Molecular Diagnostics Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global molecular diagnostics market growth forecasted to transform from $17.3 billion in 2024 to $32.7 billion by 2029, driven by a CAGR of 13.5%. There is an increased focus on funding in the areas of precision medicine and genomics by the government which has amplified the usage of molecular diagnostics-based kits and instruments. Also, the high influx of patients has led to an increasing number of hospitals being established in both developed and emerging economies that is further fuelling the demand for precise molecular based testing. Recent technological developments with respect to portability and quick turnaround times have made it easier for smaller facilities to include molecular based testing into their workflow.

Molecular Diagnostics Market Size, Dynamics & Ecosystem

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Molecular Diagnostics Market Dynamics

DRIVER: Increased investment and emphasis on R&D in molecular diagnostics

Increasing government initiatives, schemes, and funding activities support and promote research and development that enables growth prospects in the molecular diagnostics market. These financial incentives and support mechanisms for companies and research institutes lead to increased investments in R&D, infrastructure, and the development of advanced diagnostic technologies.  For instance, the Bill & Melinda Gates Foundation had awarded funding of USD 14.2 million to LumiraDx Limited (UK) in December 2022 to support the company's further development of a molecular TB point-of-care testing device. Such funding initiatives are expected to support the further growth of the molecular diagnostics market.

RESTRAINT: High cost of molecular diagnostic products

Molecular diagnostic devices are expensive; only big hospitals and reference laboratories with substantial capital budgets may be able to purchase them. Due to their lack of capital budgets, many small laboratories, healthcare clinics, and practitioners might not be able to purchase an analyzer that is very large. Therefore, high costs may limit the growth of the molecular diagnostics market.

OPPORTUNITY: Opportunities for growth in developing economies

Major players in the molecular diagnostics market could see development prospects from emerging economies including South Africa, Brazil, Turkey, Russia, and India. High disease prevalence, a sizable patient base, better healthcare facilities, rising disposable incomes, and an increase in medical tourism are some factors responsible for this. Furthermore, investing heavily in life science research and healthcare in emerging economies is also playing a crucial role in upgrading laboratory infrastructures in these countries. This in turn encourages the installation of diagnostic equipment in labs and contributes to the expanding use of molecular diagnostics.

CHALLENGE: Evolving regulatory environment for IVD and molecular diagnostics

In the US and European nations, there is growing enforcement of strict regulatory and legislative standards pertaining to IVD, especially molecular diagnostics. In the US, medical device regulations apply to IVD products, as stated in 21 CFR 809. According to a distinct IVD Directive 98/79/EC, IVD products are classified and governed differently in the EU than other medical devices.  In the European Union (EU), all medical devices marketed must comply with the Medical Device Regulation (MDR) as of May 26, 2021, by law.  Moreover, it could be necessary to install new software on an existing device, update its software, or make any other adjustments when using new applications. Thus, the market for molecular diagnostics may find it challenging to expand as a result of these regulatory restrictions.

Molecular Diagnostics Market Segmentation & Geographical Spread

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The largest share in the molecular diagnostics industry in 2023 was held by the reagents & kits segment, by product & service.

Categorized by product & service, the molecular diagnostics market includes reagents & kits, instruments, and services & software. As of 2023, the largest portion of the market was dominated by the reagents & kits segment. Reagents and kits are often in high demand and widely used because of their adaptability to meet various testing requirements. Additionally, there has been a rise in diagnostic testing because of increased awareness about the importance of early disease diagnosis and preventative healthcare. Moreover, constant technological advancements in the field of molecular diagnostics is fuelling the development of new and enhanced reagents and kits. Such sophisticated reagents and kits provide improved performance and dependability and encourages their broad use and helps the market to expand.

Lab tests segment accounted for the largest share of the molecular diagnostics industry in 2023, by test type.

