DUBLIN–(BUSINESS WIRE)–The “Subcutaneous Biologics Market Industry Trends and Global Forecasts to 2035: Distribution by Type of Biologic, Type of Therapy, End User, Payment Method Employed, Therapeutic Area, Drug Delivery Device, Geographical Regions, Leading Players and Sales Forecast of Drugs” report has been added to ResearchAndMarkets.com’s offering.
The global subcutaneous biologics market is estimated to grow from USD 251 billion in 2025, to USD 233 billion by 2035.
The demand of biologics has risen in the recent years in the pharmaceutical industry. In fact, the industry has witnessed a rise in the number of biologic drugs approved by the USFDA. This shift is due to the ability of biologics to offer targeted treatment, enabling minimal drug interactions owing to their precise binding and unique metabolic pathways.
However, developing biologics involves various challenges. These include high molecular weight, structure complexity susceptibility to degradation after administration, and productional complexities have prompted pharmaceutical companies to adopt new technologies for their development. Formulating subcutaneous biologics via conjugation, amino acid modification, and encapsulation methods are some of these technological innovations.
Additionally, novel drug delivery systems, including autoinjectors, pre-filled syringes, and needle-free methods, have been developed to administer highly viscous formulations. Previously, biologics were administered intravenously because of their swift systemic distribution and strong bioavailability. Although intravenous administration is effective, it frequently necessitates regular administration by healthcare providers, creating a hurdle for medication adherence.
In recent years, methods and devices for subcutaneous administration have become increasingly popular among healthcare practitioners due to their effectiveness, safety, and tolerability Moreover, the shift towards subcutaneous biologics is fueled by the increasing need for self-administered treatments and the presence of easy-to-use drug delivery tools such as autoinjectors and pre-filled syringes.
Subcutaneous Biologics Market: Key Segments
Antibodies Occupy the Highest Share in the Market
Based on type of biologic, the global market for approved subcutaneous biologics is segmented into antibodies, nucleotides and proteins. It is worth mentioning that, currently, antibodies occupy the highest share in the market, attributing to its higher target specificity, increased safety profile and lower toxicity. Further, approved subcutaneous biologics market for nucleotides is expected to witness substantial growth during the forecast period.
The Highest Market Share is Captured by Both Monotherapy and Combination Therapies
The global market for approved subcutaneous biologics is segmented across monotherapy, combination therapy, and both monotherapy and combination therapies. Both monotherapy and combination therapies segments occupy the largest current market share and is expected to witness a substantial growth during the forecast period.
Majority of the Approved Subcutaneous Biologics Market Share is Occupied by Injection
This segment highlights the distribution of global market for approved subcutaneous biologics across different types of methods of administration, such as injection, infusion, and both injection and infusion. It is worth highlighting that, presently, majority of the approved subcutaneous biologics market share is occupied by injection as a method of administration and is expected to remain dominant, during the forecast period. This can be attributed to the fact that delivery via injections is more convenient for the patients as well as healthcare professionals. Additionally, the chances of any allergic reaction and fluid overload are also reduced.
Autoimmune Disorders Segment Occupies the Highest Subcutaneous Biologics Market Share
Currently, autoimmune disorders segment occupies the highest subcutaneous biologics market share. This can be primarily attributed to the high efficacy of these drugs in the treatment of various prevalent autoimmune disorders, such as psoriasis, ankylosing spondylitis, ulcerative colitis and Crohn’s disease. However, during the forecast period, metabolic disorders segment is likely to capture a larger market share owing to the rising preference of subcutaneous injection for the administration in patients suffering from diabetes mellitus and obesity (wherein long-term administration of drugs is required).
