Point of Care Molecular Diagnostics Market Size, Share & Trends by Product (Assays, Kits, Instruments, Software), Application (Respiratory Diseases, HAIs, Cancer, STDs, Hepatitis), Technology (RT-PCR, INAAT), End User (Clinics, Hospitals, ICUs) & Region - Global Forecast to 2028
Point Of Care Molecular Diagnostics Market Size, Share & Trends
The size of global point of care molecular diagnostics market in terms of revenue was estimated to be worth $2.0 billion in 2023 and is poised to reach $3.4 billion by 2028, growing at a CAGR of 10.6% from 2023 to 2028. The comprehensive research encompasses an exhaustive examination of industry trends, meticulous pricing analysis, patent scrutiny, insights derived from conferences and webinars, identification of key stakeholders, and a nuanced understanding of market purchasing dynamics.
Market growth is mainly driven by rising incidence of infectious diseases and acute and chronic conditions and increased focus on improving the state of healthcare facilities and infrastructure. However, the market entry of several firms has been resisted by uncertain reimbursement circumstances. The market's expansion is further constrained by a shortage of high-complexity testing facilities that can perform POC molecular diagnostics testing.
Point Of Care Molecular Diagnostics Market Trends
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Point of Care Molecular Diagnostics Market Dynamics
Driver: Growing incidence of infectious diseases and cancer
The rising occurrence of infectious diseases and cancer in both developed and developing regions is set to have a favourable impact on the expansion of the market. The diagnosis and treatment of these diseases necessitate an increasing number of molecular diagnostic tests, leading to a surge in the demand for such tests. Moreover, the growing inclination towards preventive medicine further contributes to the anticipated rise in demand for point-of-care molecular diagnostics throughout the forecast period.
Restraint: Unfavourable reimbursement settings
The growth of the market is hindered by inadequate reimbursements. One of the significant challenges faced by diagnostic companies is obtaining payment from Medicare and private health insurers for their tests. In the United States, Medicare revised its reimbursement mechanism for certain in vitro diagnostic (IVD) tests, including point-of-care molecular tests, in 2018. Some of these tests lack specific Healthcare Common Procedure Coding System (HCPCS) codes and are billed using unlisted codes instead. In such cases, payment amounts are established by Medicare Administrative Contractors (MACs) for their respective jurisdictions. Additionally, Medicare currently does not provide coverage for genetic testing in individuals without a personal history of cancer, as indicated by the American Society of Clinical Oncology. These factors are anticipated to have an adverse impact on the point-of-care molecular testing market.
Opportunity: Growth prospects in emerging countries
Players in the market have substantial growth prospects in emerging economies like India, South Korea, Brazil, and Mexico. These opportunities stem from several factors, including relatively low regulatory barriers, advancements in healthcare infrastructure, expanding patient populations, increasing incidence of infectious diseases, and a rise in healthcare expenditure. Additionally, the regulatory policies in some of these countries are more flexible and conducive to business compared to those in developed nations.
Challenge: Establishment of alternative technologies
The emergence of alternative technologies, including those employed in COVID-19 testing, presents a potential obstacle to the growth of the market . Most diagnostic tests can be divided into serological and antigen tests and these tests result is usually available in 15 minutes, and thus they are commonly referred to as rapid tests. Antigen tests are also cheaper to manufacture than molecular tests owing to their simpler design. Thus, the introduction of alternative technologies might be challenging to the growth of the market.
Point of Care Molecular Diagnostics Market Ecosystem
Prominent companies in this market include well-established, financially stable manufacturers of point of care molecular assay and kits. These companies have been operating in the market for several years and possess state-of-the-art technologies, diversified product portfolio, strong global sales, and marketing networks. Prominent companies in this market include Abbott Laboratories (US), F. Hoffmann-La Roche Ltd. (Switzerland), bioMérieux SA (France), Danaher Corporation (US), and QIAGEN N.V. (Netherlands).
In 2022, assays & kits segment accounted for the largest share of the point of care molecular diagnostics industry, by product & service
Based on product, the point of care molecular diagnostics market is segmented into instruments & analyzers, and software & services. In 2022, the assays & kits segment accounted for the largest share of this market. The frequent purchase of these products due to their recurrent usage drives the market growth of this segment.
In 2022, RT-PCR segment accounted for the largest share in the point of care molecular diagnostics industry, by technology
The point of care molecular diagnostics market is segmented into RT-PCR, INAAT and other technologies based on technology. In 2022, the RT-PCR segment accounted for the largest share. RT-PCR is one of the most widely used technologies in diagnostics due to its ease of use, cost-effectiveness, and prompt turnaround time (4 to 6 hours).
In 2022, Physicians’ offices segment accounted for the largest share in the point of care molecular diagnostics industry, by end user
Based on end users, the point of care molecular diagnostics market is segmented into physicians’ offices, hospitals & ICUs, research institutes, and other end users. In 2022, the physicians’ offices segment accounted for the largest share of the market. Point-of-care molecular assay & kits and systems are extensively used in physicians’ offices as they provide quick results within 30 minutes. This helps in instant diagnosis which allows to diagnose or monitor a patient’s condition immediately.
North America is the largest region of the point of care molecular diagnostics industry
The global point of care molecular diagnostics market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. In 2022, North America accounted for the largest share of the global market. The high burden of infectious diseases and cancers on regional healthcare systems is one of the major drivers for market growth. Furthermore, the presence of a well-developed healthcare infrastructure and the growing adoption of advanced technologies infectious disease testing are other factors anticipated to support the growth of the market in the region.
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The major players in this market are Abbott Laboratories (US), F. Hoffmann-La Roche Ltd. (Switzerland), bioMérieux SA (France), Danaher Corporation (US), and QIAGEN N.V. (Netherlands). These players lead the market because of their extensive product portfolios and wide geographic presence. These dominant market players also have numerous advantages, such as more robust marketing and distribution networks, larger budgets for R&D, and better brand recognition.
Scope of the Point of Care Molecular Diagnostics Industry
Report Metric |
Details |
Market Revenue Size in 2023 |
$2.0 billion |
Projected Revenue Size by 2028 |
$3.4 billion |
Industry Growth Rate |
poised to grow at a CAGR of 10.6% |
Growth Driver |
Growing incidence of infectious diseases and cancer |
Growth Opportunity |
Growth prospects in emerging countries |
This report categorizes the point of care molecular diagnostics market to forecast revenue and analyze trends in each of the following submarkets:
By Product & Service
- Assays & kits
- Instruments & Analyzers
- Software & Services
By Technology
- RT-PCR
- INAAT
- Other technologies
By Application
- Respiratory Diseases
- Sexually Transmitted Diseases
- Hospital-acquired Infections
- Cancer
- Hepatitis
- Gastrointestinal Disorders
- Other Applications
By End User
- Physicians’ Offices
- Hospitals & ICUs
- Research Institutes
- Other End Users
By Region
-
North America
- US
- Canada
-
Europe
- UK
- Germany
- France
- Italy
- Rest of Europe (RoE)
-
Asia Pacific
- China
- Japan
- India
- Rest of Asia Pacific (RoAPAC)
- Rest of the World (RoW)
Recent Developments of Point of Care Molecular Diagnostics Industry:
- In April 2023, QIAGEN N.V. (Netherlands) launched QIAstat-Dx in Japan with a respiratory panel for syndromic testing.
- In June 2022, Biocartis NV (Belgium) launched the Rapid CE-marked IVD Idylla GeneFusion Panel for fast treatment decisions in lung cancer.
- In May 2022, bioMérieux SA (France) received De Novo FDA Authorization for its BIOFIRE Joint Infection (JI) Panel.
- In September 2021, F. Hoffmann-La Roche Ltd. (Switzerland) acquired TIB Molbiol (Germany) to expand its PCR test portfolio with a wide range of assays for infectious diseases.
Frequently Asked Questions (FAQ):
What is the projected market revenue value of the global point of care molecular diagnostics market?
The global point of care molecular diagnostics market boasts a total revenue value of $3.4 billion by 2028.
What is the estimated growth rate (CAGR) of the global point of care molecular diagnostics market?
The global market for point of care molecular diagnostics has an estimated compound annual growth rate (CAGR) of 10.6% and a revenue size in the region of $2.0 billion in 2023.
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The objective of the study is to analyze the key market dynamics, such as drivers, opportunities, challenges, restraints, and key player strategies. To track company developments such as acquisitions, product launches, expansions, collaborations, agreements, and partnerships of the leading players, the competitive landscape of the point-of-care molecular diagnostics market to analyze market players on various parameters within the broad categories of business and product strategy. Top-down and bottom-up approaches were used to estimate the market size. To estimate the market size of segments and subsegments, market breakdown and data triangulation were used.
