市場概況

The molecular diagnostics industry has undergone a revolution in recent decades. These tests detect specific sequences in DNA or RNA, which can be associated with diseases. In the current year, the market for molecular diagnostics was valued at USD 13.9 十億, and it is projected to grow at a CAGR of 9.22% 予測期間中.

The global distribution channels in the healthcare sector, which ensure better quality, 安全性, and innovative approaches, have been significantly impacted by disruptions caused by COVID-19. This has resulted in increased focus on the molecular diagnostics industry worldwide, with rapid development of diagnostics, expedited regulatory clearances, and enhanced distribution efforts in various regions to contain the spread of the virus.

Factors contributing to the growth of the molecular diagnostics market include large outbreaks of bacterial and viral epidemics worldwide, increasing demand for point-of-care diagnostics, advancements in pharmacogenomics, and rapid technological developments. The India TB report of 2022 indicated an increase in the number of incident TB patients, highlighting the rising prevalence and patient pool, which is expected to drive the demand for molecular diagnostics in the market.

さらに, there is a global rise in the incidence of infectious diseases such as HIV. の 2021, 約 38.4 million people worldwide were living with HIV, 含む 36.7 million adults and 1.7 million children, according to the UNAIDS update in August 2022. This high incidence of infectious diseases like HIV is expected to boost market growth as molecular diagnostics are increasingly adopted for HIV testing.

Molecular diagnostics is considered the most effective method for identifying and characterizing microorganisms. An effective test must be precise, rapid, and capable of measuring the infectious burden. Advanced technologies, such as polymerase chain reaction (PCR), have made it possible to identify antimicrobial resistance genes and provide public health information through strain characterization via genotyping. したがって, the market is expected to witness significant growth due to these factors.

しかし, the market growth may be hindered by limited R&D budgets, economic slowdown, and the need for high-complexity testing centers.

市場セグメンテーション

市場はさまざまな要因に基づいて分割されます, 製品を含む, 応用, エンドユーザー, テクノロジー, と地域.

製品ごとのセグメンテーション
楽器
Reagents
Other Products

アプリケーションごとのセグメンテーション
Infectious Disease
腫瘍学
Pharmacogenomics
Microbiology
Genetic Disease Screening
Human Leukocyte Antigen Typing
Blood Screening

エンドユーザーごとのセグメンテーション
病院
Laboratories
その他のエンドユーザー

テクノロジーによるセグメンテーション
In Situ Hybridization
Chips and Microarrays
Mass Spectrometry (MS)
Sequencing
PCR
その他の技術

地域ごとのセグメンテーション
北米 – アメリカ, カナダ, そしてメキシコ
ヨーロッパ – イギリス, ドイツ, フランス, スペイン, イタリア, およびその他のヨーロッパ
アジア太平洋地域 – 中国, 日本, インド, 韓国, オーストラリア, およびその他のアジア太平洋地域
ラテンアメリカ – ブラジル, アルゼンチン, およびその他のラテンアメリカ諸国
中東とアフリカ – 南アフリカ, GCC, and Rest of MEA

The Instruments Segment is projected to hold a significant market share throughout the forecast period. Molecular diagnostics has become crucial in assessing disease prognosis, therapy response, and detecting minimal residual disease. This growth can be attributed to advancements in chemistries and instrumentation, such as automation, integration, throughput, and random-access capabilities.

The impact of COVID-19 on molecular diagnostics instruments has been positive during and post-pandemic. Market players have implemented key strategies to develop and manufacture these instruments. To accelerate the development of affordable point-of-care molecular diagnostic platforms for COVID-19, organizations like FIND have invested in companies like Biomeme, Bioneer, Qlife, and SD Biosensor. These investments are expected to drive market growth through increased adoption of these instruments.

さらに, key market players launching new molecular diagnostic instruments have further contributed to market growth. 例えば, Roche launched the Cobas 5800 システム, which offers efficiency, simplicity, and timely results to improve patient care.

さらに, the instruments segment of the molecular diagnostics market is witnessing growth due to various strategies adopted by market players, including collaborations, 買収, 新製品の発売, and expansions. 例えば, Mylab Discovery Solutions partnered with Hemex Health to create diagnostic solutions for Point-of-Care (POC) testing. Such initiatives are expected to drive market growth through increased adoption of molecular diagnostic instruments.

Polymerase Chain Reaction (PCR) technology is gaining prominence due to its benefits, including the amplification of tiny quantities of DNA, 手頃な価格, and quick results. The PCR segment is anticipated to have the largest market share due to its increasing application in clinical diagnostics and the rising demand for personalized and precision medicines.

申請に関して, infectious diseases are expected to witness the highest compound annual growth rate (CAGR) 予測期間にわたって. The application of molecular diagnostics in infectious disease testing is experiencing rapid innovation and growth. Molecular diagnostic techniques have aided in the timely diagnosis of contagious diseases. The COVID-19 pandemic has also created opportunities for the development of diagnostic procedures and technologies. 例えば, Minute Molecular Diagnostics received FDA approval for its rapid DASH SARS-CoV-2/S test, which provides results in about 15 minutes.

Hospitals are the major end users of molecular diagnostics instruments, holding a significant market share. The increasing adoption of molecular diagnostics in hospitals is driven by factors such as improved healthcare infrastructure and the rise in infectious diseases and cancer cases.

North America is expected to hold the largest market share in the molecular diagnostics segment. This can be attributed to the region’s high incidence of bacterial and viral epidemics, growing demand for point-of-care diagnostics, rapid technological advancements, and the presence of key market players.

米国, 特に, has witnessed a shift from traditional diagnostic methods to molecular diagnostics due to factors like increased per capita health expenditures, advancements in healthcare infrastructure, and a higher prevalence of infectious diseases and cancers. 技術の進歩, the entry of new players, and the adoption of advanced molecular diagnostics systems further contribute to market growth in the United States.

結論は, the molecular diagnostics market, particularly the instruments segment, is expected to experience significant growth. This can be attributed to various factors, including advancements in chemistries and instrumentation, investments in research and development, 製品の発売, コラボレーション, and the increasing adoption of molecular diagnostics for infectious diseases and cancer diagnosis. 北米, especially the United States, is anticipated to hold a prominent market share due to its favorable market conditions and high demand for advanced diagnostic solutions.

競争環境

The molecular diagnostics market is characterized by intense competition and is composed of various prominent industry players. それにもかかわらず, smaller to medium-sized companies are seizing opportunities in this market by enhancing their market presence through the introduction of innovative devices at more affordable prices. Notable participants in this market include Abbott Laboratories, F Hoffmann-la Roche Ltd, Hologic Corporation, ダナハーコーポレーション, and Agilent Technology, among other significant players.

Key Companies Profiled in this report include F Hoffmann-la Roche Ltd, Illumina Ltd, Hologic Corporation, アジレント・テクノロジー株式会社, Qiagen NV, Myriad Genetics, ベクトン, ディキンソン アンド カンパニー, アボット研究所, Biomerieux SA, バイオ・ラッド・ラボラトリーズ株式会社, シスメックス株式会社, ダナハーコーポレーション (ベックマン・コールター社), サーモフィッシャーサイエンティフィック株式会社.

最近の業界の発展

ベクトン, Dickinson, and Company introduced a new high-throughput molecular diagnostic combination test for SARS-CoV-2 and Influenza A/B in May 2022. The BD SARS-CoV-2/Flu assay for the BD COR™ System is an automated multiplexed real-time RT-PCR test designed to identify and differentiate SARS-CoV-2, influenza A, and influenza B from a single nasal sample. This test is intended for patients exhibiting symptoms of respiratory viral infection, as well as asymptomatic individuals.

5月に 2022, miDiagnostics, based in Belgium, launched an ultrafast COVID-19 PCR test that utilizes silicon chip technology. The latest test developed by the company can deliver results in approximately 30 minutes.

Sense Biodetection obtained CE Marking for Veros COVID-19 from the European Authorities in March 2022. Veros COVID-19 is a fully integrated molecular diagnostic test that offers easy-to-use functionality and provides laboratory-quality results in just 15 minutes.

Minute Molecular Diagnostics received Emergency Use Authorization (EUA) from the United States Food and Drug Administration in March 2022 for its rapid DASH SARS-CoV-2/S Test. The DASH SARS-CoV-2/S test, which runs on the DASH Analyzer, consolidates the entire PCR testing process (including sample extraction and PCR), yielding results in approximately 15 minutes.

1月に 2021, Eurofins Technologies launched NovaType, an SARS-CoV-2 RT-PCR assay that detects and monitors new variants of COVID-19, namely B.1.1.7 and B.1.351. The company’s previous PCR test, the Eurofins Viracor SARS-CoV-2 RT-PCR diagnostic test, has been recognized as the most sensitive among more than 115 kits evaluated by the FDA SARS-CoV-2 Reference Panel.

3月 2023, 株式会社イルミナ, a US-based company specializing in DNA sequencing and array-based technologies, partnered with GenoScreen to introduce a package combining Illumina products with the GenoScreen Deeplex Myc-TB assay. The Deeplex Myc-TB assay utilizes targeted next-generation sequencing (NGS) technology for a rapid and comprehensive detection of anti-TB drug resistance.

3月 2023, Oxford Gene Technology launched eight CytoCell fluorescence in situ hybridization probes that have received certification for clinical use in accordance with the European In Vitro Diagnostics Regulation (IVDR).

主な質問への回答

What is the study period for this market?
What is the growth rate of the Molecular Diagnostics Market?
What was the size of the Molecular Diagnostics Market in 2018?
What is the projected size of the Molecular Diagnostics Market in 2028?
Which region has the highest growth rate in the Molecular Diagnostics Market?
Which region has the largest share in the Molecular Diagnostics Market?
Who are the key players in the Molecular Diagnostics Market?