아시아태평양의 세포 및 유전자 치료 제조 QC 시장 : 분석과 예측(2024-2033년)
Asia-Pacific Cell and Gene Therapy Manufacturing QC Market: Analysis and Forecast, 2024-2033
상품코드 : 1632489
리서치사 : BIS Research
발행일 : 2025년 01월
페이지 정보 : 영문
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한글목차

아시아태평양의 세포 및 유전자 치료 제조 QC 시장 규모는 2023년 2억 4,640만 달러에 달했습니다.

이 시장은 2024-2033년 예측 기간 동안 18.36%의 CAGR로 성장하여 2033년까지 13억 1,730만 달러에 달할 것으로 예상됩니다. 이 시장은 CAR T 세포와 같은 혁신적인 치료법의 채택 확대가 주요 요인으로 작용하여 두 자릿수 성장세를 보이고 있습니다. 세포와 유전자를 이용한 치료의 안전성, 유효성, 일관성을 보장하기 위해서는 탄탄한 품질 관리 프로세스가 필수적입니다. 이 시장은 제조 과정에서 엄격한 품질 관리 조치의 필요성, 제조 기술의 발전, 규제 프레임워크의 확대에 의해 주도되고 있습니다. 시장 기회를 활용하기 위해 업계 기업들은 혁신적인 QC 기술 개발, 강력한 분석법 확립, 규제 기관 및 학술 기관과의 협력에 주력하고 있습니다. 규제 요건을 충족하고 이 역동적이고 변화무쌍한 시장에서 성공하기 위해서는 제조업체가 종합적인 QC 전략을 실행하는 것이 매우 중요합니다.

주요 시장 통계
예측 기간 2024-2033년
2024년 평가 2억 8,890만 달러
2033년 예측 13억 1,730만 달러
CAGR 18.36%

아시아태평양의 세포 및 유전자 치료제 제조 QC 시장은 암, 대사성 질환, 자가면역질환 등 대상 질환의 유병률 증가에 힘입어 괄목할 만한 성장세를 보이고 있습니다. 또한, 세포 및 유전자 치료제의 승인이 증가하고 있는 것도 시장 확대에 기여하고 있습니다. 또한, 세포 및 유전자 치료 분야에 대한 신규 진입과 투자가 지속적으로 증가하고 있으며, 이는 아시아태평양의 세포 및 유전자 치료 제조 QC 시장을 강화하여 이러한 치료법 제조에 필요한 제품, 서비스 및 솔루션에 대한 수요가 급증하고 있습니다.

Danaher Corporation(Cytiva), F. Hoffmann-La Roche Ltd, THERMO FISHER SCIENTIFIC INC. 등의 주요 기업이 주도하는 아시아태평양의 세포 및 유전자 치료제 제조 QC 시장은 세포 및 유전자 치료제 제조의 전망을 바꾸어 놓았습니다. 변화시켰습니다. 이들 업계 리더들은 세포 및 유전자 치료제 제조의 안전성, 유효성 및 규정 준수라는 복잡한 과제를 해결하기 위해 혁신적인 QC 솔루션을 도입하고 있습니다.

R&D 투자와 임상시험의 증가에 힘입어 바이오의약품 혁신이 빠르게 성장함에 따라 이 지역에서는 고급 QC 메커니즘에 대한 수요가 증가하고 있습니다. 자동화, 실시간 모니터링, 통합 분석은 워크플로우를 간소화하고 비용을 절감하며, 이들 기업의 기술은 효율성의 새로운 벤치마크가 되고 있습니다.

아시아태평양의 세포 및 유전자 치료제 제조 QC 시장에 대해 조사했으며, 시장 개요, 제품별, 치료 유형별, 공정별, 기술별, 용도별, 지역별 동향, 시장 진입 기업 프로파일 등의 정보를 전해드립니다.

목차

제1장 시장

제2장 세포 및 유전자 치료 제조 QC 시장 : 규제 프레임워크

제3장 아시아태평양의 세포 및 유전자 치료 제조 QC 시장 : 시장 개요

제4장 아시아태평양의 세포 및 유전자 치료 제조 QC 시장 : 국가별

제5장 기업 개요

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영문 목차

영문목차

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
Forecast Period2024 - 2033
2024 Evaluation$288.9 Million
2033 Forecast$1,317.3 Million
CAGR18.36%

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:

Table of Contents

1 Markets

2 Cell and Gene Therapy Manufacturing QC Market: Regulatory Framework

3 Asia-Pacific Cell and Gene Therapy Manufacturing QC Market: Market Overview

4 Asia-Pacific Cell and Gene Therapy Manufacturing QC Market: by Country

5 Company Profiles

List of Tables

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