실험실 개발 테스트 시장 조사 – 규모, 점유율, 개발 및 미래 범위 2031

  • Report Code : TIPRE00019603
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 183
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실험실 개발 테스트 시장은 2021년 45억 2,475만 달러에서 2028년 72억 6,930만 달러에 이를 것으로 예상됩니다. 2021-2028년 동안 7.0%의 CAGR로 성장할 것으로 예상됩니다.



실험실 개발 테스트(LDT)는 단일 실험실 내에서 설계되고 사용되는 일종의 체외 진단 테스트입니다. 이러한 검사는 인간 피험자로부터 채취한 검체에서 추출한 단백질, 생체분자/화합물(포도당, 콜레스테롤 등), DNA 등의 분석물을 추정하거나 구별하는 데 사용할 수 있습니다. 정확하고 오류 없는 분석을 제공하기 위해 실험실 및 진료소를 위한 자동 체외 진단(IVD) 방법의 확장은 실험실에서 개발한 테스트 시장 성장을 촉진하고 있습니다.





실험실 개발 테스트 시장의 성장은 주로 암 및 유전 질환의 발생 증가와 많은 제품 출시와 같은 요인에 기인합니다. 그러나 변화하는 규제 환경은 시장 성장을 방해하고 있습니다. 예를 들어, 유럽에서는 2022년 5월부터 모든 체외 진단 테스트에 체외 장치 규정(IVDR) 준수가 의무화됩니다. 이 규정은 의료 검사의 임상적 효과와 안전성을 확보하여 시장 참여자들의 큰 관심사인 진단 산업을 변화시키는 것을 목표로 합니다.



실험실 개발 테스트 시장의 수익성 지역

시장 통찰력



맞춤형 의약품에 대한 지속적인 연구는 실험실에서 개발한 테스트 시장 참여자에게 성장 기회를 제공합니다



LDT는 유망한 수단으로 입증될 가능성이 있는 맞춤형 의약품 개발에 중요한 역할을 훨씬 회피 효과적인 치료 또는 치료를 통해 질병에 대처의. 맞춤형 의약품 연합(Personalized Medicine Coalition)에 따르면 맞춤형 의약품은 2005년에 FDA가 승인한 새로운 분자 실체의 5%만을 차지했습니다. 그러나 2016년에는 이 수치가 25% 이상으로 증가했습니다. 또한 파이프라인에 있는 모든 화합물의 42%와 종양학 화합물의 73%는 맞춤형 의약품으로 사용될 가능성이 있습니다. 바이오 제약 회사는 지난 5년 동안 맞춤형 약물에 대한 R&D 투자를 거의 두 배로 늘렸으며 향후 5년 동안 투자를 33%까지 늘릴 것으로 예상됩니다. 바이오 제약 연구자들은 또한 향후 5년 동안 맞춤형 의약품 개발이 69% 증가할 것으로 예측합니다. 실험실 테스트는 질병을 진단하고 약물 반응을 예측 및 모니터링하고 복잡한 예측 알고리즘에 필요한 정보학 데이터를 얻는 데 사용됩니다.



맞춤형 의약품은 암 치료의 트레이드마크가 되고 있습니다. 그것은 개인의 유전적 구성에 따른 치료법의 맞춤화를 기반으로 하는 지속적으로 진화하는 접근 방식입니다. 2019년 FDA는 질병의 근본 원인을 조사하고 해결하기 위해 12가지 맞춤형 약물을 승인하여 임상 치료에 정밀 의학을 결합했습니다. 맞춤형 의약품에 대한 수요 증가는 실험실 개발 테스트 시장에서 활동하는 플레이어의 성장을 위한 상당한 성장 기회를 제공하고 있습니다.





유형 기반 통찰력



실험실에서 개발한 테스트 시장은 유형별로 임상 생화학, 중환자 치료, 혈액학, 미생물학, 분자 진단으로 분류됩니다. , 면역학 및 기타. 분자 진단 부문은 2021년에 시장에서 가장 큰 점유율을 차지할 것으로 예상됩니다. 그러나 혈액학 부문은 예측 기간 동안 시장에서 가장 높은 CAGR을 기록할 것으로 예상됩니다.



유형별 실험실 개발 테스트 시장 - 2021년 및 2028년

응용 기반 통찰력



응용 프로그램별로 연구소는 학술 기관, 임상 연구 기관, 병원 실험실, 전문 진단 센터 등에 테스트 시장 응용 프로그램을 개발했습니다. 병원 실험실 부문은 2021년에 가장 큰 시장 점유율을 차지할 것으로 추정됩니다. 그러나 전문 진단 센터 부문은 예측 기간 동안 시장에서 가장 높은 CAGR을 기록할 것으로 예상됩니다.



전략적 통찰력

제품 출시 및 승인은 회사가 글로벌 입지와 제품 포트폴리오를 확장하기 위해 일반적으로 채택하는 전략입니다. 또한, 실험실 개발 테스트 시장 플레이어는 고객 확대를 위한 파트너십 전략에 초점을 맞추고 있으며, 이를 통해 전 세계적으로 브랜드 이름을 유지할 수 있습니다.



보고서는 실험실 개발 테스트 시장을 다음과 같이 분류합니다



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검사실 개발 테스트 시장은 유형에 따라 임상 생화학, 중환자 치료, 혈액학, 미생물학, 분자 진단, 면역학 등으로 분류됩니다. 응용 프로그램을 기반으로 실험실 개발 테스트 시장은 학술 기관, 임상 연구 기관, 병원 실험실, 전문 진단 센터 등으로 분류됩니다. 실험실에서 개발한 테스트 시장은 지리를 기준으로 북미(미국, 캐나다 및 멕시코), 유럽(영국, 독일, 프랑스, 이탈리아, 스페인 및 기타 유럽), 아시아 태평양(중국, 일본, 인도, 호주, 한국 및 기타 아시아 태평양), 중동 및 아프리카(UAE, 사우디아라비아, 남아프리카, 기타 중동 및 아프리카), 중남미(브라질, 아르헨티나) , 나머지 중남미).



회사 프로필





  • Quest Diagnostics Incorporated

  • F. HOFFMANN-LA ROCHE LTD.,

  • QIAGEN

  • Illumina, Inc.,

  • Eurofins Scientific

  • Biodesix

  • 적응 생명공학

  • 생물치료

  • Rosetta Genomics Ltd.,

  • Guardant Health


Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


What is laboratory developed test mean?

A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed and used within a single laboratory. These tests can be utilized to estimate or distinguish an extensive assortment of analytes materials such as proteins, chemical compounds like glucose or cholesterol, or DNA, from a specimen received from human anatomy. The expansion of automated in vitro diagnostics (IVD) methods for labs and dispensaries to render precise, and error-free analysis is anticipated to fuel the increment.

What are the driving factors for the laboratory developed test market across the globe?

The growth of the laboratory developed test market is mainly attributed to factors such as the increasing incidents of cancer and genetic disorders, large number of product launches. However, changing regulatory landscape for instance, in Europe, the In-Vitro Device Regulation (IVDR) compliance will be mandatory for all in vitro diagnostic tests from May 2022; the regulation aims to secure the clinical effectiveness and safety of medical tests, thus transforming the diagnostic industry is a great concern to hinder the market growth. In August 2021, eMed, a telehealth company democratizing healthcare through digital-point-of-care solutions, and Quest Diagnostics the world's leading provider of diagnostic information services, are collaborated to bring clinician-guided rapid antigen testing for COVID-19 to employers seeking to foster safer environments by decreasing the risk of COVID-19 exposure in their workplaces which is contributing to the growth of the target market. Such strategic steps are also projected to drive the market growth.

What is the regional analysis in terms of laboratory developed test market?

The growth of the region is attributed to factors such as rising public–private partnerships, and increasing funding activities are widely enhancing the performance of medical devices. Moreover, presence of well-developed healthcare infrastructure and government support are some of the prominent factors propelling the market growth in Asia Pacific. In Asia Pacific, India is the largest market for laboratory developed test. The market growth in Asia Pacific is mainly attributed to factors such as the growing usage of laboratory developed test in combating Covid-19, increasing incidents of cancer and genetic disorders, large number of product launches. However concerns high capital investment for setting up advanced labs hinders the market growth in Asia Pacific.

What are future trends of Laboratory Developed Test Market?

The automation of LDTs can significantly boost productivity and simplify compliance procedures. Clinical laboratories are under huge pressure to manage increasing test volumes and conduct more complex diagnostic assays, which further underlines the need for flexible automation systems. Many MedTech companies are offering automation solutions to help streamline clinical laboratory processes. For instance, Roche Cobas Omni–Utility Channel is beneficial for both IVD assays and high-volume LDTs. It is designed to meet the growing needs of efficient workflows in laboratories, as it can assist in different stages ranging from sample processing to quick data interpretation. It can run up to 96 results in about 3 hours and up to 864 results in 8 hours, thereby boosting the efficiency of laboratories.

Which type is expected to dominate the market in the forecast period?

The laboratory developed test market is led by type molecular diagnostics segment is growing significantly due to the increasing attention to the development of genetic therapeutics. The growing research in human genomics is playing a vital role in developing laboratory developed tests. The technological advantages of molecular tests make them compelling diagnostic tools, and they have become valuable for detecting a wide range of genetic diseases. For instance, in November 2017, Edico Genome launched the DRAGEN Clinical Genomics Information System (CGIS).

The List of Companies - Laboratory Developed Test Market

 

  1. Quest Diagnostics Incorporated
  2. F. HOFFMANN-LA ROCHE LTD.,
  3. QIAGEN
  4. Illumina, Inc.,
  5. Eurofins Scientific
  6. Biodesix
  7. Adaptive Biotechnologies
  8. Biotheranostics
  9. Rosetta Genomics Ltd.,
  10. Guardant Health

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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