Report Description

Forecast Period

2025-2029

Market Size (2023)

USD 1.04 Billion

Market Size (2029)

USD 1.54 Billion

CAGR (2024-2029)

6.85%

Fastest Growing Segment

Gene Therapy

Largest Market

North America

Market Overview

Global Cell and Gene Therapy Manufacturing QC Market was valued at USD 1.04 Billion in 2023 and is anticipated to project impressive growth in the forecast period with a CAGR of 6.85% through 2029. The Global Cell and Gene Therapy Manufacturing Quality Control (QC) market encompasses the rapidly evolving sector focused on ensuring the safety, efficacy, and reliability of cell and gene therapy products. Quality control is a critical component in the production process, involving rigorous testing and validation of manufacturing protocols to meet strict regulatory standards. The QC market is driven by the burgeoning demand for advanced therapies targeting complex diseases and relies heavily on cutting-edge technologies for analytics and process standardization.

Key Market Drivers

Rise in Prevalence of Cancer & Cardiovascular Diseases

Cell therapy focuses on different illnesses at the cellular level, either by rejuvenating a specific cell group or by utilizing cells as carriers for therapeutic agents. Whereas gene therapy seeks to impact the progression of various genetic and acquired conditions at the genetic level. It is expected that cardiovascular ailments will propel the demand for cell and gene therapies which will in turn drive the growth of cell and gene therapy manufacturing QC market in the forecast period.  According to the statistics of 2020, it has been observed that China has recorded highest number of deaths ascribed to cardiovascular diseases followed by India, Russia, United States of America, and Indonesia. According to the report published by British Heart Foundation in 2023, it has been concluded that around 620 million people were affected by various cardiovascular diseases across the world in 2019. Rise in number of cases were attributed to lifestyle changes, ageing, and growing population. It is estimated that around 1 in 13 people are suffering from either a heart or circulatory disease across the world. It was observed that around 290 million women were diagnosed with heart diseases in 2019 which was comparatively higher than men accounting for 260 million cases. Coronary (ischaemic) heart disease was observed to be the highest prevalent diseases with 200 million cases followed by peripheral arterial (vascular) disease with 110 million cases, stroke with 100 million cases, and atrial fibrillation with 60 million cases. One possible treatment which have emerged as a leading option for management of cardiac arrhythmias are approaches which can improve the action potential conduction and electrical excitability in the heart. Stem cell therapy has the significant potential to treat cardiac diseases mainly heart failure and coronary heart diseases. Numerous clinical trials have depicted that stem cell therapies are safe to use and acquire the extensive capability to improve the heart function thereby reducing the chances of adverse cardiovascular events. Cancer have also prevailed as a leading morbidity over past few years. As per GLOBOCAN statistics of 2018, it has been observed that Australia accounted for cancer rate of 468.0 followed by New Zealand which accounted for a cancer rate of 438.1, Ireland with a cancer rate of 373.7, Hungary with a cancer rate of 368.1, United States with a cancer rate of 352.2, and so on. Scientists can make modifications in genetics of immune cells which aids in strengthening of cancer cells to reduce the effect of cancer. Somatic gene therapy is widely used by healthcare professionals which involve the patient’s own cells and genes to manage their cancer conditions. Since 2017, six CAR T-cell therapies have been approved by Food and Drugs Administration (FDA) department for their utilization in treatment of different types of cancer such as leukemia, multiple myeloma, several type of blood cancers including lymphoma, and others. In two latest clinical trials which were conducted in 2022, it has been proved that CAR T-cell therapy can also be used for management of non-Hodgkin lymphoma in patients whose cancer returned after initial stage. Therefore, development of new cell and new therapies which are making new additions in treatment techniques of serious chronic diseases are also anticipated to bolster the growth of cell and gene therapy manufacturing QC market in the forecast period.        

