Global Contract Research Organization (CRO) Market

The Global Contract Research Organization (CRO) Market is poised to grow at a CAGR of 7.4% to reach a Market Size of USD 63,160 million by 2026 from a value of USD 44,214 million in 2021. The Market is driven by factors such as Increasing investment in pharmaceutical R&D to drive the CROs services market, Government aids and Adoption of CROs Services to Accelerate Early Phase Drug Development.

Definition / Scope
Market Overview
Market Risks
Market Drivers
Market Restraints
Industry Challenges
Technology Trends
Regulatory Trends
Post COVID-19 Recovery
Market Size and Forecast
Market Outlook
Technology Roadmap
Competitive Landscape
Competitive Factors
Key Market Players
Strategic Conclusion
References
Appendix

Definition / Scope

Contract Research Organizations (CROs) are organizations that facilitate the outsourcing of research and development services for a variety of industries, including biotechnology, pharmaceuticals, medical device industries, universities, government institutions, and foundations. Contract research organizations are experiencing a surge in demand, fueled by advancements in clinical development programme and the global demand for innovative pharmaceutical products.

Pharmaceutical product research and development can take up to 15 years. Pharmaceutical companies prefer to outsource preclinical and other drug development phases to CROs in order to save money on R&D and shorten the time it takes to market a product. Furthermore, a high failure rate of clinical trials is expected to fuel the demand for CROs by pharmaceutical and biopharmaceutical vendors looking to outsource their R&D.

The contract research organization market is divided into four sections: service type, therapeutic area, end user, and geography. Clinical research services (phase I clinical research services, phase II clinical research services, phase III clinical research services, and phase IV clinical research services), early-phase development services, laboratory services, and consulting services are the market’s service types. Oncology, infectious diseases, central nervous system (CNS) disorders, immunological disorders, cardiovascular diseases, respiratory disorders, diabetes, and other therapeutic areas comprise the market. The market is divided into three end users: pharmaceutical and biopharmaceutical companies, medical device companies, and academic institutes. The market is divided into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America.

Market Overview

The Contract Research Organization Market was worth over USD 44,214 million in 2020, and it is predicted to be worth USD 63,160 million by 2026, with a CAGR of 7.4% over the forecast period.

Due to ongoing clinical trials on the verge of finding efficient treatments and vaccines against the SARS-CoV2 virus, the COVID-19 pandemic is projected to have a substantial impact on the contract research organization industry. ICON PLC, for example, announced in January 2021 that it had partnered with Pfizer Inc. and BioNTech to provide clinical trial services for Pfizer and BioNTech’s investigational COVID-19 vaccine programme. ICON assisted in the recruitment of 44,000 participants for clinical trial studies in over 153 sites across Europe, South Africa, the United States, and Latin America as part of this programme. ICON also provided site training, document management, and operational support for patient informed consent form review. ICON also supported with clinical supply management services and organized eConsent in most countries. IQVIA and AstraZeneca also collaborated in July 2020 as part of the US Government’s Operation Warp Speed Project, which is focused on the development, manufacture, and distribution of COVID-19 vaccines, treatments, and diagnostics. As a result of the increasing focus on COVID-19 vaccine development, clinical trials have intensified, which is likely to strengthen the contract research organization market during the COVID-19 pandemic phase.

Pharmaceutical, biotechnology, and medical device companies rely on contract research groups for assistance. Growing R&D spending, greater outsourcing of R&D activities, and an increase in the number of clinical trials are all contributing to market expansion. In view of the financial pressures that pharmaceutical businesses are under from all sides, efficiency is seen as the most crucial component. Patent expirations, which result in generic competition, as well as regulatory demands, continue to have an impact on pharmaceutical businesses’ bottom lines.

According to the Pharmaceutical Research and Manufacturers of America (PhRMA), the biopharmaceutical business in the United States spent USD 102 billion on research and development in 2018. In addition, PhRMA members spent about USD 83 billion on research and development in 2019. Furthermore, according to PhRMA, 2020, biopharmaceutical companies have more than 260 vaccines in the pipeline for various diseases, including COVID-19. According to an article released by the UK Parliament, overall R&D expenditure in 2021 was EUR 37.1 billion, or EUR 558 per person, or 1.7 percent of GDP in the United Kingdom in 2018. As a result, there is a significant investment in R&D efforts, as well as a pipeline of treatments in development. Outsourcing services are predicted to grow, propelling the contract research organization market forward throughout the forecast period.