The four steps involved in estimating the market size are:
Collecting Secondary Data
The secondary research data collection process involves the usage of secondary sources, directories, databases (such as Bloomberg Businessweek, Factiva, and D&B), annual reports, investor presentations, and SEC filings of companies. Secondary research was used to identify and collect information useful for the extensive, technical, market-oriented, and commercial study of the point-of-care molecular diagnostics market. A database of the key industry leaders was also prepared using secondary research.
Collecting Primary Data
The primary research data was conducted after acquiring knowledge about the point-of-care molecular diagnostics market scenario through secondary research. A significant number of primary interviews were conducted with stakeholders from both the demand side (such as hospitals & ICUs, diagnostic laboratories, research institutes, research laboratories and home care settings) and supply side (such as included various industry experts, such as Directors, Chief X Officers (CXOs), Vice Presidents (VPs) from business development, marketing and product development teams, product manufacturers, wholesalers, channel partners, and distributors) across major countries of North America, Europe, Asia Pacific, the Middle East & Africa, and Latin America. Approximately 40% of the primary interviews were conducted with stakeholders from the demand side, while those from the supply side accounted for the remaining 60%. Primary data for this report was collected through questionnaires, emails, and telephonic interviews.
A breakdown of the primary respondents is provided below:
Note 1: *Others include sales managers, marketing managers, and product managers.
Note 2: Tiers are defined based on a company’s total revenue as of 2022: Tier 1=> USD 1 billion, Tier 2 = USD 500 million to USD 1 billion, and Tier 3=< USD 500 million.
To know about the assumptions considered for the study, download the pdf brochure
Market Size Estimation
All major product manufacturers offering various point-of-care molecular diagnostics products were identified at the global/regional level. Revenue mapping was done for the major players and was extrapolated to arrive at the global market value of each type of segment. The market value point-of-care molecular diagnostics market was also split into various segments and subsegments at the region and country level based on:
- Product mapping of various manufacturers for each type of point-of-care molecular diagnostics market at the regional and country-level
- Relative adoption pattern of each point-of-care molecular diagnostics market among key application segments at the regional and/or country-level
- Detailed primary research to gather qualitative and quantitative information related to segments and subsegments at the regional and/or country-level.
- Detailed secondary research to gauge the prevailing market trends at the regional and/or country-level
Global Point-of-Care Molecular Diagnostics Market Size: Top-Down Approach
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Data Triangulation
After arriving at the overall market size—using the market size estimation processes—the market was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics of each market segment and subsegment, the data triangulation, and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides in the point-of-care molecular diagnostics industry.
Market Definition
Point-of-care molecular diagnostics includes various portable point-of-care devices used by healthcare professionals to detect and diagnose various diseases in humans by using techniques to identify and analyze nucleic acids or proteins at the molecular level.
Key Stakeholders
- Senior Management
- End User
- Finance/Procurement Department
- R&D Department
Report Objectives
- To define, describe, segment, and forecast the global point-of-care molecular diagnostics market by product & service, technology, application, end user, and region
- To provide detailed information regarding the major factors influencing the market growth (such as drivers, restraints, opportunities, and challenges)
- To analyze the micromarkets with respect to individual growth trends, prospects, and contributions to the overall market
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
- To forecast the size of the market segments with respect to five regions, namely, North America, Europe, the Asia Pacific, Latin America, Middle East & Africa
- To profile the key players and comprehensively analyze their product portfolios, market positions, and core competencies
- To track and analyze company developments such as acquisitions, product launches and approvals, expansions, and other developments in the point-of-care molecular diagnostics market.
- To benchmark players within the market using the proprietary "Competitive Leadership Mapping" framework, which analyzes market players on various parameters within the broad categories of business and product strategy
Available Customizations
With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for this report:
Country Information
- Point-of-Care Molecular Diagnostics market size and growth rate estimates for countries in the Rest of Europe, the Rest of Asia Pacific and Rest of the World
Company profiles
- Additional ten company profiles of players operating in the point-of-care molecular diagnostics market
Growth opportunities and latent adjacency in Point of Care Molecular Diagnostics Market