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Clinical Trials Market – By Phase (Phase I, Phase II, Phase III, and Phase IV), By Indication (Oncology, Autoimmune/Inflammation Diabetes, Central Nervous System, Cardiovascular, Ophthalmology, Infectious Disease, Pain Management, and Others), By Application (vaccines, Small Molecules, Cell & Gene Therapy, and Other Applications), By Study Design (Interventional, Expanded Access, and Observational), By Sponsor Outlook (Pharmaceutical & Biopharmaceutical Companies, Medical Device Companies, and Others), By Region, And Segment Forecasts, 2022 – 2027

Global Clinical Trials Market Size (2022-2027)

As per our research report, the global clinical trials market size is valued at USD 39.7 billion in 2021 and is projected to reach USD 52.7 billion by 2027. This market is anticipated to witness a CAGR of 5.06% from 2022 to 2027. The rising prevalence of rare diseases, growing demand for specialized testing, the surge in demand for outsourcing clinical trials to CROs,growing adoption of artificial intelligence-based tools in drug discovery, rising government funding for clinical trials, and increasing R&D expenditureare some factors majorly driving the growth of the market.

Industry Overview:

Clinical trials are large-scale research studies that evaluate novel tests & treatments to analyze their effects on human health outcomes. Individuals participate in clinical trials voluntarily for testing medical interventions including drugs, biological products, and medical devices. The clinical trials are conducted in four different phases and need to be approved before their initiation. People of different ages can participate in clinical trials.

The increasing prevalence of chronic diseases combined with the growing demand for clinical trials in developing nations is fuellingthe market growth. Additionally, the market is driven by the rising number of biologics and the demand for CROs to conduct clinical trials. Currently, many pharmaceutical and biotechnology companies are initiating clinical trials for severe infectious and chronicdiseases to boost market expansion. The high demand for decentralized clinical trial services during the COVID-19 pandemic fuelledthe market. High investments in pharmaceutical research and development work have significantlyincreased the number of clinical trials in the past few years. The market is anticipated to grow robustly, owing to the ongoing advancements in healthcare and patented new chemical entities (NCE) indicated for several health conditions. Several government initiatives have encouraged the small, medium, and large players to enter drug development.

COVID-19 pandemic impact on the global Clinical Trials Market

The COVID-19 outbreak severely affected the execution of clinical trials globally. The major challenge in clinical trials is that they usually deal with vulnerable populations with a higher risk of exposure to coronavirus such as the geriatric population or patients with pre-existing conditions. The coronavirus pandemic has pushed research labs and healthcare institutions to accelerate the clinical trials for COVID-19 vaccines. In addition, several clinical trials were postponed or suspended amidst operational complications inflicted owing to COVID-19 imposed restrictions.Regulatory agencies, including the U.S. FDA, the National Institutes of Health (NIH), the European Medicines Agency (EMA), and China’s National Medical Products Administration, issued varied guidelines for conducting clinical trials supporting the implementation of virtual services during the COVID-19 pandemic. The pandemic led to the fast-track conducting of clinical trials. The WHO launched an international clinical trial, “Solidarity”, to develop multiple candidate vaccines for effective treatment against COVID-19. In March 2020, the FDA introduced a Coronavirus Treatment Acceleration Program (CTAP) for possible therapies to speed up the development of treatment against the coronavirus. High investments in manufacturing capabilities to achieve the required production of COVID-19 drugs/vaccines have worked as a catalyst clinical trials market. Strategic partnerships and collaborations between pharmaceutical companies with academic institutes have helped in combating the COVID-19 across the globe. As per the National Institute of Health data, clinical research funding by the NIH was approximately USD 17.6 billion in 2020, compared to USD 15 billion in 2019. The increasing number of clinical trials and R&D budgets of the pharmaceutical companies are set to supplement the market growth further.

