Biological Sample Collection Kits Market - Global Industry Size, Share, Trends, Opportunity and Forecast, Segmented By Product (Swabs, Viral Transport Media, Blood Collection Kits), By Application (Diagnostics, Research), By End-Use (Hospitals and Clinics, Diagnostic Centers, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 8.49 Billion
CAGR (2026-2031)	7.17%
Fastest Growing Segment	Swabs
Largest Market	North America
Market Size (2031)	USD 12.86 Billion

Market Overview

The Global Biological Sample Collection Kits Market will grow from USD 8.49 Billion in 2025 to USD 12.86 Billion by 2031 at a 7.17% CAGR. Biological sample collection kits are comprehensive assemblages of instruments and preservation reagents engineered to harvest, stabilize, and transport specimens such as blood, saliva, and tissue for diagnostic or research applications. The market is fundamentally driven by the escalating global burden of chronic and infectious diseases, which necessitates widespread clinical testing and constant disease surveillance. Additionally, the rapid expansion of biobanking facilities and the growing preference for remote patient monitoring have fueled the sustained demand for efficient and user-friendly collection solutions that enable decentralized testing.

According to MedTech Europe, in 2024, the European medical technology market was estimated at approximately €170 billion, with in vitro diagnostics remaining the largest sector and underscoring the massive scale of specimen processing requirements. Despite this robust demand, a major challenge restricting broader market reach is the high cost and complexity of maintaining cold chain logistics, as temperature fluctuations during transit can severely compromise sample integrity and diagnostic validity.

Key Market Drivers

The rising global incidence of infectious diseases and chronic conditions serves as a primary catalyst for the biological sample collection kits market, necessitating frequent diagnostic screening and continuous disease monitoring. As the prevalence of long-term health issues escalates, healthcare systems rely on efficient specimen collection tools to manage patient care and facilitate early detection. For instance, according to the Centers for Disease Control and Prevention, April 2025, in the 'Trends in Multiple Chronic Conditions' report, 76.4% of US adults reported one or more chronic conditions in 2023, highlighting the immense scale of the population requiring regular diagnostic intervention. This substantial disease burden has subsequently triggered robust financial support for research and screening programs; according to the National Cancer Institute, October 2025, the fiscal year 2025 budget allocation for cancer research and related activities was maintained at $7.22 billion, ensuring sustained demand for collection supplies in clinical trials and preventive screening initiatives.

Simultaneously, the rapid expansion of the home-based and direct-to-consumer testing market is fundamentally reshaping industry dynamics by decentralizing the diagnostic process. Patients are increasingly opting for minimally invasive, self-administered collection methods that offer convenience and privacy, thereby reducing the reliance on traditional phlebotomy centers. This shift is evidenced by the commercial success of specialized digital health providers who leverage remote sample collection logistics. According to Business & Finance, March 2025, the turnover for the at-home testing company LetsGetChecked reached $500 million in 2024, reflecting the surging consumer adoption of remote diagnostic solutions. This trend compels manufacturers to innovate user-friendly kits capable of preserving sample stability during standard mail transport, further broadening the market's reach beyond clinical infrastructure.

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Key Market Challenges

The high cost and complexity of maintaining cold chain logistics constitute a significant impediment to the growth of the biological sample collection kits market. Preserving sample integrity requires an unbroken temperature-controlled supply chain from the point of collection to the laboratory, which necessitates expensive specialized packaging, refrigerated transport, and continuous monitoring systems. This financial burden inevitably increases the overall cost of diagnostic testing, making these collection kits less accessible in cost-sensitive markets or remote regions where infrastructure is insufficient. Consequently, the reliance on such resource-intensive logistics limits the scalability of decentralized testing models, as healthcare providers struggle to justify the elevated operational expenses associated with preventing specimen degradation during transit.

The logistical rigidity required to support this market is further highlighted by the stringent standards imposed on global transport hubs. According to the International Air Transport Association, in 2024, the number of facilities certified under its specialized pharmaceutical logistics validation program surpassed 500 stations globally. This requirement for a vast, certified network demonstrates the operational complexity facing the industry, as samples must move exclusively through these highly regulated nodes to ensure viability. Any deviation or gap in this specialized infrastructure increases the risk of temperature excursions, leading to sample invalidation and financial losses that directly hamper broader market adoption.

Key Market Trends

The shift toward sustainable and biodegradable collection kit materials is fundamentally altering manufacturing and logistics strategies within the market. As environmental regulations tighten and corporate net-zero goals become a priority, manufacturers are increasingly replacing traditional single-use plastics with bio-based polymers and implementing ambient shipping solutions to minimize cold-chain dependency. This transition is further accelerated by the laboratory sustainability movement, which validates eco-friendly procurement practices to combat the immense environmental footprint of diagnostic workflows. According to the Royal Society of Chemistry, September 2024, in the article 'Lab sustainability programs LEAF and My Green Lab', global laboratories produce an estimated 5.5 million metric tons of plastic waste annually, a statistic that is driving a critical industry-wide mandate for the development of recyclable and reduced-waste specimen transport designs.

