According to an analysis by Future Market Insights, the global Healthcare Analytical Testing Services Market was valued at around USD 11.9 billion in 2021. With a projected CAGR of 14% for the next ten years, the market is likely to reach a valuation of USD 49.6 billion by the end of 2032.
| 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 |
Future Market Insights’ analysis reveals that most of the Healthcare Analytical Testing Services market revenue is grossed from Pharmaceutical Testing, which has a forecasted CAGR of 13.2% by 2032. The USA is the leading market, with a forecasted market size of USD 19 billion in 2032. The changing regulatory landscape, the need to avoid unfeasible investments, and the need to reduce or eliminate the risk of product recalls to the highest degree possible are major drivers for the Healthcare Analytical Testing Services market.
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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 USD 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.
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 USD 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 USD 2.2 billion by 2032. The Healthcare Analytical Testing Services market in the country is expected to gross an absolute dollar opportunity of USD 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 USD 2.2 billion from 2022 to 2032. The market is projected to reach a valuation of USD 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 USD 987.4 million by 2032. The market in the country is expected to register an absolute dollar opportunity of USD 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 USD 3.1 billion and a forecasted 2032 market size of USD 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 USD 11.9 billion in 2021 and is expected to grow to USD 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 USD 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.
| Estimated Size, 2025 | USD 4,330.8 million |
|---|---|
| Projected Size, 2035 | USD 9,702.0 million |
| Value-based CAGR (2025 to 2035) | 8.4% |
| CAGR (2023 to 2033) | 7.2% |
|---|---|
| Market Size (2023) | USD 52.877 billion |
| Market Size (2033) | USD 105.753 billion |
| Market Size (2023) | USD 4.2 Billion |
|---|---|
| Market Value (2033) | USD 16.2 Billion |
| Value CAGR (2023 to 2033) | 14.5% |
| Market Valuation (2023) | USD 40.9 billion |
|---|---|
| Market Valuation (2033) | USD 62.3 billion |
| Market CAGR (2023 to 2033) | 4.3% |
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