POC Molecular Diagnostics Market Size (2023 - 2030)

The POC Molecular Diagnostics Market was valued at USD 3.37 billion in 2021 and is projected to reach USD 6.27 billion by 2030. The market is anticipated to expand at a healthy CAGR of 14% over the forecast period. The rising prevalence of serious diseases and cancer, increased focus on decentralised diagnostics, increased R&D investment, increased awareness of the early diagnosis of infectious diseases, and increased usage of point-of-care diagnostic tests are all driving market expansion.

INDUSTRY OVERVIEW

Point-of-Care (POC) molecular diagnostics are tests conducted in close proximity to the patient, such as in clinics, hospitals, and ambulances. Oncology, coagulation, antigen typing, human leukocyte, infectious illnesses, and genetic disease screening are all currently performed using molecular diagnostic techniques. Speedier development and commercialization of innovative and more advanced technologies, as well as the faster movement of such advanced tests from labs to point of care (POC) settings, are driving the worldwide market growth. The rising incidence of various malignancies and infectious disease types is expected to be a prominent driver driving market expansion in the approaching years. Growing knowledge and acceptance of improved treatment and diagnostic options such as personalised medicine, biomarker discovery, and advances in proteomics and molecular methods are other major drivers driving growth.

Reforms in reimbursement policies are also helping to boost market expansion to some extent. Another key growth driver for the market is the growing usage of molecular diagnostics for home healthcare. Another factor driving growth in the molecular diagnostics market is the increasing use of healthcare information technology to provide precise diagnoses. New diagnostic tests, mainly in the infectious disease application field, are expected to keep the molecular diagnostics momentum continuing in the coming years.

COVD-19 IMPACT ON THE POC MOLECULAR DIAGNOSTICS MARKET

Most companies' overall sales were affected by the COVID-19 outbreak. The introduction of COVID-19 testing molecular diagnostic technology, however, had a favourable impact on the point-of-care molecular diagnostics industry. Because of the COVID-19 pandemic, people postponed getting their health evaluated, resulting in fewer tests and reagent sales. However, as nations relax travel restrictions, the number of people who get tested is growing. As a result, the global response to the COVID-19 epidemic has been spearheaded by molecular diagnostics. Molecular diagnostics, on the other hand, have significant limitations. Modern molecular diagnostics are designed to be used as a core diagnostic solution for doing large numbers of tests in a reasonable length of time, rather than for COVID-19 point-of-care diagnosis. As a result, pinpointing the disease's origin is crucial to preventing its spread. As a result, the market grew throughout the epidemic and will continue to rise in the following years.

MARKET DRIVERS: 

The increasing prevalence of chronic and infectious diseases throughout the world is driving up the demand for point-of-care diagnostics

Across the globe, chronic illnesses such as cardiovascular disease, diabetes, and different infectious diseases are on the rise. One of the primary reasons driving demand for point-of-care diagnostics throughout the predicted period is the rising prevalence rate of such diseases.

According to the United Nations, about 38 million people were living with HIV/AIDS in 2019. There were 1.8 million youngsters and 36.2 million adults among them. Furthermore, the human respiratory syncytial virus (RSV) is one of the most prevalent viruses to infect the respiratory tract. According to the Centers for Disease Control and Prevention (CDC), 4-5 million children worldwide contract respiratory syncytial virus (RSV) lower respiratory tract infection each year. Similarly, the IDF Diabetes Atlas estimates that 206.0 million persons worldwide will have diabetes in 2021. Additionally, by 2030, the worldwide population of diabetic individuals is anticipated to reach 643 million, and by 2045, it will reach 783 million. A large increase in the incidence of diabetes and the other chronic diseases stated above has created a need for quick point-of-care diagnostics to efficiently manage such conditions, and the market is expected to develop at a favourable rate globally.

The propagation of a decentralized healthcare system to aid market expansion

Rapid diagnostic testing is expected to grow in popularity in decentralised settings since it allows for immediate access to medical equipment and removes the need for transportation. These developments will have a beneficial impact on worldwide market growth. Since immediate diagnosis reports are essential for accurate and faster therapeutic interventions, point-of-care testing has become critical for patient-centric healthcare. Patients now have accessible access to these diagnostics thanks to a transition from centralised point-of-care testing to decentralised testing for chronic and infectious diseases. As the demand for quick turnaround testing has grown, various companies have developed infectious disease diagnostics for dispersed settings. As a result, the need for decentralised healthcare settings has risen in response to the growing desire for quick and effective diagnostics that may be conducted at home or a physician's office for patient convenience.

