POC Diagnostic Biosensors Market Size, Trends and Growth Analysis By Product (Biomarkers, Bioreceptors, Molecular Diagnostic Biosensors), By Transducer (Thermal, Piezoelectric, Electrochemical, Optical), By Application (Fertility/Pregnancy, Glucose Testing, Hb1Ac Testing, Infectious Disease, Cardiology and Oncology, Others), By End-User (Clinics, Hospitals, Home, Assisted Living Healthcare Facilities, Laboratory), By Geography, Segment revenue estimation, Forecast: 2021-2030.

Industry Report and Statistics (Facts & Figures) - Sales Volume by Product, Application & End-users

The global PoC Diagnostic Biosensors Market size was $12.31 Billion in 2021 and is predicted to reach $25.02 Billion by 2030, representing a CAGR of 8.20% during the forecast period 2021-2030.

A biosensor is a medical detection device that uses a living organism or a biomolecule (like enzymes or antibodies) to detect a specific type of chemical. The biosensor usually contains a bioreceptor (enzyme, antibody, cell, nucleic acid, aptamer etc.), a transducing component (a semiconducting material or a nanomaterial), and an electronic system which includes a signal amplifier, display, and processor. The bioreceptor detects the necessary chemical in the analyte and transmits the data to the transducer. The transducer converts this biological data into electrical signals and amplifies it by superimposing on a high-frequency noise signal. The required signal is filtered out and is converted back into the data by the processor, which is then displayed. There are six types of biosensors currently available: enzyme-based, tissue-based, immunosensors, DNA biosensors, thermal biosensors, and piezoelectric biosensors.

In 1906, M. Cremer established the relation between the concentration of acid and the electric potential that arises between the fluid located on opposite sides of a glass membrane. Leland Clark Jr. developed the first ‘true’ biosensor in 1956 for oxygen detection. Leland Clark Jr. also demonstrated the amperometric enzyme electrode for glucose detection in 1962. In 1969, GG Guilbault and JG Montalvo Jr. developed the first potentiometric biosensor to detect urea. In 1975, the first commercial biosensor was developed by Yellow Spring Instruments. Since then, various companies have developed many commercial biosensors for applications like point-of-care testing, food, home healthcare, research, security and biodefence.

 

Biosensors have a large number of advantages. The biosensors have high sensitivity and specificity, which improves the accuracy of the reading. According to a study, a semiconductor manufacturing electrochemical biosensor (SMEB) showed a low deviation from hospital results; specifically, the relative deviation was limited to about 7% across all samples taken, which indicated a minimum accuracy of 93% for the biosensor. Biosensors can take rapid and continuous measurements. It has a high specificity, fast response time, and requires fewer reagents for calibration. It can measure non-polar molecules, which are not possessed by conventional sensors.

 

The International Standard ISO 22870, Point-of-care testing (PoCT) - Requirements for quality and competence, defines point-of-care (POC) testing as a testing method performed near or at the site of a patient which could lead to a possible change in the treatment of the patient. Point-of-care tests are done in various locations, including homes, pharmacies, ambulances, nursing homes, primary care centres, and rural health centres. The type of tests and how a specific point-of-care device is used in each of the locations mentioned above may differ, along with the testing frequency and the testing requirements or fitness for purpose.

 

In 1955, haematology testing manuals documented various point-of-care testing methods in England. In 1972, Dr Gerald Kost began the study of biosensors and monitoring of pH changes under cardiopulmonary stress and shock in vivo. In the early 1980s, Dr Kost coined point-of-care testing while performing biosensor-based serial measurements of ionised calcium in whole blood at the bedside of liver transplantation patients at the University of California, Davis Medical Centre. Since then, point-of-care diagnostics has been employed in various hospitals and other testing places.

 

Point-of-care diagnostics have many benefits, which resulted in their increased adoption by various medical centres. POC diagnostics can increase the success rate of surgery. According to an NCBI study, PoC testing to measure parathyroid hormone concentration during a preoperative parathyroidectomy surgery helped improve the success rate of the surgery from 76% to 94%. The PoC test has also been proved to support the use of minimally invasive parathyroidectomy. POC Diagnostics has also assisted in reducing the number of clinical visits, the length of hospital stays, unnecessary hospital admissions, and inappropriate use of drugs, and blood products while optimising drug treatment and the quality of life.

Market Dynamics

Market Drivers (Rising Cases of Chronic and Infectious Diseases, Shift from Centralised to Decentralised POC Diagnostics):

• The rising number of chronic and infectious disease cases among the world’s population has increased the demand for point-of-care biosensors, fostering the market growth. The requirement for point-of-care biosensors to detect the SARS-CoV2 antigen rose drastically due to the advent of the COVID-19 pandemic, thus propelling the demand for point-of-care biosensors that can test for the antigen. As per the data provided by WHO, there are more than 530 million confirmed COVID-19 cases as of 8 June 2022. More than 221 million cases are from Europe, around 158 million are from the Americas, and approximately 61 million cases are reported in the Western Pacific region.

 

• A shift from centralised testing to decentralised testing for chronic and infectious diseases has helped increase the demand for point-of-care biosensors. Due to the rise in cases of diabetes worldwide, the need for decentralised testing for diabetes increased, which boosts the PoC diagnostic biosensors market trends. According to the IDF (International Diabetes Federation), approximately 537 million adults lived with diabetes in 2021. The number of cases of Americans with diabetes will rise to 643 million in 2030 and 783 million by 2045.

 

Market Restraints (High Cost of Manufacture of Point-of-Care Diagnostic Biosensors):

• The high cost of manufacturing point-of-care biosensors limits the mass development of these biosensors, which delays the delivery of the products to the consumers. Hence, these consumers look for alternative methods of diagnosis, which hinders the global POC diagnostic biosensors market growth.

 

Market Opportunities (New Technology):

• The increasing development of new technology by various established companies and start-ups helps meet the growing demand for POC diagnostic biomarkers. The increasing demand for these devices is due to rising cases of chronic and infectious diseases like cancer, diabetes, and COVID-19. The American Cancer Society estimates around 1.9 million cancer cases will be reported in 2022. Around 287 thousand new female breast cancer cases, 268 thousand new prostate cancer cases, and 237 thousand new lung and bronchial cancer cases are expected to be reported in the United States of America in 2022. The new technologies like POC sensing systems, biomedical POC devices, clinical biomarkers, protein biomarkers, nucleic acid biomarkers, metabolic biomarkers, microfluidic paper-based analytical devices, screen printing electrodes, paper-based microfluidic assay, Screen printing electrochemical POC biosensors, Lateral flow assay (LFA) based optical POC biosensors allow clinicians to provide personalised medicines to patients diagnosed with chronic and infectious diseases. These new technologies could drive the growth of the PoC diagnostic biosensors market due to the increasing demand for the devices.

Global Point-of-Care Diagnostic Biosensors Market – Analysis of Different Segments

After the global POC diagnostic biosensors market analysis, the market is divided by product, by transducer, by fabrication, by application, by end-use, and by region.

By Product

• Biomarkers

• Bioreceptors

  • Protein Bioreceptors

  • Enzyme Bioreceptors

  • Nucleic Acid Bioreceptors

• Molecular Diagnostic Biosensors

  • Immunoassays

  • Polymerase Chain Reaction

    • Insulated Isolated PCR

  • Aptamer Biosensors

    • CRISPR-Cas Biosensor

  • LAMP Biosensor

  • NEAR Biosensor

 

By Transducer

• Thermal

• Piezoelectric

• Electrochemical

• Optical

 

By Application

• Fertility/Pregnancy

• Glucose Testing

• Hb1Ac Testing

• Infectious Disease

  • Pneumonia or Streptococcus Associated Infections

  • HPV PoC

  • COVID-19

  • HCV PoC

  • HSV PoC

  • TB and Drug-resistant TB PoC

  • MRSA PoC

  • HIV POC

  • Clostridium Difficile PoC

  • Influenza/Flu POC

  • HBV PoC

  • Respiratory Syncytial Virus (RSV) PoC

  • Other Infectious Diseases

• Cardiology and Oncology

  • Cardiac Markers

  • Cancer Markers

• Others

 

