South Korea Cell and Gene Therapy Manufacturing Market by Type of Therapy, Type of Scale, Type of Mode, Type of Workflow, Type of Process, Type of Technology, End User, Region of Manufacturing and Sales Forecast - Trends and Forecast Till 2035

SOUTH KOREA CELL AND GENE THERAPY MANUFACTURING MARKET: OVERVIEW

The South Korea cell and gene therapy manufacturing market is estimated to grow from USD 1,826.0 million in the current year to USD 7,538.0 million by 2035, at a CAGR of 29.56%, during the forecast period, till 2035.

South Korea Cell and Gene Therapy Manufacturing Market: Growth and Trends

Cell and gene therapies have redefined the treatment paradigm for oncological, rare, and chronic disorders by enabling precise, cellular-level intervention. However, the manufacturing of such therapies remains inherently complex, requiring specialized workflows across cell processing, vector production, fill and finish operations, and analytical quality testing, all performed under stringent good manufacturing practice (GMP) conditions. As global demand for advanced therapy manufacturing capacity continues to outpace supply, South Korea has positioned itself as one of the fastest-emerging cell and gene therapy manufacturing hubs within the Asia-Pacific region.

South Korea's market growth is driven by the group of large, well-capitalized pharmaceutical players that have rapidly diversified into advanced therapy manufacturing. Samsung Biologics, the country's largest biologics contract manufacturer, operates an installed capacity exceeding 845,000 liters across five plants in Songdo, with more than 90% of its manufacturing undertaken domestically. SK Group has expanded its footprint through SK Pharmteco and SK Bioscience, including the acquisitions of the France-based cell and gene therapy manufacturer Yposkesi (formerly CBM) and Germany's IDT Biologika. Lotte Biologics has entered the space as a new contract manufacturing entrant, committing close to KRW 4.6 trillion toward three production plants and an integrated bio campus in Songdo.

Beyond the large industrial players, a second tier of specialized players is building dedicated cell and gene therapy manufacturing capability. GC Cell has established GMP-certified infrastructure spanning research through commercial supply to support its allogeneic CAR-NK and NK cell therapy portfolio, alongside third-party CDMO services. CHA Biotech's subsidiary, Matica Biolabs, is developing end-to-end CGT manufacturing capability and has entered manufacturing agreements such as its recent partnership with TiCARos for the CAR-T candidate TC091. The credibility of this domestic ecosystem has, in turn, attracted global CDMOs to establish a direct presence in the country; Thermo Fisher Scientific opened a dedicated Cell and Gene Therapy Vision Centre in South Korea in May 2025, while Bayer has designated South Korea as a strategic clinical development hub for its cell and gene therapy programs across the Asia-Pacific region.

This manufacturing build-out has been reinforced by a supportive regulatory and funding environment. The Act on the Safety and Support of Advanced Regenerative Medical Practice and Advanced Biopharmaceuticals, in effect since 2019, permits conditional commercial approval for products that have completed Phase II clinical trials, materially shortening the pathway to market. Recently, the government further eased regulatory requirements governing advanced regenerative medicine to speed clinical entry.

Alongside this, South Korea's Ministry of Health and Welfare has earmarked over USD 1.2 billion for regenerative medicine and cell therapy infrastructure, while the Ministry of Trade, Industry and Energy has proposed close to USD 461 million toward advanced biopharmaceutical manufacturing technology development. Collectively, these developments are expected to sustain robust, above-global-average growth in South Korea's cell and gene therapy manufacturing market through 2035.

Growth Drivers: Strategic Enablers of Market Expansion

Growth in South Korea's cell and gene therapy manufacturing market is being driven by the convergence of large-scale domestic capacity investment and an increasingly enabling regulatory framework. Conglomerates such as Samsung, SK Group, and Lotte have channeled significant capital into GMP-certified manufacturing capacity, while specialized players including GC Cell and CHA Biotech's Matica Biolabs are building dedicated cell and gene therapy infrastructure to capture rising CDMO demand.

This is reinforced by government initiatives, including conditional approval pathways for advanced regenerative products and dedicated public funding for regenerative medicine infrastructure, both of which are lowering the cost and time associated with bringing manufacturing capacity online. Further, the entry of global CDMOs, such as Thermo Fisher Scientific, and biopharmaceutical companies, such as Bayer, is strengthening South Korea's manufacturing ecosystem and is expected to drive further investment and technology transfer during the forecast period.

Market Challenges: Critical Barriers Impeding Progress

Despite this momentum, several challenges continue to hamper the market expansion. The manufacturing of cell and gene therapies demands a highly specialized workforce, and South Korea, like most emerging manufacturing hubs, faces a shortage of personnel trained in advanced therapy bioprocessing and quality control. The high cost of establishing GMP-certified facilities remains a major barrier to entry. In addition, some large manufacturers remain cautious about investing in dedicated CGT infrastructure. For instance, Samsung Biologics redirected its planned cell and gene therapy facility in Songdo to antibody manufacturing in 2022, highlighting the perceived risks associated with large-scale CGT capacity investments.

Additionally, manufacturers seeking to serve export markets must align their quality control and regulatory documentation with international standards, including those of the US FDA and the EMA, adding operational complexity. Finally, South Korea continues to compete for manufacturing investment against more established Asia-Pacific hubs in China and Japan, which currently command a larger share of regional cell and gene therapy manufacturing capacity.

SOUTH KOREA CELL AND GENE THERAPY MANUFACTURING MARKET: KEY INSIGHTS

The report delves into the current state of the South Korea cell and gene therapy manufacturing market and identifies potential growth opportunities within the industry. Some key findings from the report include:

• South Korea has emerged as one of the fastest-growing cell and gene therapy manufacturing hubs in Asia-Pacific, supported by government-backed regulatory reform and an expanding base of large-scale contract manufacturers.
• Samsung Biologics operates the country's largest biologics manufacturing base, with installed capacity exceeding 845,000 liters across five plants in Songdo, of which over 90% of manufacturing is undertaken domestically.
• SK Group has expanded its cell and gene therapy manufacturing footprint through SK Pharmteco and SK Bioscience, including the acquisitions of Yposkesi in France and IDT Biologika in Germany, in addition to its domestic operations.
• Lotte Biologics is investing close to KRW 4.6 trillion in three production plants and an integrated bio campus in Songdo, positioning the company as a new entrant in advanced therapy contract manufacturing.
• GC Cell has established GMP-certified manufacturing infrastructure spanning research and development through commercial supply, supporting its allogeneic CAR-NK and NK cell therapy portfolio alongside CDMO services.
• CHA Biotech's subsidiary, Matica Biolabs, is building end-to-end cell and gene therapy manufacturing capability, exemplified by its recent partnership with TiCARos for the CAR-T candidate TC091.
• Global CDMOs are establishing a direct presence in the country; Thermo Fisher Scientific opened a dedicated Cell and Gene Therapy Vision Centre in South Korea in May 2025 to support biopharma companies across the value chain.
• Songdo (Incheon) and Osong (Chungcheongbuk-do) have emerged as the two leading bio-clusters anchoring South Korea's cell and gene therapy manufacturing base.
• The Act on the Safety and Support of Advanced Regenerative Medical Practice and Advanced Biopharmaceuticals, in effect since 2019, permits conditional commercial approval for products that have completed Phase II trials.
• Recently, the South Korean government further eased regulatory requirements governing advanced regenerative medicine, a move expected to accelerate clinical entry and downstream manufacturing demand.
• Contract manufacturing is anticipated to remain the preferred mode of production, as pharmaceutical and biotechnology companies rely on domestic and multinational CDMOs to scale up output.
• Given the pace of capacity expansion and the supportive policy environment, the South Korea cell and gene therapy manufacturing market is anticipated to grow at a rate that outpaces the global average through 2035.

South Korea Cell and Gene Therapy Manufacturing Market

The market sizing and opportunity analysis has been segmented across the following parameters:

By Type of Therapy

• Cell Therapies (Stem Cell Therapy and Non-Stem Cell Therapy)
• Gene Therapies

By Type of Scale

• Precommercial / R&D Scale Manufacturing
• Commercial Scale Manufacturing

By Type of Mode

• Contract Manufacturing
• In-House Manufacturing

By Type of Workflow

• Cell Processing
• Cell Banking
• Process Development
• Fill & Finish Operations
• Analytical & Quality Testing
• Raw Material Testing
• Vector Production
• Other Workflow

By Type of Process

• Upstream Processes
• Downstream Processes

By Type of Technology

• Fluorescence-Activated Cell Sorting (FACS)
• Enzyme-Linked Immunosorbent Assay (ELISA)
• Chromatography
• Next-Generation Sequencing (NGS)
• Polymerase Chain Reaction (PCR)
• Other Technologies

By End User

• Pharmaceutical Companies
• Biopharmaceutical / Biotechnological Companies
• Contract Manufacturing Organizations

By Region of Manufacturing

• Incheon (Songdo)
• Chungcheongbuk-do (Osong)
• Seoul Capital Area
• Rest of South Korea

SOUTH KOREA CELL AND GENE THERAPY MANUFACTURING MARKET: KEY SEGMENTS

Cell Therapies Continue to Dominate Manufacturing Demand

Based on our market assessment, cell therapy manufacturing currently accounts for the largest share of South Korea's cell and gene therapy manufacturing market. This dominance is driven by the country's early domestic approvals in the autologous and allogeneic cell therapy space and the manufacturing scale-up efforts of players such as GC Cell. Gene therapy manufacturing, while smaller in current scale, is expected to register the faster CAGR during the forecast period, supported by rising viral vector production capacity and growing clinical interest in gene-modified cell products among domestic developers.

Contract Manufacturing Emerges as the Fastest Growing Mode of Production

Contract manufacturing is estimated to account for the largest share of South Korea cell and gene therapy manufacturing market. Pharmaceutical and biotechnology companies operating in the country are increasingly relying on domestic and multinational CDMOs, including Samsung Biologics, SK Pharmteco, Lotte Biologics, GC Cell and Matica Biolabs, to access GMP-certified capacity without the capital burden of building proprietary facilities. On the other hand, in-house manufacturing is expected to grow at a higher CAGR during the forecast period. This lucrative growth is led by larger, well-capitalized developers seeking greater control over proprietary manufacturing processes.

Pre-Commercial / R&D Scale Manufacturing Currently Leads

Given the relatively early stage of South Korea's cell and gene therapy clinical pipeline compared to more mature markets such as the US, pre-commercial and R&D scale manufacturing currently represents the larger share of activity. Commercial scale manufacturing, however, is anticipated to grow at a faster rate through 2035, supported by an expanding base of domestically approved advanced therapy products and the country's growing role as a manufacturing base for regional and export markets.

Songdo (Incheon) Anchors South Korea's Manufacturing Base

Songdo, within Incheon, has emerged as the country's principal cell and gene therapy manufacturing cluster, hosting Samsung Biologics' five-plant campus, Lotte Biologics' under-construction facilities, and a growing base of ancillary suppliers and service providers. Osong, in Chungcheongbuk-do, represents the country's second key bio-cluster, combining research infrastructure with manufacturing and quality-testing capacity. Together, these two hubs are expected to account for the substantial majority of South Korea's cell and gene therapy manufacturing capacity through the forecast period.

