Molecular Diagnostics Market

Market Overview

The global molecular diagnostics market size was worth USD 37.23 billion in 2021 and is expected to reach USD 56.3 billion by 2030, growing at a CAGR of 4.7% over the forecast period. (2022–2030)

Molecular diagnostic is an essential part of the clinical laboratory. Increased use of molecular diagnostics in pre-clinical development and approval of drugs for therapeutics and diagnosis purposes. In addition, partnerships between pharmaceutical companies with diagnostic firms for the development of their drug test facility have made it an indispensable tool. The rising prevalence of chronic disease and the need for customized solutions have paved the way for molecular diagnostics in disease diagnosis. These are also effective in identifying underlying molecular defects in hereditary diseases. In today’s time, it is the key element for the transformation of healthcare and leading in the field of molecular biology. Some of the innovations are next-generation sequencing, microarray technologies, liquid biopsies, early cancer detection, and point-of-care assays. As per Global Genes, around 350 million people suffer from rare diseases worldwide. 8 in 10 rare diseases are caused by a mutation in genes.

Technological advancements in molecular diagnostics by key players to provide greater accuracy, portability, and cost-effectiveness are positively impacting the growth of the market. For instance, in 2015, Cepheid launched GeneXpert Omni, which is the world's most portable molecular diagnostics system.

Segmental Analysis

The global molecular diagnostics market industry is segmented by product & service, technology, application and end user.

By product & service, the market is segmented into reagents and kits, instruments and software & services. The reagents and kits segment is expected to grow at the fastest CAGR. The growth can be attributed to the availability of a variety of reagents & kits and the growing usage of reagents and kits in diverse therapeutic areas such as infectious diseases and oncology.

Based on technology, the global molecular diagnostics market is segmented into PCR, INAAT, DNA sequencing & NGS, in situ hybridization, DNA microarrays, and other technologies. The PCR segment is expected to hold the largest share due to the increasing usage of PCR in genomics and the development of automated PCR instruments.

By technology, the molecular diagnostics market is segmented globally into enzyme-linked immunosorbent assays (ELISA), rapid tests, western blotting, enzyme-linked immunospot (ELISPOT), immuno-PCR, and other technologies. The ELISA segment is expected to generate the highest revenue in the forecast period as it is the most preferred immunoassay test for the diagnosis of cancer, infectious diseases, and therapeutic drug level monitoring.

The end-user segment is classified into hospitals and academic laboratories, reference laboratories, and other end users. The hospitals and academic laboratories segment as the majority of diagnostic tests are performed in hospitals.

Regional Analysis

Geographically, the global molecular diagnostics market industry is segmented into four regions: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa (LAMEA).

North America is likely to dominate the molecular diagnostics market due to the high prevalence of infectious diseases, highly developed healthcare systems,s and increasing applications of molecular diagnostics in genetic disorders and cancer screening. As per the American Cancer Society, around 609,640 Americans are expected to die of cancer in 2018. Early screening can help in the prevention and detection of these life-threatening diseases.

Europe is likely to emerge as the second-largest molecular diagnostics market globally. This can be attributed to the increasing cancer disease burden and strong government policies to reduce the number of chronic diseases. Cancer is the second leading cause of mortality in the EU after cardiovascular diseases, with around 1.4 million deaths estimated in 2018.

Asia pacific immunoassay market is expected to witness significant growth on account of increasing development and production of vaccines & drugs and growing medical treatment for infectious and chronic diseases. In 2017, there were 11,923 combined new cases of leukemia, lymphoma, and myeloma in Australia.

LAMEA is expected to witness steady growth as government health budgets in Latin America are small compared to developed economies. As per the American Cancer Society, around 1.1 million new cancer cases and 600,000 cancer deaths are estimated to occur annually in Latin America.

Molecular Diagnostics Market Segmentation

By Product & Service

• Reagents & Kits
• Instruments
• Software & Services

By Technology

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

By Application

• Infectious Diseases
• Hepatitis
• HIV
• CT/NG
• HAIS
• HPV
• Tuberculosis
• Influenza
• Other Infectious Diseases
• Oncology
• Breast Cancer
• Colorectal Cancer
• Lung Cancer
• Prostate Cancer
• Other Cancers
• Genetic Tests
• Other Applications

By End-User

• Hospital & Academic Laboratories
• Reference Laboratories
• Other End Users

Regions Covered

• North America

  • U.S.
  • Canada
  • Mexico

• Europe

  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Rest of Europe

• Asia-Pacific

  • China
  • India
  • Japan
  • South Korea
  • Australia
  • Rest of Asia-Pacific

• LAMEA

  • Brazil
  • Saudi Arabia
  • South Africa
  • Rest of LAMEA