Asia-Pacific Cell and Gene Therapy Manufacturing QC Market: Analysis and Forecast, 2024-2033

Asia-Pacific Cell and Gene Therapy Manufacturing QC Market: Analysis and Forecast, 2024-2033

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

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

Products
Services

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
Gene Therapy

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

Raw Materials Preparation
Upstream Processing
Downstream Processing
Packaging

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

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

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
Potency Testing
Identity Testing
Stability and Genetic Fidelity Testing
Others

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

In January 2023, Bio-Techne Corporation announced the expansion of its Advanced Cell Diagnostics (ACD)-branded RNAscope in situ hybridization (ISH) portfolio. It launched an RNAscope Plus smRNA-RNA detection assay that enables simultaneous fluorescence detection of small regulatory RNA together with three target RNAs or RNA biomarkers in the same tissue section at single-cell and subcellular resolution.
In August 2023, Cytiva collaborated with Genepeutic Bio to establish Thailand's first GMP-certified cell therapy manufacturing facility. The collaboration is expected to boost the capabilities of cancer treatment delivery within Thailand and Southeast Asia.
In April 2023, Cytiva launched X-platform bioreactors, which aim to streamline single-use upstream bioprocessing operations. These versatile bioreactors can be used for producing monoclonal antibodies, protein-based drugs, cell and gene therapies, and viral vectors. They offer flexibility and efficiency in bioprocessing, facilitating the development and manufacturing of various therapeutic products.
In February 2023, AcuraBio, a contract development and manufacturing organization (CDMO), is expanding its current good manufacturing practice (cGMP) plasmid DNA services using Cytiva's single-use purification technology. This expansion is aimed at addressing supply constraints for mRNA and cell and gene therapies.
In July 2022, Forecyte Bio collaborated with Cytiva to expedite the development and manufacturing of cell and gene therapies. This collaboration aimed to standardize processes within the CGT CDMO sector and drive industry growth.

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

The base year considered for the calculation of the market size is 2023. A historical year analysis has been done for the period FY2019-FY2022. The market size has been estimated for FY2023 and projected for the period FY2024-FY2033.
The scope of this report has been carefully derived based on interactions with experts in different companies across the world. This report provides a market study of products and services of the Asia-Pacific cell and gene therapy manufacturing QC market.
The market contribution of Asia-Pacific cell and gene therapy manufacturing QC is anticipated to be launched and calculated based on the historical analysis of the solutions.
The company's revenue has been referenced from their annual reports for FY2022 and FY2023. For private companies, revenues have been estimated based on factors such as inputs obtained from primary research, funding history, market collaborations, and operational history.
The market has been mapped based on the available cell and gene therapy manufacturing QC in the Asia-Pacific. This report has considered and profiled all the key companies with significant offerings in this field.

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:

Validation and triangulation of all the numbers and graphs
Validation of the report’s segmentation and key qualitative findings
Understanding the competitive landscape and business model
Current and proposed production values of a product by market players
Validation of the numbers of the different segments of the market in focus
Percentage split of individual markets for regional analysis

Secondary Research

Open Sources

Certified publications, articles from recognized authors, white papers, directories, and major databases, among others
Annual reports, SEC filings, and investor presentations of the leading market players
Company websites and detailed study of their product portfolio
Gold standard magazines, journals, white papers, press releases, and news articles
Paid databases

The key data points taken from the secondary sources include:

Segmentations and percentage shares
Data for market value
Key industry trends of the top players of the market
Qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
Quantitative data for mathematical and statistical calculations

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:

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

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