Global Market Size, Forecast, and Trend Highlights Over 2023-2035
Contract Research Organization (CRO) Market size is poised to surpass USD 108 billion by the end of 2035, growing at a CAGR of 7% during the forecast period, i.e., 2023-2035. In the year 2022, the industry size of contract research organization (CRO) was over USD 57 billion.
The growth of the market can be attributed to the increasing number of people suffering from genetic disorders and other rare diseases. A genetic disorder is a field that is still not fully explored and there are many clinical trials that are still in process for its treatment. The World Health Organization estimates that genetic disorders and congenital abnormalities impact between 2% and 5% of all live births and can account for up to 50% of newborn deaths and 30% of pediatric hospital admissions in wealthy countries.
In addition to these, factors that are believed to fuel the market growth of contract research organization (CRO) include the rise in the number of clinical trials for various therapies. Globally almost 324 of the approximately 1221 cell and gene treatments undergoing active clinical studies in 2022 are in phase 1/1b. For trials including cell therapy, gene therapy, genetic manipulation, and related approaches, a CRO is crucial. It is vital to choose a CRO with knowledge of rare disorders, such as huntington's disease, muscular dystrophy, and hemophilia. The more qualified CRO is likely to be more beneficial for the smooth running of clinical trials conforming with the standard regulations
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Contract Research Organization (CRO) Sector: Growth Drivers and Challenges
Growth Drivers
- Growing Burden of Chronic Diseases - Rising cases of chronic illness are prompting the pharmaceutical industry to pursue new and better chronic disease treatment. According to the World Health Organization, around 41 million annual fatalities are attributed to noncommunicable diseases (NCDs). Moreover, 17 million people every year die from an NCD before the age of 70.
- Rising Expenditure on R&D in Healthcare Sector - With increasing investment in healthcare is expected to increase the development of new treatments and medicines. India spends about 1 percent of its GDP on R&D in the medical technology sector. However, the total spending of the United States is around 3%. Additionally, China, and Israel, spend nearly 2% and 4% of their GDP, respectively.
- Rise in the Number of Drugs at Clinical Trial Stage – CRO is used for smooth execution of the clinical trials performed by either or pharmaceutical industry. As per the statistics on 50 states and 221 countries, at the end of 2022, there were 437,539 registered studies, which further increased by 8,707 in 2023. Moreover, it is expected that by the end of 2023, they are likely to be 446,246 registered studies.
- Growing Development of Advanced Medicinal Therapy - Rising demand for advanced medicinal therapy is expected to increase the new studies in the field. According to reported data, more than 2000 advanced therapies are currently in the research and development stage and are anticipated to treat a wider range of diseases.
- Rising Integration of Advance Technologies in Healthcare - CRO enables the smooth execution of clinical trials for medical device testing integrated with advanced technologies. Real-time creation of innovative healthcare solutions through IoT apps can lead to higher-quality patient care. In the healthcare industry, there are presently around 26 billion active IoT devices, and by 2025, that number is anticipated to increase to nearly 75 billion across the globe.
Challenges
- Issues Associated with Patents of the Trials
- Problems associated with outsourcing material – Medical devices, and drug candidates are among the few intellectual properties that are outsourced for clinical trials. However, these candidates and medical devices are patent products and in case of outsourcing them to a contract research organization, there is a huge risk of leak of sensitive data. Therefore, concerns associated with outsourcing are expected to hamper market growth.
- Exposure to regulatory risk regarding the integrity of the trial data
Contract Research Organization (CRO) Market: Key Insights
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Base Year |
2022 |
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Forecast Year |
2023-2035 |
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CAGR |
~7% |
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Base Year Market Size (2022) |
~ USD 57 Billion |
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Forecast Year Market Size (2035) |
~ USD 108 Billion |
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Regional Scope |
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Contract Research Organization (CRO) Segmentation
Therapeutic Area (Immunology, Hematology, Oncology, Infectious Disease, Neurology, Cell & Gene Therapy, Vaccines)
The global contract research organization (CRO) market is segmented and analyzed for demand and supply by therapeutic area into immunology, hematology, oncology, infectious disease, neurology, cell & gene therapy, and vaccines. Out of the seven therapeutic areas where contract research organization (CRO) is used, the oncology segment is estimated to gain the largest market share in the year 2035. The growth of the segment can be attributed to the increasing cases of cancer that have augmented the development of various drugs and medical devices. Higher demand for drugs leads to a rise in the number of new discoveries and clinical trials for the treatment of cancer. According to the World Health Organization, there were 2.26 million and 2.21 million cases of breast and lung cancer, respectively. Breast, lung, colon, rectum, and prostate cancers are the most prevalent types of cancer. Moreover, almost 10 million deaths, or roughly one in six deaths, will be caused by cancer in 2020, making it the top cause of death globally.
