Europe Phase IV Clinical Trials Market Size, Share & COVID-19 Impact Analysis, By Deployment (In-house and Outsource), By Disease Indication (Oncology, Neurology, Cardiology, Infectious Disease, Metabolic Disorder, Renal/Nephrology, and Others), By Type (Interventional and Non-interventional), and Regional Forecast, 2023-2030

The Europe phase IV clinical trials market size was valued at USD 2.58 billion in 2022. The market is projected to grow from USD 2.71 billion in 2023 to USD 3.84 billion by 2030, exhibiting a CAGR of 5.1% during the forecast period.

Clinical trials have a significant role in studying the efficacy and safety of a drug, treatment, or medical device. After the FDA approval of the drug, phase IV clinical studies or post-marketing surveillance for the drug is initiated.

The increasing prevalence of diseases such as cancer, metabolic disorders, cardiovascular, and other diseases has increased the market players' focus on research and developing new effective treatments. The pharmaceutical companies have expanded their emphasis on R&D investment, fueling the market’s growth. For instance, as per the article published by Abbvie Inc. in October 2021, the company invested around USD 50.00 billion since 2013 in developing new medicines to reduce the burden of diseases.

Moreover, the rising number of clinical trials and increasing collaboration of pharma or biotech companies with contract research organizations (CROs) to outsource new drug development has also been fueling the market’s growth.

COVID-19  IMPACT:

Pandemic Fueled Market’s Growth with Increased Demand for Effective Treatment and Prevention of the Virus

After the outbreak of COVID-19, this market experienced significant growth in 2020. The market's growth during the pandemic was attributed to increased clinical trials for developing COVID-19 vaccines. The government also accelerated the development and approval process of COVID-19 vaccines. For instance, according to the EU pharmaceutical legislation, the standard timeline for medicine evaluation is 210 working days; however, for COVID-19 products, this number was reduced to 150 days. The reduced timeline for the development and approval of the COVID-19 products increased the number of clinical trials being registered to develop effective treatments for COVID-19.

Moreover, the market players conducting phase IV clinical trials also experienced significant growth in 2020 due to the increased expenditure on clinical trials. For instance, the Labcorp Drug Development (DD) business segment of Laboratory Corporation of America Holdings generated a revenue of USD 4,877.7 million in 2020, experiencing an increase of 19.8% from the prior year.

Moreover, the market also experienced significant growth in 2021. It was due to the increase in registered phase IV clinical studies. For instance, as per the data published by World Health Organization, in 2021, 854 studies were registered for phase IV clinical trials in Europe, experiencing a growth of 11.2% from the prior year.

LATEST TRENDS

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Emerging Application of Artificial Intelligence (AI) in Designing Clinical Trials Studies

Clinical trials help to assess the safety and efficacy of the drug. However, commercialization of a new drug from R&D to government approvals can take 10-15 years and cost around USD 1.5-2.0 billion. The failure of clinical trials due to poor study design and planning can lead to a loss of money and time. Thus, Artificial intelligence (AI) helps to overcome these challenges and improve clinical trial designs by predicting patient behavior and drug efficacy.

Moreover, machine learning (ML) and deep learning (DL) tools can help analyze large unstructured data sets. Natural language processing (NLP) helps to convert machine language to human-understandable language. Human-machine interfaces (HMIs) can help exchange information between the machine and the researchers.

AI can also help collect, analyze, sort, code, and manage unstructured real-world data (RWD). This makes data management a rapid and dynamic process. In addition, improved electronic data capture (EDC) can reduce human error's impact on data collection and facilitate seamless integration with other databases.

Many AI startups such as Pangea Botanica (London, U.K.), Devs Health (Barcelona, Spain), Cortex Discovery (Munich, Germany), and others have emerged, which are collaborating with pharma companies to assist the process of drug discovery.

Many pharmaceutical companies have also increased their partnership with contract research organizations (CROs) providing Artificial Intelligence (AI) services in order to increase the efficiency of their drug development procedure. For instance, in May 2023, InSilicoTrials and IBSA Group, a manufacturer of reproductive medicine and hyaluronic acid-based products, partnered to enhance drug development using silico medicine.

DRIVING FACTORS

Increasing Number of Clinical Trials being Conducted in the Region Fuels Market Growth

Europe has a strong foundation for biotechnology. The region has several established research institutions, medical centers, and hospitals that provide a solid basis for sourcing and developing scientific and clinical innovations.

• For instance, as per the data published by Germany Trade & Invest, in 2021, Germany had around 774 biotechnological companies. Similarly, as per the data published by CoStar Group, in 2023, around 425 pharmaceutical and biotechnological companies were established in Spain.

Additionally, pharma and biotech companies have increased their focus on R&D for effective treatment due to the increased prevalence of chronic diseases. Their increasing focus on R&D has fueled the number of clinical trials registered in the region.

• For instance, around 208 clinical studies were registered for phase IV trials in Germany in 2021, whereas in 2020, the number of phase IV trials registered in Germany was around 151.


• Similarly, in Spain number of phase IV clinical trials registered was around 119 in 2021, experiencing a growth of 16.7% in the past ten years.

The increasing focus of pharmaceutical and biotechnology companies on effective drug development and the increasing number of phase IV clinical trials conducted in the region has fueled the market growth.

Increasing R&D Expenditure in Healthcare Industry Propels Market Expansion

In Europe, life science companies such as pharmaceutical and biotechnological companies have emphasized R&D expenditure for new drug development.

• For instance, Vertex Pharmaceuticals spent around USD 2,540.3 million in 2022, and Lilly spent around USD 7,190.8 million in 2022 on their R&D.

The investment by biopharmaceutical companies in Europe is significant. According to data published by the European Federation of Pharmaceutical Industries and Association (EFPIA), in 2021, research-based pharmaceutical companies invested around USD 41.01 billion in R&D in Europe in 2020, with an increase of 3.3% from 2019.

For the development and commercialization of new treatments, medical devices, or biopharmaceuticals, the company must conduct clinical trials and get regulatory approvals to evaluate the safety and efficacy of the product. Therefore, the increasing R&D expenditure by the company in the new product development and commercialization has been fueling the Europe phase IV clinical trials market growth.

RESTRAINING FACTORS

Challenges Faced During Clinical Trials Hampers Market Growth

Phase I - III clinical trials and post-regulatory surveillance (phase IV clinical trials) are significant to ensure the safety and efficacy of the product. However, certain factors can act as a challenge during clinical trials.

One of the major challenges faced in conducting phase IV clinical trials is the limited availability of funds. This can be due to an extension in the duration of clinical trials compared to the planned duration.

Moreover, other factors for insufficient funds could be the initiation of the clinical trial with limited funds and the inability of the principal investigator to gather more funds during the ongoing clinical trial.

If the principal investigator cannot gather additional funds, the study is discontinued prematurely.

Moreover, during participant recruitment, the participants are sometimes reluctant to participate in the trial, which is complex and has many protocols. The participants feel burdensome if there are more hospital visits or are required to spend more time at the recruitment site.

Furthermore, if the patients are in the advanced stages of a disease such as cancer, they are mostly weak emotionally and physically. Therefore, they are reluctant to participate in the trials.

Such challenges faced during clinical trial studies negatively impact the market growth.

SEGMENTATION

By Deployment Analysis

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Strong Presence of Biotech and Pharma Companies Dominates the In-house Segment

Based on test type, the market is classified into in-house and outsource. The in-house segment accounted for a significant market share in 2022. Europe has a strong presence of pharmaceutical and biotechnological companies such as Arctoris, CRISPR Therapeutics, and others. The increasing emphasis of these companies in investing in R&D for new treatment development has been fueling the segment’s growth.

The outsource segment is expected to grow fastest during the forecast period. The segment's growth is attributed to the increasing partnership between the pharma or biotech companies and the contract research organization (CRO) for outsourcing new drug development.

• In March 2023, ICON plc partnered with LEO Pharma for the execution of clinical trials to develop new effective medicines for dermatology diseases.

By Disease Indication Analysis

Emphasis on R&D for Effective Treatment Development Leads Oncology Segment

Based on disease indication, the market is segmented into oncology, neurology, cardiology, infectious disease, metabolic disorder, renal/nephrology, and others.

The oncology segment accounted for a significant market share in 2022 due to increased funding for cancer research projects. For instance, according to a  research study published by European Parliament in 2020, approximately 1,400 cancer research projects received a total funding of USD 2,103 million from Horizon 2020. Out of the 1,400 projects, 50 projects supporting childhood cancer received funding for USD 107.3 million.

The metabolic segment is expected to grow substantially during the forecast period. The segment's growth is attributed to the increasing prevalence of metabolic disorders, due to which the market players increased their emphasis on effective drug development.

• For instance, in June 2020, Medtronic received an investment of USD 337.0 million from Blackstone Life Sciences to enhance the R&D in its Diabetes Group.

