비침습적 산전 검사(NIPT) 시장 - 세계 및 지역별 분석 : 방법별, 검사별, 플랫폼별, 최종사용자별, 용도별, 지역별 - 분석 및 예측(2023-2033)
Non-Invasive Prenatal Testing (NIPT) Market - A Global and Regional Analysis: Focus on Method, Test, Platform, End User, Application, and Region - Analysis and Forecast, 2023-2033
상품코드:1458435
리서치사:BIS Research
발행일:2024년 04월
페이지 정보:영문
라이선스 & 가격 (부가세 별도)
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한글목차
세계 비침습적 산전 검사(NIPT) 시장 규모는 2023년 33억 5,040만 달러에 달할 것으로 예상됩니다.
이 시장은 2033년 128억 7,090만 달러에 달할 것으로 예상되며, 예측 기간 동안 14.41%의 CAGR을 기록할 것으로 예상됩니다. 세계 NIPT 시장은 NIPT 가이드라인의 장려, 선별 검사에 대한 지불자 상환, 지속적인 기술 혁신, 지역 간 상업적 잠재력, 비침습적 검사 방법에 대한 선호도 증가 등이 주요 요인으로 작용하고 있습니다.
주요 시장 통계
예측 기간
2023-2033년
2023년 평가액
33억 5,000만 달러
2033년 전망
128억 7,000만 달러
CAGR
14.41%
세계 NIPT 시장은 기존 기업과 신생 기업이 시장 점유율을 놓고 치열한 경쟁을 벌이는 것이 특징입니다. 시장의 예상 성장과 변화는 도전과 기회를 모두 가져다주며, 향후 몇 년 동안 지켜봐야 할 역동적인 풍경이 될 것입니다.
염색체 이상 조기 발견 및 예방에 대한 인식 증가, 비침습적 방법의 채택 증가, 진단 검사의 소비자화 등 미시적 및 거시적 트렌드의 결합이 향후 시장 성장의 원동력이 되고 있습니다. 염색체 이상 외에도, 연구에서 임상 검사로의 전환, 더 빠른 개입을 가능하게 하는 조기 임신 검사, 기술 발전과 보험 적용 범위 확대로 인한 경제성 증가 등 업계의 기술적 도약이 예상됩니다. 현재의 한계와 미충족 수요를 해결하기 위한 연구 개발의 증가는 향후 시장 성장을 더욱 촉진할 것으로 예상됩니다.
이 보고서는 세계 비침습적 산전 검사(NIPT) 시장에 대해 조사했으며, 시장 개요와 함께 방법별, 검사별, 플랫폼별, 최종사용자별, 용도별, 지역별 동향, 시장 진입 기업 개요 등을 제공합니다.
목차
주요 요약
제1장 시장
동향 : 현재 및 향후의 영향 평가
공급망 개요
연구개발 리뷰
규제 상황
상환 시나리오
시장 역학 개요
제2장 용도
용도 세분화
용도 개요
세계의 비침습적 산전 검사 시장(용도별)
세계의 비침습적 산전 검사 시장(최종사용자별)
제3장 제품
제품 세분화
제품 개요
세계의 비침습적 산전 검사 시장(검사별)
세계의 비침습적 산전 검사 시장(방법별)
세계의 비침습적 산전 검사 시장(플랫폼별)
제4장 지역
성장 촉진요인과 억제요인
지역별 개요
북미
유럽
아시아태평양
라틴아메리카
중동 및 아프리카
제5장 시장 - 경쟁 벤치마킹과 기업 개요
향후 전망
경쟁 상황
Agilent Technologies, Inc.
F. Hoffmann-La Roche Ltd
PerkinElmer, Inc.
Quest Diagnostics Incorporated
Illumina, Inc.
Myriad Genetics, Inc.
BGI Genomics
CENTOGENE N.V.
Laboratory Corporation of America Holdings
MedGenome Inc.
Annoroad Gene Technology
Natera, Inc.
Yourgene Health
Eurofins Scientific SE
Next Biosciences
제6장 조사 방법
ksm
영문 목차
영문목차
Global Non-Invasive Prenatal Testing Market Overview
The global NIPT market was valued at $3,350.4 million in 2023 and is expected to reach $12,870.9 million by 2033, registering a CAGR of 14.41% during the forecast period 2023-2033. The global NIPT market is primarily driven by the increase in encouraging NIPT guidelines, payers reimbursing for screening procedures, continued technology innovation, commercial potential across geographies, and growing preferences for non-invasive testing methods.
