Molecular Diagnostics Market Size, Growth by Product & Service (Reagents, Kits, Instruments), Test Type (Lab, PoC), Technology (PCR, INAAT, NGS, ISH), Application (Infectious, Oncology, Genetic Testing), End User (Diagnostic Labs, Hospitals) - Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2023-2032

The global molecular diagnostics market size was exhibited at USD 39.98 billion in 2022 and is projected to hit around USD 68.3 billion by 2032, growing at a CAGR of 5.5% during the forecast period 2023 to 2032.

Key Pointers:

• Reagents dominated the overall market majorly driven by the high usage rate of reagents due to the COVID-19 pandemic
• PCR technology accounted for a revenue share of 65.9% in 2022. The increased use of PCR for the diagnosis of COVID-19 and other infectious diseases is one of the major reasons for its dominance
• Self-testing or OTC segment is anticipated to be the fastest-growing segment, over the forecast period, as it facilitates early diagnosis and constant patient monitoring. The launch of COVID-19 molecular self-tests is also expected to boost the growth of this segment.
• North America commanded the highest revenue share in 2022, driven by a high disease prevalence, proactive government measures, high testing rate for COVID-19, technological advancements, and improvements in healthcare infrastructure.

Molecular Diagnostics Market Report Scope

The contraction in the market will be due to the decline in demand for molecular testing for COVID-19. However, factors such as the rising geriatric population and increasing demand for technologies such as NGS is expected to drive market growth.

Molecular diagnostics plays an important role in infectious disease testing as they can yield effective and fast results. Hence, the increasing prevalence of hospital-acquired infections & infectious diseases is projected to drive the market over the forecast period. Increasing incidence and awareness regarding genetic disorders is further anticipated to accelerate market growth. The miniaturization of three basic molecular assays-nanobiotechnology, biochips, and microfluidics are expected to increase the accuracy and specificity of diagnostic outcomes, and hence, increase the demand for molecular diagnostic products. These improvements are expected to enhance the availability of PoC molecular diagnostic tests to yield quick and effective test results.

Companies are expanding their product portfolios with the acquisition of smaller companies. For instance, in March 2021, Hologic announced the acquisition of Diagenode-a molecular diagnostic company with a wide range of PCR instruments, facilitating the detection of over 30 bacteria-for USD 159 million. Similarly, in April 2021, F. Hoffmann-La Roche Ltd. acquired GenMark Diagnostics, Inc. at a price of USD 24.05 per share in cash, and it holds around 82.89% of total shares of GenMark Diagnostics. GenMark Diagnostics, Inc. has proprietary technologies, such as eSensor XT-8 and ePlex, which can be utilized in developing tests for infectious diseases, including bloodstream infections.

Key players are enhancing their range of testing options for real-time PCR instruments by increasing R&D activities for the development of kits that target emerging diseases or by entering into agreements with other kit manufacturing companies. These include the introduction of Cobas HPV test assay in Cobas 4800 by Roche Diagnostics. The introduction of tuberculosis testing Xpert assay on GeneXpert platform by Cepheid is an example of such advancement. Such advances are anticipated to drive the global molecular diagnostics market.

Molecular Diagnostics Market Dynamics

Drivers: Rising focus on R&D and growing funding in molecular diagnostics

Government initiatives, schemes, or funding activities that support and promote innovation and development provide growth opportunities in the molecular diagnostics market. For instance, NIH’s Rapid Acceleration of Diagnostics (RADx) initiative, with a USD-200-million budget, was announced in August 2020. This initiative aimed to accelerate the development, commercialization, and implementation of technologies for COVID-19 testing. Additionally, in 2019, the National Institute of Allergy and Infectious Diseases (NIAID), a part of the US NIH, initiated the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program to support a broad portfolio of influenza research activities, including the development of vaccines, diagnostics, and therapeutics against seasonal and pandemic influenza. NIAID announced funds worth USD 51 million for CIVICs. Under the CIVICs program, investigators analyzed blood samples from people vaccinated against influenza and people diagnosed with the H1N1 influenza virus or H3N2 influenza viruses to check for vaccine effectiveness. As diagnostic testing is an integral part of infection control, the global market is expected to gain momentum in the near future. Such examples of funding and government initiatives are expected to support the growth of the market.

