The global molecular diagnostics market size is projected to reach USD 11.54 Billion by 2023 from USD 7.71 Billion in 2018, at a CAGR of 8.4%. The high prevalence of infectious diseases primarily drives growth in this market and various types of cancers, increasing awareness and acceptance of personalized medicine and companion diagnostics, growth in the biomarker identification market, and advancements in molecular techniques.

Molecular diagnostics is a technique used to identify and analyze nucleic acids or proteins at a molecular level. This technique assesses the genetic makeup of an individual to identify predisposition to a particular disease or condition and diagnose it.

By product & service, reagents and kits segment to register the highest CAGR during the forecast period

The reagents and kits segment is expected to account for the largest share of the molecular diagnostics market in 2018. This segment is also projected to register the highest CAGR during the forecast period. The availability of a wide range of reagents and kits, increasing use of reagents in different therapeutic areas, increase in basic research and commercial applications, and easy accessibility to a wide range of reagents are the major factors supporting the growth of the molecular diagnostic reagents and kits market. Roche, Bio-Rad, and bioM�rieux are some of the major players offering molecular diagnostic reagents and kits.

By technology, the Polymerase Chain Reaction (PCR) segment to account for the largest market share during the forecast period

In 2018, the PCR segment was expected to account for the largest share of the molecular diagnostics market. This market is projected to continue doing so during the forecast period. The large share of the PCR segment is attributed to the growing use of PCR in proteomics and genomics, the automation of PCR instruments, and the emergence of advanced technologies like qRT-PCR. However, the DNA sequencing and NGS segment are projected to register the highest growth rate during the forecast period. The increasing incidence of cancer, increasing focus of key market players on developing and launching diagnostic NGS kits and panels, growing applications of sequencing in genomics research, and increased requirement and necessity for molecular-targeted drugs/therapies (personalized medicine) are contributing to the growth of this segment.

Asia Pacific to register the highest CAGR during the forecast period

The market in Asia Pacific is projected to register the highest growth during the forecast period. Growing GDP, a significant rise in disposable income levels, increased healthcare spending by a more extensive population base, modernization of healthcare infrastructure and rising penetration of cutting-edge clinical laboratory technologies (especially in rural areas) are some of the factors driving the growth of the molecular diagnostics market in Asia Pacific.

Market Dynamics

Driver: High prevalence of infectious diseases and various types of cancers

The global prevalence of infectious diseases, such as influenza, HPV, hepatitis, HIV, and tuberculosis, is considerably high despite the significant improvements in sanitation practices and medicine. Traditionally, antimicrobial therapy was used as a powerful tool to combat infectious diseases. However, over the years, antimicrobial agents have failed to deliver the desired results due to the emergence of drug-resistant microbes. Owing to this, the prevalence of these infectious diseases is increasing globally. The high and rising incidence of infectious diseases is creating a demand for new diagnostic procedures, including molecular diagnostic tests, which are fast and specific. Similar to infectious diseases, the prevalence of cancer is also growing across the globe. With the growing incidence of cancer globally, the demand for molecular diagnostic tests for effective cancer diagnosis is expected to increase in the coming years.

Restraint: Delay in the approval of new molecular diagnostic tests

Regulatory and legal requirements applied to molecular diagnostics are becoming more stringent. For more than 20 years, the FDA has emphasized that it has supervisory authority over LDTs (laboratory-developed tests), but it has chosen to exercise enforcement discretion over such tests. In recent years, however, the FDA has declared that added oversight of LDTs is needed and that the agency plans to issue a guidance document on this. Hence, even the issuance of the draft guidance is sure to raise queries and create new issues. Without an understanding of how the regulatory environment in the LDT sector may change in the future, players may find themselves facing an uncertain regulatory future. Also, earlier, diagnostic tests were comparatively simple and used well-established technologies, such as immunoassays. Nowadays, the role of NGS and other novel genetic tests in diagnostic testing is increasing. However, it is not clear how these new technologies will be regulated in the future.

Opportunity: Advances in genomics and proteomics

Advances in genomics and proteomics have resulted in the development of a multitude of assays and technologies useful for the diagnosis and management of diseases. The new technologies, based on genomics techniques such as PCR and proteomics, help in the discovery of new molecular diagnostic approaches for disease diagnosis and disease pathogenesis. They also enable better surveillance and rapid diagnosis.

Genomics and proteomics are research-driven sectors. Thus, advanced technologies developed through combined efforts by pharmaceutical research companies, the medical community, and government agencies can help combat the threat posed by various infections and cancers. The availability of funds from organizations such as the National Institutes of Health (NIH) and the National Science Foundation (NSF) for various projects has increased the number of research activities in these fields. With growing research in proteomics and genomics, the commercialization of more advanced molecular techniques is expected in the coming years.

Challenge: Dearth of trained professionals limiting the appropriate use of new molecular diagnostic technologies

The knowledge of molecular diagnostic technologies is vital for effectively carrying out molecular diagnostic tests. Molecular assays are sensitive to the quantity and purity of the samples used, and small deviations can lead to erroneous and variable inferences. Furthermore, due to the rapid mutation of microbes and the increasing outbreak of epidemics, clinical laboratories need to adopt innovative technologies capable of timely sample diagnosis. Hence, all laboratories and setups must be well-versed with the techniques to begin practice. Well-qualified and skilled personnel with specialized training are required for the effective analysis of solutions. As the level of awareness about the latest advancements in molecular tests is low among many clinicians, it is resulting in an operational gap for clinical laboratories, and the uptake of such technologies is mostly restricted. Besides, the reluctance to move from manual operations towards automation is another challenge for market growth. Thus, the shortage of skilled, well-trained, and technically knowledgeable laboratory technicians to operate advanced molecular diagnostic products is limiting their overall adoption, particularly in emerging markets.

Scope of the Report

Report Metric Details Market size available for years 2016�2023 Base year considered 2017 Forecast period 2018�2022 Forecast units USD Million (Value) Segments covered Product & Service, Technology, Application, End-User, Region Geographies covered North America, Europe, Asia Pacific, Rest of the World Companies covered Roche Diagnostics (US), QIAGEN N.V. (Netherlands), Hologic Inc. (US), Abbott Laboratories (US), Grifols (Germany), Siemens Healthcare (Germany), Becton, Dickinson, and Company (US), Beckman Coulter Inc. (US), bioM�rieux SA (France), and Danaher Corporation (US)

The Molecular Diagnostics Market has been categorized under the following segments and sub-segments:

By Product & Service

Reagents & Kits

Instruments

Software and Service

By Technology

Polymerase Chain Reaction (PCR)

Isothermal Nucleic Acid Amplification Technology (INAAT)

DNA Sequencing and NGS

DNA Microarrays

In Situ Hybridization

Other Technologies

By Application

Infectious Disease

Oncology

Genetic Tests

Other Applications

By End-User

Hospital and Academic Laboratories

Reference Laboratories

Other End-Users

By Region

North America (USA, Canada)

Europe (Germany, France, UK, Italy, Spain, Rest of Europe)

Asia Pacific (Japan, China, India, Australia, Rest of Asia Pacific)

Rest of the World (Latin America, Brazil, Mexico, Rest of Latin America, Middle East & Africa)

Key Market Players

Recent Developments

In April 2018, Grifols agreed with IrsiCaixa AIDS Research Institute (Spain) wherein Grifols will finance current and future research for IrsiCaixa to develop new advanced treatments for HIV/AIDS and associated diseases, such as infectious, oncological, neurodegenerative and age-related conditions

In April 2018, Agilent Technologies signed an agreement with Lasergen, Inc. (Lasergen) acquiring Lasergen-an emerging biotechnology company focused on research and development of innovative technologies for DNA sequencing

In March 2018, Danaher Corporation and Integrated DNA Technologies (IDT) agreed to acquire IDT, a provider of high-value consumables for genomics applications in molecular biology, qPCR, NGS, synthetic biology, gene editing, and molecular diagnostics

In February 2018, Becton, Dickinson, and Company (BD) launched the BD Onclarity HPV assay (FDA Approval)

In September 2017, Abbott Laboratories acquired Alere (US). The acquisition of Alere helped the company enhance its point-of-care testing portfolio. This development helped the company maintain its lead in this segment.

Key Questions Addressed in the Report

Who are the major market players in the Molecular Diagnostics Market?

What are the growth trends and the largest revenue-generating region for Molecular diagnostics?

How are Molecular diagnostic products sold to customers?

What are the major technologies and applications in Molecular diagnostics?

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