Growth in Pharmaceutical Research & Development

Cell and gene therapies are a rapidly expanding domain of medicine with the capability to cure a broad spectrum of ailments. Nevertheless, these therapies are also inherently complex and require rigorous quality assurance (QA) measures to ensure their well-being and effectiveness. Research and development in the quality control of cell and gene therapies is concentrated on developing novel approaches and technologies that can enhance the precision, effectiveness, and promptness of quality control testing. Many new methods have been developed in recent years to facilitate the QC of cell and gene therapies. Scientists at the University of Pennsylvania created a novel technique for characterizing the efficacy of cellular and genetic treatments. This technique is known as functional evaluations which enables the quantification of cells' capacity to carry out designated functions, such as combating infections or generating proteins. In 2023, scientists at the National Institutes of Health developed an accelerated technique for analyzing the integrity of cellular and genetic treatments. The technique is known as flow cytometry which beholds the capacity to detect and measure various cellular categories within a sample.

Increasing Pipeline of Therapies

The burgeoning pipeline of innovative therapies, particularly in the realm of cell and gene therapy, is catalyzing a surge in demand for robust quality control (QC) solutions worldwide. With an increasing number of biopharmaceutical companies focusing on developing cutting-edge cell and gene therapies to address a diverse array of diseases, there's a pressing need for stringent QC measures to ensure safety, efficacy, and consistency of these treatments. The complexity of cell and gene therapies, often tailored to individual patients, necessitates meticulous QC protocols throughout the manufacturing process. As a result, the demand for specialized QC technologies and services tailored to the unique requirements of cell and gene therapy manufacturing is on the rise. This trend is driving significant growth in the global Cell and Gene Therapy Manufacturing QC Market, as companies seek reliable QC solutions to navigate the intricate regulatory landscape and bring innovative therapies to market efficiently and safely.

Manufacturing Scale-up

The process of scaling up manufacturing operations for cell and gene therapies is presenting a formidable challenge, one that significantly amplifies the demand for robust quality control (QC) solutions on a global scale. As promising therapies progress from early-stage development to commercial production, the need for stringent QC measures becomes paramount to ensure product quality, safety, and consistency at larger scales. Manufacturing scale-up introduces complexities such as optimizing production processes, increasing batch sizes, and maintaining uniformity across multiple manufacturing sites—all of which require meticulous QC protocols. Consequently, biopharmaceutical companies are increasingly investing in advanced QC technologies and expertise tailored specifically for cell and gene therapy manufacturing. This surge in demand for QC solutions is propelling the growth of the global Cell and Gene Therapy Manufacturing QC Market, as companies strive to meet regulatory requirements, minimize risks, and accelerate the commercialization of life-saving therapies.


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Key Market Challenges

Shortage Of Professionals Skilled in Advanced Manufacturing & Quality Control of Gene & Cell Therapies

Strict adherence to quality assurance (QA) standards within the cell and gene therapy manufacturing sector may paradoxically decrease the demand for traditional quality control (QC) solutions globally. As regulatory agencies enforce stringent QA requirements to ensure the safety and efficacy of therapies, companies are compelled to implement comprehensive QA measures throughout the manufacturing process. This robust QA framework often incorporates built-in quality control mechanisms, reducing the need for separate QC systems. Advancements in manufacturing technologies and process optimization allow for greater consistency and reliability, minimizing the occurrence of errors and deviations that typically necessitate extensive QC interventions. Consequently, there may be a shift towards integrated QA-QC approaches, where QC functions are seamlessly embedded within QA processes, leading to a potential decrease in the demand for standalone QC solutions in the cell and gene therapy manufacturing market as companies prioritize holistic quality assurance strategies.

High Cost of Quality Control

The high cost associated with quality control (QC) processes in cell and gene therapy manufacturing could potentially decrease the demand for QC solutions globally. While QC is crucial for ensuring the safety, efficacy, and consistency of therapies, the significant expenses involve. The complexity of cell and gene therapies, often requiring specialized QC technologies and expertise, can further inflate the costs of QC implementation and maintenance. Consequently, companies might opt to prioritize cost-saving measures or alternative QC strategies, such as outsourcing QC functions or utilizing less expensive QC technologies, potentially leading to a decreased demand for traditional QC solutions in the cell and gene therapy manufacturing market. This cost-conscious approach could shape the dynamics of the QC market as companies balance the need for quality assurance with financial constraints.

