According to recent study by nova one advisor, the U.S. tissue diagnostics market size was exhibited at USD 2.46 billion in 2023 and is projected to hit around USD 3.61 billion by 2033, growing at a CAGR of 3.92 % during the forecast period 2024 to 2033.
According to recent study by nova one advisor, the U.S. tissue diagnostics market size was exhibited at USD 2.46 billion in 2023 and is projected to hit around USD 3.61 billion by 2033, growing at a CAGR of 3.92 % during the forecast period 2024 to 2033. Advancements in technology, rising prevalence of chronic diseases, increasing demand for personalized medicine, aging population, and healthcare infrastructure development.
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U.S. Tissue Diagnostics Market overview
The U.S. tissue diagnosis market refers to the sector within the healthcare industry dedicated to diagnosing diseases through the analysis of tissue samples obtained from patients. This market encompasses various diagnostic techniques such as histopathology, cytology, and molecular diagnostics. Histopathology involves examining tissue samples under a microscope to detect abnormalities, while cytology focuses on studying individual cells for signs of disease. Molecular diagnostics employ techniques like PCR and DNA sequencing to identify genetic markers associated with specific conditions. The U.S. tissue diagnosis market plays a critical role in disease detection, prognosis, and treatment planning, guiding clinicians in providing personalized patient care.
Applications of tissue diagnosis in the U.S. span across numerous medical specialties, including oncology, pathology, gastroenterology, and dermatology. In oncology, tissue diagnosis is crucial for identifying cancerous cells, determining tumor type and grade, and guiding treatment decisions such as chemotherapy, radiation therapy, or surgery. Pathologists use tissue diagnosis to assess organ function and detect abnormalities, aiding in the diagnosis of various diseases. Additionally, tissue diagnosis assists gastroenterologists in identifying gastrointestinal disorders, such as inflammatory bowel disease or colorectal cancer, through biopsy analysis. Dermatologists rely on tissue diagnosis to diagnose skin conditions like melanoma or psoriasis, facilitating appropriate treatment strategies for patients. Overall, the tissue diagnosis market in the U.S. serves as a cornerstone in the accurate diagnosis and management of a wide range of medical conditions.
Key Insights
- By technology and product outlook the immunohistochemistry (IHC) segment dominated the market 35.02%.in 2023.
- By application the breast cancer segment highest revenue share of over 55% in 2023.
Tissue Diagnostics Market Size in global 2024 to 2033
The global tissue diagnostics market size was valued at USD 5.73 billion in 2023 and is anticipated to reach around USD 11.45 billion by 2033, growing at a CAGR of 7.16% from 2024 to 2033.
- The U.S. dominates the tissue diagnostics market globally due to advanced healthcare infrastructure, extensive research and development activities, and high healthcare expenditure. Key players in the U.S. tissue diagnostics market include companies like Roche Diagnostics, Danaher Corporation, Thermo Fisher Scientific, and Abbott Laboratories. These companies offer a wide range of tissue diagnostic products and services, contributing to the market’s growth.
- Major countries within the U.S. tissue diagnostics market include the United States itself, with its large population base, followed by Canada, which also benefits from advanced healthcare systems and significant investments in medical research and innovation.
- Cancer remains a formidable health challenge in the United States, consistently ranking among the top two leading causes of death for over 75 years. The National Cancer Institute (NCI) reports a sobering statistic is nearly 40% of all Americans will confront a cancer diagnosis at some juncture in their lives. With data projecting approximately 1.96 million new cancer cases in 2023 alone, the burden of this disease looms large. Tragically, the toll extends beyond diagnoses, with over 609,000 individuals projected to succumb to cancer-related complications. These figures underscore the urgent need for continued research, improved preventive measures, and enhanced treatment modalities to combat this pervasive threat to public health.
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U.S. Tissue Diagnostics Market dynamics
Drivers
Advancements in personalized medicine
Advancements in personalized medicine serve as a significant driver in the U.S. tissue diagnostics market. Personalized medicine aims to tailor medical treatment to individual patients based on their unique genetic makeup, lifestyle, and environment. Tissue diagnostics play a crucial role in this paradigm by providing detailed molecular information about diseases, enabling healthcare professionals to select the most effective therapies for patients. The integration of molecular diagnostics, such as next-generation sequencing and companion diagnostics, allows for precise disease characterization and treatment optimization. This emphasis on personalized approaches fuels the demand for innovative tissue diagnostic technologies and services, driving market growth in the United States.
- In September 2023, Lunit collaborated with Guardant Health, a US precision oncology firm, to introduce its cancer diagnosis services in Korea. Lunit will distribute Guardant Health’s liquid biopsy and tissue genetic analysis solutions, enabling precise cancer detection through blood samples across medical institutions in Korea.
Restraint
Regulatory challenges
The U.S. tissue diagnostics market faces regulatory challenges that restrain its growth trajectory. Stringent regulatory requirements imposed by agencies such as the FDA significantly impact the development and approval process for tissue diagnostic products. Compliance with these regulations necessitates extensive clinical trials and validation studies, leading to prolonged product development timelines and increased costs for manufacturers. Moreover, evolving regulatory landscape and frequent policy changes introduce uncertainties, hindering investment and innovation in the market. These regulatory hurdles not only impede market entry for new players but also pose challenges for existing companies in maintaining compliance while striving for innovation and market expansion.
Opportunity
Expansion of telepathology services
The U.S. tissue diagnostics market presents a promising opportunity for the expansion of telepathology services. Telepathology enables pathologists to remotely access and interpret tissue samples, overcoming geographical barriers and enhancing diagnostic efficiency. With the increasing demand for timely and accurate diagnoses, especially in underserved rural areas, telepathology offers a solution to improve accessibility to expert pathology services. Additionally, advancements in digital imaging technology and communication infrastructure support the seamless transmission of high-resolution images for remote analysis. By leveraging telepathology, healthcare providers can streamline workflow, reduce turnaround times, and optimize patient care delivery in the U.S. tissue diagnostics market.
By technology and product outlook
- In the realm of technology and product outlook, immunohistochemistry (IHC) stands out as a pivotal method in tissue diagnostics within the U.S. market. Its significance lies in its ability to visualize specific proteins within tissue samples, aiding in the diagnosis and classification of various diseases, notably cancer. This technique allows for precise identification of biomarkers, guiding clinicians in treatment decisions and prognostic assessments.
- When considering consumables, the reagent segment holds considerable importance. Reagents are essential components in tissue diagnostic procedures, facilitating the staining and visualization of tissue samples. They play a crucial role in achieving accurate and reliable results, thereby influencing diagnostic accuracy and patient care outcomes.
- In the realm of in situ hybridization (ISH), instruments take precedence as key components in tissue diagnostics. ISH enables the detection and localization of specific nucleic acid sequences within tissue samples, offering insights into gene expression patterns and genomic alterations associated with diseases like cancer. Instruments designed for ISH procedures enhance efficiency and reproducibility, ensuring high-quality results for diagnostic purposes.
- However, amidst these advanced techniques, the primary and special staining method known as Hematoxylin and Eosin (H&E) staining continues to dominate the U.S. tissue diagnostics market. H&E staining is a cornerstone technique in pathology, providing essential information about tissue morphology and cellular structure. Its widespread adoption is due to its versatility, cost-effectiveness, and ability to provide valuable diagnostic information across a wide range of medical specialties, from oncology to dermatology. Additionally, H&E staining serves as the foundation for subsequent diagnostic tests, making it an indispensable tool in tissue diagnostics within the U.S. market.
By application
The dominance of the breast cancer segment in the U.S. tissue diagnostics market is driven by several factors. Breast cancer is one of the most prevalent cancers among women in the United States, making early detection and accurate diagnosis crucial for effective treatment and patient outcomes. Tissue diagnostics play a pivotal role in breast cancer diagnosis, guiding treatment decisions and prognostic assessments. Techniques such as immunohistochemistry and in situ hybridization allow for the precise identification of biomarkers associated with breast cancer subtypes, enabling personalized treatment approaches. Moreover, ongoing advancements in breast cancer research and targeted therapies further underscore the significance of tissue diagnostics in this segment.
- In December 2023, Cytelabs introduced DISH testing for Breast Cancer, a FDA-approved technique revolutionizing HER2 testing accuracy. Vital for precision therapy, it minimizes waiting times, averting delays in initiating appropriate treatment plans.
- Metropolis conducted comprehensive BRCA gene testing from 2017 to 2023. Of 1003 patients tested, 13.25% had pathogenic variants, with 59.4% in BRCA1 and the remainder in BRCA2 or a combination. Family history was significant, with 33.61% having a history of breast cancer and 37.74% of ovarian cancer. 44.83% had both family histories.
U.S. Tissue Diagnostics Market Recent advancements
- In February 2024, Fujifilm India introduced the ALOKA ARIETTA 850 diagnostic ultrasound system. Endoscopic Ultrasound (EUS) offers minimally invasive assessment for digestive tract malignancies and adjacent organs. It enables precise examination of organs such as lungs, pancreas, gallbladder, liver, lymph nodes, and surrounding areas.
- In March 2024, UK diagnostics firm 52North Health plans to launch Neutrocheck, a test for neutropenic sepsis, in Europe and the US in 2025. The test utilizes a lateral flow assay and a portable device, enabling cancer patients undergoing chemotherapy to assess their risk and seek timely medical attention if necessary.
Related Report
- Oncology Clinical Trials Market: https://www.biospace.com/article/releases/oncology-clinical-trials-market-experiencing-rapid-growth/
- U.S. Point-of-Care Molecular Diagnostics Market: https://www.biospace.com/article/releases/u-s-point-of-care-molecular-diagnostics-industry-is-rising-rapidly/
- Genomics Market: https://www.biospace.com/article/releases/genomics-market-size-to-hit-usd-157-47-billion-by-2033/
- Diagnostic Testing Market: https://www.biospace.com/article/releases/diagnostic-testing-market-size-to-reach-usd-449-78-billion-by-2033/
- DNA Diagnostics Market : https://www.biospace.com/article/releases/dna-diagnostics-market-size-to-hit-usd-16-05-billion-by-2033/
- Breast Cancer Diagnostics Market: https://www.biospace.com/article/breast-cancer-diagnostics-market-size-share-and-growth-report-2033/
U.S. Tissue Diagnostics Market Top Key Companies:
- Merck KGaA
- Thermo Fisher Scientific, Inc.
- F. Hoffmann-La Roche Ltd.
- Abbott Laboratories
- Siemens Healthineers AG
- Danaher
- bioMérieux SA
- QIAGEN
- Becton, Dickinson & Company (BD)
- Agilent Technologies, Inc.
- General Electric Company (GE Healthcare)
- BioGenex
- Cell Signaling Technology, Inc.
- Bio SB
- DiaGenic ASA
- Sakura Finetek Japan Co., Ltd.
- Abcam plc
- Enzo Life Sciences, Inc.
- VITRO SA (Master Diagnóstica)
- TissueGnostics GmbH
U.S. Tissue 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. Tissue Diagnostics market.
By Technology & Product
- Immunohistochemistry
- Instruments
- Slide Staining Systems
- Tissue Microarrays
- Tissue Processing Systems
- Slide Scanners
- Other Products
- Consumables
- Reagents
- Antibodies
- Kits
- In situ Hybridization
- Instruments
- Consumables
- Software
- Primary & Special Staining
- H&E Staining
- Special Staining
- Digital Pathology & Workflow
- Whole Slide Imaging
- Image Analysis Informatics
- Information Management System Storage & Communication
- Anatomic Pathology
- Instruments
- Microtomes & Cryostat Microtomes
- Tissue Processors
- Automatic Strainers
- Other Products
- Consumables
- Reagents & Antibodies
- Probes & Kits
- Others
- Instruments
By Application
- Breast Cancer
- Non-Small Cell Lung Cancer (NSCLC)
- Prostate Cancer
- Gastric Cancer
- Other Cancers
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