Towards Healthcare

Cell and Gene Therapy Manufacturing QC Market Key Players and Company Profile

Date : 15 October 2025

Cell and Gene Therapy Manufacturing QC Market Innovators

Cell and Gene Therapy Manufacturing QC Market Companies

  • WuXi AppTec
  • Lonza
  • Thermo Fisher Scientific
  • Charles River Laboratories
  • Catalent
  • Merck KGaA / MilliporeSigma
  • Eurofins Scientific
  • Pace
  • Pharmaron
  • BioAgilytix Labs
  • Avance Biosciences
  • SGS
  • IQVIA
  • Alcami
  • Solvias
  • Pacific BioLabs
  • ProtaGene / ProtaGene
  • Labcorp
  • bioMérieux
  • Bio-Rad
  • QIAGEN
  • AGC Biologics

Company Profile

Company Historical data (2015) Recent Annual Revenue (2024) Eastablished Year
WuXi AppTec $1.0 Billion $10.1 Billion 2000
Lonza $3.5 Billion $6.7 Billion 1897
Thermo Fisher Scientific $16.0 Billion $39.2 Billion 1956
Charles River Laboratories $1.6 Billion $5.2 Billion 1947
Catalent $1.8 Billion $4.1 Billion 2007
Merck KGaA / MilliporeSigma $17.2 Billion $27.6 Billion 1668
Eurofins Scientific $3.4 Billion $6.4 Billion 1987

WuXi AppTec

Overview

WuXi AppTec is a global leader in providing comprehensive services that support the research, development, and manufacturing of life sciences products. The company offers integrated solutions across the entire life cycle of drug discovery, development, and manufacturing. WuXi AppTec has a strong presence in China and the U.S., driving innovations in biologics, cell and gene therapy, and pharmaceutical manufacturing. The company serves a wide range of industries, from pharmaceuticals to biotechnology, and has become an essential partner for many biopharmaceutical companies.

Role and Responsibilities

  1. Providing end-to-end services for drug discovery, preclinical development, and commercial manufacturing.

  2. Specializing in biologics and gene therapies, accelerating the development of novel treatments.

  3. Offering integrated solutions across biologics, small molecules, and gene therapies, streamlining processes for clients.

Dominating Factors

  1. Global Reach: WuXi AppTec's presence across North America, Europe, and Asia gives it a competitive edge.

  2. Comprehensive Service Model: By offering a one-stop-shop solution, WuXi simplifies the complex drug development and manufacturing process.

  3. Innovation in Biologics: The company’s focus on cutting-edge areas such as cell and gene therapy sets it apart.

Challenges Faced in the Industry

  1. Regulatory Compliance: Navigating through complex global regulations poses a significant challenge.

  2. High Operational Costs: Maintaining infrastructure across different regions increases operational expenses.

  3. Market Competition: The life sciences sector is highly competitive, with many players providing similar services.

Recent Developments

  1. Strategic Partnership: WuXi AppTec formed partnerships with global pharmaceutical giants to enhance the development of vaccines and gene therapies.

  2. Expansion: Opened a new state-of-the-art facility for biologics manufacturing in 2025.

  3. Innovative Platforms: Launched a next-gen cell therapy manufacturing platform to accelerate clinical trials.

Lonza

Overview

Lonza is a leading global supplier to the pharmaceutical, biotechnology, and specialty ingredients markets. With a rich history of providing high-quality manufacturing services, Lonza is well-known for its biologics manufacturing capabilities, especially for monoclonal antibodies and gene therapies. Its clients include some of the largest names in the pharmaceutical industry, benefiting from Lonza's expertise in cell and gene therapy development.

Role and Responsibilities

  1. Manufacturing biologics and cell therapies for clients in the pharmaceutical and biotechnology sectors.

  2. Providing integrated services from early-stage development to commercial manufacturing.

  3. Collaborating with pharmaceutical companies to develop and manufacture life-saving biologic therapies.

Dominating Factors

  1. Biologics Expertise: Lonza is renowned for its expertise in biologic and gene therapy manufacturing.

  2. Global Network: The company has a significant presence in both Europe and North America.

  3. Client-Focused Solutions: Offers flexible and customized solutions for biologic drug production.

Challenges Faced in the Industry

  1. Supply Chain Complexity: Managing a diverse global supply chain for biologics and gene therapies.

  2. Rising Demand for Personalized Medicine: Keeping pace with the growing demand for custom therapies is a major challenge.