By Fabrication

• Lateral Flow Assays

• Cartridges and Analysers

• Electrochemical Strips

• Continuous Monitors

 

By End-User

• Clinics

  • Urgent Care Clinic

  • Pharmacy & Retail Clinics

  • Physician Office

  • Non-practice Clinics

• Hospitals

• Home

• Assisted Living Healthcare Facilities

• Laboratory

 

By Region

• North America

• Europe

• Asia-Pacific

• LAMEA

The biomarkers segment led the global POC diagnostic biosensors market and is expected to grow at a substantial rate of 14.2% during the forecasted period. Companion diagnostics and biomarkers have become increasingly important in medical practice, resulting in improved diagnosis, treatment, and monitoring of a variety of diseases. It can be used to identify patients who are likely to respond well to specific medications or treatment options. These tests are frequently used along with a specific drug. Biomarkers also play a key role in the development of personalised medicine, whose adoption has increased recently due to the various limitations of standard treatment procedures. The growing importance of companion diagnostics and the adoption of personalised medicine have driven market growth. According to the Personalised Medicine Coalition, 286 personalised medicines were developed in 2020, more than 56 times the number of personalised medicines developed in 2008 as only 5 personalised medicines were developed in 2008).

 

In 2021, electrochemical had the largest global PoC diagnostic biosensors market share. This is because of the widespread measurement & analysis of electrochemical biosensors used in biological and biochemical procedures. Electrochemical biosensors have excellent stability, a lower limit of detection, and repeatability. In terms of market penetration and consumption, electrochemical detection dominates in the optical, thermal and piezoelectric detection domains. Few benefits include compatibility with modern microfabrication methodologies, robustness, ease of handling, affordability, disposability, & low power requirements. Electrochemical biosensors have myriad applications ranging from medicine to food testing. In June 2022, the USDA National Institute of Food and Agriculture (NIFA) granted USD 750 thousand to an international team led by a UMass Amherst (University of Massachusetts) Amherst food and environment virologist to develop portable electrochemical biosensors for detecting noroviruses and mycotoxins in food.

 

Over the time period, the optical PoC diagnostic biosensors segment is poised to grow with the fastest CAGR. Because of their wide range of coverage on an analytical basis, optical biosensors are expected to be in higher demand during the forecasted period. Optical biosensors enable fermentation monitoring, concentration, structural research, equilibrium analyses and kinetic, among other things. Due to these parameters, the optical biosensors market is poised to grow. Optical biosensors have several benefits as compared to the traditional analytical methods, like the absence of the need for extensive preparation of the sample & the capability to choose a biological sensing element. Optical biosensors’ high specificity and sensitivity cause more people to get accustomed to various point-of-care techniques, driving the segmental growth. In March 2022, EU-backed researchers developed and validated an innovative optical Nano-biosensor that identifies and quantifies SARS-CoV2 antibodies in a blood sample in under 15 minutes. The novel device demonstrated a sensitivity of around 99 % and a specificity of 100 %.

 

In 2021, the infectious diseases segment had the highest global PoC diagnostic biosensors share, with nearly 30%. The shift from centralised to decentralised point-of-care testing for infectious diseases has improved patient care. Increased demand for quick tests drives the market, prompting industry players to deliver PoC solutions to decentralised regions. The rising number of infectious diseases like COVID-19, tuberculosis, pneumonia, and influenza have caused the rise in point-of-care diagnostic biosensors, hence propelling the market growth. According to the CDC, the United States of America has seen the total number of COVID-19 cases reach 84.6 million on 7 June 2022, and the daily average number of cases is around 98,500.

 

The cardiology and oncology segment is projected to grow significantly during the forecasted period. This segment’s primary drivers are the high accuracy rates associated with these markers and the increasing prevalence of target diseases like cardiovascular diseases (like stroke and coronary artery disease). Furthermore, the segment is anticipated to see rapid growth in penetration rates in developed markets such as North America and Europe. The rising senior population and the prevalence of diseases caused by unhealthy lifestyle habits in these countries are expected to propel market growth in the forecasted period. According to the CDC, more than 795 thousand people have a stroke every year, out of which 610 thousand people suffer from a stroke for the first time. Almost 25% or 185 thousand cases are of people who have suffered strokes before.

