Preclinical CRO Market Size, Share & COVID-19 Impact Analysis, By Type (Drug Metabolism and Pharmacokinetics (DMPK), Bioanalysis, Toxicology Studies, and Safety Services), By Application (Oncology, Neurology, Cardiology, Infectious Diseases, Metabolic Disorders, and Others), By End-user (Pharmaceutical & Biotechnological Companies, Academic & Research Institutes, and Others), and Regional Forecast, 2023-2030

The global preclinical CRO market size was valued at USD 6.84 billion in 2022 and is projected to grow from USD 7.79 billion in 2023 to USD 19.41 billion by 2030, exhibiting a CAGR of 13.9% during the forecast period (2023-2030). North America accounted for a market value of USD 3.42 billion in 2022. The rising focus on cost-effective and time-efficient drug development is driving the market growth.

Biotechnology and biopharmaceutical companies have increased their focus on outsourcing their R&D for new therapeutics to contract research organizations (CROs) for cost-effective and time-efficient research studies. Factors such as enhanced preclinical testing, decentralized studies, regulatory compliance, risk management, and cost reduction have been fueling the outsourcing of research studies by healthcare companies and research institutes to preclinical CROs.

Conducting preclinical studies for new drug candidates or therapies can be quite costly and time-consuming. For instance, the total R&D cost for a new medicine can range from USD 944.0 million to USD 2,826.0 million. Moreover, this cost can go higher depending on the duration and size of the study. In order to reduce this cost and accelerate research studies, drug manufacturers, especially smaller companies with limited resources, prefer outsourcing their studies to preclinical CROs.

Moreover, the increasing focus of key players on effective drug development to control the rising burden of chronic diseases such as cancer and Alzheimer’s has also been fueling market growth.

COVID-19  IMPACT

Increased Demand for Effective Treatment for the Virus Fueled the Market Growth

The sudden outbreak of COVID-19 slowed down the research activities in the early months of 2020. However, the market experienced overall significant growth in 2020 due to the increased number of preclinical studies driven by the increased demand for vaccines and therapeutics.

• For instance, as per the World Health Organization (WHO), there were around 5,596 phase 0 trials registered in 2020, experiencing an increase of 90.6% from the prior year. 

Moreover, the market players experienced significant growth in their revenues. For instance, Laboratory Corporation of America Holdings, through its business segment Labcorp Drug Development (DD), generated revenue of USD 4,877.7 million in 2020, with a growth of 19.8% from 2019.

Furthermore, the global preclinical contract research organization (CRO) market grew significantly post-COVID-19 in 2021. This was due to the increased penetration of CROs for conducting preclinical studies. Market players experienced growth in their revenue post-COVID-19 outbreak in 2021.  For instance, Laboratory Corporation of America Holdings, through its business segment Labcorp Drug Development (DD), generated a revenue of USD 5,845.5 million in 2021, with a growth of 6.5% from 2020.

Preclinical CRO Market Trends

Increasing Penetration of CROs in Preclinical Studies Due to High Drug Development Cost

Expenditures involved in conducting preclinical studies for certain disease indications can go very high, depending upon the duration and size of the studies. The rise in average R&D expenses could be due to changes in the types of pharmaceuticals being produced or due to the number of drugs undergoing expensive research studies. R&D expenditures are high if the preclinical study success rate of biologics is low compared to the traditional small molecule pharmaceuticals.

R&D spending of private pharmaceutical companies has surged significantly in recent years. For instance, as per the European Federation of Pharmaceutical Industries and Associations (EFPIA), pharmaceutical R&D expenditure in 2021 reached USD 43,638.3 million, which was 4.6% higher than the prior year.

Higher preclinical studies cost is one of the reasons for increased pharmaceutical R&D spending. Contract research organizations (CROs) play a crucial role in helping manufacturers save time and money by reducing trial duration. CROs help in conducting preclinical studies through their service offerings, such as toxicology studies, safety services, bioanalysis, pharmacokinetics etc.

Many pharmaceutical and biotechnological companies have started collaborating with CROs to outsource their research studies.

• For instance, in January 2023, Charles River and Rznomics Inc., a biopharmaceutical company, partnered together to develop and manufacture RNA-based anticancer gene therapy.

Earlier research conducted by small pharmaceutical and biotechnological companies was limited due to a lack of facilities for conducting research studies in-house. Nowadays, with the emergence of CROs, outsourcing research studies by small or emerging countries has been increasing at a significant rate.