The molecular diagnostics market is categorized into lab tests and PoC tests, based on test type. In 2023, the lab tests segment emerged as the leading sector in the molecular diagnostics market. Technological developments in diagnostics play a major role in the lab tests segment's market expansion. Molecular diagnostic advancements such as next-generation sequencing (NGS) and polymerase chain reaction (PCR) have significantly improved the sensitivity and specificity of testing for infectious diseases and facilitate efficient treatment and control techniques and enable faster and more precise pathogen detection, promoting market expansion. Furthermore, rigorous validation procedures are used for lab-based molecular diagnostic tests to guarantee their precision, dependability, and clinical applicability, which promotes their acceptance in standard medical practice.

PCR segment dominated the molecular diagnostics industry in 2023, based on technology.

Based on technology, the molecular diagnostics market is segmented into polymerase chain reaction, isothermal nucleic acid amplification technology, in situ hybridization, DNA sequencing & next-generation sequencing, DNA microarrays, and other technologies. The polymerase chain reaction (PCR) segment accounted for the largest share of the molecular diagnostics market in 2023. Molecular diagnostics uses PCR technologies for a variety of purposes. The identification and diagnosis of numerous infectious diseases, genetic conditions, and cancer biomarkers are all made possible by this adaptability. The developing qRT-PCR technology, automation of PCR equipment, and expanding applications of PCR in proteomics and genomics are driving the PCR market.

North America accounted for the largest share of the molecular diagnostics industry in 2023.

Categorized into six primary regions, namely North America, Europe, Asia Pacific, Latin America, the Middle East & Africa, and GCC countries, the molecular diagnostics market witnessed North America taking the forefront in 2023. The substantial portion of the global molecular diagnostics market held by North America is primarily due to the advanced healthcare systems in the US and Canada. The region's commercial health insurance firms' increases in healthcare coverage are also anticipated to have a major impact on the market's expansion. Other factors that are expected to support the growth of the molecular diagnostics market in the region include the increasing adoption of cutting-edge technologies like real-time PCR, INAAT, and other technologies for testing for infectious diseases, cancer, and rare genetic diseases. These technological developments have played a major role in the molecular diagnostics market's expansion in North America.

The major players in this market are Danaher (US), F. Hoffmann-La Roche Ltd (Switzerland). Illumina, Inc. (US), bioMérieux (France), and Hologic, Inc. (US). These players lead the market because of their extensive product portfolios and wide geographic presence.

Scope of the Molecular Diagnostics Industry:

This report categorizes the molecular diagnostics market to forecast revenue and analyze trends in each of the following submarkets:

By Product & Service

• Reagents & Kits
• Instruments
• Services & Software

By Test Type

• Lab Tests
• PoC Tests

By Sample Type

• Blood, Serum & Plasma
• Urine
• Other Sample Types

By Technology

• Polymerase Chain Reaction
• Isothermal Nucleic Acid Amplification Technology
• DNA Sequencing & Next-generation Sequencing
• In Situ Hybridization
• DNA Microarrays
• Other Technologies

By Application

• Infectious Disease Diagnostics
  • Hepatitis
    • Hepatitis B
    • Hepatitis C
    • Other Hepatitis Diseases
  • HIV
  • CT/NG
  • HAI
  • HPV
  • Tuberculosis
  • Influenza
  • Other Infectious Diseases
• Oncology Testing
  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Prostate Cancer
  • Other Cancers
• Genetic Testing
• Other Applications

By End User

• Hospitals & Clinics
• Diagnostic Laboratories
• Other End Users

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Russia
  • Switzerland
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of LATAM
• Middle East & Africa
• GCC Countries

Recent Developments of Molecular Diagnostics Industry:

• In March 2024, Danaher (US) received clearance from the US Food and Drug Administration (FDA) for Xpert Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS).
• In March 2024, bioMérieux (France) received US FDA 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval for the BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel.
• In November 2023, F. Hoffmann-La Roche Ltd. (Switzerland) launched the LightCycler PRO System to advance clinical needs in molecular diagnostics and address public health challenges.
• In April 2023, Illumina, Inc. (US) and Pillar Biosciences Inc. (US) partnered to make Pillar’s suite of oncology assays commercially available globally as part of the Illumina portfolio of oncology products.
• In May 2023, Hologic announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.

Frequently Asked Questions (FAQ):

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