Molecular Diagnostics Market Growth Analysis | 2023-2028

Market Insights

The molecular diagnostics market was estimated at USD 24.68 billion in 2022 and is likely to grow at a CAGR of 4.59% during 2023-2028 to reach USD 32.33 billion in 2028.

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What are molecular diagnostics?

Molecular diagnostics encompasses a wide range of techniques that allows the detection and analysis of biological markers in the genome and proteome. These biomarkers can also include chromosomal abnormalities, protein levels, genetic mutations, gene expressions, etc. Molecular diagnostics can provide vital insights about an individual's health status and aid in disease diagnosis, by identifying these biomarkers.

COVID-19 IMPACT

The global pandemic COVID-19 impacted almost every industry and shook the market. However, the pandemic increased the need of developing diagnostic instruments and diagnostic service centers and hence there was a positive impact on the molecular diagnostics market.

Market Dynamics

The molecular diagnostics market has experienced significant growth in recent years. Several dynamics have contributed to this growth, a few are mentioned below–

• The growing incidence of infectious diseases is one of the primary growth factors over the forecast period. With the growing incidence of STIs such as HIV, HPV, etc. the need for accurate and affordable diagnosis also grows substantially. There are over 38 million (33.9–43.8 million) people living with HIV by the end of 2021, according to WHO. The health organization states that the Global Fund and Joint United Nations Programme on HIV/AIDS – UNAIDS targets to end the HIV epidemic by 2030, and to achieve this, 95% of all HIV-affected people should have a diagnosis.
• Rising government initiatives, funding activities, etc. are supporting and promoting development in this sector, providing growth opportunities. For instance – The National Institutes of Health (NIH) has the Molecular and Cellular Biology (MCB) program, the National Institute of Allergy and Infectious Diseases (NIAID) Intramural Research Program, the Molecular and Cellular Oncology (MCO) program, and more. Apart from NIH, The Food and Drug Administration (FDA), The Centers for Disease Control and Prevention (CDC), The Department of Defense (DoD), etc. also have a number of programs that support the development and use of molecular diagnostics for military, public health, and many other purposes.
• The rising geriatric population globally is increasing the risk of getting a number of diseases including cardiovascular disease, neurological disorders, diabetes, etc. The global geriatric population (people aged 65 years or older) worldwide is expected to double over the next three decades. According to World Social Report 2023 published by the United Nations (un.org), the count of elderly people will reach 1.6 billion by 2050.
• The increasing incidence of cancer calls for early diagnosis. According to the American Cancer Society (ACS), in 2023, ~1,958,310 new cancer cases are predicted in the United States. By 2040, the global cancer cases count is expected to rise to 27.5 million new cases. Since molecular diagnostics is vital in early detection, prognostics, and other clinical trials, the global market for molecular diagnostics will grow with the growing incidence of cancer.

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Key Players

Some of the key players in the market are:

• Agilent Technologies, Inc.
• BioMerieux SA
• Danaher Corporation
• F. Hoffmann-La Roche Ltd.
• Illumina, Inc.
• Novartis AG
• QIAGEN N.V.
• Siemens Healthineers AG
• TBG Diagnostics Limited
• Thermo Fisher Scientific Inc.

Segment Analysis

This report studies the market covering a period of 12 years of trend and forecast. The report provides detailed insights into the market dynamics to enable informed business decision-making and growth strategy formulation based on the opportunities present in the market.

The molecular diagnostics market is segmented into the following categories.

By Product Type

• Reagents & Kits
• Instruments
• Others

By Technique Type

• Polymerase Chain Reaction
• Isothermal Amplification
• Hybridization
• Sequencing
• Microarray
• Others

By Application Type

• Infectious Diseases
• Blood Screening
• Oncology
• Genetic Tests
• Others

By End-User Type

• Hospitals
• Diagnostic Laboratories
• Others

By Region

• North America (Country Analysis: the USA, Canada, and Mexico)
• Europe (Country Analysis: Germany, France, the UK, Russia, Spain, and the Rest of Europe)
• Asia-Pacific (Country Analysis: China, Japan, India, South Korea, and the Rest of Asia-Pacific)
• Rest of the World (Sub-Region Analysis: Latin America, the Middle East, and Others)

By Product Type

Based on the product type, the molecular diagnostics market is segmented as reagents & kits, instruments, and others. The reagents & kits segment is expected to hold the major share of the market during the forecast period. The high use of reagents in molecular diagnostic testing, increasing demand for over-the-counter diagnostic tests, and growing adoption of these tests in non-medical facilities such as home self-testing are driving the segment's growth.

