Bispecific Antibody Therapeutics Contract Manufacturing Market Size to Reach USD 71,565.5 Million in 2032
The Bispecific Antibody Therapeutics Contract Manufacturing Market size was USD 5,547.3 Million in 2024 and is expected to register a revenue CAGR of 37.6% during the forecast period
27th May, 2025 – Technological advancements in antibody engineering is a key driver driving bispecific antibody therapeutics contract manufacturing market revenue growth. As the biopharmaceutical industry shifts toward more complex protein forms, ensuring the manufacturability and scalability of these innovative medicines is critical. To act properly, bispecific antibodies require accurate matching of the heavy and light chains (HC-LC). Incorrect matching can result in lower efficacy and increased immunogenicity.
On April 2024, Fujifilm Corporation reported that it has committed USD 1.2 billion to expand its end-to-end manufacturing capability at its Holly Springs, North Carolina facility. The billion-dollar manufacturing boost will allow Fujifilm to increase large-scale production capacity by adding eight more 20,000-liter mammalian cell culture bioreactors, which are expected to be operational by 2028. The manufacturing investment is part of Fujifilm’s ambition to establish itself as a prominent contract development and manufacturing organization (CDMO) in the dynamic and profitable antibody-drug conjugate and bispecific market segments.
Tumour heterogeneity and mutational burden, intractable tumour microenvironment (TME), insufficient costimulatory signals to activate T cells, the need for continuous injection, fatal systemic side effects, and off-target toxicities to adjacent normal cells are all significant challenges for bsAb drugs in cancer therapy. Like other antibodies, bsAbs may generate an immune response that can render them ineffective or cause adverse side effects. Engineering efforts must focus on reducing this risk while maintaining the antibody’s therapeutic function.
Key Highlights:
- Monovalent bispecific antibodies segment is expected to register the largest market share in 2024. Asymmetric monovalent bispecific IgGs (bsIgGs) have the added benefit of retaining a native antibody-like structure, which can improve pharmacology and pharmacokinetic profiles. However, the synthesis of bsIgGs frequently necessitates the manufacture of asymmetric molecules, which significantly complicates the manufacturing process. A monovalent bispecific IgG, for example, is made up of two heavy chains (HCs) and two light chains (LCs), which can fold into ten distinct molecule combinations, only one of which possesses the necessary HC-LC assembly. Several strategies have been devised to induce heavy chain heterodimerization during production, such as the knobs-into-holes approach, electrostatic steering, and disulfide engineering.
- Oncology segment is expected to account for the largest market share in 2024. The American Cancer Society predicts that 234,580 lung and bronchus malignancies will be diagnosed in the United States in 2024, resulting in 125,070 fatalities. Approximately 80% of these cases are likely to be NSCLC. Women in the United States have among of the highest lung cancer fatality rates in the world. Lung cancer primarily affects people aged 50 to 70 years. Both sexes have an extremely low risk of developing lung cancer until they reach the age of 39. It then gradually rises until it reaches a peak among people over the age of 70.
- North America accounted for the largest market revenue share in the bispecific antibody therapeutics contract manufacturing market in 2024 due to investments in single-use bioreactor technology and technological advancements in antibody engineering. On November 2024, GenScript Biotech, a global biotechnology leader in life science, biologics manufacturing, synthetic biology, and cell therapies, announced that its CDMO subsidiary, ProBio, has licensed its PD-1 new molecular entity (NME) to LaNova Medicines, which recently signed an agreement with Merck to advance treatment. The deal demonstrates ProBio’s dedication to provide cutting-edge medicines, strengthens its position as an immuno-oncology leader, and distinguishes it from other CDMOs.
- Some major companies in the market report include Creative Biolabs, AbbVie, Amgen, Janssen, WuXi Biologics, Sino Biological Inc., evitria AG, Lonza, Roche, Medelis, Biointron Biologics, MabPlex International Co. Ltd., Pure Biologics, and Others.
- On January 2023, WuXi Biologics, a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), has announced a license agreement with GSK plc under which GSK will receive exclusive rights to up to four bi- and multi-specific TCE antibodies developed using WuXi Biologics’ proprietary technology platforms. WuXi Biologics will receive an initial payment of USD 40 million and up to USD 1.46 billion in subsequent payments for research, development, regulatory, and commercial milestones across the four TCE antibodies.
- On July 2022, GenScript ProBio, a global CDMO, and DAAN Bio Therapeutics, an innovative new drug developer of antibody therapies and cell therapy pharmaceuticals, announced the signing of a strategic cooperation memorandum of understanding for innovation drug research and development. This MOU between GenScript ProBio and DAAN aims to strengthen their collaboration in the fields of cell and gene therapy (CGT) and biologics.
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Navistrat Analytics has segmented bispecific antibody therapeutics contract manufacturing market size based on product type, route of administration, stage of development, fragment type, and indication:
- Product Type Outlook (Revenue, USD Million; 2022-2032)
- Monovalent Bispecific Antibodies
- Bivalent or Multivalent Bispecific Antibodies
- Route of Administration Outlook (Revenue, USD Million; 2022-2032)
- Intravenous (IV)
- Subcutaneous (SC)
- Others
- Stage of Development Outlook (Revenue, USD Million; 2022-2032)
- Clinical Stage
- Commercial Stage
- Fragment Type Outlook (Revenue, USD Million; 2022-2032)
- Bispecific T-Cell Engager (BiTE)
- Dual-Affinity Re-Targeting Proteins (DARTs)
- Tandem diabodies (TandAbs)
- Indication Outlook (Revenue, USD Million; 2022-2032)
- Oncology
- Infectious Diseases
- Neurological Disorders
- Autoimmune and Inflammatory Disorders
- Others
- Regional Outlook (Revenue, USD Million; 2022-2032)
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- France
- U.K.
- Italy
- Spain
- Benelux
- Nordic Countries
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- South Korea
- Oceania
- ASEAN Countries
- Rest of APAC
- Latin America
- Brazil
- Rest of LATAM
- Middle East & Africa
- GCC Countries
- South Africa
- Israel
- Turkey
- Rest of MEA
- North America