Healthcare Analytical Testing Services

TABLE OF CONTENT:
• Industry Overview
• Industry Growth over the years
• Market Segmentation Data(By type, By region, By end user)
• Financials
• Major Players(Global & Regional)
• Impact of Covid
• Future Industry Projections
• Expert Opinions
• Opportunities and Limitations
• Latest News
• Sources
 Industry Overview
• Medical research and development activities across the
globe is gaining speed and biopharmaceutical,
pharmaceutical, and medical device manufacturers use
these service in order to support the ongoing development
activities.
The service provides and expensive support from drug
discovery through clinical development or clinical trials to
commercial use.
 Market Growth
• High investment in drug discovery by the government and
major players and increasing number of drugs in
biopharmaceutical pipeline are major factors expected to
drive the growth of global healthcare analytical testing
services market. In addition, increasing number of clinical
trials along with outsourcing of analytical testing by
pharmaceutical companies is on rise this is another
important factor expected to augment the growth of target
market.
Major players approach towards enhancing the business
presence and increase the customer base through merger and
acquisition activities is another factor expected to further
support the growth of target market.
However, factors such as lack of skilled labor workforce and
lack of technologically advanced medical device and equipments
in developing countries are expected to hamper the growth of
global healthcare analytical testing services market.
Business development activities by major players through introduction of
innovative solution in order to attract new customer and enhance the revenue
share is the key trend observed in the target market. In 2020, Laboratory
Corporation a clinical laboratory company that offers clinical laboratory tests used
by the medical profession in routine testing, and other patient diagnosis launched
preclinical, clinical, and post-approval cell, and gene therapy development
solutions. This is expected to help the company to enhance the product portfolio
and increase the customer base.
 Market segmentation
by type

• Bioanalytical Testing Services

• Cell-Based Assay Services
• Virology Testing Services
• Immunogenicity & Neutralizing Antibody Testing Services
• Biomarker Testing Services
• Pharmacokinetic Testing Services
• Other Bioanalytical Testing Services
Physical Characterization Services
• Laser Particle Size Analysis Services
• Thermal Analysis Services
• Image Analysis Services
• Surface Area Analysis Services
• Other Physical Characterization Services
Method Development & Validation Testing Services
• Extractables & Leachable Method Development & Validation Services
• Process Impurity Method Development & Validation Services
• Stability-Indicating Method Validation Services
• Cleaning Validation Method Development Services
• Analytical Standard Characterization Services
• Technical Consulting Services
• Other Method Validation Services
• Raw Material Testing Services
• Complete Compendial Testing Services
• Heavy Metal Testing Services
• Container Testing Services
• Karl Fischer Analysis Services
• Wet Chemistry Analysis Services
• Other Raw Material Testing Services
• Batch-Release Testing Services
• Dissolution Testing Services
• Elemental Impurity Testing Services
• Disintegration Testing Services
• Hardness Testing Services
• Friability Testing Services
• Other Batch-Release Testing Services
• Stability Testing
• Drug Substance Stability Testing Services
• Formulation Evaluation Stability Testing Services
• Accelerated Stability Testing Services
• Photostability Testing Services
• Comparative Stability Testing Services
• Other Stability Testing Services
• Microbial Testing Services
• Microbial Limit Testing Services
• Sterility Testing Services
• Endotoxin Testing Services
• Preservative Efficacy Testing Services
• Water Testing Services
• Other Microbial Testing Services
• Environmental Monitoring Services
• Air Testing  Services
• Wastewater/ETP Testing Services;
• Other Environmental Monitoring Services
 Market segmentation by region
• North America
• US
• Canada
• Europe
• Germany
• UK
• France
• Italy
• Switzerland
• Rest Of Europe (RoE)
• Asia Pacific (APAC)
• China
• Japan
• India
• South Korea
• Australia
• Rest Of APAC
• Latin America
• Middle East and Africa
 Market by end user
By End User
• Pharmaceutical & Biopharmaceutical Companies
• Medical Device Companies
• Clinical Research Organizations
 Financials
• Recently, the pharmaceutical market worldwide has significantly increased. In
2019, the value of the market was on the order of USD 1.25 trillion, in
comparison to USD 390 billion in 2001 (Figure 1). The manner by which people
obtains and pays for medicine is driven by the pharmaceutical market; however,
pharmaceutical companies are well aware that some markets are better than
others.
• North America is the region with the largest portion of pharmaceutical revenue
(48.9%), and the US is still leading the pharmaceutical market; however, recently,
a group of emerging markets is playing an important role. Emergent economies
such as those of Brazil, India, Russia, Colombia, and Egypt are examples of such
markets. Despite the participation of Latin American countries in the increasing
market, their contribution to global revenue remains insignificant.
• . In contrast, the Chinese pharmaceutical industry has shown the highest growth
rates during recent years. Figure 2 shows the projected global pharmaceutical
sales for 2022 by region . Much of this prediction lies in the fact that the main
pharmaceutical companies that produce drugs are in the regions where the
greatest growth is expected as Figure 3 indicates.
 Major players globally
• Eurofins Scientific (Luxembourg)
• Laboratory Corporation of America Holdings (US)
• SGS S.A. (Switzerland)
• Charles River Laboratories (US)
• WuXi AppTec Co. Ltd. (China)
• PPD, Inc. (US)
• Element Materials Technology (UK)
• Thermo Fisher Scientific (US)
• Pace Analytical Services, LLC. (US)
• Intertek Group LLC. (UK)
• Merck KGaA (Germany)
• Danaher Corporation (US),
• Source BioScience (UK)
• Almac Group (UK)
• ICON plc (Ireland)
• Frontage Laboratories, Inc. (US)
• STERIS plc (US)
• Sartorius AG (Germany)
• ALS Life Science (US)
• Syneos Health (US)
• Medpace Holdings, Inc. (US)
• Cinven (LGC Limited) (UK)
• Anacura (Belgium)
• Impact Analytical (US)
• CD Biosciences (US).
 Chart Title

