Bioengineered Protein Drugs Market Size, Share, Growth, Trends, and Global Industry Analysis: By Therapeutic Area (Oncology, Immunology, Metabolic Disorders, Neurological Disorders, Cardiovascular Diseases), By Expression System (Mammalian Cell Culture, Bacterial Expression, Yeast Expression, Plant Expression, Insect Cell Expression), By Route of Administration (Intravenous, Subcutaneous, Intramuscular, Intraperitoneal, Topical) and Region Forecast 2020-2031

Bioengineered Protein Drugs Market size was valued at US$ 365.0 million in 2024 and is expected to reach US$ 567.2 million by 2031, growing at a significant CAGR of 6.5% from 2025-2031. Moreover, the U.S. Bioengineered Protein Drugs Market is projected to grow at 6.0% CAGR over forecast period. The market encompasses therapeutic products derived from recombinant DNA technology, designed to replicate or enhance the functions of naturally occurring proteins in the human body. These drugs are created through genetic engineering techniques that modify living cells such as bacteria, yeast, or mammalian cells to produce specific proteins with desired therapeutic effects. Bioengineered protein drugs include monoclonal antibodies, hormones, enzymes, cytokines, and blood factors that are widely used in treating chronic and complex diseases such as cancer, diabetes, autoimmune disorders, and cardiovascular conditions.

The market is experiencing robust growth driven by advancements in biotechnology, increased prevalence of chronic diseases, and rising demand for targeted and personalized therapies. Pharmaceutical companies are investing heavily in R&D to develop more stable, effective, and safer protein-based therapeutics. The integration of artificial intelligence and bioinformatics in protein design is further accelerating innovation. Moreover, growing regulatory approvals, coupled with expanding biopharmaceutical manufacturing capabilities, are supporting global market expansion. North America currently leads the market due to its strong healthcare infrastructure and research ecosystem, while the Asia-Pacific region is emerging as a key growth hub owing to rapid biotechnology advancements and increasing healthcare investments.

Facts & Figures

• In 2023, the FDA’s Center for Biologics Evaluation and Research (CBER) approved 18 novel biologics under biologics license applications (BLAs), and of these, 12 had orphan-designations, indicating they treat rare diseases.
• In 2024, the U.S. Food and Drug Administration (FDA) approved 50 novel drugs, of which 16 were biologics (monoclonal antibodies and proteins).
• Over the period 2015-2023, across new biologics approved by FDA, 123 biologics were approved, approximately 29.6% of all novel drugs approved in those years; of those 123 biologics, 60 (~48.8%) were granted Orphan Drug Designation.

Key Developments:

• In September 2025, Biocon Biologics Ltd., a subsidiary of Biocon Ltd., obtained U.S. Food and Drug Administration (FDA) approval for two biosimilars of denosumab (used in osteoporosis and bone?loss therapy). One of the approvals included interchangeability designation, which allows a biosimilar to be substituted for the reference product—boosting its potential market adoption and reinforcing the trend toward more accessible protein based therapeutics.
• In October 2025, The FDA announced the first recipients of its “National Priority Voucher” pilot programme, selecting nine therapeutics (including biologics and protein based drugs) for expedited review timelines (within 1–2 months instead of the typical 10-12 months). This signals regulatory willingness to accelerate review of important biologic therapies, potentially benefiting the broader market for bioengineered protein drugs.

Bioengineered Protein Drugs Market Segmentation:

Based on the therapeutic area:

• Oncology
• Immunology
• Metabolic Disorders
• Neurological Disorders
• Cardiovascular Diseases

Among therapeutic areas, oncology stands out as the leading segment driving growth in the market. The increasing global burden of cancer has intensified the demand for targeted and personalized therapies, positioning bioengineered proteins—particularly monoclonal antibodies, antibody-drug conjugates, and immune checkpoint inhibitors at the forefront of treatment innovation. These protein-based drugs offer superior specificity by selectively binding to tumor-associated antigens, thereby minimizing damage to healthy cells and improving patient outcomes. According to the World Health Organization (WHO), cancer accounts for nearly 10 million deaths annually, with breast, lung, and colorectal cancers being the most prevalent.

This alarming incidence has led to massive investments in oncology-focused biologic research and clinical trials. Continuous advancements in protein engineering, combined with immunotherapy breakthroughs such as PD-1/PD-L1 inhibitors, have further accelerated therapeutic progress. As a result, oncology remains the dominant and most rapidly expanding application area within the market.

Based on the expression system:

• Mammalian Cell Culture
• Bacterial Expression
• Yeast Expression
• Plant Expression
• Insect Cell Expression

Within the bioengineered protein drugs market, mammalian cell culture systems represent the leading and most widely adopted expression platform. This dominance is driven by their superior ability to produce complex recombinant proteins with human-like post-translational modifications, such as glycosylation, which are essential for biological activity, stability, and therapeutic efficacy. Mammalian systems particularly Chinese Hamster Ovary (CHO) cells are the industry standard for manufacturing monoclonal antibodies and other high-value biologics used in oncology, immunology, and metabolic disorder treatments. These cells can express intricate protein structures that bacterial or yeast systems cannot replicate with comparable accuracy.

Furthermore, advancements in cell-line engineering, serum-free media optimization, and bioreactor technology have enhanced productivity and scalability, reducing production costs over time. Regulatory agencies like the U.S. FDA and EMA also favor mammalian systems due to their proven safety and reliability profiles. Consequently, mammalian cell culture continues to be the primary driver underpinning large-scale biologics manufacturing worldwide.

Based on the route of administration:

• Intravenous
• Subcutaneous
• Intramuscular
• Intraperitoneal
• Topical

The intravenous (IV) route of administration remains the leading and most influential segment in the market, primarily due to its ability to deliver precise and immediate therapeutic effects. IV administration enables direct entry of bioengineered proteins into the bloodstream, ensuring rapid onset of action, complete bioavailability, and controlled dosing accuracy critical for biologics such as monoclonal antibodies, cytokines, and recombinant enzymes. This route is particularly favored in oncology, immunology, and critical care settings, where high molecular weight protein drugs must bypass the digestive system to maintain their structural integrity and efficacy. Hospitals and infusion centers continue to serve as major distribution points for IV biologics, supported by advanced infusion technologies and patient monitoring systems. Although research is expanding into subcutaneous and oral delivery formats, the intravenous route remains dominant due to its proven clinical reliability, consistent pharmacokinetics, and established regulatory and medical acceptance worldwide.