| Attributes | Details |
|---|---|
| Healthcare Analytical Testing Services Market Size (2021) | USD 11.9 billion |
| Healthcare Analytical Testing Services Market Size (2022) | USD 13.5 billion |
| Projected Market Value (2032) | USD 49.6 billion |
| Global Market Growth Rate (2022 to 2032) | 14% |
| USA Market Growth Rate (2022 to 2032) | 14.5% |
| Key Companies Profiles | Eurofins Scientific; Pace Analytical Services LLC; Intertek Group; Toxikon, Inc.; SGS SA; Syneos Health; Charles River Laboratories International Inc.; Labcorp; ICON plc; WUXI Apptec |
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Healthcare manufacturers and researchers dealing with a highly regulated and competitive market are turning to outsourcing their analytical testing to testing service providers. Outsourcing is a solution to the problem of a lack of resources and expertise a company might face if they choose to conduct their testing in-house. There is also a cost-benefit since there is a reduction in fixed capital requirements and operating costs since laboratories can be contacted as and when necessary.
Due to the nature of their products, companies are willing to ensure high-quality testing even when under strict budgets. Several organizations use outsourcing as a means to perform routine tests in order to reduce the time spent in the production process for a more efficient and timely rollout of products. Further, the use of reputed agencies lends further credibility to products due to the lower chances of an internal bias. The combination of these factors is giving a significant boost to the market.
Product recalls are a key concern in the healthcare industry, with the estimated cost of a recall to a manufacturer being over US$ 600 million on average. Estimates place around half of the recall costs to pharmaceutical companies that actually occur due to this business interruption. The high-risk and sensitive nature of healthcare products means that ethics are also a key concern.
Even a single flaw can lead to severe consequences on actual human life, and thus ensuring near-perfect safety is essential for both companies and official regulatory bodies. This means that there are highly strict monitoring guidelines and regulatory processes in place for both new and existing products. Efficient and thorough testing is vital to meeting these requirements. This nature of the products and the attempts to reduce recall are expected to be significant drivers for demand in the future as well.
Principal Consultant
The WHO reports that healthcare-acquired infections are a prominent cause for concern. Ensuring that the packaging selected for healthcare products is efficient is an essential component of producing these products. Even if products themselves are sterilized, the manufacturers must ensure through testing that the product will remain the same even through changes in the environment, human handling, and various other parts of the production and distribution process. They must also test for changes in the efficacy of the packing over time under varied conditions the final object is likely to be subject to.
A growing concern in recent years is Extractable and Leachable Testing. Extractables, which migrate from the product under stressed conditions, and Leachables, which migrate from the product under normal conditions, are extremely harmful since they can cause a change in the product itself. Since they directly interact with a pharmaceutical or medical product at any stage of the production process, they are in the spotlight of regulatory concern, with regulations demanding more thorough tests than the base ISO testing covers.
Before stringent rules were in place, Extractables and Leachables caused significant adverse events in the healthcare environment, For example, in 2002 the FDA had to release a notification regarding the presence of DEHP, which is a widely used plasticizer in PVC products. Traces of DEHP were found in Total Parenteral Nutrition fat emulsion infusion lines. Vanillin was another such substance, which was found in inhalation solutions within LDPE containers. A foil overwrap had to be introduced to prevent the migration of this substance once it was identified, which led to time delays and significant costs to recover from.
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Europe is an emerging region for the demand in the Healthcare Analytical Testing Services market. Regulations for medical devices in the European Union are under the MDR or Medical Device Regulation, which is currently in an adjustment period till 2024 after coming into effect in 2021. With the growing healthcare expenditure of the European countries, the revenue through healthcare analytical testing services is also expected to swell.
The United States is the nucleus of Global Medical Device Testing demand, having witnessed a CAGR of 12.6% from 2017 to 2021, and with a market value of US$ 19 billion by 2032 at a CAGR of 14.5% from 2022 to 2032. Medical devices in the USA are categorized by the FDA from CLASS I to class III based on the risk they pose. Testing differs amongst classes, with the higher classes requiring far more stringent testing. The FDA regulates pharmaceuticals as well, with the main regulatory standard being the Current Good Manufacturing Practices or GMPs regulation.
The healthcare analytical testing services market in the United Kingdom is projected to reach a valuation of US$ 2.2 billion by 2032. The Healthcare Analytical Testing Services market in the country is expected to gross an absolute dollar opportunity of US$ 1.6 billion from 2022 to 2032, with a CAGR of 14%.
The Healthcare Analytical Testing Services market in Japan is expected to gross an absolute dollar opportunity of US$ 2.2 billion from 2022 to 2032. The market is projected to reach a valuation of US$ 2.7 billion by 2032, growing at a CAGR of 18.6% from 2022 to 2032.
The Healthcare Analytical Testing Services market in South Korea is expected to reach a valuation of US$ 987.4 million by 2032. The market in the country is expected to register an absolute dollar opportunity of US$ 704.6 million between 2020 and 2032.
China is a key country for demand, having witnessed a CAGR of 16.8%, with an absolute dollar opportunity of US$ 3.1 billion and a forecasted 2032 market size of US$ 4.2 billion a CAGR of 13.9%. The demand is largely due to the strict regulatory demands by authorities. The regulation of healthcare products is handled by the National Medical Products agency, which was formerly the China Food and Drug Administration of CFDA, and is a part of the State Administration for Market Regulation.
Pharmaceuticals are leading market demand, with a forecasted CAGR of 13.2%. The testing of pharmaceutical products is a highly complex and lengthy process, which requires sophisticated technology and a wide range of resources. In recent years, the increased scrutiny of final products has led to an increase in manufacturers and researchers turning to test services to ensure that their drugs have regulatory compliance.
Healthcare Analytical Testing Service providers are focused on maintaining the quality of their services and finding efficient methods to continue testing in order to help their clients meet regulatory guidelines. The key companies operating include Eurofins Scientific, Pace Analytical Services, LLC, Intertek Group, Toxikon, Inc., SGS SA, Syneos Health, Charles River Laboratories International Inc., Labcorp, ICON plc, WUXI Apptec, and Pharmaceutical Product Development
Some of the recent development in the Healthcare Analytical Testing Services Market are as follows:
Similarly, recent developments related to companies manufacturing Healthcare Analytical Testing Services have been tracked by the team at Future Market Insights, which is available in the full report.
The global Healthcare Analytical Testing Services market was valued at US$ 11.9 billion in 2021 and is expected to grow to US$ 13.5 billion by 2032.
The Healthcare Analytical Testing Services industry is set to witness a growth rate of 14% over the forecast period and be valued at US$ 49.6 billion by 2032.
Pharmaceutical is the top Product Type in the Healthcare Analytical Testing Services Market.
ICON plc, Charles River Laboratories International Inc., Intertek Group, and Eurofins Scientific the key suppliers of Healthcare Analytical Testing Services.
The USA, United Kingdom, China, Japan, and South Korea are expected to drive the most sales growth of Healthcare Analytical Testing Services.
1. Executive Summary
1.1. Global Market Outlook
1.2. Demand-side Trends
1.3. Supply-side Trends
1.4. Technology Roadmap Analysis
1.5. Analysis and Recommendations
2. Market Overview
2.1. Market Coverage / Taxonomy
2.2. Market Definition / Scope / Limitations
3. Market Background
3.1. Market Dynamics
3.1.1. Drivers
3.1.2. Restraints
3.1.3. Opportunity
3.1.4. Trends
3.2. Scenario Forecast
3.2.1. Demand in Optimistic Scenario
3.2.2. Demand in Likely Scenario
3.2.3. Demand in Conservative Scenario
3.3. Opportunity Map Analysis
3.4. Product Life Cycle Analysis
3.5. Investment Feasibility Matrix
3.6. PESTLE and Porter’s Analysis
3.7. Regulatory Landscape
3.7.1. By Key Regions
3.7.2. By Key Countries
3.8. Regional Parent Market Outlook
4. Global Market Analysis 2017 to 2021 and Forecast, 2022 to 2032
4.1. Historical Market Size Value (US$ million) Analysis, 2017 to 2021
4.2. Current and Future Market Size Value (US$ million) Projections, 2022 to 2032
4.2.1. Y-o-Y Growth Trend Analysis
4.2.2. Absolute $ Opportunity Analysis
5. Global Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Product Type
5.1. Introduction / Key Findings
5.2. Historical Market Size Value (US$ million) Analysis By Product Type, 2017 to 2021
5.3. Current and Future Market Size Value (US$ million) Analysis and Forecast By Product Type, 2022 to 2032
5.3.1. Medical Device
5.3.1.1. Extractable & Leachable
5.3.1.2. Material Characterization
5.3.1.3. Physical
5.3.1.4. Bioburden
5.3.1.5. Sterility
5.3.1.6. Other Medical Devices
5.3.2. Pharmaceutical
5.3.2.1. Bioanalytical
5.3.2.2. Method Development & Validation
5.3.2.3. Stability
5.3.2.4. Other Services
5.4. Y-o-Y Growth Trend Analysis By Product Type, 2017 to 2021
5.5. Absolute $ Opportunity Analysis By Product Type, 2022 to 2032
6. Global Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Region
6.1. Introduction
6.2. Historical Market Size Value (US$ million) Analysis By Region, 2017 to 2021
6.3. Current Market Size Value (US$ million) Analysis and Forecast By Region, 2022 to 2032
6.3.1. North America
6.3.2. Latin America
6.3.3. Europe
6.3.4. Asia Pacific
6.3.5. Middle East and Africa
6.4. Market Attractiveness Analysis By Region
7. North America Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Country
7.1. Historical Market Size Value (US$ million) Trend Analysis By Market Taxonomy, 2017 to 2021
7.2. Market Size Value (US$ million) Forecast By Market Taxonomy, 2022 to 2032
7.2.1. By Country
7.2.1.1. The USA
7.2.1.2. Canada
7.2.2. By Product Type
7.3. Market Attractiveness Analysis
7.3.1. By Country
7.3.2. By Product Type
7.4. Key Takeaways
8. Latin America Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Country
8.1. Historical Market Size Value (US$ million) Trend Analysis By Market Taxonomy, 2017 to 2021
8.2. Market Size Value (US$ million) Forecast By Market Taxonomy, 2022 to 2032
8.2.1. By Country
8.2.1.1. Brazil
8.2.1.2. Mexico
8.2.1.3. Rest of Latin America
8.2.2. By Product Type
8.3. Market Attractiveness Analysis
8.3.1. By Country
8.3.2. By Product Type
8.4. Key Takeaways
9. Europe Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Country
9.1. Historical Market Size Value (US$ million) Trend Analysis By Market Taxonomy, 2017 to 2021
9.2. Market Size Value (US$ million) Forecast By Market Taxonomy, 2022 to 2032
9.2.1. By Country
9.2.1.1. Germany
9.2.1.2. The United Kingdom
9.2.1.3. France
9.2.1.4. Spain
9.2.1.5. Italy
9.2.1.6. Russia
9.2.1.7. Rest of Europe
9.2.2. By Product Type
9.3. Market Attractiveness Analysis
9.3.1. By Country
9.3.2. By Product Type
9.4. Key Takeaways
10. Asia Pacific Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Country
10.1. Historical Market Size Value (US$ million) Trend Analysis By Market Taxonomy, 2017 to 2021
10.2. Market Size Value (US$ million) Forecast By Market Taxonomy, 2022 to 2032
10.2.1. By Country
10.2.1.1. China
10.2.1.2. Japan
10.2.1.3. India
10.2.1.4. South Korea
10.2.1.5. Australia
10.2.1.6. Rest of APAC
10.2.2. By Product Type
10.3. Market Attractiveness Analysis
10.3.1. By Country
10.3.2. By Product Type
10.4. Key Takeaways
11. Middle East and Africa Market Analysis 2017 to 2021 and Forecast 2022 to 2032, By Country
11.1. Historical Market Size Value (US$ million) Trend Analysis By Market Taxonomy, 2017 to 2021
11.2. Market Size Value (US$ million) Forecast By Market Taxonomy, 2022 to 2032
11.2.1. By Country
11.2.1.1. South Africa
11.2.1.2. Saudi Arabia
11.2.1.3. UAE
11.2.1.4. Israel
11.2.1.5. Rest of Middle East and Africa (MEA)
11.2.2. By Product Type
11.3. Market Attractiveness Analysis
11.3.1. By Country
11.3.2. By Product Type
11.4. Key Takeaways
12. Key Countries Market Analysis
12.1. The USA
12.1.1. Pricing Analysis
12.1.2. Market Share Analysis, 2021
12.1.2.1. By Product Type
12.2. Canada
12.2.1. Pricing Analysis
12.2.2. Market Share Analysis, 2021
12.2.2.1. By Product Type
12.3. Brazil
12.3.1. Pricing Analysis
12.3.2. Market Share Analysis, 2021
12.3.2.1. By Product Type
12.4. Mexico
12.4.1. Pricing Analysis
12.4.2. Market Share Analysis, 2021
12.4.2.1. By Product Type
12.5. Germany
12.5.1. Pricing Analysis
12.5.2. Market Share Analysis, 2021
12.5.2.1. By Product Type
12.6. The United Kingdom
12.6.1. Pricing Analysis
12.6.2. Market Share Analysis, 2021
12.6.2.1. By Product Type
12.7. France
12.7.1. Pricing Analysis
12.7.2. Market Share Analysis, 2021
12.7.2.1. By Product Type
12.8. Spain
12.8.1. Pricing Analysis
12.8.2. Market Share Analysis, 2021
12.8.2.1. By Product Type
12.9. Italy
12.9.1. Pricing Analysis
12.9.2. Market Share Analysis, 2021
12.9.2.1. By Product Type
12.10. Russia
12.10.1. Pricing Analysis
12.10.2. Market Share Analysis, 2021
12.10.2.1. By Product Type
12.11. China
12.11.1. Pricing Analysis
12.11.2. Market Share Analysis, 2021
12.11.2.1. By Product Type
12.12. Japan
12.12.1. Pricing Analysis
12.12.2. Market Share Analysis, 2021
12.12.2.1. By Product Type
12.13. India
12.13.1. Pricing Analysis
12.13.2. Market Share Analysis, 2021
12.13.2.1. By Product Type
12.14. South Korea
12.14.1. Pricing Analysis
12.14.2. Market Share Analysis, 2021
12.14.2.1. By Product Type
12.15. Australia
12.15.1. Pricing Analysis
12.15.2. Market Share Analysis, 2021
12.15.2.1. By Product Type
12.16. South Africa
12.16.1. Pricing Analysis
12.16.2. Market Share Analysis, 2021
12.16.2.1. By Product Type
12.17. Saudi Arabia
12.17.1. Pricing Analysis
12.17.2. Market Share Analysis, 2021
12.17.2.1. By Product Type
12.18. UAE
12.18.1. Pricing Analysis
12.18.2. Market Share Analysis, 2021
12.18.2.1. By Product Type
12.19. Israel
12.19.1. Pricing Analysis
12.19.2. Market Share Analysis, 2021
12.19.2.1. By Product Type
13. Market Structure Analysis
13.1. Competition Dashboard
13.2. Competition Benchmarking
13.3. Market Share Analysis of Top Players
13.3.1. By Regional
13.3.2. By Product Type
14. Competition Analysis
14.1. Competition Deep Dive
14.1.1. Pharmaceutical Product Development
14.1.1.1. Overview
14.1.1.2. Product Portfolio
14.1.1.3. Profitability by Market Segments
14.1.1.4. Sales Footprint
14.1.1.5. Strategy Overview
14.1.1.5.1. Marketing Strategy
14.1.2. ICON plc
14.1.2.1. Overview
14.1.2.2. Product Portfolio
14.1.2.3. Profitability by Market Segments
14.1.2.4. Sales Footprint
14.1.2.5. Strategy Overview
14.1.2.5.1. Marketing Strategy
14.1.3. LabCorp
14.1.3.1. Overview
14.1.3.2. Product Portfolio
14.1.3.3. Profitability by Market Segments
14.1.3.4. Sales Footprint
14.1.3.5. Strategy Overview
14.1.3.5.1. Marketing Strategy
14.1.4. Charles River Laboratories International Inc.
14.1.4.1. Overview
14.1.4.2. Product Portfolio
14.1.4.3. Profitability by Market Segments
14.1.4.4. Sales Footprint
14.1.4.5. Strategy Overview
14.1.4.5.1. Marketing Strategy
14.1.5. Syneos Health
14.1.5.1. Overview
14.1.5.2. Product Portfolio
14.1.5.3. Profitability by Market Segments
14.1.5.4. Sales Footprint
14.1.5.5. Strategy Overview
14.1.5.5.1. Marketing Strategy
14.1.6. SGS SA
14.1.6.1. Overview
14.1.6.2. Product Portfolio
14.1.6.3. Profitability by Market Segments
14.1.6.4. Sales Footprint
14.1.6.5. Strategy Overview
14.1.6.5.1. Marketing Strategy
14.1.7. Toxikon, Inc.
14.1.7.1. Overview
14.1.7.2. Product Portfolio
14.1.7.3. Profitability by Market Segments
14.1.7.4. Sales Footprint
14.1.7.5. Strategy Overview
14.1.7.5.1. Marketing Strategy
14.1.8. Intertek Group
14.1.8.1. Overview
14.1.8.2. Product Portfolio
14.1.8.3. Profitability by Market Segments
14.1.8.4. Sales Footprint
14.1.8.5. Strategy Overview
14.1.8.5.1. Marketing Strategy
14.1.9. Pace Analytical Services, LLC
14.1.9.1. Overview
14.1.9.2. Product Portfolio
14.1.9.3. Profitability by Market Segments
14.1.9.4. Sales Footprint
14.1.9.5. Strategy Overview
14.1.9.5.1. Marketing Strategy
14.1.10. Eurofins Scientific
14.1.10.1. Overview
14.1.10.2. Product Portfolio
14.1.10.3. Profitability by Market Segments
14.1.10.4. Sales Footprint
14.1.10.5. Strategy Overview
14.1.10.5.1. Marketing Strategy
15. Assumptions & Acronyms Used
16. Research Methodology
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Healthcare Analytical Testing Services Market
