Biologics Market Size, Share and Growth Analysis 2025 to 2034

Report Id: 1729 Pages: 180 Last Updated: 19 December 2025 Format: PDF / PPT / Excel / Power BI
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Global Biologics Market Size is valued at USD 426.1 Bn in 2024 and is predicted to reach USD 890.2 Bn by the year 2034 at a 7.8% CAGR during the forecast period for 2025 to 2034.

Biologics Market Size, Share & Trends Analysis Report By Source (Microbial, Mammalian, Others), By Product (MABs, Vaccines, Antisense, RNAi & Molecular Therapy, Recombinant Proteins, Others), By Disease (Oncology, Immunological Disorders, Cardiovascular Disorders, Hematological Disorders, Others), By Manufacturing (Outsourced, In-house), By Route of Administration, By Drug Classification, By Mode of Purchase, By Distribution Channel, By Region, And Segment Forecasts, 2025 to 2034

Biologics Market

Biologics are drugs manufactured from organic materials that can treat various disorders, including immune-related illnesses such as Crohn's disease, psoriasis, ankylosing spondylitis, and rheumatoid arthritis. The intriguing feature is that biologics are isolated from various natural sources, whether carbohydrates, proteins, nucleic acids, or a complex mixture of these materials.

The improved understanding of disease's genetic and molecular foundation has paved the way for creating various tailored treatments. Recmbinant proteins, for example, help the immune system identify and bind foreign molecules. Advances in manufacturing capability development are expected to increase biopharmaceutical production capacity. The use of single-use systems in the synthesis and processing of biopharmaceuticals is also among these breakthroughs.

However, the COVID-19 pandemic had a large market impact. During the pandemic, there was a huge demand for biologics, which contributed significantly to the market's rise. For example, the National Research Council of Canada and China-based CanSino Biologics collaborated on the development of a COVID-19 vaccine in Canada in May 2020. During the pandemic, the considerable research and development operations for the treatment of COVID-19 contributed considerably to the expansion of the biologics market. 

Recent Developments:

  • In February 2022, The Janssen Pharmaceutical Companies of Johnson & Johnson obtained the United States Food and Drug Administration (FDA) approval for CARVYKTI (ciltacabtagene autoleucel; cilia-cel). This drug is used to treat adults with refractory or relapsed multiple myeloma (RRMM), including an a proteasome inhibitor, immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Competitive Landscape:

Some of the Biologics Market Players are:

  • Abbvie Inc.
  • Amgen
  • AstraZeneca
  • Bayer AG
  • Celltrion Inc.
  • Addgene
  • Eli Lilly & Company
  • Hoffmann-La Roche Ltd
  • GSK group of companies
  • Johnson & Johnson Services, Inc
  • Merck & Co. Inc
  • Novartis AG
  • Novo Nordisk A/S
  • Pfizer Inc.
  • Precision Biologics, Inc.
  • Samsung Biologics
  • Sanofi 

Market Segmentation:

The biologics market is segmented based on source, product, disease, manufacturing, route of administration, drug classification, mode of purchase, distribution channel. Based on source, the market is segmented as microbial, mammalian, and others. The products segment includes MABs, Vaccines, Antisense, RNAi & Molecular Therapy, Recombinant Proteins, Others. By disease category, the market is segmented into Oncology, Immunological Disorders, Cardiovascular Disorders, Hematological Disorders, Others. Manufacturing segment includes Outsourced, In-house, Route of Administration segment includes Oral and Others (IV and IP), Drug Classification segment includes Branded & Generic Drugs, Mode of Purchase segment includes Prescription & Over-The-Counter (OTC) Drugs, and Distribution Channel segment includes Hospital, Retail and online.

Based On The Source, The Microbial Segment Is A Major Contributor To The Biologics Market

The microbial category is expected to hold a major share of the global Biologics Market in 2022. This is attributed to the high number of medications developed by employing these products. Microbial expression systems commonly include E. Coli and yeast. Recombinant insulin, granulocyte-macrophage colony-stimulating factor, platelet-derived growth factor, and recombinant interferon are all products of these expression systems. Companies utilizing microbial systems include Johnson & Johnson, Novartis, and Genentech.

The Oncology Segment Witnessed Growth At A Rapid Rate

The oncology segment is projected to grow at a rapid rate in the global Biologics Market owing to the rising incidence of cancer coupled with the presence of different R&D programs. These efforts include cancer-eradication gene treatments and antisense therapeutics. Additionally, oncology is expected to retain its supremacy during the predicted period. The increased use of goods to lessen the number of adverse effects connected with the use of cancer chemotherapy is one of the drivers for the expected growth.

In The Region, The North America Biologics Market Holds A Significant Revenue Share

The North America Biologics Market is expected to register the highest market share in terms of revenue in the near future. This can be attributed to significant corporations, engaging reimbursement policies, and considerable R&D investment. In the United States, biologics account for around 38% of overall medication spending. Approval of new biologic drugs will likely boost market expansion throughout the projection period; for example, the US FDA approved 21 BLAs in 2021. Because of increased R&D spending for biologic development, as well as the availability of a high number of FDA-approved biologics in the country, the United States market for biologics will account for a considerable proportion in 2021. In addition, Germany holds the largest proportion of the European biologics market.

The presence of a sophisticated manufacturing sector, favorable reimbursement, the availability of several approved medications, and the target patient group all contribute to this market's supremacy in Europe.

Biologics Market Report Scope:

Report Attribute Specifications
Market size value in 2024 USD 426.1 Bn
Revenue Forecast in 2034 USD 890.2 Bn
Growth rate CAGR CAGR of 7.8% from 2025 to 2034
Quantitative units Representation of revenue in US$ Bn and CAGR from 2025 to 2034
Historic Year 2021 to 2024
Forecast Year 2025-2034
Report coverage The forecast of revenue, the position of the company, the competitive market statistics, growth prospects, and trends
Segments covered Source, Product, Disease, Manufacturing, Route of Administration, Drug Classification, Mode of Purchase, Distribution Channel
Regional scope North America; Europe; Asia Pacific; Latin America; Middle East & Africa
Country scope U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; The UK; France; Italy; Spain; China; Japan; India; South Korea; Southeast Asia; South Korea; Southeast Asia
Competitive Landscape Samsung BioLogics; Amgen; Novo Nordisk A/S; AbbVie Inc.; Sanofi; Pfizer Inc.; Inc.; GSK group of companies; Merck & Co., Celltrion; Precision Biologics, Inc.; Johnson & Johnson Services, Inc;  Eli Lilly and Company; Novartis AG; Merck KGaA; Bayer AG; F. Hoffmann-La Roche Ltd; and AstraZeneca
Customization scope Free customization report with the procurement of the report, Modifications to the regional and segment scope. Particular Geographic competitive landscape.
Pricing and available payment methods Explore pricing alternatives that are customized to your particular study requirements.

Segmentation of Biologics Market-

Biologics Market By Source

  • Microbial
  • Mammalian
  • Others

 biologics

Biologics Market By Product

  • MABs
  • Vaccines
  • Hormones
  • Therapeutic Enzymes
  • Recombinant Proteins
  • Antisense, RNAi & Molecular Therapy
  • Blood Factors and Anticoagulants
  • Allergenic extracts
  • Human Cells and Tissues
  • Proteins
  • Gene Therapies
  • Cellular Therapies
  • Others 

Biologics Market By Disease

  • Oncology
  • Immunological Disorders
  • Cardiovascular Disorders
  • Hematological Disorders
  • Others 

Biologics Market By Manufacturing

  • Outsourced
  • In-house 

Biologics Market By Route of Administration

  • Oral
  • Others (IV and IP) 

Biologics Market By Drug Classification

  • Branded Drugs
  • Generic Drugs 

Biologics Market By Mode of Purchase

  • Prescription Drugs
  • Over The Counter (OTC) Drugs 

Biologics Market By Distribution Channel

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

Biologics Market By Region-

North America-

  • The US
  • Canada

Europe-

  • Germany
  • The UK
  • France
  • Italy
  • Spain
  • Rest of Europe

Asia-Pacific-

  • China
  • Japan
  • India
  • South Korea
  • Southeast Asia
  • Rest of Asia Pacific

Latin America-

  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America

 Middle East & Africa-

  • GCC Countries
  • South Africa
  • Rest of the Middle East and Africa

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Research Design and Approach

This study employed a multi-step, mixed-method research approach that integrates:

  • Secondary research
  • Primary research
  • Data triangulation
  • Hybrid top-down and bottom-up modelling
  • Forecasting and scenario analysis

This approach ensures a balanced and validated understanding of both macro- and micro-level market factors influencing the market.

Secondary Research

Secondary research for this study involved the collection, review, and analysis of publicly available and paid data sources to build the initial fact base, understand historical market behaviour, identify data gaps, and refine the hypotheses for primary research.

Sources Consulted

Secondary data for the market study was gathered from multiple credible sources, including:

  • Government databases, regulatory bodies, and public institutions
  • International organizations (WHO, OECD, IMF, World Bank, etc.)
  • Commercial and paid databases
  • Industry associations, trade publications, and technical journals
  • Company annual reports, investor presentations, press releases, and SEC filings
  • Academic research papers, patents, and scientific literature
  • Previous market research publications and syndicated reports

These sources were used to compile historical data, market volumes/prices, industry trends, technological developments, and competitive insights.

Secondary Research

Primary Research

Primary research was conducted to validate secondary data, understand real-time market dynamics, capture price points and adoption trends, and verify the assumptions used in the market modelling.

Stakeholders Interviewed

Primary interviews for this study involved:

  • Manufacturers and suppliers in the market value chain
  • Distributors, channel partners, and integrators
  • End-users / customers (e.g., hospitals, labs, enterprises, consumers, etc., depending on the market)
  • Industry experts, technology specialists, consultants, and regulatory professionals
  • Senior executives (CEOs, CTOs, VPs, Directors) and product managers

Interview Process

Interviews were conducted via:

  • Structured and semi-structured questionnaires
  • Telephonic and video interactions
  • Email correspondences
  • Expert consultation sessions

Primary insights were incorporated into demand modelling, pricing analysis, technology evaluation, and market share estimation.

Data Processing, Normalization, and Validation

All collected data were processed and normalized to ensure consistency and comparability across regions and time frames.

The data validation process included:

  • Standardization of units (currency conversions, volume units, inflation adjustments)
  • Cross-verification of data points across multiple secondary sources
  • Normalization of inconsistent datasets
  • Identification and resolution of data gaps
  • Outlier detection and removal through algorithmic and manual checks
  • Plausibility and coherence checks across segments and geographies

This ensured that the dataset used for modelling was clean, robust, and reliable.

Market Size Estimation and Data Triangulation

Bottom-Up Approach

The bottom-up approach involved aggregating segment-level data, such as:

  • Company revenues
  • Product-level sales
  • Installed base/usage volumes
  • Adoption and penetration rates
  • Pricing analysis

This method was primarily used when detailed micro-level market data were available.

Bottom Up Approach

Top-Down Approach

The top-down approach used macro-level indicators:

  • Parent market benchmarks
  • Global/regional industry trends
  • Economic indicators (GDP, demographics, spending patterns)
  • Penetration and usage ratios

This approach was used for segments where granular data were limited or inconsistent.

Hybrid Triangulation Approach

To ensure accuracy, a triangulated hybrid model was used. This included:

  • Reconciling top-down and bottom-up estimates
  • Cross-checking revenues, volumes, and pricing assumptions
  • Incorporating expert insights to validate segment splits and adoption rates

This multi-angle validation yielded the final market size.

Forecasting Framework and Scenario Modelling

Market forecasts were developed using a combination of time-series modelling, adoption curve analysis, and driver-based forecasting tools.

Forecasting Methods

  • Time-series modelling
  • S-curve and diffusion models (for emerging technologies)
  • Driver-based forecasting (GDP, disposable income, adoption rates, regulatory changes)
  • Price elasticity models
  • Market maturity and lifecycle-based projections

Scenario Analysis

Given inherent uncertainties, three scenarios were constructed:

  • Base-Case Scenario: Expected trajectory under current conditions
  • Optimistic Scenario: High adoption, favourable regulation, strong economic tailwinds
  • Conservative Scenario: Slow adoption, regulatory delays, economic constraints

Sensitivity testing was conducted on key variables, including pricing, demand elasticity, and regional adoption.

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Frequently Asked Questions

Biologics Market Size is valued at USD 426.1 Bn in 2024 and is predicted to reach USD 890.2 Bn by the year 2034

Global Biologics Market expected to grow at a 7.8% CAGR during the forecast period for 2025-2034

Samsung BioLogics; Amgen; Novo Nordisk A/S; AbbVie Inc.; Sanofi; Pfizer Inc.; Inc.; GSK group of companies; Merck & Co., Celltrion; Precision Biologic

Source, Product, Disease, Manufacturing, Route of Administration, Drug Classification and Mode of Purchase, Distribution Channel are the key segments

North America region is leading the Biologics Market.
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