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HEALTHCARE

Global Biologics and Biosimilars Market - Industry Trends and Forecast to 2032

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​REPORT OVERVIEW

Global Biologics and Biosimilars Market, By Drug Class (Monoclonal Antibody, Vaccines, Recombinant Insulin, Growth Factors, Immune Modulators, Fusion Protein, Erythoprotein, Therapeutic Enzymes, Interferons, and Others Drugs), Source (Bacterial Cells, Yeast Cells, Plant Cells, Animal Cells, Other Sources), Manufacturing Type (Contract Manufacturing, In-house Manufacturing), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Specialty Pharmacies, Mail Order Pharmacies), Application (Oncology, Autoimmune Disease, Infectious Diseases, Rare Disease, Cardiovascular Disorders, Hematological Disorders, Other Application), Region (North America, Europe, Asia-Pacific, South America, Middle East and Africa) – Industry Trends and Forecast to 2032.

Market Insights
The global biologics and biosimilars market size is valued to be USD xx million in 2023 and is expected to reach USD xx million by 2032, and it is expected to register a CAGR of xx% over the forecast period 2024-2032.

Biologics are complicated medications derived from living organisms using highly involved production techniques. They cover a broad spectrum of goods, including gene therapies, blood components, and vaccines. After an original biologic product's patent expires, virtually identical replicas of the product are authorized as biosimilars. Comparing them to the reference biologic, there are no discernible changes in terms of safety, purity, or potency that are clinically significant. The biologics and biosimilars market includes the discovery, manufacture, and commercialization of these sophisticated medicines. Significant R&D, manufacturing, distribution, and regulatory clearances are all part of this market. Key companies provide affordable substitutes for branded biologics by concentrating on developing and enhancing treatment options for a range of illnesses, with an emphasis on cancer, autoimmune disorders, and chronic diseases.

The respective global report analyses market trends, consumer behaviour and industry dynamics to guide towards entry into new markets with ease. Also, it assists in tailoring market specific and related products and services to meet the needs, preferences, and expectations of target audience by delving into their psychology. The report also specializes with comprehensive and extensive competitive analysis which offers useful insights into competitor strengths, weaknesses, opportunities, and threats. The respective report offers exclusive insights into the potential impact of disruptive developments and technologies that are expected to completely transform corporate operations. The context includes tailor-made research solutions to create a stronger footprint in their particular industries thereby offering dedicated customized solutions according to the client needs which helps in addressing unique business challenges with more simplified and efficient decision-making solutions.
Market Dynamics
DRIVERS
  • Growing acceptance of personalized medicine.
  • Increasing healthcare expenditure.
RESTRAINTS
  • High cost of biologics development and production.
  • Stringent regulatory requirements.
OPPORTUNITIES
  • Growth in emerging markets.
  • Increasing collaborations and partnerships.
CHALLENGES
  • Competition from traditional pharmaceuticals.
  • Navigating patent litigations and legal challenges.

​SEGMENTATION

  • Drug Class
    • Monoclonal Antibody
    • Vaccines
    • Recombinant Insulin
    • Growth Factors
    • Immune Modulators
    • Fusion Protein
    • Erythoprotein
    • Therapeutic Enzymes
    • Interferons
    • Colony Stimulation Factors
    • Oligonucleotides
    • Others Drug
  • Source
    • Bacterial Cells
    • Yeast Cells
    • Plant Cells
    • Animal Cells
    • Other Sources
  • Manufacturing Type
    • Contract Manufacturing
    • In-house Manufacturing
  • Distribution Channel
    • Hospital Pharmacies
    • Retail Pharmacies
    • Specialty Pharmacies
    • Mail Order Pharmacies
  • Application
    • Oncology
    • Autoimmune Disease
    • Infectious Diseases
    • Rare Disease
    • Cardiovascular Disorders
    • Hematological Disorders
    • Other Application
The respective global report is completely customizable specific to regions (North America, Europe, Asia-Pacific, South America, Middle East and Africa), countries, and segments as per the client requirements.
REGIONAL SEGMENTATION
  • North America
    • U.S.
    • Canada
    • Mexico
    • Rest of North America
  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Russia
    • The Netherlands
    • Belgium
    • Turkey
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • South Korea
    • Singapore
    • Malaysia
    • Australia
    • Thailand
    • Philippines
    • Rest of Asia-Pacific
  • South America
    • Brazil
    • Argentina
    • Chile
    • Colombia
    • Rest of South America
  • Middle East and Africa
    • Kingdom of Saudi Arabia
    • South Africa
    • U.A.E.
    • Egypt
    • Rest of Middle East and Africa

