The self-administered biologics market is estimated to reach USD 94,057.6 million in 2024. It is estimated that revenue will increase at a CAGR of 4.5% between 2024 and 2034. The market is anticipated to reach USD 146,068.5 million by 2034.
There has been an increase in diagnosis of chronic diseases, including cases of autoimmune disorders, cancer, and genetic diseases. Biologics is a major part of the treatment regime for these ailments. Many small-molecule biologics are administered through subcutaneous routes. The rise in subcutaneous formulation of numerous biologics has driven the self-administered biologics market.
Subcutaneous is a safe option and does not need extensive skills in locating the vein as in the case of IV formulations. This has paved the way for the adoption of self-administered biologics formulations. The advancement in self-administrable devices such as prefilled syringes, autoinjectors, wearable injectors, drug reconstitution delivery systems, and pen injectors, etc. have catalyzed the growth of the market.
Self-administered Biologics Industry Assessment
| Attributes | Key Insights |
|---|---|
| Historical Size, 2023 | USD 90,007.3 million |
| Estimated Size, 2024 | USD 94,057.6 million |
| Projected Size, 2034 | USD 146,068.5 million |
| Value-based CAGR (2024 to 2034) | 4.5% |
Patients can administer subcutaneous formulations to themselves without the need for any elaborate pre-use training. Subcutaneous delivery is preferred over oral routes because subcutaneous delivery inherently provides better bioavailability and higher absorption rates with large molecules. The preference studies have shown a great affinity towards self-administration because of the flexibility and lower healthcare cost compared to IV doses.
Also, the incorporation of technologies like hyaluronidase increases absorption rates. COVID-19 fueled an interest in more decentralized healthcare solutions that could be more patient-centric and at home. As the costs of healthcare rise, and access becomes more of an issue, self-administered biologics afford such opportunities, a reduction of the number of clinic visits vs intravenous therapies.
While the market is experiencing growth there persist certain challenges. Certain biologics formulations having high viscosity and other technical problems are not administrable through the current self-administration devices.
However additional investments have been made in developing self-administration devices, for example, electromechanical auto-injectors that include variable-speed control for administering drugs and are capable of keeping patient electronic logs, amongst other features.
Reusable high-viscosity biologics delivery systems are developed that address challenges in drug administration and at the same time promote sustainability. The culmination of the above factors points towards a promising future for the self-administered biologics market in response to the exploding demand of patients for the most convenient, cost-effective, and improved treatment experience.
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Rise in the Approval of Subcutaneously Delivered Biologics Drive Self-Administered Biologics Market
Subcutaneous administration is easier and more convenient for self-injection, especially in the management of chronic conditions. Many drugs, such as benralizumab, dupilumab, mepolizumab, and omalizumab, are now available in pre-filled pens and syringes; quite easy for patients to administer medications on their own and without extensive training and healthcare support.
This route of administration combines the advantages of increased bioavailability and absorption rates compared with the oral routes, specifically for large molecules that are difficult to absorb in the gastrointestinal tract.
Growing acceptance of subcutaneous biologics is also supported by patient preference studies, which demonstrate a high trend in support of self-administration because of flexibility and reduced costs to healthcare. Moreover, there is the integration of technologies like hyaluronidase that increase the absorption rates of these medications.
With an increasing number of biologics getting regulatory approval for subcutaneous delivery, this market for self-administered biologics will increase further to the benefit of patients and healthcare systems. Over the past few years, the approval of subcutaneously delivered biologics has increased as a function of new drug formulation and delivery technologies.
Regulatory bodies seem to increasingly recognize patient preference data in their assessment, which allows more subcutaneous options to be approved. Finally, the COVID-19 pandemic exacerbated this trend by increasing interest in decentralized health solutions that empower patients to treat from home.
Reduced Healthcare Affordability Resulted In the Adoption of Home Healthcare Solution
In 2023 Only 55% of USA adults able to afford quality health care, down from 61% in 2022. According to the latest data, about 72.2 million people are not able to access essential health care because of the cost factor. In this manner, access barriers speed up the need for treatment that's more cost effective.
The SC administration of biologics is, therefore, quite a viable solution to such challenges. In sharp contrast to the IV routes, which require the presence of skilled personnel and possibly bring additional high fees from clinics or hospitals, SC injections can be self-administered either by patients themselves or their caregivers.
This reduces the need for frequent healthcare visits to a great extent. This brings independence to the patient, and at the same time, it saves on the financial burden associated with hospital-based treatments.
Moreover, administration through SC is quick and easier; patients can administer the medications on their own in the comfort of their houses. Innovations in drug formulation have made SC delivery a more plausible approach whereby pre-filled syringes and autoinjectors have made the mode easy to manage.