By Application Type

Based on the application type, the market is segmented as infectious diseases, blood screening, oncology, genetic tests, and others. Infectious diseases are estimated to account for the major share of the market during the forecast period on account of the increasing number of infectious diseases such as SARS-CoV-2, new multidrug-resistant TB, H1N1, and HIV strains.

Regional Insights

In terms of regions, North America is expected to be the leading region in the market during the forecast period, owing to a growing geriatric population, increasing demand for point-of-care diagnostics, and outbreaks of bacterial and viral diseases. Furthermore, technological advancements, the presence of well-established diagnostic systems, and development in the healthcare sector are expected to drive market growth during the forecast period. Europe and Asia-Pacific are also expected to offer substantial growth opportunities during the forecast period.

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Recent News & Developments

In May 2023, Hologic announced the FDA clearance of the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay. Hologic Inc. (Nasdaq: HOLX) revealed that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay. This molecular diagnostic test detects and distinguishes four of the most prevalent respiratory viruses that often present similar clinical symptoms: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (flu A), influenza B (flu B), and respiratory syncytial virus (RSV).

In April 2023, QIAGEN unveiled the launch of QIAstat-Dx in Japan, introducing a respiratory panel for syndromic testing. QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced its plans to make the QIAstat-Dx syndromic testing solution accessible for use in Japan, featuring a SARS-CoV-2 Respiratory Panel capable of detecting over 20 pathogens from a single patient sample.

In March 2023, BD received FDA 510(k) clearance for its first-of-its-kind high-throughput diagnostic test for infectious vaginitis. BD (Becton, Dickinson and Company) (NYSE: BDX), a prominent global medical technology company, announced FDA clearance for the BD Vaginal Panel on the BD COR™ System. This comprehensive diagnostic test directly identifies the three most common infectious causes of vaginitis using BD's high-throughput molecular diagnostic platform, tailored for large laboratories.

In February 2023, Siemens Healthineers and Unilabs launched a strategic partnership aimed at improving patient care by enhancing diagnostic testing infrastructure. Siemens Healthineers, a leading medical technology company, and Unilabs, a prominent diagnostic services provider, unveiled a multi-year agreement valued at over €200 million. Unilabs will invest in Siemens Healthineers' state-of-the-art technology and acquire more than 400 laboratory analyzers to further enhance its laboratory infrastructure, providing exceptional service to its customers.

In October 2022, Thermo Fisher Scientific announced its acquisition of The Binding Site Group, a global leader in specialty diagnostics, in an all-cash transaction valued at £2.25 billion or $2.6 billion at current exchange rates.

In October 2022, Roche received FDA clearance for the cobas® SARS-CoV-2 Qualitative PCR test for use on the fully automated cobas® 6800 and cobas® 8800 Systems. This standalone test is designed to qualitatively detect SARS-CoV-2, the virus responsible for COVID-19, in nasal and nasopharyngeal samples from symptomatic patients under the guidance of their healthcare providers.

Research Methodology

This report offers high-quality insights and is the outcome of a detailed research methodology comprising extensive secondary research, rigorous primary interviews with industry stakeholders, and validation and triangulation with Stratview Research’s internal database and statistical tools.

More than 1,000 authenticated secondary sources, such as company annual reports, fact books, press releases, journals, investor presentations, white papers, patents, and articles have been leveraged to gather the data.

We conducted more than 10 detailed primary interviews with the market players across the value chain in all four regions and with industry experts to obtain both qualitative and quantitative insights.

Report Features

This report provides market intelligence in the most comprehensive way. The report structure has been kept such that it offers maximum business value. It provides critical insights into the market dynamics and will enable strategic decision-making for the existing market players as well as those willing to enter the market.

What Deliverables Will You Get in this Report?

Report Customization

With this detailed report, Stratview Research offers one of the following free customization options to our respectable clients:

Company Profiling

• Detailed profiling of additional market players (up to 3 players)
• SWOT analysis of key players (up to 3 players)

Market Segmentation

• Current market segmentation by any one of the technique types by application type.

Competitive Benchmarking

• Benchmarking of key players on the following parameters: Product portfolio, geographical reach, regional presence, and strategic alliances.

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