​KEY MARKET PLAYERS

  • Pfizer Inc.
  • Hoffmann-La Roche AG
  • AbbVie Inc.
  • Novartis AG
  • Merck & Co., Inc.
  • Bristol Myers Squibb Co.
  • GSK plc
  • AstraZeneca
  • Eli Lilly & Co.
  • Bayer AG.

​Table OF CONTENTS

  • SECTION 1 - INTRODUCTION
  • 1.1 Taxonomy
  • 1.2 Market Overview
  • 1.3 Currency and Limitations
  •   1.3.1 Currency
  •   1.3.2 Limitations
  • 1.4 Key Competitors

  • SECTION 2 - RESEARCH METHODOLOGY
  • 2.1 Research Approach
  • 2.2 Data Collection and Validation
  •   2.2.1 Secondary Research
  •   2.2.2 Primary Research
  • 2.3 Market Assessment
  •   2.3.1 Market Size Estimation
  •   2.3.2 Bottom-up Approach
  •   2.3.3 Top-down Approach
  •   2.3.4 Growth Forecast
  • 2.4 Market Study Assumptions
  • 2.5 Data Sources

  • SECTION 3 - EXECUTIVE SUMMARY
  • 3.1 Global Biologics and Biosimilars Market, by Drug Class
  • 3.2 Global Biologics and Biosimilars Market, by Source
  • 3.3 Global Biologics and Biosimilars Market, by Manufacturing Type
  • 3.4 Global Biologics and Biosimilars Market, by Distribution Channel
  • 3.5 Global Biologics and Biosimilars Market, by Application
  • 3.6 Global Biologics and Biosimilars Market, by Geography
  • 3.7 Market Position Grid

  • SECTION 4 - PREMIUM INSIGHTS
  • 4.1 Regulatory Framework
  •   4.1.1 Standards
  •   4.1.2 Regulatory Landscape
  • 4.2 Value Chain Analysis
  • 4.3 Supply Chain Analysis
  • 4.4 COVID-19 Impact
  • 4.5 Russia-Ukraine War Impact
  • 4.6 PORTER's Five Force Analysis
  • 4.7 PESTLE Analysis
  • 4.8 SWOT Analysis
  • 4.9 Go to Market Strategy
  • 4.10 Opportunity Orbit
  • 4.11 Multivariate Modelling
  • 4.12 Pricing Analysis

  • SECTION 5 - MARKET DYNAMICS
  • 5.1 Trends
  •   5.1.1 Increasing prevalence of chronic diseases.
  •   5.1.2 Advancements in Biotechnology.
  •   5.1.3 Trend 3
  • 5.2 Drivers
  •   5.2.1 Growing acceptance of personalized medicine.
  •   5.2.2 Increasing healthcare expenditure.
  •   5.2.3 Driver 3
  •   5.2.4 Driver 4
  • 5.3 Restraints
  •   5.3.1 High cost of biologics development and production.
  •   5.3.2 Stringent Regulatory Requirements.
  •   5.3.3 Restraint 3
  • 5.4 Opportunities
  •   5.4.1 Growth in emerging markets.
  •   5.4.2 Increasing collaborations and partnerships.
  •   5.4.3 Opportunity 3
  •   5.4.4 Opportunity 4
  • 5.5 Challenges
  •   5.5.1 Competition from traditional pharmaceuticals.
  •   5.5.2 Navigating patent litigations and legal challenges.
  •   5.5.3 Challenge 3

  • SECTION 6 - GLOBAL BIOLOGICS AND BIOSIMILARS MARKET, BY DRUG CLASS
  • 6.1 Drug Class Summary
  • 6.2 Market Attractive Index
  • 6.3 Global Biologics and Biosimilars Market, by Drug Class (2019-2032)

  • SECTION 7 - GLOBAL BIOLOGICS AND BIOSIMILARS MARKET, BY SOURCE
  • 7.1 Source Summary
  • 7.2 Market Attractive Index
  • 7.3 Global Biologics and Biosimilars Market, by Source (2019-2032)

  • SECTION 8 - GLOBAL BIOLOGICS AND BIOSIMILARS MARKET, BY MANUFACTURING TYPE
  • 8.1 Manufacturing Type Summary
  • 8.2 Market Attractive Index
  • 8.3 Global Biologics and Biosimilars Market, by Manufacturing Type (2019-2032)

  • SECTION 9 - GLOBAL BIOLOGICS AND BIOSIMILARS MARKET, BY DISTRIBUTION CHANNEL
  • 9.1 Distribution Channel Summary
  • 9.2 Market Attractive Index
  • 9.3 Global Biologics and Biosimilars Market, by Distribution Channel (2019-2032)

  • SECTION 10 - GLOBAL BIOLOGICS AND BIOSIMILARS MARKET, BY APPLICATION
  • 10.1 Application Summary
  • 10.2 Market Attractive Index
  • 10.3 Global Biologics and Biosimilars Market, by Application (2019-2032)

  • SECTION 11 - GLOBAL BIOLOGICS AND BIOSIMILARS MARKET, BY GEOGRAPHY
  • 11.1 Regional Summary
  • 11.2 Market Attractive Index
  • 11.3 Global Biologics and Biosimilars Market, by Geography (2019-2032)

  • SECTION 12 - NORTH AMERICA BIOLOGICS AND BIOSIMILARS MARKET
  • 12.1 North America Summary
  • 12.2 Market Attractive Index
  • 12.3 North America Biologics and Biosimilars Market, by Drug Class (2019-2032)
  • 12.4 North America Biologics and Biosimilars Market, by Source (2019-2032)
  • 12.5 North America Biologics and Biosimilars Market, by Manufacturing Type (2019-2032)
  • 12.6 North America Biologics and Biosimilars Market, by Distribution Channel (2019-2032)
  • 12.7 North America Biologics and Biosimilars Market, by Application (2019-2032)
  • 12.8 North America Biologics and Biosimilars Market, by Country (2019-2032)
  •   12.8.1 U.S.
  •   12.8.2 Canada
  •   12.8.3 Mexico
  •   12.8.4 Rest of North America

  • SECTION 13 - EUROPE BIOLOGICS AND BIOSIMILARS MARKET
  • 13.1 Europe Summary
  • 13.2 Market Attractive Index
  • 13.3 Europe Biologics and Biosimilars Market, by Drug Class (2019-2032)
  • 13.4 Europe Biologics and Biosimilars Market, by Source (2019-2032)
  • 13.5 Europe Biologics and Biosimilars Market, by Manufacturing Type (2019-2032)
  • 13.6 Europe Biologics and Biosimilars Market, by Distribution Channel (2019-2032)
  • 13.7 Europe Biologics and Biosimilars Market, by Application (2019-2032)
  • 13.8 Europe Biologics and Biosimilars Market, by Country (2019-2032)
  •   13.8.1 Germany
  •   13.8.2 U.K.
  •   13.8.3 France
  •   13.8.4 Italy
  •   13.8.5 Spain
  •   13.8.6 Russia
  •   13.8.7 The Netherlands
  •   13.8.8 Belgium
  •   13.8.9 Turkey
  •   13.8.10 Rest of Europe

  • SECTION 14 - ASIA-PACIFIC BIOLOGICS AND BIOSIMILARS MARKET
  • 14.1 Asia-Pacific Summary
  • 14.2 Market Attractive Index
  • 14.3 Asia-Pacific Biologics and Biosimilars Market, by Drug Class (2019-2032)
  • 14.4 Asia-Pacific Biologics and Biosimilars Market, by Source (2019-2032)
  • 14.5 Asia-Pacific Biologics and Biosimilars Market, by Manufacturing Type (2019-2032)
  • 14.6 Asia-Pacific Biologics and Biosimilars Market, by Distribution Channel (2019-2032)
  • 14.7 Asia-Pacific Biologics and Biosimilars Market, by Application (2019-2032)
  • 14.8 Asia-Pacific Biologics and Biosimilars Market, by Country (2019-2032)
  •   14.8.1 China
  •   14.8.2 India
  •   14.8.3 Japan
  •   14.8.4 South Korea
  •   14.8.5 Singapore
  •   14.8.6 Malaysia
  •   14.8.7 Australia
  •   14.8.8 Thailand
  •   14.8.9 Philippines
  •   14.8.10 Rest of Asia-Pacific

  • SECTION 15 - SOUTH AMERICA BIOLOGICS AND BIOSIMILARS MARKET
  • 15.1 South America Summary
  • 15.2 Market Attractive Index
  • 15.3 South America Biologics and Biosimilars Market, by Drug Class (2019-2032)
  • 15.4 South America Biologics and Biosimilars Market, by Source (2019-2032)
  • 15.5 South America Biologics and Biosimilars Market, by Manufacturing Type (2019-2032)
  • 15.6 South America Biologics and Biosimilars Market, by Distribution Channel (2019-2032)
  • 15.7 South America Biologics and Biosimilars Market, by Application (2019-2032)
  • 15.8 South America Biologics and Biosimilars Market, by Country (2019-2032)
  •   15.8.1 Brazil
  •   15.8.2 Argentina
  •   15.8.3 Chile
  •   15.8.4 Colombia
  •   15.8.5 Rest of South America

  • SECTION 16 - MIDDLE EAST AND AFRICA BIOLOGICS AND BIOSIMILARS MARKET
  • 16.1 Middle East and Africa Summary
  • 16.2 Market Attractive Index
  • 16.3 Middle East and Africa Biologics and Biosimilars Market, by Drug Class (2019-2032)
  • 16.4 Middle East and Africa Biologics and Biosimilars Market, by Source (2019-2032)
  • 16.5 Middle East and Africa Biologics and Biosimilars Market, by Manufacturing Type (2019-2032)
  • 16.6 Middle East and Africa Biologics and Biosimilars Market, by Distribution Channel (2019-2032)
  • 16.7 Middle East and Africa Biologics and Biosimilars Market, by Application (2019-2032)
  • 16.8 Middle East and Africa Biologics and Biosimilars Market, by Country (2019-2032)
  •   16.8.1 Kingdom of Saudi Arabia
  •   16.8.2 South Africa
  •   16.8.3 U.A.E.
  •   16.8.4 Egypt
  •   16.8.5 Rest of Middle East and Africa

  • SECTION 17 - COMPANY SHARE ANALYSIS
  • 17.1 Global Biologics and Biosimilars Market, Company Share Analysis
  • 17.2 North America Biologics and Biosimilars Market, Company Share Analysis
  • 17.3 Europe Biologics and Biosimilars Market, Company Share Analysis
  • 17.4 Asia-Pacific Biologics and Biosimilars Market, Company Share Analysis