While the healthcare world continues wrestling with affordability issues, this movement of self-administered biologics via SC routes will stretch into the future to afford cost-effective and feasible options to patients versus traditional IV therapies.
Advancement in Self-Administration Devices Provides an Opportunity for Market Growth
Recent developments made in self-administration devices for biologics provide impetus to the market growth. Advanced features of some of these new electromechanical auto-injectors, provide patients with more convenience through variable speed control for injection and electronic logs with real-time instructions.
Research favors the fact that these devices bring improved adherence over conventional methods and hence add value to this landscape of self-administration.
Moreover, the well-developed large format ready-to-use cartridges, such as those from SCHOTT Pharma, can provide the ability for greater volumes of biologics in the home environment and hence a shift from IV to SC administration. This not only allows for patient convenience but also minimizes healthcare costs related to frequent clinic visits.
The development of reusable, MEMS-enabled actuators solves the challenge of high-viscosity biologics administration and enables improved patient experiences with assured and efficient drug delivery.
Moreover, the current consumer focus is growing toward consumer demands for reusable devices to reduce dependency on single-use plastics for responsible and sustainable healthcare practices. The advancement in the device technology is expected to increase the scope of self-administered biologics and boost the market growth.
High Viscosity Biologics and Device Limitations can hinder the Market Growth
Certain biologics formulations have high viscosity and therefore, are difficult to administer via conventional auto-injectors. If the formulation is diluted to reduce the viscosity and delivered through the 1 ml syringe. Patients may have to go through multiple injections to deliver a therapeutic dose.
This may create issues with patient compliance and adherence as the greater number of injections could deter some patients from adhering consistently to their treatment regimens. Moreover, this can create complications with administration, as the high viscosity of these biologics can present many auto-injectors with problems.
One of the problems is that functional potential in the current self-administration devices is limited. There have been innovative technologies recently developed and presented on the market, such as wearable injectors. Not all biologics can be administered using these devices, though.
This is because a wide range of biologics is available within the market, of which many have unique formulations and modes of administration not fitting into the mold of what self-administration devices can do. The manufacturers need to continue developing new technologies, capable of handling a broad range of biologics with divergent requirements so that appropriate self-administration options for particular treatments can be available for patients.
The self-administered biologics industry recorded a CAGR of 3.7% between 2019 and 2023. According to the industry, self-administered biologics generated USD 90,007.3 million in 2023, up from USD 74,543.4 million in 2018.
There has been a huge evolution in the self-administered biologics market, much of it echoing broader trends in healthcare and the empowerment of patients.
In times past, primary interest was usually focused on developing easy-to-operate systems of drug delivery, like auto-injectors and pre-filled syringes, which would allow a patient to safely and effectively self-administer the medication at home. Much of this shift could be explained by factors such as convenience and reducing hospital visits, particularly for long-term care of diseases.
For more innovative delivery mechanisms, markets look forward to the next generation of wearable devices and smart technologies to enhance patient engagement and adherence. Integration with digital health solutions inclusive of mobile applications and telehealth services will help in the monitoring and support of patients taking self-administered biologics.
The growing emphasis is being placed on patient centric care, by the needs of the patients, establishes better consequences and higher satisfaction. Ultimately, the market for self-administered biologics is now set for further transformation in the accessibility of patients and the improvement of the total experience of health services delivery.
Principal Consultant
Companies in the Tier 1 sector account for 60.9% of the global market, ranking them as the dominant players in the industry. Tier 1 players offer a wide range of products related to research laboratories, have an established industry presence, offer continuous innovation, and have a significant influence in the field.
Having financial resources that enables them to enhance their research and development efforts and expand into new markets. A strong brand recognition and a loyal customer base provide them with a competitive advantage. Prominent companies within Tier 1 include Novo Nordisk, Eli Lilly, and Johnson & Johnson.
Tier 2 players dominate the industry with a 28.9% market share. Tier 2 firms have a strong focus on a specific technology and a substantial presence in the industry, but they have less influence than Tier 1 firms. The players are more competitive when it comes to pricing and target niche markets. New products and services will also be introduced into the industry by Tier 2 companies. Tier 2 companies include Pfizer, Roche, AbbVie, and Bristol-Myers Squibb among others.
Compared to Tiers 1 and 2, Tier 3 companies have smaller revenue spouts and less influence. Those in Tier 3 have smaller work force and limited presence across the globe. Prominent players in the tier 3 category are GlaxoSmithKline, Novartis, Takeda Pharmaceutical, and AstraZeneca.
