Press Release

Asia-Pacific Cell and Gene Therapy Manufacturing QC Market to Grow with a CAGR of 6.90% through 2030

The growing advancement in healthcare infrastructure is expected to drive the Asia-Pacific Cell and Gene Therapy Manufacturing QC Market growth in the forecast period, 2026-2030.


According to TechSci Research report, “Asia-Pacific Cell and Gene Therapy Manufacturing QC Market – By Country, Competition, Forecast & Opportunities, 2030F”, the Asia-Pacific Cell and Gene Therapy Manufacturing QC Market stood at USD 526.30 million in 2024 and is anticipated to grow with a CAGR of 6.90% in the forecast period, 2026-2030. The Asia-Pacific Cell and Gene Therapy Manufacturing QC market is experiencing rapid growth as the region becomes a global leader in the development and commercialization of innovative therapies.

The increasing demand for personalized medicine, particularly for the treatment of complex diseases such as cancer and genetic disorders, has driven the need for highly efficient and reliable manufacturing processes. Cell and gene therapies, such as CAR-T (Chimeric Antigen Receptor T-cell) therapies and gene editing techniques, require rigorous quality control (QC) procedures to ensure the safety, potency, and genetic integrity of the biologics involved. The market for QC services is expanding as these therapies advance from clinical trials to commercial production. Companies are adopting state-of-the-art technologies like next-generation sequencing (NGS), real-time data monitoring, and automation to streamline QC processes, reduce the risk of contamination, and meet strict regulatory requirements. The growing biotechnology infrastructure, particularly in countries like China, Japan, and South Korea, is further contributing to the market's expansion.

In addition to the technological advancements, regulatory frameworks across the Asia-Pacific region are evolving to accommodate the unique needs of cell and gene therapies. National and regional regulatory bodies are tightening quality standards for the manufacturing of these therapies, driving the demand for comprehensive QC services that can ensure compliance. This includes everything from testing for viral vector contamination to ensuring genetic stability and ensuring that cell-based therapies meet the potency requirements. The rise of contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) in the region is also helping to accelerate the QC market by offering specialized services and expertise to biotech companies. As the cell and gene therapy landscape continues to evolve, the Asia-Pacific region will play a pivotal role in shaping the future of the Asia-Pacific Cell and Gene Therapy Manufacturing QC, driving the need for more precise, scalable, and cost-effective quality control solutions.


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The Asia-Pacific Cell and Gene Therapy Manufacturing QC Market is segmented into offering, application, technology, regional distribution, and company.

Based on application, the safety testing category is showing the fastest growth in the Asia-Pacific Cell and Gene Therapy Manufacturing QC market, driven by the increasing demand for thorough and reliable assessments of therapeutic products. As cell and gene therapies progress through clinical trials and toward commercialization, ensuring patient safety becomes paramount. These therapies involve living organisms, such as genetically modified cells or viral vectors, which can introduce risks like immune reactions, contamination, or unintended genetic alterations. Safety testing helps to identify and mitigate these risks by verifying the purity, sterility, and genetic stability of the therapies, ensuring they meet regulatory safety standards.

Based on country, Japan is experiencing significant growth in the Asia-Pacific Cell and Gene Therapy Manufacturing QC market, driven by its strong healthcare infrastructure, advanced biotechnology sector, and favorable regulatory environment. As one of the leading countries in the development and commercialization of cell and gene therapies, Japan is at the forefront of integrating cutting-edge technologies into its manufacturing processes. The demand for high-quality, efficient quality control (QC) services is rapidly increasing as more cell and gene therapies, such as CAR-T cell therapies and gene editing techniques, progress through clinical trials and toward market approval. Japan’s regulatory agencies, such as the Pharmaceuticals and Medical Devices Agency (PMDA), have set high standards for the quality and safety of these therapies, making stringent QC protocols essential to ensure compliance with global regulations.


Major companies operating in Asia-Pacific Cell and Gene Therapy Manufacturing QC Market are:

  • Bio-Techne Corporation
  • Danaher Corporation
  • 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


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"The increasing demand for advanced, high-quality manufacturing processes is significantly driving the growth of the Cell and Gene Therapy Manufacturing QC market in the Asia-Pacific region. As cell and gene therapies continue to advance in both research and clinical applications, the need for precise, reliable quality control measures is becoming increasingly vital. The integration of cutting-edge technologies such as automation, artificial intelligence (AI)-driven analytics, and real-time monitoring systems is essential to ensure the safety, potency, and genetic stability of these therapies. As the market evolves, ongoing innovations in bioprocessing, testing methodologies, and regulatory frameworks will play a crucial role in ensuring the consistent production of high-quality therapies. These advancements will ultimately transform the landscape of cell and gene therapy manufacturing in the Asia-Pacific region, making it more efficient, reliable, and capable of meeting the diverse needs of healthcare providers and patients," said Mr. Karan Chechi, Research Director at TechSci Research, a research-focused management consulting firm.

Asia-Pacific Cell and Gene Therapy Manufacturing QC Market By Offering (Products, Services), By Application (Safety Testing, Potency Testing, Identity Testing, Stability and Genetic Fidelity Testing, Others), By Technology (Polymerase Chain Reaction, Flow Cytometry, Limulus Amebocyte Lysate (LAL), Enzyme-Linked Immunosorbent Assay (ELISA), Chromatography, Mass Spectrometry, Western Blotting, Next-Generation Sequencing, Electrophoresis, Others), By Country, Competition Forecast & Opportunities, 2020-2030F”, has evaluated the future growth potential of Asia-Pacific Cell and Gene Therapy Manufacturing QC Market and provides statistics & information on market size, structure and future market growth. The report intends to provide cutting-edge market intelligence and help decision makers take sound investment decisions. Besides, the report also identifies and analyzes the emerging trends along with essential drivers, challenges, and opportunities in Asia-Pacific Cell and Gene Therapy Manufacturing QC Market.

 

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