市場調查報告書
商品編碼
1632489
亞太地區細胞與基因治療製造品質控制市場:分析與預測(2024-2033)Asia-Pacific Cell and Gene Therapy Manufacturing QC Market: Analysis and Forecast, 2024-2033 |
2023 年,亞太地區細胞和基因治療製造 QC 市場規模為 2.464 億美元。
預計到 2033 年,市場規模將達到 13.173 億美元,2024-2033 年預測期間複合年成長率為 18.36%。該市場正在經歷令人印象深刻的兩位數成長,這主要是由於 CAR T 細胞等創新治療方法的持續採用。強大的品管流程對於確保細胞和基因療法的安全性、有效性和一致性至關重要。市場是由製造過程中嚴格的品管措施、製造技術的進步和不斷擴大的法規結構的需求所推動的。為了利用市場機會,產業參與者正在專注於開發創新的品質控制技術、建立強大的分析方法以及與監管和學術機構合作。製造商實施全面的品質控制策略以滿足監管要求並在這個充滿活力和不斷變化的市場中取得成功至關重要。
主要市場統計數據 | |
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預測期 | 2024-2033 |
2024年評估 | 2.889 億美元 |
2033 年預測 | 13.173 億美元 |
複合年成長率 | 18.36% |
在癌症、代謝性疾病和自體免疫疾病等目標疾病盛行率上升的推動下,亞太地區細胞和基因治療製造品質控制市場正在顯著成長。此外,細胞和基因療法的核准增加也有助於市場擴張。此外,細胞和基因治療領域的新進入和投資持續增加,這正在加強亞太細胞和基因治療製造品質控制市場,從而增加了製造這些治療方法所需的產品數量和服務需求。
由 Danaher Corporation (Cytiva)、F. Hoffmann-La Roche Ltd 和 THERMO FISHER SCIENTIFIC INC. 等主要企業領導的亞太細胞和基因治療製造 QC 市場已經改變了細胞和基因治療製造的格局。這些行業領導者正在實施創新的品質控制解決方案,以應對確保細胞和基因治療製造的安全性、有效性和合規性的複雜挑戰。
在研發投資和臨床試驗增加的支持下,生物製藥創新的快速成長正在推動該地區對先進品質控制機制的需求。自動化、即時監控和整合分析簡化了工作流程並降低了成本,使這些公司的技術成為效率的新基準。
本報告研究了亞太地區細胞和基因治療製造品質控制市場,提供了市場概況以及按產品、治療類型、工藝、技術、應用、區域和進入市場的公司分類的趨勢。
An Introduction to Asia-Pacific Cell and Gene Therapy Manufacturing QC
The Asia-Pacific cell and gene therapy manufacturing QC market was valued at $246.4 million in 2023 and is anticipated to reach $1,317.3 million by 2033, witnessing a CAGR of 18.36% during the forecast period 2024-2033. The given figure illustrates the market revenue of the Asia-Pacific cell and gene therapy manufacturing QC market from 2023-2033. 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.
Market Introduction
KEY MARKET STATISTICS | |
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Forecast Period | 2024 - 2033 |
2024 Evaluation | $288.9 Million |
2033 Forecast | $1,317.3 Million |
CAGR | 18.36% |
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. For instance, as per an article titled 'Cell & Gene Therapy in the Asia Pacific: Revolutionizing Disease Treatment,' published in 2023, South Korea has established a $1.3 billion fund to support the development of cell and gene therapies. Further, Singapore has invested in several initiatives to support the development of cell and gene therapies, including the establishment of the Singapore Consortium for Synthetic Biology and the Bioprocessing Technology Institute. Therefore, the impact of the aforementioned factors is expected to drive the Asia-Pacific cell and gene therapy manufacturing QC market in the forecast period 2024-2033.
Industrial Impact
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.
Market Segmentation:
Segmentation 1: by Offering
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.
Segmentation 2: by Therapy Type
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.
Segmentation 3: by Process
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.
Segmentation 4: by Technology
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.
Segmentation 5: by Application
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.
Recent Developments in the Asia-Pacific Cell and Gene Therapy Manufacturing QC Market
Demand - Drivers, Challenges, and Opportunities
Market Drivers:
Increasing Number of Approvals Leading to an Upsurge in Demand for Cell and Gene Therapies QC Testing: The increasing number of regulatory approvals for cell and gene therapies is driving a significant upsurge in demand for quality control (QC) testing in the Asia-Pacific region. As innovative therapies move from clinical trials to commercial availability, ensuring their safety, efficacy, and consistency becomes paramount. Regulatory bodies across major markets such as Japan, Australia, and South Korea have established stringent approval processes, emphasizing robust QC measures. This has necessitated the adoption of advanced testing technologies capable of addressing the complexities of cell and gene therapies, including sterility, potency, identity, and safety evaluations. Key industry players have been responding to this demand by developing automated and scalable QC solutions, enabling faster and more reliable testing workflows. With the rapid expansion of manufacturing capacities and growing patient access to these therapies, the role of QC testing in maintaining compliance and ensuring product quality continues to grow, marking it as a critical factor in the industry's ongoing evolution.
Market Challenges:
Limited Adoption of Cell and Gene Therapy Due to High Manufacturing and QC Costs: The adoption of cell and gene therapies in the Asia-Pacific region is currently limited by the high costs associated with manufacturing and quality control (QC). These therapies involve complex processes, including cell isolation, genetic modification, and precision delivery, which demand highly specialized equipment, skilled personnel, and stringent QC measures. QC testing, in particular, requires advanced technologies to ensure these therapies' safety, efficacy, and consistency, driving up operational costs. This financial burden is further compounded by the lack of standardized manufacturing protocols and economies of scale, as cell and gene therapies are often produced in small batches tailored to individual patients or specific conditions.
Small and medium-sized biopharmaceutical companies face significant challenges in overcoming these cost barriers, which can delay the scaling of innovative treatments. Additionally, the need for comprehensive compliance with stringent regulatory requirements adds to the financial and operational strain. To address these challenges, industry players and governments are increasingly investing in automation, process optimization, and scalable QC solutions to reduce costs. Partnerships and collaborations among stakeholders also aim to share resources and expertise, paving the way for broader adoption and access to these life-saving therapies. However, overcoming these cost-related barriers remains a critical hurdle for the region's widespread implementation of cell and gene therapies.
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.
Methodology
Key Considerations and Assumptions in Market Engineering and Validation
Primary Research:
The primary sources involve industry experts in cell and gene therapy manufacturing QC, including the market players offering products and services. Resources such as CEOs, vice presidents, marketing directors, and technology and innovation directors have been interviewed to obtain and verify both qualitative and quantitative aspects of this research study.
The key data points taken from the primary sources include:
Secondary Research
Open Sources
The key data points taken from the secondary sources include:
Key Market Players and Competition Synopsis
The companies profiled have been selected based on inputs gathered from primary experts, who have analyzed company coverage, product portfolio, and market penetration.
Some prominent names established in this market are: