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    BRCA1 and BRCA2 Gene Market

    ID: MRFR/Pharma/33221-HCR
    128 Pages
    Kinjoll Dey
    October 2025

    BRCA1 and BRCA2 Gene Market Research Report By Test Type (Genetic Testing, Carrier Testing, Predictive Testing, Prenatal Testing), By Application (Breast Cancer, Ovarian Cancer, Prostate Cancer, Pancreatic Cancer), By Technology (Next Generation Sequencing, Polymerase Chain Reaction, Sanger Sequencing), By End User (Hospitals, Diagnostic Laboratories, Research Institutions) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Forecast to 2035

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    BRCA1 and BRCA2 Gene Market Summary

    As per MRFR analysis, the BRCA1 and BRCA2 Gene Market Size was estimated at 6.169 USD Billion in 2024. The BRCA1 and BRCA2 Gene industry is projected to grow from 6.63 in 2025 to 13.63 by 2035, exhibiting a compound annual growth rate (CAGR) of 7.47 during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    <p>The BRCA1 and BRCA2 gene market is experiencing robust growth driven by technological advancements and increasing awareness.</p>

    • The market is characterized by a rising awareness of genetic testing, particularly in North America, which remains the largest market.
    • Technological advancements in testing methodologies are propelling growth, especially in the Asia-Pacific region, recognized as the fastest-growing market.
    • The genetic testing segment dominates the market, while predictive testing is emerging as the fastest-growing segment, reflecting evolving consumer preferences.
    • Key market drivers include the increasing incidence of breast and ovarian cancer, alongside advancements in genetic testing technologies.

    Market Size & Forecast

    2024 Market Size 6.169 (USD Billion)
    2035 Market Size 13.63 (USD Billion)
    CAGR (2025 - 2035) 7.47%

    Major Players

    Myriad Genetics (US), Invitae Corporation (US), Ambry Genetics (US), Fulgent Genetics (US), GeneDx (US), Laboratory Corporation of America (US), Quest Diagnostics (US), PathGroup (US)

    BRCA1 and BRCA2 Gene Market Trends

    The BRCA1 and BRCA2 Gene Market is currently experiencing notable growth, driven by increasing awareness of genetic testing and its implications for cancer risk management. As individuals become more informed about hereditary breast and ovarian cancers, the demand for genetic screening is likely to rise. This trend is further supported by advancements in technology, which have made testing more accessible and affordable. Additionally, healthcare providers are increasingly recommending genetic counseling, which may enhance patient engagement and lead to more proactive health decisions. Moreover, the regulatory landscape appears to be evolving, with governments and health organizations emphasizing the importance of genetic testing in preventive healthcare. This shift could potentially lead to more insurance coverage for genetic tests, thereby reducing financial barriers for patients. As a result, the BRCA1 and BRCA2 Gene Market is poised for expansion, with a growing number of companies entering the field to meet the rising demand for testing services and related products. The future landscape may also see increased collaboration between biotechnology firms and healthcare providers, fostering innovation and improving patient outcomes.

    Rising Awareness of Genetic Testing

    There is a growing recognition among the public regarding the importance of genetic testing for assessing cancer risk. This heightened awareness is likely to drive demand for BRCA1 and BRCA2 testing, as individuals seek to understand their genetic predispositions.

    Technological Advancements in Testing

    Innovations in genetic testing technologies are making BRCA1 and BRCA2 testing more efficient and accessible. These advancements may lead to quicker turnaround times and improved accuracy, thereby attracting more patients to undergo testing.

    Evolving Regulatory Environment

    Changes in regulations surrounding genetic testing are anticipated to enhance the market landscape. Increased support from health authorities could lead to broader insurance coverage, making testing more financially viable for a larger segment of the population.

    The increasing awareness of genetic testing for BRCA1 and BRCA2 mutations appears to drive a notable shift in preventive healthcare strategies, potentially leading to earlier interventions and improved patient outcomes.

    U.S. National Institutes of Health (NIH)

    BRCA1 and BRCA2 Gene Market Drivers

    Rising Investment in Genetic Research

    Investment in genetic research is a crucial factor influencing the BRCA1 and BRCA2 Gene Market. Governments and private organizations are increasingly funding research initiatives aimed at understanding the genetic basis of cancer. This influx of capital is expected to accelerate the development of new testing methodologies and therapeutic options for individuals with BRCA mutations. For instance, research into gene editing technologies and novel drug development is gaining momentum, which could lead to breakthroughs in treatment. The market is likely to benefit from these advancements, as new findings may enhance the understanding of BRCA-related cancers and improve testing accuracy. Consequently, the BRCA1 and BRCA2 Gene Market stands to gain from the ongoing commitment to genetic research.

    Growing Demand for Personalized Medicine

    The shift towards personalized medicine is a significant driver for the BRCA1 and BRCA2 Gene Market. As healthcare moves away from a one-size-fits-all approach, the focus on tailored treatment plans based on genetic profiles is becoming more pronounced. Patients with BRCA mutations may benefit from targeted therapies, such as PARP inhibitors, which have shown efficacy in treating cancers associated with these mutations. The increasing recognition of the importance of genetic information in treatment decisions is likely to enhance the demand for BRCA testing. Market analysts predict that the personalized medicine segment will continue to expand, potentially leading to a more than 15% increase in the market size for BRCA1 and BRCA2 testing services over the next few years.

    Advancements in Genetic Testing Technologies

    Technological advancements in genetic testing methodologies are reshaping the BRCA1 and BRCA2 Gene Market. Innovations such as next-generation sequencing (NGS) have significantly enhanced the accuracy and efficiency of genetic testing. These technologies allow for comprehensive analysis of multiple genes simultaneously, reducing turnaround times and costs. As a result, more healthcare providers are adopting these advanced testing methods, leading to increased accessibility for patients. The market is projected to witness substantial growth, with estimates suggesting a compound annual growth rate (CAGR) of over 10% in the coming years. This technological evolution not only improves patient outcomes but also encourages more individuals to undergo testing, further propelling the BRCA1 and BRCA2 Gene Market.

    Evolving Patient Advocacy and Support Networks

    The evolution of patient advocacy and support networks plays a pivotal role in the BRCA1 and BRCA2 Gene Market. Organizations dedicated to raising awareness about hereditary cancers are increasingly active in educating the public about the importance of genetic testing. These networks provide resources and support for individuals at risk, encouraging them to pursue testing and preventive measures. The growing presence of these advocacy groups is likely to lead to higher testing rates, as they empower patients to make informed decisions about their health. Furthermore, the collaboration between advocacy organizations and healthcare providers is fostering a more supportive environment for patients. This trend is expected to contribute positively to the BRCA1 and BRCA2 Gene Market, as more individuals seek genetic testing and related services.

    Increasing Incidence of Breast and Ovarian Cancer

    The rising incidence of breast and ovarian cancer has a profound impact on the BRCA1 and BRCA2 Gene Market. As awareness of hereditary cancer syndromes grows, more individuals seek genetic testing to assess their risk. According to recent statistics, approximately 1 in 8 women will develop breast cancer in their lifetime, with a notable percentage linked to BRCA mutations. This trend is likely to drive demand for genetic testing services and counseling, thereby expanding the market. Furthermore, the increasing number of high-risk individuals seeking preventive measures, such as prophylactic surgeries, is expected to bolster the market. The BRCA1 and BRCA2 Gene Market is thus positioned for growth as healthcare providers emphasize early detection and risk management.

    Market Segment Insights

    By By Test Type: Genetic Testing (Largest) vs. Predictive Testing (Fastest-Growing)

    In the BRCA1 and BRCA2 Gene Market, Genetic Testing is the largest segment, capturing a significant portion of the market share due to its widespread acceptance and application in identifying mutations related to breast and ovarian cancer. Carrier Testing also stands out as a strong segment, followed closely by Prenatal and Predictive Testing, which are gaining traction as awareness and demand for genetic insights increase. As patients and healthcare providers recognize the importance of early detection and prevention, these segments are poised for substantial growth.