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Preclinical CRO Market Growth Factors

Increasing Demand for Effective Drugs to Control the Rising Burden of Chronic Diseases has been Fueling the Market Growth

The burden of life-threatening diseases such as cancer, neurological conditions, and heart diseases has been increasing at a significant rate.

• For instance, according to the American Cancer Society, estimates around 1.96 million new cancer cases in the U.S. in 2023. This number is equivalent to 5,370 new cancer cases every day.


• Moreover, according to the Alzheimer's Association, around 6.0 million people are living with Alzheimer’s in the U.S. This number is expected to reach 13.0 million by 2050.

The increasing prevalence of these chronic diseases has fueled the demand for the development of effective novel therapeutics. Pharmaceutical and biotechnology companies have increased their investment in R&D for investigational new drug development.

• For instance, in 2022, Lilly spent around USD 7,190.8 million and Vertex Pharmaceuticals spent around USD 2,540.3 million on their R&D.

The rising prevalence of chronic diseases and increasing expenditure of healthcare companies on R&D have been accelerating the demand for outsourcing research studies. Robust early-phase clinical studies play a crucial role in enhancing clinical trials success rate and to speed up the process of getting regulatory approvals. This factor has been accelerating the market growth.

Increasing Partnership and Collaboration of Pharmaceutical and Biotechnology Companies with CROs has been Accelerating the Market Growth

The increasing prevalence of chronic diseases has increased the demand for effective therapeutics. To fuel this demand, pharmaceutical and biotechnological companies have increased the outsourcing of their pharmaceutical R&D to contract research organizations.

• For instance, in October 2021, Parexel International Corporation partnered with Kyoto University Hospital to enhance its clinical research opportunities.


• Moreover, in February 2023, Charles River and Purespring Therapeutics partnered for the development and manufacture of gene therapy for renal diseases.

Such increased partnerships and collaboration of healthcare companies and research institutes with the CROs have been fueling the growth of this market.

RESTRAINING FACTORS

Lack of Skilled Workforce has been Hampering the Market Growth

Increasing globalization has increased the adoption of advanced technology, creating new job opportunities. Moreover, the rising industrialization has fueled the demand for advanced skills. All these factors have increased the competency in job opportunities.

The market players have been facing issues in hiring and maintaining skilled workforce, including scientists having experience in pharmaceutical, biotechnology, and medical devices businesses. Moreover, despite the growing demand for developing advanced products in the healthcare industry, there’s limited availability of skilled workforce.

For instance, as per the research study conducted by the Gatsby Foundation, by 2030, there will be a requirement of around 700,000 lab technicians in the U.K.

The limited availability of skilled workforce inhibits the efficiency of preclinical CROs, thereby limiting the market growth.

Preclinical CRO Market Segmentation Analysis

By Type Analysis

Increasing Outsourcing of R&D by Pharmaceutical Companies is Responsible for the Safety Services Segment Dominance

Based on type, the market for preclinical CRO is segmented into drug metabolism and pharmacokinetics (DMPK), bioanalysis, toxicology studies, and safety services.  

The safety services segment is expected to grow at the fastest CAGR during the forecast period. The growth of the segment is attributed to the increasing outsourcing of early-phase clinical studies by healthcare companies and academic & research institutes to preclinical CROs.

The toxicology studies segment dominated the global preclinical CRO market in 2022 and is expected to grow at a significant CAGR during the forecast period. Toxicology studies in preclinical trials are very important to understand safety exposure in human patients. Moreover, regulatory bodies such as the Food and Drug Administration (FDA) emphasize on the incorporation of experimental medicines that would represent drugs for toxicity testing in preclinical studies. All these factors are responsible for the segment’s dominance.

By Application Analysis

Increasing Demand for Effective Treatment for Cancer Fueled the Oncology Segment Growth

By application, the market for preclinical CRO is classified into neurology, infectious diseases, oncology, metabolic disorders, cardiology, and others.

The oncology segment led the market in 2022. The growth of the segment is attributed to the growing demand for effective cancer therapeutics and the increased number of research studies going on in oncology.

• For instance, according to the World Health Organization (WHO), around 111 phase 0 clinical trials were registered in the U.S. for cancer diseases in 2021. This number was equivalent to the 32.1% of the total phase 0 clinical trials registered in the U.S. 

Furthermore, the neurology segment is expected to grow at a significant CAGR during the forecast period. The increase in the prevalence of neurology disorders has been fueling the segment’s growth.

The metabolic disorders segment is expected to grow at a substantial rate during the forecast period owing to the rising prevalence of metabolic disorders, due to which pharmaceutical companies have increased their focus on new drug discovery.

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By End-user Analysis

Pharmaceutical and Biotechnological Companies Segment’s Dominated Due to Increasing Partnership between the Pharmaceutical Firms and CROs

The market for preclinical CRO is segmented into pharmaceutical and biotechnological companies, academic & research institutes, and others on the basis of end-user.

Pharmaceutical and biotechnological companies dominated the market in 2022 owing to the increased collaboration between pharmaceutical companies and CROs for the development of novel therapeutics.  

• For instance, in June 2023, Charles River collaborated with Curigin, a biotechnology company, for the production of adenoviral vector production. With this partnership, Charles River is providing its expertise in CROs to Curigin for preclinical phases and clinical trials.

Moreover, the academic & research institutes segment are expected to grow at a significant CAGR during the forecast period owing to the increasing focus of these institutes on developing novel therapeutics for life-threatening diseases.

REGIONAL INSIGHTS

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Increasing Spending by Pharmaceutical Companies in North America is Responsible for the Market’s Growth in the Region

North America accounted for a major preclinical CRO market share, generating a revenue of USD 3.42 billion in 2022. The region’s growth is attributed to increased spending by pharmaceutical companies on R&D to improve their research studies, which has been fueling the market growth.

The growth of the market in Europe is attributed to the increasing prevalence of chronic diseases and the rise in the R&D spending by major biotechnology, pharmaceutical, and MedTech companies.

• For instance, as per the report published by the European Federation of Pharmaceutical Industries and Associates in 2021, the pharmaceutical industry spent around USD 44,689.8 million in Europe. Such high spending is helping pharmaceutical companies to enhance their R&D for new therapeutics in the region.

Moreover, the market across the Asia Pacific is expected to grow with the fastest CAGR during the study period. The cost of conducting preclinical and clinical studies is comparatively cheaper in the Asia Pacific countries than in Western countries. This factor has led to increased focus by market players on conducting preclinical studies in this region, driving market growth.

The market in the rest of the world is expected to grow at a substantial CAGR during the forecast period. The increasing interest of the pharmaceutical and biotechnological companies in outsourcing their research activities in the emerging countries of Latin America and the Middle East & Africa due to cost-effectiveness is expected to fuel market growth in the region during the forecast period.

KEY INDUSTRY PLAYERS

Increasing Focus of Market Players on the Expansion of their Service offerings To Propel Market Growth

Icon plc, Syneos Health, Laboratory Corporation of America Holdings, and Charles River Laboratories are some of the significant market players as they captured a substantial global market share in 2022. The strong growth of these companies in the market is attributed to their strong focus on R&D to introduce new solutions and enhance their offerings.

• For instance, in July 2021, Laboratory Corporation of America Holdings expanded its oncology portfolio by the acquisition of Omniseq. This acquisition upskilled the company’s offerings.

Other significant players operating in the market, such as Novotech, Medpace, and Thermo Fisher Scientific, have been focusing on expanding their presence globally to strengthen their position in the market.

LIST OF KEY COMPANIES PROFILED IN PRECLINICAL CRO MARKET:

• Novotech (Australia)


• Thermo Fisher Scientific Inc. (U.S.)


• Medpace (U.S.)


• Icon plc (Ireland)


• Syneos Health (U.S.)


• Laboratory Corporation of America (U.S.)


• Eurofins Discovery (U.S.)


• EVOTEC (Germany)


• Charles River (U.S.)


• WuXi AppTec (China)

KEY INDUSTRY DEVELOPMENTS:

• December 2021 – Laboratory Corporation of America Holdings acquired Toxikon Corporation to strengthen its non-clinical development portfolio.


• December 2021 – Thermo Fisher Scientific Inc. acquired Pharmaceutical Product Development, LLC. This acquisition enhanced the services provided by the company.


• November 2021 – Icon plc expanded its Accellacare Site Network by partnering with six research sites across four countries.


• October 2021 – Syneos Health acquired RxDataScience, a data management and Artificial Intelligence (AI) company to enhance its R&D activities with advanced technologies.


• August 2021 –  Syneos Health announced its partnership with Aetion to provide regulatory-grade data and analytics-driven solutions to enhance drug development and patient outcomes.

REPORT COVERAGE

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The global preclinical CRO market report provides a detailed competitive landscape. It also includes key insights, such as top industry developments covering partnerships, mergers, and acquisitions. Additionally, it focuses on key points, such as new solution launches in the market. Furthermore, the report covers regional analysis of different segments, profiles of key market players, market trends, and the impact of COVID-19 on the market. The report consists of quantitative and qualitative insights that have contributed to the market's growth.

Report Scope & Segmentation