Tissue Diagnostics Market by Product (Consumables (Antibodies, Reagents, Tissue, Probes), Instrument (Processing System, Scanner)), Technology (ISH, IHC, Slide Staining), Disease Type (Breast Cancer, Lymphoma, Prostate Cancer) & Region - Global Forecast to 2028
The global tissue diagnostics market in terms of revenue was estimated to be worth $5.6 billion in 2023 and is poised to reach $8.4 billion by 2028, growing at a CAGR of 8.4% from 2023 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. Market growth is driven by the growing private diagnostic centers globally, and rising geriatric population with subsequent growth in chronic and infectious diseases. On the other hand, high degree of consolidation and high cost of diagnostic imaging system are expected to restrain the growth of this market to a certain extent.
Tissue Diagnostics Market Size, Dynamics & Ecosystem
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Tissue Diagnostics Market Dynamics
DRIVER: Growing demand for digital pathology
Digital pathology systems are increasingly being utilized by healthcare professionals across the globe due to the ongoing trend of automation of diagnostic laboratory processes across major healthcare markets. Moreover, improved laboratory efficiency is critical for healthcare providers and patients for accurate and timely disease diagnosis to devise effective disease management strategies. With the greater utilization of digital and automated processes, laboratory technicians can offer accurate and affordable disease diagnoses in a time-bound manner. As a result, major healthcare service providers are adopting digital pathology systems and related software to offer efficient and affordable services to their customers.
Globally, governments and industry entities are directing their attention toward diverse strategies within the realm of digital pathology, aiming to offer highly advanced, swift, and precise diagnostic solutions. Highlighted are key advancements which mentioned in below:
- In January 2023, Agilent Technologies, Inc. has entered into a partnership with Akoya Biosciences, Inc. to develop multiplex-immunohistochemistry diagnostic solutions. This collaboration intends to commercialize workflow solutions for multiplex assays dedicated to tissue analysis, ultimately providing a comprehensive multiplex IHC solution for biomarker clinical research, facilitated by digital pathology.
- In June 2022, Roche introduced the VENTANA DP 600 slide scanner, a digital pathology system designed for generating digital representations of stained tissue samples.
These advancements, coupled with the emergence of high-tech and diagnostic firms, are anticipated to drive market growth.
RESTRAINT: Stringent Regulatory requirement
The FDA's current approval process for tissue diagnostic tools and consumables poses a significant hurdle for companies aiming to introduce innovative products. Many of these fall under Class III, requiring exhaustive Premarket Approval (PMA) that scrutinizes safety and effectiveness, marking the most rigorous application route.
The recent release of FDA guidance documents further adds to the complexity. Any alterations to devices demand a 510(k) submission, whether for software updates, installations, or other modifications. Meanwhile, in the EU, In Vitro Diagnostic (IVD) products adhere to a distinct regulation, with the forthcoming Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) adding more stringent criteria for CE Marking, crucial for market legality.
Aligning with these stringent regulations presents a challenge for market players. Adapting processes to comply with these norms may affect the launch timelines for new products, especially in the US and Europe, potentially creating temporary market entry delays.
OPPORTUNITY: Significant opportunities in BRICS Countries
Growing markets like India, China, and Brazil are poised to become pivotal growth arenas for industry stakeholders in the foreseeable future. As per SRB's analysis, the BRICS nations are projected to collectively contribute 50% to the global GDP by 2030, with a combined annual GDP of USD 24,142,139 million in 2021. Notably, each of these nations has seen consistent annual GDP increases; for instance, China's GDP has surged nearly sixfold since 2003. This economic upswing is anticipated to fuel expansion in the healthcare sector, presenting lucrative prospects for participants in the market.
Furthermore, the sizable population base, especially in India and China, forms a sustainable diagnostic market. Lifestyle shifts and suboptimal diets in these regions have elevated the prevalence of chronic ailments such as cancer, cardiovascular diseases (CVDs), and autoimmune disorders. The rising incidence of chronic conditions, coupled with a substantial patient pool in these regions and augmented healthcare spending, is set to create substantial growth avenues for market players. For instance, the NIH estimates India had 1,461,427 cancer patients in 2022. Similarly, China accounted for 24% of newly diagnosed cases and 30% of global cancer-related deaths in 2020, according to PubMed. The higher mortality rates are linked to undiagnosed cases, a shortage of diagnostic labs, and insufficient histopathologists in these regions.
CHALLENGE: Lack of Infrastructure and low awareness in middle and low income countries
The burden of cancer and other non-communicable diseases is very high in developing and underdeveloped countries. However, there is a glaring disparity in the access to care and health indicators in these countries as compared to their developed counterparts. This can be attributed to the lack of access to care, the limited availability of resources in terms of infrastructure and manpower, a lack of awareness, and the social stigma associated with cancer. According to the WHO, 44% of the WHO member states report having less than 1 physician per 1000 population. Similarly, according to the 2022 OECD data, China and India, respectively recorded doctor densities of 2.5 and 0.9 doctors per 1,000 people. There is a disproportionate distribution of health workers worldwide. Countries having the lowest relative need to have the highest numbers of health workers, while those with the highest disease burden have a smaller health workforce. The African region has more than 24% of the total global burden of disease but has access to only 3% of health workers and less than 1% of the world’s financial resources.
Tissue Diagnostics Market Segmentation & Geographical Spread
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In 2022, Consumables accounted for the largest share in the tissue diagnostics industry, by product.
Based on product, the tissue diagnostics market is segmented into consumables and instruments. Consumables accounted for the largest share of the market in 2022 by product segment. The rise in government and private funding in life sciences and cancer research and growing R&D expenditure by leading pharma companies, are factors expected to drive the growth of this products segment.
In 2022, Immunohistochemistry accounted for the largest share in the tissue diagnostics industry, by technology.
Based on technology, the tissue diagnostics market is segmented into four technology segments, namely, Immunohistochemistry (IHC), In Situ Hybridization (ISH), Digital Pathology & Workflow, and Special Staining. Immunohistochemistry (IHC), accounted for the largest share of the market in 2022 by technology. In IHC technique the antibodies are used to test certain antigens in tissue by combining immunological, anatomical, and biochemical techniques. The detection of antigens is achieved by using antibodies that bind to antigens with high specificity. This technology is widely used in the diagnosis of abnormal cells.
In 2022, Breast Cancer segment accounted for the largest share in the tissue diagnostics industry, by disease type.
Based on disease type, the tissue diagnostics market is segmented into six disease segments, namely, breast cancer, gastric cancer, lymphoma, prostate cancer, non-small cell lung cancer, and other disease types. In 2022, breast cancer accounted for the largest share of the market, by disease type. A number of factors led to the formation of breast cancer such as age, change in lifestyle and the use of hormone replacement therapy. Moreover, with a rise in breast cancer screening activities, the segment is expected to witness considerable growth during the forecast period.
In 2022, hospitals accounted for the largest share in the tissue diagnostics industry, by end user.”
Based on end user, the tissue diagnostics market is segmented into Hospitals, Pharmaceutical Companies, Research Laboratories, Contract Research Organizations, and Other End Users. Hospitals accounted for the largest share of the market by end user. The share of the end user segment is owing to the rise in prevalence of cancer and infectious diseases, which require Multi-specialty hospitals, cancer specialty hospitals, or cancer treatment centers. Hospitals generally have in-house laboratories that perform various types of diagnostics & monitoring tests that enable faster and reliable results.
In 2022, North America accounted for the largest share of the tissue diagnostics industry.
Based on Region, The global tissue diagnostics market is segmented into four regions: North America, Europe, Asia Pacific, and Rest of the world. North America accounted for the largest share of the market in 2022. The increasing healthcare expenditure, and high-quality infrastructure for hospitals and clinical laboratories in the region are the major factors driving the growth of market in North America.
The major players in tissue diagnostics market are F. Hoffmann-La Roche Ltd (Switzerland), Danaher Corporation (US), PHC Holdings Corporation (Japan), Agilent Technologies Inc. (US), Thermo Fisher Scientific, Inc. (US), These players’ market leadership is due to their broad product portfolios and vast global footprint. These dominant market players have advantages, including strong research and development budgets, better marketing and distribution networks, and established brand recognition.
Scope of the Tissue Diagnostics Industry
|
Report Metric |
Details |
|
Market Revenue in 2023 |
$5.6 billion |
|
Projected Revenue by 2028 |
$8.4 billion |
|
Revenue Rate |
Poised to Grow at a CAGR of 8.4% |
|
Market Driver |
Growing demand for digital pathology |
|
Market Opportunity |
Significant opportunities in BRICS Countries |
This report categorizes the tissue diagnostics market to forecast revenue and analyze trends in each of the following submarkets:
By Product
-
Consumables
- Antibodies
- Kits
- Reagents
- Probes
-
Instruments
- Slide-staining Systems
- Scanners
- Tissue-processing Systems
- Other Instruments (automated cover slippers, microtomes, embedding systems, paraffin dispensers, and slide labelers)
By Technology
- Immunohistochemistry
- In Situ Hybridization
- Digital Pathology & Workflow Management
- Special Staining
By Disease Type
- Breast Cancer
- Gastric Cancer
- Lymphoma
- Prostate Cancer
- Non-small Cell Lung Cancer
- Other Disease Types (neurological disease, cardiovascular disease, immunological diseases, infectious diseases, cancers of the bone, colon, thyroid, cervix, and skin; gallbladder carcinoma; HBV; Epstein-Barr virus; hepatitis; muscular dystrophy; renal cell carcinoma; and pleomorphic sarcomas.)
By End User
- Hospitals
- Research Laboratories
- Pharmaceutical Companies
- Contract Research Organizations (CROs)
- Other End Users (reference laboratories and academic research laboratories)
By Region
-
North America
- US
- Canada
-
Europe
- Germany
- UK
- France
- Italy
- Spain
- Rest of Europe
-
Asia Pacific
- Japan
- China
- India
- Rest of Asia Pacific
-
Rest of The World (RoW)
- Latin America
- Middle East & Africa
Recent Developments of Tissue Diagnostics Industry
- In April 2023, Leica Biosystems received FDA clearance for BOND MMR Antibody Panel, for detection of colorectal cancer.
- In April 2023, Leica Biosystems launched its BOND-PRIME an advanced staining solution for increasing diagnostic productivity in the lab
- In February 2023, F. Hoffman-La Roche Ltd launched its IDH1 R132H (MRQ-67) Rabbit Monoclonal Antibody and the ATRX Rabbit Polyclonal Antibody for use in the BenchMark series of instruments for the detection of brain cancer.
- In October 2022, F. Hoffman-La Roche Ltd received FDA approval for its PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody use as a companion diagnostic test to identify metastatic breast cancer patients with low HER2 expression.
- In August 2022, F. Hoffman-La Roche Ltd (Switzerland) received FDA approval its for label expansion for the VENTANA MMR RxDx Panel.
Frequently Asked Questions (FAQ):
What is the projected market revenue value of the global tissue diagnostics market?
The global tissue diagnostics market boasts a total revenue value of $8.4 billion by 2028.
What is the estimated growth rate (CAGR) of the global tissue diagnostics market?
The global tissue diagnostics market has an estimated compound annual growth rate (CAGR) of 8.4% and a revenue size in the region of $5.6 billion in 2023.
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The objective of the study is to analyze the key market dynamics such as drivers, opportunities, challenges, restraints, and key player strategies. To track companies’ developments such as product launches and approvals, expansions, and partnerships of the leading players, the competitive landscape of the tissue diagnostics market to analyze market players on various parameters within the broad categories of business and product strategy. Top-down and bottom-up approaches were used to estimate the market size. To estimate the market size of segments and subsegments, the market breakdown and data triangulation were used.
The four steps involved in estimating the market size are
Collecting Secondary Data
The secondary research data collection process involves the usage of secondary sources, directories, databases (such as Bloomberg Businessweek, Factiva, and D&B), annual reports, investor presentations, and SEC filings of companies. Secondary research was used to identify and collect information useful for the extensive, technical, market-oriented, and commercial study of the tissue diagnostics market. A database of the key industry leaders was also prepared using secondary research.
Collecting Primary Data
The primary research data was conducted after acquiring knowledge about the tissue diagnostics market scenario through secondary research. A significant number of primary interviews were conducted with stakeholders from both the demand side (such as doctors, nurses, and hospital purchase managers) and supply side (such as included various industry experts, such as Directors, Chief X Officers (CXOs), Vice Presidents (VPs) from business development, marketing and product development teams, product manufacturers, wholesalers, channel partners, and distributors) across major countries of North America, Europe, Asia Pacific, and Rest of the World. Approximately 40% of the primary interviews were conducted with stakeholders from the demand side while those from the supply side accounted for the remaining 60%. Primary data for this report was collected through questionnaires, emails, and telephonic interviews.
A breakdown of the primary respondents is provided below:
Breakdown of Primary Participants:
Note 1: Others include sales managers, marketing managers, and product managers.
Note 2: Tiers are defined based on a company’s total revenue. As of 2022: Tier 1 = >USD 1 billion, Tier 2 = USD 500 million to USD 1 billion, and Tier 3 <USD 500 million.
To know about the assumptions considered for the study, download the pdf brochure
|
COMPANY NAME |
DESIGNATION |
|
F. Hoffmann-La Roche Ltd (Switzerland) |
Product Manager |
|
Danaher Corporation (US) |
VP Sales |
|
Thermo Fisher Scientific Inc. (US) |
Regional Sales Head |
|
Abbott Laboratories (US) |
Sales Director |
Market Size Estimation
All major manufacturers offering various tissue diagnostics product were identified at the global/regional level. Revenue mapping was done for the major players and was extrapolated to arrive at the global market value of each type of segment. The value of tissue diagnostics market was also split into various segments and subsegments at the region and country level based on:
- Product mapping of various manufacturers for each type of tissue diagnostics products at the regional and country level
- Relative adoption pattern of each product type among key disease segments at the regional and/or country-level
- Detailed primary research to gather qualitative and quantitative information related to segments and subsegments at the regional and/or country level.
- Detailed secondary research to gauge the prevailing market trends at the regional and/or country-level
Global Tissue Diagnostics Market Size: Botton Up Approach
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Global tissue diagnostics Market Size: Top Down Approach
Data Triangulation
After arriving at the overall market size—using the market size estimation processes—the market was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics of each market segment and subsegment, the data triangulation, and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides in the tissue diagnostics industry.
Market Definition
Tissue-based diagnostics tests are performed for screening, diagnosing, and monitoring the response of cancer patients to therapy. Tissue diagnosis refers to the examination of intact tissues obtained during a medical procedure such as biopsies and surgeries. Tissue-based diagnostic tests are used in the treatment of breast cancer, gastric cancer, lymphoma, prostate cancer, non-small cell lung cancer, and other diseases (bone cancer, cervical cancer, colon cancer, cervix cancer, gallbladder carcinoma, skin cancer, HBV, Epstein-Barr virus, hepatitis, and muscular dystrophies). These diagnostics tests are carried out to identify a medical condition in its early stage so as to establish the correct course of treatment. Tissue diagnostic tests are also carried out to determine the course of recovery and response to the treatment.
Key Stakeholders
- Senior Management
- End User
- Finance/Procurement Department
- R&D Department
Report Objectives
- To provide detailed information about the factors influencing the market growth (such as drivers, restraints, opportunities, and challenges)
- To define, describe, segment, and forecast the tissue diagnostics market by product, technology, disease type, and end user, and region
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
- To analyze micro markets with respect to individual growth trends, prospects, and contributions to the overall tissue diagnostics market
- To forecast the size of the tissue diagnostics market in four main regions along with their respective key countries, namely, North America, Europe, Asia Pacific, and Rest of the World.
- To profile key players in the tissue diagnostics market and comprehensively analyze their core competencies and market shares
- To track and analyze competitive developments, such as product launches and approvals; expansions; and partnerships; of the leading players in the tissue diagnostics market
- To benchmark players within the tissue diagnostics market using the Competitive Leadership Mapping framework, which analyzes market players on various parameters within the broad categories of business and product strategy
Available Customizations
With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for this report:
Geographic Analysis
- Further breakdown of the tissue diagnostics market into specific countries/regions in the Rest of Europe, Rest of Asia Pacific, and Rest of the World.
Company Information
- Detailed analysis and profiling of additional market players (up to 3)
Generating Response ...
Growth opportunities and latent adjacency in Tissue Diagnostics Market