Key Market Trends

Strict Adherence to QA Standards

The stringent adherence to quality assurance (QA) standards within the cell and gene therapy manufacturing sector is playing a pivotal role in driving the demand for advanced quality control (QC) solutions on a global scale. As regulatory agencies impose rigorous requirements to ensure the safety, efficacy, and consistency of these groundbreaking therapies, biopharmaceutical companies are under increasing pressure to implement comprehensive QA measures throughout the manufacturing process. Strict adherence to QA standards necessitates robust QC protocols to detect and mitigate any deviations or discrepancies promptly. Consequently, there's a growing demand for specialized QC technologies and services tailored specifically for the unique challenges of cell and gene therapy manufacturing. This escalating demand for QC solutions is fueling the expansion of the global Cell and Gene Therapy Manufacturing QC Market as companies prioritize compliance with QA standards to navigate regulatory complexities, uphold product quality, and accelerate the development and commercialization of transformative therapies.

Use of Technologies like AI In QC Systems

The integration of cutting-edge technologies, such as artificial intelligence (AI), into quality control (QC) systems, is revolutionizing the cell and gene therapy manufacturing landscape and significantly bolstering the demand for advanced QC solutions worldwide. AI-powered QC systems offer unprecedented capabilities for data analysis, predictive modeling, and real-time monitoring, enabling biopharmaceutical companies to enhance the efficiency, accuracy, and reliability of their QC processes. By leveraging AI algorithms to analyze vast datasets and identify patterns or anomalies, these systems can streamline QC protocols, accelerate decision-making, and mitigate risks during the manufacturing of complex cell and gene therapies. As a result, there's a surging demand for AI-driven QC technologies and services tailored specifically for the unique requirements of cell and gene therapy manufacturing. This increasing reliance on AI in QC systems is driving the growth of the global Cell and Gene Therapy Manufacturing QC Market as companies recognize the transformative potential of technology to optimize production processes, ensure regulatory compliance, and expedite the development and commercialization of innovative therapies.

Segmental Insights

Therapy Type Insights

Based on the Therapy Type, gene therapy has gained significant traction and is now emerging as a dominant sector within the global cell and gene therapy manufacturing quality control (QC) market. This growing trend can be attributed to several factors. The increasing approval of gene therapy products by regulatory authorities has provided a strong foundation for the sector's expansion. Secondly, substantial investments in research and development (R&D) have fuelled advancements in gene therapy, leading to breakthrough treatments and therapies. The rising demand for regenerative medicine has further fuelled the growth of gene therapy as it offers the potential to address the root causes of genetic disorders.

The impact of gene therapies goes beyond conventional treatments, as they are revolutionizing the fight against previously untreatable conditions. By targeting the underlying genetic mechanisms, gene therapies offer new hope and possibilities for patients who have long struggled with debilitating disorders. Consequently, this revolutionary approach has garnered significant interest from both the public and private sectors, driving further investment and research in this field. As the field of gene therapy continues to evolve, it holds immense promise for the future of medicine. With ongoing advancements, we can look forward to more targeted and effective treatments that could potentially transform the lives of countless individuals worldwide.

Offering Insights

Based on the Offering segment, within the global Cell and Gene Therapy Manufacturing Quality Control (QC) market, the "Instruments" segment is currently leading in terms of market share. This is attributed to the growing need for sophisticated and specialized instrumentation that can ensure the accuracy and reliability of cell and gene therapy products. High-throughput and advanced analytics are essential for the stringent quality control measures required in this field. The "Consumables" segment plays a crucial role by providing the necessary materials and reagents for sample preparation and analysis. These consumables, such as culture media, reagents, and lab supplies, are integral to the overall manufacturing process. The Others segment encompasses various supportive services, including software solutions, consulting, and regulatory compliance, which are vital for the success of cell and gene therapy manufacturing. As manufacturing processes and regulatory requirements continue to evolve, the Consumables and "Others segments are expected to experience significant growth, further contributing to the overall advancement and success of the Cell and Gene Therapy Manufacturing Quality Control market.


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Regional Insights

North America has firmly established itself as the frontrunner in the global market for cell and gene therapy manufacturing quality control (QC). This leadership position can be attributed to its highly advanced biotechnology infrastructure, which includes state-of-the-art research facilities, cutting-edge manufacturing capabilities, and a robust talent pool of scientists and experts. Substantial investments in research and development have propelled North America to the forefront of innovation in this field.

North America boasts a comprehensive regulatory framework that ensures the highest standards of safety and efficacy in therapeutic practices. These regulatory frameworks, meticulously designed and continuously updated, provide a solid foundation for the development and manufacturing of cell and gene therapies. The stringent regulations and rigorous quality control measures in place inspire confidence in the safety and effectiveness of these therapies, not only within North America but also internationally.

With its unwavering commitment to excellence and continuous advancements in technology, North America continues to raise the bar in the field of cell and gene therapy manufacturing quality control. The region's relentless pursuit of breakthroughs, coupled with its collaborative ecosystem of academia, industry, and regulatory bodies, fosters a fertile ground for innovation and ensures that North America remains at the forefront of this rapidly evolving field.

Regional Insights

  • In January 2023, Bio-Techne Corporation introduced MauriceFlex, a new addition to its ProteinSimple line. MauriceFlex is a versatile platform that facilitates the separation of protein charge variants, complementing standard cIEF (capillary isoelectric focusing) and CE-SDS (capillary electrophoresis-sodium dodecyl sulfate) tests. This advanced system offers comprehensive protein characterization, simplifying examination processes.
  • In April 2023, Danaher (Cytiva) unveiled X-platform bioreactors, designed to streamline disposable upstream bioprocessing operations. These adaptable bioreactors are capable of producing monoclonal antibodies, protein-derived medications, cellular and genetic therapies, as well as viral vectors. They provide versatility and efficiency in bioprocessing, enabling the advancement and production of a wide range of therapeutic products.
  • In January 2023, Sartorius AG entered into a collaboration with Roosterbio Inc. to drive innovation in subsequent filtration techniques for exosome development.

Regional Insights

  • Bio-Techne Corporation
  • Biomerieux (Suisse) SA
  • F. Hoffmann-La Roche AG
  • Lonza Group
  • Miltenyi Biotec B.V. & Co. KG
  • Sartorius AG
  • Thermo Fisher Scientific Inc.
  • AGC Biologics GmbH
  • Charles River Laboratories International, Inc.
  • Merck KGaA

By Therapy Type

By Offering

By Process

By Technology

By Application

By Region

  • Therapy Cell
  • Gene Therapy
  • Instruments
  • Consumables
  • Others
  • Raw Material Preparation
  • Upstream Processing
  • Downstream Processing
  • Packaging
  • Polymerase Chain Reaction (PCR)
  • Flow Cytometry
  • Limulus Amebocyte Lysate (LAL)
  • Enzyme-Linked Immunosorbent Assay (ELISA),
  • Chromatography
  • Mass Spectrometry
  • Western Blotting
  • Next-Generation Sequencing (NGS)
  • Electrophoresis
  • Others
  • Safety Testing
  • Potency Testing
  • Identity Testing
  • Stability and Genetic Fidelity Testing
  • Others
  • North America
  • Europe
  • Asia Pacific
  • South America
  • Middle East & Africa

 

Report Scope:

In this report, the Global Cell and Gene Therapy Manufacturing QC Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

  • Cell and Gene Therapy Manufacturing QC Market, By Therapy Type:

o   Therapy Cell

o   Gene Therapy

  • Cell and Gene Therapy Manufacturing QC Market, By Offering:

o   Instruments

o   Consumables

o   Others

  • Cell and Gene Therapy Manufacturing QC Market, By Process:

o   Raw Material Preparation

o   Upstream Processing

o   Downstream Processing

o   Packaging

  • Cell and Gene Therapy Manufacturing QC Market, By Technology:

o   Polymerase Chain Reaction (PCR)

o   Flow Cytometry

o   Limulus Amebocyte Lysate (LAL)

o   Enzyme-Linked Immunosorbent Assay (ELISA)

o   Chromatography

o   Mass Spectrometry

o   Western Blotting

o   Next-Generation Sequencing (NGS)

o   Electrophoresis

o   Others

  • Cell and Gene Therapy Manufacturing QC Market, By Application:

o   Safety Testing

o   Potency Testing

o   Identity Testing

o   Stability and Genetic Fidelity Testing

o   Others

  • Cell and Gene Therapy Manufacturing QC Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Cell and Gene Therapy Manufacturing QC Market.

Available Customizations:

Global Cell and Gene Therapy Manufacturing QC market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Global Cell and Gene Therapy Manufacturing QC Market is an upcoming report to be released soon. If you wish an early delivery of this report or want to confirm the date of release, please contact us at [email protected]

Table of content

1.    Product Overview

1.1.  Market Definition

1.2.  Scope of the Market

1.2.1.    Markets Covered

1.2.2.    Years Considered for Study

1.2.3.    Key Market Segmentations

2.    Research Methodology

2.1.  Objective of the Study

2.2.  Baseline Methodology

2.3.  Key Industry Partners

2.4.  Major Association and Secondary Sources

2.5.  Forecasting Methodology

2.6.  Data Triangulation & Validation

2.7.  Assumptions and Limitations

3.    Executive Summary

3.1.  Overview of the Market

3.2.  Overview of Key Market Segmentations

3.3.  Overview of Key Market Players

3.4.  Overview of Key Regions/Countries

3.5.  Overview of Market Drivers, Challenges, Trends

4.    Global Cell and Gene Therapy Manufacturing QC Market Outlook

4.1.  Market Size & Forecast

4.1.1.    By Value

4.2.  Market Share & Forecast

4.2.1.    By Therapy Type (Cell Therapy, Gene Therapy)

4.2.2.    By Offering (Instruments, Consumables, Others)

4.2.3.    By Process (Raw Material Preparation, Upstream Processing, Downstream Processing, Packaging)

4.2.4.    By Technology (Polymerase Chain Reaction (PCR), Flow Cytometry, Limulus Amebocyte Lysate (LAL), Enzyme-Linked Immunosorbent Assay (ELISA), Chromatography, Mass Spectrometry, Western Blotting, Next-Generation Sequencing (NGS), Electrophoresis, Others)

4.2.5.    By Application (Safety Testing, Potency Testing, Identity Testing, Stability and Genetic Fidelity Testing, Others)