Concurrently, the rapid adoption of liquid biopsy and non-invasive sampling methodologies is creating a surge in demand for specialized blood collection devices designed to preserve cell-free DNA (cfDNA). Unlike standard venipuncture supplies, these advanced kits contain proprietary preservatives that stabilize circulating tumor DNA at room temperature, preventing genomic degradation during transport and replacing invasive tissue biopsies in oncology care. This trend is evidenced by the escalating volume of blood-based genomic tests; according to Natera, Inc., November 2024, in the 'Third Quarter 2024 Financial Results' report, the company performed approximately 137,100 oncology tests in the third quarter alone, representing a 54.4% increase year-over-year and reflecting the massive clinical uptake of these non-invasive diagnostic tools.

Segmental Insights

The Swabs segment is identified as the fastest-growing category in the Global Biological Sample Collection Kits Market, driven by the escalating demand for efficient diagnostic testing. This growth is largely attributed to the widespread utility of swabs in detecting infectious diseases and their critical role in genetic screening applications. The segment has gained significant traction following approvals from regulatory bodies such as the U.S. Food and Drug Administration, which authorized numerous swab-based kits for at-home usage. Consequently, the ease of handling and high reliability of these tools continue to support their dominance in clinical and remote sampling environments.

Regional Insights

North America dominates the Global Biological Sample Collection Kits Market, primarily due to its highly developed healthcare infrastructure and the strong presence of key industry manufacturers. The region experiences consistent demand for diagnostic testing, driven by the rising prevalence of chronic and infectious diseases. Additionally, substantial government funding for genomic research and biobanking initiatives accelerates market expansion. The U.S. Food and Drug Administration (FDA) supports this ecosystem by maintaining rigorous regulatory standards that ensure product safety while facilitating the commercialization of new collection devices, thereby reinforcing the region's market leadership.

Recent Developments

• In July 2025, OraSure Technologies, Inc. introduced the HEMAcollect PROTEIN, a specialized blood collection tube developed for the proteomics research sector. The device was designed to stabilize plasma proteins in whole blood for up to seven days at room temperature, addressing a critical challenge in preserving sample integrity during transport. This product launch aimed to support researchers in oncology and other therapeutic areas by eliminating the strict requirement for immediate cold storage. The release highlighted the company's strategic focus on expanding its portfolio of molecular sample management solutions to facilitate operational efficiencies in large-scale biological studies.
• In December 2024, BD and Babson Diagnostics commercially launched a collaborative capillary blood collection and testing system across the United States. The offering utilized the BD MiniDraw Capillary Blood Collection System to obtain hospital-grade samples from a fingerstick, which were then processed using Babson’s automated diagnostic workflow. This launch was designed to make blood testing more accessible by enabling collection in convenient locations like pharmacies and urgent care clinics without requiring traditional phlebotomy. The partnership aimed to improve health equity by simplifying the patient experience and allowing a broader range of healthcare staff to perform collections.
• In June 2024, Lindus Health entered into a collaborative agreement with Tasso, Inc. to incorporate remote blood collection technology into its clinical trial operations. The partnership enabled the research organization to offer sponsors a patient-centric alternative to traditional venipuncture, allowing participants to self-collect blood samples at home. By reducing the requirement for travel to physical clinical sites, the initiative sought to improve participant retention and diversify study populations. This collaboration demonstrated the increasing utility of convenient, less invasive sample collection methods in streamlining drug development processes and supporting the logistical demands of decentralized clinical research studies.
• In April 2024, BD (Becton, Dickinson, and Company) India launched the BD Vacutainer UltraTouch Push Button Blood Collection Set to address patient discomfort during diagnostic procedures. The device featured specialized needle geometry designed to reduce penetration force and improve flow rates, thereby facilitating single-prick success. This introduction aimed to mitigate needle phobia and enhance operational efficiency for healthcare workers by minimizing the risk of accidental needle-stick injuries. The product availability in the Indian market reflected the company’s commitment to improving the standard of care in blood collection and ensuring high-quality sample acquisition for accurate laboratory testing.

Key Market Players

• Thermo Fisher Scientific, Inc.
• QIAGEN NV
• F. Hoffmann-La Roche Ltd
• Abbott Laboratories Inc.
• Becton, Dickinson and Company
• Laboratory Corporation of America Holdings
• Seegene Inc.
• Medline Industries, Inc.
• Altona Diagnostics GmbH
• CTK Biotech, Inc

By Product	By Application	By End-Use	By Region
Swabs Viral Transport Media Blood Collection Kits	Diagnostics Research	Hospitals and Clinics Diagnostic Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Biological Sample Collection Kits Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Biological Sample Collection Kits Market, By Product:

• Swabs
• Viral Transport Media
• Blood Collection Kits

• Biological Sample Collection Kits Market, By Application:

• Diagnostics
• Research

• Biological Sample Collection Kits Market, By End-Use:

• Hospitals and Clinics
• Diagnostic Centers
• Others

• Biological Sample Collection Kits Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE