The global clinical trial equipment ancillary solutions market size was valued at USD 2.69 billion in 2022. It is estimated to reach USD 5.25 billion by 2031, growing at a CAGR of 7.7% during the forecast period (2023–2031). The evolving clinical trial needs and rising investment in R&D promote market growth.
More materials, such as medications, equipment, and auxiliary supplies, are needed for clinical studies as they advance. Ancillary supplies include syringes, surgical knives, swabs, gloves, and any other materials the patient and healthcare provider need to deliver the medication and assess the effectiveness and safety parameters under study. Sourcing equipment and supplementary supplies entail much more than simple purchases for clinical studies. To ensure that the most pertinent tools and supplies are purchased at the ideal moment and at a fair price, it is necessary to have a thorough understanding of the study's design and requirements. It is highly advised to handle the complexity of equipment and accessory supply, restocking, logistics, and expiry management using internal knowledge and outside assistance.
Rapid change is occurring in the clinical trial scene. Due to the development of novel medications, clinical trial methodology has undergone a global shift. The logistics of adopting experimental therapies and the analytical techniques and technologies required to assess their safety and efficacy have also grown more complicated due to the increasing complexity of these medicines.
Additionally, introducing virtual trial models has led to decentralizing clinical trials. Supply chains have gotten more complicated as clinical trials need additional hardware and associated products. The entire trial may be jeopardized if just one supply chain snag or a key component isn't delivered on time. A strong supply chain must be in place to reduce hazards to patients' health, time, and money. This is where providers of supplementary solutions and clinical trial equipment may help. Such market participants offer pharmaceutical companies, clinical research facilities, biotechnology companies, and medical device companies prompt and affordable sourcing, logistics, and services.
Three hundred fifty million people worldwide are affected by the 7,000 known unique, rare diseases, and roughly 80% of these illnesses are brought on by faulty genes. There has been a change from traditional to strategic outsourcing due to the emergence of virtual pharmaceutical and genomics companies and the influx of lead compounds into the development pipeline. Companies are constantly looking for new technologies to invest in, such as combinatorial synthesis, genomics, and proteomics. Innovations are produced due to the rigorous adoption of technological developments in R&D.
Additionally, businesses are spending money on research and development to find novel chemicals and create the next big blockbusters, leading to a large rise in generic producers. Orphan medications have seen an upsurge in R&D spending because they can help businesses lessen the effects of revenue losses from blockbuster drug patent expirations. To address unmet demands and retain profitability, businesses are making significant investments in R&D. This is expected to increase demand for clinical trial tools and ancillary services.
Clinical research has grown prohibitively expensive due to the limited funding available to small and medium-sized biotechnology businesses. According to the CEO of Transparency Life Sciences, from 2008 to 2019, "the costs of clinical trials have increased by about 100%." The costs of clinical trials varied by more than 100 across the 138 pivotal trials that evaluated the 59 novel drugs approved by the U.S. FDA between 2015 and 2016, according to a 2018 study published in JAMA Internal Medicine. The anticipated costs for a central trial cluster were between 12.2 million and 33.1 million USD.
Costs associated with clinical trials are influenced by the following factors: complexity, patient recruitment challenges, extended clinical trial schedules, and the synergy and complexity of data collecting; further constraints, particularly at the clinical and CMC levels, result from rising healthcare supply and equipment costs. Because it affects pharma companies' willingness to do clinical studies, which could limit patient access to novel medications, the rising cost of clinical research has substantial consequences on public health. Due to the increasing cost of clinical trials, it is anticipated that the market for auxiliary services and equipment will grow more slowly than the overall clinical trials industry.
The incidence of chronic diseases, the need to provide high-quality healthcare services, and the rising investment in the discovery of innovative treatments are all contributing to the market's expansion. Market expansion will be driven by the transition from paper-based data collecting to efficient ePRO tools and EDC solutions. Proper use of clinical trial tools and auxiliary services is essential for their effective completion.
The market for these goods is expanding due to increased spending on research and development projects. The devices and services covered above are just a portion of what the market for clinical trial devices and auxiliary services offers. The demand for new tools and solution options grows with research and development. This market has a promising future, and we may anticipate novel solutions that will revolutionize clinical trials.
| Study Period | 2019-2031 | CAGR | 7.7% |
| Historical Period | 2019-2021 | Forecast Period | 2023-2031 |
| Base Year | 2022 | Base Year Market Size | USD 2.69 Billion |
| Forecast Year | 2031 | Forecast Year Market Size | USD 5.25 Billion |
| Largest Market | North America | Fastest Growing Market | Europe |
Based on region, the global clinical trial equipment ancillary solutions market is bifurcated into North America, Europe, Asia-Pacific, Latin America, the Middle East and Africa.
North America is the most significant global clinical trial equipment ancillary solutions market shareholder and is estimated to exhibit a CAGR of 6.7% over the forecast period. It is because of the significant R&D expenditures, the presence of international competitors, and their efforts to develop newer patents. Additionally, the market expansion is being fueled by an increase in the number of clinical trials. For instance, as of August 2021, 59,421 recruiting studies were registered on ClinicalTrials.gov out of a total of 386,248 clinical trials that were registered worldwide.
For instance, President Obama pledged USD 215 million in funding for a precision medicine project in January 2015. The expenditure will benefit the NIH, National Cancer Institute (NCI), and FDA. The money has been divided up for NIH (USD 130 million) to promote increased volunteerism through transparent, ethical data exchange. To find cancer genetic drivers and develop new therapy modalities, the NCI has been awarded USD 70 million. A lesser portion of USD 10 million has been given to the FDA to assess Next Generation Sequencing for improved patient care. The market is expanding due to technical advancements made by market participants in their efforts to shorten timeframes.