  3. Regulatory Pressure: Regulatory hurdles are increasing as biologics and gene therapies become more prevalent.

Recent Developments

  1. New Facility: Lonza opened a new manufacturing facility for cell and gene therapies in 2025.

  2. Partnerships: Collaborated with a leading biotech company to manufacture COVID-19 vaccines.

  3. Investment in Technology: Introduced a new digital platform to streamline biologics production and improve scalability.

Thermo Fisher Scientific

Overview

Thermo Fisher Scientific is a global leader in serving science, with a broad portfolio of products and services catering to research, diagnostics, and pharmaceutical development. The company’s services span from laboratory equipment and reagents to advanced diagnostic tools and solutions for life sciences. Thermo Fisher plays a key role in enabling scientists and researchers to discover and develop new therapies, vaccines, and technologies.

Role and Responsibilities

  1. Manufacturing laboratory and diagnostic equipment for the life sciences industry.

  2. Providing a broad range of services, including genomics, proteomics, and cell biology.

  3. Supporting the pharmaceutical and biotech industries with essential tools for research and development.

Dominating Factors

  1. Comprehensive Product Range: Thermo Fisher offers a vast portfolio, which strengthens its market position.

  2. Global Reach: The company operates in over 50 countries, ensuring accessibility to key markets.

  3. Innovation Focus: Thermo Fisher consistently invests in developing new solutions for emerging scientific challenges.

Challenges Faced in the Industry

  1. Cost Pressure: High costs of R&D can limit profitability, especially for cutting-edge innovations.

  2. Sustainability Concerns: There’s increasing pressure to develop sustainable solutions for laboratory consumables and equipment.

  3. Rapid Technological Changes: Staying ahead in an industry with constant technological advancements is a continual challenge.

Recent Developments

  1. Acquisition: Thermo Fisher acquired a leading biotechnology company, enhancing its life sciences portfolio.

  2. Investment in AI: Launched a new AI-driven analytics tool for life sciences research.

  3. Global Expansion: Expanded its capabilities with a new laboratory services facility in Asia.

Charles River Laboratories

Overview

Charles River Laboratories is a key player in the contract research organization (CRO) industry, offering services that support pharmaceutical, biotechnology, and medical device companies. The company specializes in preclinical and clinical laboratory services, including drug discovery, toxicology testing, and laboratory animal services. Its services are crucial for the development of safe and effective therapeutic drugs.

Role and Responsibilities

  1. Providing preclinical research services to pharmaceutical companies.

  2. Conducting toxicology testing and safety assessments for drug candidates.

  3. Supporting drug development with comprehensive data analytics and laboratory services.

Dominating Factors

  1. Preclinical Research Expertise: Charles River is a leader in preclinical research, particularly in the area of toxicology.

  2. Comprehensive Services: The company offers a broad spectrum of services, from drug discovery to commercialization.

  3. Global Network: With facilities in multiple regions, Charles River can support global drug development efforts.

Challenges Faced in the Industry

  1. Regulatory Compliance: Constantly evolving regulations pose challenges to meeting industry standards.

  2. Ethical Concerns: The use of animal models in research continues to face ethical scrutiny.

  3. Increasing Competition: The CRO market is becoming increasingly competitive, making differentiation crucial.

Recent Developments

  1. Acquisition: Charles River acquired a contract development and manufacturing organization (CDMO) to expand its capabilities.

  2. Innovative Research: Launched a new platform for accelerating the discovery of small molecules.

  3. Partnerships: Partnered with a major pharmaceutical company to provide integrated solutions for cancer research.

Catalent

Overview

Catalent provides advanced drug development, delivery technologies, and manufacturing services for the global pharmaceutical, biotechnology, and consumer health industries. The company specializes in providing solutions that support the development and commercialization of complex therapies, including biologics, cell therapies, and gene therapies. Catalent’s services are critical for accelerating the time-to-market for new drugs.

Role and Responsibilities

  1. Offering services in drug development, clinical trial support, and commercial manufacturing.

  2. Specializing in drug delivery technologies such as oral, injectable, and biologic drug forms.

  3. Providing expertise in gene and cell therapy development and manufacturing.

Dominating Factors

  1. Drug Delivery Expertise: Catalent is known for its innovative drug delivery technologies.

  2. End-to-End Solutions: Offering services across the entire drug development process from discovery to commercialization.

