Biotherapeutics Market Size, Share, Growth, Trends, and Global Industry Analysis: By Therapy Area (Oncology, Infectious Disease, Autoimmune Disease, Neurological Diseases, Haematological Disorders, Rare Diseases), By Manufacturing Type (In-house Manufacturing, Contract Manufacturing), By End User (Hospitals, Speciality Clinics, Research & Academic Institutes) and Region Forecast 2020-2031

Biotherapeutics Market size was valued at US$ 6,750 million in 2024 and is expected to reach US$ 10,240 million by 2031, growing at a significant CAGR of 6.8% from 2025-2031. Moreover, the U.S. Biotherapeutics Market is projected to grow significantly, reaching an estimated value of US$ 3,890 million by 2031. The worldwide biotherapeutic industry is entering a turning point age, with personalized therapy and precision biology rewriting clinical outcomes across oncology, autoimmune, and orphan diseases. In contrast to traditional medicines, biotherapeutics from recombinant proteins and monoclonal antibodies to cell and gene therapies are designed to work along with the body's biology.

With established biologics pipelines and patent cliffs forcing pharma giants into innovation modes, investment in future-generation biotherapeutics is increasing. Regulatory pathways are adapting to support advanced therapies, and scalable manufacturing modalities are shattering lab-to-clinic bottlenecks. The market is no longer dominated by heritage biologics; it is now driven by adaptive response-capable modular platforms, positioning biotherapeutics at the centre of future high-value, outcomes-driven healthcare.

Facts & Figures

• Over 60 biologics-derived medicines have been approved in the past two years alone worldwide, of which the largest proportion is monoclonal antibodies, attesting to the growing clinical confidence in target biotherapeutics.
• More than 20 nations have established regulatory systems with special models for faster review and approval of cell, gene, and RNA therapies.
• Top pharma players are now investing as much as 40% of R&D on biotherapeutics, spurred on by the better clinical performance and longer patent duration of biologics compared to conventional small-molecule drugs
• Manufacturing for biotherapeutics is moving towards single-use, modular technologies, allowing quicker, more local manufacturing with less risk of contamination and fewer batch cycles, particularly for precision therapies.

Key Developments:

• In July 2025, Sanofi buys Blueprint Medicines for up to $9.5?billion
• The acquisition brings Sanofi the oncology and rare disease medicine Ayvakit and biologics pipelines, new investment in high-value biologics
• In June 2025, Bio?Techne will provide USP reference standards for gene therapies and monoclonal antibodies, bringing analytical support for complex biologics together
• In May 2025, City Therapeutics and Biogen collaborate on RNAi therapies, This R&D partnership is committed to future siRNA therapeutics in neurological and immunological disease

Biotherapeutics Market Segmentation:

Based on the therapy area:

• Oncology
• Infectious Diseases
• Autoimmune Diseases
• Neurological Disorders
• Haematological Disorders
• Rare Diseases

Oncology remains the cornerstone of the market, accounting for the highest share due to the persistent global rise in cancer incidence. Biotherapeutics have revolutionized cancer care through targeted monoclonal antibodies and personalized therapies that improve survival rates while reducing side effects. Unlike traditional chemotherapy, these biologics focus on specific tumor markers, offering precision treatment. Leading products like trastuzumab and pembrolizumab demonstrate the sector’s maturity and continuous innovation.

Additionally, the pipeline for oncology-focused biotherapeutics is robust, driven by increased R&D funding, orphan drug designations, and breakthrough therapy approvals. As healthcare systems prioritize cost-effective, long-term solutions, oncology biotherapeutics continue to dominate clinical and commercial landscapes globally.

Based on the manufacturing type:

• In-house Manufacturing
• Contract Manufacturing

Contract manufacturing has become a strategic pillar in the biotherapeutics value chain, especially for emerging biotech companies lacking large-scale infrastructure. These specialized service providers offer advanced bioprocessing capabilities, regulatory expertise, and cost-effective scalability, allowing innovators to focus on core research. Contract Development and Manufacturing Organizations (CDMOs) have particularly surged in demand due to the complexity of biologics production, from cell line development to aseptic filling.

Notably, firms like Lonza and Samsung Biologics are key players trusted by pharmaceutical giants for end-to-end biotherapeutic production. As regulatory requirements grow more stringent and timelines tighten, contract manufacturing continues to rise as the preferred model for accelerating global biotherapeutics delivery.

Based on the end user:

• Hospitals
• Speciality Clinics
• Research & Academic Institutes

Hospitals remain the dominant end-users of biotherapeutics due to their comprehensive infrastructure, specialist workforce, and ability to administer complex biologics under controlled conditions. From cancer infusions to biologics for severe autoimmune or infectious diseases, hospitals serve as the critical interface between innovation and patient access. The intensive storage requirements, cold chain logistics, and monitoring needs of many biotherapeutics make hospital settings ideal for ensuring safety and efficacy.

Additionally, hospitals play a major role in clinical trials and early access programs, offering patients frontline entry to novel therapies. As biologics evolve and diversify, hospitals will continue to anchor their deployment across both acute and chronic care pathways.