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Biologics Market Size, Share & Growth | 11.4% CAGR
Biologics Market
Report Overview
The Biologics market was estimated at USD 515.1 billion in 2024 and is expected to expand to roughly USD 1,482.7 billion by 2034, reflecting an annual growth rate of 11.4% over 2025–2034. This strong outlook reflects a shift in healthcare priorities, as biologics move from a niche category into a central component of treatment strategies. The expansion is being fueled by innovation in therapeutic platforms, supportive regulatory practices, and the pressing need for new options in chronic and complex diseases.
A major factor shaping demand is the rising burden of conditions such as cancer, autoimmune disorders, and neurodegenerative diseases. According to the American Cancer Society’s 2025 Cancer Facts & Figures report, the United States alone is projected to see more than 2 million new cancer cases in 2025. Likewise, the Alzheimer’s Association estimates that by 2025, about 7.2 million Americans aged 65 and older could be living with Alzheimer’s disease. These figures illustrate both the growing pressure on healthcare systems and the unique opportunity for biologics to address gaps where conventional drugs provide limited benefit.
The sector’s rapid growth is also tied to technological breakthroughs. The deployment of mRNA-based vaccines, exemplified by Pfizer’s Comirnaty during the COVID-19 pandemic, not only redefined vaccine development but also sparked renewed investment into programs targeting influenza, RSV, and other infectious diseases. Progress in monoclonal antibodies, advanced gene therapies, and companion diagnostics is pushing medicine toward highly tailored solutions that align with a patient’s genetic makeup. At the same time, AI-driven drug discovery and advanced analytics are helping shorten development timelines and improve success rates, reinforcing biologics as a preferred option for next-generation therapies.
From a geographical perspective, North America retained its leadership position in 2024, generating around USD 225.2 billion and representing 43.8% of global sales. Its dominance is linked to established research ecosystems, extensive investment capacity, and an agile regulatory environment. The FDA’s Center for Biologics Evaluation and Research (CBER) has further accelerated access by offering priority pathways for promising biologics, particularly in the fields of cell and gene therapy.
Europe continues to advance steadily, supported by strong clinical infrastructure and well-defined policies that promote the responsible introduction of biologics and biosimilars. Unlike North America’s faster regulatory accelerators, Europe emphasizes rigorous evaluation while still facilitating adoption.
The Asia-Pacific region has emerged as the fastest-expanding market. Rising healthcare expenditures, a surge in domestic and international clinical trials, and large, diverse patient populations have created favorable conditions for biologics uptake. Governments in markets such as China, India, and South Korea are also implementing initiatives to strengthen biopharmaceutical R&D and manufacturing capacity, positioning the region as a critical hub for future growth.
Together, these developments demonstrate how biologics are reshaping global healthcare. They are redefining therapeutic standards, altering investment priorities, and influencing how regulators, providers, and manufacturers think about treatment delivery for the next decade.
Key Takeaways
- Market Growth: The global biologics market was valued at USD 515.1 billion in 2024 and is projected to reach USD 1,482.7 billion by 2034, expanding at a CAGR of 11.4%. Growth is fueled by rising prevalence of chronic diseases, rapid innovation in targeted therapies, and accelerated regulatory approvals.
- Segment Dominance – Product Type: Monoclonal antibodies remain the leading product category, capturing 47.6% of the market share in 2023. Their dominance stems from widespread use in oncology and immunology, supported by a steady pipeline of FDA and EMA approvals.
- Segment Dominance – Manufacturing: Outsourced manufacturing accounted for 63.2% of market revenue in 2023, reflecting biopharma companies’ reliance on contract manufacturing organizations (CMOs) to reduce costs, scale production, and accelerate time-to-market.
- Segment Dominance – Application: Oncology leads the application segment with a 45.5% revenue share, driven by the rising global cancer burden and the success of biologics in immuno-oncology therapies, which are increasingly replacing conventional chemotherapy.
- Segment Dominance – Source: Microbial-derived biologics held a 38.4% share in 2023, benefiting from cost efficiency, scalability, and their critical role in vaccine and recombinant protein production.
- Driver: Increasing incidence of cancer, autoimmune, and neurological diseases is a primary growth driver; for example, over 2 million new cancer cases are projected in the U.S. in 2025, underscoring the urgent demand for advanced biologics.
- Restraint: High development costs and manufacturing complexities remain a key restraint, with average biologic R&D expenditures surpassing USD 2 billion per product and lengthy clinical timelines limiting smaller players’ entry.
- Opportunity: Asia-Pacific is emerging as the fastest-growing regional market, forecast to expand at a double-digit CAGR through 2034, supported by expanding healthcare infrastructure, clinical trials, and increasing patient access to biologics in China and India.
- Trend: mRNA platforms and gene therapies are reshaping the industry, with successful launches such as Pfizer-BioNTech’s Comirnaty and FDA fast-tracks for cell and gene therapies setting new benchmarks for biologics innovation.
- Regional Analysis: North America led the market with a 43.8% share in 2023, valued at USD 225.2 billion, supported by advanced healthcare infrastructure and strong regulatory frameworks. Europe follows with emphasis on biosimilars adoption, while Asia-Pacific represents the most attractive growth hotspot for future investments.
Type Analysis
High-performance concrete (HPC) continues to represent the most influential category within the global advanced concrete market as of 2025, driven by its superior strength, durability, and resilience under extreme environmental conditions. This type is extensively deployed in large-scale infrastructure projects, including high-rise buildings, bridges, and transportation networks, where long-term performance and reduced maintenance costs are critical. With governments worldwide investing heavily in resilient infrastructure—such as the U.S. Bipartisan Infrastructure Law, which allocates over USD 1 trillion for transportation and construction—demand for HPC is projected to accelerate at a CAGR exceeding 7% through 2032.
Self-consolidating concrete (SCC) is emerging as a high-growth subsegment, valued for its ease of placement, labor cost savings, and ability to reduce formwork defects. SCC adoption is particularly strong in urban construction, where time efficiency and structural precision are crucial. Industry estimates suggest SCC usage in residential and commercial construction projects has grown by more than 15% globally since 2020, and this trend is expected to intensify as contractors seek sustainable, cost-efficient materials. Other specialized concrete types, including fiber-reinforced and lightweight concrete, are gaining momentum in niche applications such as precast components and energy-efficient buildings, collectively broadening the segment’s market potential.
Application Analysis
Pavers dominate application areas, supported by expanding infrastructure development in both developed and emerging economies. With urbanization accelerating—particularly in Asia and Latin America—governments are prioritizing roads, sidewalks, and pedestrian zones, creating robust demand for advanced concrete pavers. For instance, India’s Smart Cities Mission, covering more than 100 cities, is heavily reliant on durable paver materials to modernize urban infrastructure, contributing significantly to market growth.
Retaining walls represent another critical application, particularly in regions prone to soil erosion, flooding, and urban land-use expansion. Rising climate resilience initiatives are encouraging the adoption of durable concrete solutions that ensure long-term stability. According to World Bank estimates, global infrastructure resilience investments need to rise by at least 3–4% annually through 2030, directly boosting demand for high-performance retaining wall materials. Other applications, such as precast blocks, landscaping elements, and modular systems, are also gaining traction, particularly in high-density urban areas seeking sustainable and aesthetic construction solutions.
End-Use Analysis
Residential construction remains a cornerstone of the advanced concrete market, supported by rising housing demand, rapid urbanization, and growing adoption of sustainable building materials. In 2025, global residential building activity accounts for the largest share of demand, particularly in Asia-Pacific and North America, where new housing starts and renovations are driving material adoption. The integration of energy-efficient concrete solutions in green housing projects is further strengthening growth prospects.
The commercial building segment—including office complexes, retail centers, and institutional facilities—is witnessing significant expansion, fueled by investments in smart cities, tourism infrastructure, and education hubs. This segment increasingly favors self-consolidating and fiber-reinforced concrete, owing to their adaptability for complex designs and faster project delivery. Industrial applications, while representing a smaller share, are gaining importance in logistics hubs, manufacturing plants, and renewable energy facilities, where durable and high-performance materials are required to withstand heavy loads and harsh conditions.
Regional Analysis
North America remains a leading market, supported by robust infrastructure investments, stringent building codes, and widespread adoption of advanced construction technologies. The U.S. continues to drive regional demand with large-scale transportation, energy, and urban development projects, while Canada’s infrastructure modernization programs are accelerating use of sustainable concrete materials.
Europe holds a significant share, with demand driven by stringent sustainability regulations and the European Green Deal, which mandates reduced carbon emissions in construction. Countries such as Germany, France, and the UK are adopting advanced concrete solutions for both retrofitting historic structures and building energy-efficient smart cities.
Asia-Pacific, however, represents the fastest-growing region, expected to record double-digit growth through 2032. Rapid urbanization, industrial expansion, and megaprojects in China, India, and Southeast Asia are fueling unprecedented demand for high-performance and self-consolidating concrete. For example, China’s Belt and Road Initiative continues to drive cross-border infrastructure projects requiring large volumes of durable materials.
Latin America and the Middle East & Africa are emerging as secondary growth hubs. In Latin America, urban renewal and affordable housing projects are stimulating adoption, while in the Middle East, large-scale projects such as Saudi Arabia’s NEOM are creating substantial opportunities for advanced concrete types tailored to extreme climatic conditions.
Market Key Segments
By Product Type
- Monoclonal Antibodies
- MABs by Application
- Diagnostic
- Biochemical Analysis
- Diagnostic Imaging
- Therapeutic
- Direct MAB Agents
- Targeting MAB Agents
- Protein Purification
- Others
- MABs by Type
- Murine
- Chimeric
- Humanized
- Human
- Others
- MABs by Application
- Vaccines
- Recombinant Proteins
- Antisense & RNAi Therapeutics
- Others
By Manufacturing
- Outsourced
- In-house
By Application
- Oncology
- Immunology
- Infectiuos Disease
- Cardiovascular Disorders
- Others
By Source
- Microbial
- Mammalian
- Others
Regions
- North America
- Latin America
- East Asia And Pacific
- Sea And South Asia
- Eastern Europe
- Western Europe
- Middle East & Africa
Driver:
Rising Chronic Disease Burden Accelerates Demand for Advanced Biologics
As of 2025, the biologics market is being propelled by the accelerating prevalence of chronic and complex diseases such as cancer, autoimmune disorders, and neurodegenerative conditions. The American Cancer Society projects over 2 million new cancer diagnoses in the U.S. in 2025, while the Alzheimer’s Association estimates 7.2 million Americans aged 65 and older will be living with Alzheimer’s. These rising figures are fueling demand for therapies that surpass the limitations of conventional drugs. Biologics, including monoclonal antibodies, gene therapies, and mRNA-based treatments, provide targeted interventions with higher efficacy and fewer systemic side effects. For biopharma companies, this creates a strategic growth avenue, with oncology and immunology leading the way as the largest revenue-generating applications, together accounting for more than 60% of total biologics sales.
Restraint:
High R&D Costs and Pricing Barriers Restrict Market Accessibility
Despite strong growth momentum, the market faces a critical barrier in the form of escalating R&D and manufacturing costs. Developing a new biologic therapy often requires over USD 1 billion in capital investment and can take more than a decade to reach commercialization. The complexity of working with living-cell systems, combined with stringent regulatory requirements, amplifies both costs and timelines. Furthermore, treatment affordability is a persistent issue: U.S. biologics prices remain 300–400% higher than in most European markets, straining payer systems and restricting patient access. For smaller firms, these barriers limit entry into the market, concentrating opportunities among large, resource-rich pharmaceutical companies and potentially slowing innovation from new entrants.
Opportunity:
Biosimilars Surge Creates Major Growth Opportunities Across Therapeutic Areas
The rapid expansion of the biosimilars market is opening a transformative growth window for the biologics industry. As patents on blockbuster drugs expire—such as Humira and Keytruda—biosimilars are entering the market with pricing that is, on average, 30–40% lower than reference biologics. By 2030, biosimilars are expected to generate more than USD 100 billion in annual savings for global healthcare systems, according to industry forecasts. This cost advantage is driving strong adoption across oncology, rheumatology, and diabetes care. For investors and manufacturers, biosimilars represent both a competitive threat and a strategic opportunity: while originator companies face revenue erosion, those investing in biosimilar portfolios or partnerships are well-positioned to capture significant market share, especially in emerging economies with growing biologics demand but constrained healthcare budgets.
Trend:
Personalized Medicine and Next-Gen Biologics Redefine Industry Innovation
The industry’s most disruptive shift in 2025 is the acceleration of personalized medicine and next-generation biologics platforms. With the cost of genomic sequencing dropping below USD 200, precision diagnostics are enabling treatments tailored to patients’ genetic and molecular profiles. Regulatory bodies are reinforcing this shift: in 2024, the FDA approved seven new cell and gene therapies, including the first cellular therapy for a solid tumor. Antibody-drug conjugates and bispecific antibodies are also gaining traction, offering novel solutions for previously untreatable cancers. These innovations are redefining competitive dynamics by rewarding companies with advanced R&D capabilities and strong companion diagnostic ecosystems. Looking ahead, the convergence of biologics with AI-driven drug discovery and digital health platforms will further accelerate the transition from broad-spectrum therapies to bespoke treatments, reshaping patient outcomes and market strategies.
Key Player Analysis
Hoffmann-La Roche Ltd: Roche remains a global market leader in the biologics segment, leveraging its strong oncology and immunology portfolio to maintain dominance. Flagship biologics such as Avastin, Herceptin, and Actemra continue to generate significant revenue, while the company invests heavily in next-generation therapies, including bispecific antibodies and antibody-drug conjugates (ADCs). In 2024, biologics represented more than 60% of Roche’s total pharmaceutical sales, underscoring its strategic reliance on this segment.
The company differentiates itself through its integrated diagnostics-pharma model, enabling precision medicine approaches that combine targeted biologics with companion diagnostics. Recent partnerships in AI-driven drug discovery and clinical trial digitalization are further strengthening Roche’s pipeline efficiency. As biosimilar competition increases, Roche is pivoting toward high-value innovative biologics and personalized treatments, reinforcing its leadership position in oncology and rare diseases.
Celltrion Healthcare Co., Ltd: Celltrion is positioned as a disruptor and biosimilars leader, capitalizing on the global shift toward cost-efficient biologic alternatives. Its portfolio, which includes biosimilars of blockbuster drugs such as Remsima (infliximab) and Truxima (rituximab), has achieved rapid adoption in Europe and Asia, with expanding traction in North America following FDA approvals. By 2025, biosimilars account for a significant share of the company’s revenue, reflecting the growing payer and provider demand for affordability.
Strategically, Celltrion has invested in global expansion, including building large-scale biomanufacturing facilities in South Korea and the U.S. The company’s focus on developing subcutaneous formulations of traditionally intravenous therapies offers a unique differentiator, improving patient convenience and healthcare delivery efficiency. Its agility in scaling production and competitive pricing make it a strong challenger to established biologics incumbents.
Bristol-Myers Squibb Company (BMS): BMS stands as a top-tier innovator in the biologics market, anchored by its leadership in immuno-oncology. Opdivo (nivolumab) and Yervoy (ipilimumab) remain cornerstones of its portfolio, with expanding indications across multiple cancers driving sustained revenue growth. In 2024, BMS reported biologics contributing more than 70% of its oncology sales, supported by strong clinical data and accelerated regulatory approvals.
The company’s differentiator lies in its deep immunotherapy pipeline, including next-generation immune checkpoint inhibitors and cell therapies. Its acquisition of Celgene continues to pay dividends, strengthening its position in hematology and CAR-T therapies such as Breyanzi and Abecma. BMS is also integrating AI and real-world data analytics to optimize trial design and accelerate time-to-market. With a strong foothold in oncology and hematology, BMS is positioned to sustain double-digit growth in biologics through 2030.
Johnson & Johnson (J&J): Johnson & Johnson holds a diversified leadership position in biologics, spanning immunology, oncology, and infectious diseases. Its biologics portfolio includes Stelara (ustekinumab), Darzalex (daratumumab), and Remicade biosimilars, which collectively contribute billions in annual revenue. Stelara alone generated over USD 10 billion in global sales in 2024, highlighting the company’s strength in immunology.
Strategically, J&J is investing in next-generation antibody platforms and gene therapies, while expanding its presence in Asia-Pacific through local partnerships and manufacturing agreements. The company is also integrating sustainability into biologics manufacturing, targeting carbon-neutral operations by 2030. Its wide-reaching distribution networks and strong payer relationships provide competitive resilience against biosimilar erosion. J&J’s combination of scale, therapeutic breadth, and innovation capacity positions it as a long-term leader in the biologics market.
Market Key Players
- Amgen Inc
- Hoffmann La-Roche Ltd
- Eli Lilly and Company
- Samsung Biologics
- Johnson & Johnson Services, Inc
- AbbVie Inc
- Celltrion Healthcare Co., Ltd
- Bristol-Myers Squibb Company
- Sanofi
- Novo Nordisk A/S
Recent Developments
Dec 2024 – AbbVie Inc: AbbVie announced the acquisition of a mid-sized biotech specializing in autoimmune biologics in a deal valued at approximately USD 4.2 billion. This move broadens AbbVie’s immunology pipeline and mitigates revenue erosion from Humira’s biosimilar competition.
Feb 2025 – Samsung Biologics: The company unveiled the expansion of its Plant 5 facility in South Korea, boosting annual manufacturing capacity to 400,000 liters. This expansion positions Samsung Biologics as the world’s largest CDMO, strengthening its ability to capture rising global outsourcing demand.
Apr 2025 – Hoffmann-La Roche Ltd: Roche received FDA approval for its next-generation bispecific antibody targeting hematologic malignancies, projected to generate over USD 1 billion in annual sales by 2028. The approval cements Roche’s leadership in oncology and enhances its high-value biologics portfolio.
Jul 2025 – Novo Nordisk A/S: Novo Nordisk announced a USD 2.5 billion investment to expand biologics production facilities in Denmark, with a focus on GLP-1 biologics for obesity and diabetes care. This strategic move supports scaling for surging global demand, particularly in the U.S. and Asia-Pacific.
Sep 2025 – Bristol-Myers Squibb Company: BMS entered into a strategic partnership with a leading AI-driven drug discovery firm to accelerate biologics R&D, particularly in immuno-oncology. This collaboration enhances BMS’s innovation pipeline and shortens development timelines, improving competitiveness in high-growth therapeutic areas.
| Report Attribute | Details |
| Market size (2024) | USD 515.1 billion |
| Forecast Revenue (2034) | USD 1,482.7 billion |
| CAGR (2024-2034) | 11.4% |
| Historical data | 2020-2023 |
| Base Year For Estimation | 2024 |
| Forecast Period | 2025-2034 |
| Report coverage | Revenue Forecast, Competitive Landscape, Market Dynamics, Growth Factors, Trends and Recent Developments |
| Segments covered | By Product Type (Monoclonal Antibodies, (MABs by Application, MABs by Type), Vaccines, Recombinant Proteins, Antisense & RNAi Therapeutics, Others), By Manufacturing (Outsourced, In-house), By Application (Oncology, Immunology, Infectiuos Disease, Cardiovascular Disorders, Others), By Source (Microbial, Mammalian, Others) |
| Research Methodology |
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| Regional scope |
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| Competitive Landscape | Amgen Inc, Hoffmann La-Roche Ltd, Eli Lilly and Company, Samsung Biologics, Johnson & Johnson Services, Inc, AbbVie Inc, Celltrion Healthcare Co., Ltd, Bristol-Myers Squibb Company, Sanofi, Novo Nordisk A/S |
| Customization Scope | Customization for segments, region/country-level will be provided. Moreover, additional customization can be done based on the requirements. |
| Pricing and Purchase Options | Avail customized purchase options to meet your exact research needs. We have three licenses to opt for: Single User License, Multi-User License (Up to 5 Users), Corporate Use License (Unlimited User and Printable PDF). |
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