IVD Contract Manufacturing Market Size, Share, Growth Analysis, By Product Type (Consumables, Equipment), By Technology (Immunoassays, Clinical Chemistry), By Service Type (Manufacturing Services, Assay Development), By Region -Industry Forecast 2024-2031.


Report ID: SQMIG35H2317 | Region: Global | Published Date: November, 2024
Pages: 194 |Tables: 92 |Figures: 67

IVD Contract Manufacturing Market Insights

Global IVD Contract Manufacturing Market size was valued at USD 14.80 billion in 2022 and is poised to grow from USD 16.52 billion in 2023 to USD 39.74 billion by 2031, growing at a CAGR of 11.60% during the forecast period (2024-2031).

The IVD contract manufacturing market will expand due to increasing emphasis on personalized medicine, with gene expression, biomarker discovery and targeted drugs driving these trends as well as driving demand a regarding standardized diagnostic solutions has increased.

The market expansion will be driven by the provision of diagnostic products to contracting organizations primarily due to the continued rise in healthcare costs, especially in emerging markets. IVD contract manufacturing will be in high demand due to continued advances in diagnostic technologies, including digital pathology, next-generation sequencing, and advanced imaging techniques to support the development for the diagnosis and development.

In vitro, biomedical instrumental displays are experiments applied to biological models to select conditions that are in the best interests of the individual. A wide range of in vitro diagnostics (IVDs), from personalized pregnancy tests to blood glucose tests for individuals with diabetes to sophisticated tests in clinical laboratories, drive the market. The use of IVD devices in the pharmaceutical industry is increasing as end-user adoption of these devices increases. Interest in point-of-care monitoring devices and their ability to test, diagnose, and prevent disease will increase as the phase progresses. Expanding interest in customized high-speed display devices will contribute to the development of IVD devices in the market. Moreover, many market players are involved in the key drive execution, thereby enhancing the growth of the segment.

Market Snapshot - 2024-2031

Global Market Size

USD 14.80 billion

Largest Segment

Consumables

Fastest Growth

Manufacturing Services

Growth Rate

11.60%

Global IVD Contract Manufacturing Market ($ Bn)
Country Share for North America Region (%)

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IVD Contract Manufacturing Market Segmental Analysis

Global IVD Contract Manufacturing Market is segmented into Product Type, Technology, Service Type, and region. By Product Type, the market is classified into Consumables, and Equipment. Depending on the Technology, it is categorized into Immunoassays, Clinical Chemistry, Molecular Diagnostics, Hematology, Microbiology, Coagulation & Hemostasis, and Other Technologies. According to Service Type, the market is divided into Manufacturing Services, Assay Development, and Other Services. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & and Africa. 

Analysis by Technology

In 2023, the immunoassay segment accounted for the highest revenue. The field of immunology focuses on the detection and estimation of clear particles using different aspects of the immune system. This includes the testing of proteins, drugs, and antibodies, and provides important experience with a variety of diseases. An example of IVD contracting for immunoassays incorporates enhanced interest for multiple signaling measures, allowing simultaneous testing of different analytes. In addition, improvements in testing for it is in function and clarity, beside the shift to computers for improved skills.

The molecular diagnostics segment is expected to witness the fastest growth during the forecast period. Molecular diagnostics in the IVD contract manufacturing market use nucleic acids, proteins, or other clear subatomic markers recognized for the diagnosis of diseases. In this category, examples recall pharmaceutical inventions a growing emphasis on customization and a widening interest in improving customized products. Advances in nucleic acid-based development, for example, PCR and the latest sequencing techniques are driving the growth. IVD contract manufacturers benefit from these models by offering unique expertise in the sub-atomic analytical assay industry, meeting the need for precise and customized systems in the medical field.Analysis by Service TypeThe assay development services category leads the market. The research development phase includes the creation and improvement of characterization assays to identify underlying biomarkers or analytes. This helps to incorporate various developments including reagent information, custom development and assay approval. An example in this category is the growing interest in customized, tested development for obvious business needs driven by the development of customized medicine. IVD contract manufacturers with their capabilities implements these needs, providing specific analytical enhancements used to improve signal accuracy and precision.

IVD contract manufacturing market’s manufacturing services segment is expected to witness the fastest growth during the forecast period. The product development phase includes the creation and development of flexible product displays. This includes improving manufacturing skills, stabilizing the workforce and developing new, innovative, coordinated products. The latest topics in this segment focus on robotics, rapid prototyping, and customization and combination approaches to meet the needs of modified and simulated IVD systems role as IVD organizations look to build the best manufacturing, financially savvy, best-performing business teams in this sector.

 

Global IVD Contract Manufacturing Market By Technology (%)

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IVD Contract Manufacturing Market Regional Insights

North America, especially the US, is an important part of the IVD contract manufacturing market. The dominance of this segment can be attributed to advanced healthcare, well-established diagnostic companies and appropriate regulatory framework. Companies in North America are leading the adoption of cutting-edge technology with molecular diagnostics and personalized medicine along with atom, which significantly strengthens the market. North America emerged as the dominant region in the global IVD contract manufacturing market in 2023. North America boasts a well-developed healthcare infrastructure, including advanced medical facilities, research institutes and regulatory framework. The region is a hub for technological innovation and research in the health and life sciences industries.

Asia-Pacific is emerging as a key player in the IVD contract manufacturing market, driven by the region’s low manufacturing costs, rapidly expanding healthcare infrastructure and increasing local demand for diagnostic instruments. Consequently, Asia Pacific is expected to witness the highest growth in the market, which will attract global manufacturers looking to reduce production costs while maintaining high standards. Asia-Pacific dominated the market with a revenue share of over 41.3% in 2022, which is estimated to grow significantly during the forecast period. This growth is driven by the increasing number of the companies outsourcing services to countries as developing in the region. In recent years, countries such as Singapore, China and India have been identified as major players in the pharmaceutical sector, as they expand their operations. The availability of cash in Asian companies drives the closure of the contracting sector. Larger investment tons of Asian CMOs are expected to drive significant growth.

Global IVD Contract Manufacturing Market By Geography
  • Largest
  • Fastest

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IVD Contract Manufacturing Market Dynamics

Drivers

Increasing Demand for IVD Devices

  • Increasing incidence of chronic diseases such as diabetes, cancer and heart disease is driving the need for advanced In Vitro Diagnostics (IVD) devices This demand has fueled the growth of the IVD contract manufacturing market, period whose manufacturers seek to increase productivity to address global health challenges. Contractors play a key role in providing cost-effective, quality solutions to IVD companies to help them meet rigorous regulatory standards.

Technological Advancement in IVD Production

  • Rapid advancement in diagnostic technologies including point-of-care diagnostics and molecular diagnostics is driving the market growth. Contractors adopt advanced manufacturing processes such as automation and precision engineering, enabling them to deliver specialized services. These improvements help companies increase their product offerings, improve test accuracy, and reduce time to market.

Restraints

High Development and Manufacturing Costs

  • The IVD contract manufacturing market faces major cost-related challenges. The development and manufacture of IVD devices requires significant investments in research, compliance, and manufacturing facilities. The high cost of developing new diagnostic technologies can prevent small and medium-sized companies from entering the market, stifling growth.

Stringent Regulatory Requirements

  • IVD products are subject to stringent regulations, such as FDA approval in the US and CE marks in Europe. Complying with these regulations can be costly and time-consuming for contract manufacturers. Frequent updates to regulatory standards require manufacturers to invest heavily in compliance programs, affecting both profitability and growth potential.

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IVD Contract Manufacturing Market Competitive Landscape

The global IVD contract manufacturing market is highly competitive, driven by a mix of established players, key service providers and emerging companies. Increasing demand for advanced diagnostic, regulatory solutions challenges and technological advances have shaped this competitive landscape. Companies compete based on their ability to offer innovative, cost-effective solutions while complying with stringent regulatory requirements. Jabil is a leading contract manufacturer in the market, offering a wide range of business services including manufacturing, assembly and compliance.

Top Player’s Company Profiles

  • Jabil Inc.  
  •  Sanmina Corporation  
  •  TE Connectivity  
  •  Celestica, Inc.  
  •  West Pharmaceutical Services, Inc.  
  •  Savyon Diagnostics, Ltd.  
  •  KMC Systems  
  •  Cenogenics Corporation  
  •  Nova Biomedical  
  •  Cone Bioproducts  
  •  Kimball Electronics, Inc.  
  • Roche Diagnostics  
  •  Viant Medical Holdings, Inc.  
  • Sysmex Corporation  
  •  Stratec Se  
  •  Thermo Fisher Scientific, Inc.  
  •  Fujirebio  
  •  Biokit (Werfen)  
  •  Sekisui  
  •  Prestige Diagnostics

Recent Developments

  • In May 2023, Significant organization formed between two new biotech companies, Reagent IVD Assets Pvt. Ltd. Ltd. (RIVDR), based in Jaipur and involved in diagnostic research, and TechInvention Lifecare Pvt. Ltd., of Mumbai, to manufacture and supply various diagnostics. Offering life sciences laboratory and in-vitro diagnostics (IVD), RIVDR is a contract manufacturer to provide creative integrated responses to the rapidly growing market.
  • In November 2022, launch of biotechnology emphasizing diagnostics, reagent IVD Assets Pvt. Ltd (RIVDR), based in Jaipur, and Mumbai-based biotech firefighter. TechInvention Lifecare Pvt. Ltd., was actively involved in the development and distribution of a wide range of the diagnostic drugs.
  • In July 2023, Cenegenix introduced a partnership with Cleerly, an agency that targets to get rid of the coronary heart disorder by means of growing a brand-new paradigm for treating coronary heart ailment.

IVD Contract Manufacturing Key Market Trends

  • Outsourcing to Emerging Markets: A developing trend inside the marketplace is outsourcing products to emerging markets, particularly in Asia-Pacific. Many groups are shifting to these regions due to the lower labor costs, increasing manufacturing strains and skilled personnel. This trend enables manufacturers to cut expenses and tap into the growing market.
  • Transition to Personalized Medicine: The future of IVD devices is being formed with the aid of an increased consciousness on drug personalization. Contractors are increasingly being tasked with developing diagnostic gear that aligns with customized remedy protocols, which include the ones used in oncology or genetic testing. This trend is driving innovation inside the enterprise, they have been searching out a streamlined diagnostic solution.

IVD Contract Manufacturing Market SkyQuest Analysis

SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research. 

According to SkyQuest analysis, the IVD contract manufacturing market is witnessing strong growth owing to increasing the global demand for diagnostic devices and technological advancements. While challenges such as the high manufacturing costs and regulatory barriers remain, there are emerging trends such as manufacturing outsourcing to Asia-Pacific and the shift towards pharmaceutical supply per capita creates new growth opportunities. The market is positioned to grow exponentially as manufacturers adopt advanced technologies and adapt to regulatory frameworks.

Report Metric Details
Market size value in 2022 USD 14.80 billion
Market size value in 2031 USD 39.74 billion
Growth Rate 11.60%
Base year 2023
Forecast period 2024-2031
Forecast Unit (Value) USD Billion
Segments covered
  • Product Type
    • Consumables, Equipment
  • Technology
    • Immunoassays, Clinical Chemistry, Molecular Diagnostics, Hematology, Microbiology, Coagulation & Hemostasis, Other Technologies
  • Service Type
    • Manufacturing Services, Assay Development, Other Services
Regions covered North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA)
Companies covered
  • Jabil Inc.  
  •  Sanmina Corporation  
  •  TE Connectivity  
  •  Celestica, Inc.  
  •  West Pharmaceutical Services, Inc.  
  •  Savyon Diagnostics, Ltd.  
  •  KMC Systems  
  •  Cenogenics Corporation  
  •  Nova Biomedical  
  •  Cone Bioproducts  
  •  Kimball Electronics, Inc.  
  • Roche Diagnostics  
  •  Viant Medical Holdings, Inc.  
  • Sysmex Corporation  
  •  Stratec Se  
  •  Thermo Fisher Scientific, Inc.  
  •  Fujirebio  
  •  Biokit (Werfen)  
  •  Sekisui  
  •  Prestige Diagnostics
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Table Of Content

Executive Summary

Market overview

  • Exhibit: Executive Summary – Chart on Market Overview
  • Exhibit: Executive Summary – Data Table on Market Overview
  • Exhibit: Executive Summary – Chart on IVD Contract Manufacturing Market Characteristics
  • Exhibit: Executive Summary – Chart on Market by Geography
  • Exhibit: Executive Summary – Chart on Market Segmentation
  • Exhibit: Executive Summary – Chart on Incremental Growth
  • Exhibit: Executive Summary – Data Table on Incremental Growth
  • Exhibit: Executive Summary – Chart on Vendor Market Positioning

Parent Market Analysis

Market overview

Market size

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • SWOT Analysis

KEY MARKET INSIGHTS

  • Technology Analysis
    • (Exhibit: Data Table: Name of technology and details)
  • Pricing Analysis
    • (Exhibit: Data Table: Name of technology and pricing details)
  • Supply Chain Analysis
    • (Exhibit: Detailed Supply Chain Presentation)
  • Value Chain Analysis
    • (Exhibit: Detailed Value Chain Presentation)
  • Ecosystem Of the Market
    • Exhibit: Parent Market Ecosystem Market Analysis
    • Exhibit: Market Characteristics of Parent Market
  • IP Analysis
    • (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
  • Trade Analysis
    • (Exhibit: Data Table: Import and Export data details)
  • Startup Analysis
    • (Exhibit: Data Table: Emerging startups details)
  • Raw Material Analysis
    • (Exhibit: Data Table: Mapping of key raw materials)
  • Innovation Matrix
    • (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
  • Pipeline product Analysis
    • (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
  • Macroeconomic Indicators

COVID IMPACT

  • Introduction
  • Impact On Economy—scenario Assessment
    • Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
  • Revised Market Size
    • Exhibit: Data Table on IVD Contract Manufacturing Market size and forecast 2021-2027 ($ million)
  • Impact Of COVID On Key Segments
    • Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
  • COVID Strategies By Company
    • Exhibit: Analysis on key strategies adopted by companies

MARKET DYNAMICS & OUTLOOK

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • Regulatory Landscape
    • Exhibit: Data Table on regulation from different region
  • SWOT Analysis
  • Porters Analysis
    • Competitive rivalry
      • Exhibit: Competitive rivalry Impact of key factors, 2021
    • Threat of substitute products
      • Exhibit: Threat of Substitute Products Impact of key factors, 2021
    • Bargaining power of buyers
      • Exhibit: buyers bargaining power Impact of key factors, 2021
    • Threat of new entrants
      • Exhibit: Threat of new entrants Impact of key factors, 2021
    • Bargaining power of suppliers
      • Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
  • Skyquest special insights on future disruptions
    • Political Impact
    • Economic impact
    • Social Impact
    • Technical Impact
    • Environmental Impact
    • Legal Impact

Market Size by Region

  • Chart on Market share by geography 2021-2027 (%)
  • Data Table on Market share by geography 2021-2027(%)
  • North America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • USA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Canada
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Europe
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Germany
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Spain
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • France
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • UK
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Europe
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Asia Pacific
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • China
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • India
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Japan
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Korea
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Asia Pacific
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Latin America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Brazil
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of South America
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Middle East & Africa (MEA)
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • GCC Countries
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Africa
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of MEA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)

KEY COMPANY PROFILES

  • Competitive Landscape
    • Total number of companies covered
      • Exhibit: companies covered in the report, 2021
    • Top companies market positioning
      • Exhibit: company positioning matrix, 2021
    • Top companies market Share
      • Exhibit: Pie chart analysis on company market share, 2021(%)

Methodology

For the IVD Contract Manufacturing Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:

1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.

2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the IVD Contract Manufacturing Market.

3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.

4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.

Analyst Support

Customization Options

With the given market data, our dedicated team of analysts can offer you the following customization options are available for the IVD Contract Manufacturing Market:

Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.

Regional Analysis: Further analysis of the IVD Contract Manufacturing Market for additional countries.

Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.

Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.

Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.

Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.

Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.

Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.

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FAQs

Global IVD Contract Manufacturing Market size was valued at USD 14.80 billion in 2022 and is poised to grow from USD 16.52 billion in 2023 to USD 39.74 billion by 2031, growing at a CAGR of 11.60% during the forecast period (2024-2031).

The global IVD contract manufacturing market is highly competitive, driven by a mix of established players, key service providers and emerging companies. Increasing demand for advanced diagnostic, regulatory solutions challenges and technological advances have shaped this competitive landscape. Companies compete based on their ability to offer innovative, cost-effective solutions while complying with stringent regulatory requirements. Jabil is a leading contract manufacturer in the market, offering a wide range of business services including manufacturing, assembly and compliance. 'Jabil Inc.  ', ' Sanmina Corporation  ', ' TE Connectivity  ', ' Celestica, Inc.  ', ' West Pharmaceutical Services, Inc.  ', ' Savyon Diagnostics, Ltd.  ', ' KMC Systems  ', ' Cenogenics Corporation  ', ' Nova Biomedical  ', ' Cone Bioproducts  ', ' Kimball Electronics, Inc.  ', 'Roche Diagnostics  ', ' Viant Medical Holdings, Inc.  ', 'Sysmex Corporation  ', ' Stratec Se  ', ' Thermo Fisher Scientific, Inc.  ', ' Fujirebio  ', ' Biokit (Werfen)  ', ' Sekisui  ', ' Prestige Diagnostics'

Increasing incidence of chronic diseases such as diabetes, cancer and heart disease is driving the need for advanced In Vitro Diagnostics (IVD) devices This demand has fueled the growth of the IVD contract manufacturing market, period whose manufacturers seek to increase productivity to address global health challenges. Contractors play a key role in providing cost-effective, quality solutions to IVD companies to help them meet rigorous regulatory standards.

Outsourcing to Emerging Markets: A developing trend inside the marketplace is outsourcing products to emerging markets, particularly in Asia-Pacific. Many groups are shifting to these regions due to the lower labor costs, increasing manufacturing strains and skilled personnel. This trend enables manufacturers to cut expenses and tap into the growing market.

North America, especially the US, is an important part of the IVD contract manufacturing market. The dominance of this segment can be attributed to advanced healthcare, well-established diagnostic companies and appropriate regulatory framework. Companies in North America are leading the adoption of cutting-edge technology with molecular diagnostics and personalized medicine along with atom, which significantly strengthens the market. North America emerged as the dominant region in the global IVD contract manufacturing market in 2023. North America boasts a well-developed healthcare infrastructure, including advanced medical facilities, research institutes and regulatory framework. The region is a hub for technological innovation and research in the health and life sciences industries.

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