Biologics Statistics and Facts (2025)
Updated · Mar 20, 2025
WHAT WE HAVE ON THIS PAGE
- Introduction
- Editor’s Choice
- Biologics Market Value
- Global Biopharmaceutical Excipients Market Size By Type Of Biologic
- Shipments Of Biological Products
- Projected Global Subcutaneous Biologics Market
- Biological Non-traditional Indicators
- Biologics Statistics By Region
- Biologicals & Biosimilars Research And Development Cost
- The Future Growth Of Biologics In The Pharmaceutical Market
- Conclusion
Introduction
Biologics Statistics: Biologics are known as biological products which have become the very basic components of contemporary medicine, providing novel treatments for chronic diseases, cancers, autoimmune disorders, and even rare genetic conditions. For example, the year 2024 marks an important turning point for biopharma, and today, the biologics markets are growing very impressively and undergoing phenomenal transformation.
Below are the Biologics statistics trends and projections that mould the critical sector’s future.
Editor’s Choice
- The global biologics market is expected to surpass USD 120 billion in sales by 2027, accounting for 55% of total innovative drug sales.
- The subcutaneous biologics market is projected to grow from USD 82 billion in 2014 to USD 171 billion by 2025, driven by advancements in biotechnology and increasing demand for biologic medicines.
- The biopharmaceutical excipients market for antibodies is estimated to reach USD 1.3 billion by 2024, while vaccines, cell therapy, and other biologics will add USD 0.39 billion, USD 0.45 billion, and USD 0.59 billion, respectively.
- Monoclonal antibodies accounted for 68% of the biologics market in 2023, representing the largest product segment.
- The antisense and RNAi therapeutics segment is expected to achieve an impressive CAGR of 20.7% during the forecast period.
- Oncology remains the dominant disease segment in biologics, holding a 29.40% market share.
- The haematological disorders segment is expected to register the highest growth rate, with a CAGR of 11.8% over the forecast period.
- The microbial expression systems segment led the biologics market in 2023, capturing a 59.23% share, while the mammalian expression systems segment is projected to grow rapidly in the coming years.
- The in-house manufacturing segment accounted for 85.87% of the biologics market in 2023, whereas the outsourcing segment is forecasted to expand at a CAGR of 10.8% during the forecast period.
- The Asia-Pacific region is expected to experience a CAGR of 11.2%, making it one of the fastest-growing regions in the biologics market.
- North America accounted for the largest revenue share in 2023, contributing 46% to the global biologics market.
- The biologics lead optimization market was valued at USD 4.2 billion, while the global biologics drug discovery market was worth USD 8.1 billion in 2016.
- The U.S. biological product shipments stood at USD 27.37 billion in 2016, indicating significant growth between 2008 and 2016.
- The development timelines and costs for different biologics vary, with generics taking 2-3 years and costing USD 2-3 million, biosimilars requiring 8-10 years and USD 100-200 million, and originator biologics needing 8-10 years with a cost of approximately USD 800 million.
- The nontraditional biologics pipeline includes 42 drug candidates for Alzheimer’s disease, 36 for asthma, 31 for HIV, along with others targeting Parkinson’s, Ebola, and COPD.
Biologics Market Value
(Reference: proxy.parisjc.edu:8293)
- The biologics statistics reflect how big a market biologics drug discovery was in 2016 and what it is estimated to be in 2025 under various phases of drug development.
- The market is measured in billions of U.S. dollars. It reflects the international biologics drug discovery market, which in 2016 had an overall value of approximately 8.1 billion dollars.
- The largest part of this was lead optimisation, which refers to the phase where potential drug candidates are refined for efficacy, safety, or other characteristics; this accounted for about 4.2 billion dollars of total market size.
- Hence, almost half of the investment and activity in biologics drug discovery in 2016 was connected with lead optimisation, illustrating its importance in the drug development process. 2025 is probably indicating some changes or growth in the different phases of the market.
Global Biopharmaceutical Excipients Market Size By Type Of Biologic
(Reference: statista.com)
- According to Biologics statistics, around 2024, biopharmaceutical excipients, the marketplace for antibodies, accounted for about US$1.3 billion.
- This could be further divided into various types of biologics, in which antibodies were those leading the pack, followed closely by vaccines, valued at US$0.39 billion, with cell therapy accounting for US$0.45 billion and the other biologics category making up US$0.59 billion.
- Compared to traditional small-molecule drugs, biological medicines are more sensitive and less stable and, as such, require excipients who stabilise the drug during manufacturing and long-term storage to maintain its safety and effectiveness.
Shipments Of Biological Products
(Reference: proxy.parisjc.edu:8293)
- Biologics statistics predict the anticipated value of shipments resulting from biological product manufacture in the United States during 2008 and 2013. In addition, it is forecasted to be up to 2020.
- The value of shipment refers to the total worth of the goods produced and shipped by the manufacturers of such kinds of biological products.
- This value was anticipated to be about 27.37 billion dollars, approximately, by the year 2016, thus indicating the growth of this sector for the period between 2008 and 2016.
Projected Global Subcutaneous Biologics Market
(Reference: statista.com)
- According to Biologics statistics, The projected market size for subcutaneous biologics in the billion U.S. dollars from 2014 to 2025 is shown in the information given.
- Subcutaneous biologics are medicines injected under the skin, usually to treat various diseases, such as cancers or autoimmune disorders.
- Worldwide, it is estimated that the market size for subcutaneous biologics will reach a whopping 82 billion U.S. dollars in 2014.
- Annual growth is indicated by this constant increase in market values, ramping up to 171 billion U.S. dollars by 2025.
- This growth is expected to increase demand for subcutaneous biologics with each passing year due to improved biotechnology, new treatment development, and the growing patient pool for biologic drugs.
- The market size increases from 82 billion to 86 billion USD from 2014 to 2015. Entirely in 2020, the market reached 122 billion and continues to rise to 171 billion by 2025.
Biological Non-traditional Indicators
(Reference: iqvia.com)
- Biologics statistics show that there is a huge 25% of the current biologic pipeline targeted at indications with very similar characteristics: highly genericised for almost non-existent small molecules and very large patient populations which might benefit from treatment.
- Indeed, the data describe the number of biologics drug candidates available now under the development pipeline for different non-traditional indications.
- It is observed that Alzheimer’s disease topped the competition with 42 candidates, indicating that there is considerable focused research effort on it.
- Asthma came next, with 36 candidates, while HIV got 31 candidates, indicating progressive efforts geared toward the fight against the agent of infection.
- Biologics statistics show that Allergy, with 27 candidates, made its way deep into the list, followed by 25 candidates in research on Parkinson’s disease, 21 for Ebola, and so on. They reflect different areas of therapeutic priorities.
- Each has 14 candidates for pain, heart failure, and COPD, respectively, thus indicating only a moderate interest in these areas.
- Far lower on the table, 13 candidates could be found for malaria, while for osteoarthritis and stroke, the figure is 12 for each.
- There are 10 for osteoporosis, while 9 each fall under dengue fever and uveitis. This points out that there is very wide coverage of biologics and diseases other than the traditions for this intervention.
Biologics Statistics By Region
Amidst the developed markets of the world, in the 2023 Biologics statistics, the regional disparities could easily be gleaned concerning the market share.
North America
- North America turned out to be one of those markets that accounted for an amazing 46% of the total market share.
- The North American biopharmaceutical company’s presence for decades has made the healthcare infrastructure very much developed, while R&D investments are also quite significant.
- Thus, even besides these factors, the presence of a strong regulatory framework coupled with the growing demand for newer therapies in North America raises the mantle of North America.
Europe
- Followed by Europe holding a 24% share of the biologics market, the region’s advantages comprise a burgeoning pharmaceutical industry, supportive government initiatives, and an ageing population.
- Demand for advanced biologic treatment continues to trend upward. Though still significantly less than North America’s share, the market in Europe is growing.
Asia Pacific
- In the year 2023, it is estimated that about 19% of the market share of biologics will be accounted for by the Asia-Pacific region.
- This is largely contributed to by rapid economic development, rising healthcare expenditures, and growing investments in biopharmaceutical research.
- Emerging countries, such as China and India, are becoming a real force in the area owing to the large number of patient populations and growing manufacturing capabilities built in by the two countries.
Latin America
- The holding for Latin America was the smallest by far, at 11%.
- Although small compared to several regions, the market in that portion of the world is picking up speed due to improved healthcare access, further rising awareness of biologics, and even increasing government support of pharmaceutical innovations.
- However, the speed of this growth would be slowed by limited infrastructure and poor regulatory frameworks that lead to bottlenecks and even lower responsiveness to changing environments.
Biologicals & Biosimilars Research And Development Cost
Comparison between the development of different drugs
| Investment | Approval time | Number of patients in studies | |
| Generic drug | US$2 million–US$3 million | 2 to 3 years | 20 to 50 patients |
| Biosimilar | US$100 million–US$200 million | 8 to 10 years | 500 patients |
| Originator biological | US$800 million | 8 to 10 years | 800 to 1,000 patients |
(Source: gabionline.net)
- The above Biologics statistics have elaborated on the cost and time difference between various drug types. The investment required for approving a generic drug is generally US$2 million to US$3 million, along with a time frame of two to three years and clinical studies with 20 to 50 patients.
- In contrast, the necessary investment for the development of a biosimilar is between US$100 million and US$200 million. The process requires eight to ten years with approximately 500 patient clinical studies before the product can be marketed.
- Developing an originator biological product will take more than US$800 million expenditure, eight to ten years of time, and studies including 800 to 1,000 patients.
- There are also other costs beyond the development of biological products and biosimilar manufacture.
- Besides that, biological products and biosimilars would, however, have many production problems, such as a complex understanding of both process and product, variability among host cells, and bottlenecks in downstream processing.
- Finally, several scientific, legal, and regulatory hurdles must be overcome for biosimilars in their development.
The Future Growth Of Biologics In The Pharmaceutical Market
- According to Biologics statistics made by the report, ‘Future of Pharma—Looking Ahead to 2022,’ there will be five years when sales of biologics will exceed those of novel small molecules.
- For the coming year of 2027, biologics are forecasted to exceed sales by US$120 billion.
- Most, if not all, subtypes of biologics tracked by GlobalData are expected to have healthy sales growth and are forecasted to represent 55% of all innovative drug sales by 2027.
- Currently, some of the key biologics driving sales opportunities in this segment include monoclonal antibodies such as Opdivo (Ono Pharmaceuticals), Dupixent (Regeneron Pharmaceuticals), and Keytruda (Merck), which account for an estimated 46% of biologic sales in 2027.
- Specifically, Keytruda, with applications in oncology indications, is expected to represent 4% of total biologic sales in 2027.
- Monoclonal antibodies will keep dominating the market, though the highest growth will be shown by gene therapies and gene-modified cell therapies, where over a 1,000% rise between 2022 and 2027 has been projected for both types of molecules in sales.
Conclusion
Biologics are said to be altering the contours of healthcare through hope for millions of patients worldwide. Biologics statistics for 2024 corroborate the rapid growth of the sector, driven by innovation, increasing prevalence of diseases, and access to the sites. There are problems attached to biologics, but it pushes the entire tower with leaps and bounds toward a healthier future.
Sources
FAQ.
The biologics market will be growing by 2025. The global biologics drug discovery market had a worth of US$8.1 billion in 2016 and is expected to boom only with lead optimisation at US$4.2 billion. The subcutaneous biologics market is estimated to rise from US$82 billion in 2014 to US$171 billion by 2025.
North America registered 46% of its total revenue of the biologics market in 2023 due to its advanced health infrastructures besides high R and D investments. Europe now holds 24%, thanks to the booming pharmaceutical industry and ageing population. Asia-Pacific has been fast catching up with a projection of 11.2% CAGR owing to emerging markets such as China and India. It has a 1% share in Latin America, but its growth is hampered by infrastructure and regulatory issues.
Generics: US$2-US$3 million, 2-3 years, clinical studies in 20-50 patients; biosimilars: US$100-US$200 million, 8-10 years, clinical studies in ~500 patients; originator biologics: US$800 million, 8-10 years, clinical studies in 800-1,000 patients. As in the case of generic medicines, the development of biologics and biosimilars faces challenges such as product complexity, host cell variability, and regulatory hurdles, in addition to lengthy production times.
Oncology leads the market with a 29.4% share, followed by haematological disorders, which are projected to show a CAGR of 11.8%. Monoclonal antibodies are in a commanding first position in the category with an overall 68% market share; meanwhile, gene therapies and cell therapies are expected to expand more than 1,000% in revenue sales over 2027.
Currently, non-traditional indications account for 25% of the total biologics pipeline. Among the major indications under research, Alzheimer’s disease has 42 candidates, asthma 36 candidates, and HIV 31 candidates. In addition, there are developments for Parkinson’s disease; Ebola, chronic obstruction pulmonary disease, and other diseases are examples that reflect the widening of this sector.
Barry is a technology enthusiast with a passion for in-depth research on various technological topics. He meticulously gathers comprehensive statistics and facts to assist users. Barry's primary interest lies in understanding the intricacies of software and creating content that highlights its value. When not evaluating applications or programs, Barry enjoys experimenting with new healthy recipes, practicing yoga, meditating, or taking nature walks with his child.
