In Vivo CRO Market

Market Overview

The global in vivo CRO market size was valued at USD 4.23 billion in 2022. It is estimated to reach USD 8.6 billion by 2031, growing at a CAGR of 8.2% during the forecast period (2023–2031). The rising international standards adoption by contract researchers in emerging nations is projected to improve demand for contract research by pharmaceutical and biotech organizations, contributing to the market's growth.

An In Vivo CRO (Contract Research Organization) is a specialist organization that offers outsourced clinical research services with an emphasis on managing experiments and trials involving living creatures. In Vivo, CRO is essential in facilitating the development of new pharmaceuticals and cures because of the complexity and regulatory demands of the pharmaceutical and biotechnology sectors.

Preclinical and clinical studies, frequently incorporating animal models, are designed and carried out by in vivo CRO companies to evaluate new drug candidates' safety, effectiveness, and pharmacokinetics. They collaborate closely with pharmaceutical corporations, academic institutions, and governmental organizations to ensure adherence to moral standards and regulatory requirements. These institutions have cutting-edge facilities and toxicology, pharmacology, and veterinary sciences knowledge. The In Vivo CRO offers comprehensive services, including creating study protocols, subject recruiting, data collecting, analysis, and reporting. They work with qualified scientists, vets, and support staff who are educated in the proper care of animals and who follow strict quality control procedures.

Market Dynamics

Global In Vivo CRO Market Drivers:

Rising Price Competition and Requirement to Reduce Cost

One factor that positively affects market growth is the in vivo industry's development into a mature market. Intense competition, price increases, and pressure on profitability are further factors. In every country on earth, the level of industry competition is gradually increasing. Brazil, Korea, Taiwan, and China are just a few emerging nations that are increasingly formidable competitors on the world stage. While pharmaceutical and biotech firms headquartered in the Netherlands, Germany, Bermuda, and Japan compete fiercely with US companies, these nations also face fierce competition from emerging economies.

Many pharmaceutical and biotech companies have adopted an outsourcing business model to reduce costs and better manage the risks connected with their operations as a direct result of the confluence of growing challenges and changing market dynamics.

Implementation of International Standards by CROs

CROs, particularly those in industrialized nations such as the United States, the European Union, and Japan, adhere to international standards for quality management systems. Consequently, Clinical Research Organizations (CROs) located in these countries are more desirable destinations than those located in India and China. Additionally, the governments of developing countries are currently adopting new regulatory mechanisms to monitor and verify that contract researchers conform to the regulations.

Therefore, rising international standards adoption by contract researchers in emerging nations is projected to improve demand for contract research by pharmaceutical and biotech organizations, contributing to the market's growth. This demand for contract research would also contribute to the market's growth.

Global In Vivo CRO Market Restraint:

Compliance Issues While Outsourcing

Service providers in underdeveloped countries may not comply with laws passed more recently. Consequently, pharmaceutical and biotech companies operating in Europe and the United States may face difficult compliance issues. As a direct result, several companies prefer to use in-house research institutes or regional service providers to avoid violations of regulations.

As a consequence of the expansion of infrastructure and the rising demand for high-quality services, CROs all over the world are subject to the expectation that they would comply with the existing regulatory standards. Because of this, CROs have developed quality assurance and control systems and ensured compliance with regulations.

Global In Vivo CRO Market Opportunities:

Complex Cell and Gene Therapies Require Innovative Clinical Trial Designs

Gene and cell therapies are complex and require much specialized training. It is believed that they fulfill requirements in the medical field that are currently unfulfilled. There has been an increase in investment in developing and commercializing innovative cell and gene therapies because of this. As of April 2021, the FDA has blessed sixteen cell and gene therapies. In the year 2020, there were approximately 362 cell and gene therapies that have advanced to the clinical trial stage.

As a result of the rapidly increasing number of potential cell therapy candidates and their rapid progression through the various stages of clinical development, there has been an increase in the demand for institutions that provide research and development services for these therapies. Due to this, the end users, such as biotech businesses and academic institutions, have decided to rely on CROS for their specialized expertise and scientific understanding. In addition to this, CROS offers increased clarity on regulatory requirements and a broader geographic reach for clinical trials. As a result, the market for CRO services would be driven forward by these reasons.

Regional Analysis

North America Dominates the Global Market

Based on region, the global in vivo CRO market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global in vivo CRO market shareholder and is estimated to exhibit a CAGR of 8.5% over the forecast period. Due to the presence of technologically advanced Contract Research Organizations (CROs) and a growth in the number of funding granted by government organizations (such as the National Institute of Health (NIH) to stimulate research activities), North America leads the global market for in vivo CROs. It is anticipated that additional expenditures will be made in research throughout the projected period due to the high quality and track record of companies operating in the region. In addition, the numerous drug development activities, the presence of several pharmaceutical and biotech businesses, and the number of clinical trials in the region are contributing to the expansion of the market.

Asia-Pacific is anticipated to exhibit a CAGR of 9.4% over the forecast period. The cost-effectiveness of clinical research organizations (CROs) in countries such as India and China is anticipated to drive growth in the Asia Pacific region at the quickest compound annual growth rate (CAGR). This is in addition to the region's economic development and advanced healthcare infrastructure. The growing number of partnerships and investments made by CROs, as well as the growing percentage of in vivo services that are outsourced to emerging economies such as India and China, are two of the factors that are predicted to accelerate market expansion throughout the forecast period. Other factors predicted to accelerate market expansion throughout the forecast period include the growth of the global population.

In Europe, some reasons likely to drive market growth during the forecast period include increased spending by large pharmaceutical companies on outsourcing, a greater emphasis on rare illnesses with unmet requirements, the expiration of biological patents, and the introduction of novel biosimilars. Rapid shifts are taking place in the approach that is taken to the discovery of new drugs in Europe. Combinatorial chemistry, genomics, high throughput screening, and proteomics have altered the progression of a drug from the period of discovery to the phase of development due to a massive increase in the amount of data available due to advances in database management systems.

In Latin America, it is estimated that throughout the time under consideration, the market would witness growth that is not only considerable but also lucrative. There are a variety of distinct groups in this region that are exerting much effort to enhance their capacities for in vivo testing. It is projected that government changes will enhance the market for pharmaceutical products, which will produce a need in the region for in vivo testing. This need will be met by companies that specialize in providing such services. It is anticipated that legislative changes will lead to an increase in the demand for pharmaceutical products, which will lead to an increase in the requirement to carry out in vivo testing.

In the Middle East and Africa, growth in the number of research and development projects and life sciences organizations in the region is predicted to be the primary driver of market expansion throughout the period covered by the projection. The nation is adopting practices common in other parts of the world and collaborating closely with CROs in other parts to bolster its position in the market. In addition, the in vivo CRO industry in the Middle East and Africa (MEA) offers advantages such as high-quality medical facilities, well-developed infrastructure, and low operational costs, all contributing to the market's rise.

Segmental Analysis

The global in vivo CRO market is bifurcated into type, disease indication, and GLP type.

Based on the type, the global in vivo CRO market is bifurcated into rodent and non-rodent. 

The Rodent segment dominates the global market and is predicted to exhibit a CAGR of 8.6% during the forecast period. Because of the strong similarities between rodents and humans regarding their behavioral, biochemical, and genetic makeup, rodents are frequently employed as models in medical research. They are the species that are employed in clinical trials the most frequently. Rodents are capable of mimicking several human disease signs. 95% of all laboratory animals are rats, claims the Foundation for Biomedical Research (FBR). Rats and mice are little, simple to care for, and able to blend in with their surroundings. Several rodent generations can be seen in a short amount of time because they reproduce frequently and live brief lives. The Foundation for Biomedical Research (FBR) states that immune-deficient animals, such as Severe Combined Immune Deficiency (SCID) mice, can be used as models for studying cancerous and healthy human tissue.

Based on disease indication, the global in vivo CRO market is bifurcated into autoimmune/inflammation conditions, pain management, oncology, CNS conditions, diabetes, obesity, and others. 

The oncology segment owns the highest market share and is predicted to exhibit a CAGR of 8.2% over the forecast period. The mouse has proven to be an excellent model for studying human cancer since tumors in humans and mice share many of the same physiological and genetic characteristics. This is due to mice and humans' high proportion of cancer-causing genes. Mice and people are remarkably similar in their molecular, cellular, and anatomical makeup. It is good knowledge that certain characteristics of cancer have significant functions and characteristics. Mice are a very effective experimentally tractable model for investigating how cancer reacts to the treatment and the basic mechanisms it develops because mouse RNI-like genes are more than 80% identical to human genes. Mouse tumors, on the other hand, have low levels of heterogeneity, while human cancers have significant levels. This poses a challenge for scientists trying to study cancer animal models. The most widely used and least expensive conventional tumor research models are mice-bearing xenografted and syngeneic tumors orthotopically or subcutaneously transplanted into immunodeficient or immunocompetent animals.

Based on GLP type, the global in vivo CRO market is divided into non-GLP and GLP toxicology. 

The GLP toxicology segment is the most significant contributor to the market and is estimated to exhibit a CAGR of 8.8% over the forecast period. Clinical investigations, such as safety pharmacology, genotoxicity, and repeated dosage toxicity, are essential for the safe exposure of people and need to be carried out in line with GLP criteria. Additionally, these clinical investigations must be conducted promptly. These investigations must be finished before an application for an IND may be submitted. After the IND has been approved, additional GLP studies must be conducted during the clinical phase of development. These studies must address chronic toxicity, developmental and reproductive toxicity, genotoxicity, and carcinogenicity. The requirements of good laboratory practice (GLP) must be adhered to when analyzing the findings of safety studies.

Recent Developments

• March 2023- ClinChoice Medical Development, a US-based contract research organization (CRO) that provides research services to accelerate drug and device approvals, acquired Cromsource S.r.l. for an undisclosed amount.
• October 2022- Moderna, Inc., and Merck reported that Merck had exercised its option to develop and commercialize personalized cancer vaccine (PCV) jointly mRNA-4157/V940 under the terms of its existing Collaboration and License Agreement.