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Japan Biomarker Test Market

ID: MRFR/MED/54578-HCR
200 Pages
Rahul Gotadki
October 2025

Japan Biomarker Test Market Research Report By Application (Oncology, Cardiovascular, Neurology, Infectious Diseases, Metabolic Diseases), By Type of Test (Genetic Tests, Proteomic Tests, Metabolomic Tests, Microbiomic Tests), By Technology (Polymerase Chain Reaction, Mass Spectrometry, Immunoassays, Next-Generation Sequencing) and By End Use (Hospitals, Clinical Laboratories, Research Institutions, Pharmaceutical Companies)-Forecast to 2035

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Japan Biomarker Test Market Summary

As per MRFR analysis, the Japan biomarker test market size was estimated at 939.6 USD Million in 2024. The Japan biomarker test market is projected to grow from 974.27 USD Million in 2025 to 1400.0 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 3.69% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The Japan biomarker test market is poised for substantial growth driven by technological advancements and increasing demand for personalized medicine.

  • The largest segment in the Japan biomarker test market is the oncology segment, reflecting a growing focus on cancer diagnostics.
  • The fastest-growing segment is the cardiovascular segment, indicating a rising awareness of heart disease prevention.
  • Technological advancements in testing methodologies are enhancing the accuracy and efficiency of biomarker tests.
  • Key market drivers include the increasing prevalence of chronic diseases and growing investment in healthcare infrastructure.

Market Size & Forecast

2024 Market Size 939.6 (USD Million)
2035 Market Size 1400.0 (USD Million)
CAGR (2025 - 2035) 3.69%

Major Players

Roche (CH), Thermo Fisher Scientific (US), Abbott Laboratories (US), Agilent Technologies (US), Bio-Rad Laboratories (US), Illumina (US), Qiagen (DE), PerkinElmer (US), Merck KGaA (DE)

Japan Biomarker Test Market Trends

The biomarker test market in Japan is currently experiencing notable growth, driven by advancements in technology and an increasing emphasis on personalized medicine. The integration of biomarker testing into clinical practice is becoming more prevalent, as healthcare providers recognize the potential for these tests to enhance diagnostic accuracy and treatment efficacy. Furthermore, the aging population in Japan is contributing to a rising demand for innovative diagnostic solutions, which may lead to a greater focus on biomarker tests that can identify diseases at earlier stages. This trend appears to be supported by government initiatives aimed at promoting research and development in the healthcare sector, which could further bolster the market's expansion. In addition, the regulatory environment in Japan is evolving to accommodate the rapid advancements in biomarker testing. Regulatory bodies are likely to streamline approval processes for new tests, thereby encouraging innovation and facilitating market entry for novel diagnostic tools. The collaboration between academic institutions and industry stakeholders is also expected to foster the development of cutting-edge biomarker tests tailored to the specific health challenges faced by the Japanese population. As a result, the biomarker test market is poised for continued growth, with the potential to significantly impact patient care and treatment outcomes in the coming years.

Rising Demand for Personalized Medicine

The biomarker test market is witnessing an increasing demand for personalized medicine in Japan. This trend is driven by the need for tailored treatment approaches that consider individual patient characteristics. Biomarker tests enable healthcare providers to identify specific disease profiles, leading to more effective and targeted therapies.

Technological Advancements in Testing

Recent technological advancements are significantly influencing the biomarker test market. Innovations in testing methodologies, such as next-generation sequencing and liquid biopsy, are enhancing the accuracy and efficiency of biomarker detection. These developments are likely to improve diagnostic capabilities and patient outcomes.

Government Support for Research and Development

The Japanese government is actively supporting research and development initiatives in the biomarker test market. This support may include funding for innovative projects and collaboration with academic institutions. Such efforts are expected to accelerate the development of new biomarker tests and improve healthcare delivery.

Japan Biomarker Test Market Drivers

Advancements in Genomic Research

The rapid advancements in genomic research are transforming the landscape of the biomarker test market. Japan has made significant strides in genomics, with numerous research institutions focusing on the identification of novel biomarkers linked to various diseases. This research is expected to yield innovative testing solutions that enhance diagnostic precision and treatment efficacy. The biomarker test market is poised for growth as these advancements translate into clinically relevant tests that can be integrated into routine healthcare practices. The collaboration between academia and industry is likely to accelerate the development of new biomarker tests, further driving market expansion.

Increasing Prevalence of Chronic Diseases

The rising incidence of chronic diseases in Japan is a pivotal driver for the biomarker test market. As the population ages, conditions such as cancer, diabetes, and cardiovascular diseases become more prevalent. This trend necessitates advanced diagnostic tools, including biomarker tests, to facilitate early detection and personalized treatment strategies. According to recent statistics, chronic diseases account for approximately 60% of all deaths in Japan, underscoring the urgent need for effective diagnostic solutions. The biomarker test market is thus positioned to expand significantly as healthcare providers seek to implement these tests to improve patient outcomes and reduce healthcare costs.

Rising Awareness of Preventive Healthcare

There is a notable shift towards preventive healthcare in Japan, which significantly influences the biomarker test market. As individuals become more health-conscious, there is an increasing demand for tests that can identify potential health risks before they develop into serious conditions. This trend is reflected in the growing number of health screenings and wellness programs offered by employers and healthcare providers. The biomarker test market is likely to thrive as more people seek proactive measures to monitor their health, leading to a higher uptake of biomarker tests for early detection and risk assessment.

Regulatory Support for Innovative Diagnostics

The regulatory environment in Japan is becoming increasingly supportive of innovative diagnostic solutions, which is beneficial for the biomarker test market. The Pharmaceuticals and Medical Devices Agency (PMDA) has streamlined approval processes for new diagnostic tests, encouraging the introduction of cutting-edge biomarker tests. This regulatory support is crucial for fostering innovation and ensuring that patients have access to the latest diagnostic technologies. As a result, the biomarker test market is expected to experience accelerated growth, as companies are incentivized to develop and commercialize novel tests that meet the evolving needs of the healthcare system.

Growing Investment in Healthcare Infrastructure

Japan's commitment to enhancing its healthcare infrastructure plays a crucial role in the growth of the biomarker test market. The government has allocated substantial funding to modernize healthcare facilities and integrate advanced diagnostic technologies. In 2025, healthcare expenditure is projected to reach ¥42 trillion, with a significant portion directed towards innovative diagnostic solutions. This investment is likely to foster the adoption of biomarker tests, as healthcare providers increasingly recognize their value in improving diagnostic accuracy and patient management. The biomarker test market stands to benefit from this trend, as enhanced infrastructure facilitates the implementation of cutting-edge testing methodologies.

Market Segment Insights

By Application: Oncology (Largest) vs. Infectious Diseases (Fastest-Growing)

In the Japan biomarker test market, Oncology holds the largest share, reflecting the region's increased focus on cancer diagnosis and treatment options. The demand for advanced biomarker tests in Oncology is driven by rising cancer incidences, technological advancements, and a healthcare system that supports innovative therapies. Infectious Diseases has also gained significant traction, attributed to heightened awareness and testing efforts prompted by recent global health crises. Growth trends for these segments indicate a robust trajectory, particularly for Infectious Diseases, which is experiencing rapid innovation and development driven by the need for timely diagnoses and personalized treatments. The push for precision medicine in both Oncology and Infectious Diseases is bolstered by extensive research funding and improved healthcare infrastructures, enhancing patient outcomes and contributing to market expansion.

Oncology (Dominant) vs. Infectious Diseases (Emerging)

Oncology remains the dominant application segment in the Japan biomarker test market, characterized by advanced diagnostic tools designed for early cancer detection and personalized treatment planning. The segment's maturity is marked by continuous innovation and integration of novel biomarkers, catering to the specific needs of oncology professionals. On the other hand, Infectious Diseases is emerging rapidly, driven by innovative testing methods that allow for quicker and more accurate identification of pathogens. With the persistent threat of infectious outbreaks, the focus on developing sophisticated biomarker tests is intensifying. This emerging segment is characterized by its adaptability and response to public health demands, aiming to provide healthcare professionals with essential tools for effective disease management.

By Type of Test: Genetic Tests (Largest) vs. Proteomic Tests (Fastest-Growing)

In the Japan biomarker test market, the segment distribution shows that genetic tests hold the largest market share due to their widespread application in personalized medicine and disease prevention. Proteomic tests, while smaller in market share, are increasingly gaining attention for their potential in early disease detection and monitoring, posing significant growth opportunities in the biomarker testing landscape. The growth trends within this segment are driven by advancements in technology and increasing healthcare awareness in Japan. Genetic testing benefits from robust research backing, while proteomic testing is emerging as a vital tool in clinical settings. The collaborative efforts between biotechnology firms and healthcare providers are anticipated to further enhance the adoption of these tests, establishing a more substantial market presence.

Genetic Tests (Dominant) vs. Microbiome Tests (Emerging)

Genetic tests are characterized by their ability to provide insights into hereditary conditions and predispositions, making them indispensable in the Japan biomarker test market. The technology supporting genetic tests is well-established, with rigorous validation processes ensuring reliability and accuracy. In contrast, microbiome tests are emerging as innovative solutions that assess the gut flora's impact on health. While still developing, microbiome testing is gaining traction, primarily due to rising interest in holistic health approaches and the connection between gut health and diseases. This juxtaposition highlights genetic tests as the dominant force, while microbiome tests represent a burgeoning frontier with potential for significant growth.

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

In the Japan biomarker test market, Polymerase Chain Reaction (PCR) holds a significant portion of the share, showcasing its longstanding application in diagnostics and research. Following PCR, Immunoassays also demonstrate noteworthy market presence, driven by their effectiveness in various clinical settings. Mass Spectrometry, while essential, captures a smaller segment, primarily appealing to specialized applications. Conversely, Next-Generation Sequencing (NGS) is rapidly gaining traction as cutting-edge technology, catering to the increasing demand for comprehensive genetic insights. The growth trends in this segment reflect substantial advancements in technology and effectiveness. With a rising focus on precision medicine, the demand for NGS continues to soar, supported by decreasing costs and improved efficiency. Conversely, PCR, while established, remains vital, particularly for infectious disease diagnostics. Immunoassays maintain steady growth, propelled by their versatility in diverse testing environments. Overall, these technologies are expanding the possibilities within the Japan biomarker test market, driving innovation and improving patient outcomes.

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

Polymerase Chain Reaction (PCR) is recognized as the dominant technology in the Japan biomarker test market, primarily due to its reliability and established presence in molecular diagnostics. Its ability to amplify DNA sequences quickly and accurately makes it indispensable, particularly in infectious disease testing and genetic research. On the other hand, Next-Generation Sequencing (NGS) is an emerging player, positioned to transform the landscape with its capability for high-throughput sequencing. NGS allows for comprehensive genomic analysis, which is becoming increasingly important for tailored therapies. Despite being newer to the market, NGS is expanding rapidly, bolstered by advancements in bioinformatics and a growing emphasis on personalized healthcare solutions.

By End-Use: Hospitals (Largest) vs. Clinical Laboratories (Fastest-Growing)

In the Japan biomarker test market, hospitals dominate the end-use segment, commanding the largest market share due to their extensive diagnostic capabilities and the increasing prevalence of chronic diseases. Clinical laboratories are catching up rapidly, experiencing robust growth attributed to technological advancements and a rising number of diagnostic tests driving demand. Both segments are essential, yet they serve different aspects of healthcare and research needs. The growth in the hospitals segment is fueled by the integration of biomarker tests into routine clinical practice and personalized medicine approaches. Conversely, clinical laboratories are witnessing swift expansion due to their agility in adopting new technologies and the demand for rapid testing solutions. With research institutions and pharmaceutical companies also contributing to the market, the landscape remains competitive and dynamic, indicating a bright future for biomarker testing in the region.

Hospitals (Dominant) vs. Clinical Laboratories (Emerging)

Hospitals are the dominant players in the end-use segment of the Japan biomarker test market, providing a wide array of testing services that cater to various medical conditions. Their infrastructure allows for comprehensive patient care, and their ability to perform complex tests in-house enhances their position. On the other hand, clinical laboratories represent an emerging segment, characterized by their flexibility and focus on innovative testing solutions. They are increasingly integrating advanced technology to streamline processes and improve accuracy. As the demand for rapid and reliable diagnostic tests continues to rise, clinical laboratories are expected to play a crucial role in the future of biomarker testing, complementing the established services provided by hospitals.

Get more detailed insights about Japan Biomarker Test Market

Key Players and Competitive Insights

The biomarker test market in Japan is characterized by a dynamic competitive landscape, driven by advancements in precision medicine and personalized healthcare. Key players such as Roche (CH), Thermo Fisher Scientific (US), and Abbott Laboratories (US) are at the forefront, leveraging their extensive research capabilities and innovative product portfolios. Roche (CH) focuses on integrating digital health solutions with biomarker testing, enhancing diagnostic accuracy and patient outcomes. Meanwhile, Thermo Fisher Scientific (US) emphasizes strategic partnerships to expand its reach in the Japanese market, particularly in oncology and infectious diseases. Abbott Laboratories (US) is also investing in localized manufacturing to streamline supply chains and reduce costs, thereby enhancing its competitive positioning.

The market structure appears moderately fragmented, with several players vying for market share. Key business tactics include localizing manufacturing and optimizing supply chains to meet the specific needs of the Japanese healthcare system. This localized approach not only reduces operational costs but also enhances responsiveness to market demands. The collective influence of these major players shapes a competitive environment where innovation and operational efficiency are paramount.

In September 2025, Roche (CH) announced a collaboration with a leading Japanese university to develop next-generation biomarker tests for early cancer detection. This strategic move is likely to bolster Roche's position in the oncology segment, aligning with the growing demand for early diagnostic solutions in Japan. The partnership underscores Roche's commitment to innovation and its focus on addressing local healthcare challenges.

In October 2025, Thermo Fisher Scientific (US) launched a new biomarker assay specifically designed for the Japanese market, targeting rare diseases. This initiative not only demonstrates Thermo Fisher's dedication to meeting local healthcare needs but also positions the company as a leader in niche biomarker testing. The introduction of this assay is expected to enhance patient care by providing more accurate diagnostic tools for rare conditions.

In August 2025, Abbott Laboratories (US) expanded its biomarker testing capabilities by acquiring a local diagnostics firm in Japan. This acquisition is anticipated to enhance Abbott's product offerings and strengthen its market presence. By integrating local expertise and technologies, Abbott aims to accelerate the development of innovative biomarker tests tailored to the Japanese population.

As of November 2025, current trends in the biomarker test market include a pronounced shift towards digitalization, sustainability, and the integration of artificial intelligence (AI) in testing processes. Strategic alliances among key players are increasingly shaping the competitive landscape, fostering innovation and enhancing product offerings. Looking ahead, competitive differentiation is likely to evolve from traditional price-based competition to a focus on technological advancements, innovation, and supply chain reliability. This shift indicates a growing recognition of the importance of quality and efficiency in meeting the demands of a rapidly changing healthcare environment.

Key Companies in the Japan Biomarker Test Market market include

Industry Developments

The Japan Biomarker Test Market has experienced significant developments recently, driven by advancements in personalized medicine and increased demand for early disease detection. Leading companies such as Agilent Technologies, Takara Bio, and Mitsubishi Tanabe Pharma are actively innovating and enhancing their product portfolios to incorporate cutting-edge technologies in biomarker testing. In July 2023, Roche unveiled a new testing platform that significantly improves the accuracy of cancer diagnostics, reflecting the ongoing trend toward advanced molecular testing.

Market growth has been further fueled by a surge in collaborations, with Thermo Fisher Scientific and Illumina advancing their offerings through strategic partnerships to enhance high-throughput genomic testing capabilities. Furthermore, the Japan Pharmaceuticals and Medical Devices Agency has been streamlining approval processes for biomarker tests, thus encouraging market entry for new players.

Although recent mergers and acquisitions are limited, noteworthy activities include the collaboration between QIAGEN and Fujifilm in May 2023 to jointly develop innovative diagnostic solutions. Overall, the Japan Biomarker Test Market is poised to grow, supported by an increasing focus on precision medicine and strong research from key players in the industry.

 

Future Outlook

Japan Biomarker Test Market Future Outlook

The Biomarker Test Market in Japan is projected to grow at a 3.69% CAGR from 2024 to 2035, driven by technological advancements, increasing prevalence of chronic diseases, and rising demand for personalized medicine.

New opportunities lie in:

  • Development of point-of-care biomarker testing devices for rapid diagnostics.
  • Expansion of biomarker-based companion diagnostics partnerships with pharmaceutical companies.
  • Investment in AI-driven data analytics for enhanced biomarker discovery and validation.

By 2035, the biomarker test market is expected to achieve substantial growth, reflecting evolving healthcare needs.

Market Segmentation

Japan Biomarker Test Market End-Use Outlook

  • Hospitals
  • Clinical Laboratories
  • Research Institutions
  • Pharmaceutical Companies

Japan Biomarker Test Market Technology Outlook

  • Polymerase Chain Reaction
  • Mass Spectrometry
  • Immunoassays
  • Next-Generation Sequencing

Japan Biomarker Test Market Application Outlook

  • Oncology
  • Cardiovascular
  • Neurology
  • Infectious Diseases
  • Metabolic Diseases

Japan Biomarker Test Market Type of Test Outlook

  • Genetic Tests
  • Proteomic Tests
  • Metabolomic Tests
  • Microbiome Tests

Report Scope

MARKET SIZE 2024 939.6(USD Million)
MARKET SIZE 2025 974.27(USD Million)
MARKET SIZE 2035 1400.0(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR) 3.69% (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 Laboratories (US), Agilent Technologies (US), Bio-Rad Laboratories (US), Illumina (US), Qiagen (DE), PerkinElmer (US), Merck KGaA (DE)
Segments Covered Application, Type of Test, Technology, End-Use
Key Market Opportunities Advancements in personalized medicine drive demand for innovative biomarker test market solutions.
Key Market Dynamics Rising demand for personalized medicine drives innovation and competition in the biomarker test market.
Countries Covered Japan

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FAQs

What is the expected market size of the Japan Biomarker Test Market in 2024?

The Japan Biomarker Test Market is expected to be valued at 939.6 million USD in 2024.

What is the projected market value of the Japan Biomarker Test Market by 2035?

By 2035, the Japan Biomarker Test Market is projected to reach a value of 1,870.0 million USD.

What is the expected CAGR for the Japan Biomarker Test Market from 2025 to 2035?

The expected CAGR for the Japan Biomarker Test Market from 2025 to 2035 is 6.457 percent.

Which application segment is expected to dominate the Japan Biomarker Test Market?

The oncology application segment is expected to dominate the Japan Biomarker Test Market, valued at 300.0 million USD in 2024.

How much is the cardiovascular application segment valued at in the Japan Biomarker Test Market for 2024?

The cardiovascular application segment is valued at 200.0 million USD in the Japan Biomarker Test Market for 2024.

What will be the market value for the neurology application in 2035?

The neurology application segment is projected to reach a market value of 300.0 million USD by 2035.

Who are the major players in the Japan Biomarker Test Market?

Key players in the Japan Biomarker Test Market include Agilent Technologies, Takara Bio, and Mitsubishi Tanabe Pharma.

What is the expected market size for infectious diseases applications in 2024?

The market size for infectious diseases applications is expected to be 175.0 million USD in 2024.

How much is the metabolic diseases application segment projected to be worth by 2035?

The metabolic diseases application segment is projected to be worth 220.0 million USD by 2035.

What are the growth drivers for the Japan Biomarker Test Market?

Growth drivers for the Japan Biomarker Test Market include increased prevalence of diseases and advancements in technology.

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