Cell and Gene Therapy Manufacturing Quality Control (QC) Market Size, Share & Trends Analysis Report By Component (Equipment & Accessories, Consumables, Others), By Application (Sterility Testing, Purity Testing, Potency Testing, Identity Testing, Others (stability, viability, etc.)), By Process (Upstream Processing, Downstream Processing, Packaging), By End-User (Pharmaceutical & Biotechnology Companies, Contract Manufacturing Organizations), By Region, And By Segment Forecasts, 2025-2034

Report Id: 2395 Pages: 179 Last Updated: 16 May 2025 Format: PDF / PPT / Excel / Power BI
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Segmentation of Cell and Gene Therapy Manufacturing Quality Control (QC) Market-

Cell and Gene Therapy Manufacturing Quality Control (QC) Market By Component

  • Equipment & Accessories
  • Consumables
  • Others

Cell and Gene Therapy Manufacturing Quality Control (QC) Market seg

Cell and Gene Therapy Manufacturing Quality Control (QC) Market By Application

  • Sterility Testing
  • Purity Testing
  • Potency Testing
  • Identity Testing
  • Others (stability, viability, etc.)

Cell and Gene Therapy Manufacturing Quality Control (QC) Market By Process-

  • Upstream Processing
  • Downstream Processing
  • Packaging

Cell and Gene Therapy Manufacturing Quality Control (QC) Market By End-User-

  • Pharmaceutical & Biotechnology Companies
  • Contract Manufacturing Organizations

Cell and Gene Therapy Manufacturing Quality Control (QC) 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

Chapter 1. Methodology and Scope

1.1. Research Methodology

1.2. Research Scope & Assumptions

Chapter 2. Executive Summary

Chapter 3. Global Cell and Gene Therapy Manufacturing Quality Control (QC) Market Snapshot

Chapter 4. Global Cell and Gene Therapy Manufacturing Quality Control (QC) 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 Component Estimates & Trend Analysis

5.1. by Component & Market Share, 2024 & 2034

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

5.2.1. Equipment & Accessories

5.2.2. Consumables

5.2.3. Others

Chapter 6. Market Segmentation 2: by Analytical Method Estimates & Trend Analysis

6.1. by Analytical Method & Market Share, 2024 & 2034

6.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2021 to 2034 for the following by Analytical Method:

6.2.1. Sterility Testing

6.2.2. Purity Testing

6.2.3. Potency Testing

6.2.4. Identity Testing

6.2.5. Others (Stability, Viability, Etc.)

Chapter 7. Market Segmentation 3: by Process Estimates & Trend Analysis

7.1. by Process & Market Share, 2024 & 2034

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

7.2.1. Upstream Processes

7.2.2. Downstream Processes

7.2.3. Process Development

Chapter 8. Market Segmentation 4: by End-User Estimates & Trend Analysis

8.1. by End-User & Market Share, 2024 & 2034

8.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2021 to 2034 for the following by End-User:

8.2.1. Pharmaceutical & Biotechnology Companies

8.2.2. Contract Manufacturing Organizations

Chapter 9. Cell and Gene Therapy Manufacturing Quality Control (QC) Market Segmentation 5: Regional Estimates & Trend Analysis

9.1. North America

9.1.1. North America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Component, 2021-2034

9.1.2. North America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Analytical Method, 2021-2034

9.1.3. North America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Process, 2021-2034

9.1.4. North America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034

9.1.5. North America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034

9.2. Europe

9.2.1. Europe Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Component, 2021-2034

9.2.2. Europe Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Analytical Method, 2021-2034

9.2.3. Europe Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Process, 2021-2034

9.2.4. Europe Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034

9.2.5. Europe Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034

9.3. Asia Pacific

9.3.1. Asia Pacific Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Component, 2021-2034

9.3.2. Asia Pacific Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Analytical Method, 2021-2034

9.3.3. Asia-Pacific Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Process, 2021-2034

9.3.4. Asia Pacific Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034

9.3.5. Asia Pacific Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034

9.4. Latin America

9.4.1. Latin America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Component, 2021-2034

9.4.2. Latin America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Analytical Method, 2021-2034

9.4.3. Latin America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Process, 2021-2034

9.4.4. Latin America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034

9.4.5. Latin America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034

9.5. Middle East & Africa

9.5.1. Middle East & Africa Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Component, 2021-2034

9.5.2. Middle East & Africa Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Analytical Method, 2021-2034

9.5.3. Middle East & Africa Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Process, 2021-2034

9.5.4. Middle East & Africa Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034

9.5.5. Middle East & Africa Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034

Chapter 10. Competitive Landscape

10.1. Major Mergers and Acquisitions/Strategic Alliances

10.2. Company Profiles

10.2.1. bioMérieux SA

10.2.2. Bio-Rad Laboratories, Inc.

10.2.3. Bio-Techne Corporation

10.2.4. QIAGEN

10.2.5. Charles River Laboratories International, Inc.

10.2.6. Lonza Group AG

10.2.7. Merck KGaA

10.2.8. Intertek Group plc

10.2.9. Thermo Fisher Scientific, Inc.

10.2.10. Eurofins Scientific S.E.

10.2.11. F. Hoffmann-La Roche Ltd.

10.2.12. Catalent

10.2.13. Wuxi AppTec

10.2.14. Takara Bio Inc

10.2.15. Oxford Biomedica plc

10.2.16. Cell and Gene Therapy Catapult

10.2.17. FUJIFILM Holdings Corporation

10.2.18. Danaher (Cytiva)

10.2.19. Sartorius AG

10.2.20. AGC Biologics.

10.2.21. Eurofins Scientific

10.2.22. 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

Cell and Gene Therapy Manufacturing Quality Control (QC) Market Size is valued at USD 2.71 Bn in 2024 and is predicted to reach USD 16.32 Bn by the ye

Cell and Gene Therapy Manufacturing Quality Control (QC) Market is expected to grow at a 19.8% CAGR during the forecast period for 2025-2034.

Wuxi AppTec, Takara Bio Inc, Oxford Biomedica plc, Cell and Gene Therapy Catapult, FUJIFILM Holdings Corporation, Danaher (Cytiva), Sartorius AG, AGC

Cell & Gene Therapy Manufacturing Quality Control (QC) the market is segmented on the basis of component, process, application and end-user.

North America region is leading the Cell & Gene Therapy Manufacturing Quality Control (QC) the market.

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