Recombinant Proteins & Nucleic Acids

A synthetic biology perspective

A subset of SynBio - recombinant proteins & nucleic acids related patents were identified during the hybrid topic modelling stage applied to SynBio EPO patents. The publication year trends are shown in figure 13.1, together with the subset related to enzyme based patents within the recombinant proteins & nucleic acids topic. Publication trends discussed below are based on EP A1/A2 applications.

In figure 13.1, the peak publication figures for SynBio recombinant proteins & nucleic acids occurred in 2011 (2267 publications) which has been identified as an outlier year for divisionals. Since 2011, there has been an increasing trendline during 2014-23 growing with a compound annual growth rate (CAGR) of 7.4% during 2014-2023. The antibody uses & therapeutics subset had a CAGR of 8.7% during 2014-2023. The antibody related subset accounted for 35% of the total drug delivery & targeting topic. The recent evidence suggests strong growth amongst SynBio- drug delivery & targeting related publications.

The INPADOC legal status breakdown of the SynBio recombinant proteins & nucleic acids subset published during 2014-2023 is shown in figure 13.2.

The INPADOC based legal status stats in figure 13.2 revealed approx. 49% of patents are pending with approx. 28% already granted, reflecting an established and growing field. The legal status data suggests the topic has a large proportion of alive patents (77%) and the high pending proportion (49%) indicates the potential for further growth.

Publication year subtrends

The publication trends for further subtopic areas within the recombinant proteins & nucleic acids topic were investigated; Other compounds, pharma etc., fusion proteins, genetically modified microorganisms (GMOs) and gene expression regulation, shown in figure 13.3.

The subtrends reveal how fusion proteins grew at 10.4% CAGR, genetically modified microorganisms at 13.6% CAGR and gene expression regulation at 12.3% CAGR during 2014-23, representing fast growing key subtopic areas. Other compounds, pharma, etc. have been produced using recombinant technology consistently during the last 10 years analysed (2014-23) but lag behind the peak in 2011, an outlier for EPO divisionals.

The filing trends for the SynBio recombinant proteins & nucleic acids subset and subtrend areas are shown in figure 13.4. 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 13.4, there exists an increasing trend for SynBio recombinant proteins & nucleic acids with recent peak filing levels, a trend present amongst other subset areas such as antibody uses & therapeutics, fusion proteins, genetically modified microorganisms (GMOs) and gene expression regulation, all contributing to the development of the topic. The recombinant production of other compounds and pharma experienced a declining filings trendline.

In figure 13.5, the top 20 CPC class distribution is heavily influenced by antineoplastic agents (A61P35/00) with 4292 publications. Unsurprisingly given the recombinant aspect of this topic, there exists a variety of genetic engineering based classification codes, where DNA or RNA fragments (C12N15/11) is the largest classification identified with 3823 publications. Medicinal preparations comprising peptides, gene therapy and antibodies are quite prominent. CRISPR is also a top 10 classification code with 1981 publications. The class descriptors are manually refined for readability, the counts are cumulative publications and publication year based.

The top 20 CPC classification analysis reveals a number of areas which have peaked either recently or in 2023. Antineoplastic agents has almost doubled in size between 2014-23 with a CAGR of 6.9% during this period, recombinant proteins and nucleic acids are an important agent in the fight against cancer. The genetic engineering of DNA and RNA fragments has more than tripled during 2014-23, CAGR of 13.5%, similarly antisense type nucleic acids have grown at 16.1% CAGR. Antibody and fusion protein based medicinals have roughly doubled during 2014-2023, unsurprisingly CRISPR related recombinant proteins and nucleic acids patenting has grown explosively at 63.6% CAGR during 2014-23. The use of viral vectors for protein expression, etc. grew at 23.9% CAGR during 2014-23, peaking with 397 publications in 2023.

Growing areas within SynBio - recombinant proteins & nucleic acids: compound annual growth rate (CAGR)

The SynBio recombinant proteins & nucleic acids related CPC classifications were further investigated to identify areas with a positive compound annual growth rate (CAGR) to identify trending areas, shown in figure 13.6. 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 13.6, the genetic engineering related cluster of classifications grew rapidly at a CAGR range between 23.1% to 53.6% during 2014-23. The influence of CRISPR related patenting, mutagenising nucleic acids, genetically modified cells and viral genomes such as Dependovirus (Adeno Associated virus) has contributed to recombinant protein and nucleic acid topic innovation. The use of recombinant proteins and nucleic acids within immunotherapy has also accelerated between 27.6-43.45 CAGR. The specific cellular immunotherapy class (A61K39/4611) grew at 27.6% CAGR. The therapeutic classification codes such as chimeric antigen receptors grew at 42.9% CAGR during 2014-23, driven by the development of recombinant produced antibodies.

Growing areas within SynBio - recombinant proteins & nucleic acids: average growth rate

The average number of publications during two 5 year publication periods; 2014-18 & 2019-23 are contrasted in figure 13.7. The CPC classification codes within the recombinant proteins & nucleic acids topic, related to SynBio and with sufficient publication totals are analysed.

In figure 13.7, within the recombinant and nucleic acid topic, antineoplastic agents for cancer treatment has risen to 514 publications on average per year in 2019-23, representing one of the largest therapeutic areas. The use of non-coding nucleic acids modulating gene expression more than doubled to 462 publications per year in 2019-23. Nucleic acids involving CRISPR increased by nearly 5 times to 329 publications on average per year in 2019-23. There is strong growth in several areas related to viral vectors, medicinal preparations comprising peptides and immunotherapy related classification areas.

SynBio - recombinant proteins & nucleic acids: top 30 applicants

The total number of publications for the top 30 SynBio recombinant proteins & nucleic acids related applicants are shown in figure 13.8, contrasting the overall publication period (2004-23) with a more recent perspective during 2014-2023.