Markt für im Labor entwickelte Tests – Erkenntnisse aus globaler und regionaler Analyse – Prognose bis 2031

  • Report Code : TIPRE00019603
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 183
Buy Now

Der Markt für im Labor entwickelte Tests wird bis 2028 voraussichtlich 7.269,3 Millionen US-Dollar erreichen, gegenüber 4.524,75 Millionen US-Dollar im Jahr 2021; Es wird erwartet, dass er zwischen 2021 und 2028 mit einer jährlichen Wachstumsrate von 7,0 % wächst.



Ein im Labor entwickelter Test (LDT) ist eine Art In-vitro-Diagnosetest, der in einem einzigen Labor entwickelt und verwendet wird. Diese Tests können zur Schätzung oder Unterscheidung von Analyten wie Proteinen, Biomolekülen/Verbindungen (Glukose, Cholesterin usw.) und DNA verwendet werden, die aus Proben menschlicher Probanden extrahiert wurde. Die Ausweitung automatisierter In-vitro-Diagnosemethoden (IVD) für Labore und Apotheken, um präzise und fehlerfreie Analysen zu ermöglichen, treibt das Wachstum des Marktes für im Labor entwickelte Tests voran.





Das Wachstum des Marktes für im Labor entwickelte Tests ist hauptsächlich auf Faktoren wie die zunehmende Häufigkeit von Krebs und genetischen Störungen sowie die große Anzahl von Produkteinführungen zurückzuführen. Allerdings behindert die sich ändernde Regulierungslandschaft das Marktwachstum. In Europa beispielsweise wird die Einhaltung der In-Vitro Device Regulation (IVDR) ab Mai 2022 für alle In-vitro-Diagnosetests verpflichtend sein; Ziel der Verordnung ist es, die klinische Wirksamkeit und Sicherheit medizinischer Tests zu gewährleisten und so die Diagnostikindustrie zu verändern, was für die Marktteilnehmer ein großes Anliegen ist.



Lukrative Regionen im Markt für im Labor entwickelte Tests

Markteinblicke



Kontinuierliche Forschung zu personalisierten Medikamenten bietet Wachstumschancen für Marktteilnehmer für im Labor entwickelte Tests



LDTs spielen eine entscheidende Rolle bei der Entwicklung personalisierter Medikamente, die sich wahrscheinlich als vielversprechende Mittel erweisen werden Krankheiten durch bisher unbekannte wirksame Behandlungen oder Heilmittel zu bekämpfen. Laut der Personalized Medicine Coalition machten personalisierte Medikamente im Jahr 2005 nur 5 % der neuen, von der FDA zugelassenen molekularen Einheiten aus; Im Jahr 2016 stieg diese Zahl jedoch auf über 25 %. Darüber hinaus haben 42 % aller Wirkstoffe und 73 % der onkologischen Wirkstoffe in der Pipeline das Potenzial, als personalisierte Medikamente zu dienen. Biopharmazeutische Unternehmen haben ihre F&E-Investitionen in personalisierte Medikamente in den letzten fünf Jahren nahezu verdoppelt und es wird erwartet, dass sie ihre Investitionen in den nächsten fünf Jahren um 33 % steigern werden. Biopharmazeutische Forscher prognostizieren außerdem einen Anstieg der Entwicklung personalisierter Medikamente um 69 % in den nächsten fünf Jahren. Labortests werden verwendet, um Krankheiten zu diagnostizieren und die Reaktion auf Medikamente vorherzusagen und zu überwachen sowie um Informatikdaten zu erhalten, die für komplexe Vorhersagealgorithmen benötigt werden.



Personalisierte Medikamente werden zum Markenzeichen der Krebsbehandlung; Es handelt sich um einen sich ständig weiterentwickelnden Ansatz, der auf der Anpassung der Behandlungen an die individuelle genetische Ausstattung basiert. Im Jahr 2019 hat die FDA zwölf personalisierte Medikamente zur Untersuchung und Bekämpfung der Grundursachen von Krankheiten zugelassen und so Präzisionsmedizin in der klinischen Versorgung kombiniert. Die steigende Nachfrage nach personalisierter Medizin bietet erhebliche Wachstumschancen für das Wachstum der Akteure, die auf dem Markt für im Labor entwickelte Tests tätig sind.





Typbasierte Erkenntnisse



Der Markt für im Labor entwickelte Tests ist nach Typ in klinische Biochemie, Intensivpflege, Hämatologie, Mikrobiologie und Molekulardiagnostik unterteilt , Immunologie und andere. Es wird erwartet, dass das Segment Molekulardiagnostik im Jahr 2021 den größten Marktanteil halten wird. Allerdings wird erwartet, dass das Segment Hämatologie im Prognosezeitraum die höchste CAGR auf dem Markt verzeichnen wird.



Markt für im Labor entwickelte Tests nach Typ - 2021 und 2028

Anwendungsbasierte Erkenntnisse



Durch Anwendung entwickelte das Labor Testmarktanwendungen in akademischen Instituten, klinischen Forschungsorganisationen, Krankenhauslaboren, Spezialdiagnosezentren und anderen. Es wird geschätzt, dass das Segment der Krankenhauslabore im Jahr 2021 den größten Marktanteil ausmacht. Es wird jedoch erwartet, dass das Segment der Spezialdiagnostikzentren im Prognosezeitraum die höchste CAGR auf dem Markt verzeichnen wird.



Strategische Einblicke

Produkteinführungen und -zulassungen sind gängige Strategien von Unternehmen, um ihre globale Präsenz und ihr Produktportfolio zu erweitern. Darüber hinaus konzentrieren sich die Marktteilnehmer für im Labor entwickelte Tests auf die Partnerschaftsstrategie, um ihren Kundenkreis zu vergrößern, was ihnen wiederum ermöglicht, ihren Markennamen weltweit aufrechtzuerhalten.



Der Bericht segmentiert den Markt für im Labor entwickelte Tests wie folgt

Je nach Typ ist der Markt für im Labor entwickelte Tests in klinische Biochemie, Intensivpflege, Hämatologie, Mikrobiologie, Molekulardiagnostik, Immunologie und andere unterteilt. Basierend auf der Anwendung ist der Markt für im Labor entwickelte Tests in akademische Institute, klinische Forschungsorganisationen, Krankenhauslabore, Spezialdiagnosezentren und andere unterteilt. Auf der Grundlage der geografischen Lage ist der Markt für im Labor entwickelte Tests in Nordamerika (USA, Kanada und Mexiko), Europa (Großbritannien, Deutschland, Frankreich, Italien, Spanien und übriges Europa), den asiatisch-pazifischen Raum (China, Japan, Indien, Australien, Südkorea und der übrige asiatisch-pazifische Raum), der Nahe Osten und Afrika (die Vereinigten Arabischen Emirate, Saudi-Arabien, Südafrika und der übrige Nahe Osten und Afrika) sowie Süd- und Mittelamerika (Brasilien, Argentinien). , und der Rest von Süd- und Mittelamerika).



Unternehmensprofile




  • Quest Diagnostics Incorporated

  • F. HOFFMANN-LA ROCHE LTD.,

  • QIAGEN

  • Illumina, Inc.,

  • Eurofins Scientific

  • Biodesix

  • Adaptive Biotechnologien

  • Biotheranostik

  • 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.

Your data will never be shared with third parties, however, we may send you information from time to time about our products that may be of interest to you. By submitting your details, you agree to be contacted by us. You may contact us at any time to opt-out.

Related Reports