Asia-Pacific Cell and Gene Therapy Manufacturing QC Market Set to Surge to $1,317.3 Million by 2033 – BIS Research

Market Overview: 

Market Size and Growth Rate: 

The Asia-Pacific CGT Manufacturing QC market is set to grow from $288.9 million in 2024 to $1,317.3 million by 2033, registering a strong CAGR of 18.36% over the forecast period. This robust expansion is attributed to increasing investments in gene-modified cell therapies and a growing number of regional biotech firms. 

Trends & Innovation: 

The market is undergoing a shift toward automation and real-time testing. Key innovations include the integration of process analytical technologies (PAT), quality risk management (QRM), and next-generation sequencing (NGS). These are enabling earlier detection of quality issues and more streamlined regulatory compliance. The transition from batch-based to continuous manufacturing also marks a pivotal trend, improving efficiency and consistency in therapy development. 

Access insights on Asia-Pacific Cell and Gene Therapy Manufacturing QC Market 

Key Highlights: 

Report USP: 

• Detailed segmentation by therapy, technology, and process stages. 
• Country-level insights across key Asia-Pacific markets. 
• Competitive profiling with focus on QC innovations and strategies. 

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Demand Drivers, Challenges & Opportunities: 

Demand Drivers 

The Asia-Pacific region is witnessing a rapid surge in approved cell and gene therapy (CGT) products, significantly fueling the need for robust quality control mechanisms. This growth is further propelled by strong government backing and national biotechnology initiatives in countries like China, Japan, and South Korea, aiming to build competitive CGT ecosystems. Additionally, the global pivot toward personalized therapies is creating a heightened demand for stringent and sophisticated quality controls, ensuring safety, efficacy, and regulatory compliance throughout the therapeutic lifecycle. 

Challenges 

Despite promising growth, the CGT quality control market faces considerable hurdles. High capital expenditure is required to establish state-of-the-art quality infrastructure, which can be prohibitive, especially in less developed economies. The lack of regulatory harmonization across Asia-Pacific countries adds another layer of complexity, forcing manufacturers to navigate fragmented compliance requirements. Moreover, limited access to skilled professionals and technical know-how in emerging markets further constrains the region’s ability to scale and standardize quality assurance practices efficiently. 

Opportunities 

There is substantial opportunity in the emergence of contract development and manufacturing organizations (CDMOs) that offer tailored QC services to CGT developers, thereby lowering entry barriers and accelerating time-to-market. Additionally, increased collaboration between academia and industry is helping to establish region-specific quality benchmarks and training modules. The integration of artificial intelligence and data analytics into quality control workflows also presents a transformative potential, enabling predictive quality modeling and real-time risk mitigation to enhance overall process reliability and compliance. 

Market Segmentation: 

Segmentation 1: Offering based Segmentation 

•    Products  

•    Services 

Segmentation 2: Therapy Type based Segmentation 

•    Cell Therapy 

•    Gene Therapy 

Segmentation 3: Process based Segmentation 

•    Raw Materials Preparation 

•    Upstream Processing 

•    Downstream Processing 

•    Packaging 

Segmentation 4: Technology based Segmentation 

•    Polymerase Chain Reaction 

•    Flow Cytometry 

•    Limulus Amebocyte Lysate (LAL) 

•    Enzyme-Linked Immunosorbent Assay (ELISA) 

•    Chromatography 

•    Mass Spectrometry 

•    Western Blotting 

•    Next-Generation Sequencing 

•    Electrophoresis 

•    Other Technologies 

Segmentation 5: Application based Segmentation 

•    Safety Testing 

•    Potency Testing 

•    Identity Testing 

•    Stability and Genetic Fidelity Testing 

•    Others 

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Competitive Landscape: 

Key Players:

•    Bio-Techne Corporation 

•    Danaher Corporation (Cytiva) 

•    F. Hoffmann-La Roche Ltd 

•    Lonza 

•    Miltenyi Biotec B.V. & Co. KG  

•    Sartorius AG 

•    Thermo Fisher Scientific Inc. 

•    WuXi AppTec 

•    Fujifilm Holdings Corporation 

•    Merck KGaA 

Strategic Initiatives: 

The market is witnessing strategic collaborations, licensing deals, and regional expansions. Examples include investments in automated QC platforms, establishment of dedicated CGT manufacturing facilities, and joint ventures with local biotech startups. 

Case Studies & Success Stories: 

The Asia-Pacific cell and gene therapy manufacturing QC market is poised for strong growth, driven by rapid biopharmaceutical advancements, rising R&D investments, and an increasing number of clinical trials. Leading companies like Cytiva, Roche, and Thermo Fisher are spearheading innovation with advanced QC technologies that ensure safety, efficacy, and regulatory compliance. Growing manufacturing capacity and strict regulations in countries like Japan, Australia, and South Korea are fueling demand for scalable QC solutions. Technologies such as automation, integrated analytics, and real-time monitoring are streamlining QC, while emerging tools like AI-driven analytics and real-time release testing are set to further accelerate market expansion. 

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Related Reports from BIS Research 

Cell and Gene Therapy Biomanufacturing Market 

Medical X-Ray Detectors Market 

Clinical Biomarkers Market 

About BIS Research 

BIS Research is a global B2B market intelligence and advisory firm focusing on deep technology and related emerging trends, which can disrupt the market dynamics in the near future. We publish over 200 market intelligence studies annually, focusing on several deep technology verticals.   

Our strategic market analysis emphasizes market estimations, technology analysis, emerging high-growth applications, deeply segmented granular country-level market data, and other important market parameters useful in the strategic decision-making for senior management.    

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