Personalized Medicine Outsourcing Market Size, Share & Trends Analysis Report By Phase (Clinical, Preclinical), By Application (Oncology, Rare Diseases), By Service, By Type, By End-use, By Region, And Segment Forecasts, 2024 - 2030

Market Size & Trends

The global personalized medicine outsourcing market size was estimated at USD 101.62 billion in 2023 and is projected to grow at a CAGR of 12.21% from 2024 to 2030. The increasing awareness about the benefits of personalized medicine, increasing application of personalized medicine in various diseases, such as rare diseases, cancer, infectious diseases, and others, the requirement of specialized expertise, and the benefits of outsourcing the services are some of the major factors driving the market growth.

The increasing prevalence of diseases such as chronic diseases, rare diseases and infectious diseases is further increasing the demand for these medicines as it offers enhanced patient outcomes. According to the data published by American Cancer Society, cancer was expected to cause around 609,820 deaths in the U.S. in 2023 and was expected to diagnose over 1.9 people in the same year.

The applications of personalized medicine have significantly increased in cancer care, which is one of the major factors contributing to the market growth. Personalized medicine or precision medicine is utilized for several purposes in oncology such as early detection of certain cancers, identifying people with higher cancer risk, evaluation of treatment alternatives, and effect of treatment on patient’s health. As the burden of these diseases increase, the demand for personalized medicine is also anticipated to witness growth.

Furthermore, CROs and CDMOs have witnessed significant growth during the past few years as most of the pharmaceutical companies are opting to outsource their drug development and manufacturing activities to these outsourcing companies. Building and maintaining internal capabilities for all aspects of personalized medicine, from development to manufacturing, requires several resources and investments. Therefore, outsourcing these activities can allow companies to access specialized expertise, infrastructure, and resources according to their needs, thereby offering a cost-effective solution. Moreover, the complexity and risk associated with the development of personalized solutions, such as failures in the preclinical and clinical phases, offer a significant risk factor, while CROs can handle the complexities of later-stage development and manufacturing, allowing companies to streamline their operations and enhance their efficiency.

The awareness about personalized medicine has significantly increased in recent years owing to its several benefits, such as reducing trial and error prescribing, helping in avoiding adverse drug reactions, and shifting the medical emphasis from prevention to reaction. Personalized medicine offers the ability to use molecular markers that can indicate the disease risk or presence even before clinical signs and symptoms appear, allowing for early treatments of diseases and thereby improving patient outcomes.

Similarly, the patient’s non-compliance with offered treatment and medication can lead to adverse health effects such as Adverse Drug Reactions (ADR), which have been on a significant rise in past years. Thus, increasing cases of ADRs would boost the demand for better treatment options among people further driving the demand for personalized medicine. For instance, according to an article published by the National Institute of Health (NIH) in January 2024, there were around 1.25 million serious adverse effects and approximately 175,000 deaths were recorded in the U.S. in 2022.

Industry Dynamics

The global market is characterized by a high degree of innovation driven by technological advancements and increasing adoption of personalized medicine. Precision medicine is a rapidly evolving field with constant advancements in genetic testing, biomarker discovery, and therapeutic development. Outsourcing companies are investing in R&D to keep pace with these innovations.

The industry is witnessing significant mergers and acquisition activities undertaken by several key players. This helps consolidate resources, expand service offerings, and gain a competitive edge. For instance, inOctober 2023, QHP Capital acquired Applied StemCell, Inc. Applications of ASC’s TARGATT gene editing technology and GMP-grade allogeneic induced pluripotent stem cells (iPSC) platform are expected to evolve from personalized drugs to cell therapies.

The market is characterized with a high impact of regulations. Personalized medicine deals with sensitive patient data and complex therapies. Regulations around data privacy such as HIPAA, genetic testing, and drug development plays a major role. Companies need to ensure compliance to operate effectively.

Key players are adopting this strategy to increase their service offering and offer comprehensive service suite beyond traditional areas such clinical trials and include new services such as biobanking, companion diagnostics development, and regulatory support.

The industry is witnessing significant regional expansion. There's an increasing presence of outsourcing companies in emerging economies with lower operational costs and a skilled workforce. Moreover, the increasing awareness of precision medicine globally increases the opportunity for outsourcing companies to serve the client base.

Phase Insights

The clinical segment dominated the market with the largest revenue share of 67.8% in 2023 and is anticipated to witness the fastest growth at a CAGR of 12.8% over the forecast period. Clinical trials, especially in later phases, require significantly more resources, a large patient population, long durations, and extensive monitoring. This increases the complexity and expenses associated with the clinical trials. Therefore, outsourcing these trials to CROs with specialized expertise and infrastructure helps pharmaceutical companies optimize costs and timelines and improves their regulatory compliance. Moreover, the CROs offering clinical trials utilize advanced solutions such as machine learning for patient identification and enrolment, which further improves the efficiency and effectiveness of clinical trials. These attributes of outsourcing clinical trials are expected to drive the segment’s growth over the forecast period.

The preclinical segment is expected to grow at a CAGR of 10.9% over the forecast period. The developing field of personalized medicine is the growing emphasis on optimizing drug candidates in the preclinical phase. This allows for better selection of candidates and reduces the risk of expensive clinical trial failures. Moreover, identifying these ineffective drug candidates in early development process can save time and resources of the company. Similarly, outsourcing preclinical personalized medicine activities can allow these companies to access specialized expertise and infrastructure without the upfront investment required for in-house capabilities.

Application Insights

The oncology segment dominated the market in 2023 and is anticipated to witness the fastest growth over the forecast period. This can be attributed to the rising prevalence of cancer globally coupled with increasing applicability of personalized medicines in cancer treatments. Moreover, the increasing preference of companies developing personalized medicine to outsource complex clinical research is further driving the segment growth. For instance, in February 2022, Tempus, a precision medicine solution company, chose Highline Sciences, an oncology-focused full-service CRO, to enhance its capabilities of complex clinical research.

The rare diseases segment is expected to witness significant growth over the forecast period. This can be attributed to increasing prevalence of rare diseases, and supportive government regulation are some of the factors which are driving the segment’s growth. The instance, the U.S. government has launched an Orphan Drug Act in the US, which offers incentives for companies developing treatments for rare diseases. Outsourcing allows companies to navigate the complexities of applying for and complying with these regulations, further enhancing the development process.

Service Insights

Contract manufacturing dominated the market in 2023 as CMOs offers several customized services to the companies and can adapt their production lines to handle smaller batch sizes, complex formulations, and stringent quality control measures. Moreover, CMOs often have the necessary regulatory approvals and quality management systems, which ensure compliance with stringent regulations for personalized medicines, reducing the regulatory threat for companies. Thus, these are some of the factors contributing to the segment's growth.

Contract development is expected to witness the fastest growth over the forecast period. This can be attributed to companies' increasing focus on cost-effectiveness, the complexity of personalized medicine development, and the growing emphasis on risk reduction. The development process of personalized medicine from the preclinical to clinical phase is inherently risky, and outsourcing these services can help companies mitigate risk and improve cost-effectiveness. Similarly, outsourcing development activities to a single CDMO can streamline the entire process, leading to improved efficiency and faster development timelines.

Type Insights

The inhibitor drugs segment dominated the market in 2023 owing to the presence of several approved inhibitor drugs which can be used for the treatment of diseases such as cancer, rare diseases, among others. Inhibitor drugs, which block specific molecules involved in disease processes which are utilized as a crucial component in personalized medicine to develop patient-specific solutions. Developing safe and effective inhibitor drugs often requires expertise in complex areas such as protein-protein interactions and targeted delivery mechanisms. Outsourcing these components with experience in these areas allows companies to leverage this expertise and accelerate the development process, increasing the trend of outsourcing inhibitor drug service, thereby driving the segment growth.

Cell and gene therapy is expected to witness the fastest growth over the forecast period owing to growing product pipeline of these drugs and their subsequent approval in the coming years. Cell and Gene therapy development and manufacturing involve several complex procedures, such as extracting genetic material (DNA) from a patient, altering it to develop a personalized therapy, and injecting it back into the patient. Such therapies are based on state-of-the-art technology and can require specialized expertise to manufacture. Moreover, outsourcing these complex activities can also enhance the efficiency of therapy’s path to the market.

End-use Insights

The pharmaceutical companies segment dominated the market with the largest share of 64.0% in 2023 as most of the companies prefer to outsource its drug development and manufacturing activities to CROs/CDMOs. Moreover, increasing partnerships and collaboration between pharmaceutical companies and outsourcing partners to utilize advanced technologies for enhancing the development of personalized medicines would further contribute to the segment growth. For instance, in March 2024, Teva UK entered in a strategic partnership with Closed Loop Medicines to advance personalized medicine development. The partnership aims to collectively utilize Closed Loop Medicine’s software as a medical device (SaMD) technology platform to improve patient outcomes with certain chronic disorders.

Biotechnology companies are expected to witness the fastest growth over the forecast period. The complexity of developing personalized medicines, regulatory compliance, growing investments in R&D, and increasing partnerships and collaborations between biotechnology and outsourcing companies are some of the major factors driving the segment growth. For instance, in April 2024, Miltenyi Biotec entered into a strategic partnership with MiLaboratories to revolutionize next-generation therapies. According to the partnership terms, Miltenyi Biotec. Gets the rights of MiLaboratories’s RNA kits immune sequencing technology, which is to be utilized to make an impact in the fields of personalized medicine and genomics.

Regional Insights

North America dominated the market and accounted for a 33.3% share in 2023, owing to the presence of a large number of pharmaceutical companies, a supportive regulatory environment, better access to advanced technologies, and increasing investments in R&D activities. Moreover, increasing adoption of advanced technologies such as next-generation sequencing, big data analytics, and artificial intelligence (AI) are some of the factors driving the development for personalized medicine development in the region. Furthermore, the increasing prevalence of various diseases, such as chronic diseases and rare diseases, is further expected to drive the demand for personalized medicines in the region. For instance, according to the Canadian Cancer Society, around 247,100 cancer cases and around 88,100 cancer mortalities are expected in 2024.

U.S. Personalized Medicine Outsourcing Market Trends

The U.S. personalized medicine outsourcing market is anticipated to witness lucrative growth over the forecast period. This can be attributed to the presence of key market players, supportive regulatory framework and increasing R&D efforts by pharmaceutical and biotechnology companies. The US Food and Drug Administration (FDA) has implemented initiatives to accelerate the development and approval of precision medicine therapies, such as offering funding and guidance for the development of targeted therapies. Moreover, there is a significant rise in focus on developing personalized solutions. For instance, according to the Personalized Medicine Coalition (PMC) report 2022, around 12 personalized medicines were approved by the FDA in 20022, representing around 34% of all therapeutic molecular entities approved in the same year.

Europe Personalized Medicine Outsourcing Market Trends

Europe personalized medicine outsourcing market is projected to witness significant growth over the forecast period. Several technological advancements, such as progress in next-generation sequencing, bioinformatics, and other cutting-edge technologies, are significantly accelerating biomarker discovery, which is allowing outsourcing providers to offer innovative solutions to their clients. According to the European Commission data, out of the region’s total population of approximately 448.8 million, around 21.3% were aged above 65 years in January 2023. This, growing aging population is expected to boost the demand for personalized medicines as there will be a growing demand for more targeted and effective treatments for the geriatric population base suffering from chronic and rare diseases. Thus, the aforementioned would drive the region’s market growth.

The UK personalized medicine outsourcing market is influenced by the increasing demand for precision medicine, presence of robust biotechnology industry, advancements in genomics and bioinformatics, and expertise gap in the development and manufacturing of the personalized medicine, leading to the trend of outsourcing.

The personalized medicine outsourcing market in France is influenced by the increasing focus on innovation and research, developments in the regulatory framework, such as the implementation of the 2025 France Genomic Medicine Initiative, the increasing geriatric population, and the rising prevalence of chronic diseases.

The Germany personalized medicine outsourcing market is observed to be a lucrative market in the region owing to the growing pipeline of innovative therapies, partnerships and collaborations between pharmaceutical and biotechnology companies and outsourcing partners, coupled with increasing investments in R&D for the development of advanced treatments and therapies.

Asia Personalized Medicine Outsourcing Market Trends

Asia Pacific personalized medicine outsourcing market is anticipated to witness the fastest growth at a CAGR of 13.5% from 2024 to 2030. This can be attributed to the growing healthcare infrastructure, increasing presence of outsourcing companies, increasing clinical trials, and high prevalence of chronic diseases such as cancer and diabetes. For instance, according to the WHO, around 2.3 million people are diagnosed, and around 1.4 million die each year due to cancer in the Southeast Asia region. This high prevalence of chronic diseases, coupled with the growing pharmaceutical and biotechnology industry, is expected to drive the market in the region.

The market for personalized medicine outsourcing in China is experiencing significant growth owing to the presence of diverse genetical data, growing demand for innovation in country’s healthcare sector, increasing government initiatives and funding.

The Japan personalized medicine outsourcing market is expected to witness lucrative growth over the forecast period owing to the growing geriatric population base, increasing prevalence of chronic diseases, and growing emphasis on R&D initiatives in the country’s healthcare sector are driving the market growth. According to the World Bank, 30% of Japan’s population is aged 65 years and above. This geriatric population base is expected to increase the demand for personalized medicine in the country, thereby driving market growth.

The India personalized medicine outsourcing market is experiencing growth due to factors such as the significant presence of pharmaceutical companies in the country, rising investments in healthcare infrastructure, growing focus on R&D activities and increasing prevalence of chronic diseases. According to the National Centre for Disease Informatics and Research, the cancer incidence rate in India was expected to be 100.4 per 100,000, with a total of 1,461,427 cancer cases. Such high prevalence of cancer in the country is expected to increase the demand for precision medicine, thereby driving the market growth.

The personalized medicine outsourcing industry in the Middle East and Africa is projected to grow in the near future due to the increasing applications of biotechnology in healthcare and increasing efforts by government bodies to develop region’s healthcare sector. The continuous advancements in technology have enabled researchers are now able to isolate primary cells from individual patients, which allows the development of more advanced personalized treatment approaches. This development is expected to drive their demand in the region as healthcare professionals are focused on developing more effective and targeted therapies.

Saudi Arabia personalized medicine outsourcing market is expected to witness growth owing to the increasing government initiatives such as National Biotechnology Strategy, increasing investment and collaborations, and supportive regulatory framework and policies such as research incentives.

The UAE personalized medicine outsourcing market is driven by growing emphasis on innovation in healthcare, the focus of pharmaceutical and biotechnology companies on improving cost-effectiveness, and rising trend of accessing specialized expertise and advanced technology to manage complex reimbursement processes.

Key Personalized Medicine Outsourcing Company Insights

Key players operating in the personalized medicine outsourcing market are undertaking various initiatives to strengthen their market presence and increase the reach of their products and services. Strategies such as expansion activities, acquisitions and partnerships are playing a key role in propelling market growth.

Recent Developments

• In February 2024, Standard BioTools Inc. entered into a collaboration agreement with Navignostics AG to integrate Hyperion XTi Imaging System with personalized medicine service offerings and clinical research applications to offer crucial biological insights and guide treatment decisions.

• In August 2021, Precision for Medicine and Trialbee, a patient enrollment platform, entered into a partnership that aims to utilize Trialbee’s advanced analytics to recruit and match patients to Precision for Medicine's trials, which can lead to the development of advanced, personalized medicine.

Personalized Medicine Outsourcing Market Report Scope

Global Personalized Medicine Outsourcing Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global personalized medicine outsourcing market report based on phase, application, service, type, end-use, and region.

• Phase Outlook (Revenue, USD Million, 2018 - 2030)

  • Clinical

    • Phase I

    • Phase II

    • Phase III

    • Phase IV

  • Preclinical

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

  • Rare Diseases

  • Infectious Diseases

  • Others

• Service Outlook (Revenue, USD Million, 2018 - 2030)

  • Contract Manufacturing

  • Contact Development

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Inhibitor Drugs

  • Monoclonal Antibodies

  • Cell & Gene Therapy

  • Other Therapeutic Products

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmaceutical Companies

  • Biotechnology Companies

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • Germany

    • UK

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • MEA

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait