Antibody Uses/Therapeutics

A synthetic biology perspective

A subset of SynBio - antibody uses/therapeutics related patents were identified during the hybrid topic modelling stage applied to SynBio EPO patents. The publication year trends are shown in figure 11.1, together with the subset related to fusion protein patents within the antibody uses/therapeutics topic. Publication trends discussed below are based on EP A1/A2 applications.

In figure 11.1, the peak publication figures for SynBio antibodies occurred in 2023 (2980 publications), with a compound annual growth rate (CAGR) of 13% during 2014-2023. The antibody subset related to fusion proteins also peaked in 2023 (1091 publications) with a CAGR of 18.1% during 2014-2023. The fusion protein related subset accounted for 30.3% of the total antibody based publications during 2004-2023. The recent evidence suggests strong growth amongst SynBio- antibody uses & therapeutics related publications.

The INPADOC legal status breakdown of the SynBio antibody uses/therapeutics subset published during 2014-2023 is shown in figure 11.2.

The INPADOC based legal status stats in figure 11.2 revealed approx. 55% of patents are pending with 23% already granted, reflecting an established and growing field. The legal status data suggests the topic has a large proportion of alive patents (78%) plus the high pending proportion (55%) indicates the potential for further growth.

Publication year subtrends

The publication trends for further subtopic areas within the antibody uses/therapeutics topic were investigated; vaccine related, immunotherapy related, drug delivery & targeting and biomarkers and diagnostics, shown in figure 11.3a.

During 2014-2023, the vaccine subtrend grew at 14.1% CAGR, immunotherapy related at 26.8% CAGR and drug delivery and targeting at 15.6% CAGR, all exhibiting rapidly growing trendlines peaking in 2023, representing strong areas of growth within the SynBio antibody topic. Biomarkers and diagnostics patenting has lagged behind the peak in 2011. The publication trends for additional subtopic areas within the antibody uses/therapeutics topic were investigated; chimeric antigen receptors, pathogen detection, antibody-drug conjugates and CRISPR, shown in figure 11.3b.

During 2014-2023, the chimeric antigen receptors related subtrend grew explosively at 49.2% CAGR, antibody-drug conjugate related at 13.4% CAGR and CRISPR exploded at 69.1% CAGR (2015-23), all exhibiting rapidly growing trendlines peaking in 2023, representing strong areas of growth within the SynBio antibody topic. Pathogen detection has lagged behind the peak in 2011 but has been resurgent recently, potentially antibody testing for COVID-19 having an influence here.

The filing trends for the SynBio antibody uses/therapeutics subset and subtrend areas are shown in figures 11.4a & 11.4b. Here we explore the filing or application date of published applications, data is restricted to 2021 due to the potential for an 18 month delay between filing and publication.

In figure 11.4a the overall antibody filings trendline is growing rapidly, experience 23.1% growth year-on-year in 2021. There is also a surge for vaccines (69%) and drug delivery (29.2%) year-on-year in 2021. Fusion proteins and Immunotherapy exhibit strong growing trendlines contributing to the growth of SynBio antibody filings overall.

In figure 11.4b, there is a surge of 61.2% year-on-year In 2021 for pathogen detection, the increasing trend potentially driven by antibody testing of COVID-19. Chimeric antigen receptors exhibit a rapidly increasing filings trendline peaking in 2021, similarly antibody drug conjugates and CRISPR are also contributing to the growth of the SynBio antibody topic.

The distribution of top 20 CPC classifications is skewed towards therapeutic applications including cancer treatment e.g. A61P35/00, immunotherapy (C07K14/7051, A61K39/4611, etc.) and chimeric antigen receptors (A61K39/4631), amongst others in figure 11.5. The class descriptors are manually refined for readability, the counts are cumulative publications and publication year based.

In figure 11.5, a fast growing classification area identified is antineoplastic agents (A61P35/00), growing at 15.8% CAGR during 2014-2023. Antineoplastic agents represent the largest CPC classification identified within the antibody topic, peaking in 2023 with a 6.4% percentage increase year-on-year. Antibody based medicinals comprising viral antigens (A61K39/12) increased rapidly in 2023 with a 65.6% increase year-on-year, potentially influenced by the recent rise in vaccine related patenting activity. The chimeric antigen receptor classification area (A61K39/4631) grew explosively by 53% CAGR during 2014-23. Another immunotherapy related area concerning t-cells (A61K39/4611) grew at 31.9% CAGR during 2014-23.

Growing areas within SynBio - antibody uses/therapeutics: compound annual growth rate (CAGR)

The SynBio antibody uses/therapeutics related CPC classifications were further investigated to identify areas with a positive compound annual growth rate (CAGR) to identify trending areas, shown in figure 11.6. The selected classes have a cumulative total above 500 publications (due to the number of candidates) during the publication period and are relevant for SynBio subject matter.

In figure 11.6, the fastest growing classifications identified relate to vaccines (61% CAGR) and medicinals comprising antigens/antibodies for Coronaviridae (59% CAGR), with COVID-19 influencing the growth occurring here. Chimeric antigen receptor (CAR) related medicinals grew at 53% CAGR representing a fast paced innovative area within the antibody topic. There exists a cluster of immunotherapy related classifications with strong growth in the range of 32.7% to 48.7%. Specific applications such as fusion polypeptides, single domain antibodies, cancer antigen medicinals, liposomes / nanoparticles for delivery of antibodies and antibody drug peptides all had strong compound annual growth rates. Notable patent examples within the classes identified using citing patent counts, top assignees, etc. include EP3929216A1 (HOFFMAN LA ROCHE) disclosing anti-pd-l1 antibodies and their use to enhance t-cell function, EP3660029A1 (UNI PENNSYLVANIA) disclosing chimeric antigen receptor-modified t cells to treat cancer. From a UK perspective, PROKARIUM with EP4124342A1 disclosing cancer therapy with a live attenuated bacteria which could be administered in combination with a therapeutic antibody.

Growing areas within SynBio - antibody uses/therapeutics: average growth rate

The average number of publications during two 5 year publication periods; 2014-18 & 2019-23 are contrasted in figure 11.7. The CPC classification codes within the antibody uses/therapeutics topic, related to SynBio and with sufficient publication totals are analysed.

In figure 11.7, antineoplastic agents within the antibody topic more than doubled to 1258 publications on average per year during 2019-23. This is likely influenced by the growth of chimeric antigen receptors or CAR-T cell therapy which increased by over 5 times to 423 publications per year on average during 2019-23. Immunotherapy related classifications such as A61K35/17 (567 publications) and C07K14/7051 peptides – t-cell receptor (496 publications) have seen strong growth on average per year during 2019-23. The drug peptides, or antibody conjugates grew to 114 publications and the use of liposomes and nanoparticles for drug delivery, etc. grew to 88 publications on average per year during 2019-23, representing a niche area of innovation.

SynBio - antibody uses/therapeutics: top 30 applicants

The total number of publications for the top 30 SynBio antibody uses/therapeutics related applicants are shown in figure 11.8, contrasting the overall publication period (2004-23) with a more recent perspective during 2014-2023.