A site
management organization (SMO) is an organization that provides clinical trial related
services for contract research organizations (CRO), pharmaceutical companies,
biotechnology companies, medical device companies, or clinical sites. SMO was
born in the United States in the 1970s, which helped research institutions
build a clinical trial execution system by providing on-site management. Since
then, SMO expanded rapidly in Europe, America and Japan in the 1990s. After
nearly 30 years of development, SMO has gradually become an indispensable link
in the pharmaceutical R&D industry chain.
There are
three types of SMO, one is drug testing, and it is also the most common one.
This refers to the systematic study of drugs in humans (patients or healthy
volunteers) to confirm or discover the clinical, pharmacological or other
pharmacodynamic effects, adverse reactions, or absorption, distribution,
metabolism and excretion of the tested drugs, to determine the safety and
effectiveness of the trial drug. Drug clinical trials are generally divided
into phase I, II, III, IV clinical trials, drug bioequivalence trials and human
bioavailability trials. The second is device testing. It refers to the process
of a medical institution that has obtained gastrointestinal clinical trial
qualifications under normal conditions of use to test or verify the safety and
effectiveness of the gastrointestinal tract that has been applied for
registration in accordance with regulations. Its purpose is to evaluate whether
the tested product has expectations. The safety and effectiveness. The third is
procedural testing, which refers to surgical operations, radiological
operations, and other operations that require clinical trials.
The site management organization can be applied to clinical trials related to tumor, cardiovascular system, endocrine system, respiratory system, anti-infection, mental state, gastrointestinal tract, and skin to help researchers improve research efficiency. If these systems and tissues of the human body are damaged, it is likely to cause disease. In order to solve this problem, it is necessary to develop new drugs and therapeutic equipment and conduct clinical trials. Judging from the current data, cancer has become a major cause of human deaths worldwide. Therefore, cancer prevention, screening, treatment and methods are particularly important, and the site management organization applied to tumors has become the one with the highest market share.
Industry Analysis of Site Management Organizations in Various Regions
The Asia-Pacific region is the largest revenue market, with a market share of 54.10% in 2015 and 57.20% in 2020, an increase of 3.10%. The European and North American markets rank second and third, with a market share distribution of 18.95% and 18.03%. South America, the Middle East and Africa have the smallest markets, with a total market share of 6.00% in 2020.
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In fact, in Europe and the United States, many large hospitals have sufficient projects and funds, as well as their own management teams, so they rely less on SMO. In contrast, SMO is more popular in the Asia-Pacific. As the number of clinical trial institutions in developing countries continues to grow, the number of cities where clinical trial institutions are located has also increased. In order to achieve coverage of clinical trial institutions, the SMO industry is in a period of rapid development.
From the perspective of corporate distribution, companies in the industry are dominated by the Asia-Pacific, with a high degree of market concentration. The top three companies in 2019 accounted for a total market share of 21.08%, namely EPS, CMIC Group and MPR Development Group.
The Development Prospects of the Site Management Organization Industry Under the Influence of Covid-19
Under the influence of the COVID-19 epidemic, the number of patients in hospitals and other medical institutions has increased rapidly, thus the demand for medical services has also increased rapidly. The epidemic has had a huge impact on the global economy and human health. Governments of all countries are speeding up the research and development of new coronavirus vaccines, conducting clinical trials, and then distributing them to medical institutions. Therefore, affected by the epidemic, the demand for site management organizations continues to increase, which promotes the continuous development of the site management organization industry.
In addition, the Covid-19 epidemic is changing the economy, the way residents work, and the health system. Affected by the epidemic, people are paying more and more attention to health issues, and the country is paying more and more attention to medical care, which has promoted life science research. Life science research requires clinical trials, so it is necessary to organize related services for clinical trials. The increase in life science research has promoted the industry demand for site management organizations, thereby promoting the development of the site management organization industry.
Driven by
increasingly stringent healthcare agendas, the business environment for
pharmaceutical and life science companies has become increasingly challenging.
The global demand for innovative and cost-effective drugs continues to grow,
while regulatory agencies, payers, healthcare providers, and patients demand
higher cost performance, reliable product efficacy, greater transparency, and
access to information. To meet these needs, the company is looking for ways to
increase R&D productivity, increase operational efficiency, rationally
arrange sales and marketing expenses, and improve financial performance. Human demand
for life and health is increasing, and companies are required to develop more
new drugs and medical devices. In order to conduct more effective drug
development and experimental research, there is an increasing demand for
on-site management organizations, which promotes the continuous development of
on-site management organizations.
The
market value of the global field management organization industry in 2015 was
636.53 million U.S. dollars, and in 2020 it will increase to 1437.93 million
U.S. dollars. With the gradual expansion of market demand for on-site
management organizations, we predict that its market value will reach
US$4281.33 million by 2025.
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