Market Lifecycle Stage
KEY MARKET STATISTICS
Forecast Period
2023 - 2033
2023 Evaluation
$3.35 Billion
2033 Forecast
$12.87 Billion
CAGR
14.41%
The global NIPT market is characterized by intense competition, as established entities and emerging players compete for a share of the market. The anticipated growth and transformation of the market bring forth both challenges and opportunities, rendering it a dynamic landscape to observe in the upcoming years.
Industry Impact
The confluence of micro and macro trends such as increasing awareness for early chromosomal abnormality detection and prevention, rise in adoption of non-invasive methods, and consumerization of diagnostic tests are driving the market toward future growth. The industry is expected to witness technological leaps with offerings beyond chromosomal abnormalities moving from research to clinical testing, early pregnancy testing enabling faster intervention, and increased affordability due to technological advancements and wider insurance coverage. Increase in research and development to address the current limitations and unmet needs will further propel the market growth in future.
The industry's advancements in NIPT research and development continually address population health trends, disease prevalence, and treatment outcomes. As a result, the NIPT market's impact extends beyond technological integration for diagnosis, making it an integral component of global health strategies and broader ecosystem.
Market Segmentation:
Segmentation 1: by Application
Trisomy Detection
Microdeletion Detection
Sex Chromosome Aneuploidy Detection
Others
Trisomy Detection to Dominate the Global Non-Invasive Prenatal Testing Market (by Application)
The trisomy detection segment dominated the global NIPT market (by application) in FY2022.
The high specificity, efficiency, and safety of NIPT (over 99% for trisomy 21), increased accessibility, rising incidence of chromosomal abnormalities, and increasing maternal age are collectively driving the market growth.
Segmentation 2: by End User
Hospitals
Diagnostic Laboratories
Others
Hospitals to Dominate the Global Non-Invasive Prenatal Testing Market (by End User)
Larger patient database due to existing maternity and prenatal care services, both public and private hospitals specialized medical staff, easier access to genetic counselors and other specialists for pre- and post-test consultations, and potential integrated workflow with diagnostic procedures like amniocentesis in case of positive NIPT results are driving the hospital segment growth.
Segmentation 3: by Platform
NGS
PCR
Others
NGS to Dominate the Global Non-Invasive Prenatal Testing Market (by Platform)
The global NIPT market (by product) was dominated by the NGS segment in FY2022. NGS-based NIPT tests are more prevalent due to shift in its affordability, high throughput and accuracy, integration with other technologies enabling efficient data interpretation, and shorter turnaround times.
Segmentation 4: by Method
cfDNA
FCMB
cfDNA to Dominate the Global NIPT Market (by Method)
The global NIPT market (by product) was dominated by the cfDNA segment in FY2022. cfDNA analysis is being explored for additional applications like determining fetal sex, identifying single-gene disorders, and even assessing fetal health and development driving the growth.
Segmentation 5: by Region
North America
Europe
Asia-Pacific
Latin America
Middle East and Africa
The NIPT market in the Asia-Pacific region is witnessing significant growth of 15.43% in the forecast period, marked by increasing number of market players, and shifting healthcare landscape. In 2022, Asia-Pacific accounted for a share of 19.50% of the global NIPT market.
Demand - Drivers, Restraints, and Opportunities
Market Drivers:
High Incidence of Genetic Disorders: With the rising incidence of genetic diseases, early diagnostic intervention is a key factor leading to the growth of NIPT solutions worldwide.
Market Restraints:
Stringent Regulatory Guidelines and Ethical Hurdles: Numerous regulatory bodies worldwide express concerns that the widespread implementation of NIPT and the subsequent surge in prenatal testing adoption could lead to an increase in abortion rates.
Market Opportunities:
Leveraging the Opportunities Arising from the Growing Markets in Asia: The growing markets in Asia present a significant opportunity for the noninvasive prenatal testing (NIPT) sector, providing avenues for expansion and innovation. As healthcare awareness and infrastructure continue to improve across Asian countries, there is an increasing demand for advanced prenatal screening technologies. Leveraging these opportunities involves tailoring NIPT solutions to meet the diverse genetic profiles and cultural considerations in the region.
How can this report add value to an organization?
Workflow/Innovation Strategy: The NIPT market (by application) has been segmented into detailed segments of the application of NIPT based on applications, including trisomy detection, microdeletion detection, sex chromosome aneuploidy detection, and others.