MARKET RESTRAINTS:

Adoption is being hampered by the inaccuracy of point-of-care diagnostics

In the field of point-of-care testing, pre-analytical mistakes are common. As a result, such situations may limit new product releases, limiting industry growth. For example, Siemens Healthcare issued a Class 2 Device Recall in August 2020 for their BGEM Evaluate Card In-vitro Diagnostic Device, which is used to objectively test capillary whole blood, venous, or unanticoagulated arterial in the laboratory or at the point of care. This was due to the card lot 01-20095-10's irregular glucose values. This might lead to a delay in detecting hyperglycemia or needless hypoglycemic therapy. As a result, throughout the projection period, the lack of precision in POC testing is likely to limit market growth globally.

An unfavourable reimbursement scenario may act as a hindrance to market growth

Unsatisfactory reimbursements policies are a key stumbling block to the point-of-care molecular diagnostics market's expansion. Most diagnostic firms have significant difficulty in commercialising their tests: convincing Medicare and private health insurers to pay for them. In 2018, Medicare in the United States changed its reimbursement policy for various IVD tests, including point-of-care molecular diagnostics. Some of these tests don't have their codes in the Healthcare Common Procedure Coding System (HCPCS), thus they're invoiced with unlisted codes. Medicare Administrative Contractors (MACs) set a payment amount for their local jurisdictions in such circumstances. The Medicare reimbursement rate for COVID-19 tests based on high throughput technology has been decreased to USD 75 unless laboratories can process findings in less than two days, according to the Centers for Medicare & Medicaid Services (CMS). Thus, the unfavourable reimbursement policies are having a negative impact on the market growth.

This research report on the POC Molecular Diagnostics Market has been segmented and sub-segmented based on By Product, By Test location, By Technology, By Application and By Region.

POC MOLECULAR DIAGNOSTICS MARKET - BY PRODUCT

• Instruments
• Reagents
• Others

Based on products, the POC Molecular Diagnostics Market is segmented into Instruments, Reagents and Others. In 2021, the reagents category had the most revenue share in the market. Because of its widespread use in research and clinical contexts, it is projected to retain its prominence in the future years. Standard reagents aid in the production of timely and accurate findings. The market is projected to grow due to standardised outcomes, increased efficiency, and cost-effectiveness.

In addition, the increasing usage of tools to detect coronavirus, which was previously developed for other infectious disorders, is supposed to propel market expansion. For example, Roche Diagnostics expanded its Covid RT-PCR assays offering to include the new Cobas 5800 system in February 2022 in countries that received the CE mark approval.

POC MOLECULAR DIAGNOSTICS MARKET- TEST LOCATION

• Point-of-Care
• Self-test or Over the Counter
• Central Laboratories

Based on test location, the POC Molecular Diagnostics Market is segmented into Point-of-Care

Self-test or Over the Counter and Central Laboratories. Due to high treatment volumes for Covid testing in central labs, central laboratories held the greatest share of the market in 2021. Another key driver estimated to boost the market is a growth in the number of government efforts to provide various services, such as payment for diagnostic testing.

The development of molecular diagnostic platforms that may be employed in PoC scenarios is gaining popularity. As a result, several businesses are developing assays and molecular diagnostic platforms for point-of-care (POC) or near-patient testing. In addition, market growth is expected to be aided by the increasing development of novel assays that provide speedy PoC findings.

POC MOLECULAR DIAGNOSTICS MARKET- BY TECHNOLOGY

• PCR-based
• Genetic Sequencing-based
• Hybridization-based
• Microarray-based

Based on technology, the POC Molecular Diagnostics Market is segmented into PCR-based, Genetic Sequencing-based, Hybridization-based and Microarray-based. The PCR category commanded more than 58 per cent of the market share in 2020, thanks to increasing precision and accuracy as well as the expansion of its application. Furthermore, RT-PCR and DNA/RNA purification are gaining popularity due to advantages such as minimal reagent use, real-time process monitoring, workflow automation, and improved accuracy and repeatability. As a result, rising rates of genetic abnormalities and infectious illnesses, as well as increased public-private investments, grants, and financing for PCR-based research will further aid in market expansion.

