Molecular Diagnostics Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2031 - By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa)

The global molecular diagnostics market is poised for significant growth, with its value projected to increase from US$ 23 billion in 2024 to US$ 35 billion by the end of 2031, reflecting a compound annual growth rate (CAGR) of 6%. This steady expansion underscores the increasing importance of molecular diagnostics in healthcare.

Market Introduction and Definition

Molecular diagnostics involves analyzing biological markers at the molecular level to detect specific genetic sequences or mutations associated with various diseases. This field has seen substantial advancements and steady market growth due to the rising prevalence of infectious diseases, genetic disorders, and cancer. The growth prospects of the molecular diagnostics industry depend on economic development, infrastructure projects, urbanization rates, and construction activity. Strategic partnerships and collaborations with research institutions, healthcare providers, and technology firms are essential to access expertise, resources, and novel technologies.

According to the Nature Reviews Microbiology Journal, molecular technologies are nimble, rapid, and versatile, making them an effective solution for infectious disease diagnostics in resource-limited settings with diverse potential etiologies. Healthcare systems utilizing molecular diagnostics can achieve economies of scale, maximize limited expertise, and respond quickly to emerging threats.

Market Growth Drivers

Expanding Role of Companion Diagnostics Across Therapeutic Fields

Companion diagnostics, a subset of molecular diagnostics, plays a crucial role in the increased use of targeted medications in oncology and other therapeutic areas. Next-generation sequencing (NGS), using a multi-analyte approach, provides comprehensive biomarker information, integrating precision medicine into everyday clinical practice.

Regulatory agencies like the FDA support the development and use of companion diagnostics, often requiring their approval for related prescription medications. While initially focused on cancer treatments, companion diagnostics are now expanding to other therapeutic areas, including infectious diseases, cardiovascular conditions, and neurological disorders, broadening the market for related diagnostic tools.

Market Restraints

High Cost of Both Equipment and Reagents

Modern molecular diagnostic tools and supplies can be expensive, posing a challenge for laboratories to invest in advanced technology without exceeding their budgets. The high upfront costs of molecular diagnostic equipment discourage smaller labs or establishments with limited finances. Establishing specialized facilities and infrastructure adds to the financial burden.

Reagents, including enzymes, PCR kits, and DNA probes, are also costly. Regular restocking of these consumables adds to the ongoing operating costs, particularly in resource-limited settings. Additionally, maintenance, calibration, and upgrades of equipment contribute to the total cost of ownership.

Skilful Workforce Training

Operating molecular diagnostic equipment requires specific knowledge and skills in molecular biology, genetics, biochemistry, and related fields. Training personnel to use molecular diagnostic equipment and interpret results necessitates investment in training programs, workshops, and educational resources. High training costs can be prohibitive for smaller healthcare organizations or laboratories with limited finances.

Opportunities

Increasing Government Support and Favorable Regulations

The COVID-19 pandemic has significantly boosted the adoption of real-time PCR (RT-PCR) and other molecular diagnostic technologies. The pressure to expand diagnostics rapidly has led to over 3,000 testing laboratories in India alone performing molecular testing. The prevalence of RT-PCR, viral amplification, and genome sequencing is revolutionizing molecular diagnostics.

Differences in legislative stances between the US and the EU regarding laboratory-developed tests (LDTs) and in-house tests present an opportunity for molecular diagnostic companies to drive innovation. Companies can highlight FDA-compliant testing for the US market and position themselves as collaborators supporting improved internal testing capacities in the EU. This strategic approach allows businesses to maximize market share and product offerings by leveraging different regulatory frameworks.

Key Market Players Include

• Becton, Dickinson and Company
• Bio-Rad Laboratories In
• Merck KgaA
• Thermo Fisher Scientific Inc
• Agilent Technologies, Inc.
• F. Hoffman - La Roche Ltd.
• Illumina, Inc.
• Qiagen N.V.
• Hologic Inc.
• Siemens Healthineers AG
• Seegene, Inc.
• DiaSorin S.p.A
• Grifols, S.A.
• bioMérieux
• QuidelOrtho Corporation
• RapidBio
• Abbott Laboratories
• Danaher Corporation

Global Molecular Diagnostics Market is Segmented as Below:

By Product Type:

• Instruments
• Polymerase Chain Reaction (PCR) Systems
• Hybridization (In-Situ Hybridization & Fish) Systems
• DNA Sequencing and Next-Generation Sequencing Platforms
• Microarrays
• Reagent
• Antibodies
• DNA Template
• DNA Polymerase
• Oligonucleotide Primers
• Deoxyribonucleotide Triphosphate (dNTPs)
• Buffer
• Assay Kits
• Consumables

By Disease Area:

• Infectious Disease
• Diabetes
• Cardiology
• Oncology
• Nephrology
• Autoimmune Disease
• Dermatology
• Wound Care
• Others

By End Use:

• Hospitals & Clinics
• Diagnostics Laboratories
• Academic and Research Institutes
• Biopharmaceutical Companies

By Region:

• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• Middle East & Africa