North America Cancer Tissue Diagnostics Market Key Details and Outlook by Top Companies till 2027

The North America cancer tissue diagnostics market is expected to reach US$ 1,587.38 Mn in 2027 from US$ 923.79 Mn in 2018. The market is estimated to grow with a CAGR of 6.5% from 2019-2027.

The growth of the market is driven by the factors such as, growing cancer prevalence in North American region and new product launches & FDA approvals. However, the market is likely to slower down its growth due to the lack of reimbursement policies for cancer diagnosis in the region.

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Frequent FDA approvals and product launches fuel the growth of the market for cancer tissue diagnostics. Most of the major market players are involved in the manufacturing wide range of cancer diagnostics products that offer maximum advantages and early diagnosis. For instance, in June 2019, Agilent Technologies Inc. received the U.S. Food and Drug Administration (FDA) approval for its PD-L1 IHC 22C3 pharmDx assay. The assay is approved to aim in identifying patients with head and neck squamous cell carcinoma (HNSCC) for treatment with KEYTRUDA (pembrolizumab), anti-PD-1 therapy manufactured by Merck. Furthermore, In March 2018, Agilent Technologies Inc. launched a new color for immunohistochemistry: HRP Magenta for Dako Omnis. The latest staining characteristics of the chromogen will help it for the assessment of skin and lung tissue. Thus, the constant developments in technology in diagnostics along with, FDA approvals accelerate the market growth during the forecast period.

US is expected to lead the market in the North America region owing to increasing prevalence of cancer, improved diagnosis and treatment of the condition along with the advancements made by market players. Moreover, the country has several hospitals, super specialty hospitals which offers diagnostic and treatment services for the cardiovascular diseases. Therefore, considering the above mentioned factors the growth of the market in the country is likely to contribute largest share in the North America region during the forecast period.

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The List of Companies

Hoffmann-La Roche Ltd
Thermo Fisher Scientific Inc.

Bio Rad Laboratories Inc.

Abbott

Enzo Life Sciences, Inc.

Agilent Technologies, Inc.

Cancer Genetics Inc.

Merck KGaA (Sigma-Aldrich Co. LLC)

Danaher Corporation

Abcam plc

North America Cancer Tissue Diagnostics Market

The North America Cancer Tissue Diagnostics market is a rapidly evolving sector within the global healthcare industry. This market primarily involves the use of advanced diagnostic tools and techniques to detect and diagnose various forms of cancer in tissue samples. The rise in the prevalence of cancer, along with advancements in technology, is driving significant growth in the cancer tissue diagnostics market. In North America, particularly in the United States and Canada, there is a strong focus on improving diagnostic accuracy, expanding access to testing, and enhancing treatment outcomes for patients.

Market Overview

Cancer is one of the leading causes of death in North America. According to the American Cancer Society, an estimated 1.9 million new cancer cases are expected to be diagnosed in the United States in 2025, with nearly 600,000 deaths from the disease. This highlights the urgent need for effective and timely diagnostic tools that can accurately detect cancer at various stages of progression. Tissue diagnostics, including techniques like immunohistochemistry (IHC), in situ hybridization (ISH), and molecular diagnostics, play a pivotal role in identifying the presence of cancer and providing information that can guide treatment decisions.

North America Cancer Tissue Diagnostics: Strategic Insights
The North American Cancer Tissue Diagnostics market is a highly dynamic and competitive landscape, driven by continuous technological advancements, regulatory approvals, and an increasing demand for early and precise cancer detection. As the region accounts for a significant share of the global cancer diagnostics market, key players must stay ahead of trends, respond to shifting demands, and recognize emerging opportunities. Strategic insights into this market enable industry stakeholders-including investors, manufacturers, and healthcare providers-to make informed decisions that drive profitability and ensure long-term success. Below is a comprehensive data-driven analysis of the current landscape, trends, key players, and strategic recommendations.

1. Market Landscape and Key Trends
The North American Cancer Tissue Diagnostics market is characterized by several emerging trends and market dynamics:

Technological Advancements: Technological innovation is a major driver in the cancer diagnostics field. The market has witnessed the introduction of advanced molecular diagnostic technologies like Next-Generation Sequencing (NGS) and liquid biopsy. These innovations allow for a more detailed genetic analysis, enabling early detection of cancer and better-targeted therapies. The rise of digital pathology and artificial intelligence (AI) is also transforming the way pathologists review and interpret tissue samples. AI-powered algorithms can analyze vast amounts of data quickly, enhancing diagnostic accuracy and speed.

Personalized and Precision Medicine: Personalized medicine continues to gain traction in oncology, where treatments are tailored to the unique genetic profile of patients' tumors. Tissue diagnostics plays a pivotal role in this shift, as it helps identify specific biomarkers that can guide therapeutic decision-making. Diagnostic assays that identify genetic mutations or protein expressions are becoming critical in the treatment of cancer, particularly in precision therapies for cancers like breast, lung, and colorectal cancer.

FDA Approvals and Regulatory Developments: Frequent approvals by the S. Food and Drug Administration (FDA) for innovative diagnostic products play a significant role in market growth. Products such as the PD-L1 IHC 22C3 pharmDx assay (approved for use with Merck's KEYTRUDA) are creating new avenues for treatment and diagnosis, especially in cancers like head and neck squamous cell carcinoma (HNSCC). The FDA's evolving regulatory stance, especially for advanced diagnostic tools, enhances market confidence and allows rapid market penetration for new products.

Demand for Early Detection: The increasing focus on early cancer detection is transforming the cancer diagnostics space. Early diagnosis significantly improves treatment outcomes, leading to better survival rates and reduced treatment costs. As awareness around early detection rises, the adoption of diagnostic tools like immunohistochemistry (IHC), in situ hybridization (ISH), and biopsy-based testing is increasing among healthcare professionals and patients.
Healthcare System Investments: Investments in cancer diagnostics by public and private stakeholders, such as government funding for cancer research and hospital infrastructure development, continue to support the growth of the market. In particular, the Cancer Moonshot Initiative and funding from the National Cancer Institute (NCI) are expected to fuel further innovation in cancer diagnostics and treatment in the U.S.

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