Contract Research Organization (CRO) Market Analysis by Type (Early Phase, Consulting, and Clinical Lab); by Therapeutic Area (Immunology, Hematology, Oncology, Infectious Disease, Neurology, Cell & Gene Therapy, and Vaccines); and by End-User (Pharma & Biopharma Companies, Academic Institutes, and Medical Device Companies) – Global Supply & Demand Analysis & Opportunity Outlook 2023-2035
Buy Now Report ID: 4754 | Published Date: Mar 28, 2023
The global contract research organization (CRO) market size is estimated to reach ~USD 108 Billion by the end of 2035 by growing at a CAGR of ~7% over the forecast period, i.e., 2023 – 2035. In addition to this, in the year 2022, the market size of contract research organization (CRO) was ~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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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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Growth Drivers
Challenges
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.
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 contract research organization (CRO) 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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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.
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.
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
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.
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.
In 2023, market players might incur losses due to huge gap in currency translation followed by contracting revenues, shrinking profit margins & cost pressure on logistics and supply chain.
Controlling Inflation has become the first priority for global economies from last quarter of 2022 and to be followed in 2023. With skewed economic situations, rise in interest rate by governments to control spending and inflation, spiked oil and gas prices, high inflation, geo-political issues including U.S. & China trade war, Russia-Ukraine conflict to intensify the global economic issues.
The interest rates in the U.S. may be less sensitive in 2023 as compared to 2022; sigh of relief for businesses. Positive business sentiments, healthy business balance sheets, growth in construction spending (private construction value in 2022 stood at $1,429.2 billion, 11.7 percent (±1.0 percent) above the $1,279.5 billion spent in 2021, Residential construction in 2022 was $899.1 billion, up by 13.3 percent (±2.1 percent) from $793.7 billion in 2021, non-residential construction touched $530.1 billion, 9.1 percent (±1.0 percent) above the $485.8 billion in 2021.) showcases minimal impact of recession in the country.
Similarly, spiked spending in the European and major Asia economics including, India, China & Japan to showcase less impact on the global demand.
Author Credits: Radhika Gupta, Shivam Bhutani
Ans: Increasing incidences of chronic illness, the rising popularity of advanced medicinal therapies, and higher investment for carrying out research and development of various drugs and therapies are the major factors driving the market growth.
Ans: The market size of contract research organization (CRO) is anticipated to attain a CAGR of ~7% over the forecast period, i.e., 2023 – 2035.
Ans: The risk of violating the regulation, and concerns associated with outsourcing medical devices are estimated to be the growth hindering factors for the market expansion.
Ans: The market in the North American region is projected to hold the largest market share by the end of 2035 and provide more business opportunities in the future.
Ans: The major players in the market are ICON plc, Abbott Laboratories, Apple, Inc., Dexcom, Inc., Fitbit, Inc., F. Hoffmann-La-Roche Ltd., Johnson & Johnson, Medtronic plc, NeuroMetric, Inc., and IQVIA, Inc.
Ans: The company profiles are selected based on the revenues generated from the product segment, the geographical presence of the company which determines the revenue generating capacity as well as the new products being launched into the market by the company.
Ans: The market is segmented by type, therapeutic area, end user, and by region.
Ans: The oncology segment is anticipated to garner the largest market size by the end of 2035 and display significant growth opportunities.
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