MARKET DRIVERS:

The surge in demand for outsourcing clinical trials to CROs is likely to spur the clinical trials' market value

The demand for efficient, trustworthy, and fast-paced clinical trial programs is anticipated to expand with the growing demand for novel medications and advanced medical technologies. Also, the medication development process with much lower approval rates and expansive expenses is dangerous for biotechnology and pharmaceutical businesses. Outsourcing the clinical trials program to various contract research organizations (CROs) saves the pharmaceutical businesses a substantial amount of time and money. Thus, the rise in the demand for outsourcing clinical trials is fuelling the growth of the clinical trials market.

The rising prevalence of rare diseases and growing demand for specialized testing is driving the growth of the clinical trials market

Increased focus on manufacturing drugs for rare diseases by pharmaceutical companies is anticipated to drive the clinical trials market growth in the forthcoming years. This can be attributed to the technological advancements to enhance the genetic identification of rare disorders. In addition, incentives and initiatives around the world toward the development of drugs for rare disorder therapeutics are positively influencing the market growth. In 2020, FDA approved over 30 novel drugs and biologics. Whereas, the Center for Drug Evaluation and Research (CDER) approved nearly 80% of the novel orphan designated products. Increasing approvals of orphan drugs havespurred the clinical trial service providers to expand their portfolio, thereby driving the clinical trials market growth.

Growing adoption of artificial intelligence-based tools and predictive analysis for drug discovery is likely to fuel the market growth

The emergence of artificial intelligence (AI) has made the drug discovery process efficient and has improved the success rates of drug development substantially. AI algorithms help in the analysis of data in huge amounts to further facilitate the identification of potential drug candidates in lesser time. In addition, deep learning systems are being utilized to generate drug candidates that show no adverse effects upon administration. The integration of AI inthe drug discovery process is likely to propel market growth.

MARKET RESTRAINTS:

The high cost of clinical trials is a major challenge in the clinical trials market 

The clinical trial services are costly with high labor costs which can be a restricting factor for the market growth. Patenting and contracting are complicated processes in the clinical trials market. The high cost of clinical trials raises the industry’s overall operating costs and can reduce the demand in a few markets. This can hamper the development of new medicines and can negatively affect academia, pharmaceutical companies, as well as consumers. Drug companies are investing more in recruitment for clinical trials. The challenge of discovering new products has prompted some companies to develop treatments for chronic conditions and clinical trials for such drugs are often complex and expensive. 

Stringent regulatory framework and language barriers can slow down the growth of clinical trials and market progression

Conducting clinical trials in different countries comes with regulatory challenges that can affect market growth. The restrictions can be streamlined with the cooperation of different regulatory authorities, however, currently, there is a sluggish operating speed. For instance, the Institutional Review Board approval, regulatory framework, import authorization, and contract negotiations are processed all together in some countries while others process these separately. Additionally, many nations demand local language translation, presentation of data on local patients, and import and export licensing. As a result, a complex regulatory structure along with a considerable language barrier can lower regional growth.

This research report on the global Clinical Trials Market has been segmented and sub-segmented based on phase, indication, application, study design, sponsor outlook, and region.

Clinical Trials Market – By Phase

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

Based on the type of Phase, the Clinical Trials Market is categorized into Phase I, Phase II, Phase III, and Phase IV. The Phase III segment held the largest revenue share contributing to 53.4% of the global market in 2021. This can be attributed to the large-scale testing and rising demand to evaluate the new treatment with existing treatment. Also, Phase III clinical trials focus on demonstrating and confirming the preliminary evidence gathered in the previous trials that the drug is safe. Phase III clinical trials ascertain if the new drug or combination of drugs is equivalent to the standard of care. Phase III clinical trials aim to obtain statistical evidence related to drug safety and efficacy accelerating the approval process.

Clinical Trials Market – By Indication

  • Oncology
  • Autoimmune/Inflammation
  • Diabetes
  • Central Nervous System
  • Cardiovascular
  • Ophthalmology
  • Infectious Disease
  • Pain Management
  • Others

Based on Indication, the Clinical Trials Market is segmented into Oncology, Autoimmune/Inflammation Diabetes, Central Nervous System, Cardiovascular, Ophthalmology, Infectious Disease, Pain Management, and Others. The Oncology segment accounted for a significant revenue share of 23.5% in 2021 owing to the rising incidence of cancer which accelerates the new drug development and clinical trial process for disease treatment. As per the American Cancer Society, more than half of the total healthcare spending in the country is allocated to cancer which necessitates the development of more advanced treatments. Robust funding for the development of novel medicines for cancer and a rise in the number of oncology CRO services are likely to accelerate the market growth.

The Autoimmune/Inflammation segment accounted for a significant revenue share owing to a large number of interventional studies on autoimmune/inflammation across the globe. Interventional studies minimize the effects of confounding, which helps avoid bias in allocation to exposure groups and efficient detection of clinically important effects. There are more than 7,000 interventional studies listed on clinicaltrails.gov associated with autoimmune/inflammation.

The Cardiovascular segment is also likely to witness lucrative growth over the forecast period. This is due to the rising prevalence and strong demand for cost-effective pharmaceuticals around the world, as well as significant investment in R&D in this area.The major part of the drugs in the pipeline are indicated for lipid disorders, vascular diseases, heart failure, and stroke.

Clinical Trials Market – By Application

  • Vaccine
  • Small Molecules
  • Cell & Gene Therapy
  • Other Applications

Based on Application, the Clinical Trials Market is segmented into vaccines, Small Molecules, Cell & Gene Therapy, and Other Applications. The Vaccine segment is anticipated to register the highest growth during the forecast period. The COVID-19 outbreak has augmented the considerable increase in the number of clinical trials registered in the last two years. About 1000 new trials have been registered against COVID-19 which has compelled clinical research service providers with vaccine expertise to spread their service portfolio and help in combating issues faced by vaccine enrolment goals.

Clinical Trials Market – By Study Design

  • Interventional
  • Expanded Access
  • Observational

Based on Study Design, the Clinical Trials Market is segmented into Interventional, Expanded Access, and Observational. The Interventional design segment accounted for the largest revenue share with 45.7% in the global clinical trials market in 2021. Interventional studies are one of the most prominent methods in clinical trials and account for the largest percentage of all investigations, medicines, biologics, clinical procedures, behavioral, and other studies. These studies account for 94.0% of the total studies that posted results, in which drug or biologics contribute the most, followed by behavioral, clinical procedure intervention studies.

Clinical Trials Market – By Sponsor Outlook

  • Pharmaceutical & Biopharmaceutical Companies
  • Medical Device Companies
  • Others

Based on Sponsor Outlook, the Clinical Trials Market is segmented into Pharmaceutical & Biopharmaceutical Companies, Medical Device Companies, and Others.The Pharmaceutical & Biopharmaceutical Companies registered the largest market share with 70.0% in 2021. This can be attributed to the increasing number of clinical trials funded by pharmaceutical & biopharmaceutical companies for the development of new drugs and the growing interest of the pharmaceutical industry in the research field. Although most of the basic research in academic laboratories is funded by grants from the National Institutes of Health (NIH), it is largely the pharmaceutical & biopharmaceutical industry that bears the cost of identifying new molecular entities and testing on animalsand human subjects. Currently, in the United States, nearly75% of the funding for clinical studies is granted by corporate sponsors.

Clinical TrialsMarket - By Region:

  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World

Geographically, the North American Clinical Trials Market accounted for the largest revenue share of 50.7% of the global market in 2021. This is attributed to the increasing focus of pharmaceutical companies on novel drug development for the treatment of various chronic diseases, the growing geriatric population, advanced hospital infrastructure, increase in R&D investments, and a well-defined regulatory system. The US is a global hub for clinical trials, wherein the majority of pharmaceutical development research is conducted. According to the data by ClinicalTrials.gov, as of June 2021, there were a total of 380,943 registered clinical studies globally. One-third of these registered clinical studies, i.e., 123,890, were conducted in the US. The implementation of virtual services in various clinical trial stages by key market players, such as IQVIA and PRA Health Sciences, is further driving the North American market growth.

The Clinical Trials Market in Europe is anticipated to showcase significant growth during the forecast period owing to high R&D spending by the pharmaceutical industry and the increasing prevalence of diseases.

Asia Pacific Clinical Trials Market is anticipated to grow at the fastest CAGR of 6.8% during the forecast period. This is attributed to the increasing prevalence of diseases, availability of a large patient pool, growing focus on developing medicines for rare diseases, and growing government support in the development of the outsourcing hubs. The Asia Pacific’s largest, biotech CRO “Novotech”, witnessed an increase in demand from biotechnology sponsors owing to good quality and quick turnaround. The COVID-19 pandemic fuelled the clinical trials market in APAC. An increasing number of biotechnology firms are preferring the APAC region for conducting COVID-19 trials to leverage a large patient pool and fast-track procedures. Countries like China, Australia, and India often havea low cost to operate clinical trial facilities which is boosting the clinical trials market growth in this region.

The Clinical Trials Market in Latin America, the Middle East, and Africa is anticipated to account for the least share of the global clinical trials market. This can be attributed to less technical facilities, poor economies, lack of scientific knowledge, and fewer clinical trial centers, especially in the African region.  It is anticipated that a majority of the clinical trials in the Middle East & Africa market is held in the Middle East owing to the presence of a well-developed healthcare sector and high healthcare expenditure.  

Major Key Players in the Market

Companies like C.R. Bard, Baxter, Laboratory Corporation of America Holdings, Charles River Laboratories, IQVIA, Eli Lilly and Company, Pharmaceutical Product Development and PRA Health Science, PAREXEL International, ICON plc, Bioclinica, Stryker, Ethicon (Subsidiary of Johnson & Johnson), Medtronic plc, Novo Nordisk. Braun Melsungen AG,  Teleflex Incorporate, and Pfizer are playing a pivotal role in the global Clinical Trials Market.

The Clinical Trials market is highly competitive, and thus, the prominent pharmaceutical companies are focusing on enormous R&D investments, especially in the emerging nations, to gain market growth in the major regions. The growing partnerships between pharmaceutical companies and CROs are likely to impact the market growth. Also, the quick adoption of advanced technology for improved healthcare is a significant factor affecting the competitive landscape. Major players are involved in new product launches, mergers, and acquisitions to expand the product portfolio.

In December 2021, Pfizer Inc. declared the final results from an analysis of 2,246 adults enrolled in its Phase 2/3 EPIC-HR trial of its novel COVID-19 oral antiviral candidate PAXLOVID.In December 2021, Optimus Pharma announced the successful completion of the Phase 3 Clinical Trial for its frontline COVID-19 medication Molnupiravir on 1,218 subjects covering 29 geographical study sites all over India.

Notable happenings in the Global Clinical Trials Market in the recent past:

Acquisition- In March 2021, Charles River Laboratories International, Inc. announced the acquisition of Cognate BioServices, Inc. for approximately  USD 875 million, subject to customary closing adjustments.

Collaboration- In September 2021, IQVIA™ collaborated with HealthCore, Inc., a leading real-world research organization in the US, to advance real-world evidence studies with enhanced quality and efficiency.

Product Launch-In January 2020, Wuxi AppTec announced a fully integrated adeno-associated virus vector suspension platform to advance the development, manufacture, and launch of cell & gene therapy, to expand its service capabilities.

Acquisition- In February 2020, Charles River Laboratories International, Inc. agreed to acquire Citoxlab for USD 510 million. Citoxlab is a CRO specialized in medical device testing, regulated safety assessment services, and non-regulated discovery services.

Acquisition- In February 2020, PAREXEL International announced the acquisition of Model Answers, a consultancy firm. The company is specialized in developing preclinical pharmacokinetic (PK) and pharmacodynamic (PD) models.

Collaboration-In November 2020, Parexel formed a strategic collaboration with Synairgen plc to conduct a Phase III study of an Interferon-beta treatment for COVID-19.

Acquisition- In October 2019, Icon plc announced the acquisition of Symphony Clinical Research to enhance itsoffering in customers' hybrid trial solutions and improve the services in the research centers.

Product Launch-In November 2019, PPD, Inc. launched a site coach where doctors and healthcare centers can receive clinical research at new sites, which provides sufficient training to physicians and other academic institutions for the new clinical researchers.

 

 

Chapter 1. CLINICAL TRIALS MARKET– Scope & Methodology

1.1. Market Segmentation

1.2. Assumptions

1.3. Research Methodology

1.4. Primary Sources

1.5. Secondary Sources

Chapter 2. CLINICAL TRIALS MARKET– Executive Summary

2.1. Market Size & Forecast – (2022 – 2026) ($M/$Bn)

2.2. Key Trends & Insights

2.3. COVID-16 Impact Analysis

      2.3.1. Impact during 2022 - 2026

      2.3.2. Impact on Supply – Demand

Chapter 3. CLINICAL TRIALS MARKET– Competition Scenario

3.1. Market Share Analysis

3.2. Product Benchmarking

3.3. Competitive Strategy & Development Scenario

3.4. Competitive Pricing Analysis

3.5. Supplier - Distributor Analysis

Chapter 4. CLINICAL TRIALS MARKET- Entry Scenario

4.1. Case Studies – Start-up/Thriving Companies

4.2. Regulatory Scenario - By Region

4.3 Customer Analysis

4.4. Porter's Five Force Model

       4.4.1. Bargaining Power of Suppliers

       4.4.2. Bargaining Powers of Customers

       4.4.3. Threat of New Entrants

       4.4.4. Rivalry among Existing Players

       4.4.5. Threat of Substitutes

Chapter 5.CLINICAL TRIALS MARKET- Landscape

5.1. Value Chain Analysis – Key Stakeholders Impact Analysis

5.2. Market Drivers

5.3. Market Restraints/Challenges

5.4. Market Opportunities

Chapter 6. CLINICAL TRIALS MARKET–  By Phase

6.1. Phase I

6.2. Phase II

6.3. Phase III

6.4. Phase IV

Chapter 7. CLINICAL TRIALS MARKET– By Indication

7.1. Oncology

7.2. Autoimmune/Inflammation

7.3. Diabetes

7.4. Central Nervous System

7.5. Cardiovascular

7.6. Ophthalmology

7.7. Infectious Disease

7.8. Pain Management

7.9. Others

Chapter 8. CLINICAL TRIALS MARKET– By Application

8.1. Vaccine

8.2. Small Molecules

8.3. Cell & Gene Therapy

8.4. Other Applications

Chapter 9. CLINICAL TRIALS MARKET– By Study Design

9.1. Interventional

9.2. Expanded Access

9.3. Observational

Chapter 10. CLINICAL TRIALS MARKET– By Sponsor Outlook

10.1. Pharmaceutical & Biopharmaceutical Companies

10.2. Medical Device Companies

10.3. Others

Chapter 11. CLINICAL TRIALS MARKET– By Region

11.1. North America

11.2. Europe

11.3.The Asia Pacific

11.4. Rest of the World

Chapter 12. CLINICAL TRIALS MARKET– Company Profiles – (Overview, Product Portfolio, Financials, Developments)

12.1. C.R. Bard

12.2. Baxter

12.3. Laboratory Corporation of America Holdings

12.4. Charles River Laboratories

12.5. IQVIA

12.6. Eli Lilly and Company

12.7. Pharmaceutical Product Development and PRA Health Science

12.8. PAREXEL International

12.9. ICON plc

12.10. Bioclinica

12.11. Stryker

12.12. Ethicon (Subsidiary of Johnson & Johnson)

12.13. Medtronic plc

12.14. Novo Nordisk

12.15.  Braun Melsungen AG

12.16. Teleflex Incorporate

12.17. Pfizer

 

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