Market Overview:

Global Tissue Diagnostics Market size was valued at around 8.04 billion in 2023 and is expected to reach a value of USD 16.75 billion by 2032, at a CAGR of 5.9% over the forecast period (2024–2032).

The Pan American Health Organisation (PAHO) estimated that by 2023, there will be 10 million deaths due to cancer and 20 million new cases, and 30 million cases are estimated to be reported every year by 2040. Some of the factors driving market growth include the requirement for early disease detection, ageing populations, and developments in in situ hybridisation and immunohistochemistry methods. Increasing healthcare expenses and global awareness of cancer screening programs are also fuelling market growth further.

One out of five men and one out of six women are likely to develop cancer at some point in their lifetime, statistics say, and thus it becomes a significant concern. The prevalence rate of 5 years in 2020 was approximately 50.5 million. As per WHO projections, there would be more than 35 million new cases of cancer by 2050, up from the 77% increase projected in 20 million cases for 2022. Lung cancer is also the most commonly occurring cancer with more than 234,580 new cases predicted to occur in the US alone by 2024, as indicated by the American Cancer Society.

Digital pathology is transforming classical histopathology methods with greater productivity, advanced analysis, and communication between pathology clinics. Classical processes such as slide scanning, visualization, and analysis are initially converted to digital form with advanced digital tools to initiate the change. This reform is enhancing laboratory operations, access to quality care, and diagnostic accuracy. PoCGS-Pro, an automated gramme stainer that enhances staining technique, was launched by Kobe University and CarbGeM Inc. in January 2024 Although the PoCGS-Pro is legally approved as a specified maintenance regulated medical device, CarbGeM Inc. is now selling it as a general medical device that requires special maintenance. The National Centre for Global Health and Medicine worked together with CarbGeM in developing this new technology, and this will give the company and its partners a competitive advantage in the market. By improved accuracy of diagnosis, offering access to advanced treatment within various health care settings, as well as streamlined workflow efficiency, the expansion is expected to be further boosted through these tissue diagnostics developments.

Key Findings:

• In 2022, breast cancer killed 670,000 people globally.
• Aside from age and gender, women with no specific risk factors represent nearly half of the total number of breast cancer cases.
• In 2022, breast cancer was the most common cancer among women in 157 of the 185 countries.
• Breast cancer exists in every country of the world.
• Men are also impacted by breast cancer in approximately 0.5–1% of instances.

Market Drivers

Global impact

• In high-income countries, the age-standardized mortality rate from breast cancer reduced by 40% from the 1980s to 2020. In those countries that have been successful at reducing the mortality rate from breast cancer, the annual decline has been in the range of 2 and 4%.
• Improving outcomes from breast cancer needs a transformation at the fundamental level of the health system to offer proven effective treatments. These are also essential in treating non-malignant noncommunicable diseases (NCDs) and other cancers. An example would be creating reliable networks of referral between primary care offices, district hospitals, and specialised cancer treatment centres.
• The care for prostate, colorectal, lung, and cervical cancers all depend on the development of reliable networks of referral from primary care offices to secondary facilities and specialized cancer centres. Breast cancer is thus said to be an indicator disease, and measures for the management of other cancers can be planned on this basis.

Market Opportunities

Significant opportunities in BRICS Countries

• Later, growing economies such as China, India, and Brazil will also be important sources of growth for industry players. According to SRB's analysis, the BRICS countries are expected to generate USD 24,142,139 million in 2021, or 50% of the world's GDP, by 2030. Notably, the GDPs of each of these countries have consistently increased each year; for example, China's GDP has increased by about six times since 2003. The healthcare industry is expected to grow because of this economic upturn, offering market participants profitable opportunities.
• The big population base supports a persistent diagnostic market in China and India, especially. Chronic illnesses such as cancer, cardiovascular diseases (CVDs), and autoimmune diseases are prevalent in these regions because of lifestyle changes and unhygienic food. Market participants will have ample growth opportunities as the incidence of chronic disease is on the rise, there is a large base of patients in these regions, and healthcare expenditure is on the rise. For instance, as per the estimates of NIH, 1,461,427 cancer patients were diagnosed with cancer in 2022. Likewise, from PubMed, in 2020, China was the cause of 30% of all fatalities due to cancers globally and accounted for 24% of those newly diagnosed with cancer. Untreated cases, absence of lab facilities for diagnostic purposes, and absence of histopathologists to perform such tasks are all found to be associated with the heightened death rates.

