Clinical Trial Biorespository Archiving Solutions Market

Market Overview

The global clinical trial biorespository archiving solutions market size was valued at USD 3.58 billion in 2022. It is estimated to reach USD 6.99 billion by 2031, growing at a CAGR of 7.7% during the forecast period (2023–2031). The rise in medical imaging technology advancements and global adoption due to pharmaceutical companies' increased drug discovery rates is boosting demand for clinical trial biorepository and archiving solutions services and driving market growth over the forecast period.

Solutions for storing, managing, and preserving biological samples and related data gathered during clinical trials are called clinical trial biorespository archiving solutions. These solutions guarantee the samples and data's accuracy, traceability, and durability for the next investigations and analyses. Biological specimens from patients in clinical trials, such as blood, tissue, urine, or genetic material, are frequently collected. Future research, such as biomarker analysis, genetic sequencing, and other molecular investigations, may benefit from the information found in these samples. A framework for properly managing, monitoring, and preserving these samples both during and after the clinical trial is provided by biorespository archiving solutions.

Market Dynamics

Global Clinical Trial Biorespository Archiving Solutions Market Drivers

Growing Number of Pharmaceutical and Biotechnology Companies

The growth of biotechnology and pharmaceutical firms pressures producers to offer the best treatments and medicines. Since these businesses are concentrating on developing novel drugs, this is increasing the number of clinical studies and fostering market expansion. Additionally, the rise in medical imaging technology advancements and global adoption due to pharmaceutical companies' increased drug discovery rates is boosting demand for clinical trial biorepository and archiving solutions services and driving market growth over the forecast period.

Growing Disease Variation and Prevalence

The growing prevalence of chronic diseases and increasing incidence of new diseases are expected to boost the clinical trial biorepository and archiving solutions market. The global population has varied disease profiles, and emerging countries have the most diverse ones. This is expected to promote clinical trials of new or rare diseases, which otherwise would not have found any sponsors. More patients suffering from a specific disease would stimulate biopharmaceutical companies to invest more in clinical trials for a disease segment. A diverse population would also mean easy recruitment of patients and a faster clinical trial process. Rare diseases are given the status of “Orphan disease” in the U.S., and biopharmaceutical companies that sponsor clinical trials for orphan drugs receive incentives for the process. This trend will positively impact clinical trials for rare diseases, boosting the demand for clinical trial biorepository and archiving solutions.

Global Clinical Trial Biorespository Archiving Solutions Market Restraint

Regulations in New Drug Development

Major obstacles preventing biopharmaceuticals from investing in the development of new treatments are the complicated laws that govern the clinical trial process, from applying a dossier to approving new products. Biopharmaceutical companies submit applications to various nations to approve a particular medicine. In regions like the EU, businesses must submit individual applications in many nations, which is exceedingly time-consuming and deters businesses from investing in RandD. Most medications in preclinical studies never reach the end of a clinical trial, which deters biopharmaceutical companies from making significant investments. The global market for clinical trial biorepository and archiving solutions is anticipated to benefit from EU laws that streamline drug development and approval.

Global Clinical Trial Biorespository Archiving Solutions Market Opportunities

Precision Medicine and Personalized Therapies

The move towards precision medicine necessitates thorough molecular profiling and genetic analysis, including customized therapies based on specific patient features. Researchers can use biorepository archiving systems to preserve biological samples and their accompanying data. This paves the way for retrospective studies and the discovery of biomarkers for customized treatments. Precision medicine uses patient features to tailor treatments. Molecular profiling and genetic analysis help find biomarkers and understand illness causes. Biorepository archiving systems preserve biological samples and data for examination. These technologies keep clinical trial and patient care samples intact and viable. These archiving systems enable retrospective analyses using preserved samples and data.

Retrospective studies use historical samples and data to find illness or treatment response biomarkers or genetic signatures. These investigations can inform patient stratification, treatment selection, and tailored therapies. Researchers can study and evaluate biomarkers for individualized treatment using biorepository archiving systems. Biorepository archiving systems also allow researchers and organizations to share data. These systems centralize sample and data storage and management, giving researchers access to a wide range of samples to improve statistical power and generalizability. Biorepository archiving systems preserve biological samples and data in precision medicine research, enabling retrospective analyses, biomarker identification, and patient-specific medicines.

Regional Analysis

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

North America Dominates the Global Market

North America is the most significant C global clinical trial biorespository archiving solutions market shareholder and is estimated to exhibit a CAGR of 6.7% over the forecast period. This is a significant factor in the region's market growth for clinical trial biorepository and archiving solutions. The dominance of this region in the clinical trial biorepository and archiving solutions market is mostly due to the growth in clinical trials and participants in this market, as well as the accessibility of cutting-edge technologies. The majority of the clinical studies that are carried out in this area are undertaken in nations like the United States and Canada. The language barrier is diminished in this area because English is commonly spoken.

Therefore, it is desirable to conduct clinical studies in North America. The majority of CROs and biopharmaceutical businesses are situated here. The need for efficient clinical trial biorepository and archiving solutions in the area is rising due to technological improvements. Therefore, during the forecast period, this region is anticipated to have significant expansion in the clinical trial biorepository and archiving systems market.

Europe is anticipated to exhibit a CAGR of 6% over the forecast period. More clinical trials are being conducted in this area, and prominent companies here provide clinical trial biorepository and archiving solutions. For instance, to satisfy the increased demand for clinical trial sample preservation and research, Avantor opened a new biorepository facility in Europe in November 2020. Additionally, emerging economies like Eastern Europe are anticipated to rise quickly in this market because of quicker processes and greater cost-effectiveness. Over the projection period, Western Europe is anticipated to be one of the key markets for clinical trial biorepository and archiving solutions. Due to advantages including cost-effectiveness and ease of access to a broad patient group for recruiting, Eastern Europe is also predicted to experience significant expansion.

Asia-Pacific has emerged as one of the fastest-growing regions in the global market. The market for clinical trial biorepository and archiving solutions is anticipated to expand in the region due to the enormous growth in clinical research. Low patient costs in Asia Pacific nations and the availability of a diversified patient population that is simple to recruit are the main drivers of the growth of clinical research in these regions. In a Pharma IQ study, 60.0% of participants said that China and India might host clinical research in five years.

In addition, the expansion of the clinical trial biorepository and archiving solutions market in the Asia-Pacific area is demonstrated by the entry of Almac Group, a multinational clinical research and manufacturing organization. Almac Group announced opening a new clinical trial supply facility and regional headquarters in 2015 to better serve its clients in Asia, home to 23.0% of the world's new biopharmaceutical product clinical trials. Clinical trial biorepository and archiving solutions providers' entry into this region is mostly driven by the relocation of clinical trial sites from Western regions like Europe and North America to the Asia Pacific. The market for clinical trial biorepository and archiving solutions in the region is likely to expand due to the trend, which is expected to continue.

In Latin America, Clinical research is growing in other rising countries partly because it is more affordable, there are regulatory bodies for it, it is simple to enroll patients, and the region has developing economies, which increases research capability. More than 20 nations make up Latin America, offering a sizable volunteer pool for drug trials. In addition, the prevalence of lifestyle-related illnesses like obesity, cardiovascular disease, and diabetes is rising along with urbanization. As a result, Latin America is starting to exhibit a comparable disease pattern to that of the United States and Europe. Therefore, it is anticipated that there will be more clinical trials, which will fuel the market for clinical trial biorepository and archiving solutions.

In the Middle East and Africa, due to the rising demand for high-quality healthcare, a diverse population, and the simplicity of patient recruitment. The Middle East and Africa are emerging areas for conducting clinical trials. Additionally, this area offers logistic advantages because European pharmaceutical firms are closer to African countries than Latin American regions. For American businesses, regions of Africa would be more economically advantageous than Asia for finding patients and delivering clinical supplies. More than 12,000 trials are underway in African and Middle Eastern nations, with Kenya, Jordan, Uganda, Israel, and Egypt leading. The regional market for clinical trial biorepository and archiving solutions is forecast to increase due to the trend, which is predicted to continue and draw competitors.

Segmental Analysis

The global clinical trial biorespository archiving solutions market is bifurcated into service and phase.

Based on the service, the global clinical trial biorespository archiving solutions market is bifurcated into Biorepository Services and Archiving Solution Services. 

The Biorepository Services segment dominates the global market and is projected to exhibit a CAGR of 8.2% over the forecast period. Sample collection, processing, storage, distribution, and other associated services are the major components of biorepository services. It is anticipated that strict laws governing sample custody and ownership, human tissues and informed consent, and access to biospecimens will enhance data protection and patient privacy. These laws include the Health Insurance Portability and Accountability Act (HIPAA), Right to Withdraw, European Union General Data Protection Regulation, and others. Sample collection, processing, storage, distribution, and other associated services are the major components of biorepository services. It is anticipated that strict regulations governing sample custody and ownership, human tissues and informed consent, and access to biospecimens will enhance data protection and patient privacy. These regulations include HIPAA, the Right to Withdraw, and the European Union General Data Protection Regulation.

The strong product pipelines of pharmaceutical and biopharmaceutical businesses are projected to accelerate segment expansion further. Early in 2020, Novartis had three clinical studies and almost seven molecules in phase II for various immunology, hepatology, and dermatology illnesses. For treating atopic dermatitis, Crohn's disease, COVID-19, and other disorders, Eli Lilly and Company had roughly four molecules in phase II and III trials and almost five molecules in phase I clinical trials. Additionally, it is projected that the COVID-19 pandemic will encourage only research and development (R&D) operations in vaccine and antiviral medicines. It will also boost the number of clinical trials conducted internationally to commercialize a successful treatment candidate, favorably affecting market growth.

Based on phase, the global clinical trial biorespository archiving solutions market is bifurcated into Phase I, Phase II, Phase III, and Phase IV. 

The phase III segment owns the highest market share and is predicted to exhibit a CAGR of 7.7% over the forecast period. Three thousand people with a condition that the new medicine intends to treat typically participate in this phase. Since there are some dangers and difficulties, this trial phase must be completed over several years. Additionally, researchers must confirm that the drug is at least as reliable and secure as currently available therapies. Additionally, because of the larger sample size and longer length, this phase is more likely to have long-term and uncommon side effects. Because phase III trials include storing various samples and specimens for long-term research, clinical trial biorepository and archiving solutions services are mostly needed for these trials. As a result, this market sector is anticipated to increase significantly over the coming years.

The global clinical trial biorespository archiving solutions market is bifurcated into Preclinical and Clinical Products based on product. 

The clinical product segment owns the highest market share and is predicted to exhibit a CAGR of 7.9% over the forecast period. This can be linked to a rise in the registration of clinical trials during the previous few years. ClinicalTrials.gov reports that as of August 2021, about 386,583 trials have been registered in 219 countries, up from around 362,524 in 2020 and roughly 325,787 in 2019. The number of compounds in Phase I increased by around 7.2% from 2018 to 2019, while the number of molecules in Phase II increased by 9.2%, according to the Pharma RandD Annual Review 2019 Report, which helped fuel segment growth. Due to the necessity of finding and commercializing effective treatments and vaccinations, it is also projected that the COVID-19 pandemic will increase clinical trials globally.

Recent Developments

• January 2022- The biorepository of South Carolina State University (SCSU), in association with the MUSC Hollings Cancer Center. The expanded biorepository project seeks to enhance cancer treatment in underprivileged areas.