The expanding trend of collaborations, as well as the growing range of services supplied by CROs, are driving market expansion. PPD Inc., for example, announced its expansion in October 2020 with the opening of a new multipurpose clinical research laboratory in Suzhou, China, which will provide bioanalytical, biomarker, and vaccine services for clinical trials at all stages of pharmaceutical development. As a result of the aforementioned factors, the market under consideration is predicted to increase significantly over the forecast period.

Market Risks

The Prime Risk in the Global Contract Research Organization (CRO) Market is

Fragmented Market

The Global CRO is largely fragmented, with a number of conglomerates and medium-sized and small start-up companies accounting for the majority of global market share. Lower entry barriers, a lack of economies of scale, and fierce market competition are all factors contributing to the Global CRO Market’s fragmentation. Businesses with lower margins and higher costs will benefit from a fragmented market. When interacting with other countries, they also lack the benefit of size.

Top Market Opportunities

The Top Opportunities in the Global Contract Research Organization (CRO) Market are

Growth in the drugs and biologics market

Despite the ongoing Covid-19 pandemic in 2020, the pharmaceutical sector had its second-best year in terms of medicine approvals by the US Food and Drug Administration. This year, 53 medications were approved, a record only surpassed in 2018 with 59 pharmacological agents. In 2020, the FDA will approve 53 novel chemical entities and 13 biologics, including 10 monoclonal antibodies, two antibody–drug conjugates, three peptides, and two oligonucleotides. In the last three years (2018–2020), the FDA has approved 160 medications, compared to only 21 pharmaceuticals in 2010. This increase in the number of approved drugs worldwide can be ascribed to biopharmaceutical companies’ increasing spending in the development of biologics and biosimilars.

Significant Opportunities from Emerging Economies

Cancer cases are increasing in the Asia-Pacific and Latin American areas, according to the International Agency for Research on Cancer (IARC) and the Global Cancer Observatory (GLOBOCAN). According to data, China had the most cancer cases in Asia in 2018, with 4,285,033 new cases, followed by India and Japan with 1,157,294 and 883,395 new cases, respectively. In China, the number of new cases is predicted to climb to 5,696,125, with 1,554,849 in India and 978,296 in Japan. From 1,412,732 new cases in 2018, the number of cases in Latin America and the Caribbean is anticipated to climb to 1,979,072 in 2030. As a result of this rise in population, these areas now have a huge opportunity to provide data to oncology clinical trials, genetic testing equipment, and other cutting-edge oncology medications.

In addition, greater public and private financing for R&D, as well as increased government initiatives, are supporting the pharmaceutical industry’s expansion in these countries.

The Australian government allocated $1.3 billion on health and medical research in the 2018-19 budget. $248 million was been up in this budget for research on uncommon cancers, rare diseases, and clinical trial programme, which aided the region’s pharmaceutical industry’s expansion.

The Innovate in India (i3) programme was launched in June 2017 by the Indian government in conjunction with the World Bank to solve difficulties connected to the development and design of biopharmaceutical treatments. The programme began with a $250 million investment, with approximately $70 million going toward the development of biosimilars.

Therefore, due to these initiatives and increasing incidences of chronic illnesses such as cancer, this region offers high growth opportunities for the CROs market.

Greater Number of Partnership Agreements

CROs have long sought to expand their role beyond that of a fee-for-service provider by forming strategic collaborations with pharmaceutical corporations. The advantages of such an agreement include increased team cohesion, collaboration on laboratory research, and sharing best practices. Increased industry investment in biosimilars is creating a climate that will substantially benefit from such collaborations. These partnerships will allow the companies to benefit from each other’s innovation in order to improve biosimilar medication development. Partnerships haven’t ended at the pharmaceutical level, either, as the largest laboratory players in the US have recently aligned themselves strategically with top CROs through M&A and JV initiatives.

Rising focus on specialty medicines

The growing focus on specialty pharmaceuticals, together with technology advancements such as artificial intelligence, IoT, and big data for clinical research, is likely to propel the global contract research organization (CRO) services market during the forecast period.

Market Drivers

The Major Factors driving the growth of the Global Contract Research Organization (CRO) Market are

Increasing investment in pharmaceutical R&D to drive the CROs services market

The majority of pharmaceutical, biopharmaceutical, and medical device businesses continue to put significant resources into developing new medications and technologies. The pharmaceutical business, in particular, is heavily invested in research and development. Pharmaceutical firms engage in research and development in order to bring high-quality, innovative goods to market. The trend implies that major pharma companies are enhancing their R&D efficiencies by investing heavily in R&D in the long run to see a return on their investment, as well as through collaborating on R&D. According to a survey published by EvaluatePharma, global pharmaceutical R&D spending was valued at USD 136 billion in 2012, rising to USD 256 billion in 2021.

Government aids

Government support for biopharmaceutical manufacturing research and development is favorably influencing the growth of the contract research organization (CRO) market during the next five years. In addition, the high expense of in-house medication research is stifling expansion. Contract research organizations (CROs) are research-based businesses that help the pharmaceutical and biotechnology sectors conduct research and clinical trials.

Furthermore, these organizations assist government agencies, foundations, and universities with their research.

Adoption of CROs Services to Accelerate Early Phase Drug Development

Inefficiencies in operations and processes are mostly due to a lack of horizontal integration in the contract research organization (CRO) services sector. Additionally, this has segregated drug development processes, encouraging the development of integrated CRO services models. The increasing use of integrated models in the pharmaceutical industry has helped to increase efficiency and shorten the make-test cycle. While the horizontal integration strategy provided considerable benefits and savings throughout the drug development phase, it was adopted more slowly in the United States than in European countries such as the United Kingdom.

Due to a variety of factors, including improved efficiency, streamlined management of R&D costs, low risk of repeat studies, accelerated drug development, and lower operational costs, the demand for CRO services for early phase drug development and clinical research is expected to grow in the coming decade. Integrated contract organization services are expected to simplify the supply chain and efficient management of clinical data, in addition to providing financial benefits.

Market Restraints

The Major Factors Restraining the growth of the Global Contract Research Organization are

Stringent And Differing Regulations

The CRO market’s growth was hampered by severe and inconsistent pharmaceutical industry laws across countries. Clinical trials and other research activities are outsourced to multiple nations at the same time. Different guidelines and regulatory processes apply to medications, registration, and clinical trials in these target countries, which might pose problems and operate as a market constraint. Pharmaceutical companies face a hurdle when conducting multi-location trials of a same medicine in different procedures in different nations since they must follow a completely separate protocol in each region. This is regarded as one of the most significant hurdles for research outsourcing in several nations, and as a result, a corporation wants to limit outsourcing to a single destination country. On a worldwide scale, this limits the market for research outsourcing. Clinical studies, regulatory applications, and drug approval in India and China, for example, differ. India and China are the two most popular research outsourcing destinations, enticing pharmaceutical corporations to outsource research to any of them.

High Quality Standards

To be eligible to conduct studies, CROs must meet a number of conditions. First and foremost, they must adhere to global standard operating procedures (SOPs) and conduct systems audits to ensure that all employees are following them. All trial staff should be trained in Good Clinical Practice (GCP), as well as local rules and other recommendations.

The ultimate responsibility for the quality and integrity of the trial data always rests with the sponsor, according to GCP rules. CROs must, however, meet quality assurance and quality control criteria because their reputation and client satisfaction are dependent on their capacity to obtain regulatory approval for their products.

Industry Challenges

The Primary Factors Challenging the growth of the Global Contract Research Organization (CRO) Market are

Dearth of skilled professionals

CROs confront issues in attracting and maintaining highly competent experts, as they compete for qualified and experienced scientists with pharmaceutical, biotechnology, and medical device businesses, as well as academic and research institutions. Companies must give higher compensations and other incentives to compete effectively; this may have an impact on players’ finances and operational outcomes, particularly small-scale analytical testing providers. This scarcity of qualified personnel may stymie the adoption of new technology and procedures, as well as the market for CRO services in the coming years.

