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South Korea Companion Diagnostics Oncology Market

ID: MRFR/MED/48451-HCR
200 Pages
Rahul Gotadki
October 2025

South Korea Companion Diagnostics Oncology Market Research Report By Technology (Next Generation Sequencing, Polymerase Chain Reaction, In Situ Hybridization, Immunohistochemistry), By Applications (Therapeutic Monitoring, Patient Stratification, Predictive Testing, Disease Diagnosis), By End-user (Hospitals, Diagnostic Laboratories, Research Institutions, Pharmaceutical Companies), and By Test Type (Genetic Tests, Protein Biomarker Tests, MicroRNA Tests, Pathological Analysis)- Forecast to 2035

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South Korea Companion Diagnostics Oncology Market Summary

As per MRFR analysis, the South Korea companion diagnostics-oncology market size was estimated at 114.25 USD Million in 2024. The South Korea companion diagnostics-oncology market is projected to grow from 122.68 USD Million in 2025 to 250.04 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 7.38% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The South Korea companion diagnostics-oncology market is poised for growth driven by innovation and increasing demand for personalized medicine.

  • Regulatory support and innovation are shaping the landscape of the companion diagnostics-oncology market in South Korea.
  • The largest segment in this market is the biomarker testing segment, while the fastest-growing segment is the genetic testing segment.
  • Rising cancer incidence is prompting a surge in demand for effective diagnostic solutions across the region.
  • Technological advancements in diagnostics and growing demand for personalized medicine are key drivers propelling market expansion.

Market Size & Forecast

2024 Market Size 114.25 (USD Million)
2035 Market Size 250.04 (USD Million)
CAGR (2025 - 2035) 7.38%

Major Players

Roche (CH), Thermo Fisher Scientific (US), Abbott (US), Agilent Technologies (US), Illumina (US), Qiagen (DE), Myriad Genetics (US), Hologic (US), Guardant Health (US)

South Korea Companion Diagnostics Oncology Market Trends

The companion diagnostics-oncology market in South Korea is experiencing notable growth, driven by advancements in personalized medicine and an increasing emphasis on targeted therapies. The integration of companion diagnostics into oncology practices is becoming more prevalent, as healthcare providers seek to enhance treatment efficacy and patient outcomes. Regulatory support from the South Korean government further facilitates the development and approval of these diagnostic tools, fostering innovation within the sector. As a result, the market is witnessing a surge in collaborations between pharmaceutical companies and diagnostic developers, aiming to create tailored therapies that align with specific patient profiles. Moreover, the rising incidence of cancer in South Korea is prompting a greater demand for effective diagnostic solutions. The healthcare system is increasingly prioritizing precision medicine, which necessitates the use of companion diagnostics to identify suitable treatment options for patients. This trend is likely to continue, as ongoing research and development efforts focus on expanding the range of biomarkers and tests available. The companion diagnostics-oncology market appears poised for further expansion, with a strong emphasis on improving patient care and optimizing therapeutic strategies.

Regulatory Support and Innovation

The South Korean government is actively promoting the development of companion diagnostics through supportive regulatory frameworks. This encouragement is likely to stimulate innovation, leading to the introduction of new diagnostic tools that can enhance treatment precision in oncology.

Rising Cancer Incidence

The increasing prevalence of cancer in South Korea is driving demand for advanced diagnostic solutions. As healthcare providers focus on personalized treatment approaches, the need for companion diagnostics is expected to grow, aligning with the shift towards precision medicine.

Collaborative Efforts in Development

There is a noticeable trend of collaboration between pharmaceutical companies and diagnostic firms in South Korea. These partnerships aim to develop integrated solutions that combine targeted therapies with companion diagnostics, enhancing treatment outcomes for patients.

South Korea Companion Diagnostics Oncology Market Drivers

Regulatory Framework Enhancements

The evolving regulatory framework in South Korea is positively influencing the companion diagnostics-oncology market. Recent updates to regulations have streamlined the approval processes for diagnostic tests, making it easier for companies to bring innovative products to market. The Ministry of Food and Drug Safety has implemented measures to expedite the review of companion diagnostics, which is likely to encourage more companies to invest in this sector. As a result, the market is expected to grow, with an anticipated increase in the number of approved diagnostic tests that can aid in the treatment of various cancers.

Rising Awareness of Genetic Testing

The growing awareness of genetic testing among patients and healthcare professionals is driving the companion diagnostics-oncology market. In South Korea, educational campaigns and initiatives by healthcare organizations are promoting the benefits of genetic testing in cancer diagnosis and treatment. This heightened awareness is leading to an increase in the number of patients seeking genetic testing services, which in turn supports the demand for companion diagnostics. It is estimated that the market could see a growth of 15% in the next few years as more patients understand the importance of genetic information in their treatment plans.

Increased Investment in Cancer Research

Investment in cancer research is significantly impacting the companion diagnostics-oncology market. In South Korea, both public and private sectors are allocating substantial funds to oncology research initiatives. This financial support is fostering the development of innovative diagnostic tools that can identify specific cancer types and their corresponding treatments. The government has committed over $200 million to cancer research in the past year, which is likely to enhance the capabilities of companion diagnostics. As research progresses, the market is expected to expand, with new diagnostic tests emerging that align with the evolving landscape of cancer treatment.

Growing Demand for Personalized Medicine

The shift towards personalized medicine is a key driver for the companion diagnostics-oncology market. In South Korea, healthcare providers are increasingly recognizing the value of tailored treatment approaches that consider individual genetic profiles. This trend is supported by a growing body of evidence indicating that personalized therapies can lead to improved patient outcomes and reduced healthcare costs. The market for companion diagnostics is expected to reach $500 million by 2027, reflecting the rising demand for targeted therapies. As patients and clinicians seek more effective treatment options, the role of companion diagnostics in identifying suitable therapies becomes increasingly critical.

Technological Advancements in Diagnostics

The companion diagnostics-oncology market is experiencing a surge due to rapid technological advancements in diagnostic tools. Innovations such as next-generation sequencing (NGS) and polymerase chain reaction (PCR) are enhancing the precision of cancer diagnostics. In South Korea, the integration of artificial intelligence in diagnostic processes is streamlining the identification of biomarkers, which is crucial for personalized treatment plans. The market is projected to grow at a CAGR of approximately 10% over the next five years, driven by these technological improvements. Furthermore, the increasing adoption of digital health solutions is facilitating better patient management and outcomes, thereby reinforcing the importance of companion diagnostics in oncology.

Market Segment Insights

By Technology: Next Generation Sequencing (Largest) vs. Polymerase Chain Reaction (Fastest-Growing)

In the South Korea companion diagnostics-oncology market, the distribution of market share among various technologies exhibits a clear hierarchy. Next Generation Sequencing (NGS) takes the lead, commanding a significant portion of the market. Meanwhile, Polymerase Chain Reaction (PCR) is gaining traction as an effective diagnostic tool, rapidly increasing its share due to its efficiency and reliability. Both In Situ Hybridization and Immunohistochemistry, while important, hold smaller portions of the overall market yet contribute to the diversity of technologies available. The growth trends in this market are driven by advancements in biotechnology and increasing demand for personalized medicine. NGS is favored for its high throughput and comprehensive genetic analysis, establishing itself as the dominant technology. In contrast, PCR is witnessing rapid adoption due to its simplicity and cost-effectiveness, making it the fastest-growing segment. The overall push for more accurate, efficient diagnostics continues to foster innovation across all technology categories.

Technology: Next Generation Sequencing (Dominant) vs. Polymerase Chain Reaction (Emerging)

Next Generation Sequencing (NGS) stands out as the dominant technology within the South Korea companion diagnostics-oncology market, renowned for its ability to analyze multiple genes simultaneously, providing extensive insights into tumor genomics. This comprehensive approach leads to better-targeted therapies and improved patient outcomes. On the other hand, Polymerase Chain Reaction (PCR) is recognized as an emerging technology, valued for its rapid results and ease of use. PCR's adaptability allows it to be applied across various diagnostic scenarios, driving its growth as healthcare providers increasingly seek efficient and reliable testing methods. Both technologies play crucial roles, each with unique strengths contributing to the enhancement of oncology diagnostics.

By Applications: Therapeutic Monitoring (Largest) vs. Predictive Testing (Fastest-Growing)

In the South Korea companion diagnostics-oncology market, the market share distribution among the applications reveals that Therapeutic Monitoring holds a significant portion due to its critical role in managing cancer treatments. Following closely are Patient Stratification and Disease Diagnosis, which contribute noteworthy shares as well. Predictive Testing, while currently smaller in market share, is emerging rapidly with a growing interest from stakeholders. Growth trends in this segment are driven by the increasing emphasis on personalized medicine, which enhances treatment efficacy. The rise in cancer prevalence has intensified the need for accurate diagnostics and monitoring. Innovations in molecular diagnostics and advancements in technology are encouraging the adoption of predictive testing, positioning it as a leading trendsetter in this segment, poised for substantial growth in the coming years.

Therapeutic Monitoring (Dominant) vs. Predictive Testing (Emerging)

Therapeutic Monitoring is characterized by its essential role in guiding oncology treatments, ensuring that therapies are optimized for individual patients. It provides insights into drug efficacy, allowing healthcare professionals to make informed decisions. This application is deeply entrenched in clinical practices, making it the dominant force in the market. On the other hand, Predictive Testing is gaining traction as an emerging application that assesses the likelihood of a patient responding to specific therapies. It leverages genetic and molecular profiling to inform treatment choices, fulfilling the demand for personalized care. As the healthcare landscape evolves, Predictive Testing is expected to gain momentum, driven by advancements in technology and an increasing demand for individualized treatment plans.

By End User: Hospitals (Largest) vs. Pharmaceutical Companies (Fastest-Growing)

In the South Korea companion diagnostics-oncology market, hospitals hold a significant market share due to their extensive patient interactions and diagnostic capabilities. They play a critical role in the adoption of companion diagnostics, as they directly influence treatment decisions and patient outcomes. Diagnostic laboratories also contribute positively, facilitating the testing processes but remain somewhat secondary to hospitals. Research institutions focus on innovation and advancement in diagnostics, while pharmaceutical companies are increasingly integrating companion diagnostics into their drug development processes. Growth trends in this segment indicate a robust increase in the demand for companion diagnostics across various end users. Hospitals are expected to continue being pivotal with their large patient populations. However, pharmaceutical companies are emerging as the fastest-growing segment, fueled by collaborations with diagnostic firms to enhance precision medicine initiatives and improve drug efficacy for oncology treatments.

Hospitals: Dominant vs. Pharmaceutical Companies: Emerging

Hospitals represent the dominant force in the South Korea companion diagnostics-oncology market due to their established infrastructures and capabilities in leading patient care. They are integral in utilizing diagnostic data to personalize oncology treatments. Pharmaceutical companies, on the other hand, are positioned as the emerging segment, rapidly developing partnerships with diagnostics firms to leverage personalized medicine. This collaboration allows them to create targeted therapies that align with specific patient profiles, thus driving innovation and enhancing the overall treatment landscape. As precision medicine gains traction, the roles of both hospitals and pharmaceutical companies evolve, leading to a more integrated approach to oncology care.

By Test Type: Genetic Tests (Largest) vs. Protein Biomarker Tests (Fastest-Growing)

In the South Korea companion diagnostics-oncology market, Genetic Tests hold the largest market share, driven by their advanced capabilities in identifying genetic mutations linked to various cancers. This segment's dominance is complemented by the increasing adoption of personalized medicine, which relies heavily on genetic insights for tailored treatment plans. On the other hand, Protein Biomarker Tests are rapidly gaining traction, recognized for their ability to provide critical information about tumor behavior and response to therapy, positioning them as the fastest-growing segment in this landscape. The growth trends in these segments reflect a broader shift towards precision medicine, where diagnostic tests are essential in informing treatment options. The rising prevalence of cancer in the region is driving investment and innovation in both Genetic Tests and Protein Biomarker Tests, with healthcare providers emphasizing the need for more accurate and early diagnostics. Research and development continue to focus on enhancing these tests' accuracy and efficiency, ensuring that they meet the demands of a changing healthcare environment.

Genetic Tests (Dominant) vs. Protein Biomarker Tests (Emerging)

The Genetic Tests segment stands as a dominant force in the South Korea companion diagnostics-oncology market, characterized by its utilization of advanced genomic technologies to detect mutations that are critical for effective treatment. These tests are pivotal for oncologists in selecting appropriate therapies, making them instrumental in the drive towards personalized medicine. Meanwhile, the Protein Biomarker Tests segment represents an emerging player, valued for its ability to assess protein expressions related to cancer. This segment is gaining momentum due to its capacity to provide insights into treatment responses, making it increasingly relevant in clinical decision-making. Both segments are set to play crucial roles in the evolution of oncology diagnostics, catering to the growing demand for personalized and effective cancer therapies.

Get more detailed insights about South Korea Companion Diagnostics Oncology Market

Key Players and Competitive Insights

The companion diagnostics-oncology market in South Korea is characterized by a dynamic competitive landscape, driven by rapid technological advancements and an increasing emphasis on personalized medicine. Key players such as Roche (CH), Thermo Fisher Scientific (US), and Illumina (US) are at the forefront, leveraging their extensive research capabilities and innovative product offerings to capture market share. Roche (CH) focuses on integrating diagnostics with therapeutic solutions, enhancing its position through strategic partnerships and collaborations. Meanwhile, Thermo Fisher Scientific (US) emphasizes its broad portfolio of genomic and proteomic solutions, aiming to streamline workflows and improve patient outcomes. Illumina (US) continues to innovate in next-generation sequencing technologies, which are pivotal in companion diagnostics, thereby reinforcing its competitive edge.

The business tactics employed by these companies reflect a concerted effort to optimize operations and enhance market presence. Localizing manufacturing and optimizing supply chains are prevalent strategies, allowing for greater responsiveness to regional demands. The market structure appears moderately fragmented, with several players vying for dominance, yet the collective influence of major companies shapes a competitive environment that is increasingly collaborative, particularly in research and development initiatives.

In September 2025, Roche (CH) announced a strategic partnership with a leading South Korean biotechnology firm to co-develop a novel companion diagnostic test aimed at improving treatment outcomes for lung cancer patients. This collaboration is significant as it not only enhances Roche's local market presence but also aligns with the growing trend towards personalized medicine in oncology, potentially leading to improved patient stratification and treatment efficacy.

In October 2025, Thermo Fisher Scientific (US) launched a new platform designed to integrate artificial intelligence (AI) into its diagnostic workflows, enhancing the accuracy and speed of genomic analyses. This move is indicative of the increasing importance of digital transformation in the companion diagnostics space, as AI capabilities can significantly reduce turnaround times and improve diagnostic precision, thereby meeting the evolving needs of healthcare providers.

In August 2025, Illumina (US) expanded its collaboration with a prominent South Korean research institution to advance the development of genomic biomarkers for cancer therapies. This initiative underscores the critical role of strategic alliances in fostering innovation and enhancing the capabilities of companion diagnostics, as it allows for the pooling of resources and expertise to accelerate the discovery of novel biomarkers.

As of November 2025, the competitive trends within the companion diagnostics-oncology market are increasingly defined by digitalization, sustainability, and the integration of AI technologies. Strategic alliances are shaping the landscape, facilitating innovation and enhancing operational efficiencies. Looking ahead, it is likely that competitive differentiation will evolve, with a pronounced shift from price-based competition towards a focus on innovation, technological advancements, and supply chain reliability, ultimately driving better patient outcomes and more effective treatment strategies.

Key Companies in the South Korea Companion Diagnostics Oncology Market market include

Industry Developments

Recent developments in the South Korea Companion Diagnostics Oncology Market reflect significant advancements and strategic movements among major players such as Illumina, Samsung Medical Center, Novartis, Merck, Bristol-Myers Squibb, Hanmi Pharmaceutical, Abbott Laboratories, Pfizer, GenoMediX, Amgen, Roche, OncoOne, LG Chem, and Genexine.

Notably, in May 2023, Illumina announced a partnership with Samsung Medical Center to enhance genomic testing capabilities. As of June 2023, Merck and Bristol-Myers Squibb expanded their collaboration on cancer therapies, focusing on precision medicine, while Novartis and Amgen each reported increased investments in R&D for companion diagnostics.

On the M&A front, LG Chem acquired a biotech firm in January 2023 to bolster its oncology pipeline. The South Korean Companion Diagnostics Oncology Market has seen a notable increase in valuation, currently estimated at USD 200 million, growing due to increased adoption of personalized medicine and robust government support for innovative therapies.

Significant happenings in the market over the past two years include advancements in biomarker discovery and the integration of AI in clinical decision-making, which have streamlined diagnostics and improved patient outcomes.

Future Outlook

South Korea Companion Diagnostics Oncology Market Future Outlook

The Companion Diagnostics Oncology Market is projected to grow at a 7.38% CAGR from 2024 to 2035, driven by advancements in personalized medicine, regulatory support, and increasing cancer prevalence.

New opportunities lie in:

  • Development of AI-driven diagnostic platforms for precision oncology
  • Expansion of partnerships with biopharmaceutical companies for co-development
  • Investment in telehealth solutions for remote patient monitoring and diagnostics

By 2035, the market is expected to achieve substantial growth, reflecting its critical role in oncology.

Market Segmentation

South Korea Companion Diagnostics Oncology Market End User Outlook

  • Hospitals
  • Diagnostic Laboratories
  • Research Institutions
  • Pharmaceutical Companies

South Korea Companion Diagnostics Oncology Market Test Type Outlook

  • Genetic Tests
  • Protein Biomarker Tests
  • MicroRNA Tests
  • Pathological Analysis

South Korea Companion Diagnostics Oncology Market Technology Outlook

  • Next Generation Sequencing
  • Polymerase Chain Reaction
  • In Situ Hybridization
  • Immunohistochemistry

South Korea Companion Diagnostics Oncology Market Applications Outlook

  • Therapeutic Monitoring
  • Patient Stratification
  • Predictive Testing
  • Disease Diagnosis

Report Scope

MARKET SIZE 2024 114.25(USD Million)
MARKET SIZE 2025 122.68(USD Million)
MARKET SIZE 2035 250.04(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR) 7.38% (2024 - 2035)
REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR 2024
Market Forecast Period 2025 - 2035
Historical Data 2019 - 2024
Market Forecast Units USD Million
Key Companies Profiled Roche (CH), Thermo Fisher Scientific (US), Abbott (US), Agilent Technologies (US), Illumina (US), Qiagen (DE), Myriad Genetics (US), Hologic (US), Guardant Health (US)
Segments Covered Technology, Applications, End User, Test Type
Key Market Opportunities Integration of advanced genomic technologies enhances precision medicine in the companion diagnostics-oncology market.
Key Market Dynamics Rising demand for personalized medicine drives growth in the companion diagnostics-oncology market in South Korea.
Countries Covered South Korea

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FAQs

What is the projected market size of the South Korea Companion Diagnostics Oncology Market in 2024?

The South Korea Companion Diagnostics Oncology Market is expected to be valued at 142.75 million USD in 2024.

What is the anticipated market value for the South Korea Companion Diagnostics Oncology Market by 2035?

By 2035, the South Korea Companion Diagnostics Oncology Market is expected to reach a valuation of 355.6 million USD.

What is the expected CAGR for the South Korea Companion Diagnostics Oncology Market from 2025 to 2035?

The expected CAGR for the South Korea Companion Diagnostics Oncology Market from 2025 to 2035 is 8.651%.

Which technology segment holds the largest market value in 2024 within the South Korea Companion Diagnostics Oncology Market?

In 2024, the Next Generation Sequencing segment is valued at 45.5 million USD, making it the largest in the market.

What will be the market value of the Polymerase Chain Reaction technology segment by 2035?

The Polymerase Chain Reaction segment is expected to be valued at 74.0 million USD by 2035.

Who are the key players in the South Korea Companion Diagnostics Oncology Market?

Major players in the market include Illumina, Novartis, Merck, and Abbott Laboratories among others.

What are the projected market values for In Situ Hybridization and Immunohistochemistry technologies in 2024?

In 2024, In Situ Hybridization is valued at 25.0 million USD, while Immunohistochemistry is valued at 42.25 million USD.

What are the expected market values for In Situ Hybridization and Immunohistochemistry by 2035?

By 2035, In Situ Hybridization is expected to reach 61.5 million USD, and Immunohistochemistry is expected to reach 107.0 million USD.

What are the main growth drivers for the South Korea Companion Diagnostics Oncology Market?

The growth drivers include advancements in technology and increasing demand for personalized medicine.

How is the current competitive landscape of the South Korea Companion Diagnostics Oncology Market characterized?

The competitive landscape is characterized by major pharmaceutical and diagnostic companies actively innovating and expanding their offerings.

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