U.S. Large Molecule Drug Discovery Outsourcing Market Size, Share & Trends Analysis Report By Workflow (Target Identification & Screening), By Service, By Therapeutics Area (Ophthalmology, Hematology), By End-use, And Segment Forecasts, 2025 - 2033

Market Size & Trends

The U.S. large molecule drug discovery outsourcing market size was estimated at USD 968.60 million in 2024 and is projected to grow at a CAGR of 9.20% from 2025 to 2033. The market is experiencing robust growth, driven by the accelerating shift in the pharmaceutical industry towards innovative biologics and expanding pipeline biologics. Besides, large molecules, including monoclonal antibodies, bispecific, fusion proteins, and antibody-drug conjugates (ADCs), continue to witness rising demand to treat various diseases, including cancer, autoimmune disorders, and chronic conditions.

In the U.S., pharmaceutical and biotechnology companies are increasingly turning to contract research organizations (CROs) to accelerate the discovery process, lower costs, and gain access to specialized technologies. These outsourcing partnerships provide various services, including lead identification, candidate optimization, biology services, and preclinical development, with a shift toward integrated, platform-based outsourcing models. Moreover, rising demand for biologics, particularly next-generation formats such as fusion proteins and engineered antibodies, has led companies to outsource discovery tasks to reduce cycle times and manage complexity.

Outsourcing the company's focus on precision screening, target biology, and in vitro functional analysis enhances molecular optimization and early manufacturability assessments. The rise of niche therapeutic areas, such as rare diseases and personalized immunotherapies, further increases the need for highly customized discovery solutions. Besides, integrated outsourcing models that combine discovery, preclinical, and early development activities through a single partner network are expected to drive the market over the estimated period. With a focus on technological advancements in the U.S., including AI-driven target discovery, microfluidics-based screening, cryo-electron microscopy, and cloud-native platforms, outsourcing for extensive molecule drug discovery is becoming a strategic enabler of biologic drug discovery across diverse development programs, which further supports the market growth.

Market Opportunity Analysis

The U.S. market for outsourcing large molecule drug discovery is expected to witness significant growth, influenced by increased investments in biologics R&D, the emergence of innovative modalities, and changes in the biotech funding environment. Currently, over half of new drug approvals are biologics including monoclonal antibodies, bispecific, and antibody-drug conjugates leading biotech companies to seek specialized CRO partners for early-stage discovery. This trend presents new growth opportunities for service providers equipped with integrated capabilities in target discovery, protein engineering, and lead optimization. Moreover, the rise of RNA therapeutics and cell-based biologics further drives the need for platform-enabled outsourcing, with mid-sized CROs that offer AI and single-cell screening capabilities being particularly well-positioned to capitalize on this demand. The focus on de-risking clinical pipelines through more thorough preclinical validation also increases the need for advanced discovery services. In addition, the emphasis on speed and intellectual property (IP) security is prompting biotech firms to prefer U.S.-based CROs over overseas options.

Furthermore, there are a growing number of strategic opportunities to establish long-term discovery partnerships, provide modular services for emerging biopharmaceutical companies, and invest in cloud-native infrastructure to enhance collaboration. As biotech venture funding recovers and pharmaceutical companies continue to outsource discovery efforts, U.S. CROs that blend innovation, adaptability, and therapeutic expertise are expected to drive the market growth.

Impact of U.S. Tariffs on the Large Molecule Drug Discovery Outsourcing Market

U.S. tariffs have significant impact on the large molecule drug discovery outsourcing landscape. While discovery-stage services are less exposed to direct tariffs compared to manufacturing, upstream inputs like reagents, lab equipment, and custom research tools often sourced from China or Europe have faced cost inflation since the 2018-2020 tariff rounds. This has modestly increased operational expenses for U.S. based CROs and impacted margins, particularly for early-stage service providers.

Besides, some CROs have localized procurement or shifted to alternative suppliers in India, South Korea, or Mexico. In addition, the uncertainty surrounding global trade policy has led biotech clients to prefer U.S.-based discovery partners over offshore options, boosting domestic outsourcing demand. Tariffs on downstream biologic APIs and intermediates have also prompted clients to initiate more early-stage research domestically to de-risk future supply chain disruptions. Moreover, for international CROs entering the U.S. market, tariffs have boosted the companies to establish local discovery units or joint ventures. Overall, tariffs have slightly raised input costs but indirectly strengthened the strategic positioning of U.S. large molecule discovery CROs as reliable and secure innovation partners.

Technological Advancements

Technological innovations are transforming the landscape of large molecule drug discovery outsourcing in the U.S., facilitating faster, more accurate, and cost-effective research and development. Besides, AI-driven target identification has become a fundamental service, with CROs employing machine learning models that analyze multi-omics and clinical data to uncover novel disease targets and improve hit validation precision. In addition, microfluidics technology enables ultra-high-throughput screening of extensive antibody libraries, optimizing reagent usage while enhancing specificity and binding efficacy. Moreover, the advancements in synthetic biology are boosting the creativity in modular protein design, allowing for the development of multifunctional biologics such as fusion proteins, bispecific antibodies, and tailored antibody fragments. This integration of cryo-electron microscopy (Cryo-EM) into early discovery phases provides near-atomic resolution insights into biologic-target interactions, guiding structure-informed design, particularly for complex or intracellular targets.

Furthermore, the cloud-native discovery platforms are revolutionizing data integration and client collaboration, offering real-time access to experimental findings, predictive models, and audit-ready documentation. Thus, these advancements are making U.S.-based CROs increasingly competitive and essential for biotech clients navigating the complexities of biologics development in oncology, immunology, and rare diseases. Such factors are expected to drive the new technological innovations in the U.S. large molecule drug discovery outsourcing market.

Pricing Model Analysis

In U.S. large molecule drug discovery outsourcing, pricing models are evolving to better reflect the details, risks, and timelines associated with biologics research and development. The milestone-based pricing model has gained widespread traction, especially in the early stages of discovery. In this approach, payments are linked to the achievement of specific research milestones, such as validating targets, identifying hits, or optimizing leads. This alignment of incentives helps sponsors mitigate financial risk. It's estimated that more than 60% of global discovery-stage contracts incorporate milestone components. In addition, the value-based pricing is becoming increasingly relevant, particularly in collaborations involving innovative modalities such as bispecific antibodies or gene therapies. Besides, in this pricing model, the CROs share both risks and rewards based on the clinical or commercial success of the projects. Although this model is currently seen in less than 15% of partnerships, its adoption is on the rise as trust and intellectual property-sharing frameworks continue to evolve.

Moreover, the fixed-fee model remains prevalent, especially for well-defined services such as in vitro screening or assay development, offering cost predictability for both contracting parties. Besides, approximately 25-30% of contracts in the Asia-Pacific and European regions utilize this model. Whereas, the subscription or retainer model is steadily gaining popularity in partnerships with biotech companies, whereby clients pay a recurring fee for ongoing access to discovery platforms and expertise. Though it represents less than 10% of global deals, this model is appreciated for its strategic flexibility, particularly in engagements focused on specific target classes or therapeutic areas.

Market Concentration & Characteristics

The U.S. large molecule drug discovery outsourcing market growth stage is moderate, and growth is accelerating. The market is characterized by the degree of innovation, level of M&A activities, regulatory impact, service expansion, and regional expansion.

The outsourcing of large molecule drug discovery in the U.S. is experiencing significant innovation, particularly with the integration of AI and machine learning, high-throughput screening techniques, and advanced biologics platforms. Besides, companies such as Charles River and Eurofins are implementing predictive modeling and automation to enhance the speed of discovery cycles. The notable shift towards complex modalities, including bispecific and antibody-drug conjugates (ADCs) are expected to drive the market growth. In addition, an emerging number of startups and established CROs utilize novel screening libraries, improved cellular models, and computational biology approaches to achieve quicker and more accurate early-stage outcomes in large molecule development.

U.S. FDA regulations significantly influence the large molecule drug discovery outsourcing by imposing rigorous standards for quality, data integrity, and biosafety. Besides, adhering to Good Laboratory Practice (GLP) and the evolving biologics guidelines, such as the Biologics License Application (BLA) pathway further adds the operational complexity faced by CROs. Nevertheless, established regulatory pathways for biosimilars, along with accelerated programs such as the Fast Track and Breakthrough Therapy designations, are expected to drive the growth in outsourcing activities. Moreover, the increased regulatory oversight drives investment in comprehensive documentation systems, validated bioanalytical methods, and facilities compliant with Good Manufacturing Practices (GMP) further highlights the necessity for specialized expertise in outsourcing.

M&A activity in the U.S. large molecule discovery outsourcing is expected to witness new growth opportunities, as most of the CROs seek to consolidate their strength in areas such as AI, bioinformatics, and biologics. In addition, Syngene’s acquisition of a facility in the U.S. and collaborations with technology companies, illustrate a growing trend toward vertical integration and full-service models, as well as enhanced access to advanced biologic discovery platforms.

Service providers are expanding from target validation to IND-enabling studies, incorporating high-throughput screening, cell line development, and bioinformatics into their offerings Besides, in U.S. CROs provide comprehensive solutions that span from discovery to clinical development for biologics, including bispecific antibodies and mRNA therapeutics. This growth is fueled by a rising demand for turnkey discovery platforms and a trend toward greater outsourcing by emerging biotechnology companies.

CROs are broadening their geographical reach within the U.S., targeting biotech hubs like Boston, San Diego, and the Research Triangle. By establishing facilities close to their clients, they aim to expedite project timelines and enhance collaboration. In addition, international companies like Syngene and Enzene are entering the U.S. market through acquisitions or by launching new divisions, taking advantage of local talent and proximity to innovative biopharma clusters to expand their presence in large molecule discovery and better serve the U.S. biotech market.

Workflow Insights

On the basis of workflow segment, the lead identification & candidate optimization segment accounted for the largest revenue share of 32.68% in 2024. The segment's growth is driven by growing demand for biologics and an increasing focus on identifying drug candidates with the best possible balance of potency. Besides, biologics and fusion proteins have led biopharmaceutical companies to increasingly partner with CROs with specialized expertise to convert initial discoveries into optimized preclinical candidates. In addition, providers in the U.S. utilize advanced AI modeling, high-throughput screening, and next-generation sequencing to speed up the identification of promising, high-affinity leads suitable for further development.

Services focused on candidate optimization, such as affinity improvement, stability enhancement, and reduction of immunogenicity risks, are critical for ensuring success in later stages. This emphasis supports biotech companies in mitigating risks associated with their pipelines before committing to significant clinical investments. Furthermore, the rising popularity of modular biologics and platform technologies requires more iterative and collaborative design processes, enhancing the outsourcing dynamic. This trend is expected to drive investments in biologics and the pharmaceutical industry’s demand for external innovation. Such factors are expected to drive the market over the estimated period.

The preclinical development segment is expected to grow at the fastest CAGR over the forecast period. The segment growth is driven by a rise in complex biologics entering early-stage pipelines. As biopharmaceutical companies seek to shorten timelines and minimize risks associated with clinical entry, there is a growing trend of partnering with CROs that offer integrated services in pharmacology, toxicology, and bioanalytical evaluations designed for large molecules such as monoclonal antibodies, antibody-drug conjugates (ADCs), and RNA-based therapies. In addition, CROs in the U.S. are increasingly emphasizing the provision of specialized in vivo models, pharmacokinetic/pharmacodynamic (PK/PD) profiling, and immunogenicity assessments that align with the continuously evolving FDA regulations.

Besides, the emergence of innovative modalities, including cell-engaging and immune-modulatory biologics, necessitates preclinical collaborators with extensive expertise in biologics and flexible workflows to contribute to market growth. Furthermore, the need for IND-readiness within stringent timelines has led to rising requirements for comprehensive preclinical services that include Chemistry, Manufacturing, and Controls (CMC) readiness and Good Laboratory Practice (GLP) support, major contributors to market growth. With increased investment in biologics and a growing trend of outsourcing among small to mid-sized biotech companies, the preclinical development is expected to witness new growth opportunities over the estimated time period.

Service Insights

On the basis of service segment, in 2024, the biology services segment held the largest revenue share in the market, attributed to the necessity for functional validation and characterization of complex biologics, including bispecific antibodies, ADCs, and cytokine-based therapies. Besides, pharmaceutical and biotechnology companies are increasingly relying on outsourcing service providers for cell-based assays, mechanism-of-action investigations, and receptor-binding studies, further supporting the early stages of discovery. In addition, the U.S. CROs are enhancing their capabilities in primary cell systems, immuno-oncology models, and multiplex biomarker platforms to fulfill the growing demand for these services. Moreover, the emergence of new drug innovation in the range of diseases has further increased the need for biology platforms that facilitate precise and data-rich experimentation. The integration of AI-driven analytics further supports improving the assays and aids in decision-making. For early-stage biotech companies, these services provide adaptable and scalable support throughout the discovery cycle, from hit validation to lead optimization. Thus, as biologics pipelines diversify, biology services continue to play a crucial role in advancing candidates with greater efficiency, which further contributes to market growth.

The chemistry services segment is expected to grow at the second fastest CAGR during the forecast period.  The segment growth is driven by the increasing complexity of biologics such as antibody-drug conjugates (ADCs), bispecific antibodies, and fusion proteins. There is a rising demand for specialized site-specific conjugation, PEGylation, and linker design aimed at improving the safety and effectiveness of therapies. Besides, U.S.-based CROs are making advances in peptide synthesis and synthetic biology to facilitate modular protein assembly. By integrating this chemistry with biology, discovery models are becoming more efficient in optimizing candidates. Thus, with the growing need for intricate design and modification tasks by biopharma companies, chemistry services are expected to witness rising demand in the large molecule drug discovery market.

Therapeutics Area Insights

On the basis of therapeutics area segment, the respiratory system segment accounted for the largest market share in 2024, primarily attributed to the rising demand for biologics that address chronic and immune-related pulmonary diseases. Besides, several biopharmaceutical companies are making advancements in monoclonal antibodies, fusion proteins, and inhalable biologics to treat conditions such as asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, and various rare respiratory disorders. Moreover, pharmaceutical companies are increasingly collaborating to enhance their capabilities in mucosal immunology, lung organoid models, and aerosol delivery technologies to support discovery initiatives specifically designed for respiratory conditions. Furthermore, the prolonged effects of COVID-19 have increased the interest in lung health, leading to growing investment in R&D for biologics that target inflammation and fibrosis. CROs specializing in respiratory biomarkers, immune profiling, and formulation development are increasingly recognized as valuable partners that support market growth. Besides, robust funding from the National Institutes of Health (NIH) and a rising interest from pharmaceutical companies in innovative respiratory therapies contribute to ongoing outsourcing activities. As organizations strive for first-in-class and disease-modifying biologics, the services focusing on respiratory discovery are anticipated to witness rising growth over the estimated period.

The oncology segment is expected to grow at the fastest CAGR during the forecast period. The segment is driven by ongoing investment in immunotherapies, bispecific antibodies, and advanced ADCs. Besides, biopharma companies are rapidly expanding oncology pipelines, driving demand for CROs with deep expertise in tumor biology, immune checkpoint pathways, and tumor microenvironment analysis. In addition, a growing focus on enhancing capabilities in 3D tumor assays, PDX models, and high-content biologic screening is anticipated to drive the market over the estimated time period. Furthermore, the complexity of cancer biology and the focus on accelerated IND timelines further increase the need for CRO outsourcing services. Besides, integrated services spanning biology, chemistry, and preclinical support are expected to support the market growth. Such factors are expected to drive the market over the estimated time period.

End-use Insights

On the basis of the end use segment, the pharmaceutical & biotechnology companies segment accounted for the largest market share in 2024. In the U.S., pharmaceutical and biotechnology companies are the primary consumers of large molecules due to the rise in early-stage research and development and the expanding pipelines for biologics. In addition, these companies are increasingly turning to CROs to witness advanced technologies, meet stringent timelines, and greater cost efficiency. Furthermore, pharmaceutical companies are adopting hybrid R&D approaches by outsourcing the early stages of discovery to boost productivity, while biotech companies often depend on CROs because of their limited internal resources. As a result, the growing emphasis on innovation and the development of a diverse range of biologics is anticipated to drive the demand for outsourcing in the pharmaceutical and biotech industries.

The academic institute’s segment is expected to grow at the second fastest CAGR during the forecast period. The segment growth is driven by increased research initiatives and the establishment of public-private partnerships. As universities progress from fundamental research to therapeutic applications, they increasingly turn to specialized CROs for services such as antibody engineering, protein analysis, and screening processes. In addition, support from federal agencies such as the NIH and BARDA further promotes early-stage biologics research. Moreover, in the U.S., academic institutions and biotech startups are opting for CRO services to strengthen proof-of-concept studies and preclinical validation, which further contributes to market growth. Furthermore, U.S.-based CROs that provide adaptable project frameworks, collaborative intellectual property agreements, and budget-friendly pricing further support the academic institutes in drug discovery. Thus, with growing research activities on oncology, rare diseases, and infectious diseases, academic institutions are expected to drive outsourced discovery services over the estimated period.

Key U.S. Large Molecule Drug Discovery Outsourcing Company Insights

The key players operating across the market are adopting strategic initiatives such as service launches, mergers & acquisitions, partnerships & agreements, and expansions to gain a competitive edge in the market. For instance, in July 2024, Ligand Pharmaceuticals Incorporated mentioned acquisition to acquire APEIRON Biologics AG, focusing on the treatment of high-risk neuroblastoma, for a total of USD 100 million. In addition, Ligand will provide APEIRON shareholders with further compensation linked to future regulatory and commercial milestones, which could include up to USD 28 million if QARZIBA royalties surpass specific predetermined thresholds by either 2030 or 2034.

Recent Developments

• In March 2025, Syngene International Limited mentioned the acquisition of its first biologics site in the USA, which includes several manufacturing lines for monoclonal antibodies (mAbs). The site was purchased from Emergent Manufacturing Operations in Baltimore, enhancing Syngene's expanding global presence in the biologics sector and allowing the company to better cater to clients in both human and animal health market.

• In March 2025, Charles River Laboratories International, Inc. and Valo Health, Inc. announced the advanceable product candidate aimed at treating various forms of lupus and other autoimmune disorders. This discovery marks the first application of Logica, an AI-driven drug development solution designed to convert biological insights into enhanced preclinical assets.

U.S. Large Molecule Drug Discovery Outsourcing Market Report Scope

U.S. Large Molecule Drug Discovery Outsourcing Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. large molecule drug discovery outsourcing market report based on workflow, service, therapeutics area, and end-use:

• Workflow Outlook (Revenue, USD Million, 2021 - 2033)

  • Target Identification & Screening

  • Target Validation & Functional Informatics

  • Lead Identification & Candidate Optimization

  • Preclinical Development

  • Others

• Service Outlook (Revenue, USD Million, 2021 - 2033)

  • Chemistry Services

  • Biology Services

• Therapeutics Area Outlook (Revenue, USD Million, 2021 - 2033)

  • Respiratory system

  • Pain and Anesthesia

  • Oncology

  • Ophthalmology

  • Hematology

• End-use Outlook (Revenue, USD Million, 2021 - 2033)

  • Pharmaceutical & Biotechnology companies

  • Academic Institutes