The section below covers the industry analysis for the self-administered biologics market for different countries. Market demand analysis on key countries in several regions of the globe, including North America, Latin America, East Asia, South Asia, Western Europe, Eastern Europe, and Middle East and Africa (MEA), is provided. The United States is anticipated to remain at the forefront in North America through 2034. India is projected to witness a CAGR of 6.5% from 2024 to 2034.
| Countries | Value CAGR (2024 to 2034) |
|---|---|
| Canada | 3.5% |
| Germany | 4.0% |
| France | 3.8% |
| Italy | 3.5% |
| China | 7.4% |
| India | 6.5% |
| Japan | 4.5% |
The USA self-administered biologics industry is expected to grow at a 3.4% CAGR from 2024 to 2034. The rise in chronic diseases, particularly diabetes and autoimmunity disorders is demanding treatment continuously. This also enabled self-administered biologics among the sufferers. With over 537 million adults having the condition of diabetes worldwide in 2021, the demand for insulin and other biologics increased, which promoted the uptake of self-injection systems.
The United States is also characterized by the presence of a developed USA biopharmaceutical industry. Several innovative therapies, such as monoclonal antibodies and RNA-based treatments, have been approved, further increasing the portfolio of self-administered options for patients.
Patients are managing their health at home to escape costs and time wastage at multiple visits for health care. The user-friendly delivery devices such as auto-injectors and pre-filled syringes, enhance patient compliance and ease of use. More emphasis on patient-centered care and growing awareness about health management are making patients take control of their treatment regimens. All these factors make the USA a strong market.
A CAGR of 7.4% is predicted for the forecast period. The supportive policy framework adopted by the Chinese government has been boosting the biopharmaceutical sector in terms of regulatory reform. It has made the approval process for new biologics smooth.
This move would boost innovation and investments in R&D, thereby aiding the launch of self-administered therapies. The country's rapidly aging population is also providing impetus from the demand side. With the current pace of growth of the aging population, there will be a need for more convenient therapy options.
Moreover, the rising middle class and increased consumer awareness of health-related matters foster a growing demand for accessible, effective treatment options. As a consequence, patients are seeking self-administration solutions to help themselves avoid costs and time expenditures related to frequent hospital visits. The interplay of all these factors places China as a fast-growing market for self-administered biologics.
Japan has a high percentage of elderly people, which are suffering from chronic diseases such as diabetes, rheumatoid arthritis, cancer, and others. This creates a demographic shift and a corresponding high demand for convenient at-home treatment options.
The sophisticated Japanese healthcare system is driven by a strong emphasis on technological innovation. This led to increased adoption of self-administration devices. As such, more development of user-friendly delivery devices, such as auto-injectors and pre-filled syringes, is done in the country.
Additionally, Japan's leading-edge reimbursement system including the DPC payment model, encourages the adoption of more cost-effective therapies, including biosimilars and self-administered biologics. Indeed, this encourages health professionals to preferentially prescribe self-administered options since they cost less to the patient and the health system.
All these factors, when put together, make for a strong growth of the self-administered biologics market in Japan. Between 2024 and 2034, Japan is expected to expand at a CAGR of 4.5%.
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A description of the leading segments in the industry is provided in this section. The diabetes segment held 73.4% of the value share in 2024. Based on the product, pen injectors held 39.6% of the market in 2024.
| Application | Value Share (2024) |
|---|---|
| Diabetes | 73.4% |
| Rheumatoid Arthritis | 12.2% |
| Anaphylaxis | 8.2% |
| Others | 6.3% |
The International Diabetes Federation estimated that about 537 million adults around the world have diabetes. This is likely to increase significantly in the coming years. The rising patient pool will continuously be under treatment, wherein the medication is administered into the body with the help of insulin injections, mostly subcutaneously.
The convenience of self-administration resonated very well with management requirements for diabetes. At-home treatment options help patients a lot, also by reducing the frequency of healthcare visits. The ease of self-administration is greatly enhanced by the development of delivery devices like pre-filled syringes and auto-injectors, hence encouraging patients to be able to manage their conditions by themselves.
Taken together, these factors firmly entrench diabetes as a leading indication for the self-administered biologics market and provide a strong impetus for the development of new delivery systems that cater to this chronic condition.
| Capacity | Value Share (2024) |
|---|---|
| Pen Injectors | 39.6% |
| Prefilled Syringes | 21.9% |
| Autoinjectors | 17.2% |
| Wearable Injectors | 12.2% |
| Drug Reconstitution Delivery Systems | 9.2% |
Pen injectors dominate due to user-friendly design and convenience. The patient suffering from chronic conditions of diabetes and rheumatoid arthritis needs medication regularly over long period. In this scenario pen injector allows patients to inject medications without extensive training or assistance, thus aiding in independence and adhering to the treatment regime.
Besides, pen injectors come either in disposable or reusable models to serve different patient preferences and needs. Being replaceable with only a new needle and cartridge, reusable pens happen to be cost-effective in the long run, further boosting their popularity.
Growing cases of chronic diseases and the rising demand for safer and more effective means of drug delivery add to other major factors that are helping the market grow. With a patient-centric healthcare model, pen injectors represent a practical solution toward an overall better experience of treatment, hence further bolstering this lead position in the self-administered biologics market.
Industry players considering restructuring their pricing strategies to increase the adoption of the products. As healthcare costs have skyrocketed, this pricing strategy is expected to provide a boost to the sales of the company. Market players are investing in research and development and gaining approvals for novel products.
The route of administration is of prime consideration. Companies are developing new strategies to enable self-administration of the existing biologic drug products. This step serves a critical role in offering convenience and aids in saving hospital/clinic fees.
Recent Industry Developments in the Self-administered Biologics Market
In terms of indication, the industry is segregated into diabetes, rheumatoid arthritis, anaphylaxis, and others.
In terms of product, the industry is segmented into prefilled syringes, autoinjectors, wearable injectors, drug reconstitution delivery systems, and pen injectors.
In terms of mode of delivery, the industry is bifurcated into subcutaneous, intramuscular, and transdermal.
In terms of end users, the industry is segregated into homecare settings and hospitals/clinics.
In terms of brand, the industry is segmented into branded biologics and biosimilars.
In terms of technology, the industry is bifurcated into conventional devices and smart devices.
Key countries of North America, Latin America, Western Europe, Eastern Europe, South Asia, East Asia, the Middle East, and Africa have been covered in the report.
Self-administered Biologics industry is expected to increase at a CAGR of 4.5% between 2024 and 2034.
The diabetes segment is expected to occupy a 73.4% market share in 2024.
The market for self-administered biologics is expected to reach USD 146,068.5 million by 2034.
The United States is forecast to see a CAGR of 3.4% during the assessment period.
The key players in the self-administered biologics industry include Novo Nordisk, Eli Lilly, Johnson & Johnson, Pfizer, Roche, AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Novartis, Sanofi, Takeda Pharmaceutical, AstraZeneca, and Bayer.
1. Executive Summary 2. Industry Introduction, including Taxonomy and Market Definition 3. Market Trends and Success Factors, including Macro-economic Factors, Market Dynamics, and Recent Industry Developments 4. Global Market Pricing Analysis 5. Global Market Size USD Million & Volume (Units) Analysis 2019 to 2023 and Forecast 2024 to 2034, including Historical Analysis and Future Projections 6. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034 6.1. By Indication 6.2. By Product 6.3. By Mode of Delivery 6.4. By End User 6.5. By Brand 6.6. By Technology 6.7. By Region 7. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Indication 7.1. Diabetes 7.2. Rheumatoid Arthritis 7.3. Anaphylaxis 7.4. Others 8. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Product 8.1. Prefilled Syringes 8.2. Autoinjectors 8.3. Wearable Injectors 8.4. Drug Reconstitution Delivery Systems 8.5. Pen Injectors 9. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Mode of Delivery 9.1. Subcutaneous 9.2. Intramuscular 9.3. Transdermal 10. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by End User 10.1. Homecare Settings 10.2. Hospitals/Clinics 11. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Brand 11.1. Branded Biologics 11.2. Biosimilars 12. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Technology 12.1. Conventional Devices 12.2. Smart Devices 13. Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Region 13.1. North America 13.2. Latin America 13.3. East Asia 13.4. South Asia and Pacific 13.5. Western Europe 13.6. Eastern Europe 13.7. Middle East and Africa 14. North America Sales USD Million & Volume (Units) Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 15. Latin America Sales USD Million & Volume (Units) Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 16. East Asia Sales USD Million & Volume (Units) Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 17. South Asia & Pacific Sales USD Million & Volume (Units) Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 18. Western Europe Sales USD Million & Volume (Units) Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 19. Eastern Europe Sales USD Million & Volume (Units) Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 20. Middle East and Africa Sales USD Million & Volume (Units) Analysis 2019 to 2023 and Forecast 2024 to 2034, by Key Segments and Countries 21. Sales Forecast 2024 to 2034 by Indication, Product, and Mode of Delivery for 30 Countries 22. Competition Outlook, including Market Structure Analysis, Company Share Analysis by Key Players, and Competition Dashboard 23. Company Profile 23.1. Novo Nordisk 23.2. Eli Lilly 23.3. Johnson & Johnson 23.4. Pfizer 23.5. Roche 23.6. AbbVie 23.7. Bristol-Myers Squibb 23.8. GlaxoSmithKline 23.9. Novartis 23.10. Sanofi 23.11. Takeda Pharmaceutical 23.12. AstraZeneca 23.13. Bayer
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Self-administered Biologics Market