Opportunities: Growth opportunities in emerging countries

As markets in the US and Europe are maturing, most players are shifting their focus to emerging markets. The high investments in healthcare and life science research in emerging markets play an essential role in upgrading laboratory infrastructures in these countries. This, in turn, supports the installation of diagnostic systems in laboratories and leads to the growing adoption of molecular diagnostics.

Restraints: Unfavorable reimbursement scenario

According to MedPAC (Medicare Payment Advisory Commission), medical testing has seen a 40% decline in reimbursement over the last 40 years. This decline and additional budgetary concerns among healthcare systems will be a major obstacle to implementing novel diagnostic techniques in clinical laboratories.

The Centers for Medicare & Medicaid Services (CMS) reduced the Medicare reimbursement rate for COVID-19 tests based on high-throughput technology to USD 75 unless labs can process results in under two days. Medicare does not currently provide genetic testing coverage for individuals without a personal history of cancer (Source: American Society of Clinical Oncology). These factors are expected to affect the US molecular testing market adversely.

Challenges: Operational barriers

Clinical laboratories across major markets are still evolving; technicians face operational challenges in ensuring effective sample procurement, storage, and transportation, especially while adopting novel technologies such as NGS and lab-on-a-chip PCR devices. Laboratory spaces also need to be reconfigured to conduct specific molecular diagnostic tests used for pathogen detection to avoid cross-contamination and ensure efficient time management. This results in considerable cost escalations in maintaining and operating advanced molecular diagnostic instruments, particularly those capable of handling a single sample type.

Furthermore, due to the rapid mutation of microbes and the increasing outbreak of epidemics, clinical laboratories need to adopt innovative technologies capable of rapid sample diagnosis. However, the shortage of skilled and technically knowledgeable laboratory technicians to operate advanced molecular diagnostic products has hindered their overall adoption, particularly in emerging markets.

Asia Pacific is expected to be the fastest growing region of molecular diagnostics market during the forecast period.

Low infrastructure & treatment costs and the availability of highly educated physicians have driven medical tourists to APAC countries. This is a major factor driving the growth of the molecular diagnostics market in this region. Furthermore, supportive government regulations will further aid the growth of this market during the forecast period.

However, factors such as the reluctance of healthcare professionals to adopt advanced diagnostic technologies due to budget constraints and pricing pressures faced by prominent product manufacturers are expected to restrain the market growth during the forecast period.

Recent Developments:

In September 2021, F. Hoffmann-La Roche Ltd. (Switzerland) announced the acquisition of TIB Molbiol (Germany) to expand its PCR test portfolio with a wide range of assays for infectious diseases.

In June 2021, QIAGEN N.V.(Netherlands) partnered with Verogen (US) to broaden its portfolio in NGS technologies.

In June 2021, Hologic, Inc. (US) acquired Mobidiag Oy (Finland), an innovator in acute care molecular diagnostic testing. This acquisition will aid in expanding Hologic’s molecular diagnostics product portfolio.

In November 2020, Hologic, Inc. (US) received additional FDA approval for the AptimaHIV-1 Quant Dx Assay for use as an aid in the diagnosis of HIV infection.

Some of the prominent players in the Molecular Diagnostics Market include:

• F. Hoffmann-La Roche Ltd. (Switzerland), 
• Hologic, Inc. (US), 
• PerkinElmer, Inc. (US), 
• Thermo Fisher Scientific, Inc. (US),
•  Abbott Laboratories (US).
• Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the global Molecular Diagnostics market.

By Product & Service

• Reagents & Kits
• Instruments
• Services & Software

By Test Type

• Lab Tests
• PoC Tests

By Technology

• Polymerase Chain Reaction (PCR)
• Isothermal Nucleic Acid Amplification Technology (INAAT)
• DNA Sequencing & Next- generation Sequencing (NGS)
• In Situ Hybridization (ISH)
• DNA Microarrays
• Other Technologies

By Application

• Infectious Disease Diagnostics
  • COVID-19
  • Hepatitis
  • 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

• Diagnostic Laboratories
• Hospitals & Clinics
• Other End Users

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)