    Predictive Testing: Emerging vs. Carrier Testing: Dominant

    Carrier Testing is currently the dominant force in the BRCA1 and BRCA2 Gene Market, as it provides essential insights for individuals at risk of hereditary cancers, aiding in family planning and treatment decisions. In contrast, Predictive Testing, while emerging, is rapidly gaining attention as advancements in technology enhance its accuracy and accessibility. Predictive Testing uses genetic information to assess the likelihood of developing cancer, thereby empowering at-risk individuals with proactive measures. As public health initiatives promote genetic education and awareness, both segments are expected to evolve with their respective strengths, each addressing unique patient needs in the context of genetic risk.

    By By Application: Breast Cancer (Largest) vs. Ovarian Cancer (Fastest-Growing)

    In the BRCA1 and BRCA2 Gene Market, the application segments showcase varied market shares, with Breast Cancer leading as the largest shareholder. This application benefits from heightened awareness and screening initiatives that have catalyzed its growth. Ovarian Cancer, although smaller in terms of current market share, is rapidly gaining traction due to increasing diagnostic innovations and an upsurge in preventive genetic testing driven by rising incidence rates. Together, these two applications represent a significant focus in the market.

    Breast Cancer (Dominant) vs. Ovarian Cancer (Emerging)

    Breast Cancer remains the dominant application in the BRCA1 and BRCA2 Gene Market, largely due to the extensive research funding and public health campaigns aimed at early detection and prevention. The established treatment protocols and outcomes for breast cancer screening further solidify its standing. In contrast, Ovarian Cancer is emerging as an influential segment, spurred by advancements in genetic screening technologies and increased awareness among at-risk populations. This set of factors is leading to a growing emphasis on innovative therapeutic strategies which may enhance treatment outcomes and improve patient prognosis.

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

    In the BRCA1 and BRCA2 Gene Market, Next Generation Sequencing (NGS) occupies the largest share among the various technology segments, primarily due to its comprehensive genetic analysis capabilities and cost-effectiveness. NGS not only allows for whole-genome sequencing but also provides high-throughput data, making it a preferred choice for both healthcare professionals and researchers. Conversely, the Polymerase Chain Reaction (PCR) technology, while smaller in market share compared to NGS, is witnessing rapid growth as it becomes more affordable and accessible, especially for specific targeted tests regarding BRCA1 and BRCA2 mutations. The growth trends within the technology segment are significantly influenced by advancements in genomic research and increased awareness of genetic testing. The rising prevalence of breast and ovarian cancers associated with BRCA mutations is driving demand for efficient testing methods. Additionally, the integration of PCR technology into routine diagnostics is enhancing its appeal, emerging as a critical asset in early detection scenarios. Overall, the combination of robust market demand and technological innovation is poised to propel the segment further in the coming years.

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

    Next Generation Sequencing (NGS) remains the dominant technology in the BRCA1 and BRCA2 Gene Market, favored for its ability to provide extensive insights into genetic variations with high accuracy. This technology leverages advanced algorithms and sequencing methods, making it crucial for comprehensive cancer risk assessments and personalized medicine. Its versatility allows it to adapt to various research and clinical applications, solidifying its position as a leader in the genomic testing landscape. On the other hand, Polymerase Chain Reaction (PCR) is steadily emerging as a vital tool, particularly in scenarios requiring rapid and targeted testing. Its specificity and reliability for detecting BRCA mutations at a molecular level have made it increasingly popular among clinicians and researchers alike. As PCR technology evolves, with enhancements such as real-time PCR, it promises to establish a significant foothold in the market.

    By By End User: Hospitals (Largest) vs. Diagnostic Laboratories (Fastest-Growing)

    In the BRCA1 and BRCA2 Gene Market, hospitals hold the largest share due to their comprehensive cancer care services and capacity for advanced genetic testing. Diagnostic laboratories closely follow, playing a crucial role by providing specialized tests at a high volume, although they maintain a smaller share compared to hospitals. Research institutions, while important, represent a lesser portion of the market as they primarily focus on scientific studies and advanced understanding rather than direct clinical applications.

    Hospitals (Dominant) vs. Research Institutions (Emerging)

    Hospitals are the dominant end user in the BRCA1 and BRCA2 Gene Market, offering extensive resources for cancer diagnostics and treatment. They possess the infrastructure to adopt the latest technologies rapidly and have established relationships with patients, ensuring consistent gene testing and counseling services. In contrast, research institutions are emerging as vital contributors, driving innovation and deeper insights into genetic mutations associated with breast and ovarian cancers. They are increasingly collaborating with clinical environments to translate research findings into practical applications, potentially expanding their market role.

    Get more detailed insights about BRCA1 and BRCA2 Gene Market

    Regional Insights

    North America : Leading Innovation and Research

    North America is the largest market for BRCA1 and BRCA2 gene testing, accounting for approximately 60% of the global market share. The region benefits from advanced healthcare infrastructure, high awareness of genetic testing, and supportive regulatory frameworks. The increasing prevalence of breast and ovarian cancers drives demand, alongside initiatives promoting genetic screening. Regulatory bodies like the FDA are actively involved in ensuring the safety and efficacy of genetic tests, further catalyzing market growth. The United States is the primary player in this market, with key companies such as Myriad Genetics, Invitae Corporation, and Ambry Genetics leading the charge. The competitive landscape is characterized by continuous innovation and strategic partnerships among these firms. The presence of established laboratories and diagnostic companies enhances accessibility to genetic testing services, ensuring that patients receive timely and accurate results. This competitive environment fosters advancements in testing technologies and personalized medicine.

    Europe : Emerging Market with Growth Potential

    Europe is witnessing significant growth in the BRCA1 and BRCA2 gene testing market, holding approximately 25% of the global share. The region's growth is driven by increasing awareness of genetic disorders, supportive healthcare policies, and advancements in genetic research. Countries like Germany and the UK are at the forefront, with regulatory bodies promoting genetic testing as part of routine healthcare. The European Medicines Agency (EMA) is actively involved in establishing guidelines for genetic testing, which is expected to further enhance market growth. Leading countries in Europe include Germany, the UK, and France, where the presence of key players like Fulgent Genetics and GeneDx is notable. The competitive landscape is evolving, with a mix of established companies and emerging startups focusing on innovative testing solutions. The collaboration between public health systems and private entities is fostering a conducive environment for genetic testing, ensuring that patients have access to essential services and information regarding their genetic health.

    Asia-Pacific : Rapidly Growing Genetic Testing Hub

    Asia-Pacific is emerging as a significant player in the BRCA1 and BRCA2 gene testing market, accounting for about 10% of the global market share. The region's growth is fueled by rising awareness of genetic disorders, increasing disposable incomes, and advancements in healthcare infrastructure. Countries like China and India are witnessing a surge in demand for genetic testing services, driven by a growing population and increasing incidences of hereditary cancers. Regulatory bodies are beginning to establish frameworks to support genetic testing, which is expected to further boost market growth. China and India are leading the charge in this region, with a growing number of local and international players entering the market. Companies like Laboratory Corporation of America and Quest Diagnostics are expanding their reach in these countries. The competitive landscape is characterized by a mix of established firms and new entrants, focusing on affordable and accessible genetic testing solutions. This dynamic environment is fostering innovation and improving patient access to essential genetic services, paving the way for future growth in the region.

    Middle East and Africa : Untapped Market with Potential

    The Middle East and Africa region represents an untapped market for BRCA1 and BRCA2 gene testing, holding approximately 5% of the global market share. The growth in this region is driven by increasing awareness of genetic disorders, improving healthcare infrastructure, and rising disposable incomes. Countries like South Africa and the UAE are beginning to recognize the importance of genetic testing, with regulatory bodies starting to establish guidelines to support this emerging market. The potential for growth is significant as healthcare systems evolve and adapt to include genetic services. In the Middle East and Africa, South Africa is leading the market, with a growing number of healthcare providers offering genetic testing services. The competitive landscape is still developing, with both local and international players exploring opportunities in this region. The presence of key players is limited, but as awareness increases, more companies are likely to enter the market, driving innovation and improving access to genetic testing services for patients across the region.

    Key Players and Competitive Insights

    The BRCA1 and BRCA2 Gene Market is characterized by a dynamic competitive landscape, driven by increasing awareness of genetic testing and the rising incidence of hereditary cancers. Key players such as Myriad Genetics (US), Invitae Corporation (US), and Ambry Genetics (US) are at the forefront, each adopting distinct strategies to enhance their market positioning. Myriad Genetics (US) has focused on innovation, particularly in expanding its testing portfolio to include additional hereditary cancer genes, thereby broadening its appeal to healthcare providers and patients alike. Meanwhile, Invitae Corporation (US) emphasizes accessibility and affordability, aiming to democratize genetic testing through partnerships with insurance providers and healthcare systems. Ambry Genetics (US) has carved a niche by specializing in comprehensive genetic testing services, which positions it well in a market that increasingly values personalized medicine. Collectively, these strategies contribute to a competitive environment that is both collaborative and competitive, as companies seek to differentiate themselves while also addressing the growing demand for genetic insights.

    In terms of business tactics, companies are increasingly localizing manufacturing and optimizing supply chains to enhance efficiency and responsiveness to market demands. The BRCA1 and BRCA2 Gene Market appears moderately fragmented, with several players vying for market share. However, the collective influence of major companies is significant, as they set industry standards and drive innovation through competitive practices. This structure allows for a diverse range of offerings, catering to various segments of the healthcare market.

    In August 2025, Myriad Genetics (US) announced a strategic partnership with a leading telehealth provider to integrate genetic counseling services into its testing process. This move is likely to enhance patient engagement and streamline the testing experience, reflecting a broader trend towards digital health solutions. Such partnerships may not only improve service delivery but also position Myriad as a leader in patient-centric care within the genetic testing space.

    In September 2025, Invitae Corporation (US) launched a new initiative aimed at reducing the cost of genetic testing for underserved populations. This initiative underscores Invitae's commitment to accessibility and aligns with its strategy to expand its market reach. By addressing financial barriers, Invitae could potentially capture a larger share of the market, particularly among demographics that have historically been underrepresented in genetic testing.

    In October 2025, Ambry Genetics (US) unveiled a new suite of tests that includes advanced AI-driven analytics to enhance the accuracy of genetic interpretations. This innovation not only positions Ambry at the cutting edge of technology but also reflects a growing trend towards the integration of artificial intelligence in healthcare. Such advancements may lead to improved patient outcomes and further solidify Ambry's reputation as a leader in genetic testing.

    As of October 2025, the competitive trends in the BRCA1 and BRCA2 Gene Market are increasingly defined by digitalization, sustainability, and the integration of artificial intelligence. Strategic alliances are becoming more prevalent, as companies recognize the value of collaboration in enhancing their service offerings and expanding their market presence. Looking ahead, competitive differentiation is likely to evolve from traditional price-based competition to a focus on innovation, technological advancements, and supply chain reliability. This shift may ultimately reshape the landscape of genetic testing, fostering an environment where quality and accessibility are paramount.

    Key Companies in the BRCA1 and BRCA2 Gene Market market include

    Industry Developments

    Recent developments in the BRCA1 and BRCA2 Gene Market highlight significant advancements and activities among major players such as Myriad Genetics, Invitae, and Illumina. Myriad Genetics has reported an expansion of its testing portfolio, which focuses on hereditary cancer risk assessments, enhancing its market position. Additionally, Invitae has been active in integrating genetic data into clinical practice, promoting accessibility for patients seeking genetic testing related to BRCA mutations. The current affairs also indicate a surge in collaborations among key companies aimed at advancing genetic research and testing capabilities, notably Abbott Laboratories and Roche.

    These partnerships are intended to innovate and streamline genetic testing solutions. Furthermore, the market has observed growth in valuations, particularly for companies emphasizing advanced diagnostics and personalized medicine, which have contributed to increased competitive dynamics. Regarding mergers and acquisitions, no recent significant transactions have been publicly reported among the listed companies, suggesting a focus on organic growth and strategic alliances instead. Nonetheless, the market is expected to evolve rapidly as consumer demand for genetic testing rises, driven by heightened awareness of hereditary cancer risks.

    Future Outlook

    BRCA1 and BRCA2 Gene Market Future Outlook

    The BRCA1 and BRCA2 Gene Market is projected to grow at a 7.47% CAGR from 2024 to 2035, driven by advancements in genetic testing and personalized medicine.

    New opportunities lie in:

    • Development of AI-driven genetic analysis platforms
    • Expansion of direct-to-consumer genetic testing services
    • Partnerships with healthcare providers for integrated screening programs

    By 2035, the market is expected to be robust, driven by innovation and increased consumer awareness.

    Market Segmentation

    BRCA1 and BRCA2 Gene Market End User Outlook

    • Hospitals
    • Diagnostic Laboratories
    • Research Institutions

    BRCA1 and BRCA2 Gene Market Test Type Outlook

    • Genetic Testing
    • Carrier Testing
    • Predictive Testing
    • Prenatal Testing

    BRCA1 and BRCA2 Gene Market Technology Outlook

    • Next Generation Sequencing
    • Polymerase Chain Reaction
    • Sanger Sequencing

    BRCA1 and BRCA2 Gene Market Application Outlook

    • Breast Cancer
    • Ovarian Cancer
    • Prostate Cancer
    • Pancreatic Cancer

    Report Scope

    MARKET SIZE 20246.169(USD Billion)
    MARKET SIZE 20256.63(USD Billion)
    MARKET SIZE 203513.63(USD Billion)
    COMPOUND ANNUAL GROWTH RATE (CAGR)7.47% (2024 - 2035)
    REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR2024
    Market Forecast Period2025 - 2035
    Historical Data2019 - 2024
    Market Forecast UnitsUSD Billion
    Key Companies ProfiledMarket analysis in progress
    Segments CoveredMarket segmentation analysis in progress
    Key Market OpportunitiesAdvancements in genetic testing technologies enhance accessibility in the BRCA1 and BRCA2 Gene Market.
    Key Market DynamicsRising demand for genetic testing drives innovation and competition in the BRCA1 and BRCA2 gene market.
    Countries CoveredNorth America, Europe, APAC, South America, MEA

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    FAQs

    What is the current valuation of the BRCA1 and BRCA2 Gene Market?

    The BRCA1 and BRCA2 Gene Market was valued at 6.169 USD Billion in 2024.

    What is the projected market size for the BRCA1 and BRCA2 Gene Market by 2035?

    The market is projected to reach 13.63 USD Billion by 2035.

    What is the expected CAGR for the BRCA1 and BRCA2 Gene Market during the forecast period?

    The expected CAGR for the market from 2025 to 2035 is 7.47%.

    Which companies are considered key players in the BRCA1 and BRCA2 Gene Market?

    Key players include Myriad Genetics, Invitae Corporation, Ambry Genetics, Fulgent Genetics, GeneDx, Laboratory Corporation of America, Quest Diagnostics, and PathGroup.

    What are the main segments of the BRCA1 and BRCA2 Gene Market?

    The main segments include Test Type, Application, Technology, and End User.

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