Dublin, Jan. 16, 2025 (GLOBE NEWSWIRE) — The “Asia-Pacific Cell and Gene Therapy Manufacturing QC Market: Analysis and Forecast, 2024-2033” report has been added to ResearchAndMarkets.com’s offering.
The Asia-Pacific cell and gene therapy manufacturing QC market was valued at $246.4 million in 2023 and is anticipated to reach $1.31 billion by 2033, witnessing a CAGR of 18.36% during the forecast period 2024-2033
The market has been witnessing impressive double-digit growth, largely driven by the increasing adoption of innovative therapies such as CAR T-cells and others. Robust quality control processes are essential to ensure cell and gene-based treatments’ safety, efficacy, and consistency.
The market is driven by the need for stringent QC measures throughout the manufacturing journey, advancements in manufacturing technologies, and expanding regulatory frameworks. To capitalize on market opportunities, industry players are focusing on developing innovative QC technologies, establishing robust analytical methods, and collaborating with regulatory bodies and academic institutions. It is crucial for manufacturers to implement comprehensive QC strategies to meet regulatory requirements and position themselves for success in this dynamic and transformative market.
The Asia-Pacific cell and gene therapy manufacturing QC market has been experiencing notable growth, driven by the escalating prevalence of target diseases such as cancers, metabolic disorders, autoimmune disorders, and others. Additionally, the increasing approval of cell and gene therapies has further contributed to this market expansion.
Furthermore, there has been a consistent rise in the number of new entrants and investments in the field of cell and gene therapy, which has strengthened the Asia-Pacific cell and gene therapy manufacturing QC market, thereby providing a surge in demand for the products and services solutions required in the manufacturing of these therapies.
Industrial Impacts
The Asia-Pacific cell and gene therapy manufacturing QC market, driven by leading companies such as Danaher Corporation (Cytiva), F. Hoffmann-La Roche Ltd, and THERMO FISHER SCIENTIFIC INC., has transformed the landscape of cell and gene therapy manufacturing. These industry leaders have introduced innovative QC solutions to address the complexities of ensuring safety, efficacy, and compliance in cell and gene therapy production.
The region’s rapid growth in biopharmaceutical innovation, supported by increased R&D investments and clinical trials, has created a robust demand for advanced QC mechanisms. Automation, real-time monitoring, and integrated analytics have streamlined workflows and reduced costs, with technologies from these companies setting new benchmarks for efficiency.
The region’s stringent regulatory environment and expanding manufacturing capacities further drive the adoption of scalable and precise QC technologies. With a focus on tailored solutions for diverse regional needs, these advancements are accelerating time-to-market for therapies, enhancing product integrity, and reinforcing regulatory compliance. As the market evolves, trends such as AI-driven predictive analytics and real-time release testing will continue to shape its trajectory in cell and gene therapy manufacturing.
Services Segment to Dominate the Asia-Pacific Cell and Gene Therapy Manufacturing QC market (by Offering)
Based on offering, the Asia-Pacific cell and gene therapy manufacturing QC market was led by the services segment, which held a 70.28% share in 2023. The high growth of the services segment can be attributed to the increase in outsourcing manufacturing and QC operations to CDMOs and CROs.
Cell Therapy Segment to Dominate the Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
Based on therapy type, the cell therapy segment accounted for the largest share of 58.42% in the Asia-Pacific cell and gene therapy manufacturing QC market in 2023. In addition, cell therapy is expected to witness the highest growth rate of 19.47% in the forecast period 2024-2033. The growth of the cell therapy segment can be attributed to the ongoing advancements and increasing regulatory approvals for CAR-T cell therapies.
Upstream Processing Segment to Dominate the Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Process)
Based on process, the upstream processing segment accounted for the largest share of 47.10% in the Asia-Pacific cell and gene therapy manufacturing QC market in 2023. Moreover, upstream processing is expected to hold the highest growth rate of 19.45% in the forecast period 2024-2033. This can be attributed to the shift toward the usage of single-use bioreactors for cell and gene therapy manufacturing, as these systems reduce contamination risks and allow for streamlined QC protocols.
PCR Segment to Dominate the Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Technology)
Based on technology, the PCR segment accounted for the largest share of 23.98% in the Asia-Pacific cell and gene therapy manufacturing QC market in 2023. However, the next-generation sequencing segment is expected to hold the highest growth rate of 22.68% in the forecast period 2024-2033. The high growth of the next-generation sequencing segment can be attributed to the ability of NGS to provide detailed genetic profiles with high sensitivity, allowing for a thorough assessment of cell lines, vector purity, off-target effects in gene editing, and genetic modifications.
Safety Testing Segment to Dominate the Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Application)
Based on application, the safety testing segment accounted for the largest share of 46.15% in the Asia-Pacific cell and gene therapy manufacturing QC market in 2023. However, the potency testing segment is expected to hold the highest growth rate of 20.28% in the forecast period 2024-2033. The high growth rate of the potency testing segment can be attributed to the continuous developments in potency assays and their essential role in efficacy validation.
How can this report add value to an organization?
Product/Innovation Strategy: The Asia-Pacific cell and gene therapy manufacturing QC market has been extensively segmented based on offering, therapy type, process, technology, and application. This can help readers understand which segments account for the largest share and which are well-positioned to grow in the coming years.
Competitive Strategy: The Asia-Pacific cell and gene therapy manufacturing QC market has numerous established players with significant product portfolios. Key players in the Asia-Pacific cell and gene therapy manufacturing QC market analyzed and profiled in the study involve established players offering products and services for cell and gene therapy.
Key Market Players and Competition Synopsis
- 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
Key Attributes:
| Report Attribute | Details |
| No. of Pages | 142 |
| Forecast Period | 2024 – 2033 |
| Estimated Market Value (USD) in 2024 | $288.9 Million |
| Forecasted Market Value (USD) by 2033 | $1310 Million |
| Compound Annual Growth Rate | 18.3% |
| Regions Covered | Asia Pacific |
Key Topics Covered:
1 Markets
1.1 Product Definition
1.2 Market Scope
1.3 Research Methodology
2 Cell and Gene Therapy Manufacturing QC Market: Regulatory Framework
2.1 Chemistry, Manufacturing, and Control (CMC) Requirements by the Food and Drug Administration (FDA)
2.1.1 Product Testing
2.1.2 Microbial Testing
2.1.3 Identity
2.1.4 Purity
2.1.5 Potency
2.1.6 Viability
2.1.7 Cell Number or Dose
2.2 Quality Aspects of Cell and Gene Therapy Products by the European Medicines Agency (EMA)
2.2.1 Characterization
2.2.2 Identity Testing
2.2.3 Purity Testing
2.3 Current Good Manufacturing Practice (CGMP) Regulations
2.3.1 U.S.
2.3.2 Europe
2.3.3 Asia-Pacific
2.4 Global Regulatory Framework: Cell and Gene Therapy Manufacturing QC Market
3 Asia-Pacific Cell and Gene Therapy Manufacturing QC Market: Market Overview
3.1 Market Overview
3.1.1 Realistic Growth Scenario
3.1.2 Optimistic Scenario
3.1.3 Pessimistic Scenario
3.2 Market Footprint and Growth Potential
3.3 Future Potential
3.4 COVID-19 Impact on Market
3.4.1 Impact on Research and Clinical Operations
3.4.2 COVID-19 Impact: Current Scenario of the Market
3.4.3 Pre- and Post-COVID-19 Impact Assessment
3.4.3.1 Pre-COVID-19 Phase
3.4.3.2 Post-COVID-19 Phase
3.5 Market Dynamics
3.6 Market Sizing and Forecast
3.6.1 Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Offering)
3.6.2 Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
3.6.3 Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Process)
3.6.4 Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Technology)
3.6.5 Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Application)
4 Asia-Pacific Cell and Gene Therapy Manufacturing QC Market: by Country
4.1 Singapore
4.1.1 Singapore Cell and Gene Therapy Manufacturing QC Market (by Offering)
4.1.2 Singapore Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
4.1.3 Singapore Cell and Gene Therapy Manufacturing QC Market (by Process)
4.1.4 Singapore Cell and Gene Therapy Manufacturing QC Market (by Technology)
4.1.5 Singapore Cell and Gene Therapy Manufacturing QC Market (by Application)
4.2 Japan
4.3 South Korea
4.4 Australia
4.5 India
4.6 Thailand
4.7 Malaysia
4.8 Indonesia
4.9 Rest-of-Asia-Pacific
5 Company Profiles
5.1 Company Overview
5.2 Role in the Cell and Gene Therapy Manufacturing QC Market
5.3 Product Portfolio
5.4 Key Competitors
5.5 Financials
5.6 Analyst Perspective
For more information about this report visit https://www.researchandmarkets.com/r/x4v1bz
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- Asia-Pacific Cell and Gene Therapy Manufacturing QC Market
