세계 분자진단 시장 규모는 2023년 143억 1,000만 달러에서 2031년 308억 3,000만 달러에 이를 것으로 예측되며, 2024-2031년 예측 기간에 CAGR로 10.07%의 성장이 예상됩니다.
분자진단은 중요한 정보를 제공함으로써 환자와 의료 종사자가 치료에 대한 충분한 지식을 가진 판단을 내리고 좋은 결과를 도출하는 데 도움이 됩니다. 분자진단 기술은 민감하고 신속한 검출 방법을 허용하기 때문에 임상 현장에서 유용한 것으로 나타났으며 암 및 기타 만성 질환을 포함한 다양한 감염성 질환의 모니터링이 용이합니다. 됩니다. 질병 증가, 병원체 증가, 심지어 질병에 걸리기 쉽고 지속적인 진단이 필요한 노년 인구 증가에 의해 분자진단 시장의 확대가 전망되고 있습니다. 유전학적 검사, 미생물, 성병, 종양, 혈액 스크리닝, 바이러스, 조직형, 출생전 진단 등 분자진단의 보급에 의해 수많은 의학 질환이 효과적으로 확인되고 있습니다. DNA, RNA, 단백질 연구를 이용한 실험실 기반의 분자진단은 인간 질환의 검출에 사용되는 중요한 기구입니다. 분자진단 키트 및 시약은 원하는 용도에 따라 조정되며 특정 박테리아, 바이러스 및 기생충의 서열에 특이적인 프로브를 포함합니다. 분자진단 시장은 모든 유형의 투약 및 치료를 시작하기 전에 필수적인 바이오마커에 특화된 검사 키트의 사용이 증가하고 있기 때문에 확대될 것으로 예상됩니다. 예를 들어, USFDA는 2023년 5월에 Hologic, Inc.의 Panther Fusion SARS-CoV-2/Flu A/B/RSV 분석의 510(k) 인가를 받았습니다. 이 분석은 분자진단 검사로 가장 유행하는 네 가지 유형의 호흡기 바이러스를 구별합니다.
만성 질환의 유병률 증가로 인한 시장 성장
분자진단 시장은 만성 질환의 이환율이 증가함에 따라 크게 확대되고 있습니다. 고령화, 라이프 스타일의 변화, 환경 요인 등은 모두 암, 당뇨병, 심혈관 질환 등의 만성 질환 증가에 기여하고 있습니다. 이러한 질병을 관리하고 효과적으로 치료하려면 고급 진단 방법이 필요합니다. 이러한 상황에서는 유전자, 유전체, 단백질체학 데이터를 분석하는 첨단 기술을 이용한 분자진단이 필수적입니다. 만성 질환과 관련된 특정 바이오마커 및 유전자 변화를 확인하면 질병의 적시에 정확한 발견이 용이해집니다. 각 환자 고유의 분자 프로파일에 따라 치료 요법을 맞춤화하면 치료 효과가 향상되고 환자 결과가 향상됩니다. 예를 들어, 종양에 특이적인 돌연변이를 검출함으로써 분자진단은 약물 선택 시 시행 착오의 필요성을 최소화하여 최적의 암 치료법을 결정하는 데 도움을 줄 수 있습니다. 이러한 진단은 질병의 진행과 치료에 대한 신체의 반응을 추적하는 것을 용이하게 하고, 신속한 치료법의 변경을 가능하게 합니다.
만성 질환의 유병률이 계속 증가함에 따라 질병의 원인과 환자의 건강 상태에 대한 종합적이고 개인화된 발견을 제공하는 분자진단에 대한 요구가 커지고 있습니다. 이러한 동향은 분자진단 산업의 지속적인 개발과 혁신을 촉진하고 장기적인 질병치료 개선에 기여하고 있습니다. 예를 들어, International Diabetes Federation은 2023년에 2형 당뇨병의 유병률이 전 세계적으로 현저하게 증가하고 있다고 보고했습니다. 이 연맹의 조사에 따르면 2023년 세계에서 5억 3,700만 명의 성인이 당뇨병을 앓고 있으며 전년보다 크게 증가하고 있습니다. 고령화, 비만율 증가, 앉기 쉬운 생활 습관이 이 동향의 원인으로 되어 있습니다. 2형 당뇨병 환자 증가는 이 장기적인 질병의 영향을 조절하고 완화하기 위한 더 나은 예방책과 의학적 치료에 대한 요구를 부각시킵니다.
기술 개발이 시장성장 촉진
기술 개발은 분자진단 시장 확대에 큰 역할을 하고 있습니다. 이 분야는 하이스루풋 시퀀싱, 실시간 PCR, 차세대 시퀀싱(NGS) 기술의 진보로 혁명적인 변화를 이루고 정확도, 속도, 종합적인 진단 능력이 향상되었습니다. 이러한 기술을 통해 이전에는 생각할 수 없었던 정확도로 유전 물질을 분석 할 수 있으며 질병의 조기 발견과 개인화 치료에 도움이 됩니다.
본 보고서에서는 세계의 분자진단 시장에 대한 조사 분석, 시장 규모와 예측, 시장 역학, 주요기업의 정세와 전망 등의 정보를 제공합니다.
Global molecular diagnostics market is projected to witness a CAGR of 10.07% during the forecast period 2024-2031, growing from USD 14.31 billion in 2023 to USD 30.83 billion in 2031.
Molecular diagnostics help patients and healthcare professionals make educated decisions about their treatment, which leads to positive results, by offering vital information. Molecular diagnostics techniques have shown to be useful in clinical settings since they allow sensitive and quick detection methods, which makes it easier to monitor a variety of infectious disorders, including cancer and other chronic illnesses. The market for molecular diagnostics is expected to rise due to the growing illness, rising numbers of pathogens and even rising geriatric population, which is more prone to disease and hence needs continuous diagnosis. Numerous medical diseases have been effectively identified by the widespread use of molecular diagnostics, including genetic testing, microbiology, STDs, oncology, blood screening, virology, tissue type, and prenatal diagnosis. Using the study of DNA, RNA, or proteins, laboratory-based molecular diagnostics are vital instruments used for the detection of human diseases. Molecular diagnostic kits and reagents are tailored according to the desired use and contain probes that are unique to certain bacterial, viral, or parasitic sequences. The market for molecular diagnostics is expected to rise due to the growing use of biomarker-specific testing kits, which are essential before starting any kind of medication or treatment. The USFDA, for instance, granted 510(k) clearance for Hologic, Inc.'s Panther Fusion SARS-CoV-2/Flu A/B/RSV assay in May 2023. This assay distinguishes between the four most prevalent respiratory viruses by molecular diagnostic testing.
Market Growth Due to Rising Prevalence of Chronic Ailments
The market for molecular diagnostics is expanding significantly due to the increased incidence of chronic illnesses. Aging populations, changing lifestyles, and environmental factors are all contributing to the rise in chronic diseases such as cancer, diabetes, and cardiovascular ailments. For these illnesses to be managed and treated effectively, sophisticated diagnostic methods are required. In this setting, molecular diagnostics, which use advanced technology to analyze genetic, genomic, and proteomic data, are essential. Through the identification of particular biomarkers and genetic alterations linked to chronic disorders, they facilitate the timely and accurate detection of diseases. Customizing therapy regimens according to each patient's unique molecular profile increases treatment effectiveness and boosts patient outcomes. For instance, by detecting mutations unique to a tumor, molecular diagnostics might assist in determining the best cancer treatments by minimizing the need for trial-and-error when choosing medications. These diagnostics make it easier to continue tracking how the disease progresses and how the body responds to treatment, which enables prompt therapeutic modifications.
The need for molecular diagnostics that offer comprehensive and individualized insights into disease causes and patient health is growing as the prevalence of chronic diseases keeps rising. The pattern promotes ongoing development and innovation in the molecular diagnostics industry, aiding in the improved treatment of long-term medical disorders. For instance, the International Diabetes Federation reported in 2023 that there has been a notable global increase in prevalence of Type 2 diabetes. According to the federation's research, 537 million adults worldwide had diabetes in 2023, i.e., a significant increase over the previous year. Ageing populations, an increase in obesity rates, and sedentary lifestyles are blamed for the trend. The increasing number of people with Type 2 diabetes highlights the critical need for better preventative measures and medical therapies to control and lessen the effects of this long-term illness.
Technological Developments Fuel Market Growth
Technological developments have a major role in propelling the molecular diagnostics market's expansion. The area has seen a revolutionary change due to the advancement of high-throughput sequencing, real-time PCR, and next-generation sequencing (NGS) technologies, which offer enhanced precision, speed, and comprehensive diagnostic capabilities. These technologies make it possible to analyze genetic material with previously unheard-of precision, which helps with disease early detection and individualized therapy. High-throughput sequencing makes it possible to analyze multiple genetic variants which improves the efficiency of identifying mutations linked to disease. To diagnose infections and genetic abnormalities, real-time PCR improves the sensitivity and specificity of detecting particular genetic sequences. Deep genetic data insights are provided by NGS, which helps with focused therapy development and the identification of new biomarkers. Moreover, developments in data analytics and bioinformatics have enhanced the ability to comprehend intricate molecular data, enabling the extraction of useful insights from sizable datasets. Molecular diagnostics benefits from the integration of artificial intelligence (AI) and machine learning, which improves predictive analytics facilitates early diagnosis and personalized medication. The market for molecular diagnostics is growing due to these technical advancements since they provide more advanced instruments for accurate and effective illness detection and treatment. For instance, F. Hoffmann-La Roche Ltd. introduced the LightCycler PRO System in November 2023 to improve the usefulness of molecular PCR testing for applications such as in vitro diagnostics and translational research.
Instruments to Dominate the Global Molecular Diagnostics Market Share
Due to the high cost of equipment and the requirement for regular replacement or updates, the instruments category holds the highest revenue share of the market based on products and services. The rising incidence of chronic illnesses including cancer, genetic abnormalities, and infectious diseases, which need more sophisticated diagnostic techniques, expected to drive the demand for molecular diagnostic tools. This expansion can be linked to the growing need for personalized medicine and companion diagnostics, which need specifically designed instruments for particular uses. New and affordable diagnostic assays are anticipated to drive growth in the reagent and kit market. As more people are using electronic health record (EHR) and laboratory information management system (LIMS) systems, the software market is predicted to grow significantly over the course of the forecast period. More accurate and efficient patient diagnosis and treatment are expected to be made possible by the integration of molecular diagnostic software with electronic medical records.
Furthermore, it is anticipated that the advancement of machine learning and artificial intelligence (AI) technologies would support the growth of molecular diagnostic software by enabling the automated analysis of big datasets. For instance, Thermo Fisher Scientific, Inc. announced the release of a new digital PCR research tool called QuantStudio, Applied Biosystems, Absolute Q AutoRun dPCR (digital polymerase chain reaction) Suite in February 2023. Additionally, in May 2023, Sansure Biotech Inc. showcased its extensive line of IVD devices at EuroMedLab Rome 2023, which included the iconic III portable molecular workstations.
North America Dominates the Global Molecular Diagnostics Market Share
With the highest market share, North America led the largest proportion of the market. This is ascribed to the increasing prevalence of both infectious and chronic illnesses, which in turn motivates businesses to launch cutting-edge molecular diagnostic tests and propel market expansion. The growth is due to the robust healthcare infrastructure present in the region. Highly advanced diagnostic centers and laboratories in the region aid scientific development and growth, leading to a highly competitive market. For instance, QIAGEN N.V.'s therascreen PDGFRA RGQ PCR kit was approved by the USFDA in August 2023. This tool helps doctors detect individuals who have gastrointestinal stromal tumors (GIST). Additionally, the VIASURE Monkeypox viral Real-Time PCR Reagents, created by Becton, Dickinson and Company and CerTest Biotec, S.L. for Mpox viral identification, was authorized by the USFDA in January 2023. Furthermore, a strong healthcare system, excellent living standards, and consumer knowledge of early diagnosis serve as important growth-promoting factors.
Future Market Scenario (2024 - 2031F)
The main factors contributing to the anticipated growth of the molecular diagnostics market are the rising numbers of pathogens, the increasing prevalence of diseases, and, thus, the rising requirement to conduct diagnostic tests. However, the growing need to have precision medicine to maintain a healthy population is going to fuel market growth in the future. Players in this market are expanding at an unparalleled rate, introducing cost-effective and efficient technologies. Policies by welfare bodies and the government are greatly fueling the market expansion. For instance, the USFDA gave the COVID-19 and Flu Home Test, the first and only Emergency Use Authorization (EUA) for OTC usage at home and other non-laboratory locations.
Key Players Landscape and Outlook
Several companies are expanding their businesses by planning and adopting new strategies. They are complying with new strategic initiatives regarding the launch of newly developed molecular diagnostics to help researchers and strengthen their presence in the market. New product launches, agreements based on contracts, acquisitions and mergers, investments, and partnerships are a few ways through which they are trying to achieve the same.
For example, in October 2023, QIAGEN N.V. and Myriad Genetics, Inc. collaborated to create companion diagnostic tests for cancer based on PCR, dPCR, and NGS technology.
Additionally, Oxford Nanopore and bioMerieux SA established a strategic alliance in April 2023 to use nanopore technology to provide innovative cures for infectious diseases.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.