Medpace Holdings, Inc.

Wuxi Apptec

Parexel International Corp. (2017)

Charles River Laboratories International, Inc.

Icon Public Limited Corp.

PRA Health Sciences, Inc.

Pharmaceutical Product Development, LLC

Syneos Health

IQVIA (QuintilesIMS Holdings)

Laboratory Corp. of America Holdings (incl. Covance)

0 2000 4000 6000 8000 10000 12000 14000

 COVID-19 Impact on the Healthcare analytical testing services
Market
To assess the impact of COVID-19 and provide market forecasts, scenario-based approaches are
considered.

In the optimistic scenario, the COVID-19 pandemic would have a significant positive long-term
impact on the healthcare analytical testing services market. Initially, because of lockdowns and
quarantine measures, the growth of this market was hampered, especially due to delays in
starting new clinical trials and suspended enrolment in most ongoing clinical studies by leading
players in the pharmaceutical industry. However, the overwhelming global demand for COVID-19
testing, treatment, and vaccine development has driven the growth of the healthcare analytical
testing services market due to the simultaneous increase in demand and requirement for
bioanalytical testing, method development, and validation, as well as safety testing of potential
treatments and vaccines.
There has also been a steady rise in investment in the pharmaceutical industry and many
opportunities arising from new technologies and advances concerning the COVID-19 pandemic.
The global health crisis triggered by the COVID-19 pandemic has made it imperative for the
pharmaceutical industry to move rapidly alongside researchers, regulators, and CROs to develop
diagnostics, treatment, and vaccines. Healthcare analytical testing services play an important
role in this scenario to maintain quality, safety, and efficacy.

In a pessimistic scenario, it could be assumed that the COVID-19 pandemic has resulted only in a
temporarily positive impact on the healthcare analytical testing services market. In this scenario,
it may be assumed that there would be a significant reduction in new offerings and customer
outsourcing trends in the post-pandemic period, which could affect the growth of the healthcare
analytical testing service market in the coming years. Moreover, the efficacy of current vaccines
against new variants of the coronavirus is unknown. This could indicate future lockdown and
other virus containment measures that would negatively affect the healthcare analytical testing
services market.

In a realistic scenario, it could be assumed that the effect of COVID-19 on the healthcare
analytical testing services market has been positive and possibly long-term.
In this scenario, the markedly positive impact on the healthcare
analytical testing services market due to COVID-19 related vaccine and
drug development in 2020 and 2021 would subside slowly in the coming
years. Thereafter, the market growth is likely to stabilize and grow
steadily, similar to the pre-pandemic scenario.
 Future Industry Projections
Healthcare Analytics Market size exceeded USD
11.4 billion in 2020 and is poised to grow at a CAGR
of more than 11.4% between 2021 and 2027.
 
Increasing healthcare costs due to growing portfolio
of healthcare services, sophistication of treatment
coupled with need for reducing expenses and
improving operational efficiencies will drive the
market growth. Also, growing amount of complex
data due to transition from written to electronic
health records and its ability to improve physician
practice will foster the industry demand.
Furthermore, technological advancements along
with increasing interest of investors in healthcare
analytical tools will boost the market expansion.
 Expert opinion
• The panel discussion that followed included three blocks: the potential of AI; risk and
challenges; and recommendations for a CEO.
 
• Asked about what will happen with AI in the next few years, Dr Halamka pointed out the
growing need for care at a distance, which means more algorithms, more chatbots, more
AI-enabled workflow. “There is no question that algorithms will explode in the next few
years,” he noted. Dr Meskó shared this opinion commenting that it was obvious AI did
certain tasks better than physicians, and that patients might actually be the driving force
behind wider AI adoption in healthcare. He remarked, however, that AI would not be
able to provide empathy in a way medical professionals could, or control the whole
process of healthcare. Dr Halamka explained that data would always need curation and
clean-up, “so we won’t see raw data used for AI algorithm development”, and that we
needed “algorithms that augment human behaviour and not replace it”.
• Prompted by another poll, the audience (64%) and the panellists
agreed that there would not be many diagnostic processes that were
not fully supported by AI in the next five to ten years.
 
• Answering a question about who should be in control of a patient’s
health data, over half of the respondents believed it should be
individuals themselves; national governments and hospitals were
voted by about 18% of respondents each.
• Concluding the discussion, the speakers gave their recommendations to a CEO of
a pharma/medtech company. According to Dr Halamka, “doctors will always
need to be human empathetic people providing much more than just probabilistic
and statistical analysis”. However, pharma, providers and payors should
recognise that healthcare in the next five years will be a data business, so their
future is in the curation of large data and the algorithms based on that data.

• Dr Meskó stressed that patients were the biggest new player in the healthcare
field, hence any CEO or decision-maker should embrace the concept of patient
design. “Nobody should think that they are able to create services, technologies,
medications, protocols, or treatments for patients without involving those patients
at the highest level,” he said.
 Opportunities and Limitations
• Driver: Increasing outsourcing of analytical testing by pharmaceutical
companies and medical device companies
• Outsourcing analytical testing helps pharmaceutical companies mitigate risks by
avoiding large investments in purchasing analytical equipment and maintaining
manpower, especially when development efforts are in the early stages. The
availability of specialized analytical testing service providers with key capabilities to
provide optimum results rapidly has led to increasing consideration among
pharmaceutical companies to outsource testing services to third-party service
providers.
• Medical device testing is also increasingly being outsourced by companies due to
challenges faced by manufacturers to bring these devices to the market. There is a
rising requirement to streamline medical device testing, ease internal resources and
ensure necessary expertise and process credibility. This has led to productive
partnerships between medical device manufacturers and healthcare analytical testing
services companies, especially in the face of a changing regulatory landscape and
disruptions caused by the current pandemic scenario.
• Restraint: Shortage of skilled professionals
• Healthcare analytical testing service providers face challenges in attracting
and retaining highly skilled professionals. These companies compete with
pharmaceutical, biotechnology, medical device, contract research
companies, and academic and research institutions for qualified and
experienced scientists. To compete effectively, companies are required to
offer higher compensation and other benefits, which may affect the
financial condition and results of operations, especially for small-scale
analytical testing providers.
• Another factor responsible for the dearth of skilled professionals in this
field is the growth of the pharma industry towards novel molecular
constructs and modes of action. This requires that staff be continually
trained, with healthcare analytical testing companies working together with
pharmaceutical companies and CROs to develop suitable industry training
programs.
 Recent Developments:
• In August 2021, WuXi AppTec (China) acquired a drug product manufacturing
facility in Couvet, Switzerland, from Bristol Myers Squibb.
• In June 2021, WuXi AppTec (China) announced that WuXi STA would open a new
pharmaceutical manufacturing campus in Delaware, US.
• In April 2021, SGS S.A. (Switzerland) acquired SYNLABS Analytics & Services
(Germany) to strengthen SGS’ presence in Northwestern Europe, especially in
Germany, Benelux, and the Nordic countries.
• In April 2021, Charles River Laboratories (US) acquired Retrogenix Ltd. (UK),
which provides air sampling and quality and offers cell microarray services, to
boost its early-stage contract research organization offerings.
• In May 2020, The Covance Drug Development business of Laboratory Corporation
of America Holdings (US) expanded its technology ecosystem to accelerate the
adoption of decentralized clinical trials.
 Sources

• www.gminsights.com
• healthmanagement.org
• www.marketsandmarkets.com
• www.mordorintelligence.com
• www.genomind.com
• www.sgsgroup.in
• https://www.foresightmarketresearch.com/healthcare-analytical-testi
ng-services-market