Biopharmaceutical / Biotechnological Companies Account for the Largest End-User Share

Biopharmaceutical and biotechnological companies represent the leading end users of cell and gene therapy manufacturing capacity in South Korea. This dominance reflects the country's biotech-heavy developer base. Contract manufacturing organizations are anticipated to register the highest CAGR growth in end-user share, as more domestic CDMOs expand beyond service provision into offering integrated development through commercialization solutions for both local and international clients.

Example Players in the South Korea Cell and Gene Therapy Manufacturing Market

• Bayer
• Celltrion
• CHA Biotech (Matica Biolabs)
• Daewoong Pharmaceutical
• GC Cell
• Hanmi Pharmaceutical
• Lotte Biologics
• MEDIPOST
• Samsung Biologics
• SK Bioscience
• SK Pharmteco
• Thermo Fisher Scientific

SOUTH KOREA CELL AND GENE THERAPY MANUFACTURING MARKET: RESEARCH COVERAGE

• Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the South Korea cell and gene therapy manufacturing market, focusing on key market segments, including [A] type of therapy, [B] type of scale, [C] type of mode, [D] type of workflow, [E] type of process, [F] type of technology, [G] end user and [H] region of manufacturing within South Korea.
• South Korea Cell and Gene Therapy Manufacturing Landscape: A detailed assessment of the overall manufacturing landscape within the country, featuring information on several relevant parameters, such as type of therapy manufactured, type of scale, type of mode, type of workflow, and location of manufacturing facility. Additionally, it also features an analysis of manufacturers, based on parameters such as year of establishment, company size (based on employee count), and location of headquarters.
• Manufacturing Capacity Analysis: An assessment of current and planned cell and gene therapy manufacturing capacity in South Korea, including facility-level capacity additions and expansion timelines announced by leading domestic and multinational players.
• Company Profiles: In-depth profiles of prominent players engaged in cell and gene therapy manufacturing in South Korea, featuring information on their year of establishment, location of headquarters, company size (in terms of number of employees), management team, manufacturing portfolio, and key initiatives.
• Recent Developments: A detailed analysis of recent developments in this industry, including partnerships and collaborations, funding and investments, and facility expansions and capacity additions, based on several relevant parameters.
• Regulatory Landscape: An overview of the regulatory framework governing cell and gene therapy manufacturing in South Korea, including the Act on the Safety and Support of Advanced Regenerative Medical Practice and Advanced Biopharmaceuticals, the MFDS approval pathway, and related government funding programs.
• Porter's Five Forces Analysis: A qualitative analysis of five competitive forces in this domain, namely, threat of new entrants, bargaining power of buyers, bargaining power of suppliers, threat of substitute solutions, and rivalry among existing competitors.
• Market Impact Analysis: The report analyzes various factors, such as drivers, restraints, opportunities, and challenges, affecting market growth.

KEY QUESTIONS ANSWERED IN THIS REPORT

• Which are the leading companies in the South Korea cell and gene therapy manufacturing market?
• Which manufacturing hub within South Korea dominates the market?
• What are the key trends observed in the South Korea cell and gene therapy manufacturing market?
• What factors are likely to influence the evolution of this market?
• What are the primary challenges faced by cell and gene therapy manufacturers in South Korea?
• What is the current and future market size?
• What is the CAGR of this market?
• How is the current and future market opportunity likely to be distributed across key market segments?
• How does South Korea's regulatory framework compare in supporting advanced therapy manufacturing?

REASONS TO BUY THIS REPORT

• The report provides a comprehensive market analysis, offering detailed revenue projections of the overall South Korea cell and gene therapy manufacturing market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
• The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.
• The report can aid businesses in identifying future manufacturing capacity opportunities in South Korea. It also helps in understanding if those opportunities are worth pursuing.
• The report helps in identifying customer demand by understanding the needs, preferences, and behavior of the target audience in order to tailor manufacturing services effectively.
• The report equips new entrants with requisite information regarding the South Korea market to help them build successful market entry and business strategies.
• The report allows for more effective communication with the audience and in building strong business relations.

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