세계 항균제 감수성 시험(AST) 시장 규모는 2024-2031년 예측 기간 동안 6.07%의 CAGR로 2023년 40억 1,000만 달러에서 2031년 64억 3,000만 달러로 확대될 것으로 예상됩니다. 항균제 감수성 시험 시장은 임상 진단 산업의 중요한 부분이며, 헬스케어 산업에서 가장 빠른 성장률을 보이고 있습니다. 시장을 이끄는 요인은 감염성 질환의 유행, 미생물 내성 증가, 기술 발전, 정부의 노력 등입니다.
임상 검사실에서 항균제 감수성 시험(AST)은 질병을 일으키는 특정 미생물에 대해 어떤 항생제 및 기타 항균제가 효과가 있는지, 그리고 어느 정도의 양을 투여해야 효과가 있는지를 확인하기 위해 사용됩니다. 이러한 검사는 항균제 감수성 시험에 사용되는 다양한 의료기기의 도움으로 이루어집니다. FDA의 CDRH(Center for Devices and Radiological Hygiene)는 미국에서 AST 기기를 판매하기 전에 임상 실험실에서 사용할 수 있도록 검사 및 승인을 받아야 합니다. 기존 AST 외에도 항생제 내성 박테리아 관련 유전자 정보 또는 내성 지표를 확인하기 위한 다양한 신속 진단 검사가 있습니다. CDRH는 미생물이 시간이 지남에 따라 적응하여 약물에 반응하지 않는 것을 항균제 내성 또는 항균제 내성(AMR)이라고 부르는 경우 이러한 검사를 검토하고 승인하고 있습니다. 미국 질병예방통제센터(CDC)는 매년 35,000명 이상이 항균제 내성 질환으로 목숨을 잃고 있으며, 미국에서는 매년 최소 280만 명이 감염되는 것으로 추정하고 있습니다.
감염증 발병률의 증가는 항균제 감수성 시험 시장의 수요를 촉진하는 주요 요인 중 하나입니다. 전 세계적으로 박테리아, 곰팡이 및 바이러스에 의한 감염이 증가함에 따라 항생제를 통한 보다 효과적인 치료가 필요하게 되었습니다. 이러한 질병의 식별 및 치료는 다양한 유형의 병원체가 다양한 유형의 항생제에 어떻게 반응하는지를 나타내는 AST에 크게 의존합니다. 항생제 감수성 검사는 의사가 적절한 항균제 치료법을 식별하여 효과적인 치료를 처방하는 데 도움이 되며, 그 결과 항균제 내성 가능성을 줄이고 환자의 결과를 개선할 수 있습니다. 감염이 더 흔해짐에 따라 감염에 대한 새로운 진단 검사의 개발 및 배포로 인해 빠르고 정확한 AST에 대한 수요가 크게 증가하고 있습니다.
이 보고서는 세계 항균제 감수성 시험 시장을 조사하여 시장 개요와 함께 제품 유형별, 용도별, 최종사용자별, 지역별 동향, 시장 진입 기업 개요 등을 제공합니다.
Global antimicrobial susceptibility testing market is projected to witness a CAGR of 6.07% during the forecast period 2024-2031, growing from USD 4.01 billion in 2023 to USD 6.43 billion in 2031. The antimicrobial susceptibility testing market is an important part of clinical diagnostics industry, accounting for one of the fastest growth rates in the healthcare industry. Factors are driving the market such as growing prevalence of infectious diseases, rising microbial resistance, technological advancements, and government initiatives.
In clinical laboratories, antimicrobial susceptibility tests (ASTs) are used to identify which antibiotics or other antimicrobial medicines are expected to be successful against a certain microbe causing an illness and what dose is required to be effective. These tests are performed with the help of different medical devices used for antimicrobial susceptibility tests. The FDA's Center for Devices and Radiological Health (CDRH) must examine and approve any AST devices before they may be marketed in the United States for use in clinical labs. A number of fast diagnostic tests are available to identify genetic information, or resistance indicators linked to bacteria that are resistant to antibiotics, in addition to traditional ASTs. CDRH examines and approves these tests when microorganisms adapt over time and stop responding to medications, it's known as antimicrobial resistance, or antimicrobial resistance (AMR). The Centers for Disease Control and Prevention (CDC) estimate that over 35,000 individuals lose their lives to antimicrobial-resistant illnesses each year, which account for at least 2.8 million infections in the United States annually.
The UN views AMR as a worldwide threat and issues a warning by 2050, wherein drug-resistant illnesses might claim 10 million lives annually. Antimicrobial resistance may push up to 24 million people into severe poverty by 2030, according to the United Nations estimates.
Growing Prevalence of Infectious Diseases
The growing incidence of infectious diseases is one of the key factors driving the demand for antimicrobial susceptibility testing market. The increasing rate of infections caused by bacteria, fungi, and viruses around the world has necessitated more effective treatment through antibiotics. The identification and treatment of these diseases relies heavily on AST which shows how different types of pathogens response to different kinds of antibiotics. Antibiotic susceptibility testing helps doctors to prescribe effective treatments by identifying the right antimicrobial therapy, thus reducing the likelihood of resistance to antimicrobials, improving patient outcomes. Since infectious diseases are becoming more common, the demand for fast and accurate ASTs has increased significantly due to the development and distribution of new diagnostic tests for infectious diseases.
As per HIV.gov in 2022, there were more than 39 million patients globally. Out of which, 37.5 million were adults and 1.5 million were children. WHO estimates that close to 25% of the global population i.e 1.8 billion people have tuberculosis.
Government Initiatives to Support the Global AST Market
Government funding and government initiatives are playing an important role in supporting and increasing the adoption of antimicrobial susceptibility testing kits and devices. Regulatory agencies such as the FDA (Food and Drug Administration) in the United States have issued guidance and necessary steps to help animal drugs sponsors establish defined duration of use for certain medically important antimicrobial drugs, supporting the appropriate drug usage and growing need for antimicrobial susceptibility testing. Additionally, the FDA has funded R&D initiatives through programs such as Broad Agency Announcement for supporting regulatory science and innovation in antimicrobial resistance. Government-funded partnerships, such as CARB-X, provide funding and support for early-stage projects focused towards new antibiotics, diagnostics, and other technologies to fight against drug-resistant bacteria. In March 2024, CARB-X announced its 100th project funding for addressing antibiotic resistance. CARB-X granted USD 1.06 million to Germany-based company named HIPS for the development of new class of small-molecule inhibitors.
Drug Discovery and Development is Expected to Grow at the Fastest Rate in the Forecast Period
Drug discovery and development will grow at a fast pace in the upcoming years in the global antimicrobial susceptibility testing market. Testing the antibiotic susceptibility of notable bacterial isolates is an essential function of the clinical microbiology lab. Testing ensures the susceptibility of the recommended medication for a disease and the identification of potential drug resistance in living organisms. Once the bacteria or fungi causing an individual's infection are collected in the sample culture, the susceptibility testing is carried upon it. Drug susceptibility testing can be carried out utilizing nucleic acid-based techniques, semiquantitative approaches, or qualitative methods.
At ESCMID 2024 (European Society of Clinical Microbiology and Infectious Disease), several advancements in drug resistance testing were announced, such as rapid nanomotion-based susceptibility testing and MALDI-TOF-MS could be used to identify resistance mechanisms of several deadly organisms. The conference discussed different types of novel resistance testing technologies such as machine learning models, and matrix-assisted laser desorption ionization time-of-flight mass spectrometry.
North America Dominates the Global Antimicrobial Susceptibility Testing Market
North America dominated the share of the global antimicrobial susceptibility testing market in 2023, and is expected to maintain the dominance in the forecast period. High prevalence of infectious diseases and growing burden of antibiotic resistance in countries such as the United States, Canada, and Mexico are some major drivers. The United States and Canada have advanced healthcare technologies and infrastructure couple with high healthcare spending and priority towards extensive research and development, which is facilitating the adoption of advanced antimicrobial susceptibility testing technologies. In February 2024, Visby Medical received a grant of USD 1.8 million to develop a fast and portable gonorrhoea diagnosis test that includes testing for antibiotic susceptibility. Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a US-based non-profit organization granted funds to a Boston-based company to develop a portable rapid polymerase chain reaction (PCR) diagnostic to identify the presence of Neisseria gonorrhoeae, a pathogen that causes gonorrhea, and its susceptibility to ciprofloxacin.
Future Market Scenario (2024-2031F)
The phenotyping of AST using flow cytometry, isothermal microcalorimetry, and digital imaging is becoming increasingly popular. Compared to standard growth-based AST, which can take 18-24 hours, can yield findings typically in 1-2 hours.
Whole genome sequencing is a genomic technique that may quickly identify genetic markers linked to antibiotic resistance. It is being investigated for AST. When contrasted with culture-based approaches, this could enable faster turnaround times.
Integrated diagnostic tools that are capable of AST and microbiological identification are becoming more common. These systems are designed to streamline the testing process and deliver fast results through data that will help with antibiotic selection.
Various regions and organizations, including the European Commission, European Food Safety Authority, European Medicines Agency, and European Centre for Disease Prevention and Control, are working to standardize and unify advancements in fast antimicrobial susceptibility testing.
Key Players Landscape and Outlook
Several medical device companies are flourishing in the antimicrobial susceptibility testing market by planning and adopting new strategies. They are complying with new strategic initiatives for antimicrobial susceptibility testing devices to increase their market presence. New agreements, contracts, acquisitions, mergers, investments, and partnerships are major ways through which they are trying to achieve higher market share.
In April 2023, Biomeriux SA and JMI labs established a six-year partnership to work together on projects aimed at assessing the effectiveness and expanding the potential of rapid and innovative microbiological diagnostics as crucial instruments in the fight against antibiotic resistance.
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.