Point of Care Diagnostics Market Analysis, Growth, Share - 2028

Point of Care Diagnostics Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Product (Glucose Monitoring Products, Infectious Disease Testing Products, Cardiometabolic Testing Products, Pregnancy and Fertility Testing Products, Coagulation Testing Products, Tumor/Cancer Marker Testing Products, Cholesterol Testing Products, Urinalysis Testing Products, Hematology Testing Products, and Other POC Products), Prescription Mode (Prescription-Based Testing and OTC Testing), and End User (Professional Diagnostic Centers, Home Care, Research Laboratories, and Others), and Geography

Publication Month : Jun 2021

  • Report Code : TIPRE00006394
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 245
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[Research Report] The point of care diagnostics market was valued at US$ 36,000.4 million in 2021 and is projected to reach US$ 82,958.3 million by 2028; it is expected to grow at a CAGR of 12.7% from 2021 to 2028.

Market Insights and Analyst View:

Point-of-care (POC) testing is a term that describes diagnostic testing which is performed in the patient’s unit rather than in the hospital’s central lab or outside reference lab. Point of care tests may be done on blood, urine, swabs from mucosal surfaces, or saliva. In the emergency department (ED), POC testing is typically performed by both ED technicians (EDTs) and nurses. In some jurisdictions, emergency medical services providers use POC tests in pre-hospital settings. Most hospitals have developed a rigorous quality process for their POC testing programs. Point-of-care testing (POCT) is essential for the rapid detection of analytes near to the patient, which facilitates in disease diagnosis, monitoring, and management. It enables quick medical decisions, as the diseases can be diagnosed at a very early stage, and is an important criterion in preventing advanced disease types. This primarily leads to improved health outcomes for patients by enabling the early start of treatment. Recent advancements in biosensors, which is a critical component for point of care diagnostics is directly responsible for the bioanalytical performance of assay.

Growth Drivers and Challenges:

Point-of-care testing (POCT) plays a critical role in diagnosis, treatment, and prevention of infectious diseases. POC testing can be used to detect several major pathogens, including malarial parasites, human immunodeficiency virus (HIV), human papillomavirus (HPV), dengue, Ebola, and Zika viruses; and Mycobacterium tuberculosis (TB bacteria). HIV has infected over 38 million people worldwide; ~85% of this population resides in developing countries, which have a limited availability of clinical diagnostics and antiretroviral therapy (ART) monitoring platforms. To narrow down the diagnostic time, companies are developing POC test kits and reagents. For instance, Food and Drug Administration (FDA) has approved the ARCHITECT HIV Ag/Ab EIA, a fourth-generation assay, introduced by Abbott Laboratories. The increasing incidence of infectious diseases such as HIV is the major global public health issue. In 2019, World Health Organization (WHO) claimed that more than 38 million people were diagnosed with HIV, out of which 1.7 million people were newly diagnosed worldwide, including 62% adults and 54% children. According to a study published by UNAIDS, in 2019, around 690,000 people died because of HIV and associated conditions. As per the European Centre for Disease Prevention and Control, ~2 million people in Europe were infected with HIV in 2019. Moreover, healthcare-associated infections (HAIs) such as central line-associated bloodstream infections and catheter-associated urinary tract infections might affect the patients in hospitals and other healthcare facilities. According to a recent study published on NCBI in 2020, HAI causes around 16 million additional hospitalization days in Europe each year. Moreover, according to the same study, HAI leads to additional financial burden of around US$ 8.5 billion in Europe each year. In addition, according to the Office of Disease Prevention and Health Promotion, 1 out of 25 hospitalizations in the US suffers from HAI at any given time. Such increase in prevalence of infectious diseases is expected to create a demand for point of care tests kits across the world. Such a factor has assisted the growth of point of care diagnostics market and is expected to follow a similar trend during the forecast period.

Product recalls are rising in size and number in the industry, predominantly driven by the increasing complexity of global supply chains, as well as increasingly stringent regulations. In 2018, PTS Panels CHOL+GLU test strips, which are considered as in vitro diagnostic medical devices were recalled in Australia. The cause of recall was related to medical device activity. According to the Department of Health, these devices were manufactured by point-of-care Diagnostics Australia Pty Ltd. Based on the results of internal testing, there was malfunctioning in measurement of the glucose test. This issue may result in the delay in diagnosis of diabetes. Similarly, in April 2020, Trividia Health, Inc. issued a notice for nationwide voluntary recall for its TRUE METRIX AIR Blood Glucose Meter. The company issued this notice due to malfunctioning of measurement units in the glucose meter. Such events are anticipated to hamper the customer confidence toward the use of point of care devices, which will eventually deter the point of care tests market growth.

Moreover, turnaround time for molecular diagnostic tests is important in detecting infectious agents, in determining a patient's ability to metabolize a drug or drug class. This is also essential in detecting minimal residual disease. These applications would benefit from the development of a point-of-care device for nucleic acid extraction, amplification, and detection. The device would have a low cost per test, use a disposable unit use device for all steps in the assay, should be portable, and provide a result that requires no interpretation. The creation of such a device requires miniaturization of current technologies and the use of microfluidics, microarrays, and small-diameter capillary tubes to reduce reagent volumes. This will simplify heat conduction by convection during nucleic acid amplification. This ideal device may be available in in the coming years and will expand the global point of care molecular diagnostics market.

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Point of Care Diagnostics Market: Strategic Insights

point-of-care-diagnostics-market
Market Size Value inUS$ 36,000.4 Million in 2021
Market Size Value byUS$ 82,958.3 Million by 2028
Growth rateCAGR of 12.7% from 2021-2028
Forecast Period2021-2028
Base Year2021
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Report Segmentation and Scope:

The “Global Point of Care Diagnostics Market” is segmented based on product, end user, prescription mode, and geography. Based on product, the point of care diagnostics market is segmented into glucose monitoring, infectious disease testing, cardiometabolic testing, pregnancy and fertility testing, coagulation testing, tumor/cancer marker, cholesterol testing, urinalysis testing, hematology testing, and other testing products. Based on end user, the point of care diagnostics market is segmented into professional diagnostic centers, research laboratories, homecare, and others. Based on prescription mode, the point of care diagnostics market is bifurcated into OTC testing and prescription-based testing.  The point of care diagnostics market based on geography is segmented into North America (the US, Canada, and Mexico), Europe (Germany, France, Italy, the UK, Russia, and Rest of Europe), Asia Pacific (Australia, China, Japan, India, South Korea, and Rest of Asia Pacific), the Middle East & Africa (South Africa, Saudi Arabia, the UAE, and Rest of the Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America).

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Segmental Analysis:

Based on product, the point of care diagnostics market is segmented into glucose monitoring, infectious disease testing, cardiometabolic testing, pregnancy and fertility testing, coagulation testing, tumor/cancer marker, cholesterol testing, urinalysis testing, hematology testing, and other testing products. In 2020, the glucose monitoring product segment held the largest share of the market, whereas, infectious disease testing segment is anticipated to register the highest CAGR of 14.1% during the forecast period. The glucose monitoring devices market consists of components such as glucometers, lancets, testing strips and other glucose monitoring devices. In 2020, the testing strips segment held the largest market share among the glucose monitoring devices segments. The glucose monitoring devices or glucose meters are medical devices are used to determine the approximate levels or the concentration of glucose in the blood of the patients living with diabetes. The concentration of the glucose level can be measured by various means such as through testing strips, lancets and others. In the market various market players have introduced their devices for the glucose monitoring that includes Contour Net EZ, Accu-Check Aviva, Abbott FreeStyle, One Touch Verio. They are being offered by player/market participants such as Abbott, F. Hoffman-La Roche Ltd, and others. In addition, due to the rise in the technology advancements, the developments for the new products are offering various benefits to the user. For instance, diamontech GmbH has invented non-invasive glucose monitoring device. The company offers DMT Base, DMT Pocket and DMT Band that helps the diabetes patients for monitoring their glucose level. Therefore, owing to the presence of the various market players that are offering various products and rise in the technological advancements are likely to propel the growth of global point of care diagnostics market.

Infectious diseases are caused by microorganisms, such as bacteria, viruses, fungi, and parasites. Diagnostic test for an infectious agent is used to demonstrate the presence of the infection. Specimens such as urine, blood, sputum, cerebrospinal fluid, and others are subjected to various tests and the disease-causing bacteria and viruses, known as the infectious agents, are identified quickly.

Real-time test results are important for early diagnosis and in determining treatment orientation in medical practice. Point of Care Testing (POCT) provides beneficial and helpful information for diagnosis and treatment through real-time testing at the bedside. Hence, POCT has high utility value in field of infectious diseases. Infectious disease rapid test kits are widely available for a wide variety of prophlogistic pathogen targets, including bacterial, viral, fungal, protozoal, and other disease agents. In January 2023, Cipla Limited announced the launch of Cippoint, a point- of-care testing device. This state-of-the-art device offers a wide range of testing parameters including cardiac markers, diabetes, infectious diseases, fertility, thyroid function, inflammation, metabolic markers, and coagulation markers. The device is CE IVD approved. This essentially indicates that the device is approved by the European In-Vitro Diagnostic Device Directive, thus ensuring reliable testing solutions. With entry in these new segments, Cipla has expanded its product offerings for diagnostics laboratories and their goal is to bridge the current gap in the diagnostic ecosystem in India by providing accurate and reliable test methods at affordable prices.

point of care diagnostics market, by Product– 2020 and 2028

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Based on end use, the point of care diagnostics market is segmented into professional diagnostic centers, research laboratories, homecare, and others. In 2020, the professional diagnostic centers segment held the largest share of the market and is expected to witness a similar trend during the forecast period. However, the homecare segment is anticipated to register the highest CAGR of 13.3% during the forecast period. Patients can easily monitor their glucose levels at home and this essentially helps them in customizing their insulin therapy to manage their diabetes levels. During the pandemic situation, the homecare point of care diagnostics was at boom as this led to fewer hospital visits. Advancements such as telemedicine and technological advancements in point of care testing devices assisted the global market during the COVID-19 crisis.

Regional Analysis:

Based on geography, the point of care diagnostics market is segmented into five key regions: North America, Europe, Asia Pacific, South & Central America, and the Middle East & Africa. In 2022, North America held the largest share of the point of care diagnostics market followed by Europe. Growing prevalence of infectious diseases, government support for advanced diagnostics kits and instruments, and increasing efforts in R&D activities undertaken by the market players operating in the market is expected to aid the regional growth. According to EBSCO Information Services, as of September 2020, more than 1,000 cases of Hepatitis A has been reported in each of these states: Florida, Georgia, Indiana, Kentucky, Ohio, Tennessee, and West Virginia. The number of cases reported since the arrival of COVID-19 has reached 6,358 (as of September 26, 2020), and with some of the current state outbreaks dating back to 2016, 2017, or 2018, the overall number has now exceeded 32,000 cases. Generally, Hepatitis A largely under control in the United States until three years ago, can be easily prevented through the use of a safe and effective vaccine. However, the number of reported cases has taken a dramatic up-turn during the current COVID-19 pandemic. During such situations, the point of care diagnostic solutions proved to be an effective solution for the patients as government organizations issued various rules and regulations to avoid social distancing owing to COVID-19. Lesser hospital visits were one of the main reasons that increased the demand for point of care tests. Such factors is expected to aid the point of care diagnostic tests market during the forecast period.

Industry Developments and Future Opportunities:

Various initiatives taken by key players operating in the global point of care diagnostics market are listed below:

  1. In April 2019, Roche launched VENTANA HER2 Dual ISH companion diagnostic test for breast and gastric cancer patients.
  2. In April 2019, Bio-Rad Laboratories, Inc. received U.S. Food and Drug Administration (FDA) approval for its BioPlex 2200 Lyme Total Assay. This was an innovative multiplex test method for the diagnosis of Lyme disease.

Competitive Landscape and Key Companies:

Companies such as Roche, Bio-Rad, bioMérieux, Siemens Healthineers, Nova Biomedical, Danaher, PTS Diagnostics, and Abbott has been implementing various strategies that have helped the growth of the company and in turn have brought about various changes in the market. The companies have utilized strategies such as product launch, product up-gradation, patents, expansion of their product portfolio and area expansion for the growth of their organizations. In addition, the companies have invested their efforts to develop products and have received approvals from regulatory bodies such as the US FDA for their products.

Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Product , Prescription Mode , and End User , and Geography

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States

The List of Companies - Point of Care Diagnostics Market

  1. F. Hoffmann-La Roche Ltd
  2. Abbott
  3. bioMérieux SA
  4. Johnson & Johnson Services, Inc.
  5. Nova Biomedical
  6. Siemens AG
  7. Bio Rad Laboratories Inc.
  8. BD
  9. Danaher Corporation
  10. PTS Diagnostics  

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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