According to recent study by nova one advisor, the U.S. oncology molecular diagnostics market size was valued at USD 0.85 billion in 2023 and is anticipated to reach around USD 2.74 billion by 2033, growing at a CAGR of 12.41% from 2024 to 2033
According to recent study by nova one advisor, the U.S. oncology molecular diagnostics market size was valued at USD 0.85 billion in 2023 and is anticipated to reach around USD 2.74 billion by 2033, growing at a CAGR of 12.41% from 2024 to 2033
U.S. oncology molecular diagnostics market include precision medicine, personalized treatment, technological advancements, and rising cancer prevalence.
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U.S. Oncology Molecular Diagnostics Market Overview
The U.S. oncology molecular diagnostics market refers to the sector within the medical industry that specializes in using molecular biology techniques to detect and analyze biomarkers associated with cancer. These diagnostics provide vital information about a patient’s cancer, such as its molecular subtype, genetic mutations, and potential treatment options. By analyzing the genetic makeup of tumors, oncologists can tailor treatment plans to each patient’s specific needs, leading to more personalized and effective therapies. This market encompasses various diagnostic tools, including polymerase chain reaction (PCR), next-generation sequencing (NGS), and fluorescence in situ hybridization (FISH), which enable precise identification and characterization of cancer biomarkers.
The applications of oncology molecular diagnostics are diverse and encompass various stages of cancer care. They are used for early detection and screening of cancer, enabling physicians to identify tumors at their earliest, most treatable stages. Additionally, these diagnostics play a crucial role in guiding treatment decisions, helping oncologists select the most appropriate therapies based on the molecular profile of the tumor. Furthermore, they are essential for monitoring disease progression and detecting any potential resistance to treatment, allowing for timely adjustments in therapy. Overall, oncology molecular diagnostics significantly contribute to improving patient outcomes by enabling personalized and targeted approaches to cancer management.
U.S. Oncology Molecular Diagnostics Market Key Takeaways
- By type, the breast cancer segment dominated the market in 2023.
- By type, the liver cancer segment is expected to grow at a notable rate in the market during the forecast period.
- By technology, the polymerase chain reaction (PCR) segment held the largest market share in 2023.
- By technology, the sequencing segment is expected to experience significant growth in the market during the forecast period.
- By product, the reagents segment is dominated the market in 2023.
- By product, the instruments segment is expected to grow at a considerable rate during the forecast period.
Oncology Molecular Diagnostic Market Size in the global 2024 to 2033
The global oncology molecular diagnostic market size was estimated at USD 2.55 billion in 2023 and is expected to be worth around USD 8.06 billion by 2033, poised to grow at a compound annual growth rate (CAGR) of 12.20% during the forecast period 2024 to 2033, North America contributed more than 41% of the market share in 2023.
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Geographical instances
The U.S. oncology molecular diagnostics market is highly dynamic, driven by advancements in precision medicine and personalized treatment approaches. In regional instances, key players in the market include California-based companies like Foundation Medicine and Guardant Health, which specialize in comprehensive genomic profiling and liquid biopsy testing, respectively. Meanwhile, in the Midwest, organizations like Exact Sciences Corporation, headquartered in Wisconsin, focus on non-invasive screening tests for various cancers. Additionally, in the Northeast, institutions like Memorial Sloan Kettering Cancer Center in New York play a pivotal role in research and development of novel molecular diagnostic technologies for oncology.
Market dynamics
Driver
Advancements in precision medicine
Advancements in precision medicine serve as a significant market driver for the U.S. oncology molecular diagnostics market. As understanding of cancer biology improves, there is a growing emphasis on tailoring treatment approaches to individual patients based on their unique genetic makeup and tumor characteristics. Molecular diagnostics play a crucial role in this paradigm shift by enabling the identification of specific genetic mutations and biomarkers associated with different types of cancer. This personalized approach not only improves treatment outcomes but also reduces adverse effects and healthcare costs. Consequently, the demand for oncology molecular diagnostics continues to rise as precision medicine gains traction in clinical practice.
- In October 2023, Dxcover plans a 2025 launch for its brain cancer blood test in Europe. The Glasgow-based oncology diagnostics firm utilizes infrared light on blood samples to predict cancer presence, leveraging evidence of light-molecule interaction to generate biological signals, classified by machine-learning algorithms for predictive analysis.
- In March 2024, Srikar Raman, a mechanical engineering alumnus of UIC, founded Tvaster Genkalp in 2021, focusing on early cancer detection. Understanding the critical importance of timely diagnosis for improved treatment outcomes, the company aims to provide accessible solutions to enhance survival rates and reduce healthcare costs associated with cancer care.
Restraint
Regulatory challenges
The U.S. oncology molecular diagnostics market faces significant regulatory hurdles, which can impede market growth. Stringent regulations by agencies such as the FDA require extensive clinical validation and approval processes for new diagnostic technologies, leading to delays in product commercialization and increased development costs. Additionally, evolving regulatory frameworks and changing reimbursement policies create uncertainty for market players, hindering investment in research and development. Compliance with complex regulatory requirements adds complexity and time to market for diagnostic products, limiting the ability of companies to introduce innovative solutions and potentially slowing down the adoption of advanced molecular diagnostics in oncology care.
Opportunity
Expanding applications in liquid biopsy
The U.S. oncology molecular diagnostics market holds immense potential in leveraging liquid biopsy technologies for early cancer detection, treatment monitoring, and assessment of therapeutic response. Liquid biopsies offer a non-invasive method for analyzing circulating tumor DNA, RNA, and proteins, providing valuable insights into tumor heterogeneity and evolution. With ongoing advancements in technology and the increasing adoption of liquid biopsy assays by healthcare providers, there’s a significant opportunity to further develop and commercialize these solutions. This presents a compelling avenue for companies to innovate and capitalize on the growing demand for minimally invasive diagnostic approaches in oncology.
- In June 2023, Labcorp introduced Labcorp Plasma Focus, a revolutionary liquid biopsy test designed to aid in the selection of targeted therapies for patients with advanced or metastatic solid tumors. By analyzing circulating cell-free DNA (cfDNA) through genetic sequencing, oncologists gain valuable insights to optimize patient care.
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Reports highlights
By type
In the U.S. oncology diagnostics market, breast cancer holds a dominant position by type. This is largely due to the high prevalence of breast cancer and the emphasis on early detection and screening programs. Molecular diagnostics for breast cancer encompass a range of tests, including genetic profiling, hormone receptor testing, and HER2/neu testing, which guide treatment decisions and improve patient outcomes. Key players in this segment include companies like Myriad Genetics and Genomic Health, which offer molecular assays for assessing the risk of recurrence and guiding therapy selection in breast cancer patients, contributing to the segment’s dominance.
By technology
In the U.S. oncology diagnostics market, the polymerase chain reaction (PCR) stands out as the dominant technology segment. PCR’s widespread adoption is attributed to its high sensitivity, specificity, and ability to amplify small amounts of DNA. This technology is instrumental in detecting genetic mutations, gene expression levels, and infectious agents associated with various cancers. Companies such as Roche Diagnostics and Thermo Fisher Scientific lead in providing PCR-based oncology diagnostic solutions. With continuous advancements in PCR techniques and automation, it remains a cornerstone in the arsenal of molecular diagnostic tools for precise cancer detection and monitoring in the United States.
By product
In the U.S. oncology diagnostics market, the reagent segment stands out as the dominant product category. Reagents play a crucial role in various diagnostic tests, including molecular assays and immunoassays, enabling the detection of specific biomarkers associated with cancer. Key factors driving the dominance of this segment include the increasing demand for accurate and reliable diagnostic tests, advancements in technology facilitating the development of innovative reagents, and the rising prevalence of cancer cases requiring early detection and personalized treatment strategies. Additionally, the reagent segment benefits from ongoing research and development efforts aimed at enhancing the sensitivity and specificity of diagnostic assays.
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U.S. Oncology Molecular Diagnostics Market Recent Developments
- In April 2024, Naveris, Inc., a leading provider of precision oncology diagnostics for viral-induced cancers launched Phase II clinical study in minimal residual disease positive (MRD+) HPV-driven neck and head cancer with the leading cancer research and institution Memorial Sloan Kettering Cancer Center (MSKCC).
- In July 2022, a next-generation molecular diagnostics organization, BillionToOne, launched Northstar Select and Northstar Response, its first liquid biopsy products.
- In April 2024, Envisagenics, an artificial intelligence driven biotechnology organization announced the launch of its journal Molecular Systems Biology the study is the evaluation of the organization’s SpliceCore AI/ML platform in Triple Negative Breast Cancer (TNBC).
- In April 2024, Genetic Technologies Limited, a leading global provider of genomics-based test in wellness, health, and serious disease announced the launch of company’s precision oncology division and the portfolio of the latest diagnostics tests under the gene Type precision oncology brand.
- In April 2024, Labcorp, a leading brand in the innovative and comprehensive laboratory services launched the Labcorp® Plasma Detect™, a clinically authorized tumor-informed molecular residual disease (MRD) and whole-genome sequencing circulating tumor DNA (ctDNA) solution for the early stage of colon cancer patients with the higher risk after the surgery or adjuvant chemotherapy (ACT).
- In April 2024, TwinStrand Biosciences®, a leading player in Duplex Sequencing technology that delivers the precise results to researchers from the applications from genetic toxicology to residual cancer detection announced the acceptance of standard project submission form (SPSF) from the company for Economic Cooperation and Development (OECD).
U.S. Oncology Molecular Diagnostics Market Top Key Companies:
- Roche Diagnostics
- Abbott Laboratories
- Thermo Fisher Scientific Inc.
- Illumina, Inc.
- Bio-Rad Laboratories, Inc.
- Myriad Genetics, Inc.
- Agilent Technologies, Inc.
- Danaher Corporation (Cepheid)
- Hologic, Inc.
- Foundation Medicine, Inc.
U.S. Oncology Molecular Diagnostics Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Oncology Molecular Diagnostics market.
By Type
- Breast Cancer
- Liver Cancer
- Prostate Cancer
- Colorectal Cancer
- Cervical Cancer
- Lung Cancer
- Blood Cancer
- Kidney Cancer
- Other Cancer
By Technology
- PCR
- Sequencing
- In Situ Hybridization
- INAAT
- Chips and Microarrays
- Mass Spectrometry
- TMA
- Others
By Product
- Reagents
- Instruments
- Others
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