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Biopharmaceutical benchmarks 2018

Walsh, Gary·2018·Nature Biotechnology

DOI 10.1038/nbt.4305

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Car t cell immunotherapy for human cancer
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Background
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“[1] Walsh G (2018) Biopharmaceutical benchmarks 2018.”
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Background
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Background
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Method
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Background
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Background
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“The global market value of recombinant coagulation factors was approximately $8.5 billion in 2017 (Walsh, 2018).”
BackgroundInfluential
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Background
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“Because mammalian cells can carry out intricate post-translational alterations, such as appropriate folding and glycosylation, they are favored for the manufacture of therapeutic antibodies [8].”
A biosensor toolbox for monitoring recombinant protein production in Escherichia coli
Mürköster, M., Bałka, M., Kamp, C. J., Källström, J., Karlsson, L., Aparicio, C. A. R., Tunäng, E., Ögren, H.-L., Theopold, S., Cumming, A. J., et al. (2026) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2026.1956994
“…may be purified for use as biopharmaceuticals, vaccines, diagnostic tools, biotechnology reagents, foods and food additives, or research objects (Walsh, 2018; Gavrilescu and Chisti, 2005; McElwain et al., 2022; De Pinho Favaro et al., 2022; Choi et al., 2024; Graham and Ledesma-Amaro, 2023).”
Near UV Photo-Degradation of IgG1-Fc Promoted by His and Fe(III): Probing the Role of the Metal-Binding Pocket by Site-Directed Mutagenesis
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Bolla, V., O’Dell, W. B., Kolanupaka, S. H. B., Dahodwala, H., Cavicchi, R. E., Lyon, R. B., Kelman, Z., Marino, J. P., & Karageorgos, I. L. (2026) · Protein Expression and Purification · doi:10.1016/j.pep.2026.107020
Improved clone selection by combining a manufacturability index with semi-perfusion scale-down screening systems
Dorn, M., Ferng, C., Klottrup-Rees, K., Lee, K., & Micheletti, M. (2026) · Current Research in Biotechnology · doi:10.1016/j.crbiot.2026.100423
Enzymatic Bioremodelers: From Molecular Mechanisms to Clinical Applications in Aesthetic and Regenerative Medicine
Barbosa, A. D. P. (2026) · Journal of Cosmetic Dermatology · doi:10.1111/jocd.71180
“Recent advances in recombinant DNA technology, protein engineering, and directed evolution have transformed therapeutic enzymes from niche biological tools into sophisticated precision therapeutics [7, 68, 69].”
An expression framework for production of recombinant methionine aminopeptidase in Escherichia coli: a case study of upstream process.
Kuznetsov, G., Yarovikova, M., Buslaeva, E., Bochkareva, M., Salimova, D., Tilga, E., Khasanshina, Z., & Dray, R. (2026) · Protein Expression and Purification · doi:10.1016/j.pep.2026.106996
Paving the Way for a Minimal CHO ChassisExploring the Upper Limits of Megabase-Scale Deletions through DNA Repair Modulation
Bräuer, M., Walker, E., Schneider, S., Weiß, L., Geiger, A., Lindner, B., Hädicke, O., Schmidt, M. J., Fischer, S., & Otte, K. (2026) · ACS Synthetic Biology · doi:10.1021/acssynbio.6c00460
Translational insights into manufacturability and stability of broadly neutralizing antibodies for pediatric HIV prevention: lessons from plant-produced CAP256-VRC26.25
Tsekoa, T. L., Kwezi, L., Pillay, P., Mtimka, S., Moralo, M., Alexandre, K. B., Nkolola, J. P., Barouch, D. H., & Chikwamba, R. (2026) · Frontiers in Pediatrics · doi:10.3389/fped.2026.1837801
“These systems rely on large-scale bioreactor facilities, extensive purification processes, and highly specialized supply chains, all of which contribute to the high cost of antibody medicines (19).”
Smart protein therapeutics as a biological closed loop control system for neural regulation
Alfaifi, K. A. (2026) · Discover Neuroscience · doi:10.1186/s13064-026-00309-x
“…interface technologies and bioelectronic systems have introduced new possibilities for responsive neuromodulation, their functionality is often constrained by static programming, limited molecular responsiveness, and insufficient integration with intrinsic biological feedback mechanisms [1–5].”
Enhancing intracellular delivery of nucleic acid cargo by cell-penetrating peptide-based nanoparticles with small-molecule additives by post-formulation incorporation
Arya, G., Porosk, L., Maloverjan, M., Lorents, A., Emenike, C. R., Lehto, T., & Pooga, M. (2026) · Materials Today Nano · doi:10.1016/j.mtnano.2026.100895
Recombinant protein drug metabolism and pharmacokinetics
Jiang, J.-B., Zhao, H.-Y., Miao, Z., & Miao, C. (2026) · Pharmacological Reviews · doi:10.1016/j.pharmr.2026.100155
Beneficial Hepatokines in MASLD/MASH: Therapeutic Potentials and Drug Delivery Challenges
Amatya, R., Min, K. A., & Shin, M. C. (2026) · International Journal of Molecular Sciences · doi:10.3390/ijms27167118
Engineering Antivenom: Research Progress and Future Directions in Snakebite Envenoming Therapy
Laustsen, A. H. (2026) · Annals of the New York Academy of Sciences · doi:10.1111/nyas.70385
“In contrast to traditional antiven-oms, which comprise heterogeneous mixtures of polyclonal antibodies, recombinant approaches enable the development of well-defined oligoclonal mixtures targeting toxins of high medical relevance [ 94, 95 ] (Figure 4 ).”
From Bioreactor to Market: Opportunities and Challenges of Animal-Free Proteins from Precision Fermentation, Cell Culture and Molecular Engineering
Fernandes, B., Teixeira, I., Barros, J., Pinto, C. A., & Saraiva, J. A. (2026) · Applied Sciences · doi:10.3390/app16157392
Biological Functions of Glycosylation and Their Application in Glycoengineered Therapeutics
Kubalek, C., Gardiner, S., Heaps, W. P., McCammon, K. M., Talcott, S., Argyle, M., Bundy, B. C., & Corte, D. D. (2026) · ChemEngineering · doi:10.3390/chemengineering10070085
“CHO cells are highly adaptable to suspension culture, amenable to a broad range of genetic engineering modifications, and benefit from decades of regulatory precedent [111,112].”
Analytical Ultracentrifugation for Biopharmaceutical Characterization and Quality Control
Yu, X.-J., Chu, W.-D., Chang, Q., Zhao, K., Wang, Z.-X., Zeng, C.-S., Wang, L., Yu, C.-F., & Li, W.-Q. (2026) · International Journal of Molecular Sciences · doi:10.3390/ijms27136075
“Significant differences exist in the molecular structures, manufacturing processes, mechanisms of action, and quality attributes among the different biotechnological drug categories, collectively forming a diversified biopharmaceutical system [1].”
Development of a Process Toolbox to Modulate the Afucosylation of Antibodies
Dopp, J. L., Hoshan, L., Cherecheş, D., Bui, A., Keil, G., & Khetan, A. (2026) · Biochemical engineering journal · doi:10.1016/j.bej.2026.110318
Pathways to Sustainable Biomanufacturing: Scalable Production of Biopharmaceutical Raw Materials and Biologics for Health Security
Reedy, J. M., Mariita, R. M., Munga, H. G., & Häfner, B. (2026) · Global South & Sustainable Development · doi:10.53941/gssd.2026.100019
“In particular, recombinant pharmaceutical biologics is a multibillion-dollar industry encompassing monoclonal antibodies [16], hormones such as insulin [17], growth factors such as growth hormones [18], therapeutic enzymes [19], among others.”
Anti-inflammatory and immunomodulatory therapies are associated with reduced risk of age-associated neurodegenerative diseases: impact of sex and treatment duration
Cortes-Flores, H., Torrandell-Haro, G., & Brinton, R. (2026) · Frontiers in Aging Neuroscience · doi:10.3389/fnagi.2026.1818660
“Biologic drugs are therapeutic products derived from living organisms that are typically large, complex molecules (U.S. Food and Drug Administration [FDA], 2020; Walsh, 2018).”
Sequence-dominant protein therapeutics: mechanistic foundations for efficient biologics development
Niazi, S. K. (2026) · Frontiers in Drug Discovery · doi:10.3389/fddsv.2026.1781560
Therapeutic Alternatives to Recombinant Biologics: Mechanistic Framework, Clinical Evidence, and Selection Guidance
Niazi, S. (2026) · Drug Design, Development and Therapy · doi:10.2147/dddt.s576169
A novel chassis for high-quality recombinant protein expression: apoptosis pathway engineering via multi-gene knockout and efficacy improvement of CHO cells
Wu, Y., Cao, Y., Guo, Z., Ma, Y., Zan, X., Gu, X., Zhang, F., Chai, C., Nui, R., Shang, Q., et al. (2026) · Journal of Biological Engineering · doi:10.1186/s13036-026-00669-2
“Chinese hamster ovary (CHO) cell lines serve as the cornerstone of the modern biopharmaceutical industry, accounting for the production of over 80% of recombinant therapeutic proteins worldwide, including monoclonal antibodies, enzymes, and hormones [1].”
DNA Damage Driven Viability Loss and Transcriptional Reprogramming in Chinese Hamster Ovary Cell Perfusion Culture
Hitchcock, N. B., Annoh, M., Grassi, L., Das, S., Ferreira, C. S., Ray, D., Elgendy, R., Wang, L., Lee, K., Sudbery, I. M., et al. (2026) · bioRxiv · doi:10.64898/2026.03.16.712126
Mitigating alkaline instability induced by tyrosine–tyrosine repulsion in an FcγRIIIa-binding protein through phenylalanine substitution
Okuda, R., Tokunaga, Y., Nagatoishi, S., Matsunaga, R., Terao, Y., Ide, T., & Tsumoto, K. (2026) · Journal of Biochemistry (Tokyo) · doi:10.1093/jb/mvag023
“Proteins are essential biomolecules for various industrial applications, including biopharmaceuticals, enzyme-based catalysis and biosensors (1, 2) .”
Generative Protein Design for Physiological Intervention: Progress and Horizons
Chien, P., & Wu, C.-C. (2026) · Journal of physiological investigation. · doi:10.4103/ejpi.ejpi-d-25-00068 · Cited by 1
AI‐Designed Cyclic Peptides Enable Controllable Modulation of the CD28 Immune Checkpoint
Kuncewicz, K., Upadhyay, S., Zhu, R., Duan, H., & Gabr, M. T. (2026) · Advanced Science · doi:10.1002/advs.75892 · Cited by 1
“To date, immune checkpoint modulation has been dominated by biologic agents, including monoclonal antibodies and receptor fusion proteins such as abatacept and belatacept, which effectively engage extended protein-protein interaction surfaces [ 14– 16 ].”
Molecular Pharming: Advances, Applications, and Future Prospects in Biotechnology and Medicine
Ahmed, M. H., Khan, M. U., Dutta, S., Rahman, M. F., Islam, M. S., Hosen, M. N., Hossain, M. S., Rahman, M. A., Sahil, M., Hira, T. T., et al. (2026) · Engineering in Life Sciences · doi:10.1002/elsc.70075
“…molecular pharming in microbes does not represent a distinct manufacturing strategy but rather a conceptual or semantic rebranding of recombinant microbial fermentation, with greater emphasis on pharmaceutical applications and platform comparison across biological production hosts [ 64, 68 ].”
"Biophysical and colloidal properties govern anti-drug antibody generation: A case study using the tumoricidal murine-derived monoclonal antibody 4713".
Yesmin, S., Islam, M. M., Islam, M. D., Tsurui, H., Saotome, T., Matsuoka, S., & Kuroda, Y. (2026) · International Journal of Biological Macromolecules · doi:10.1016/j.ijbiomac.2026.151430
Novel NTA-Ni2+ Agarose-Based Microspheres: Structural Features and Chromatographic Capacity
Zhao, M., Liang, C., Liu, B.-H., Javed, A., Zhou, R., Diao, X.-Z., Ren, C., & Wu, W.-H. (2026) · Polymers · doi:10.3390/polym18050566
“The rapid development of recombinant protein technology has increased the demand for efficient, specific downstream purification processes [1–3].”
Shear flow during reciprocal shaking does not disrupt protein films at the solid–liquid interface
Torisu, T., Iwamoto, N., Okada, R., Degura, N., Uchiyama, S., Osaka, N., Kukimoto, S., Watanabe, D., Motoori, Y., & Goto, S. (2026) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2026.126732
Advances in Pharmaceutical Research and Development through Artificial Intelligence and Machine Learning: A Review
Tiwari, A. K., Rai, K., Kahar, H., Khan, A., Quadiri, R., Lokhande, N., & Pandey, S. (2026) · Asian Journal of Research in Chemistry · doi:10.52711/0974-4150.2026.00006
Control strategy for subvisible particulates of therapeutic protein injections in pre-filled syringes using flow imaging.
Zhang, B., Flores, K., Horvath, N., Lopez, N. G., Sawant, N., Falcone, E. M., Kwok, S. C., Minocha, S., & Radhakrishnan, V. (2026) · Journal of Pharmacy and Science · doi:10.1016/j.xphs.2026.104168
Comparative analysis of common potency assays for assessing human TNF-alpha neutralising antibodies
Pradeep, R., Zhdanov, A. V., & Allen, E. A. (2025) · Analytical Biochemistry · doi:10.1016/j.ab.2025.116011
Development of a UCOE-Based Lentiviral Vector System for Recombinant COVID-19 Antigen Production in CHO Cells
Kose, P., BAYINDIRLI, K., Arslan, A. O., & Anakök, Ö. F. (2025) · International Journal of Peptide Research and Therapeutics · doi:10.1007/s10989-025-10775-2
“CHO cell lines account for approximately 60–70% of recombinant protein production in commercial products (Kim et al. 2012; Walsh 2018).”
Monoclonal Antibodies: Production, Therapeutic Applications and Real World Case Study in Cancer Management
Mithra, J. M., & Mund, A. (2025) · International Journal of Innovative Research in Engineering & Multidisciplinary Physical Sciences · doi:10.37082/ijirmps.v13.i5.232762
Interpretable Allergen Classification Using Protein Language Models and SHAP Explainability
Kirubakaran, A., & Bhargav, S. (2025) · 2025 IEEE MIT Undergraduate Research Technology Conference (URTC) · doi:10.1109/urtc68753.2025.11533101
“Recombinant proteins, specifically, are widely used in modern medicine for treating diseases such as cancer and autoimmune disorders [2].”
“Biophysical and Colloidal Properties Govern Anti-Drug Antibody Generation: A Case Study Using the Tumoricidal mAb 4713”Preprint
Yesmin, S., Islam, M. M., Islam, M. D., Tsurui, H., Saotome, T., Matsuoka, S., & Kuroda, Y. (2025) · bioRxiv · doi:10.1101/2025.09.03.674127
“Protein therapeutics are becoming increasingly important for the treatment of life-threatening diseases, including cancer and autoimmune disorders [1].”

Authors: Walsh, G.
Affiliations: University of Limerick (IE)
Corresponding author: Walsh, Gary
ORCID: Walsh, Gary
Venue: Nature Biotechnology
Publisher: Springer Science and Business Media LLC
Published: 2018-12
Volume: 36
Issue: 12
Pages: 1136-1145
ISSN: 0733-222X (ISSN-L)
1087-0156
1546-1696
DOI: 10.1038/nbt.4305
OpenAlex: W2917928050
Cited by: 978
References: 15
Citations by year: 2026: 68 · 2025: 68 · 2024: 88 · 2023: 141 · 2022: 173 · 2021: 197 · 2020: 173 · 2019: 65
FWCI: 165.34
Type: journal article
Language: en
Open access: closed
Licence: www.springernature.com/gp/researchers/text-and-data-mining (tdm)
www.springernature.com/gp/researchers/text-and-data-mining (vor)
Locations: Nature Biotechnology (publishedVersion)
PubMed (publishedVersion)
Topics: Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
Life Sciences › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
Keywords: biopharmaceutical market, monoclonal antibodies, cell therapy, gene therapy, biosimilars, biologics, market growth
MeSH terms: Animals, Antibodies, Monoclonal, Biological Products, Biotechnology, Drug Industry, European Union, Humans, Nucleic Acids, Recombinant Proteins, United States, United States Food and Drug Administration, Drug Approval, Benchmarking, Biosimilar Pharmaceuticals

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