Blood & Tissue Kit Market
The future of the global blood & tissue kit market looks promising with opportunities in the R&D organization and biotechnology company markets. The global blood & tissue kit market is expected to reach an estimated $666 million by 2035 from $412 million in 2027 with a CAGR of 8.4% from 2027 to 2035. The major drivers for this market are the increasing demand for clinical diagnostic testing, the rising adoption of molecular biology research, and the growing need for efficient sample collection.
- Lucintel forecasts that, within the type category, whole blood is expected to witness the highest growth over the forecast period due to increased usage of whole blood in genomic research.
- Within the application category, biotechnology companies is expected to witness higher growth over the forecast period due to increased demand for extraction kits by biotech companies.
- In terms of regions, APAC is expected to witness the highest growth over the forecast period due to increased biotech and research funding and growth in the biotech sector in APAC.
Emerging Trends in Blood & Tissue Kit Market
The blood and tissue kit market will change in the 2025-2027 time frame toward more integrated and more complex offerings to better support end-user workflows. Other market drivers leading to an increased demand for blood and tissue collection kits include the expansion of biobanking, the need for more secure and traceable specimens, as well as the increasing demand for decentralized specimen collection and testing. According to Lucintel, other market trends include more automation in specimen collection and distribution as well as more special kit formats.
- Automation: Automation in specimen collection and aliquoting continued in 2025 and is especially beneficial in achieving higher workflow consistency. Further, continuous automation and integration of workflows is desired to minimize specimen handling.
- Special Kit Formats: The demand for specialized collection and stabilization kits for cell therapy and other specimens where the integrity of nucleic acids and/or tumor cells is of importance is increasing. The collection of specimens for biobanking continues to increase and more advanced, higher throughput biobanking is of increasing importance.
- Digital Identity: The adoption of digital specimen identity, e.g. through 2D barcodes, to maintain secure and traceable specimen workflows further increased in 2025.
- Sustainability: There is ongoing effort to reduce the use of high-temperature transport, shipping and packaging, as well as to utilize recyclable plastics. In 2025, several suppliers introduced designs to reduce the material used in blood and tissue kits. From 2022 to 2025, there was increased interest in environmental sustainability; this trend is projected to continue. As a result, suppliers of blood and tissue collection kits will have to further minimize kit waste in order to remain competitive.
- Supply Diversification: Manufacturers are strategically re-locating their production facilities to diverse geographic regions (i.e. North America, Europe, Asia, etc.) to mitigate supply chain and transportation disruption risks. This has increased the competitive supply and production capacity in the target geographic regions. This manufacturing model will allow companies to serve the diagnostic and research requirements of customers in target regional markets.
From a supply and demand perspective, it will be more profitable for suppliers to focus on a small number of high demand markets (i.e. biobanking, molecular diagnostics and cell therapy). There will be continuous price reduction, however, the positive impact of failure on research and/or clinical cases will help bolster profit margins.
Recent Developments in the Blood & Tissue Kit Market
The market is projected to grow from 2025 to 2027 as automation in extraction and molecular testing increases. Lucintel has identified trends in biobanking, oncology testing, and clinical research. Additionally, decentralized or "going to the patient" diagnostic testing is on the rise. Automation has led to an increase in throughput. Suppliers that can provide automation for multiple specimen types are preferable.
- Automation in Molecular Extraction: Thermo Fisher's 2025 release of KingFisher 96 automated molecular extraction kits allows for lower hands-on time and reduced costs, especially if testing volume increases.
- Diagnostics Partnerships: QIAGEN and Myriad Genetics' 2025 agreement expanded their collaboration to include other molecular cancer testing kits. These types of agreements provide the extraction kits along with the diagnostic tests.
- Increased Biobanking: The addition of 500,000 participants to the existing UK Biobank, along with other similar large-scale biobanking projects, increases the demand for high-quality kits for the long-term storage of blood and tissue specimens.
- Clinical Testing Approvals: The FDA cleared several automated molecular testing workflows in 2025, allowing expansion of centralized testing from research laboratories. One such clearance allowed processing of 96 tests in a batch.
- Locational Manufacturing: In 2025, several suppliers in the U.S. and Europe announced over $100 million investments for manufacturing expansion of reagents and assay consumables. Some customers, like hospitals, prefer that their suppliers maintain securities of supply and quickly respond to their demand.
Automation of sample preparation is becoming the status quo. Centralized diagnostic testing and biobanking are trends gaining traction. Oligopolies in the sample preparation and automation space will likely persist, but competition in the space is expected to increase. Validation of automation workflows will help alleviate price pressure. Price pressure will remain in the 2026-2027 time frame as sponsors of automation workflows enter into long-term supply and services agreements with suppliers and negotiate follow-on contracts for consumables.
Strategic Growth Opportunities in the Blood & Tissue Kit Market
The market for blood and tissue testing kits is projected to grow due to hospitals performing more lab tests away from the hospital (i.e., out-lab), expansion of biobanks, and the increasing requirements of blood and tissue kit traceability by regulatory agencies. Lucintel predicts that from 2024 to 2026, the market will be increasingly automated and integrated to assist with the development of personalized medicine and stimulate the sale of blood and tissue testing kits. During this timeframe, Lucintel expects the supplier mix will change and include integrators of other components (services and/or software) along with the supply of blood and tissue testing kits.
- Out-lab (or Near-lab) Molecular Testing: As of January 2025, according to the WHO report, 70% of world's countries still did not have adequate diagnostic testing. Decentralized molecular testing will continue to gain importance, especially for emergency care.
- Biobanking: As translational research continues to grow, so will the demand for stabilization kits for viable tissue and other specimens.
- Reduce Identification and Chain of Custody Errors: Traceability of smart kits using Radio Frequency Identification (RFID) or Bar codes have the potential to substantially reduce identification and Chain of Custody (CoC) errors. In February 2025, the FDA's Device Tracking Database reported over 24,000 unique device identification (UDI) records. It is expected that as the Food and Drug Administration's (FDA) compliance focus shifts to other areas, connected and electronic packaging will gain interest within the medical device industry.
- Sustainable Kit Platforms: Packaging innovations that eliminate or reduce the use of plastics, create packages that are easy to recycle and/or stabilize a product for transport at ambient temperatures will gain a competitive edge. The NHS announced in April 2025, that they plan to be net zero by 2040. This goal may create a similar focus by other National Health Services (NHS).
- Blood Safety in Emerging Markets: The use of multiplex PCR kits could increase blood donor testing in developing nations. According to the World Health Organization (WHO), in 2025, only 3% of the world's blood supply was collected in developing countries. The use of Cascade or other similar business models, would aid the expansion of blood donor testing in developing countries.
There are many possibilities for new product development in the in vitro diagnostics industry. Suppliers should consider establishing partnerships to fully integrate their products into the clinical workflow. Buyers will reward suppliers that improve workflow, reduce waste and sample loss. Long term, sustainable revenue can be achieved by integrating additional clinical services.
Blood & Tissue Kit Market Drivers and Challenges
The blood and tissue kits industry is growing due to several reasons including advancements in technology and the need for personalized medicine. At the same time, cost-constraints, and regulatory changes, affect this industry as well. Blood and tissue collection requires various workflow processes, including transportation, storage and extraction. Implementation of automation and other information technology improve these workflows; however, compliance with regulatory standards remains a major constraint. According to Lucintel, balance of affordability and innovation will help blood and tissue kit industry to thrive in the near future.
The factors responsible for driving this market include :
- Increasing Demand for Diagnostics: The ongoing transition from conventional diagnostics to next-generation sequencing and molecular diagnostics increases the demand for reliable blood and tissue collection kits. According to WHO, 1.25 million people lost their lives due to tuberculosis in 2023. Such statistics demonstrate the need for diagnostic testing, and, in turn, collect and ship specimens. Within the next 5 years, it is expected that numerous diagnostic and screening programs will be launched to increase the overall population health and wellness.
- The Need for Improved Testing: Automation and other advances have reduced the need for laboratory personnel to physically manipulate and test samples. The U.S. Food and Drug Administration announced in February 2025 that it had approved more than 800 In-vitro Diagnostic Devices (IVDs) based on molecular or digital technology. IVDs using more automated technologies allow laboratories to perform a greater number of tests. The improved IVDs will allow laboratories to automate and increase the number of tests they perform.
- Rise of Personalized Medicine: Use of specific tumor markers to monitor the efficacy of anticancer therapies and other personalized therapies requires the collection and storage of tumor tissues and other biological specimens under specific conditions. In April 2025, the National Cancer Institute awarded grants for ongoing research using tumor specimens collected in large clinical studies. There is expected growth in the need for specialized reagents for the storage and preservation of biological specimens over the next five years.
- Improved Regulatory Frameworks: Reliable evidence of performance and quality assurance increases the traceability of lots and lots' consistency in how specimens are handled. Many IVDs have benefited from recent updates to various regulatory frameworks. While this provides opportunities for suppliers to launch new, improved IVDs on the market, continuous investment in post-market surveillance will be necessary.
- Manufacturing Improvements: Improvements in production and packaging have combined with increased reagent stability to reduce waste and improve availability of products. Many healthcare procurement systems signed multi-year supply agreements in March 2025, to improve the certainty of essential diagnostic supplies. In the coming years, institutions that have improved their Cold Chain capabilities will take larger shares of the market.
The challenges facing this market include:
- Increased Cost of Doing Business: Rising costs of doing business, largely due to the need for increased validation, have posed challenges for market entrants. The IVDR was enacted in the EU in 2017 and provided device manufacturers a grace period for compliance. In 2025, the EC extended the grace period again for several manufacturers. Rising costs of regulatory compliance will be a barrier to market for manufacturers that do not have the financial and human capital to keep up with changing regulations.
- Supplies and Raw Materials: Raw materials and inputs for in-vitro diagnostic kits have caused challenges for manufacturers. In 2025, the procurement of laboratory consumables was difficult due to shipping disruptions and limited competition among manufacturers. This situation will likely continue as producers extend their supply and production networks.