POC MOLECULAR DIAGNOSTICS MARKET - BY APPLICATION

• Infectious Diseases
• Oncology
• Hematology
• Prenatal Testing
• Endocrinology
• Other

Based on applications, the POC Molecular Diagnostics Market is segmented into Infectious Diseases, Oncology, Hematology, Prenatal Testing and Endocrinology among others. The infectious illness segment generated a revenue of USD 2 billion in 2021. The dominance of this sector is due to the growing use of molecular diagnostics, particularly PCR tests, for the diagnosis of COVID-19. The sector will expand as laboratory capacity for infectious disease diagnostics and early identification of developing pandemic strains grows. Over the forecast period, the rising prevalence of infectious disease among the elderly, newborn newborns, and persons with certain chronic conditions will drive the expansion. Additionally, the rising availability of rapid testing will affect future product demand, resulting in more applications in faster disease diagnosis. Traditional testing flaws include long turnaround times, poor in vitro kinetic development, difficulties cultivating organisms in manually produced culture medium, and lack of sensitivity that has been mitigated by technology advances like PCR and ISH and thus is propelling the segmental growth.

POC MOLECULAR DIAGNOSTICS MARKET - BY REGION

• North America
• Europe
• The Asia Pacific
• Latin America
• The Middle East
• Africa

By region, the POC Molecular Diagnostics Market is grouped into North America, Europe, Asia Pacific, Latin America, The Middle East and Africa. Throughout the forecast period, the Asia Pacific area is expected to have the quickest CAGR. The increasing prevalence of chronic diseases due to ageing demography, the emergence of key market players operating in the market, a lack of advanced central laboratory testing services, and the potential cost-effectiveness of POC molecular diagnosis are driving the Asia Pacific POC molecular diagnostics market. In 2020, the market for point-of-care molecular diagnostics in North America was worth more than USD 1.4 billion. The expanding use of POC tests for safe and early diagnosis, as well as the rising prevalence of infectious illnesses, will drive up demand for such quick testing. Moreover, throughout the projected period, governments and key market players would invest heavily in research and development to develop POC molecular diagnostic tests, which will boost market revenue.  As the number of cases of COVID-19 in the region rises, so will the use of point-of-care molecular diagnostic kits to effectively treat the condition. Furthermore, the increasing usage of PCR-based diagnostic methods and the commercialization of real-time PCR products will have an impact on regional demand. In 2021, Europe contributed 27.4 per cent of total sales. This may be ascribed to the increased epidemiology of infectious and chronic illnesses, which has boosted market growth by stimulating R&D activity. The high level of life, as well as consumer awareness of early diagnosis and a well-established healthcare system, are major growth factors.

POC MOLECULAR DIAGNOSTICS MARKET - BY COMPANIES

The market for molecular diagnostics at the point of care is concentrated. The bulk of point-of-care molecular testing methods is developed by globally leading companies. Industry leaders have built their position in the market by investing more in research and having a superior distribution system. Furthermore, due to increased awareness, Asia-Pacific is seeing the rise of several minor companies, which has aided the market's growth. Some of the major players operating in the POC Molecular Diagnostics Market include:

• BD
• bioMérieux SA
• Bio-Rad Laboratories, Inc.
• Abbott
• Agilent Technologies, Inc.
• Danaher
• Hologic Inc. (Gen Probe)
• Illumina, Inc.
• Johnson & Johnson Services, Inc.
• Grifols, S.A.
• QIAGEN
• F. Hoffmann-La Roche, Ltd.
• Siemens Healthineers AG
• Sysmex Corporation

NOTABLE HAPPENING IN POC MOLECULAR DIAGNOSTICS MARKET

PRODUCT LAUNCH- Seegene announced the introduction of their forthcoming Allplex SARS-CoV-2 Fast PCR Assay in January 2022. The test has a 60-minute turnaround time, making it ideal for bulk testing.

PRODUCT LAUNCH- Biodesix launched the GeneStrat NGSTM Test, a blood-based tumour profiling test, in January 2022 to help clinicians treat severe lung cancer based on mutations.

ACQUISITION- Roche bought GenMark Diagnostics for USD 1.8 billion in May 2021. Roche will be able to increase its molecular diagnostics range as a result of this takeover.

COLLABORATION- In October 2020, bioMérieux SA joined with Africa Medical Supplies Platform (AMSP) to provide African Union Member States with high-quality COVID-19 testing tools from the bioMérieux Pandemic Response Array.