Moreover, the neurology segment is expected to grow at a significant CAFR during the forecast owing to the increasing prevalence of central nervous system (CNS) disorders, fueling increased demand for effective treatment development.

By Type Analysis

Increasing Number of Interventional Clinical Studies Fuels Segmental Growth in Europe

Based on type, the market is bifurcated into interventional and non-interventional. The interventional segment dominated the market by accounting for a significant market share. The segment's dominance is attributed to the larger number of clinical trials registered in Europe as interventional studies. 

• For instance, as per the data published by World Health Organization (WHO), out of the total 474 registered phase IV clinical trials, 442 were interventional.

The non-interventional segment is expected to grow substantially during the forecast period. The segment's growth is attributed to its application in studying the efficacy and safety of an approved drug during post-commercialization surveillance.

COUNTRY INSIGHTS

Increasing Number of Hospitals in Europe to Drive the Segment’s Growth

U.K. dominated the market in 2022, generating a revenue of USD 0.59 billion. The country’s dominance in the market was due to the strong presence of clinical research networks offering good infrastructure for supporting clinical research in the country.

• For instance, the National Health Service (NHS) is a publicly funded healthcare system in England that helps to conduct clinical trials.

Similarly, the market in Germany is expected to grow at the fastest CAGR during the forecast period. The segment's growth is attributed to the market players increasing focus on conducting clinical trials in the country.

• For instance, as per the World Health Organization (WHO), 128 phase IV clinical trials were registered in Germany in 2022.

Moreover, the market in France is expected to grow significantly during the forecast period owing to the increasing presence of pharmaceutical companies in the country with their emphasis on R&D for new drug development.

KEY INDUSTRY PLAYERS

Increasing Focus of Market Players to Enhance its Service Offerings is Responsible for Company’s Dominance

Market players such as IQVIA Inc., ICON plc, and Syneos Health are one of the major players in the market, accounting for a significant share in 2022. These players' growth is attributed to its increasing focus on R&D to incorporate technological advances for clinical trials and the introduction of new services.

• For instance, in November 2021, IQVIA announced about data aggregation strategy as the foundation to optimize the market insights. It helped the company to harness the right data and services to optimize the patients. This increased the efficiency of the company’s services.

Other market players such as Laboratory Corporation of America Holdings, Parexel International (MA) Corporation, PHASTAR, and others have emphasized mergers and partnerships to enhance their service offerings.

• For instance, in July 2021, Laboratory Corporation of America Holdings announced the expansion of its oncology portfolio by acquiring Omniseq. This acquisition upskilled the company’s offerings.

LIST OF KEY COMPANIES PROFILED:

• IQVIA Inc. (U.S.)


• Parexel International (MA) Corporation (U.S.)


• ICON plc (Ireland)


• Laboratory Corporation of American Holdings (U.S.)


• Charles River Laboratories (U.S.)


• PHASTAR (U.K.)


• PSI (Switzerland)


• Medpace (U.S.)


• Worldwide Clinical Trials (U.S.)


• ProRelix Services LLP (U.S.)


• Sofpromed (Spain)

KEY INDUSTRY DEVELOPMENTS:

• June 2023 - Laboratory Corporation of America Holdings announced the formation of new company Fortrea after the spinning-off of its Labcorp's Clinical Development and Commercialization Services business.


• May 2023 – Worldwide Clinical Trials collaborated with NEXT Oncology in Spain and Pratia Research through its Site Alliance Collaboration. This collaboration expanded the company’s presence in U.S. and Europe region.


• March 2023 – ICON plc partnered with LEO Pharma for the execution of clinical trials to develop new effective medicines for dermatology patients.


• February 2023 – Sofpromed announced the availability of Chordoma trial. It is a phase 2 clinical trial study on effectiveness of the drug palbociclib.


• January 2021 – Phastar acquired S-Cubed ApS, a specialist biometrics and data visualization company. This acquisition not only enhanced the company’s data visualization and analytics solution but also strengthened its position in the Nordic region.

REPORT COVERAGE

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The Europe phase IV clinical trials market report provides a detailed competitive landscape. It also includes key insights, such as top industry developments covering partnerships, mergers, and acquisitions. Additionally, it focuses on key points, such as new solution launches in the market. Furthermore, the report covers regional analysis of different segments, profiles of key market players, market trends, and the impact of COVID-19 on the market. The report consists of quantitative and qualitative insights that have contributed to the market's growth.

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