- Reimbursement and Pricing Pressure: Hospitals and laboratories are reluctant to pay higher prices for more advanced tests. At the same time, current reimbursement policies rarely cover advanced testing. As a result, higher-end kits are rarely purchased. Continuing with the ongoing trend, health care systems in developed countries will put a greater emphasis on cost reduction for lab services and lab consumables in the next three to five years. During this time, a greater focus will be placed on the total cost of ownership for various lab automation and integrated systems. The objective will be to improve the total turnaround time and the overall efficiency of the lab while reducing the total lab workforce.
The growing demand for higher-throughput automation in laboratory testing and the increased implementation of laws and regulations for managing samples in the laboratory, medical, transplantation, research, and biobanking fields will fuel the market for advanced sample management and control kits. While these trends are expected, the level of competition will increase to a point where suppliers will be forced to strategically evaluate how best to leverage their available resources to support and serve their customers. It is likely that in the coming years, the sample management and control kit industry will witness greater consolidation.
List of Blood & Tissue Kit Market Companies
Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. Through these strategies blood & tissue kit market companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the blood & tissue kit market companies profiled in this report include-
- QIAGEN
- Thermo Fisher Scientific
- Sigma-Aldrich
- Roche
- Axygen
Blood & Tissue Kit Market by Segment
The study includes a forecast for the global blood & tissue kit market by type, application, and region.
Blood & Tissue Kit Market by Type [Value ($M) from 2019 to 2035]:
- Whole Blood
- Plasma or Serum
- Buffy Coat
Blood & Tissue Kit Market by Application [Value ($M) from 2019 to 2035]:
- R&D Organisations
- Biotechnology Companies
Blood & Tissue Kit Market by Region [Value ($M) from 2019 to 2035]:
- North America
- Europe
- Asia Pacific
- The Rest of the World
Country Wise Outlook for the Blood & Tissue Kit Market
The markets for blood and tissue testing kits are undergoing modifications with the introduction of automation and decentralized molecular testing. During the next few years, suppliers are expected to implement end-to-end solutions for diagnostic testing. According to Lucintel, these market trends are creating a demand for diagnostic kits that are robust and reliable.
- United States: As part of the BARDA-funded program, Project NextGen, the US Government allocated $5 billion in May 2025 to develop next-generation vaccines, diagnostic and enabling technologies. Additionally, in February 2025, Thermo Fisher announced its plans to construct a 45,000 square feet automated bioprocessing facility in Frederick, MD. These investments in automation and bioprocessing are expected to impact the US blood and tissue testing market in the next 3-5 years.
- China: In March 2025, BGI announced that its sequencing systems were in more than 100 countries, and in April, MGI released the DNBSEQ-G400RS. Increasing adoption of Chinese sequencing systems will enhance the need for associated blood and tissue sampling and testing kits.
- Germany: Manufacturing Investment and Integration of Labs: Qiagen opened a new facility in Hilden in June 2025, estimated to have cost around €100 million, for the manufacture and distribution of consumables. With additional Diagnostic production capacity situated near European laboratories, Qiagen will enhance the reliable supply of sample preparation kits, thus encouraging the standardization of laboratory processes.
- India: Public Sector Diagnostics: Instrumentation and consumables manufacture will gain from the Indian Government's May 2025 announcement of 12 semiconductor manufacture projects worth ₹1.26 trillion including a ₹91,000 crore project by Tata Electronics. Within a similar timeframe it is plausible to expect that Indian companies will have the capability to produce blood and tissue kits.
- Japan: Manufacturing of Products for Regenerative Medicine: Takara Bio will commence a cell processing manufacture in Shiga in 2026. The facility should encourage the development of more sophisticated cell processing and tissue products.
Features of the Global Blood & Tissue Kit Market
- Market Size Estimates: Blood & tissue kit market size estimation in terms of value ($B).
- Trend and Forecast Analysis: Market trends (2019 to 2026) and forecast (2027 to 2035) by various segments and regions.
- Segmentation Analysis: Blood & tissue kit market size by type, application, and region in terms of value ($B).
- Regional Analysis: Blood & tissue kit market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
- Growth Opportunities: Analysis of growth opportunities in different type, application, and regions for the blood & tissue kit market.
- Strategic Analysis: This includes M&A, new product development, and competitive landscape of the blood & tissue kit market.
Analysis of competitive intensity of the industry based on Porter's Five Forces model.
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This report answers following 11 key questions:
- Q.1. What are some of the most promising, high-growth opportunities for the blood & tissue kit market by type (whole blood, plasma or serum, and buffy coat), application (R&D organisations and biotechnology companies), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
- Q.2. Which segments will grow at a faster pace and why?
- Q.3. Which region will grow at a faster pace and why?
- Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
- Q.5. What are the business risks and competitive threats in this market?
- Q.6. What are the emerging trends in this market and the reasons behind them?
- Q.7. What are some of the changing demands of customers in the market?
- Q.8. What are the new developments in the market? Which companies are leading these developments?
- Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
- Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
- Q.11. What M&A activity has occurred in the last 8 years and what has its impact been on the industry?