Introduction
As we approach the end of 2024, the word “challenging” springs to mind as an overall summation. The year began with signs of cautious optimism, as noted during the J.P. Morgan Healthcare Conference. However, difficult global macroeconomic conditions persisted in 2024, driven by tightening investment funding, rising development costs, and increasingly demanding regulatory hurdles. Inflation and political instability, with changes in governments across multiple countries, further added to these pressures.
Despite the challenges, the biotechnology sector is beginning to show signs of improvement. Merck Life Sciences’ most recent Q3 2024 quarterly sales figures indicated the first growth in organic sales since Q1 20231. Similarly, Danaher observed sales growth in the third quarter of 20242. Examining the initial public offering (IPO) market as an indicator of overall health revealed the resurgence of biotech IPOs in 2024, signalling renewed confidence in the sector.
Research and innovation are constantly evolving. This is evident through the introduction of breakthrough therapies, streamlined workflows, and the increasing application of AI technology in biotechnology and website integration to enhance customer experiences. This year’s highlights in the biotech sector demonstrate an increasing recognition of the importance of reliable, high-quality reagents. The industry aims to understand the needs of end users better while acknowledging the challenges they face within research institutions.
Increased funding of gene and cell therapy-based companies by investors
Generating investment at every stage of a biotech business’s life cycle is critical to ensuring long-term success and sustainability. From early-stage research to commercialisation, financing is essential. Pivotal Scientific work with private equity and venture capital investors to enable biotech companies of different sizes to gain the financial assistance they require to grow and develop. In 2024, we noted that PE firms and venture capitalists are increasingly interested in targeting biotech companies with advanced technologies for gene editing, RNA therapeutics, and CAR-T cell therapies.
This increased interest in gene and cell-therapy-based companies by PE firms and venture capitalists is mirrored by the FDA approvals in the same therapy area at the end of 2023. The U.S. Food and Drug Administration (FDA) approved two cell-based gene therapies to treat sickle cell disease. This condition arises when individuals inherit two mutated haemoglobin genes — one from each parent — resulting in a defective haemoglobin protein. The first FDA-approved therapy to utilise the gene editing technology, CRISPR/Cas9, Casgevy, was developed by CRISPR Therapeutics and Vertex Pharmaceuticals Incorporated. In contrast, Lyfgenia, developed by bluebird bio, utilises a lentiviral vector to deliver a functional version of a haemoglobin-producing gene.
Heightened significance of antibody validation
Ensuring an antibody’s specificity and sensitivity has always been a cornerstone of scientific rigour. It is essential for passing the peer-review process to publish findings in high-profile scientific journals or to utilise them in a diagnostic workflow. Not only does ensuring reproducibility contribute to the rapid advancement of scientific and drug development pipelines, but it also saves money. The highest estimates report that over $1 billion is squandered annually due to poorly performing antibodies.
In 2015, Andrew Bradbury and Andreas Pluckthun published an influential article that highlighted the lack of standardised validation processes and the need for rigorous validation3. The following year, an ad hoc committee of international scientists with diverse research interests formed the International Working Group for Antibody Validation (IWGAV); they outlined five pillars required for antibody validation4. The committee recommended utilising multiple strategies to enhance the validity of conclusions regarding antibody validation4.
Similar good practice guidelines — RIVER recommendations (Reporting In Vitro Experiments Responsibly) — have been put together by the UK-based scientific organisation NC3Rs in collaboration with the Only Good Antibodies (OGA) community to increase integrity and reproducibility in biomedical research. The NC3Rs put these guidelines to the test when they gathered feedback from stakeholders from the bioscience community to assess the recommendations. A meeting organised by NC3Rs in February 2024, which included representatives of antibody manufacturers and end-users, emphasised that antibody manufacturers should provide “clear information on how to perform validation experiments in product datasheets”5.
Producing and publishing validation data is key in convincing end-users to purchase antibodies. This would, in turn, help encourage end users to consider the available information without simply purchasing historically well-published antibodies. In the context of the UK, this is particularly important against the increasingly unstable financial landscape of the UK’s life sciences university research sector, driven by increasing operational costs and a drop in international students, among other factors. Despite these issues, research funding remains strong, with the UK government committed to spending on research and innovation, with record levels — £20.4 billion allocated for science and technology in 2025/20266. Given UK universities’ extreme financial difficulties, this places added pressure on budgets. This has consequences for antibody suppliers and distributors, meaning end-users may exercise more prudence when purchasing research reagents, such as antibodies and may opt to encourage resource sharing through repositories or collaborations. So, providing an end-user with as much information on research reagents remains vital.
Increased focus on equitable risk-sharing arrangements
As a scientific consultancy company, Pivotal Scientific works with multiple clients on strategic partnerships. We have noticed that companies are increasingly taking a “try before you buy” approach to joint ventures or collaborations to share potential development and regulatory risks. This can be explained by the increased pressures of rising development costs — increases in raw materials, labour and operation, energy, and related costs to facilities and equipment — as well as the expenses and extensive supporting workflows required for meeting regulatory compliance.
Whether a company is going through the due diligence process to seek investment, for mergers or acquisitions, regulatory compliance reasons or strategic partnerships, a company working in the biotech space must be ready to anticipate the question beforehand on the related technology, process or partner. These questions may encompass aspects such as market trends, related technology, valuations, regulatory and IP considerations, strategy growth, and financing.
Unified workflows for studying spatial biology
Spatial biology encompasses the study of the interactions of cells and molecules in their native environment across multiple dimensions. One branch of spatial biology —spatially resolved transcriptomics — was voted Method of the Year 2020. Spatial proteomics has been recognised as Nature’s Method of the Year for 2024. Spatial biology is becoming increasingly significant in biotechnology, driven by new businesses and technologies.
Spatial biology is particularly important in drug development, personalised medicine and diagnostics. The increasing application of spatial biology is illustrated by the increase in citations in scientific literature by more than 500% in the last 20 years (from 2003-2023). This sector has also been the recipient of extensive funding awards. The state of development of the field, as seen in the high publication rate, is mirrored by the compound annual growth rate of elements of the overall field. A recent estimate placed the global spatial genomics and transcriptomics market size at $305.7 million US dollars and expected to grow at a compound annual growth rate (CAGR) of 15.2& from 2023 to 20327.
In early October of this year, we learned that Bruker is forming a new, single division from multiple assets acquired over the past four years related to spatial biology. The integration includes technologies originating from NanoString, Canopy Biosciences, and Bruker Spatial Genomics Inc. (formerly known as Acuity Spatial Genomics). The goal of merging these is to consolidate technology and provide customised solutions to meet customer needs in spatial biology research. In the same month, the two spatial biology companies, Vizgen (single-cell spatial genomics) and Ultivue (multiplex proteomic biomarker detection) announced a merger.
The unification of these spatial biology entities seeks to bridge the chasm between spatial genomics, transcriptomics and proteomics, which have historically existed as separate entities due to the distinct nature of the biological material analysed (DNA, RNA, and proteins, respectively) in addition to the different methodologies and equipment needed for applicable workflows. We will observe this sector with interest in 2025 to ascertain whether the combination of advanced technologies will better serve customers’ needs in spatial biology research.
Increased application and integration of AI technology
Due to their specificity, affinity, and remarkable versatility, antibodies are the most important class of biotherapeutics and have revolutionised modern-day medicine with personalised treatment of patients. Recent advancements in Artificial Intelligence (AI) have enhanced in silico antibody representations, improved structure prediction from sequences, and facilitated the design of novel antibodies optimized for specific developability properties.
One notable example of an AI tool that predicts protein structure is AlphaFold, for which the developers were awarded the Nobel Prize in Chemistry 2024. The initial version was developed in 2020 by Google DeepMind and Isomorphic Labs and demonstrated remarkable accuracy in predicting protein structure. Like large language models such as GPT, AlphaFold uses deep learning techniques to interpret patterns in protein sequences rather than focusing on language.
The new version of the model was released in May 2024 with the additional feature of predicting the joint structure of complexes, including proteins with other biomolecules, such as DNA, RNA and small chemicals. Unlike the previous version, AlphaFold 3 does not heavily rely on multiple sequence analysis, a common tool in phylogenetics in which a protein’s structure is deduced from evolutionarily similar proteins. Instead, it incorporates other methodologies, such as diffusion-based deep learning architecture. This enables biomolecular predictions to be more accurate and efficient, which means that novel or diverse structures can be better predicted8.
Models like AlphaFold can potentially aid epitope mapping to accelerate drug discovery pipelines in therapeutic antibody design. This model may not necessarily replace computational docking or modelling techniques and structural experimental methods but can speed up initial assessment and provide information when structural data is unavailable. The usage terms for AlphaFold 3 have changed and become more restrictive for commercial use, reflecting a trend of increasing commercialisation of AI technology in healthcare.
Another trend relating to AI technology is its increased integration into websites to improve website engagement and lead generation. For selling scientific products, integrating an AI chatbot into a website can act as an intermediary to aid customers by answering questions and distilling information about a scientific reagent or service.
Focus on high-growth areas
In 2024, M&A deals have increasingly focused on high-growth areas such as immunology, neurodegenerative diseases, and cell and gene therapy. Key deals included Merck’s acquisition of Curon Biopharmaceutical’s T-cell-engager bispecific antibody, CN201, which is currently being evaluated in Phase I/Ib/II clinical trials for B-cell malignancies. AbbVie also added to their existing oncology portfolio with the acquisition of ImmunoGen.
These focus areas were also highlighted in the NIH 2024 funding priorities. Although the final NIH budget remained essentially flat in the US, there were increases for these focus areas over 2023 levels. This included increased funding for the National Institute of Cancer as well as increased funding for Alzheimer’s disease and related dementia research.
Increased emphasis on knowing who you are working with — Chinese market
The biotechnology sector in China has experienced significant growth in mergers and acquisitions (M&A) activity through 2024, fuelled by progress in research and development, along with the rising interest in cutting-edge treatments such as CAR-T cell therapies and biologics. M&A transactions of Chinese biotech firms in 2024 have highlighted the growing interest of multinational companies in making strategic moves into the Chinese biopharma and healthcare markets through acquisitions.
Notable examples included the completion of the acquisition of Gracell Biotechnologies by AstraZeneca’s for $1.2 billion. Gracell Biotechnologies is a China-based clinical-stage bio-pharmaceutical company dedicated to discovering and developing innovative cell therapies. It is thought to be a significant step in expanding AstraZeneca’s portfolio of chimeric antigen receptor (CAR) T-cell therapies.
In 2024, Novartis took significant steps to strengthen its presence in China by acquiring SanReno Therapeutics. SanReno Therapeutics is a clinical-stage company specialising in developing innovative kidney disease therapies. This acquisition is noteworthy as it marks the purchase of a Chinese biotech firm by a multinational pharmaceutical company, highlighting the increasing interest of international companies in accessing China’s expanding healthcare market.
Knowing the individuals you work with is essential for achieving success. With Chinese biotech companies facing potential legal consequences due to links with the military and intelligence agencies related to national security, it remains vital to know the background of the companies. Whether it be for reasons of acquiring technologies or entering into the lucrative Chinese biotech market, Pivotal Scientific have worked alongside Chinese companies for decades. We offer diverse services to help biotech companies find reliable and high-quality partners in China and access to the Chinese Market.
Concluding remarks
The biotech industry is facing ongoing challenges. Companies are tackling these issues by gaining a better understanding of their end users and providing high-quality, flexible solutions.
Note: Specific mentions of products, technologies, or resources are included in this text. However, these are used solely as examples, and alternatives are available.
Author: Tania Puvirajesinghe A PhD-qualified writer, Tania has 16 years’ experience with diagnostic devices and life sciences products in academia and industry for several therapy areas.
References
Merck. Q3: All sectors onto profitable growth. (2024).
2. Danaher. Danaher Reports Third Quarter 2024 Results. (2024).
3. Bradbury, A. & Plückthun, A. Reproducibility: Standardize antibodies used in research. Nature vol. 518 Preprint at https://doi.org/10.1038/518027a (2015).
4. Uhlen, M. et al. A proposal for validation of antibodies. Nature Methods vol. 13 Preprint at https://doi.org/10.1038/nmeth.3995 (2016).
5. NC3R. Improving the reproducibility of research using antibodies. https://nc3rs.org.uk/news/improving-reproducibility-research-using-antibodies (2024).
6. HM Treasury. Policy paper Autumn Budget 2024. Policy paper https://www.gov.uk/government/publications/autumn-budget-2024/autumn-budget-2024-html (2024).
7. Global Market Insights. Spatial Genomics and Transcriptomics Market Size. https://www.gminsights.com/industry-analysis/spatial-genomics-and-transcriptomics-market (2024).
8. Abramson, J. et al. Accurate structure prediction of biomolecular interactions with AlphaFold 3. Nature 630, 493–500 (2024).
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