The pharmaceutical market is growing fast. According to Statista, revenue in the global pharmaceuticals market is expected to reach US$1,156.00 billion in 2024, growing at an annual growth rate (CAGR) of 6.19% between 2024 and 2028. The largest market is oncology, predicted to be worth US$214.10 billion in 2024.
It’s also an industry that’s changing fast. Basic research is adding new approaches to treating specific diseases, and new technologies are allowing researchers to find new leads at lower risk of failure.
Changing the balance between small molecules and biologics
Biologics have changed the way that diseases are treated, allowing more effective management of life-limiting diseases such as cancer, and diseases like Crohn’s disease and rheumatoid arthritis that have major impacts on quality of life. Since the launch of the first biologic, Genentech/Lilly’s recombinant human insulin (Humalin), in 1982, the biologics market has grown, with half of the top 10 bestselling drugs in 2023 being biologics, all with blockbuster incomes. With the launch of new biologics expected in 2024, this market will continue to grow, challenging the traditional dominance of small molecule drugs.
The use of biologics, especially in low- and middle-income (LMIC) countries, is limited by the cost. The most expensive drug in the world, CSL Behring’s gene therapy Hemgenix (etranacogene dezaparvovec-drlb), costs $3.5 million per one-time dose. When biologics’ patents expire, this opens up the market to the launch of biosimilars, and the competition drives the price of the drug down. AbbVie’s biologic Humira (adalimumab), the best-selling drug of all time, lost its patent exclusivity in 2023. In July 2023 alone, seven number of biosimilar versions of Humira were launched in the USA. With this and other expiries, the biosimilars market will continue to grow in 2024.
The growth of AI in biopharma
Drug discovery and development is a long and costly process. According to the business services consultancy Deloitte in 2022, the average cost of drug development is around $2.3 billion. Taking a drug through clinical development can take ten or 15 years. Biopharma companies are looking to artificial intelligence and machine learning to speed up development, reduce the risk of failure and lower costs.
Training AI on patient data from medical records and clinical trials, and drug data from published literature, helps researchers to better understand diseases and learn more about the mechanism of action of existing drugs. It will also allow researchers to tweak molecules virtually and predict drug efficacy, safety and side effects before synthesis, so allowing the selection of only the compounds most likely to succeed in studies. AI has a role in repurposing drugs – either those that have reached the market successfully or failed during development – for a new indication.
AI can also be used to improve the manufacturing process, reducing waste, increasing efficiency and maintaining quality control. However, problems remain with the use of AI, including issues with patient confidentiality, the challenges of digitizing existing data, and the lack of standardization of tools and data across the industry.
Precision medicine growth outside oncology
Precision medicine has been a game-changer for cancer treatment. Using knowledge of biomarkers to select the right treatment for the right patient means that the patients most likely to respond can be fast-tracked onto the best medications for them, and those least likely to respond can move onto other treatments. Immunotherapeutics used in precision oncology are also associated with better outcomes and fewer side effects.
Interest is growing in precision medicines for those indications where the patient populations are heterogenous, there are a number of gene variants associated with the disease, and not all drugs are effective for all patients. Precision medicine has a huge potential in antibiotic stewardship, with rapid diagnostics allowing healthcare professionals to select the most appropriate antibiotic for a particular infection, rather than using broad-spectrum antibiotics that risk increasing antibiotic resistance. Other therapeutic areas that could benefit from a precision medicine approach include rare diseases, neuroscience, immunology, women’s health, cardiovascular and metabolic disorders, and a wide range of diseases such as asthma, chronic kidney disease (CKD) and chronic obstructive pulmonary disease (COPD).
Continuing links between diagnostics and therapeutics
Approvals for diagnostics used for diagnosis and screening, prognosis and risk assessment, therapy guidance and monitoring are growing. As the use of precision medicine grows, in oncology and beyond, companion diagnostics will be essential for researchers to be able to select the right patients for clinical trials, and healthcare professionals to tailor treatments to individual patients.
Changes in clinical trials
Using real world data (RWD) in clinical trials isn’t new, but it’s likely to become a more regular part of drug development. Regulatory authorities are increasingly accepting observational studies and real-world evidence (RWE) to support the design of clinical trials and back up study findings.
Biomedical research has historically excluded women. Women and people of color are less likely to enroll in clinical trials than men, and many studies do not differentiate between gender or ethnic origin in the data analysis. Studies also exclude people based on age or health status. As there can be differences in the way that different groups of patients respond to drugs, or the stage they seek treatment, it is vital that studies are as diverse as possible in order to reflect the real-world environment where the treatments will be used.
Growing demand for accessibility to medicines
Many medicines, especially biologics, are unaffordable for patients in LMICs. There will be an increasing demand for the pharmaceutical industry to improve access for affected patients through responsible pricing strategies, subscription models, partnership programs and better supported supply chains. Companies will also be encouraged to focus on global health priorities, not just the priorities of higher-income countries, and see the importance of a business strategy that includes LMICs as growing markets.
Climate change driving drug demands
It is impossible to hide from the growing impact of climate change. The global surface temperature and levels of atmospheric carbon dioxide are increasing, sea ice and glaciers are melting, and the weather is becoming more extreme. This will affect the distribution of communicable diseases, with warming increasing the potential range of disease-carrying vectors such as ticks and mosquitoes, and deforestation exposing humans to animal pathogens.
Biopharma companies are dealing with this driver in a number of different ways. In order to reduce their impact on the climate, companies are already cutting greenhouse gas emissions, both in-house and throughout their supply chain, through more efficient manufacturing processes, the use of renewable energy, reducing the amount of physical paperwork, improving packaging, and managing recycling and waste.
As a response to changes in temperature and weather, companies will need to take steps to ensure that medications are heat stable to make packaging and transportation easier. There is also expected to be an increase in investment to fight existing and emerging infectious diseases, particularly those with the potential to evolve into a global pandemic.
About the Author:
Based in the north of England, Suzanne Elvidge is a freelance medical writer with a 30-year experience in journalism, feature writing, publishing, communications and PR. She has written features and news for a range of publications, including BioPharma Dive, Pharmaceutical Journal, Nature Biotechnology, Nature BioPharma Dealmakers, Nature InsideView and other Nature publications, to name just a few. She has also written in-depth reports and ebooks on a range of industry and disease topics for FirstWord, PharmaSources, and FierceMarkets. Suzanne became a freelancer in 2006, and she writes about pharmaceuticals, consumer healthcare and medicine, and the healthcare, pharmaceutical and biotechnology industries, for industry, science, healthcare professional and patient audiences.
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