 

The lateral flow assay segment holds the largest global PoC diagnostic biosensors market share and will grow at a CAGR of 4%. The high prevalence of infectious diseases worldwide, rapidly rising geriatric population, increasing use of home-based lateral flow assay devices, and the need for rapid diagnostic testing for COVID-19 has contributed to the enhancement of the segment. According to the WHO’s malaria report released in 2021, there were an estimated 241 million new malaria cases in 2020. There was an observed increase of 14 million new cases compared to 2019.

 

In 2021, the clinic's segment had the highest revenue share of the global POC diagnostic biosensors market. Pharmacies and retail clinics primarily generate this segment’s revenue. The key factors driving the expansion of POC diagnostics applications are increased access to novel diagnostic technologies, improved healthcare coverage, and affordability. As a result, community pharmacies and retail clinics have emerged as potential medical settings for such lab tests, particularly cholesterol and glycosylated haemoglobin (A1C) testing. Improved healthcare accessibility for the senior population, increased frequency in cases of infectious diseases (like pneumonia, influenza, tuberculosis, and COVID-19), and growing strain on traditional clinics contribute to global market growth. The CDC estimated up to 13 million people living with latent tuberculosis in 2021 in the United States of America, with only 7860 reported cases (at a rate of 2.4 per 100 thousand people).

 

From 2020 to 2030, the home end-use segment is estimated to grow at the fastest CAGR. Home care is a lucrative segment due to the cost-effectiveness and comfort level of PoC Diagnostic Biosensors provided to patients at home. POC Diagnostics in the home healthcare sector also enables patients to address healthcare issues (like diabetes) at home and make decisions quickly. As the focus of healthcare shifts toward disease detection and prevention, the PoC diagnostics-based home healthcare biosensors market is expected to grow rapidly during the forecasted period. According to the American Diabetes Association, more than 34 million people in the United States of America suffered from diagnosed and undiagnosed diabetes in 2020. 1.6 million Americans have Type 1 diabetes, including around 187 thousand children and adolescents.

 

In 2021, North America had the largest global PoC diagnostic biomarkers market size. The rapidly increasing diabetes and COVID-19 cases have contributed to the segment’s growth. According to the IDF (International Diabetes Federation), the number of diabetes cases in the North American and the Caribbean region was more than 50 million in 2021. More than 12 million people in this region had undiagnosed diabetes. The presence of key players in the United States and Canada also causes the region to maintain its dominance in the global POC diagnostic biosensors throughout the forecasted period.

 

From 2020 to 2030, Asia Pacific is expected to be the fastest-growing regional market. The Asia Pacific point-of-care market is expected to be driven by a growing pool of local diagnostic kits and reagent manufacturers offering a wide range of testing solutions to diagnose coronavirus infection. Countries are constantly increasing their capacity to increase COVID-19 testing. The rising number of COVID-19 cases in the region also drives market growth. According to a report published by Reuters, there are more than 153 million reported infections caused by COVID-19 in Asia so far. Taiwan leads the total number of reported infections daily with more than 72,500 cases, followed by Japan with 18,000 cases.

 

