KRAS Tests Market Report: Trends, Forecast and Competitive Analysis to 2031

The global KRAS tests market is expected to grow with a CAGR of 9.5% from 2025 to 2031. The major drivers for this market are the rising innovations in genomic testing technologies and the increasing incidence of KRAS-related cancers.

The future of the global KRAS tests market looks promising with opportunities in the colorectal cancer and lung cancer markets.

• The publisherl forecasts that, within the type category, KRAS sanger sequencing tests are expected to witness the highest growth over the forecast period.
• Within the application category, lung cancer is expected to witness higher growth.
• In terms of region, APAC is expected to witness the highest growth over the forecast period.

Gain valuable insights for your business decisions with our comprehensive 150+ page report. Sample figures with some insights are shown below.

Emerging Trends in the KRAS Tests Market

The KRAS tests market is evolving rapidly due to advancements in technology, increasing demand for personalized treatment options, and broader adoption of molecular diagnostics. Key trends shaping the market include the rise of liquid biopsy tests, the integration of KRAS testing with other biomarkers, and the push for global accessibility in cancer care. Below are the key trends driving the KRAS test market.

• Rise of Liquid Biopsy Testing: Liquid biopsy, a non-invasive method of detecting KRAS mutations through blood samples, is gaining popularity in oncology. This trend allows for easier, quicker, and less painful testing, which is critical in monitoring cancer progression and treatment efficacy. Liquid biopsy offers advantages like the ability to track mutations in real-time, enabling doctors to adjust treatment plans as necessary. This trend is reshaping the KRAS testing landscape by making mutation detection more accessible and efficient, especially in patients who are unable to undergo traditional tissue biopsy procedures.
• Integration of KRAS Testing with Other Biomarkers: Increasingly, KRAS testing is being integrated with testing for other genetic mutations to provide a more comprehensive view of the cancer profile. This multi-biomarker approach helps in identifying more precise therapeutic targets, thereby improving treatment outcomes for patients. Combining KRAS testing with other molecular markers such as EGFR, ALK, and ROS1 is becoming standard practice, particularly for lung cancer and colorectal cancer patients. This trend allows for better stratification of patients and more personalized treatment strategies, optimizing patient care in oncology.
• Adoption of Next-Generation Sequencing (NGS): Next-generation sequencing (NGS) is revolutionizing the KRAS testing market by enabling the simultaneous detection of multiple genetic mutations, including KRAS. NGS is becoming the gold standard in cancer diagnostics due to its high sensitivity, accuracy, and ability to provide a detailed mutation profile. NGS platforms are increasingly being used in clinical settings to identify KRAS mutations and other key genetic alterations. This trend is allowing for more comprehensive and precise diagnostics, leading to better-informed treatment decisions for patients, especially in complex cancer cases.
• Expansion of KRAS Testing in Routine Clinical Practice: KRAS testing is gradually becoming a routine part of cancer diagnostics, particularly for non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). As more clinical guidelines incorporate KRAS testing into standard cancer care protocols, its adoption is expanding. This trend reflects a broader shift towards personalized medicine, where molecular diagnostics play a critical role in tailoring treatments to individual patients as healthcare systems worldwide embrace precision oncology, the demand for routine KRAS testing is expected to increase, ultimately improving patient outcomes.
• Global Expansion and Accessibility: There is a growing push to expand the accessibility of KRAS testing, particularly in emerging markets. Efforts are being made to reduce the cost of testing and make it available in both public and private healthcare settings in countries with limited access to advanced cancer diagnostics. Government initiatives and partnerships with international diagnostic companies are helping to address these barriers, allowing more patients to benefit from KRAS testing. This trend is expected to drive growth in the KRAS test market, especially in regions with a high cancer burden, like Asia and Africa.

The KRAS tests market is being reshaped by several emerging trends, including the rise of liquid biopsy testing, integration with other biomarkers, and the adoption of next-generation sequencing. These trends are making KRAS testing more accessible, accurate, and efficient, enabling healthcare providers to deliver personalized treatment plans. As the global market expands, particularly in emerging regions, these trends will continue to drive innovation and improve patient care in oncology.

Recent Developments in the KRAS Tests Market

The KRAS testing market has undergone significant developments driven by technological advancements, regulatory changes, and the growing importance of personalized oncology. Below are five key developments in the market that are shaping the future of KRAS mutation testing and its role in cancer treatment.

• FDA Approvals for KRAS Mutation Testing Platforms: Several KRAS testing platforms have received approval from the U.S. Food and Drug Administration (FDA), ensuring their reliability and accuracy in clinical use. These FDA-approved platforms are now widely used for detecting KRAS mutations, particularly in cancers like non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). The approval of these diagnostic tools has increased confidence among healthcare providers, enabling more widespread use of KRAS tests in oncology practice and facilitating the integration of targeted therapies for patients with KRAS mutations.
• Growth of Liquid Biopsy Platforms: Liquid biopsy platforms are gaining ground in the KRAS testing market as a less invasive and more patient-friendly alternative to traditional tissue biopsies. Companies have developed advanced liquid biopsy tests that can detect KRAS mutations in blood samples, making it easier to monitor cancer progression and treatment response. This development is particularly valuable for patients who are unable to undergo invasive tissue biopsies. The growing adoption of liquid biopsy is transforming the KRAS testing market by offering a more convenient and effective testing option.
• Introduction of Next-Generation Sequencing (NGS) in Clinical Practice: Next-generation sequencing (NGS) technologies are rapidly becoming a standard method for detecting KRAS mutations in cancer patients. NGS offers the advantage of analyzing multiple genetic markers simultaneously, providing a comprehensive genetic profile for patients. This development has significantly improved the accuracy and efficiency of KRAS testing, allowing for better-targeted therapies and more precise cancer treatments. NGS is expected to continue to grow in clinical practice, further driving the KRAS testing market.
• Increased Focus on Personalized Medicine: The growing emphasis on personalized medicine has led to an increase in the use of KRAS tests in oncology. KRAS mutation status plays a crucial role in determining the appropriate course of treatment for patients with cancers like colorectal cancer and non-small cell lung cancer. This development is driving the demand for KRAS testing as part of routine cancer care, as oncologists seek to tailor treatments to the individual genetic profiles of their patients.
• Emerging Markets Adopting KRAS Testing: Emerging markets, particularly in Asia and Africa, are increasingly adopting KRAS testing as part of their cancer diagnostics. Governments and healthcare organizations in these regions are investing in advanced molecular diagnostics to improve cancer care. The availability of more affordable KRAS testing options is helping to drive this adoption, ensuring that more patients in these regions can benefit from personalized oncology treatments. This development is expected to expand the global KRAS testing market and improve cancer care accessibility.

Recent developments in the KRAS testing market, such as FDA approvals, the rise of liquid biopsy platforms, and the integration of NGS, are making KRAS testing more accessible and accurate. These innovations are driving the growth of personalized oncology, improving treatment outcomes for patients with KRAS mutations. Additionally, the expansion of KRAS testing in emerging markets is helping to make advanced cancer diagnostics more accessible to a broader population, further accelerating the growth of the market.

Strategic Growth Opportunities in the KRAS Tests Market

As the demand for personalized medicine and molecular diagnostics grows, the KRAS testing market offers numerous strategic growth opportunities across various applications. By capitalizing on advancements in technology, expanding market access, and integrating KRAS testing with other cancer treatments, stakeholders in the KRAS tests market can benefit from sustained growth. Below are five key growth opportunities in the KRAS tests market.

• Expanding Applications in Non-Small Cell Lung Cancer (NSCLC): NSCLC is one of the most common cancers where KRAS mutations play a critical role in treatment decision-making. As the use of targeted therapies for NSCLC patients grows, the demand for KRAS testing is expected to rise. Accurate KRAS testing helps oncologists determine whether targeted therapies, such as MEK inhibitors, will be effective for a patient. This growing application of KRAS testing in lung cancer provides significant market growth opportunities for companies specializing in diagnostic tools for NSCLC.
• Increasing Use in Colorectal Cancer (CRC): KRAS testing is a critical component in the management of colorectal cancer (CRC), particularly in selecting patients for anti-EGFR therapies. As personalized treatment for CRC becomes more prevalent, the demand for KRAS mutation testing is expected to increase. Companies can capitalize on this opportunity by developing more precise and cost-effective testing solutions that can be widely adopted in both developed and emerging markets, where CRC is becoming more common.
• Liquid Biopsy Market Expansion: The rise of liquid biopsy for detecting KRAS mutations presents a significant growth opportunity in the KRAS tests market. Liquid biopsy platforms offer a non-invasive alternative to traditional tissue biopsies, allowing for regular monitoring of cancer mutations. As this technology advances and becomes more accurate, the potential for liquid biopsy to replace traditional methods and expand the KRAS testing market is substantial. This is particularly beneficial for patients who cannot undergo invasive procedures.
• Increasing Global Demand in Emerging Markets: Emerging markets in Asia, Africa, and Latin America are experiencing significant growth in cancer incidence. With the increasing focus on improving healthcare infrastructure, there is a growing demand for molecular diagnostics like KRAS testing. Companies can capitalize on this demand by offering affordable KRAS testing solutions tailored to local healthcare systems, expanding their reach in these high-growth regions.
• Integration with Other Genetic Biomarkers: There is growing interest in combining KRAS testing with other genetic tests for a more comprehensive cancer diagnostic approach. Integrating KRAS testing with biomarkers like EGFR, ALK, and ROS1 can enhance the precision of personalized treatment plans. This integration offers an opportunity for companies to develop multi-biomarker testing platforms that can provide a more holistic understanding of a patient's genetic profile, thus improving treatment outcomes.

The KRAS testing market presents multiple growth opportunities, particularly in applications like NSCLC, CRC, and liquid biopsy. Expanding market access in emerging regions and integrating KRAS testing with other genetic biomarkers will further enhance the growth of the market. As personalized medicine continues to evolve, these opportunities will play a key role in advancing the KRAS testing landscape.

KRAS Tests Market Driver and Challenges

The KRAS tests market is influenced by various technological, economic, and regulatory drivers and challenges. These factors shape the development and adoption of KRAS mutation testing across global healthcare systems. Below are the key drivers and challenges impacting the KRAS testing market.

The factors responsible for driving the kras tests market include:

• 1. Advancements in Molecular Diagnostics: Technological advancements in molecular diagnostics, including next-generation sequencing and liquid biopsy, have significantly improved the accuracy and efficiency of KRAS testing. These innovations make it easier to detect KRAS mutations and support the growing trend of personalized cancer treatment. As molecular diagnostics continue to evolve, the demand for KRAS testing is expected to rise.
• 2. Increasing Demand for Personalized Medicine: Personalized medicine is gaining momentum in oncology, with KRAS testing playing a key role in tailoring treatment to individual patients. By identifying KRAS mutations, oncologists can select the most effective therapies, improving patient outcomes. This trend towards precision medicine is driving the growth of the KRAS testing market, as more patients benefit from targeted therapies.
• 3. Growing Cancer Incidence: The increasing incidence of cancers, particularly lung, colorectal, and pancreatic cancers, is fueling the demand for KRAS testing. As the need for accurate genetic testing grows, more healthcare providers are incorporating KRAS testing into standard diagnostic protocols. This rise in cancer cases is a key driver for the market.
• 4. Regulatory Support and Approvals: Regulatory agencies like the FDA are increasingly approving KRAS testing platforms for clinical use, which is boosting the adoption of these tests. As regulatory support increases, more diagnostic tools enter the market, further expanding the availability of KRAS testing worldwide.
• 5. Rising Healthcare Investments: Increased investments in healthcare infrastructure and molecular diagnostics, particularly in emerging markets, are driving the growth of the KRAS testing market. As governments and private entities invest in cancer care, more patients gain access to critical genetic tests, including KRAS mutation testing.

Challenges in the kras tests market are:

• 1. High Cost of Testing: The high cost of KRAS testing, particularly advanced technologies like NGS and liquid biopsy, remains a significant challenge. In many regions, especially emerging markets, the cost of these tests can limit access for patients. Efforts to reduce testing costs or offer more affordable solutions are critical for expanding access to KRAS testing.
• 2. Limited Access to Testing in Developing Regions: In developing regions, limited healthcare infrastructure and diagnostic capabilities hinder the widespread adoption of KRAS testing. While cancer incidence is rising in these regions, the lack of access to advanced diagnostic tools presents a significant barrier. Addressing these disparities is essential to expanding the reach of KRAS testing.
• 3. Regulatory Complexity: The regulatory landscape for KRAS testing is complex, with varying standards across regions. Companies must navigate different regulatory frameworks to ensure that their products meet local requirements. This complexity can delay market entry and limit the availability of KRAS testing in certain regions.

The KRAS testing market is driven by advancements in molecular diagnostics, growing demand for personalized medicine, and increasing cancer incidence. However, challenges such as high testing costs, limited access in developing regions, and regulatory complexity must be addressed to unlock the full potential of the market. Overcoming these barriers will ensure sustainable growth and broader access to KRAS testing.

List of KRAS Tests Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies KRAS tests companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the KRAS tests companies profiled in this report include:

• Qiagen NV
• F. Hoffmann-La Roche
• Thermo Fisher Scientific
• Takara Bio
• Panagene

KRAS Tests Market by Segment

The study includes a forecast for the global KRAS tests market by type, application, and region.

KRAS Tests Market by Type [Value from 2019 to 2031]:

• KRAS Sanger Sequencing Tests
• KRAS Nucleic Acid Amplification Tests
• KRAS Other Tests

KRAS Tests Market by Application [Value from 2019 to 2031]:

• Colorectal Cancer
• Lung Cancer

KRAS Tests Market by Region [Value from 2019 to 2031]:

• North America
• Europe
• Asia Pacific
• The Rest of the World

Country Wise Outlook for the KRAS Tests Market

The KRAS (Kirsten rat sarcoma viral oncogene homolog) mutation test is an important diagnostic tool used in oncology to detect specific mutations in the KRAS gene, which plays a role in cancer cell growth, particularly in lung, colorectal, and pancreatic cancers. The global KRAS tests market has witnessed significant developments in recent years, driven by advancements in molecular diagnostics, growing demand for personalized medicine, and the increasing prevalence of cancer. Countries like the United States, China, Germany, India, and Japan are at the forefront of these advancements as they work to expand access to these tests and incorporate them into broader cancer care strategies.

• United States: In the United States, the KRAS test market has expanded significantly with the increasing focus on precision oncology. The U.S. Food and Drug Administration (FDA) has approved several KRAS testing platforms for clinical use, facilitating their integration into cancer diagnostics. Additionally, there has been a rise in liquid biopsy tests, which offer non-invasive options for detecting KRAS mutations, making testing more accessible and less burdensome for patients. The market is also seeing growing adoption of KRAS testing in routine clinical practice, driven by healthcare policies supporting personalized treatment approaches, including targeted therapies for cancer patients.
• China: China has made strides in expanding its KRAS testing market, primarily due to the rapid development of its healthcare infrastructure and the increasing prevalence of cancer. The Chinese government has been investing heavily in cancer research and expanding access to molecular diagnostics. KRAS testing has become an integral part of the oncology care process in China, particularly in major urban areas. As more Chinese hospitals adopt advanced testing technologies, there is an increasing demand for accurate and efficient KRAS mutation testing, which is being met by both local and international diagnostic companies offering affordable, high-quality testing options.
• Germany: Germany, with its advanced healthcare system, continues to be a leader in the KRAS testing market in Europe. The country has witnessed a growing adoption of next-generation sequencing (NGS) and other molecular diagnostic techniques for detecting KRAS mutations. Germany’s healthcare system emphasizes personalized medicine, which has led to increased demand for KRAS testing, especially in the treatment of non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Research in KRAS mutations has also led to the development of targeted therapies, driving the need for more comprehensive and precise KRAS diagnostic tests in both clinical and research settings.
• India: In India, the KRAS testing market is growing as the country grapples with an increasing cancer burden. The market is being shaped by government initiatives to improve cancer care and access to molecular diagnostic tests. However, the adoption of KRAS testing in India has been slower compared to Western countries due to cost and accessibility challenges. Nonetheless, rising healthcare awareness and the introduction of more affordable testing options are improving the reach of KRAS mutation testing in both public and private healthcare sectors. Personalized medicine is gradually gaining traction, boosting the demand for KRAS testing in cancer treatment.
• Japan: Japan has become a significant player in the KRAS testing market due to its robust healthcare system and high cancer incidence rate. The country has been focusing on improving cancer diagnostics with advanced molecular techniques, including KRAS mutation testing. Japanese researchers and healthcare providers are increasingly incorporating KRAS testing as part of routine care for cancer patients, particularly those with lung and colorectal cancers. Japan’s regulatory framework for cancer diagnostics has also supported the integration of KRAS testing into clinical practice, with a rising emphasis on personalized and targeted therapies.

Features of the Global KRAS Tests Market

• Market Size Estimates: KRAS tests market size estimation in terms of value ($B).
• Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.
• Segmentation Analysis: KRAS tests market size by type, application, and region in terms of value ($B).
• Regional Analysis: KRAS tests market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
• Growth Opportunities: Analysis of growth opportunities in different types, applications, and regions for the KRAS tests market.
• Strategic Analysis: This includes M&A, new product development, and competitive landscape of the KRAS tests market.
• Analysis of competitive intensity of the industry based on Porter’s Five Forces model.

This report answers the following 11 key questions:

Q.1. What are some of the most promising, high-growth opportunities for the KRAS tests market by type (KRAS sanger sequencing tests, KRAS nucleic acid amplification tests, and KRAS other tests), application (colorectal cancer and lung cancer), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
Q.2. Which segments will grow at a faster pace and why?
Q.3. Which region will grow at a faster pace and why?
Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
Q.5. What are the business risks and competitive threats in this market?
Q.6. What are the emerging trends in this market and the reasons behind them?
Q.7. What are some of the changing demands of customers in the market?
Q.8. What are the new developments in the market? Which companies are leading these developments?
Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?