  3. Strategic Partnerships: Collaborates with top pharmaceutical and biotech companies to deliver cutting-edge therapies.

Challenges Faced in the Industry

  1. Regulatory Challenges: Complying with global regulations for biologics and gene therapies is complex.

  2. Technological Advancements: Keeping up with the fast-paced innovations in drug delivery systems.

  3. Cost Efficiency: Balancing high-quality services with cost-effective solutions is a constant challenge.

Recent Developments

  1. Expansion: Catalent expanded its gene therapy manufacturing facilities to support the growing demand for gene-based treatments.

  2. Partnership: Entered into a strategic partnership with a major pharmaceutical company to accelerate vaccine production.

  3. Technology Upgrade: Launched a new platform for faster biologics development and production.

Merck KGaA / MilliporeSigma

Overview

Merck KGaA, Darmstadt, Germany, is a global science and technology company that operates through its Life Science division, MilliporeSigma, providing a wide range of innovative solutions in the fields of biotechnology, pharmaceuticals, and laboratory supplies. The company focuses on helping customers in the healthcare and life sciences industries improve the efficiency and effectiveness of their research, development, and manufacturing processes.

Role and Responsibilities

  1. Providing high-quality laboratory supplies and solutions for biotech and pharmaceutical industries.

  2. Delivering products and services for drug discovery, development, and production.

  3. Supporting biopharmaceutical manufacturing with cutting-edge technologies in biologics and gene therapies.

Dominating Factors

  1. Innovation in Biotechnology: Merck KGaA is a leader in life sciences innovation, particularly in biologics.

  2. Extensive Product Range: Their broad catalog of products spans chemicals, laboratory equipment, and reagents.

  3. Global Presence: With a strong global footprint, Merck KGaA can cater to customers worldwide.

Challenges Faced in the Industry

  1. Intense Competition: The biotechnology market is highly competitive, and differentiating from competitors is crucial.

  2. Global Regulations: Meeting diverse regulatory requirements across multiple regions is a significant challenge.

  3. Supply Chain Risks: Managing supply chain disruptions due to global events poses operational risks.

Recent Developments

  1. Acquisition: Merck KGaA acquired Versum Materials, expanding its life science business.

  2. New Innovations: Launched a new range of lab reagents designed for advanced molecular biology applications.

  3. Sustainability Efforts: Announced plans to reduce its carbon footprint by 30% by 2030.

Eurofins Scientific

Overview

Eurofins Scientific is a global group specializing in laboratory services, with a focus on providing testing, research, and analysis solutions for the pharmaceutical, food, environmental, and agricultural industries. The company is recognized for its expertise in providing high-quality testing services, especially in the pharmaceutical and biotech industries, where it supports drug development and regulatory compliance.

Role and Responsibilities

  1. Offering laboratory testing services for the pharmaceutical, food, and environmental sectors.

  2. Providing specialized services for clinical trials, drug development, and regulatory testing.

  3. Supporting the biopharmaceutical industry with GMP-compliant laboratory services.

Dominating Factors

  1. Comprehensive Testing Services: Eurofins offers a wide range of testing services, making it a go-to provider for many industries.

  2. Global Reach: With over 800 laboratories worldwide, Eurofins has a strong international presence.

  3. Focus on Quality: Known for its commitment to delivering reliable and high-quality results.

Challenges Faced in the Industry

  1. Increasing Demand for Testing: Rising demand for testing services is putting pressure on Eurofins’ resources.

  2. Regulatory Compliance: Constant changes in regulatory frameworks require agile processes.

  3. Operational Efficiency: Managing a large number of global laboratories and maintaining consistency in service quality can be challenging.

Recent Developments

  1. Expansion: Eurofins acquired a series of clinical and environmental testing companies to extend its capabilities.

  2. Technology Integration: Launched an AI-powered testing platform to improve testing accuracy and speed.

  3. Sustainability Efforts: Introduced green laboratory practices to reduce its environmental footprint.

Pace

Overview

Pace Analytical is a premier provider of laboratory testing services, specializing in analytical and environmental testing, as well as solutions for the pharmaceutical, food, and industrial sectors. With a strong emphasis on regulatory compliance, Pace serves a wide variety of industries by providing reliable testing and compliance data that supports product development and regulatory approvals.

Role and Responsibilities

  1. Providing laboratory testing services across various sectors, including pharmaceuticals and environmental.

  2. Ensuring high-quality, compliant testing services to meet global regulatory standards.

  3. Offering custom testing services to support drug development and regulatory approvals.

Dominating Factors

  1. Regulatory Expertise: Pace is known for its in-depth knowledge of global regulatory requirements.

  2. Customized Services: The company offers tailored testing services to meet specific client needs.

  3. Technological Integration: Pace uses advanced technologies to enhance testing accuracy and efficiency.

Challenges Faced in the Industry

  1. Competitive Landscape: The testing services market is highly competitive, with numerous players vying for market share.

  2. Rising Costs: The increasing cost of specialized testing can affect profit margins.

  3. Complex Regulatory Environment: Navigating complex global regulations for pharmaceutical and environmental testing is challenging.

Recent Developments

  1. Partnership: Formed a partnership with a global pharmaceutical company to offer specialized drug testing services.

  2. Facility Expansion: Opened new testing facilities in Asia to cater to increasing market demand.

  3. Innovative Platforms: Launched a new digital platform to enhance testing service efficiency and reporting.

Market Forecast

The global cell and gene therapy manufacturing QC market size is calculated at USD 2.66 billion in 2024, grew to USD 3.11 billion in 2025, and is projected to reach around USD 12.35 billion by 2034. The market is expanding at a CAGR of 16.89% between 2025 and 2034.

Geographical Expansion: Companies expand their geographical presence to deliver their proprietary products to a diverse range of customers by complying with the regulatory standards of respective nations, fostering the cell and gene therapy manufacturing QC market.

  • In June 2025, AGC Biologics announced the initiation of cell therapy process development and clinical manufacturing services at its Yokohama Technical Center, Japan. The company also aims to open a new AGC Biologics Yokohama manufacturing facility by 2027.

Demand for CGT Products: The increasing demand for CGT products encourages companies to develop CGTs, providing cutting-edge personalized therapies for a wide range of diseases.

  • In March 2025, Bharat Biotech International Limited (BBIL), a vaccine manufacturer, entered into the CGT space with a vertically integrated CGT and viral production facility at Genome Valley, Hyderabad, India. The 50,000 sq. ft. facility was developed with an investment of $75 million.

U.S. Market Trends

Key players, such as Thermo Fisher Scientific, Charles River Laboratories, and Catalent, either conduct CGT manufacturing activities or provide advanced QC services. The Food and Drug Administration (FDA) regulates the approval of CGTs. As of August 2025, a total of 46 CGT products were approved by the FDA. The U.S. government invested $98 million in New York’s CGT hub to support R&D.

Canada Market Trends

As of 2023, 12 CGTs have been approved by Health Canada, with 75% approved between 2020 and 2023. In March 2025, the Canadian government supported OmniaBio for the expansion of its CGT manufacturing facility in Hamilton and helped OmniaBio to provide production services to companies globally, strengthening Canada’s participation in global value chains.

India Market Trends

The total number of biotech startups in India increased from 5,365 to 8,531, an increase of 59% between 2021 and 2023. It is expected that the number of biotech startups will rise to 35,460 by 2030. India is the second-largest market for venture capital and growth funding in the Asia-Pacific region.

Latest Announcement by Industry Leaders

Fabian Gerlinghaus, CEO of Cellares, commented that the Cell Q platform enables the company to offer a real end-to-end solution for the customers, providing 10 times higher capacity and up to 50% lower batch price than the Cell Shuttle platform. He also stated that their proprietary platform technologies support the company’s mission of becoming the de facto standard for cell therapy manufacturing, thereby accelerating access for patients and meeting the total global demand for cell therapies.

Recent Developments

  • In May 2025, QIAGEN announced the expansion of its CGT portfolio with an enhanced digital PCR (dPCR) workflow that includes lentivirus-based applications. The solution supports QC processes, including high-precision analytics for process development, batch release, and regulatory compliance, as well as enabling a standardized workflow.
  • In May 2025, researchers from the University of Osaka reported the significance of a novel technique, mass photometry, as a quality control technique to accelerate the detection and quantification of delivery system components for therapeutic genes. They tested the binding activity of full and empty viral particles within rAAVs, cell lysate, and the conditioned medium.

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