End-user (Pharma & Biopharma Companies, Academic Institutes, Medical Device Companies)
The global contract research organization (CRO) market is also segmented and analyzed for demand and supply by end-user into pharma & biopharma companies, academic institutes, and medical device companies. Amongst these three segments, the pharma & biopharma companies segment is expected to garner a significant share in the year 2035. Over the past 20 years, both R&D spending and the release of new medications have surged. The segment growth is primarily attributed to rising spending by pharmaceutical companies on the research and development of drugs. In the United States, the pharmaceutical sector invested USD 83 billion in R&D in 2019. It is roughly ten times what the sector spent annually in the 1980s. Moreover, compared to the previous decade, the number of new pharmaceuticals licensed for sale climbed by around 60% between 2010 and 2019, moreover, in 2018 around 60 drugs were approved. Most of the recently approved medications frequently fall under the category of specialty pharmaceuticals that are used for treating chronic, complicated, or uncommon illnesses.
Our in-depth analysis of the global market includes the following segments:
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By Type |
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By Therapeutic Area |
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By End User |
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Customize this ReportContract Research Organization (CRO) Industry - Regional Synopsis
North American Market Forecast
The market share of contract research organization (CRO) in North America, amongst the market in all the other regions, is projected to be the largest with a share of about ~35% by the end of 2035. The growth of the market can be attributed majorly to the increasing cases of cancer and the higher number of people suffering from rare genetic disorders in the region. It is propelling the need for the development and research for therapies and drugs. Over 2 million new cases of cancer were detected in the United States in 2022, and around 600,000 deaths are expected to be related to cancer cases. Moreover, a well-known American pharmaceutical company, Pfizer Inc., said in 2019 that it will invest USD 500 million to expand its Sanford, North Carolina, gene therapy production facility.
APAC Market Statistics
The Asia Pacific contract research organization (CRO) market is estimated to be the second largest, registering a share of about ~24% by the end of 2035. The growth of the market can be attributed majorly to the increasing investment by the government in healthcare and pharmaceutical centers. According to the India Brand Equity Foundation, the Federal Budget of India for 2022–2023 had a budget of USD 11.3 billion for the healthcare and pharmaceutical industry. Moreover, China has emerged as a significant factor influencing the growth of global R&D investment, with a net annual increase of around USD 51 billion in 2021. It has surpassed Germany and Japan to become the second-largest R&D spender in the world since the year 2000.
Europe Market Forecast
Further, the market in the Europe, amongst the market in all the other regions, is projected to hold a majority of the share by the end of 2035. The growth of the market can be attributed majorly to the rise in the number of clinical trials in the region. According to the European Commission, the EU Clinical Trials Registry now lists 43388 clinical trials, 7179 of which are trials involving patients under the age of 18. Also, the register provides details about 18700 earlier pediatric trials that fall under the purview of Article 45 of the Pediatric Regulation (EU) No 1901/2006. The number of clinical trials are increasing as European Medicines Agency (EMA) requires plenty of thorough investigation to prove that a vaccine is secure, offers sufficient defence, and is of acceptable quality. In the European Union, any vaccine and drugs are approved only after careful assessment that demonstrates the same high standards of quality, safety, and efficacy
 Market Size.webp)
Companies Dominating the Contract Research Organization (CRO) Landscape
- IQVIA, Inc.
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
- ICON plc
- Abbott Laboratories
- Apple, Inc.
- Dexcom, Inc.
- Fitbit, Inc.
- F. Hoffmann-La-Roche Ltd.
- Johnson & Johnson
- Medtronic plc
- NeuroMetric, Inc.
In the News
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IQVIA, Inc. announced the partnership with Argenx SR by signing a multi-year contract. It covers the creation of additional indications for VYVGARTTM, an FDA-approved neonatal Fc receptor blocker for the treatment of generalized myasthenia gravis in individuals over the age of 18.
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ICON plc signed a concluding agreement to completely acquire PRA Health Sciences, Inc. The buy-out has been finalized in stock and cash transaction of USD 12 Billion. With this acquisition, the two companies aim to execute high-quality and effectively clinical trials from Phase 1 through post-approval studies.
Author Credits: Radhika Pawar
- Report ID: 4754
- Published Date: Mar 28, 2023
- Report Format: PDF, PPT
