Subcutaneous Biologics Market Set for Major Growth, Roots Analysis Finds

Subcutaneous biologics offer a significant advantage over the traditional parenteral route, which, while commonly used for biologic candidates, necessitates frequent medication and administration by healthcare professionals. This reliance on hospital visits creates an additional financial burden, is invasive, and negatively impacts medication adherence. 

By contrast, subcutaneous delivery enables patient self-medication and is less invasive, addressing many of the challenges associated with parenteral administration. Consequently, subcutaneous biologics and their associated formulation technologies have attracted considerable attention from stakeholders across the healthcare industry.

According to Roots Analysis the global subcutaneous biologics market size for approved drugs is projected to reach USD 275 billion by 2027 from USD 236 billion in the current year, growing at a CAGR of ~5%. Further, the global market size is projected to reach USD 2.7 billion by 2035 from USD 0.29 billion in the current year, growing at a CAGR of ~22%, in the forecast period.

Key Report Takeaways

§  Presently, more than 175 subcutaneous biologics have been approved for the treatment of various chronic disorders; around 50% of these biologics are proteins approved for once daily administration.

§  More than 340 subcutaneous biologics are in clinical-stages of development; around 10% of these biologics are antibodies that have received orphan drug designation.

§  Recent advances have prompted stakeholders to develop novel technology platforms to aid the development and administration of biologics through subcutaneous route.

§  In pursuit of gaining a competitive edge, industry stakeholders are actively innovating and developing novel subcutaneous formulation technologies that can be utilized for the treatment of various indications.

§  The rising interest in this domain is reflected by the rise in partnership activity; in fact, close to 70% of the deals were inked in the last three years.

§  There are several new and innovative drug delivery systems that facilitate subcutaneous administration; we identified over 560 such systems that are presently available / under development.

§  With several self-medication enabling devices, such as wearable injectors and autoinjectors, available in the market, developers are actively differentiating their offerings by incorporating advanced, patient-friendly features.

§  Driven by the increased emphasis towards patient compliance and improved treatment outcome, the approved subcutaneous biologics market is likely to grow at a CAGR of ~5%, till 2027.

§  Owing to the numerous advantages offered by subcutaneous formulation technologies and increase in the number of licensing deals, the market is anticipated to grow at an annualized rate of 22.7% in the coming decade.

Market Players:

Top companies in subcutaneous biologics market are Adocia, Alteogen, Ascendis Pharma, CD Bioparticles, Creative Biolabs, Creative BioMart, Foresee Pharmaceuticals, Pacira Biosciences, Wyss Institute, Xeris Biopharma.

Regional Outlook

Based on the geographical regions, the approved subcutaneous biologics market can be segmented into five major regions, including North America, Europe, Asia Pacific, Middle East and North Africa, and Latin America. North America is anticipated to capture the majority share of the approved market in the current year and this trend is likely to remain unchanged during the forecast period. The advanced healthcare infrastructure and research capabilities in North America enable drug developers to conduct extensive clinical trials, which is necessary to meet the required regulatory guidelines provided by the approval bodies.

Market Segments

Based on the Type of Biologic, the market is segmented into Antibodies, Nucleotides and Proteins

§  The antibodies segment led the approved subcutaneous biologics market, capturing the largest revenue share (~60%) in the current year.

§  The nucleotides segment is anticipated to grow at an annualized growth rate of 13.1%, during the forecast period.

Based on the Type of Therapy, the market is segmented into Monotherapy, Combination Therapy, and Both Monotherapy and Combination Therapy

§  The segment for both monotherapy and combination therapy in the market is likely to capture the largest market share of around 50% in the current year.

§  The segment for both monotherapy and combination therapy is anticipated to grow at an annualized growth rate of 0.3%, during the forecast period.

Based on the Method of Administration, the market is segmented into Injection, Infusion, and Both Injection and Infusion

§  The injection segment led the approved subcutaneous biologics market, capturing the largest revenue share (~95%) in the current year.

§  The segment for both injection and infusion is anticipated to grow at an annualized growth rate of 4.7%, during the forecast period.

Based on the Therapeutic Area, the market is segmented into Autoimmune Disorders, Metabolic Disorders, Oncological Disorders, Hematological Disorders, Inflammatory Disorders, Neurological Disorders, Bone Disorders and Other Disorders

§  The autoimmune disorders segment led the approved subcutaneous biologics market, capturing the largest revenue share (~30%) in the current year.

§  The metabolic disorders segment is anticipated to grow at an annualized growth rate of 4.5%, during the forecast period.

Based on the Regional Insights, the market is segmented into North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America

§  North America dominated the approved market and accounted for the largest revenue share (~50%) in the current year.

§  In Asia-Pacific, the approved market is anticipated to show lucrative growth during the forecast period.

About Roots Analysis

Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by us are structured in a way that enables the reader to develop a thorough perspective on the given subject. Apart from writing reports on identified areas, we provide bespoke research / consulting services dedicated to serve our clients in the best possible way.

Contact Details

Gaurav Chaudhary

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