North America is Likely to Capture a Majority Share in the Overall Market
North America is likely to capture a majority share (~50%) in the overall market. Further, it is worth highlighting that the market in Asia-Pacific is expected to grow at a relatively higher CAGR, during the forecast period, till 2035. The growth of the market in Asia-Pacific can be ascribed to the rapidly growing patient population, the rising incidence of chronic disorders (including neurological disorders, genetic disorders and autoimmune disorders), and the rising demand for effective and advanced therapeutics. Further, the increasing investments and initiatives taken by regulatory bodies in the Asian countries to promote the adoption of biologics among patients and physicians is likely to drive the market in future.
Subcutaneous Biologics Market for Formulation Technologies
Market Share by Fundamental Principle
Presently, the revenues generated through the licensing of technologies that are based on encapsulation principle are likely to capture majority share in the overall market and is expected to remain dominant during the forecast period. It is worth highlighting that encapsulation helps in increasing the solubility of the biologics that are hydrophobic, which further results in increased absorption of the drugs in the patient’s body. Further, drug encapsulation also leads to high target specificity, thereby reducing the likelihood of adverse effects (that usually occur due to high systemic exposure).
Oncological Disorders Hold the Largest Share in the Subcutaneous Technology Market
It is worth highlighting that the oncological disorders hold the largest share in the current technology market. This can be attributed to the high incidence rate of oncological disorders, accounting for around 1.9 million cases in 2022 and over 2 million cases in 2023. Further, the global subcutaneous biologics market for formulation technology for autoimmune disorders is estimated to grow at the highest CAGR, during the forecast period.
Subcutaneous Biologics Formulation Technology Market in Asia-Pacific is Expected To Grow with the Highest CAGR
North America captures close to 65% of the current global subcutaneous biologics market for formulation technology. Further, the subcutaneous biologics formulation technology market in Asia-Pacific is expected to grow with the highest CAGR, during the forecast period. The growth of market in Asia-Pacific can be attributed to the rise in number of technology developers in this region, that will be actively involved in inking licensing deals with the drug developers.
Milestone Payments Occupy the Majority Share
Based on payment method employed, the global subcutaneous formulation technology market is segmented into milestone payments and upfront payments. It is worth mentioning that milestone payments occupy the majority share in the current market and this trend is unlikely to change in the future.
Some key findings from the report include:
- 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.
- ~20% of the subcutaneous biologics have been approved post-2020, majority of which are antibodies that can be administered as monotherapy alone.
- More than 340 subcutaneous biologics are in clinical-stages of development; ~10% of these biologics are antibodies that have received orphan drug designation.
- Around 60% of the clinical-stage subcutaneous biologics are based on inhibition mechanism; interestingly, majority of these biologics can be administered as monotherapy alone.
- Close to 20% of technologies are based on encapsulation principle; notably, all these technologies are focused towards providing extended / controlled / sustained drug release
- 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.
- 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.
Primary Research Overview
- Founder and Chief Executive Officer, Small Company, US
- Founder and Chief Technology Officer, Mid-sized Company, UK
- Chief Executive Officer & Founder, Small Company, US
- Chief Executive Officer, Small Company, Denmark
- Chief Executive Officer, Mid-sized Company, US
- Chief Technical Officer, Very Large Company, India
- Vice President and Chief Scientist, Large Company, Israel
- Senior Portfolio Director, Large Company, US
- Managing Director, Small Company, Austria
- Communication Leader, Mid-sized Company, France
- Former Founder and Chief Scientific Officer, Vice President and Product Development, Former Senior Scientist Formulation, Mid-sized Company, US
- Former Chief Commercial Officer, Large Company, Germany
- Anonymous, a US-based company
- Anonymous, a Europe-based company
Players in the Subcutaneous Biologics Market, Profiled in the Report Include:
- Adocia
- Alteogen
- Ascendis Pharma
- CD Bioparticles
- Creative Biolabs
- Creative BioMart
- Foresee Pharmaceuticals
- Pacira Biosciences
- The Wyss Institute
- Xeris Biopharma
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For more information about this report visit https://www.researchandmarkets.com/r/nmkim8
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