4.2.6.    By Region

4.2.7.    By Company (2023)

4.3.  Market Map 

5.    North America Cell and Gene Therapy Manufacturing QC Market Outlook

5.1.  Market Size & Forecast

5.1.1.    By Value

5.2.  Market Share & Forecast

5.2.1.    By Therapy Type

5.2.2.    By Offering

5.2.3.    By Process

5.2.4.    By Technology

5.2.5.    By Application

5.2.6.    By Country

5.3.  North America: Country Analysis

5.3.1.    United States Cell and Gene Therapy Manufacturing QC Market Outlook

5.3.1.1.                Market Size & Forecast

5.3.1.1.1.               By Value

5.3.1.2.                Market Share & Forecast

5.3.1.2.1.               By Therapy Type

5.3.1.2.2.               By Offering

5.3.1.2.3.               By Process

5.3.1.2.4.               By Technology

5.3.1.2.5.               By Application

5.3.2.    Mexico Cell and Gene Therapy Manufacturing QC Market Outlook

5.3.2.1.            Market Size & Forecast

5.3.2.1.1.            By Value

5.3.2.2.            Market Share & Forecast

5.3.2.2.1. By Therapy Type

5.3.2.2.2. By Offering

5.3.2.2.3. By Process

5.3.2.2.4. By Technology

5.3.2.2.5. By Application

5.3.3.    Canada Cell and Gene Therapy Manufacturing QC Market Outlook

5.3.3.1.            Market Size & Forecast

5.3.3.1.1.            By Value

5.3.3.2.            Market Share & Forecast

5.3.3.2.1. By Therapy Type

5.3.3.2.2. By Offering

5.3.3.2.3. By Process

5.3.3.2.4. By Technology

5.3.3.2.5. By Application

6.    Europe Cell and Gene Therapy Manufacturing QC Market Outlook

6.1.  Market Size & Forecast

6.1.1.    By Value

6.2.  Market Share & Forecast

6.2.1.    By Therapy Type

6.2.2.    By Offering

6.2.3.    By Process

6.2.4.    By Technology

6.2.5.    By Application

6.2.6.    By Country

6.3   Europe: Country Analysis

6.3.1.   France Cell and Gene Therapy Manufacturing QC Market Outlook

6.3.1.1.            Market Size & Forecast

6.3.1.1.1.            By Value

6.3.1.2.            Market Share & Forecast

6.3.1.2.1. By Therapy Type

6.3.1.2.2. By Offering

6.3.1.2.3. By Process

6.3.1.2.4. By Technology

6.3.1.2.5. By Application

6.3.2.   Germany Cell and Gene Therapy Manufacturing QC Market Outlook

6.3.2.1.            Market Size & Forecast

6.3.2.1.1.            By Value

6.3.2.2.            Market Share & Forecast

6.3.2.2.1. By Therapy Type

6.3.2.2.2. By Offering

6.3.2.2.3. By Process

6.3.2.2.4. By Technology

6.3.2.2.5. By Application

6.3.3.   United Kingdom Cell and Gene Therapy Manufacturing QC Market Outlook

6.3.3.1.            Market Size & Forecast

6.3.3.1.1.            By Value

6.3.3.2.            Market Share & Forecast

6.3.3.2.1. By Therapy Type

6.3.3.2.2. By Offering

6.3.3.2.3. By Process

6.3.3.2.4. By Technology

6.3.3.2.5. By Application

6.3.4.   Italy Cell and Gene Therapy Manufacturing QC Market Outlook

6.3.4.1.            Market Size & Forecast

6.3.4.1.1.            By Value

6.3.4.2.            Market Share & Forecast

6.3.4.2.1. By Therapy Type

6.3.4.2.2. By Offering

6.3.4.2.3. By Process

6.3.4.2.4. By Technology

6.3.4.2.5. By Application

6.3.5.   Spain Cell and Gene Therapy Manufacturing QC Market Outlook

6.3.5.1.            Market Size & Forecast

6.3.5.1.1.            By Value

6.3.5.2.            Market Share & Forecast

6.3.5.2.1. By Therapy Type

6.3.5.2.2. By Offering

6.3.5.2.3. By Process

6.3.5.2.4. By Technology

6.3.5.2.5. By Application

7.    Asia-Pacific Cell and Gene Therapy Manufacturing QC Market Outlook

7.1.  Market Size & Forecast       

7.1.1.    By Value

7.2.  Market Share & Forecast

7.2.1.    By Therapy Type

7.2.2.    By Offering

7.2.3.    By Process

7.2.4.    By Technology

7.2.5.    By Application

7.2.6.    By Country

7.3.  Asia-Pacific: Country Analysis

7.3.1.    China Cell and Gene Therapy Manufacturing QC Market Outlook

7.3.1.1.                Market Size & Forecast

7.3.1.1.1.               By Value

7.3.1.2.                Market Share & Forecast

7.3.1.2.1.               By Therapy Type

7.3.1.2.2.               By Offering

7.3.1.2.3.               By Process

7.3.1.2.4.               By Technology

7.3.1.2.5.               By Application

7.3.2.    India Cell and Gene Therapy Manufacturing QC Market Outlook

7.3.2.1.                Market Size & Forecast

7.3.2.1.1.               By Value

7.3.2.2.                Market Share & Forecast

7.3.2.2.1.               By Therapy Type

7.3.2.2.2.               By Offering

7.3.2.2.3.               By Process

7.3.2.2.4.               By Technology

7.3.2.2.5.               By Application

7.3.3.    South Korea Cell and Gene Therapy Manufacturing QC Market Outlook

7.3.3.1.                Market Size & Forecast

7.3.3.1.1.               By Value

7.3.3.2.                Market Share & Forecast

7.3.3.2.1.               By Therapy Type

7.3.3.2.2.               By Offering

7.3.3.2.3.               By Process

7.3.3.2.4.               By Technology

7.3.3.2.5.               By Application

7.3.4.    Japan Cell and Gene Therapy Manufacturing QC Market Outlook

7.3.4.1.                Market Size & Forecast

7.3.4.1.1.               By Value

7.3.4.2.                Market Share & Forecast

7.3.4.2.1.               By Therapy Type

7.3.4.2.2.               By Offering

7.3.4.2.3.               By Process

7.3.4.2.4.               By Technology

7.3.4.2.5.               By Application

7.3.5.    Australia Cell and Gene Therapy Manufacturing QC Market Outlook

7.3.5.1.                Market Size & Forecast

7.3.5.1.1.               By Value

7.3.5.2.                Market Share & Forecast

7.3.5.2.1.               By Therapy Type

7.3.5.2.2.               By Offering

7.3.5.2.3.               By Process

7.3.5.2.4.               By Technology

7.3.5.2.5.               By Application

8.    South America Cell and Gene Therapy Manufacturing QC Market Outlook

8.1.  Market Size & Forecast       

8.1.1.    By Value

8.2.  Market Share & Forecast

8.2.1.    By Therapy Type

8.2.2.    By Offering

8.2.3.    By Process

8.2.4.    By Technology

8.2.5.    By Application

8.2.6.    By Country

8.3.  South America: Country Analysis

8.3.1.    Brazil Cell and Gene Therapy Manufacturing QC Market Outlook

8.3.1.1.                Market Size & Forecast

8.3.1.1.1.               By Value

8.3.1.2.                Market Share & Forecast

8.3.1.2.1.               By Therapy Type

8.3.1.2.2.               By Offering

8.3.1.2.3.               By Process

8.3.1.2.4.               By Technology

8.3.1.2.5.               By Application

8.3.2.    Argentina Cell and Gene Therapy Manufacturing QC Market Outlook

8.3.2.1.                Market Size & Forecast

8.3.2.1.1.               By Value

8.3.2.2.                Market Share & Forecast

8.3.2.2.1.               By Therapy Type

8.3.2.2.2.               By Offering

8.3.2.2.3.               By Process

8.3.2.2.4.               By Technology

8.3.2.2.5.               By Application

8.3.3.    Colombia Cell and Gene Therapy Manufacturing QC Market Outlook

8.3.3.1.                Market Size & Forecast

8.3.3.1.1.               By Value

8.3.3.2.                Market Share & Forecast

8.3.3.2.1.               By Therapy Type

8.3.3.2.2.               By Offering

8.3.3.2.3.               By Process

8.3.3.2.4.               By Technology

8.3.3.2.5.               By Application

9.    Middle East and Africa Cell and Gene Therapy Manufacturing QC Market Outlook

9.1.  Market Size & Forecast          

9.1.1.    By Value