Europe is anticipated to exhibit a CAGR of 7.9% over the forecast period. Growing emphasis on clinical trial research, supportive government programs and regulations, adherence to the Good Clinical Practice (GCP) standards, and larger patient pools are some of the market’s major drivers. A growing number of clinical trials are also promoting market expansion. The European Union is implementing various programs and policies to support orphan drug and rare illness medication research through public funding, which is anticipated to generate a lucrative opportunity for the rising number of clinical trials.
Furthermore, large patient populations and cutting-edge medical knowledge can be found in nations like Germany and the U.K. The doctors support these trials, which helps patients and research by attracting more participants. In contrast to the U.K. and France, where the legal components are completely developed, Germany is still in the development stage. The rules are designed to guarantee volunteers' rights, safety, and fair compensation. Europe is anticipated to be a good place for clinical trials with clearer standards and more funding. The clinical research industry in Europe is driven by easier access to a patient population that has not yet experienced therapy, a higher concentration of patients close to facilities, low labor costs, and intimate relationships between doctors and patients.
Asia-Pacific has emerged as one of the fastest-growing regions in the global market. Clinical phase biotechnology companies prize Asia Pacific for accelerating patient enrolment, particularly in infectious diseases, oncology, metabolic disorders, immune-oncology, and rare diseases. Over the past few years, the activity in clinical research has grown by 10% annually. Many foreign pharmaceutical companies and CROs have operated in the region for over 20 years, and clinical research is well-established there. Additionally, the area is home to centers of excellence in several therapeutic fields and major thought leaders. By dedicating additional funds to data gathering and scientific infrastructure, enhancing intellectual property protection, and providing access to patient populations, the government is also taking steps to expand the clinical trials sector.
Latin America has 80% urban dwellers. Sao Paulo, Buenos Aires, and Mexico City have massive patient pools. Latin American regulatory timelines are negative, but patient recruitment time is saved. Health patient-physician relationships boost patient recruitment and retention. Lower cost, qualified investigators, medical staff, and study coordinators with GCP understanding increase clinical trial success. Due to its cost advantage over established economies like the US and European nations like Germany, Mexico, and Brazil, the clinical trials industry is predicted to grow. Clinical trial equipment and ancillary solutions benefit. Due to multinational companies' growing interest in Latin America for clinical trials, Latin American clinical studies meet international criteria. Access to thousands of treatment and trial candidates helps investigators. This helps recruit and retain patients, lowering trial costs. Clinical trial equipment and ancillary solutions markets benefit from the rising clinical trial market.
The Middle East and Africa provide average potential in clinical trial tools and ancillary products. Conducting clinical trials in MEA has benefits such as a diverse patient population, lower costs, infrastructure, and top-notch medical facilities. The problem is that different regional laws differ from one another. Many regions are starting to collaborate with other international CROs to establish their footprint and conform to global norms. These elements modestly expand the area's clinical trial supplies and auxiliary services market.
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The global clinical trial equipment ancillary solutions market is bifurcated into type and application.
Based on the product, the global clinical trial equipment ancillary solutions market is bifurcated into Sourcing, Supply/Logistics, Service, and Others.
The Supply/Logistics segment dominates the global market and is projected to exhibit a CAGR of 8% over the forecast period. Because more clinical trial studies are being conducted in North America and Europe region, the market is expanding. Therefore, it is required to deliver all trial requirements to the location according to a specific schedule. Additionally, it eliminates site efforts and does not require attention to logistical issues. Growing demand for clinical trial equipment and ancillaries has been spurred by an increase in clinical trials, which several causes, including rising healthcare costs and an increase in the prevalence of chronic diseases worldwide, have propelled. The market entry of biologics and biosimilars is also advancing research initiatives.
Due to the increased demand for COVID-19 vaccines worldwide, supply and logistics have rapidly expanded during the COVID-19 pandemic. International clinical trials are also required to access larger participant pools for studies and protect medications. During the projected period, the fluctuation of norms and regulations in emerging economies is anticipated to increase demand for supply/logistic services.
Based on phase, the global market is bifurcated into Phase I, Phase II, Phase III, and Phase IV.
The Phase III segment owns the highest clinical trial equipment ancillary solutions market share and is predicted to exhibit a CAGR of 8% over the forecast period. Clinical trials in phase III are more involved than those in earlier phases. Even though there aren't many medications in this phase, it is the most complex. Since the sample size and study design require sophisticated dosing at an optimum level, this phase has the highest failure rate. Failure results in a loss on both a human and financial level, and most failures are brought on by noncompliance with safety and efficacy criteria. According to a Nice Insights survey on clinical trial logistics, 35.0% of phase III clinical trials are outsourced, and this number is projected to rise as more experimental medications go on to the next stage of development.
Two separate long-term safety studies are done for registration and post-marketing commitments in phase III trials. A pivotal study is included in the first section and is planned and carried out to obtain substantial proof of efficacy, safety, and post-marketing obligations. Studies that are not intended for regulatory filings but rather to support statements in publications or to get ready for the introduction of medicine are included in the second section. Phase III trials help compare novel drugs to those commonly prescribed. These examinations assess the drawbacks of each drug while determining which medication performs better. Regulatory authorities frequently need phase III clinical trial results before approving new medicine. Only one-third of drugs examined in clinical trials make it to phase III trials.
