Biologics Drug Discovery Market- Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Monoclonal Antibodies, Recombinant Proteins, Others), By Method (Target Identification/ validation, Hit Generation/ Validation, Lead Identification, Lead Optimization), By Manufacture Type (In-House, Outsourced), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 9.66 Billion
CAGR (2026-2031)	8.19%
Fastest Growing Segment	Recombinant Proteins
Largest Market	North America
Market Size (2031)	USD 15.49 Billion

Market Overview

The Global Biologics Drug Discovery Market will grow from USD 9.66 Billion in 2025 to USD 15.49 Billion by 2031 at a 8.19% CAGR. Biologics drug discovery encompasses the research and identification of therapeutic agents derived from living organisms, including monoclonal antibodies and recombinant proteins, to address complex medical needs. Key drivers supporting market growth include the rising global incidence of chronic diseases such as cancer and autoimmune disorders requiring targeted treatments and the patent expiration of major biologic drugs stimulating biosimilar development.

One significant challenge impeding market expansion is the high capital expenditure and rigorous regulatory scrutiny required during the development phase which leads to elevated attrition rates and prolonged timelines. According to the International Federation of Pharmaceutical Manufacturers and Associations, in 2024, biologics accounted for approximately half of the 12,700 drugs in clinical development worldwide. This substantial proportion highlights the industry reliance on this complex modality despite the significant financial and operational hurdles involved.

Key Market Drivers

The integration of Artificial Intelligence (AI) and Machine Learning (ML) is revolutionizing the Global Biologics Drug Discovery Market by streamlining the identification and optimization of complex therapeutic candidates. By leveraging advanced algorithms for predictive modeling and de novo protein design, pharmaceutical companies can significantly mitigate the high attrition rates traditionally associated with early-stage biologics development. This technological synergy allows for the rapid analysis of genomic data and the precise engineering of monoclonal antibodies, thereby accelerating the timeline from target validation to clinical trials. According to Sanofi, September 2025, in the 'Press Release', the company committed an additional $625 million to its venture capital arm to accelerate investments in artificial intelligence and digital health technologies, underscoring the sector's strategic pivot toward computational discovery tools.

Surging biopharmaceutical R&D expenditure and investments serve as a foundational driver, propelling the continuous exploration of next-generation biologics such as gene therapies and bispecific antibodies. The high cost of biologics development, necessitated by rigorous safety testing and complex manufacturing requirements, demands sustained capital infusion to ensure a robust pipeline of innovative treatments. According to Johnson & Johnson, January 2025, in the 'Fourth Quarter and Full Year 2024 Results', the corporation reported a total research and development expenditure of $17.4 billion for the fiscal year 2024, reflecting the intense financial commitment required to drive therapeutic breakthroughs. This investment ecosystem directly supports regulatory productivity; according to the FDA, January 2025, in the 'Novel Drug Approvals for 2024' report, the agency approved 50 novel drugs, highlighting the successful translation of these substantial R&D outlays into approved therapies.

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Key Market Challenges

The high capital expenditure and rigorous regulatory scrutiny required during the development phase act as substantial barriers to the expansion of the Global Biologics Drug Discovery Market. These challenges compel companies to allocate immense financial resources toward research and development, often diverting funds from pipeline diversification. The strict regulatory standards enforced by health authorities necessitate comprehensive clinical trials and safety assessments, which prolong development timelines and increase the risk of late-stage attrition. Consequently, smaller biotechnology firms may struggle to sustain operations without partnerships, leading to a consolidation of market activity that stifles the broader pace of innovation and product introduction.

The financial magnitude of these hurdles significantly impacts the industry's ability to scale operations and bring new therapies to patients efficiently. This burden is reflected in the substantial investments required to navigate the complex discovery and development landscape. According to the European Federation of Pharmaceutical Industries and Associations, in 2024, the pharmaceutical industry invested approximately €55 billion in research and development within Europe. This heavy financial commitment illustrates the intense pressure on market players to manage costs while adhering to compliance requirements, a dynamic that directly constrains the overall growth trajectory of the global market.

Key Market Trends

The Rise of Antibody-Drug Conjugates (ADCs) in Oncology Pipelines is fundamentally reshaping the Global Biologics Drug Discovery Market, driving a surge in strategic acquisitions to access proprietary linker and payload technologies. Pharmaceutical companies are increasingly prioritizing these targeted therapies to improve efficacy while minimizing systemic toxicity, a shift that has precipitated high-value consolidation within the sector to secure validated platforms. This aggressive pursuit of next-generation assets is exemplified by major industry players integrating specialized capabilities to bolster their oncology portfolios. According to Johnson & Johnson, March 2024, in the 'Press Release', the corporation successfully completed the acquisition of Ambrx Biopharma for an equity value of approximately $2.0 billion, a strategic move designed to accelerate the development of precision antibody-drug conjugates for the treatment of prostate cancer and other solid tumors.

The Expansion of Contract Research Organization (CRO) Outsourcing Partnerships has become a dominant operational trend as the complexity of biologic modalities necessitates specialized external expertise. Innovators are pivoting away from fully vertical integration, opting instead to collaborate with end-to-end service providers that offer advanced capabilities in cell line development, functional screening, and scalable manufacturing. This reliance on strategic partnerships allows firms to navigate technical challenges and accelerate time-to-market without bearing the full burden of capital-intensive infrastructure. According to Samsung Biologics, January 2025, in the 'Fourth Quarter and Fiscal Year 2024 Financial Results', the company reported a record full-year consolidated revenue of KRW 4.55 trillion, marking a 23% increase driven by the expanded capacity of its manufacturing plants and the successful operational launch of dedicated services for complex biologics.

Segmental Insights

The Recombinant Proteins segment represents the fastest-growing area within the Global Biologics Drug Discovery Market. This surge is attributed to the vital role these proteins play in replacing or supplementing natural biological functions to treat complex chronic diseases. Their high specificity allows for effective management of conditions such as cancer and metabolic disorders with reduced side effects. Additionally, the increasing number of product approvals by major regulatory bodies like the US FDA strengthens industry confidence, prompting pharmaceutical companies to prioritize these therapeutics in their development pipelines.

Regional Insights

North America maintains a dominant position in the Global Biologics Drug Discovery Market, driven by significant investments in pharmaceutical research and a high concentration of key industry players. The region benefits from a supportive regulatory framework established by the US Food and Drug Administration, which streamlines the development and approval of complex therapeutic programs. Furthermore, the rising incidence of chronic health conditions accelerates the demand for novel biologic therapies. This strong clinical pipeline, combined with strategic collaborations between biotechnology companies and research institutions, secures the region's leadership in advancing global drug discovery efforts.

Recent Developments

• In October 2024, Merck and Moderna initiated a pivotal Phase 3 clinical trial, INTerpath-009, evaluating their investigational individualized neoantigen therapy, mRNA-4157, in combination with a programmed death receptor-1 blocking antibody. The study focused on patients with resectable non-small cell lung cancer who did not achieve a pathological complete response after neoadjuvant therapy. This research milestone highlighted the continued advancement of mRNA technology in the Global Biologics Drug Discovery Market, aiming to harness the immune system to target specific tumor mutations. The trial represented a significant step in expanding the clinical utility of personalized cancer vaccines for broader patient populations.
• In June 2024, AstraZeneca completed the acquisition of Fusion Pharmaceuticals, a clinical-stage biopharmaceutical company specializing in next-generation radioconjugates. This strategic move significantly bolstered the company's oncology portfolio by adding a pipeline of actinium-based radioconjugates, which combine the precise targeting of antibodies or biologics with potent radioisotopes. The deal, valued at approximately $2.4 billion, included the lead program FPI-2265, a potential new treatment for metastatic castration-resistant prostate cancer. The acquisition underscored the company's commitment to replacing traditional regimens with targeted therapies and expanding its capabilities in biologics engineering and radiopharmaceutical development.
• In May 2024, Sanofi, Formation Bio, and OpenAI announced a strategic collaboration to develop artificial intelligence-powered software aimed at accelerating the discovery and development of new medicines. This partnership marked a first-of-its-kind alliance within the pharmaceutical and life sciences industries, combining proprietary data, engineering resources, and advanced AI models. The initiative focused on creating custom, purpose-built solutions across the drug development lifecycle to improve efficiency and productivity. By integrating these technologies, the companies aimed to transform the pace at which innovative treatments, including biologics, are brought to patients worldwide in the Global Biologics Drug Discovery Market.
• In February 2024, AbbVie entered into a multi-year collaboration with Tentarix Biotherapeutics to discover and develop conditionally active, multi-specific biologics for oncology and immunology. The partnership leveraged Tentarix's proprietary Tentacles platform to design multifunctional antibody-based therapies that activate immune cells specifically within disease pathways while minimizing safety concerns. Under the agreement, AbbVie was granted an exclusive option to acquire the programs following candidate nomination. This collaboration aimed to expand the company's biologics pipeline with innovative molecules capable of targeting complex immune interactions that drive cancer and inflammatory diseases in the Global Biologics Drug Discovery Market.

Key Market Players

• AbbVie, Inc.
• Astellas Pharma, Inc.
• AstraZeneca PLC
• Bayer AG
• Bicon Ltd.
• Boehringer Ingelheim International GmbH
• Eli Lilly and Company
• F. Hoffmann-La Roche Ltd.
• Gilead Sciences, Inc.
• Catalent, Inc.

By Type	By Method	By Manufacture Type	By Region
Monoclonal Antibodies Recombinant Proteins Others	Target Identification/ validation Hit Generation/ Validation Lead Identification Lead Optimization	In-House Outsourced	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Biologics Drug Discovery Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Biologics Drug Discovery Market, By Type:

• Monoclonal Antibodies
• Recombinant Proteins
• Others

• Biologics Drug Discovery Market, By Method:

• Target Identification/ validation
• Hit Generation/ Validation
• Lead Identification
• Lead Optimization

• Biologics Drug Discovery Market, By Manufacture Type:

• In-House
• Outsourced

• Biologics Drug Discovery Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE