“The healthcare analytical testing services market is projected to grow at a CAGR of 11.4%.”

The global healthcare analytical testing services market size is projected to reach USD 8.4 billion by 2025 from USD 4.9 billion in 2020, at a CAGR of 11.4% during the forecast period. Market growth is attributed to the shift of focus towards the analytical testing of biologics and biosimilars, increasing outsourcing of analytical testing by pharmaceutical companies, increasing acceptance of the QbD approach in pharma research/manufacturing, and the adoption of FTE contracts in R&D outsourcing.

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“By type, with in the bioanalytical testing services segment, cell-based assay services hold the largest share in the forecast period.”

Based on type, the healthcare analytical testing services market has been segmented into bioanalytical testing services, physical characterization services, method development & validation services, raw material testing services, and batch-release testing services, among others. Bioanalytical testing services accounted for the largest share of the market in 2019. Within this segment, the cell-based assay services segment is expected to grow at the highest CAGR. This is due to their ability to provide relevant in vivo biological information in comparison to biochemical assays.

“By end user, the medical device companies segment is expected to grow at the fastest rate during the forecast period (2020-2025)”

Based on End User, the healthcare analytical testing services market has been segmented into pharmaceutical & biopharmaceutical companies, medical device companies, and CROs.The medical device companies segment is expected to grow at the highest CAGR due to increasing demand by OEMs for more services and expertise, an evolving regulatory scenario, technological advancements in medical devices, and the adoption of POC testing.

“North America to hold the largest share.”

North America is expected to account for the largest share of the global healthcare analytical testing services market in 2019.The large share of this region can primarily be attributed to the presence of a well-established base of pharmaceutical and biopharmaceutical companies, high investments in the biosimilars and biologics segment, and increasing R&D expenditure. On the other hand, the APAC is expected to witness the highest CAGR during the forecast period due to the large number of qualified researchers, low cost of operations in APAC countries, presence of a large treatment-naïve population, retention of participants in clinical trials, and continuously improving regulatory procedures.

The breakdown of primary participants is mentioned below:

By Company Type: Tier 1–30%, Tier 2–45%, and Tier 3–25%
By Designation: C-level–35%, Director Level–25%, and Others–40%
By Region: North America–35%, Europe–30%, the Asia Pacific–15%,Latin America–10%, Middle East & Africa – 10%
Research Coverage:

The report analyzes the various healthcare analytical testing services products and their adoption patterns in different industries such as pharmaceutical and biopharmaceutical companies, medical device companies, and CROs. It aims at estimating the market size and future growth potential of the global healthcare analytical testing services market for different segments such as by type,end user,and regions. The report also includes an in-depth competitive analysis of the key players in this market, along with their company profiles, product offerings, and recent developments.

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The report will enrich established firms as well as new entrants/smaller firms to gauge the pulse of the market, which would help the magner a greater share. Firms purchasing the report could use one or any combination of the below-mentioned five strategies for strengthening the market.

This report provides insights on the following pointers:

Market Penetration: Comprehensive information on the service portfolios offered by the top players in the global healthcare analytical testing services market
Product Development/Innovation: Detailed insights on the upcoming trends, R&D activities,and product launches in the global healthcare analytical testing services market
Market Development: Comprehensive information on lucrative emerging regions,by type and end user.
Market Diversification: Exhaustive information about new products, growing geographies, and recent developments in the global healthcare analytical testing services market
Competitive Assessment: In-depth assessment of market shares, growth strategies, and services offered by leading players in the global healthcare analytical testing services market
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Table of Contents

1 Introduction
1.1 Objectives Of The Study
1.2 Market Definition
1.3 Market Scope
1.3.1 Markets Covered
1.3.2 Years Considered For The Study
1.4 Currency
1.5 Limitations
1.6 Stakeholders

2 Research Methodology
2.1 Research Data
2.1.1 Secondary Data
2.1.1.1 Key Data From Secondary Sources
2.1.2 Primary Data
2.1.2.1 Key Data From Primary Sources
2.1.2.2 Breakdown Of Primary Sources
2.2 Market Size Estimation
2.3 Market Breakdown And Data Triangulation
2.4 Market Share Estimation
2.5 Assumptions For The Study

3 Executive Summary

4 Premium Insights
4.1 Healthcare Analytical Testing Services Market Overview
4.2 Healthcare Analytical Testing Services Market: Geographic Growth Opportunities
4.3 Healthcare Analytical Testing Services Market: Regional Mix (2020–2025)
4.4 Healthcare Analytical Testing Services Market: Developing Vs. Developed Countries

5 Market Overview
5.1 Introduction
5.2 Market Dynamics
5.2.1 Drivers
5.2.1.1 Focus On Analytical Testing Of Biologics & Biosimilars
5.2.1.2 Increasing Outsourcing Of Analytical Testing By Pharmaceutical Companies
5.2.1.3 Increasing Number Of Clinical Trials
5.2.1.4 Rising Acceptance Of The Quality-By-Design Approach In Pharma Research And Manufacturing
5.2.2 Restraints
5.2.2.1 Shortage Of Skilled Professionals
5.2.3 Opportunities
5.2.3.1 Specialized Testing
5.2.3.2 Emerging Markets
5.2.4 Challenges
5.2.4.1 Specific Requirements Of Innovative Formulations And Medical Devices
5.2.4.2 Need To Improve The Sensitivity Of Bioanalytical Methods

6 Industry Insights
6.1 Industry Trends
6.1.1 Focus On Acquisitions To Enhance Capabilities And Service Portfolio
6.1.2 Long-Term Outsourcing And Preferred Vendor Partnerships
6.2 Regulatory Analysis
6.3 Impact Of Covid-19 On Healthcare Analytical Testing Services

7 Healthcare Analytical Testing Services Market, By Type
7.1 Introduction
7.2 Bioanalytical Testing Services
7.2.1 Cell-Based Assays
7.2.1.1 Cell-Based Assays Help Check The Strength And Stability Of The Product Through All Phases Of Clinical Study
7.2.2 Virology Testing
7.2.2.1 Potential Effects Of Viral Contamination Support Demand For Testing Services
7.2.3 Immunogenicity & Neutralizing Antibody Testing
7.2.3.1 Increasing Application Of Immunogenicity & Neutralizing Antibodies To Drive The Market During Forecast Period
7.2.4 Biomarker Testing
7.2.4.1 Emphasis On Development Of Personalized Medicines To Drive Biomarker Testing Services Market
7.2.5 Pharmacokinetic Testing
7.2.5.1 Increasing Incidence Of Infectious Diseases Will Augment Market Growth
7.2.6 Other Bioanalytical Testing Services
7.3 Physical Characterization Services
7.3.1 Laser Particle Size Analysis
7.3.1.1 Need To Maintain Particle Size Uniformity And Consistency In Pharmaceutical Drug Products Is Driving Market Growth
7.3.2 Thermal Analysis
7.3.2.1 Rising Use Of Analyzers In Research To Further Support The Growth Of The Market
7.3.3 Image Analysis
7.3.3.1 Need To Identify Product Structures During Drug Development Has Sustained Demand For Image Analysis
7.3.4 Surface Area Analysis
7.3.4.1 Surface Area Analysis Helps Determine Performance Characteristics Of Products
7.3.5 Other Physical Characterization Services
7.4 Method Development & Validation Services
7.4.1 Extractable & Leachable Method Development & Validation
7.4.1.1 Extractable Studies Are Required To Facilitate The Analysis Of Leachables And Control Leachables In Final Drug Products
7.4.2 Process Impurity Method Development & Validation
7.4.2.1 Presence Of Drug-Substance And Drug-Product Impurities To Further Support Market Growth
7.4.3 Stability-Indicating Method Validation
7.4.3.1 Stability Testing Is Regarded As Being Essential In Understanding Drug Quality Changes Over Time
7.4.4 Cleaning Validation
7.4.4.1 Cleaning Validation Processes Are Necessary To Evaluate Cleaning Practices And Ensure Complete Decontamination
7.4.5 Analytical Standard Characterization
7.4.5.1 Analytical Standard Characterization Plays A Vital Role In Drug Development
7.4.6 Technical Consulting
7.4.6.1 Technical Consulting Services Assist Pharmaceutical And Biopharmaceutical Companies In Meeting Regulatory Requirements
7.4.7 Other Method Development & Validation Services
7.5 Raw Material Testing Services
7.5.1 Complete Compendial Testing
7.5.1.1 Complete Compendial Testing Detects The Efficacy And Safety Of Therapeutic Products
7.5.2 Heavy Metal Testing
7.5.2.1 Heavy Metals In Finished Pharmaceutical Products And Raw Materials Are Tested To Ensure The Quality Of The Product & Patient Safety
7.5.3 Container Testing
7.5.3.1 Container Closure Integrity Testing Helps Optimize Sealing, Evaluate Temperature Impact, And Replace Sterility Tests For Product Stability Batches
7.5.4 Karl Fischer Analysis
7.5.4.1 Need To Check For Water Content In Pharmaceutical Products To Support The Market Growth
7.5.5 Wet Chemistry Analysis
7.5.5.1 Wet Chemistry Analysis Provides Qualitative And Quantitative Data On Elements In Samples
7.5.6 Other Raw Material Testing Services
7.6 Batch-Release Testing Services
7.6.1 Dissolution Testing
7.6.1.1 Dissolution Testing Plays A Vital Role In The Pharmaceutical Industry, From R&D To The Control And Evaluation Of Drug Quality
7.6.2 Elemental Impurity Testing
7.6.2.1 The Need To Detect Organic And Inorganic Impurities In Active Pharmaceuticals And Ingredients Drives Demand For Elemental Impurity Testing
7.6.3 Disintegration Testing
7.6.3.1 Disintegration Testing Is Performed To Ensure Batch-To-Batch Consistency Of Pharmaceutical Dosage Forms
7.6.4 Hardness Testing
7.6.4.1 Hardness Testing Helps Determine Resistance To Mechanical Shocks And Tablet Strength
7.6.5 Friability Testing
7.6.5.1 Friability Testing Measures The Resistance Of Tablets And Granules To Abrasion Or Fracture
7.6.6 Other Batch-Release Testing Services
7.7 Stability Testing Services
7.7.1 Drug Substance Stability Testing
7.7.1.1 Substance Stability Testing Is A Necessary Step In The Drug Approval Process
7.7.2 Formulation Evaluation Stability Testing
7.7.2.1 These Tests Provide Data On Expiry And Storage Conditions Required
7.7.3 Accelerated Stability Testing
7.7.3.1 Accelerated Stability Testing Determines The Shelf-Life Of A Pharmaceutical Product By Measuring Degradation Caused By Stress
7.7.4 Photostability Testing
7.7.4.1 Photostability Tests Establish The Effect Of Light Exposure On Products
7.7.5 Comparative Stability Testing
7.7.5.1 Comparator Studies And Blind Comparator Stability Testing Are Performed To Check If A Pharmaceutical Product Is Equivalent Or Superior To The Marketed Drug Product In The Same Therapeutic Class
7.7.6 Other Stability Testing Services
7.8 Microbial Testing Services
7.8.1 Microbial Limit Testing
7.8.1.1 Microbial Limit Testing Determines Whether A Product Complies With Compendial Specifications For Microbial Quality
7.8.2 Sterility Testing
7.8.2.1 Sterility Testing Of A Pharmaceutical Product Is Required During The Sterilization Validation Process And Routine Release Testing To Enhance Product Quality
7.8.3 Endotoxin Testing
7.8.3.1 Lal Tests Are Used To Test For The Presence Of Endotoxins, In Compliance With Regulatory Requirements
7.8.4 Preservative Efficacy Testing
7.8.4.1 Preservative Efficacy Testing Determines The Type And Minimum Effective Concentration Of Preservatives Required For A Formulation
7.8.5 Water Testing
7.8.5.1 Need To Ensure Water Quality Creates Demand For Water Testing
7.8.6 Other Microbial Testing Services
7.9 Environmental Monitoring Services
7.9.1 Air Testing
7.9.1.1 Air Contamination Can Prove Highly Harmful To Product Quality, Which Necessitates Regular Testing
7.9.2 Wastewater/Etp Testing
7.9.2.1 Need To Minimize Water Contamination Supports The Demand For Wastewater Testing
7.9.3 Other Environmental Monitoring Services

8 Healthcare Analytical Testing Services Market, By End User
8.1 Introduction
8.2 Pharmaceutical & Biopharmaceutical Companies
8.2.1 Pharmaceutical & Biopharmaceutical Companies To Dominate The Healthcare Testing Services Market
8.3 Medical Device Companies
8.3.1 R&D Spending On Medical Device Development Has Increased In Recent Years
8.4 Contract Research Organizations
8.4.1 Increasing Focus On Outsourcing Will Support Market Growth

9 Healthcare Analytical Testing Services Market, By Region
9.1 Introduction
9.2 North America
9.2.1 Us
9.2.1.1 The Us Dominated The North American Healthcare Analytical Testing Services Market In 2019
9.2.2 Canada
9.2.2.1 Increasing Number Of Clinical Trials To Support The Growth Of The Market
9.3 Europe
9.3.1 Germany
9.3.1.1 Germany Is The Largest Market For Healthcare Analytical Testing Services In Europe
9.3.2 Uk
9.3.2.1 Increasing Partnerships Between The Government, The Nhs, And The Life Sciences To Support The Market Growth
9.3.3 France
9.3.3.1 Growing Number Of Biologics To Drive The Demand For Analytical Testing Services
9.3.4 Italy
9.3.4.1 Growing Number Of Clinical Trials To Support The Market In Italy
9.3.5 Switzerland
9.3.5.1 Large And Growing Pharma Production Volume Will Drive Demand For Analytical Testing Services
9.3.6 Spain
9.3.6.1 Rising R&D Expenditure To Boost The Growth Of Analytical Testing Services
9.3.7 Rest Of Europe
9.4 Asia Pacific
9.4.1 China
9.4.1.1 Large Pharmaceutical R&D Footprint In China Will Drive Market Growth
9.4.2 Japan
9.4.2.1 Japan Is Notable For Demonstrating Strong Support For R&D
9.4.3 India
9.4.3.1 India To Offer Lucrative Growth Opportunities For Market Players
9.4.4 Australia
9.4.4.1 Australia Is A Favorable Location For Drug Discovery Due To The Large Number Of Research Institutes In The Country
9.4.5 South Korea
9.4.5.1 Growth In Clinical Trial Activity To Support The Market In South Korea
9.4.6 Rest Of Asia Pacific
9.5 Latin America
9.5.1 Growing R&D Expenditure To Drive Market Growth
9.6 Middle East & Africa
9.6.1 Middle Eastern Countries Are Becoming Attractive Destinations For Pharma & Medical Device Manufacturers

10 Competitive Landscape
10.1 Overview
10.2 Growth Strategy Matrix (2017–2020)
10.3 Market Share Analysis
10.3.1 Market Share Analysis: Healthcare Analytical Testing Services Market
10.4 Competitive Leadership Mapping
10.4.1 Visionary Leaders
10.4.2 Innovators
10.4.3 Dynamic Differentiators
10.4.4 Emerging Companies
10.5 Competitive Situation And Trends
10.5.1 Service Launches And Upgrades
10.5.2 Acquisitions
10.5.3 Partnerships And Collaborations
10.5.4 Expansions

11 Company Profiles

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