Growth/Marketing Strategy: Constant advancement and innovation to enhance performance and efficiency can enabled prominent players to command premium prices while maintaining growth in revenue and volume.
Competitive Strategy: Key players in the global NIPT market have been analyzed and profiled in the study, including manufacturers involved in new product launches, acquisitions, expansions, and strategic collaborations. Moreover, a detailed competitive benchmarking of the players operating in the global NIPT market has been done to help the reader understand how players stack against each other, presenting a clear market landscape. Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the market.
Methodology
Key Considerations and Assumptions in Market Engineering and Validation
The base year considered for the calculation of the market size is 2022. The historical year analysis has been done from FY2020 to FY2021, and the market size has been calculated for FY2022 and projected for the period 2023-2033.
The geographical distribution of the market revenue is estimated to be the same as the company's net revenue distribution. All the numbers are adjusted to two digits after decimals for report presentation reasons. However, the real figures have been utilized for compound annual growth rate (CAGR) estimation. CAGR is calculated from 2023 to 2033.
The market has been mapped based on different types of products available in the market and based on several indications. All the key manufacturing companies that have a significant number of offerings to the NIPT market have been considered and profiled in the report.
In the study, the primary respondent's verification has been considered to finalize the estimated market for the NIPT market.
The latest annual reports of each market player have been taken into consideration for market revenue calculation.
Market strategies and developments of key players have been considered for the calculation of sub-segment split.
The base currency considered for the market analysis is US$. Currencies other than the US$ have been converted to the US$ for all statistical calculations, considering the average conversion rate for that particular year. The currency conversion rate has been taken from the historical exchange rate of the Oanda website or from the annual reports of the respective company if stated.
Primary Research
The key data points taken from the primary sources include:
Validation and triangulation of all the numbers and graphs
Validation of the report's segmentation and key qualitative findings
Understanding of the numbers of the various markets for market type
Percentage split of individual markets for regional analysis
Secondary Research
Open Sources
Food and Drug Administration (FDA), PubMed, and National Center for Biotechnology Information (NCBI)
Annual reports, SEC filings, and investor presentations of the leading market players
Company websites and detailed study of their portfolio
Gold standard magazines, journals, whitepapers, press releases, and news articles
Databases
The key data points taken from the secondary sources include:
Segmentations, split-ups, and percentage shares
Data for market value
Key industry trends of the top players in the market
Qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
Quantitative data for mathematical and statistical calculations
Key Market Players and Competition Synopsis
NIPT refers to a method of examining fetal deoxyribonucleic acid (DNA) to determine the risk of genetic abnormalities in the developing fetus. The testing is usually done by taking a sample of blood from a pregnant woman and analyzing small fragments of DNA that are circulating in a pregnant woman's blood. The test helps in the screening of chromosomal abnormalities, specifically the trisomies that cause Down's, Edward's, and Patau's syndromes.
The global non-invasive prenatal testing market is in growth phase and rapidly expanding, creating opportunities for emerging players embracing targeted analysis without PCR or sequencing methods to enable broader adoption and challenge large players position in the market such as Natera, Illumina, LabCorp, Roche Molecular Systems/BioReference Laboratories, and BGI Genomics.
Some of the prominent companies in this market are:
Agilent Technologies, Inc.
F. Hoffmann-La Roche Ltd
PerkinElmer, Inc.
Quest Diagnostics Incorporated
Illumina, Inc.
Myriad Genetics, Inc.
BGI Genomics
CENTOGENE N.V.
Laboratory Corporation of America Holdings
MedGenome Inc.
Annoroad Gene Technology
Natera, Inc.
Yourgene Health
Eurofins Scientific SE
Next Biosciences
Companies that are not a part of the aforementioned pool have been well-represented across different sections of the report (wherever applicable).
