비침습적 산전 검사(NIPT) 시장 - 세계 및 지역별 분석 : 방법별, 검사별, 플랫폼별, 최종사용자별, 용도별, 지역별 - 분석 및 예측(2023-2033)

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

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

• 5.1 Next Frontiers
• 5.2 Competitive Landscape
  • 5.2.1 Agilent Technologies, Inc.
    • 5.2.1.1 Overview
    • 5.2.1.2 Product Portfolio
    • 5.2.1.3 Top Competitors
    • 5.2.1.4 Key Personnel
    • 5.2.1.5 Target Customers
    • 5.2.1.6 Analyst View
  • 5.2.2 F. Hoffmann-La Roche Ltd
    • 5.2.2.1 Overview
    • 5.2.2.2 Product Portfolio
    • 5.2.2.3 Top Competitors
    • 5.2.2.4 Target Customers
    • 5.2.2.5 Key Personnel
    • 5.2.2.6 Analyst View
  • 5.2.3 PerkinElmer, Inc.
    • 5.2.3.1 Overview
    • 5.2.3.2 Product Portfolio
    • 5.2.3.3 Top Competitors
    • 5.2.3.4 Target Customers
    • 5.2.3.5 Key Personnel
    • 5.2.3.6 Analyst View
  • 5.2.4 Quest Diagnostics Incorporated
    • 5.2.4.1 Overview
    • 5.2.4.2 Product Portfolio
    • 5.2.4.3 Top Competitors
    • 5.2.4.4 Target Customers
    • 5.2.4.5 Key Personnel
    • 5.2.4.6 Analyst View
  • 5.2.5 Illumina, Inc.
    • 5.2.5.1 Overview
    • 5.2.5.2 Product Portfolio
    • 5.2.5.3 Top Competitors
    • 5.2.5.4 Target Customers
    • 5.2.5.5 Key Personnel
    • 5.2.5.6 Analyst View
  • 5.2.6 Myriad Genetics, Inc.
    • 5.2.6.1 Overview
    • 5.2.6.2 Product Portfolio
    • 5.2.6.3 Top Competitors
    • 5.2.6.4 Target Customers
    • 5.2.6.5 Key Personnel
    • 5.2.6.6 Analyst View
  • 5.2.7 BGI Genomics
    • 5.2.7.1 Overview
    • 5.2.7.2 Product Portfolio
    • 5.2.7.3 Top Competitors
    • 5.2.7.4 Target Customers
    • 5.2.7.5 Key Personnel
    • 5.2.7.6 Analyst View
  • 5.2.8 CENTOGENE N.V.
    • 5.2.8.1 Overview
    • 5.2.8.2 Product Portfolio
    • 5.2.8.3 Top Competitors
    • 5.2.8.4 Target Customers
    • 5.2.8.5 Key Personnel
    • 5.2.8.6 Analyst View
  • 5.2.9 Laboratory Corporation of America Holdings
    • 5.2.9.1 Overview
    • 5.2.9.2 Product Portfolio
    • 5.2.9.3 Top Competitors
    • 5.2.9.4 Target Customers
    • 5.2.9.5 Key Personnel
    • 5.2.9.6 Analyst View
  • 5.2.10 MedGenome Inc.
    • 5.2.10.1 Overview
    • 5.2.10.2 Product Portfolio
    • 5.2.10.3 Top Competitors
    • 5.2.10.4 Target Customers
    • 5.2.10.5 Key Personnel
    • 5.2.10.6 Analyst View
  • 5.2.11 Annoroad Gene Technology
    • 5.2.11.1 Overview
    • 5.2.11.2 Product Portfolio
    • 5.2.11.3 Top Competitors
    • 5.2.11.4 Target Customers
    • 5.2.11.5 Key Personnel
    • 5.2.11.6 Analyst View
  • 5.2.1 Natera, Inc.
    • 5.2.1.1 Overview
    • 5.2.1.2 Product Portfolio
    • 5.2.1.3 Top Competitors
    • 5.2.1.4 Target Customers
    • 5.2.1.5 Key Personnel
    • 5.2.1.6 Analyst View
  • 5.2.2 Yourgene Health
    • 5.2.2.1 Overview
    • 5.2.2.2 Product Portfolio
    • 5.2.2.3 Top Competitors
    • 5.2.2.4 Target Customers
    • 5.2.2.5 Key Personnel
    • 5.2.2.6 Analyst View
  • 5.2.3 Eurofins Scientific SE
    • 5.2.3.1 Overview
    • 5.2.3.2 Product Portfolio
    • 5.2.3.3 Top Competitors
    • 5.2.3.4 Target Customers
    • 5.2.3.5 Key Personnel
    • 5.2.3.6 Analyst View
  • 5.2.4 Next Biosciences
    • 5.2.4.1 Overview
    • 5.2.4.2 Product Portfolio
    • 5.2.4.3 Top Competitors
    • 5.2.4.4 Target Customers
    • 5.2.4.5 Key Personnel
    • 5.2.4.6 Analyst View

6 Research Methodology

• 6.1 Data Sources
  • 6.1.1 Primary Data Sources
  • 6.1.2 Secondary Data Sources
  • 6.1.3 Data Triangulation
• 6.2 Market Estimation and Forecast