  • SECTION 18 - COMPANY PROFILES
  • 18.1 Pfizer Inc.
  •   18.1.1 Company Snapshot
  •   18.1.2 Financial Overview
  •   18.1.3 Product Portfolio
  •   18.1.4 Recent Developments
  • 18.2 Hoffmann-La Roche AG
  •   18.2.1 Company Snapshot
  •   18.2.2 Financial Overview
  •   18.2.3 Product Portfolio
  •   18.2.4 Recent Developments
  • 18.3 AbbVie Inc.
  •   18.3.1 Company Snapshot
  •   18.3.2 Financial Overview
  •   18.3.3 Product Portfolio
  •   18.3.4 Recent Developments
  • 18.4 Novartis AG
  •   18.4.1 Company Snapshot
  •   18.4.2 Financial Overview
  •   18.4.3 Product Portfolio
  •   18.4.4 Recent Developments
  • 18.5 Merck & Co., Inc.
  •   18.5.1 Company Snapshot
  •   18.5.2 Financial Overview
  •   18.5.3 Product Portfolio
  •   18.5.4 Recent Developments
  • 18.6 Bristol Myers Squibb Co.
  •   18.6.1 Company Snapshot
  •   18.6.2 Financial Overview
  •   18.6.3 Product Portfolio
  •   18.6.4 Recent Developments
  • 18.7 GSK plc
  •   18.7.1 Company Snapshot
  •   18.7.2 Financial Overview
  •   18.7.3 Product Portfolio
  •   18.7.4 Recent Developments
  • 18.8 AstraZeneca
  •   18.8.1 Company Snapshot
  •   18.8.2 Financial Overview
  •   18.8.3 Product Portfolio
  •   18.8.4 Recent Developments
  • 18.9 Eli Lilly & Co.
  •   18.9.1 Company Snapshot
  •   18.9.2 Financial Overview
  •   18.9.3 Product Portfolio
  •   18.9.4 Recent Developments
  • 18.10 Bayer AG.
  •   18.10.1 Company Snapshot
  •   18.10.2 Financial Overview
  •   18.10.3 Product Portfolio
  •   18.10.4 Recent Developments

  • SECTION 19 - RELATED REPORTS

  • SECTION 20 - DISCLAIMER

​RESEARCH METHODOLOGY

The research methodology employed in Uniprism Market Research involves four basic steps namely research and data collection, data pre-processing, modeling and forecasting, quality assurance and output.
RESEARCH AND DATA COLLECTION
A tripod model research technique is followed for research and data collection in which various approaches such as primary research, secondary research, and product mapping are considered.

Primary research basically involves the process of conducting personalized interviews with market related professionals of major market players, investors, distributors, vendors and many more.

The secondary research include data published by government, annual reports, press releases, investor presentations of companies, white papers, certified publications, annual manufacturing limit of the respective industries related to the market, production consumption analysis of certain products respective to the market and many more.

Below mention are few of the sources which we have considered while estimating the market size:
For instance,
  • Research articles published on Technium
  • Science and MDPI
  • Research publications by government approved associations and societies

Product mapping means the process of mapping the list of products that a key player contributes to the market as well as estimating the revenue of those products in order to define the Global Company share analysis of the respective Global Company in global, regional, and country level markets.
DATA PRE-PROCESSING

The term "data pre-processing" refers to the collection of procedures and methods used to clean, modify, and make ready for analysis the raw data gathered during research and data collection. The completion of this phase is necessary to guarantee that the data are reliable, consistent, and appropriate for statistical analysis and other data-driven tasks. The data pre-processing ensures that the information gathered from research and data collection is comparable and expressed in standard units, by the integration of missing data pointers and algorithmic approaches.

MODELING AND FORECASTING
The process of developing mathematical, statistical, or computational representations of real-world occurrences or relationships is known as modelling. These models are intended to replicate and explain market interactions, interdependence, and dynamics. These models are used by Uniprism Market Research to acquire a better knowledge of numerous market characteristics such as customer preferences, pricing elasticity, competition dynamics, and more. Depending on the individual study aims, many types of models are utilized, such as regression models, econometric models, decision tree models, and machine learning models.

Forecasting is the process of predicting future market conditions, trends, and occurrences using past data and models. Forecasting is used by Uniprism Market Research to estimate future sales, demand for products or services, market growth, and other important performance metrics. Forecasting accurately can assist organizations in making educated decisions about resource allocation, pricing, inventory management, and marketing tactics.

We create standardized bottom-up or top-down models that scale by leveraging data science and machine learning technology. All our market models consider the unique market characteristics of each country. Forecasting is based on major market indicators and a combination of traditional methodologies, such as exponential smoothing, time series analysis, regression analysis, and more modern techniques such as machine learning algorithms are all forecasting methodologies. The method chosen is determined on the nature of the data and the specific forecasting aims.
QUALITY ASSURANCE AND OUTPUT

Quality assurance and output involves the process of validation, adjustments, further publications of key market indicators. Extensive plausibility and consistency tests are performed on derived time series to ensure the high degree of quality of our market analysis. This quality assurance procedure also includes rigorous inspection, validation, and editing by an experienced management team to assure the dependability of the published data.

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