Data Security

Healthcare businesses are responsible for 19 percent of global data leaks, according to 2018 research. CROs, on the other hand, take data security very seriously because their sponsors care a lot about keeping their information secret. While security breaches result in data leaks, R&D operations are hampered, and faith in the organization is eroded.

CROs create their own set of dependable tools to assure data protection. Web-based document management systems with access control and electronic signatures, clinical trial management systems (CTMS), electronic data capture (EDC), and other similar systems are typical examples.

Technology Trends

Technology Trends in the Global Contract Research Organization (CRO) Market are

New methods of Drug Development

One of the greatest scientific achievements in human history may be the invention of many safe and efficient Covid-19 vaccines in less than a year. The process was accelerated not only by regulatory expediting, but also by advancements in the way medical trials are conducted: virtual clinical trials, which were largely conducted online, made participation easier. They could pave the way for a bright future in drug research if they are combined with a spirit of collaboration rather than competition among pharmaceutical corporations.

With the Covid-19 epidemic, some of the eased regulatory procedures around medication development will vanish, but creative techniques to testing and collaboration may persist. Several pharmaceutical behemoths, like Gilead, Novartis, and WuXi AppTec, have already started working together to develop novel antiviral medications and share preliminary results. The FDA has issued virtual trial guidelines, ushering in a new era in the development and testing of new pharmaceuticals.

Data-driven healthcare

According to Bain, a consulting firm, the healthcare big data market is estimated to reach about $70 billion by 2025. As the collection of health data becomes more common, so does its application, and its potential for enhancing treatment options and patient outcomes soars. The most significant impediment has been a lack of interoperability: data from one healthcare institution is difficult to transfer to (and analyses by) another. Covid-19 emphasized the issue even more.

When Google Cloud announced its healthcare interoperability preparation programme in November 2020, interoperability took a big stride forward. It gives programme members access to data templates, app blueprints, security tools, and implementation guidelines in order to help payers, providers, and other organizations prepare for the federal government’s interoperability standards. If healthcare organizations can be on the same page, the industry’s big data potential might become dynamic very rapidly.

Regulatory Trends

Regulatory Trends in the Global Contract Research Organization (CRO) Market are

Regulation in the USA

The Food and Drug Administration (FDA) is the regulatory authority that oversees clinical trials of medical products in the United States, as defined by the FDCAct, 21CFR50, and 21CFR312 (US). In line with the FDCAct, 21CFR50, and 21CFR312, the FDA’s role in examining and authorizing investigational new drug applications (INDs) to conduct clinical trials in people utilizing investigational drugs or biological products is covered in this profile. The Pre2018-ComRule and RevComRule, which are implemented by the Department of Health and Human Services (HHS) in subpart A of 45CFR46, are also looked at.

Regulation in Europe

EUCROF is the regulatory body governing the regulation of Contract Research Organizations (CRO) in Europe. The aims and objectives of EUCROF were defined as follows:

Promote high-quality clinical research in Europe in general and the European Union in particular;
Form a legal body to represent CROs’ interests in the EU, such as when dealing with regulatory bodies, the pharmaceutical-biotechnology business, and the medical research community;
Encourage national member associations and the above-mentioned bodies to have a tight relationship and mutual understanding;
Encourage the flow of information among member organizations;
Develop clinical research training and educational programme, and help national member associations in establishing and guaranteeing the quality of these programme;
Health workers should be informed about new breakthroughs in clinical research.
Organize international gatherings and conferences.

Regulation in China

The National Medical Products Administration (NMPA) (the Chinese name translates as “State Drug Administration”) is the regulatory authority responsible for national drug registration management, which includes clinical trial regulation, according to the DRR, the NMPA-Org, the DAL, the RegImplemDAL, the RegImplemDAL-Amndt, the SC-Opinions-No44, the NMPA-No50-2018, and the NMPA-No230-2015.

According to the DRR, the NMPA’s Center for Drug Evaluation (CDE) is in charge of evaluating drug clinical trial applications, drug marketing authorisation applications, additional applications, and applications for overseas drug production registration. In accordance with the DAL, the VaccineLaw, the DRR, the SC-Opinions-No44, the NMPA-No50-2018, and the NMPA-No230-2015, the NMPA grants approval for clinical trials to be undertaken in China. The drug category in which an applicant chooses to register determines the clinical trial application review and approval or filing process.

Regulation in India

The Drugs Controller General of India (DCGI), who heads the Central Drugs Standard Control Organization (CDSCO), is responsible for reviewing and approving clinical trial applications for all new drugs, investigational new drugs (INDs), and imported drugs to be registered in India, according to the 2019-CTRules and the Hdbk-ClinTrial.

Additionally, according to the 2019-CTRules, the G-ICMR, and IND-31, a clinical trial application must be approved by the DCGI and a DCGI-registered ethics committee (EC) prior to the sponsor initiating the trial, with the exception of non-regulatory academic/research clinical trials, which only require EC approval. For further information on non-regulatory academic/research clinical needs, see the Ethics Committee item, Scope of Review subtopic.

Post COVID-19 Recovery

COVID-19 is a newly identified novel coronavirus that causes an infectious sickness. COVID-19, which was largely unknown before the outbreak in Wuhan, China, in December 2019, has evolved from a regional issue to a global pandemic. The COVID-19 pandemic has put a strain on healthcare systems all around the world. According to the World Health Organization, there have been 177,108,695 confirmed cases of COVID-19, with 3,840,223 deaths (as of June 18, 2021). The Americas had the highest number of deaths, followed by Europe and Southeast Asia.

With the World Health Organization (WHO) calling the COVID-19 outbreak a pandemic, a number of prominent pharmaceutical and biopharmaceutical businesses have ramped up R&D and production efforts to create and sell SARS-CoV-2 viral diagnostic kits, vaccines, and treatments. Many pharmaceutical and biotechnology businesses have partnered with CROs through long-term agreements, partnerships, and collaborations all over the world to speed up the R&D process.

CROs have also built COVID-19 research-specific services. There have been a number of new service launches in 2020, as well as agreements, partnerships, and collaborations with other pharmaceutical firms and academic institutes for the research and development of COVID-19 vaccines, treatments, and diagnostics all over the world. For example, Parexel’s Biotech division announced a strategic collaboration with Synairgen Ltd (UK) in October 2020 to conduct a major phase III research of an interferon beta (IFN-beta) medication for COVID-19 patients.

Market Size and Forecast

The Contract Research Organization Market was worth over USD 44,214 million in 2020, and it is predicted to be worth USD 63,160 million by 2026, with a CAGR of 7.4% over the forecast period.

The COVID-19 pandemic has had a major influence on the CRO industry. The international search for a coronavirus vaccine has had a major impact on the development of various vaccines and medications. COVID-19 vaccines and therapies accounted for 30% of all trials in the United States at the height of the epidemic. As a result, other trials were postponed.

The CRO market is slowly rebounding thanks to a hybrid strategy. Contract research businesses are assisting sponsors and sites with the start-up of clinical studies. Virtual clinical trials are already supported by strong tools developed by market players. They are prepared to assist sponsors in quickly transitioning to this new environment and utilizing the available resources.

By type, the clinical research services segment accounted for the largest share

Early-phase services, clinical research services, laboratory services, consultancy services, and data management services are the types of CRO services available. In the year 2021, clinical research services dominated the market. The rapid development of the elderly population, the following rise in the prevalence of chronic diseases, and the rising demand for novel pharmaceuticals can all be attributable to this segment’s substantial share.

By therapeutic area, oncology segment accounted for the largest share

Oncology, infectious diseases, neurology, cardiovascular system (CVS) disorders, metabolic disorders/endocrinology, immunological disorders, respiratory disorders, psychiatry, dermatology, hematology, ophthalmology, gastrointestinal diseases, genitourinary & women’s health, and other therapeutic areas make up the global CRO services market. The largest section of the CRO services market is oncology, which may be ascribed to the increasing incidence of cancer and a pipeline of late-stage medications.

By molecule type, cell and gene therapy segment is projected to register the highest CAGR

The global CRO services market is divided into three categories: vaccines, cell and gene therapy, and other compounds. Due to potential medicines in the pipeline and increased R&D expenditure in regenerative medicine, the cell and gene therapy segment is predicted to grow at the fastest rate throughout the projection period.

By end user, the pharmaceutical & biopharmaceutical companies segment accounted for the largest share

The global CRO services market is divided into three segments based on end users: pharmaceutical and biopharmaceutical firms, medical device businesses, and academic institutes. Pharmaceutical and biopharmaceutical firms led the market in 2020, owing to pharmaceutical companies’ increased outsourcing of early-phase development services, as well as clinical and laboratory testing services.

North America accounted for the largest share of the contract research organization (CRO) services market

North America, followed by Europe, accounted for the highest proportion of the contract research organization (CRO) services market in 2020. The presence of a well-established foundation of pharmaceutical and biopharmaceutical businesses, as well as substantial investments in the biosimilars and biologics segment, can be ascribed to the North American regional segment’s large share.

Market Outlook

The Contract Research Organization Market was worth approximately USD 44,214 million in 2020, and it is expected to be over USD 63,160 million by 2026, with a CAGR of 7.4%.

The pandemic of COVID-19 has had a significant impact on the CRO business. The worldwide hunt for a coronavirus vaccine has influenced the development of a variety of vaccinations and treatments. At the peak of the outbreak, COVID-19 vaccines and therapeutics accounted for 30% of all trials in the United States. As a result, further trials have been rescheduled.

Thanks to a hybrid strategy, the CRO market is steadily recovering. Sponsors and sites are aided in the start-up of clinical studies by contract research firms. Strong tools developed by market players already assist virtual clinical trials. They’re ready to help sponsors make a smooth transition to this new environment and make the most of the available tools.

Because it includes four elaborate phases, involving human subjects, the clinical sector dominated the market by type in 2020, with a revenue share of almost 75.0 percent.

Clinical monitoring had the highest revenue share of over 20.0 percent in 2020, based on service. This is due to an increase in the number of clinical trials and the need to monitor those trials, which is driving up demand for services.

Due to the presence of multiple worldwide firms who invest a significant portion of their sales in research activities, North America had the second-largest revenue in 2020.

Asia Pacific is likely to grow at the quickest rate throughout the forecast period due to cheaper costs than the United States and other developed countries.

China, Japan, and India are likely to increase rapidly in the next years due to the high prevalence of diseases.

Distribution Chain Analysis

The Supply Chain of the Global Contract Research Organization (CRO) Market is as in the below image

Competitive Landscape

The market for contract research organizations is fiercely competitive, with a slew of companies. However, only a few key businesses control a significant portion of the market globally. With a number of local and niche businesses, the remaining market share is highly fragmented. The contract research organization market is led by IQVIA, ICON PLC, Charles River Laboratories, Envigo, and PPD Inc.

The market’s big participants have amassed a massive amount of data, which they are using to gain a competitive advantage. In order to establish a presence in the global market, the big firms have formed strategic partnerships. PPD Inc., for example, partnered with LUPUS Therapeutics in September 2020 to extend and improve lupus clinical research for PPD’s pharmaceuticals and biotech firms.

Key Market Developments

In April 2021, IQVIA acquired Q2 Solutions, a clinical laboratory services organization, from Quest Diagnostics.

In November 2020, WuXi Apptec expanded its Cell & Gene Therapy Platforms with capabilities to provide high-quality and cost-effective supplies of R&D and GMP Plasmids

In April 2020, IQVIA launched COVID-19 trial matching service to accelerate treatment and vaccine development against the COVID-19 pandemic in U.S. The company launched comprehensive online screener and trial matching tool for all COVID-19 trials in the US.

