations are acquiring smaller biotech players to strengthen their biosimilars pipelines and global footprints. There is also a trend of partnering and cross-licensing deals between biosimilars companies to share development risks and product portfolios across different regions. For instance, Amgen recently acquired Nuevolution and its T-cell redirecting bispecific antibody programs. Pfizer has a portfolio of multiple biosimilar assets following its Hospira and Merck KGaA acquisitions. Such consolidation facilitates critical mass and integration of complementary strengths needed in the intricately regulated biosimilars landscape.

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Table of Contents with Major Points:

Executive Summary

Introduction
Key Findings
Recommendations
Definitions and Assumptions

Market Overview

Definition of Biosimilars Market
Market Dynamics
Drivers
Restraints
Opportunities
Trends and Developments

Key Insights

Key Emerging Trends
Key Developments Mergers and Acquisition
New Product Launches and Collaboration
Partnership and Joint Venture
Latest Technological Advancements
Insights on Regulatory Scenario
Porters Five Forces Analysis

Qualitative Insights Impact of COVID-19 on Global Biosimilars Market

Supply Chain Challenges
Steps taken by Government/Companies to overcome this impact
Potential opportunities due to COVID-19 outbreak
Conclusion

Appendix

Data Sources
Abbreviations
Disclaimer
TOC Continued…!

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Coherent Market Insights is a global market intelligence and consulting organization that provides syndicated research reports, customized research reports, and consulting services. We are known for our actionable insights and authentic reports in various domains including aerospace and defense, agriculture, food and beverages, automotive, chemicals and materials, and virtually all domains and an exhaustive list of sub-domains under the sun. We create value for clients through our highly reliable and accurate reports. We are also committed in playing a leading role in offering insights in various sectors post-COVID-19 and continue to deliver measurable, sustainable results for our clients.

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