Non-Oncology Biologics and Biosimilars Market Size, Share & Trends Analysis Report By Drug Category (Monoclonal Antibody, Toxins, Fusion Proteins, Insulin, Hormones, Gene Therapy, and Others), By Application Type, By Product Type, By Region, And By Segment Forecasts, 2025-2034

Report Id: 2238 Pages: 180 Last Updated: 31 July 2025 Format: PDF / PPT / Excel / Power BI
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Segmentation Of Global Non-Oncology Biologics And Biosimilars Market-

Non-Oncology Biologics And Biosimilars Market By Drug Category-

  • Monoclonal Antibody
  • Toxins
  • Fusion Proteins
  • Insulin
  • Hormones
  • Gene Therapy
  • Others

 biosimilar

Non-Oncology Biologics And Biosimilars Market By Application Type-

  • Dermatology
  • Endocrinology
  • Neurology
  • Immunology
  • Respiratory
  • Rheumatology
  • Ophthalmology
  • Others

Non-Oncology Biologics And Biosimilars Market By Product Type-

  • Biologics
  • Biosimilars

Non-Oncology Biologics And Biosimilars 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
  • South East Asia
  • Rest of Asia Pacific

Latin America-

  • Brazil
  • Argentina
  • Mexico
  • Rest of Latin America

 Middle East & Africa-

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

Chapter 1. Methodology and Scope

1.1. Research Methodology

1.2. Research Scope & Assumptions

Chapter 2. Executive Summary

Chapter 3. Global Non-oncology Biologics and Biosimilars Market Snapshot

Chapter 4. Global Non-oncology Biologics and Biosimilars Market Variables, Trends & Scope

4.1. Market Segmentation & Scope

4.2. Drivers

4.3. Challenges

4.4. Trends

4.5. Investment and Funding Analysis

4.6. Industry Analysis – Porter’s Five Forces Analysis

4.7. Competitive Landscape & Market Share Analysis

4.8. Impact of Covid-19 Analysis

Chapter 5. Market Segmentation 1: By Drug Category Estimates & Trend Analysis

5.1. By Drug Category, & Market Share, 2024 & 2034

5.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following By Drug Category:

5.2.1. Monoclonal Antibody

5.2.2. Toxins

5.2.3. Fusion Proteins

5.2.4. Insulin

5.2.5. Hormones

5.2.6. Gene Therapy

5.2.7. Others

Chapter 6. Market Segmentation 2: By Application Type Estimates & Trend Analysis

6.1. By Application Type & Market Share, 2024 & 2034

6.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following By Application Type:

6.2.1. Dermatology

6.2.2. Endocrinology

6.2.3. Neurology

6.2.4. Immunology

6.2.5. Respiratory

6.2.6. Rheumatology

6.2.7. Ophthalmology

6.2.8. Others

Chapter 7. Market Segmentation 3: By Product Type Estimates & Trend Analysis

7.1. By Product Type & Market Share, 2024 & 2034

7.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following By Product Type:

7.2.1. Biologics

7.2.2. Biosimilars

Chapter 8. Non-oncology Biologics and Biosimilars Market Segmentation 4: Regional Estimates & Trend Analysis

8.1. North America

8.1.1. North America Non-oncology Biologics and Biosimilars Market revenue (US$ Million) estimates and forecasts By Drug Category, 2021-2034

8.1.2. North America Non-oncology Biologics and Biosimilars Market revenue (US$ Million) estimates and forecasts By Application Type, 2021-2034

8.1.3. North America Non-oncology Biologics and Biosimilars Market revenue (US$ Million) estimates and forecasts By Product Type, 2021-2034

8.1.4. North America Non-oncology Biologics and Biosimilars Market revenue (US$ Million) estimates and forecasts by country, 2021-2034

8.2. Europe

8.2.1. Europe Non-oncology Biologics and Biosimilars Market revenue (US$ Million) By Drug Category, 2021-2034

8.2.2. Europe Non-oncology Biologics and Biosimilars Market revenue (US$ Million) By Application Type, 2021-2034

8.2.3. Europe Non-oncology Biologics and Biosimilars Market revenue (US$ Million) By Product Type, 2021-2034

8.2.4. Europe Non-oncology Biologics and Biosimilars Market revenue (US$ Million) by country, 2021-2034

8.3. Asia Pacific

8.3.1. Asia Pacific Non-oncology Biologics and Biosimilars Market revenue (US$ Million) By Drug Category, 2021-2034

8.3.2. Asia Pacific Non-oncology Biologics and Biosimilars Market revenue (US$ Million) By Application Type, 2021-2034

8.3.3. Asia Pacific Non-oncology Biologics and Biosimilars Market revenue (US$ Million) By Product Type, 2021-2034

8.3.4. Asia Pacific Non-oncology Biologics and Biosimilars Market revenue (US$ Million) by country, 2021-2034

8.4. Latin America

8.4.1. Latin America Non-oncology Biologics and Biosimilars Market revenue (US$ Million) By Drug Category, (US$ Million) 2021-2034

8.4.2. Latin America Non-oncology Biologics and Biosimilars Market revenue (US$ Million) By Application Type, (US$ Million) 2021-2034

8.4.3. Latin America Non-oncology Biologics and Biosimilars Market revenue (US$ Million) By Product Type, (US$ Million) 2021-2034

8.4.4. Latin America Non-oncology Biologics and Biosimilars Market revenue (US$ Million) by country, 2021-2034

8.5. Middle East & Africa

8.5.1. Middle East & Africa Non-oncology Biologics and Biosimilars Market revenue (US$ Million) By Drug Category, (US$ Million) 2021-2034

8.5.2. Middle East & Africa Non-oncology Biologics and Biosimilars Market revenue (US$ Million) By Application Type, (US$ Million) 2021-2034

8.5.3. Middle East & Africa Non-oncology Biologics and Biosimilars Market revenue (US$ Million) By Product Type, (US$ Million) 2021-2034

8.5.4. Middle East & Africa Non-oncology Biologics and Biosimilars Market revenue (US$ Million) by country, 2021-2034

Chapter 9. Competitive Landscape

9.1. Major Mergers and Acquisitions/Strategic Alliances

9.2. Company Profiles

9.2.1. Accord Healthcare S.L.U.

9.2.2. Alvotech

9.2.3. Amgen

9.2.4. AYUMI Pharmaceutica

9.2.5. Biocon

9.2.6. Biogen

9.2.7. Biosimilar Collaborations Ireland Limited

9.2.8. Boeheringer Ingelheim

9.2.9. Celltrion

9.2.10. Cipla

9.2.11. Coherus Biosciences

9.2.12. Cordavis Ltd.

9.2.13. Epirus Biopharmaceuticals

9.2.14. Formycon AG

9.2.15. Fresenius Kabi

9.2.16. Glenmark Pharmaceuticals

9.2.17. Hanwha Chemical

9.2.18. Hetero

9.2.19. Innovent Biologics

9.2.20. Kyowa Hakko Kirin (Fujifilm Kyowa Kirin Biologics)

9.2.21. LG Chem

9.2.22. Lupin

9.2.23. Mabpharm

9.2.24. Merck

9.2.25. Midas Pharma GmbH

9.2.26. Mylan

9.2.27. Nichi-Iko Pharmaceutical

9.2.28. Organon & Co.

9.2.29. Pfizer

9.2.30. Qilu Pharma Spain S.L.

9.2.31. Ranbaxy Laboratories (now Sun Pharma)

9.2.32. Samsung Bioepis

9.2.33. Sandoz

9.2.34. Shanghai CP Guojian Pharmaceutical

9.2.35. Sorrento Therapeutics (partner)

9.2.36. STADA Arzneimittel AG

9.2.37. Sunshine Guojian Pharmaceutical

9.2.38. Synermore

9.2.39. Teva

9.2.40. Torrent Pharmaceuticals

9.2.41. YL Biologics

9.2.42. Zydus Cadila

9.2.43. Other prominent players

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

Non-Oncology Biologics and Biosimilars Market Size is predicted to witness a 22.0% CAGR during the forecast period for 2025-2034.

Novo Nordisk A/S, Pfizer Inc., Takeda Pharmaceuticals, BioMarin Pharmaceuticals, GSK, AstraZeneca, and Biogen.

Non-Ooncology Biologics and Biosimilars Market is segmented based on drug category, application type, and product type.

North America region is leading the Non-Oncology Biologics and Biosimilars Market.

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