Clinical Trials Market

Market Overview

The global clinical trials market size was valued at USD 49.49 billion in 2022. It is estimated to reach USD 16.77 billion by 2031, growing at a CAGR of 5.2% during the forecast period (2023–2031). Globalization of clinical trials has led to an increase in investment in new product development in emerging nations, thereby positively impacting the overall clinical trials market. 

Clinical trials are investigation studies conducted with human participants to evaluate the safety and success of new medical interventions. These interventions can include drugs, vaccines, medical devices, diagnostic tests, or treatment methods. The primary motive of clinical trials is to gather scientifically rigorous evidence regarding the intervention under investigation. The trials aim to determine whether the new intervention is safe, how well it works, and how it compares to existing treatments or standard care. A clinical trial follows a well-defined protocol or plan that outlines various aspects of the study. This protocol includes the trial's objectives, the study design, participant eligibility criteria, treatment procedures, data collection methods, and statistical analysis. By adhering to this protocol, researchers ensure that the trial is conducted consistently and reliably.

Clinical trials are typically conducted in various phases. In Phase 1, a few healthy participants are enrolled to assess the intervention's safety, dosage, and potential side effects. Phase 2 trials concern a larger group of participants, including patients with the target condition or disease. The main objective of Phase 2 is to gather preliminary data on the intervention's effectiveness and further evaluate its safety. Phase 3 trials involve a larger population and are usually randomized and controlled. They compare the new intervention against the current standard treatment or placebo to determine its overall efficacy, safety, and side effects. Phase 4 trials are conducted after the intervention is approved and available to the public. They aim to monitor its long-term safety, effectiveness in different populations, and any rare or long-term side effects that may emerge over time.

Market Dynamics

Global Market Drivers

Globalization of Clinical Trials

The number of clinical studies in each area is slowly changing from growing nations to emerging countries. The rising cost of clinical trials and difficulty in patient recruitment have led biopharmaceutical companies to shift towards regions like central and Eastern Europe, Asia pacific, Latin America, and the Middle East for cost savings and quick patient recruitment. Emerging countries also possess greater disease variation than the West, where traditional diseases are growing. The greater disease variation among developing countries helps biopharmaceutical companies to perform clinical trials for rare diseases.

Additionally, regions like Asia-Pacific provide greater economic benefits to biopharmaceutical companies as governments in countries like Singapore and China allocate funds to promote biomedical research. Regions like Latin America, where the population speaks only Portuguese and Spanish, also reduce barriers to informed consent, which helps in easy patient recruitment and faster clinical trials. The Middle East is expected to be a potential region for clinical research owing to its increasing population, improved infrastructure, and greater disease variation. Globalization of clinical trials has led to an increase in investment in new product development in emerging nations, thereby positively impacting the overall Clinical trials market.

Shift Toward Personalized Medicine

The paradigm shift towards personalized medicine will positively impact the clinical trial market. The classic clinical trial process is carried out on thousands of people, while personalized medicine focuses only on the effect of drugs on individual patients for a specific period. Due to the traditional clinical trial approach, few medicines in the development phase pass all clinical trial phases. The mentality of “one size will fit all” is a barrier for drugs currently in the pipeline, but we will never see the day.

The use of pharmacogenetics in the clinical trial process is expected to increase the number of drugs passing all phases of the clinical trial process. The shift towards personalized medicine is expected to increase the use of pharmacogenetics in the clinical trial phase, thereby increasing the pipeline of drugs. This trend is expected to instigate biopharmaceutical companies to invest more in the clinical trial phase.

Global Market Restraints

Regulations in New Drug Development

The complex regulation in the clinical trial process, from the dossier application to the approval of new drugs, is a major barrier for biopharmaceuticals to invest in the recent drug development phase. Biopharmaceutical companies file applications in different countries for approval of a specific drug. In regions like the EU, companies file separate applications in different countries, and this process is very tedious and discourages companies from investing in R&D. Majority of the drugs in preclinical studies are not passed through the final stages of a clinical trial, and this discourages biopharmaceutical companies from investing heavily on the clinical trial process. The regulations in the EU are expected to streamline the drug development and approval process, which is a positive sign for the global clinical trials market.

Global Market Opportunities

Expansion of Precision Medicine

The expansion of precision medicine presents a significant opportunity in the global clinical trials market. Precision medicine involves tailoring treatments to individual patients based on their genetic and molecular characteristics. This approach represents a shift from a generalized treatment approach to a more personalized and targeted approach to patient care. Clinical trials plays an important role in advancing precision medicine by identifying biomarkers, validating diagnostic tests, and assessing the effectiveness of targeted therapies.

One key contribution of clinical trials is identifying and validating biomarkers associated with specific diseases or treatment responses. Through careful analysis of patient samples and monitoring of biomarkers throughout the trial, researchers gain insights into disease mechanisms, treatment effectiveness, and patient stratification.

Regional Analysis

North America Dominates the Global Market

Based on region, the global clinical trials market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global clinical trials market shareholder and is estimated to grow at a CAGR of 4.9% over the forecast period. North America dominates global clinical trials, accounting for the largest market share in 2020. This is primarily attributed to several factors, including significant investments in research and development, the presence of global players, and efforts to develop newer patents.

In addition, the region has witnessed substantial R&D investments, contributing to its market leadership. One notable example is the precision medicine initiative announced by President Obama in January 2015. The initiative involved a substantial investment of USD 215 million in the National Institutes of Health (NIH), the National Cancer Institute, and the Food and Drug Administration. The funding was allocated to various areas, such as encouraging volunteer participation, genomic driver identification in cancer, and evaluating Next Generation Sequencing for enhanced patient care.

Europe is anticipated to exhibit a CAGR of 5.7% over the forecast period. Countries like Germany and the U.K. have a large patient pool and advanced medical expertise. The doctors advocate for these trials, thus increasing patient recruitment and benefiting research and patients. The legal aspects are developing in Germany but fully evolved in the U.K. and France. The regulations are formulated to ensure volunteers' safety, rights, and proper reimbursement. With clearer protocols and increased funding, Europe is expected to be a promising region for clinical trials. Factors such as greater access to the treatment-naïve patient pool, a higher concentration of patients near sites, cheap labor costs, and close relationships between doctors and patients drive the clinical research market in Europe.

Asia-Pacific is the fastest-growing market as many developed nations invest in Asia-Pacific regions. In October 2014, the Australian CRO Novotech started a new office in China with its ninth office in Asia. Novotech as a company has expanded in many developing nations owing to the requests of its U.S. and EU clients. In the case of China, Novotech is not the only company. Even Charles River Laboratories, in February 2014, declared China as having disproportionate growth and expressed interest in merging with potential regions.

In Latin America, 80% of the residents live in metropolitan cities. Three megacities, Sao Paulo, Buenos Aires, and Mexico City, have a huge patient pool. Though the regulatory timelines in Latin America are a drawback, the time saved in patient recruitment compensates for it. In addition to patient recruitment, patient retention is very high due to the healthy patient-physician relationship. Lower cost, highly qualified investigators, medical personnel, and study coordinators with GCP-compliant knowledge contribute to a higher clinical trial success rate. Moreover, Mexico and Brazil are expected to witness lucrative growth in the CRO market due to their cost advantage over developed economies such as the U.S. and European nations such as Germany.

Conducting clinical trials in the Middle East and Africa offers advantages such as patient diversity, cost advantage, infrastructure, and world-class medical facilities. The only drawback is discrepancies between the laws of different regions. Many regions are initiating to adapt to the global standards and collaborating with other global CROs to mark their presence. For instance, Hassan Labs of Egypt and Saham Group of North Africa joined hands to provide international medical expertise across Africa. MCT participated in the Partnership in Clinical Trials in April 2014 to reach out to clients and expand in developed countries. Through this, even MCT met sponsors from North America and presented the advantages of conducting trials in MEA.

Segmental Analysis

The global clinical trials market is bifurcated into phase, study design, and indication.

Based on phase, the global market is bifurcated into phase I, phase II, phase III, and phase IV. 

The phase I segment dominates the global market and is projected to exhibit a CAGR of 6.8% over the forecast period. Phase I studies evaluate the safety of a device or drug and the tolerability and pharmacokinetics of molecules. It determines the result of a device or drug on the person, including how it is absorbed, metabolized, and excreted. It also examines the side effects of the drug in case of increased dosage levels. The stage includes 20 to 100 healthy volunteers or people with the disease.

In addition, conducting other studies to assess drug-drug interaction and the effects of food is also necessary in this phase. For patients with clear tolerability studies, oncology studies must be conducted as a primary endpoint. The main aim of phase I is to evaluate doses and their adverse effects, which includes testing about 70% of experimental drugs.

The global market is bifurcated based on study design into interventional, observational, and expanded access. 

The interventional segment dominates the global market and is projected to exhibit a CAGR of 5.5% over the forecast period. The growth can be attributed to many interventional studies being conducted on autoimmune/inflammation across the globe. Over 7,000 interventional studies listed on clinicaltrails.gov related to autoimmune/inflammation. For instance, an interventional study titled Immunoadsorption or Plasma Exchange - What is the Best Treatment Option of Steroid Refractory Neurological Autoimmune Diseases was completed on December 1, 2019.

Based on the study design, the global market is bifurcated into Autoimmune/inflammation, pain management, oncology, CNS conditions, diabetes, obesity, cardiovascular, and others. 

The autoimmune/inflammation segment dominates the global market and is projected to exhibit a CAGR of 5.4% over the forecast period. Autoimmune diseases have increased considerably in the past decade and are expected to rise further owing to the lifestyle and aging population. Due to significant growth in the prevalence of autoimmune diseases, there has been a significant increase in R&D spend on autoimmune diseases. The autoimmune diseases affect one in 15 Americans, including 18 million women and 5 million men. They are among the top 10 causes of death in women and female children in all age groups up to 64 years of age. According to the NIH’s estimate, autoimmune medical care costs approximately USD 100 billion yearly.

Recent Developments

• January 2023- the FDA announced that it would streamline the clinical trial process for certain drugs and biologics. This is expected to make it easier and faster for companies to bring new therapies to market.
• February 2023- the European Medicines Agency (EMA) announced that it would be launching a new initiative to improve the efficiency of clinical trials. This initiative is expected to reduce the time and cost of bringing new therapies to market in Europe.