Over the years, the incidence and prevalence of chronic diseases, such as diabetes, multiple sclerosis and rheumatoid arthritis, have increased significantly. This has led to the growing research and development towards the development of biologics for therapy purpose. These biologics are generally administered through parenteral route of administration in order to ensure maximum therapeutic benefit. Thus, patients suffering from such long-lasting clinical conditions generally end up getting frequent intravenous administrations. This also increases the cost of the treatment, in terms of both the cost of the prescribed therapeutic regimen and transportation / hospital cost (due to numerous hospital visits and other healthcare costs). In order to help circumvent these disadvantages, several drug delivery devices, which enable patients to self-administer drugs through subcutaneous route are now being developed. Moreover, such therapies have been shown to have a profound impact on patient compliance as well as therapy adherence, where the patients can self-administer the drugs.
Approved Subcutaneous Biologics Market Analysis: Current Landscape
The subcutaneous biologics market analysis for approved drugs presents over 175 subcutaneous biologics developed by around 50 drug developers, worldwide. Notably, the subcutaneous biologics market features the presence of very large and large players in the industry, which constitutes close to 90% of all the overall players. This indicates that the domain is well-established, providing drug developers with significant growth opportunities due to their necessary expertise and knowledge for the development of subcutaneous biologics. Notable examples of companies having a strong foothold in this industry include AstraZeneca, Bristol-Myers Squibb and Novo Nordisk. Further, the majority of the companies in the approved market are presently headquartered in North America.
The below figure presents the distribution of subcutaneous biologics based on initial approval year and type of biologic. It is important to note that, for the purpose of subcutaneous biologics market analysis, the biologics were segregated into antibodies, nucleotides, proteins and vaccines.
As can be observed in the figure, the highest number of subcutaneous biologics were approved between 2011 and 2020. Further, majority of the approved subcutaneous biologics are proteins. This can be attributed to the increased preference of proteins as drugs since these do not interfere with the normal biologic processes occurring within the body and have lower likelihood of causing adverse effects. Moreover, protein-based drugs are also well tolerated inside the body, thereby reducing the chances of causing any immune response in the body.
Clinical-Stage Subcutaneous Biologics Market Analysis: Current Landscape
The subcutaneous biologics market analysis for clinical-stage drugs presents over 340 subcutaneous biologics developed by around 120 drug developers, worldwide. Notably, the domain is predominantly characterized by the presence of mid-sized companies and small companies. This is indicative of the fact that the domain is currently expanding and holds the potential to present lucrative opportunities for players in the coming future. Notable examples of very large companies include Lundbeck, R-Pharm and UCB.
Different mechanisms of action through which subcutaneous biologics achieve their desired therapeutic effect were identified. For the purpose of subcutaneous biologics market analysis, we have categorized them into four types, namely inhibition, modulation, stimulation and other mechanisms. It is worth mentioning that the mechanism of action for around 60% of the clinical-stage subcutaneous biologics is based on inhibition, followed by those based on stimulation mechanism.
Subcutaneous Biologics Market Analysis: Formulation Technologies Landscape
The current technology landscape features over 40 subcutaneous formulation technologies that have been developed by more than 40 players engaged in this domain. The subcutaneous biologics market analysis exhibits the presence of mid-sized players and small players, constituting close to 70% of the overall market. Further, the majority of the subcutaneous formulation technology developers are based in North America, followed by those in Europe. It is worth noting that within North America, all the developers are based in the US. Further, within Europe, the UK emerged as the operational hub.
Interestingly, technology developers in the subcutaneous biologics market are actively leveraging their capabilities for the development of technologies utilizing different principles for the formulation / delivery of biologics and small molecules. For example, AstraZeneca’s technology leverages the unique characteristics of ultra-small silica particles, enabling the targeted delivery of biologics. These particles then can be combined with drugs and imaging agents, allowing for precise therapy directed at specific tissues, such as tumors. The below figure presents the subcutaneous biologics market analysis (for formulation technology), based on fundamental principle.
Further, majority of the technologies in the subcutaneous biologics industry are working on encapsulation principle. This can be attributed to the fact that encapsulation technology allows tailored release of the active compounds, enabling sustained or targeted delivery to specific sites in the body. This is particularly suitable for the biologics having short half-life and requiring frequent administrations.
Subcutaneous Biologics Market Analysis: Partnerships and Collaborations (Formulation Technology)
Based on the subcutaneous biologics market analysis, stakeholders in this domain are known to adopt a variety of partnership models in order to collaborate with other companies / organizations. Such deals are inked to allow companies to expand their respective technology / product portfolios, and gain additional capabilities related to subcutaneous biologics. Notably, technology licensing agreements emerged as the most popular type of partnership model adopted by stakeholders in the subcutaneous biologics market.
Insights on Approved Subcutaneous Biologics Market Analysis
Driven by the increased emphasis towards patient compliance and improved treatment outcome, the approved subcutaneous biologics market is anticipated to grow at an annualized growth rate of around 5%, till 2027. Currently, antibodies segment is likely to occupy the largest share in the overall market. Further, the market for nucleotides is anticipated to grow at a relatively faster pace, in the forecast period.
Future Evolution of Subcutaneous Biologics Formulation Technologies Market
Owing to numerous advantages offered by subcutaneous formulation technologies and increase in the number of licensing deals, our proprietary subcutaneous biologics market analysis suggests the formulation market to grow at an annualized rate of 22.7% in the coming decade. Currently, North America accounts for the majority share in the subcutaneous formulation technologies market. Numerous factors contribute to the region’s dominance in this industry, including advanced healthcare infrastructure and robust research capabilities that enable a greater number of technology developers to conduct extensive research and development required for developing highly efficient technologies that meet the stringent regulatory guidelines of the regulatory bodies.
Concluding Remarks
The subcutaneous drug delivery method is an emerging area with considerable potential for the future owing to its several advantages compared to traditional delivery methods. Recently, subcutaneous drug delivery devices such as wearable infusion pumps, autoinjectors, pen injectors, microneedles, needle-free injectors, and large-volume injectors have garnered significant attention within the pharmaceutical industry. This interest stems from their efficient and patient-friendly approach to administering medications. The subcutaneous drug delivery industry is rapidly evolving, with a focus on developing more convenient systems designed to enhance medication adherence. Moreover, as the availability of subcutaneous biologics increases, the demand for innovative delivery devices within the subcutaneous biologics market is also expected to rise. Further, it has been observed that many pharma companies are directing their efforts towards introducing subcutaneous versions of their drugs by re-engineering and reformulating products that were initially developed for delivery via the intravenous route.
To know more details on the market opportunity for subcutaneous biologics market, visit here >> https://www.rootsanalysis.com/reports/subcutaneous-biologics-delivery/314.html
Author bio
Dakshita has been working as a competent business research analyst since she joined Roots Analysis in 2023. She holds a bachelor’s degree in Pharmaceutical Sciences which has provided her with a solid foundation in the ever-growing domain of life-sciences. Throughout her dynamic tenure, Dakshita has made significant strides to evaluate emerging trends and technologies within the pharmaceutical industry, contributing critically to numerous comprehensive research reports that provide in-dept views on topics such as gene-editing, subcutaneous biologics and cell therapy packaging. With an analytical mind along with an inquisitive, obstinate and inventive personality, she brings knowledge and pivotal insights into the field of Analytical Research.
LinkedIn- https://www.linkedin.com/in/dakshitadhawan/