Table of Contents
Executive Summary
Scope and Definition
1 Markets
1.1 Trends: Current and Future Impact Assessment
1.1.1 Increasing Strategic Partnerships and Alliances between Market Players
1.1.2 Expanding Applications in NIPT Products
1.2 Supply Chain Overview
1.3 Research and Development Review
1.3.1 Patent Filing Trend (by Country, Year)
1.4 Regulatory Landscape
1.4.1 Regulatory Scenario in the U.S.
1.4.2 Regulatory Scenario in Canada
1.4.3 Regulatory Scenario in the U.K.
1.4.4 Regulatory Scenario in Germany
1.4.5 Regulatory Scenario in France
1.4.6 Regulatory Scenario in Spain
1.4.7 Regulatory Scenario in Italy
1.4.8 Regulatory Scenario in the Netherlands
1.4.9 Regulatory Scenario in China
1.4.10 Regulatory Scenario in India
1.4.11 Regulatory Scenario in Australia
1.4.12 Regulatory Scenario in Japan
1.5 Reimbursement Scenario
1.6 Market Dynamics Overview
1.6.1 Market Drivers
1.6.1.1 High Incidence of Genetic Disorders
1.6.1.2 Rising Maternal Age
1.6.1.3 Increasing Number of Reimbursement Policies toward Genetic Coverage
1.6.1.4 Increased Emphasis on Early Detection and Prevention
1.6.2 Market Restraints
1.6.2.1 Stringent Regulatory Guidelines and Ethical Hurdles
1.6.2.2 Lack of Awareness Regarding NIPT
1.6.2.3 Limitations and Considerations in Non-Invasive Prenatal Testing
1.6.3 Market Opportunities
1.6.3.1 Leveraging the Opportunities Arising from the Growing Markets in Asia
1.6.3.2 Increasing Focus on Non-Invasive Pre-Implantation Genetic Testing (niPGT)
2 Application
2.1 Application Segmentation
2.2 Application Summary
2.2.1 Application Summary
2.2.2 End User Summary
2.3 Global Non-Invasive Prenatal Testing Market (by Application)
2.3.1 Trisomy Detection
2.3.2 Microdeletion Detection
2.3.3 Sex Chromosome Aneuploidy Detection
2.3.4 Others
2.4 Global Non-Invasive Prenatal Testing Market (by End User)
2.4.1 Hospital
2.4.2 Clinics
2.4.3 Diagnostic Labs
2.4.4 Others
3 Products
3.1 Product Segmentation
3.2 Product Summary
3.2.1 Test Summary
3.2.2 Platform Summary
3.2.3 Method Summary
3.3 Global Non-Invasive Prenatal Testing Market (by Test)
3.3.1 Panorama and Vistara
3.3.2 MaterniT GENOME, MaterniT21 PLUS, and informaSeq
3.3.3 Verifi and Verifi Plus Prenatal Tests
3.3.4 NIFTY Test and NIFTY-Test Oro
3.3.5 QNatal Advanced
3.3.6 PrenaTest, GenaSafe, and PrenatalSAFE
3.3.7 Bambini Test
3.3.8 IONA and Sage
3.3.9 Other Harmony Test
3.4 Global Non-Invasive Prenatal Testing Market (by Method)
3.4.1 cfDNA
3.4.2 FCMB
3.5 Global Non-Invasive Prenatal Testing Market (by Platform)
3.5.1 NGS
3.5.2 PCR
3.5.3 Others
4 Regions
4.1 Drivers and Restraints
4.2 Regional Summary
4.3 North America
4.3.1 Regional Overview
4.3.2 Driving Factors for Market Growth
4.3.3 Factors Challenging the Market
4.3.4 Application
4.3.5 Product
4.3.6 U.S.
4.3.7 Canada
4.4 Europe
4.4.1 Regional Overview
4.4.2 Driving Factors for Market Growth
4.4.3 Factors Challenging the Market
4.4.4 Application
4.4.5 Product
4.4.6 France
4.4.7 Germany
4.4.8 U.K.
4.4.9 Spain
4.4.10 Italy
4.4.11 Rest-of-Europe
4.5 Asia-Pacific
4.5.1 Regional Overview
4.5.2 Driving Factors for Market Growth
4.5.3 Factors Challenging the Market
4.5.4 Application
4.5.5 Product
4.5.6 China
4.5.7 India
4.5.8 Japan
4.5.9 Rest-of-Asia-Pacific
4.6 Latin America
4.6.1 Regional Overview
4.6.2 Driving Factors for Market Growth
4.6.3 Factors Challenging the Market
4.6.4 Application
4.6.5 Product
4.6.6 Brazil
4.6.7 Mexico
4.6.8 Rest-of-Latin America
4.7 Middle East and Africa
4.7.1 Regional Overview
4.7.2 Driving Factors for Market Growth
4.7.3 Factors Challenging the Market
4.7.4 Application
4.7.5 Product
4.7.6 U.A.E.
4.7.7 South Africa
4.7.8 Rest-of-Middle East and Africa
5 Markets - Competitive Benchmarking & Company Profiles