9.2.  Market Share & Forecast

9.2.1.    By Therapy Type

9.2.2.    By Offering

9.2.3.    By Process

9.2.4.    By Technology

9.2.5.    By Application

9.2.6.    By Country

9.3.  MEA: Country Analysis

9.3.1.    South Africa Cell and Gene Therapy Manufacturing QC Market Outlook

9.3.1.1.  Market Size & Forecast

9.3.1.1.1.   By Value

9.3.1.2.  Market Share & Forecast

9.3.1.2.1.   By Therapy Type

9.3.1.2.2.   By Offering

9.3.1.2.3.   By Process

9.3.1.2.4.   By Technology

9.3.1.2.5.   By Application

9.3.2.    Saudi Arabia Cell and Gene Therapy Manufacturing QC Market Outlook

9.3.2.1.  Market Size & Forecast

9.3.2.1.1.   By Value

9.3.2.2.  Market Share & Forecast

9.3.2.2.1.   By Therapy Type

9.3.2.2.2.   By Offering

9.3.2.2.3.   By Process

9.3.2.2.4.   By Technology

9.3.2.2.5.   By Application

9.3.3.    UAE Cell and Gene Therapy Manufacturing QC Market Outlook

9.3.3.1.  Market Size & Forecast

9.3.3.1.1.   By Value

9.3.3.2.  Market Share & Forecast

9.3.3.2.1.   By Therapy Type

9.3.3.2.2.   By Offering

9.3.3.2.3.      By Process

9.3.3.2.4.      By Technology

9.3.3.2.5.      By Application

10. Market Dynamics

10.1.1. Drivers

10.1.2. Challenges

11. Market Trends & Developments

11.1.             Merger & Acquisition (If Any)

11.2.             Product Launches (If Any)

11.3.             Recent Developments

12. PESTLE Analysis

13. Porter’s Five Forces Analysis

13.1.1. Competition in the Industry

13.1.2. Potential of New Entrants

13.1.3. Power of Suppliers

13.1.4. Power of Customers

13.1.5. Threat of Substitute Product

14. Competitive Landscape 

14.1.             Bio-Techne Corporation

14.1.1. Business Overview

14.1.2. Company Snapshot

14.1.3. Products & Services

14.1.4. Financials (As Reported)

14.1.5. Recent Developments

14.1.6. Key Personnel Details

14.1.7. SWOT Analysis

14.2.        Biomerieux (Suisse) SA

14.3.        F. Hoffmann-La Roche AG

14.4.        Lonza Group

14.5.        Miltenyi Biotec B.V. & Co. KG

14.6.        Sartorius AG

14.7.        Thermo Fisher Scientific Inc.

14.8.        AGC Biologics GmbH

14.9.        Charles River Laboratories International, Inc.

14.10.      Merck KGaA

15. Strategic Recommendations

16. About Us & Disclaimer

Figures and Tables

Frequently asked questions

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The market size of the Global Cell and Gene Therapy Manufacturing QC Market was estimated to be USD 1.04 Billion in 2023.

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The "Instruments" segment is currently dominating the global Cell and Gene Therapy Manufacturing Quality Control (QC) market, driven by the demand for advanced and specialized instrumentation to ensure accuracy and reliability of therapy products.

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North America leads the global market for cell and gene therapy manufacturing quality control. Its advanced biotechnology infrastructure, research investments, and robust regulatory frameworks ensure safety and efficacy. With cutting-edge technologies, North America sets new benchmarks in this field.

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Growth in pharmaceutical research & development and increasing pipeline of therapies are the major drivers for the Global Cell and Gene Therapy Manufacturing QC Market.

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Sakshi Bajaal

Business Consultant
Press Release

Cell and Gene Therapy Manufacturing QC Market to Grow at 6.85% CAGR thorugh 2029

Apr, 2024

Rise in prevalence of cancer & cardiovascular diseases and growth in pharmaceutical research & development is expected to drive the Global Cell and Gene Therapy Manufacturing QC Market growth in the