Report Attribute	Details
Forecast Period	2021 - 2030
Market size value in 2021	USD 12.31 billion
Revenue forecast in 2030	USD 25.02 billion
Growth rate	CAGR of approximately 8.20%
Base year for estimation	2020
Historical data	2015 – 2019
Unit	USD Billion, CAGR (2020 - 2030)
Segmentation	By Product, By Transducer, By Application, By Fabrication, By End-Use, and By Region
By Product	Biomarkers, Molecular Diagnostic Biosensors
By Fabrication	Lateral Flow Assays, Cartridges and Analysers, Electrochemical Strips, Continuous Monitors
By Transducer	Thermal, Piezoelectric, Electrochemical, Optical
By Application	Fertility/Pregnancy, Glucose Testing, Hb1Ac Testing, Coagulation Testing, Infectious Disease, Ambulatory Chemistry, Primary Care Systems, Drug of Abuse (DOA) Testing, Cardiac Markers, Cancer Marker, Faeces, Decentralized Clinical Chemistry, Haematology, Lipid Testing, Thyroid Stimulating Hormone, Blood Gas/Electrolytes, Urinalysis/Nephrology
By End-Use	Clinics, Hospitals, Homes, Assisted Living Healthcare Facilities, Laboratory
By Region	Asia Pacific, North America, Europe, LAMEA
Country Scope	United States of America, Saudi Arabia, United Kingdom, Germany, France, Italy, Spain, Russia, Canada, China, Japan, India, South Korea, Australia, Brazil, Mexico, South Africa,
Company Usability Profiles	Molecular devises Corp., Bio-Rad Laboratories Inc., Zimmer & Peacock AS, Medtronic, Koninklijke Philips N.V., Abbott Laboratories, Molex LLC,  Biosensors International Group, Ltd., DuPont Biosensor Materials, Johnson & Johnson, LifeScan, Inc., QTL Biodetection LLC, Nova Biomedical, TDK Corporation, Siemens Healthineers AG, GE Healthcare

 

Global Point-of-Care Diagnostic Biosensors Market – Competitive Landscape Analysis

The market for point-of-care diagnostic biosensors is moderately competitive, with several major players. Few major players currently dominate the global point-of-care diagnostic biosensors market. Other new players are expected to enter the market as disease prevalence rises, and the ageing population grows. The major competitors in the global point-of-care diagnostic biosensors market are:

• Molecular Devices Corp.

• Abbott Laboratories

• QTL Biodetection LLC

• Biosensors International Group, Ltd.

• Nova Biomedical

• Medtronic

• Siemens Healthineers AG

• DuPont Biosensor Materials

• Johnson & Johnson

• LifeScan, Inc.

• TDK Corporation

• Molex LLC

• Zimmer & Peacock AS

• Koninklijke Philips N.V.

• GE Healthcare

• Bio-Rad Laboratories Inc.

 

Global Point-of-Care Diagnostic Biosensors Market – Recent Developments

• In June 2022, Abbott Laboratories announced the development of a new bio-wearable point-of-care diagnostic biosensor that will continuously keep an eye on glucose and ketone levels in the body. Abbott believes that the launch of this device would be a big breakthrough for people with diabetes, especially people at risk of developing diabetic ketoacidosis.

 

• In February 2022, Swiss-based start-up Momm Diagnostics announced the development of a point-of-care biosensor for pre-eclampsia. Momm Diagnostics believes that various physicians can use the PoC biosensor to rule out the disease developing on the spot and expect to launch this product by 2024.

 

• In November 2021, EKF Diagnostics announced the acquisition of the ADL health molecular diagnostic testing laboratory. EKF Diagnostics believes that the acquisition will help them to be a leading provider of diagnostics and services, such as the PoC biosensor.

 

• In December 2021, FIND announced an investment of USD 21 million in four companies – Biomeme, Bioneer, Qlife, and SD Biosensor to accelerate the development, manufacturing, and launch of affordable, multi-pathogen, molecular diagnostic point-of-care platforms (like PoC biosensors). FIND believes that the investment would help bring PoC testing to more people suffering from COVID-19 in low- and middle-income countries.

 

• In May 2020, Koninklijke Philips NV announced the launch of a new wearable biosensor for early patient deterioration detection, including clinical surveillance for COVID-19. Koninklijke Philips NV believes that clinicians can better identify the subtle signs of deterioration in a patient’s condition using these point-of-care biosensors, hours before a potential adverse condition.

 

List of Various Point-of-Care Diagnostic Biosensors that Key Market Leaders Develop:

 

Product	Function	Key Player
Biacore 8K	Biotherapeutic screening and characterisation using surface plasmon resonance (SPR) biosensor.	GE Healthcare
Nellcor Portable SpO2 Patient Monitoring System, PM10N	Point-of-care pulse oximetry	Medtronic
Freestyle Libre	Point-of-care glucose monitoring	Abbott Laboratories
Biosensor BX100m	Point-of-care SARS-CoV2 monitoring	Koninklijke Philips NV
ZPS-KET-000-00072	Point-of-care ketone monitoring	Zimmer & Peacock