Market Restraining Factors

Stringent Regulatory requirement

• The principal challenge to firms seeking to bring innovative products to market is the FDA's current approval process for tissue diagnostic devices and disposables. Numerous of them qualify as Class III, the most rigorous application pathway and requires extensive Premarket Approval (PMA) testing for efficacy and safety.
• The complexity is compounded by the recent release of FDA guideline documents. A 510(k) filing must be done for any modifications done to devices, such as software updates, installations, and others. The future Medical Device law (MDR) and In Vitro Diagnostic Device Regulation (IVDR) will impose stricter regulations on CE Marking, which is mandatory for market legitimacy. Meanwhile, In Vitro Diagnostic (IVD) products are governed by a different law in the EU.
• Compliance is challenging to these stringent guidelines by market players. Procedures must be adjusted for these standards to meet, hence a potential reason for short-run lags to gain access into markets and changing product launch calendars, especially the US and EU.

Segmentation Analysis

The market scope is segmented because of by Product, by Technology, by Disease Type, By End User.

• By Product

Based on the Product of the market is segmented into Acrylic, Polyurethanes, Epoxy, Others.

Acrylic adhesive resin was the leading segment in 2023 with the largest revenue share of more than 44.69%. In the construction industry, acrylic adhesives are becoming increasingly popular due to their superior impact strength, high water resistance, and adhesive qualities. The growth rate for this segment is expected to be 4.8% during the period from 2024 to 2030.

Epoxies are construction adhesives that are poised to register growth of 4.4% in terms of revenue over the duration of the forecast period. In applications where high bonding is required, such adhesives may be applied on many different substrates used in construction. In laminated timber, they are applied in walls, decking, roofs, and so on. They join stone, glass, metal, wood, and many different types of polymers together and have good heat and chemical resistance.

The polyurethanes industry will grow profitably and have a volume share of about 11.0% in 2023. Polyurethane adhesives are paintable, possess protest to water, low Odor, low VOC content, as well as cold and hot operating conditions. They find applications in interior as well as exterior Disease Types in construction applications.

• By Technology

Based on the Technology of the market is segmented into Immunohistochemistry, In Situ Hybridization, Digital Pathology & Workflow Management, Special Staining.

Among the technology sub-segments of the tissue diagnostics market, Immunohistochemistry (IHC) dominated the market. IHC is a widely applied method that utilizes antibodies to detect specific antigens in tissue specimens and diagnose and classify diseases, primarily cancers. Its dominance is driven by its key applications in cancer diagnosis where it detects tumour origin, subtype, and biomarker expression pivotal for treatment decision-making, including targeted therapies.

The specificity and range of IHC are the strength behind it. It is a highly useful tool in the identification of biomarkers like HER2, PD-L1, and ER/PR and is a major determinant in therapy selection in oncology. Rising incidence of cancer worldwide has provided a boost to the demand for IHC-based tests. Technology developments in IHC procedures, e.g., highly sensitive monoclonal antibodies and computerized stainers, have ensured that it became more accurate, efficient, and convenient and thus accelerated its application further.

But one of the reasons for IHC's success is its inclusion in personalized medicine. As medicine moved towards precision therapy, IHC was the preferred method of choice for defining the patient population for targeted treatments and immunotherapies. Moreover, IHC is more affordable and readily available compared to cutting-edge molecular diagnostic technologies, thus becoming the preferred option in developed as well as emerging economies.

• Regional Snapshots

By region, Insights into the markets in North America, Europe, Asia-Pacific, Latin America and MEA are provided by the study. Amongst the mentioned regions, North America leads the market in tissue diagnostics presently. The reasons are mostly attributed to having advanced healthcare facilities, significant expenditure on healthcare, and an overall focus on research and development. The United States of America takes the lead here with the excellent uptake of novel diagnostic technologies like automated tissue diagnostic platforms and artificial intelligence-driven solutions. Also, the region has a high incidence of cancer and other chronic conditions, coupled with established healthcare policies and reimbursement mechanisms, further enhancing the need for tissue diagnostics. The region also enjoys many industry participants, comprising both diagnostic firms and biotechnology companies, that drive quick innovations and extensive usage of tissue diagnostics.

Concerning the region growing the fastest, Asia-Pacific will be the most rapidly growing tissue diagnostics market. This is because there are numerous factors, such as the expanding healthcare infrastructure, growing incidence of cancer and other diseases, and heightened healthcare awareness, that drive growth in this region. Other nations such as China, India, and Japan are heavily investing in enhancing healthcare facilities, leading to the embracement of enhanced diagnostic technologies. Further, the rising tide of healthcare programs coupled with the greater emphasis on personalized care is fuelling the demand for tissue diagnostics in the region. The large population of the region as well as increasing disposable incomes also add to the increasing market opportunities.

List of Companies Profiled

• Hoffmann-La Roche Ltd.
• Abbott Laboratories
• Thermo Fisher Scientific Inc.
• Siemens
• Danaher
• bioMérieux SA
• QIAGEN
• BD
• Merck KGaA
• GE Healthcare
• BioGenex
• Cell Signaling Technology, Inc.
• Bio SB
• DiaGenic ASA
• Agilent Technologies

Key Industry Developments

In January 2024, through its location of a new regional headquarters in Dubai, United Arab Emirates, QIAGEN extended business in the Middle East region. The decision strengthens the firm's objective of raising its share in the expanding world and extend access to sample preparation and molecular diagnostics technology further. By supporting significant projects in healthcare, research, and industry with funding, the new headquarters will support QIAGEN's vision for its greater role in the region and for forming regional partnerships.

In February 2024, to provide better service to its life science customers, Merck KGaA inaugurated a new $21.88 million distribution centre in Cajamar, São Paulo, Brazil. Through enhanced operational efficiency and responsiveness, this investment enables Merck to bring advanced tissue diagnostics solutions to the region.

Report Coverage

The report will cover the qualitative and quantitative data on the global Tissue Diagnostics Market. The qualitative data includes latest trends, market players analysis, market drivers, market opportunity, and many others. Also, the report quantitative data includes market size for every region, country, and segments according to your requirements. We can also provide customize report in every industry vertical.

Report Scope and Segmentations

Regional Snapshots

By region, Insights into the markets in North America, Europe, Asia-Pacific, and the rest of the world are provided by the study. North America accounted for 45.87% of the tissue diagnostics market due to the region's high cancer incidence. To lower the number of cancer cases and raise demand for cancer detection in the local market, several public measures have been put in place. Cancer prevention in this domain is the focus of the Cancer Prevention and Control Research Network, the principal project of the Centers for Disease Control and Prevention. For the creation of novel tests, human tissue is a crucial component of personalized medicine.

The Asia Pacific region is anticipated to expand profitably throughout the projection period due to the increased number of international companies offering a wide range of tissue diagnostic tests. For instance, Indica Labs and Hamamatsu Photonics K.K. declared in October 2022 that they will collaborate to develop better integrated processes for digital pathology.

Tissue Diagnostics Market Report is also available for below Regions and Country Please Ask for that

North America

• U.S
• Canada

Europe

• Switzerland
• Belgium
• Germany
• France
• U.K
• Italy
• Spain
• Sweden
• Netherland
• Turkey
• Rest of Europe

Asia-Pacific

• India
• Australia
• Philippines
• Singapore
• South Korea
• Japan
• China
• Malaysia
• Thailand
• Indonesia
• Rest Of APAC

Latin America

• Mexico
• Argentina
• Peru
• Colombia
• Brazil
• Rest of South America

Middle East and Africa

• Saudi Arabia
• UAE
• Egypt
• South Africa
• Rest Of MEA

Points Covered in the Report:

• The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.
• The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analysed 5 years data history and forecast.
• The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail.
• Data and information by market player, by region, by type, by application and etc., and custom research can be added according to specific requirements.
• The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

Key Questions:

• How much the global Tissue Diagnostics Market valued?
• Which region has the largest share in 2024 for the global Tissue Diagnostics Market?
• What are the driving factors for the market?
• Which is the leading segment in the global market?
• What are the major players in the market?

Research Scope of Tissue Diagnostics Market:

• Historic year: 2019- 2022
• Base year: 2023
• Forecast: 2024 to 2032
• Representation of Market revenue in USD Billio

Tissue Diagnostics Market Trends: Market key trends which include Increased Competition and Continuous Innovations Trends: