Biologics Market to Surpass US$ 1,140.2 Bn by 2035 Amid Surge in Chronic Disease Therapies and Biomanufacturing Advances

The global biologics market was valued at US$ 448.8 Bn in 2024 and is projected to expand at a CAGR of 8.8% from 2025 to 2035 to reach over US$ 1,140.2 Bn by the end of 2035, according to a study by Transparency Market Research Inc.

Biologics-therapeutics derived from living organisms-are revolutionizing chronic disease treatment by offering targeted, high-efficacy therapies for conditions such as cancer, autoimmune disorders, and infectious diseases. With expanding regulatory support and technological breakthroughs in biomanufacturing, biologics are expected to dominate the pharmaceutical industry over the next decade.

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Analysts' Viewpoint

The rapid evolution of biotechnology and increasing incidence of chronic and autoimmune diseases are significantly driving market growth. Biologics, including monoclonal antibodies, cell & gene therapies, and recombinant proteins, have become central to disease-modifying strategies, offering superior patient outcomes, lower side effects, and higher adherence.

The market is further bolstered by increased investment in biosimilars, widespread hospital formulary inclusion, and expedited drug approvals. The growing pipeline of biologics under development-particularly in oncology-signals sustained long-term momentum.

Key Market Drivers

Rising Chronic and Autoimmune Disease Burden
Biologics are reshaping treatment regimens for diseases such as rheumatoid arthritis, psoriasis, multiple sclerosis, and Crohn's disease. Clinical studies show that biologics like TNF-α inhibitors reduce hospitalization by up to 60% compared to conventional therapies. Their targeted action and long-term safety profiles make them ideal for managing chronic conditions.

Technological Advancements in Manufacturing
Modern biomanufacturing innovations-such as single-use bioreactors, modular plants, and AI-based process optimization-have reduced production timelines by 30-40% and improved cost efficiency. Companies are also adopting continuous bioprocessing and digital twins to enhance yield and quality, thereby increasing scalability and accessibility of biologic drugs.

Segment Insights

By Product Type: Monoclonal Antibodies Dominate

Monoclonal antibodies (mAbs) represent the largest share of the biologics market due to their clinical efficacy and precision targeting.
Anti-PD-1 and anti-PD-L1 mAbs have become standard-of-care treatments in oncology, particularly for melanoma, NSCLC, and renal cell carcinoma.
The market also sees rapid growth in antibody-drug conjugates (ADCs) and biosimilars of blockbuster mAbs, making treatments more affordable and accessible.

Other Products Include:

Recombinant Proteins
Vaccines
Cell & Gene Therapies
RNAi and Antisense Therapies

By Indication:

Oncology (largest share)
Autoimmune Disorders
Infectious Diseases
Hematological Disorders
Others (e.g., cardiovascular conditions)

Regional Outlook

North America Remains the Global Leader

North America, led by the United States, commands the largest share of the global biologics market.
Key innovation clusters include Boston, San Diego, and San Francisco Bay Area.
Over 60% of global biologics patents originate from the U.S., and FDA fast-track approvals have streamlined market entry.

North America benefits from:

High R&D investment
Comprehensive insurance coverage
Established clinical trial ecosystem
Specialty medicine access

Key Players in the Biologics Market

AbbVie, Inc.
Amgen
AstraZeneca plc
Bristol-Myers Squibb Company
Eli Lilly & Company
Gilead Sciences, Inc.
GSK plc
Johnson & Johnson Services, Inc.
Merck & Co., Inc.
Novartis AG
Pfizer, Inc.
F. Hoffmann-La Roche Ltd.
Regeneron Pharmaceuticals Inc.
Other Prominent Players

Recent Developments

July 2025 - Sunshine Biopharma Inc. (via Nora Pharma Inc.) launched NIOPEG, a biosimilar PEG-filgrastim product for oncology supportive care.
July 2025 - AGC Biologics launched a cell therapy R&D hub in Yokohama, expanding capacity for gene and cell therapy development in the Asia-Pacific region.

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