DUBLIN--(BUSINESS WIRE)--The "Biosimilars Market Industry Trends and Global Forecasts to 2035 - Distribution by Drug Class, Therapeutic Area, Type of Manufacturer, Distribution Channel, Geographical Regions and Leading Players" report has been added to ResearchAndMarkets.com's offering.

The global biosimilars market is valued at USD 24.2 billion in 2024, growing at a CAGR of 16.5% during the forecast period, till 2035.

In recent years, the biologics market has experienced significant growth, owing to its improved effectiveness in managing chronic diseases. However, the high costs associated with biologics pose considerable economic and healthcare challenges.

As the demand for biologics continues to increase, developers are exploring innovative strategies to enhance returns on investment while addressing the need for more affordable alternative biological products that encompass similar safety and efficacy profiles. Amidst patent expirations, shrinking drug pipelines, and pressure to reduce the treatment costs, biosimilars are expected to occupy a significant share within the biopharmaceutical industry.

This trend is further supported by surge in investments and collaborations among biosimilar developers in the past few years. Further, regulatory advancements, such as streamlining approval processes and establishing clearer guidelines for biosimilar development have facilitated the development of biosimilars. Moreover, studies on interchangeability, which assess the feasibility of substituting biosimilars with reference biologics with similar safety or efficacy, have also played a critical role in advancing biosimilar development.

In addition, the rising demand for biosimilars as a cost-effective alternative has promoted the need for increased in-house development and outsourcing operations, thereby creating significant growth opportunities for biosimilar developers.

Key Market Segments

Drug Class

• Monoclonal Antibodies
• Proteins
• Peptides
• Others

Therapeutic Area

• Oncological Disorders
• Autoimmune and Inflammatory Disorders
• Hematological Disorders
• Metabolic Disorders
• Other Disorders

Type of Manufacturer

• Contract Manufacturers
• In-house Developers

Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

Research Coverage:

• An overview of the systematic research methodology adopted in this study, which includes research assumptions, forecasting methodologies, primary and secondary research techniques, as well as the various analytical frameworks integrated into the report.
• A summary of the comprehensive methodologies and frameworks used to forecast and analyze market trends, examining key factors that influence market dynamics while emphasizing the rigorous quality control measures implemented to ensure transparency and credibility in the insights presented throughout the report.
• A brief overview of the economic factors affecting the biosimilars market, including currency fluctuations, foreign exchange rates, and existing trade barriers. Additionally, it assesses the impact of global recession and inflation on market growth, drawing insights from significant historical events to inform future decision-making.
• An executive summary of the insights obtained during our research, featuring key takeaways from the current state of the biosimilars industry and its likely evolution in the short to mid-to-long term.
• A general overview of biosimilars, highlighting the key differences between innovator biologics, biosimilars, and generics. Further, it also provides information on the need for biosimilars, the manufacturing process, development timelines, and future perspectives related to the evolution of the biosimilar industry.
• A comprehensive evaluation of marketed and clinical-stage biosimilars based on several parameters, including the stage of development, therapeutic area, drug class. Additionally, it includes detailed analyses of biosimilar developers based on parameters, such as year of establishment, company size, headquarters location, and the most active players.
• Detailed profiles of prominent companies in North America, Europe, Asia-Pacific, and the rest of the world. Each profile includes an overview of the company, financial information, biosimilar pipeline details, recent developments and future outlook.
• A brief overview of the regulatory guidelines established by regulatory bodies across different regions, such as North America, Europe, and Asia-Pacific. It also presents details on regulatory approval pathways issued by authorities in these regions.
• An analysis of the factors contributing to the high pricing of novel biologics, including factors influencing biosimilar pricing. This section also presents a price comparison between various biosimilars and their reference biologics.
• A case study focused on the growing global biosimilars market and associated opportunities for biologics CMOs and CDMOs. It discusses the need for outsourcing manufacturing operations for biosimilar drugs and examines the impact of biosimilars on the global contract manufacturing market, along with the associated challenges and future perspectives.
• An in-depth analysis of factors impacting the growth of the biosimilars industry. This includes information on key drivers, potential restraints, emerging opportunities, and existing challenges within the sector.
• A detailed estimation of the current market size and future growth potential within the biosimilars market over the next decade. Based on various parameters and validations from reliable secondary and primary sources, we've provided informed estimates on market evolution till 2035. The report also features the likely distribution of the current and forecasted opportunities along with three forecast scenarios, namely conservative, base, and optimistic, representing different growth trajectories.
• A detailed estimation of the current market size and future opportunities in the biosimilars market across various drug classes, such as monoclonal antibodies, proteins, peptides, and others.
• A detailed projection of current market size and future opportunities in the biosimilar market across different therapeutic areas, including oncological disorders, autoimmune and inflammatory disorders, hematological disorders, metabolic disorders, and others.
• A detailed projection of current market size and future opportunities in the biosimilars market across different types of manufacturers, such as contract manufacturers and in-house developers.
• A detailed projection of the current market size and future opportunities in the biosimilars market across different distribution channels, such as hospital pharmacies, retail pharmacies and online pharmacies.
• A detailed projection of current market size and future opportunities in the biosimilars market across different geographical regions.
• Detailed information on leading players engaged in the development of biosimilars.

Complimentary Excel Data Packs

• Market Landscape
• Market Forecast and Opportunity Analysis

Key Benefits of Buying this Report

• The report offers valuable insights into revenue estimation for both the overall market and its sub-segments, in order to empower market leaders and newcomers with critical information requisite for establishing their footprint in the industry.
• Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
• The report provides stakeholders with an overview of the global biosimilars market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.

Leading Market Players in the Biosimilars Market Industry Profiled in the Report include:

• Amgen
• BIOCAD
• Biocon
• Celltrion
• Coherus BioSciences
• Reddy's Laboratories
• Eli Lilly
• Fresenius Kabi
• Intas Pharmaceuticals
• Pfizer
• Sandoz
• STADA
• Teva Pharmaceuticals

Key Topics Covered:

INTRODUCTION

• Overview of Biologics
• Overview of Biosimilars and Biobetters
• Difference between Innovator Biologics, Biosimilars and Generics
• Advantages of Biosimilars
• Manufacturing of Biosimilars
• Development Timeline of Biosimilars
• Future Perspectives

MARKET LANDSCAPE

• Biosimilars: Developers Landscape
• Biosimilars: Overall Market Landscape

COMPANY PROFILES: BIOSIMILAR DEVELOPERS BASED IN NORTH AMERICA

• Amgen
• Coherus BioSciences
• Eli Lilly
• Pfizer

COMPANY PROFILES: BIOSIMILAR DEVELOPERS BASED IN EUROPE

• BIOCAD
• Fresenius Kabi
• Sandoz
• STADA

COMPANY PROFILES: BIOSIMILAR DEVELOPERS BASED IN ASIA-PACIFIC AND REST OF THE WORLD

• Biocon
• Dr. Reddy's Laboratories
• Celltrion
• Intas Pharmaceuticals
• Teva Pharmaceuticals

REGULATORY LANDSCAPE

COST PRICE ANALYSIS

• Factors Contributing to High Price of Novel Biologics
• Pricing of Biosimilars
• Concluding Remarks

CASE STUDY: OUTSOURCING OF BIOSIMILARS

• Need for Outsourcing Manufacturing Operations
• Impact of Biosimilars on the Global Contract Manufacturing Market
• Biosimilars Contract Manufacturing Service Providers
• Challenges Associated with Outsourcing of Biosimilar Manufacturing Operations
• Future Perspectives

MARKET IMPACT ANALYSIS

GLOBAL BIOSIMILARS MARKET

BIOSIMILARS MARKET, BY DRUG CLASS

BIOSIMILARS MARKET, BY THERAPEUTIC AREAS

BIOSIMILARS MARKET, BY TYPE OF MANUFACTURER

BIOSIMILARS MARKET, BY DISTRIBUTION CHANNELS

BIOSIMILARS MARKET, BY GEOGRAPHICAL REGIONS

BIOSIMILARS MARKET, BY LEADING PLAYERS

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