Competitive Factors

Leading players focus on launch of new products, expansion and diversification of market presence, and acquisition of new customer base for tapping the prevailing business opportunities. For Instance,

In June 2021, Charles River Laboratories completed the acquisition of Vigene Biosciences for US$ 292.5 million in cash. The acquisition of Vigene Biosciences’ extensive gene therapy capabilities further enhances Charles River’s position as a premier scientific partner for cell and gene therapies.

Key Market Players

Some of the Prime Players in the Global Contract Research Organization (CRO) Market are

IQVIA Holdings Inc. is a life sciences company that provides advanced analytics, technology solutions, and clinical research services. Technology & Analytics Solutions, Research & Development Solutions, and Contract Sales & Medical Solutions are the company’s segments. Life science clients rely on Technology & Analytics Solutions for critical information, technology solutions, and real-world insights and services. Research & Development Solutions is a research and development firm that primarily serves biopharmaceutical clients. It also offers clinical research and clinical trial services. Contract Sales & Medical Solutions sells contract to biopharmaceutical clients as well as the broader healthcare market.

Charles River Laboratories International, Inc. is a full-service contract research organization that specializes in early-stage research. The company provides products and services to pharmaceutical and biotechnology companies, government agencies, and academic institutions to aid in drug development and research. The business is divided into two divisions: Discovery and Safety Assessment (DSA) and Manufacturing Solutions (Manufacturing). The DSA segment includes services needed to move a drug through the early development process, such as discovery services, which are non-regulated services that help clients identify, screen, and select a lead compound for drug development, and regulated and non-regulated (Good Laboratory Practice (GLP) and non-GLP) safety assessment services.

WuXi AppTec Co., Ltd. is a China-based investment holding company primarily engaged in new drug R&D, production, and supporting services, as well as related technology platform services. The Company’s primary activities are the discovery, development, and production of small molecule drugs, cell therapies, and gene therapies, as well as the provision of medical device testing services. The Company primarily operates in four segments: China-based Laboratory Services, Contract Manufacturing Organization/contract Development and Manufacturing Organization Services (CMO/CDMO services), US-based Laboratory Services, and Clinical Research.

Syneos Health, Inc. provides biopharmaceutical solutions. Customers in the pharmaceutical, biotechnology, and healthcare industries can rely on the company for a variety of clinical and commercial services. It provides stand-alone and integrated biopharmaceutical product development solutions ranging from early phase (Phase I) clinical trials to full commercialization of biopharmaceutical products. Clinical Solutions and Commercial Solutions are the two business segments of the company. To assist customers with their drug development process, the Clinical Solutions segment provides a range of services spanning Phases I to IV of clinical development, including full service global studies as well as individual service offerings such as clinical monitoring, investigator recruitment, data management, and study startup.

ICON Public Limited Company conducts clinical research (CRO). The company provides outsourced services to pharmaceutical, biotechnology, medical device, government, and public health organisations. The company specialises in the strategic development, management, and analysis of clinical development programmes ranging from compound selection to Phase I-IV clinical trials. Clinical trial management, biometric activities, consulting, imaging, contract staffing, informatics, and laboratory services are among its offerings. Throughout the trial, it performs various laboratory tests on the patient’s blood, urine, and other bodily fluids. Clinical development services provided by the company include investigator recruitment, patient registries, outcomes research, clinical data management, immunoassay development, and others.

Strategic Conclusion

The CRO industry is still in its early stages. There are only a few customers and a few companies selling the service. However, the market is expected to expand in tandem with the number of CRO consumers.

Our analysts predict that the CRO market is transitioning from a low-revenue market to a high-revenue market, and that many enterprises will notice changes in the industry. The rapid revenue growth is expected to drive the establishment of new CROs. As this trend continues, the market is expected to become more fragmented, with numerous CROs competing for market share.

References

Appendix

CROs – contract Research Organizations
CNS – Central Nervous System
PhRMA – Pharmaceutical Research and Manufacturers of America
IARC – International Agency for Research on Cancer
GLOBOCAN – Global Cancer Observatory
CTMS – Clinical Trial Management Systems
EDC – Electronic Data Capture
FDA – Food & Drug Administration
DCGI – Drugs Controller General of India
CDSCO – Central Drugs Standard Control Organization