Subcutaneous Biologic Market By Drug Type (Monoclonal Antibodies, Hormones (e.g., Insulin), Cytokines, Vaccines, Others); By Indication (Diabetes, Rheumatoid Arthritis, Oncology, Inflammatory Bowel Disease (IBD), Others); By Distribution Channel (Hospitals and Clinics, Retail Pharmacies, Online Pharmacies); By Geography, Segment revenue estimation, Forecast, 2024–2032.

The subcutaneous biologic market was USD 80 billion in 2023 and is expected to reach around USD 160 billion by 2030 at a CAGR of 10.5% during the forecast period from 2024-2030. This is catalyzed by the progressing rates of chronic diseases, improved developing solution types, and the need for personalized medicine.

 

Subcutaneous biologics are injectable biologic drugs administered into the skin's subcutaneous tissue. These drugs are intended for long-term use to manage various diseases such as rheumatoid arthritis, diabetes, inflammatory bowel disease, and some autoimmune cancers. Subcutaneous delivery has the following advantages: convenience to the patient, fewer presentations to healthcare establishments, and better compliance with treatment. Technological advancements in prefilled syringes, autoinjectors, and drug formulation have also contributed to the increased use of subcutaneous biologics.

 

Market Drivers

Rising Prevalence of Chronic Diseases: The rise in several chronic diseases, including diabetes, autoimmune disorders as well as cancer, contributes to the growth of the subcutaneous biologic market. These conditions require the use of subcutaneous biologics for their long-term control. According to WHO, the diabetes population reached 422 million in the year 2023, and autoimmune diseases are present in close to 128 million people globally, accounting for 3.7% of the world population. Example: In 2022, an international pharma firm introduced a subcutaneous biologic for rheumatoid arthritis as an improved treatment modality due to its efficiency and convenience.

 

Advancements in Drug Delivery Systems: New advanced drug delivery systems like auto-injector and wearable injector systems have enhanced patient compliance and utility. These innovations improve the functional utility of subcutaneous biologics. Example: Moving to 2023, a U.S.-based company developed a wearable injector for cancer administration. This way, the patient gets the medicine at home and does not have to attend the hospital frequently.

 

Growing Adoption of Self-Administration: Patients are increasingly interested in treatment options that can be given at home. Subcutaneous biologics intended for patients' administration enable less reliance on healthcare institutions and enhance patients’ well-being. According to the survey in 2023, 65% of patients opted for SC-biologics because it is convenient and time-saving compared to IV treatments. Example: According to a Europe-based integrated pharmaceutical company, in 2023, sales of this SC biologic for multiple sclerosis increased by 20% due to better self-administration from the patients.

 

Rising Focus on Biologic Drugs: Biologic drug development has emerged as one of the industry's strategic trends, with many companies considering subcutaneous formulations to meet patients' needs. Biologics were worth $450 billion in global pharmaceutical sales in 2023, with subcutaneous delivery systems contributing to a large share of this market.

 

Market Opportunities

Emerging Markets in Asia-Pacific and Latin America: The factors creating a good market prospect include increased access to healthcare, growing healthcare costs, and growing awareness of biologic therapies in developing markets. For example, in 2023, an Indian biotechnology firm introduced a subcutaneous biosimilar for rheumatoid arthritis targeting middle-income groups.

 

Shift Toward Biosimilars: The growing access to biosimilars and cheaper copies of original biologics is a key factor boosting market penetration in low-price sensitive areas. For example, in 2022, the first copy of an anti-inflammatory subcutaneous biologic was approved in Latin America and offered a 30% cost savings compared to the brand drug.

 

Integration of Digital Health Technologies: Using mHealth technologies for injection tracking and monitoring improves patient compliance and thus adds new growth prospects. Example: The other product launched in 2023 was the wearable injector with a built-in application that could help patients receive occasional and real-time therapy.

 

Market Restraints

High Cost of Biologics: The use of many subcutaneous formulations depends on the availability of biological drugs, which are expensive and, therefore, not readily available in less developed areas.

 

Regulatory and Manufacturing Challenges: Technical regulation standards and challenging product development processes in the manufacture of biologics often lead to delayed product approval and high production costs.

 

Market Segmentation

By Drug Type:

• Monoclonal Antibodies

• Hormones (e.g., Insulin)

• Cytokines

• Vaccines

• Others

 

By Indication:

• Diabetes

• Rheumatoid Arthritis

• Oncology

• Inflammatory Bowel Disease (IBD)

• Others

 

By Distribution Channel:

• Hospitals and Clinics

• Retail Pharmacies

• Online Pharmacies

 

By Region:

• North America

• Europe

• Asia-Pacific

• Latin America

• Middle East & Africa

 

Segment Analysis

Leading Drug Segment: Monoclonal Antibodies

Monoclonal antibodies account for the largest share of revenue, 50% in 2023, owing to their utilization in autoimmune disease and cancer. For instance, in 2023, an outstanding biotech company unlocked a subcutaneous monoclonal antibody for inflammatory bowel disease and gained a competitive market share.

 

Leading Indication Segment: Diabetes

Diabetes is the largest indication segment, accounting for 40% of market revenue in 2023 due to the global diabetes crisis and a growing need for insulin biologics. The global insulin market was estimated to be USD 25 billion in 2023, and subcutaneous formulations held the largest market share.

 

Regional Analysis

North America is the market-dominating region that can contribute to 45% of the global revenue in 2023 due to high healthcare expenditure, developed drug delivery technologies, and increased patients. The United States took 75% of the shares of North American demand because of America’s predominance in biological drug development and utilization. Example: In 2023, a subcutaneous biologic was approved in the United States and, within a few years, turned out to be a standard first-line treatment in some cancer types.

 

Europe is responsible for one-third of global revenue and has a good strategy for pursuing biosimilars and patient-engaged therapeutics. The active markets are Germany, France, and the United Kingdom. Example: In 2022, a subcutaneous biologic for rheumatoid arthritis was actively promoted in Germany due to its cost advantages.

 

Asia Pacific is the fastest-growing region due to higher healthcare spending, a higher prevalence of chronic diseases, and better access to innovative therapies. Together, China and India were responsible for 50 % of the Asia-Pacific market in 2023. Example: In 2023, a Chinese biotech firm launched a subcutaneous biologic for diabetes, aiming at rural low-income patients.

 

Key Players

• AbbVie Inc.

• Amgen Inc.

• Roche Holding AG

• Sanofi S.A.

• Novo Nordisk A/S

• Eli Lilly and Company

• Johnson & Johnson

• Pfizer Inc.

• Biogen Inc.

• Teva Pharmaceutical Industries Ltd.

 

Future Outlook

The subcutaneous biologic market is promising due to continually growing awareness and application of self-injection, new drug delivery technologies, and premature diseases. The market in Asia-Pacific, which is experiencing growth in Latin America, will also be important, facilitated by increasing health care spending and knowledge.

 

Companies operating in biosimilars, innovative drug delivery systems, and addressing cost structures are expected to obliterate their competitors. Subcutaneous biologics will continue to be a significant component in shifting the approach to chronic diseases in the world by 2030.