The biopharmaceutical industry is growing rapidly as a result of significant advancements in biotechnology and drug development. Due to developments in gene therapies, vaccines, monoclonal antibodies, and next-generation biologics, treatment paradigms are shifting in a variety of therapeutic areas. These developments enhance patient outcomes, address unmet medical needs, and boost treatment efficacy. Recent occurrences highlight the significance of biopharmaceuticals in the fight against disease and show how these advancements have impacted the global healthcare landscape.
WESTFORD, Mass., July 31, 2025 /PRNewswire/ -- SkyQuest Technology Consulting published a report, titled, Biopharmaceuticals Market- Global Opportunity Analysis and Industry Forecast, 2025-2032", valued at USD 462.8 Billion in 2024. With a projected CAGR of 9.4% from 2025 to 2032, the market is expected to reach USD 948.6 Billion by the end of 2032. The primary forces behind the global biopharmaceutical market growth are the aging population, the increasing incidence of chronic illnesses, advances in biotechnology, and the rising need for targeted treatments.
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Biopharmaceuticals Market Key Growth Drivers
The global biopharmaceuticals sector is projected to grow at a rapid pace due to the increasing demand for targeted therapies, the increase in chronic diseases, and ongoing advances in biotechnology. One key driver of market growth is the rising preference for biologics over traditional small-molecule drugs because of their efficacy and selectivity. The inherent momentum of the biopharmaceutical market is assisted by the approval of new monoclonal antibodies, vaccines, and cell and gene therapies, our aging global population, and rising healthcare costs.
In addition, strategic activities are becoming an important component of market growth, as companies take action to enhance patient access, strengthen supply and distribution chains, and expand their research and development pipeline. The Middle East Respiratory Syndrome (MERS) is a highly lethal disease that has no approved vaccines or treatments.
- In January 2024, Barinthus Biotherapeutics announced plans to partner with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford to further develop VTP-500, a new vaccine candidate targeting MERS disease. In addition to earlier funding provided to the University of Oxford for the emergency stockpiling of MERS vaccine, CEPI is also investing up to USD 34.8 million to Barinthus Bio.
Recent Developments in Biopharmaceuticals Market
- In 2025, significant organizational changes within the U.S. Food and Drug Administration (FDA), including leadership transitions and restructuring, have led several biotechnology firms to consider conducting early-stage clinical trials outside the United States. This shift aims to mitigate potential delays in regulatory reviews, with companies exploring alternative pathways in regions like the European Union and Australia.
- In January 2025, Samsung Bioepis and Teva Pharmaceutical Industries Ltd. inked a license, development, and commercialization agreement for EPYSQLI (eculizumab-aagh), a biosimilar to Soliris, in the US.
- In September 2024, Regeneron Pharmaceuticals, Inc. announced Dupixent (dupilumab), the first biologic drug ever authorized in China for adults and adolescents with moderate-to-severe atopic dermatitis. This marks a significant milestone in the creation of innovative treatments for Chinese patients with this chronic skin condition.
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Competitive Landscape
To stay at the top of the competitive biopharmaceuticals market, major players are utilizing strategies like mergers, strategic alliances, and R&D expenditures. Companies like Pfizer, Roche, and Amgen have made developing biosimilars and personalized medicine their top priorities. For instance, Roche raised its biologics R&D spending by 12% in 2024 to fortify its oncology pipeline, while Pfizer expanded production capacity in Asia to enhance global distribution and reduce manufacturing costs.
The major players in the Biopharmaceuticals industry include,
- Pfizer Inc
- Roche Holding AG
- Johnson & Johnson (Janssen Biotech)
- Merck & Co. (MSD outside the U.S. and Canada)
- AbbVie, Inc.
- Sanofi
- Novartis AG
- Bristol-Myers Squibb
- AstraZeneca Plc
- Amgen, Inc.
- GSK (GlaxoSmithKline)
- Eli Lilly and Company
- Regeneron Pharmaceuticals
- Biogen
- Gilead Sciences
- Moderna
- Bayer AG
- CSL Limited
- Takeda Pharmaceutical Company
- Genmab
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Biopharmaceuticals Market Segmental Analysis
The global biopharmaceuticals market is segmented into type, disease, technology, drug type, source, manufacturing type, formulation, prescription type, distribution channel, and region.
- By type, monoclonal antibodies emerged as the top product type in 2024, with a significant proportion of the market, due to their high specificity and efficacy in treating autoimmune, inflammatory, and cancer conditions. Their use was further boosted by a steady stream of FDA approvals and promising pipelines from large pharmaceutical companies. The medicines were regarded as a preferred therapeutics option due to their low off-target effects.
- By disease, the oncology led the market as the disease type, as a result of an increase in biologic-based targeted therapies, and an increasing incidence of cancer globally. Immunotherapies such as antibody-drug conjugates, and checkpoint inhibitors, became commonplace in 2024. The dominance of oncology was supported by substantial investment in cancer research and development.
- By technology, in 2024, monoclonal antibodies were at the top of the market by a significant margin because of their minimal side effects and ability to be effectively targeted. Drug companies are increasingly using monoclonal antibodies when developing exact treatments. Improvements in productivity from advances in hybridoma and recombinant technology has also enhanced productivity.
- By drug type, the biologics category has continued to have the largest share of the market for a number of reasons, including a proven ability to treat complex chronic diseases (such as diabetes, cancer, and autoimmune diseases). In 2024, biologics benefited from a global increase in physician acceptance of biologics and greater access to healthcare. Biologics also accounted for a far greater share of the market than biosimilars.
- By source, as it produces the glycosylated proteins (post-translationally modified proteins) which are necessary for human therapies., mammalian cell culture continues to be the predominant platform of biopharmaceutical manufacturing. Even in 2024, it is still essential for making monoclonal antibodies as well as vaccine production. Overall, the mammalian cell culture platform was the one that all biopharma companies preferred because of its reliability and scalability.
- By manufacturing model, in 2024, in-house manufacturing was the preferred option with all leading players, mainly because they wanted to keep control of production and ultimately quality, and protect their proprietary technologies. Companies like Pfizer and Roche extended their internal capabilities to keep pace with the increasing demand for biopharmaceutical globally. An in-house model also helped to reduce reliance on the supply chain.
- By formulation, the liquid formulations is the dominant formulation type in 2024 due to their ease of delivery, faster onset of action, and patient adherence. There is extensive use of liquid formulations in homecare and hospital settings. The delivery of prefilled syringes and vials with liquid formulations is still a high priority for biopharmaceutical companies.
- By prescription type, the prescription biopharmaceuticals had the largest market share in 2024 because biologic therapies are prescribed due to their safety profile with potential side effects and complexity requiring medical supervision. Typically, these medications are provided under the physical supervision of a healthcare provider in a clinical setting. Few supplements and gentler biologics are provided without a prescription.
- By distribution channel, due to the clinical nature and need to be administered by a professional and also stored in a cold chain, in 2024, hospital pharmacies was the primary distribution channel. Hospitals remain the primary dispensing location for biologics, which must go through a number of conditions the high need for biologics is crucial for many critical conditions, which was further strengthened in 2024 by an increase in hospital visits for biologic therapy.
Regional Outlook
- In 2024, the biopharmaceutical market in North America will be the largest due to significant R&D expenditures, a robust healthcare system, and robust regulatory frameworks. Monoclonal antibodies, vaccines, and RNA-based treatments for immunology, metabolic disorders, and cancer are all becoming more and more popular in the region. Due to their intricate administration and storage needs, hospital pharmacies are heavily involved in the distribution of biologic therapies.
- The biopharmaceutical sector in Europe is steadily growing, with Germany, France, and the UK at the forefront. The region gains from increased use of biosimilars, government-supported biotech innovation, and a robust clinical research infrastructure. Vaccines and monoclonal antibodies remain the most common, especially when it comes to treating infectious, immunological, and cancerous conditions. Because biologic drugs must be administered and monitored under strict control, hospital pharmacies distribute the majority of these medications.
- The Asia Pacific biopharmaceutical industry has grown rapidly due to a number of factors, including the prevalence of chronic diseases, expanding access to healthcare, and government support for biopharmaceutical innovation. In countries like China, India, and Japan, local biologic manufacturing is growing, regulatory frameworks are being reinforced, and biosimilar adoption is increasing.
- The growing demand for biologic therapies in the Latin American biopharmaceutical industry is being driven by government healthcare investments and expanding biopharma manufacturing capabilities. Brazil leads the market for biologics, which are increasingly used in oncology, blood disorders, and metabolic diseases. Hospital pharmacies play a crucial role in providing complex biologic treatments.
- In the expanding biopharmaceutical sector in the Middle East & Africa, Saudi Arabia is emerging as a significant player. Government investments in biotech infrastructure and healthcare modernization are driving the use of biologic therapies in immunology, metabolic disorders, and oncology. The bulk of biologic distribution is managed by hospital pharmacies due to the need for cold chain logistics and knowledgeable administration.
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Major Challenges in Biopharmaceuticals Industry
The high cost of production and R&D is one of the main restraining factors for the biopharmaceuticals market. Starting from complex biological processes of production, the establishments needed for biopharmaceutical manufacturing are often highly sophisticated, quality-controlled, and manned by highly trained personnel. Manufacturing costs equated to 25% of the average costs to develop a biopharmaceutical, which was more than 2.6 billion USD in 2024. These high costs thus impede access in cost-sensitive markets and restrict entry by smaller companies.
Biopharmaceuticals come under intense scrutiny by regulators due to their complexity and possible hazards. Quite often, longer approval times are the result of compliance with changing international regulations, such as those by the FDA, EMA, and other authorities. Between 2024 and 2025, the approval time for new biologics was much longer than that for small-molecule medication, spanning on average 12 to 15 months.
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SkyQuest Technology Consulting is a leading Business Consulting and Market Research firm, provides syndicated as well as customized research reports and consulting services. The company comprises a team of research analysts and consultants, adding more than 1200 market research reports to its database each year. These reports offer in-depth analysis on 40+ industries across 25 major countries worldwide, serving global clients across diverse industries. The company specializes in delivering customized intelligence, data-driven insights, and strategic advisory services that enable businesses to stay competitive and make informed decisions in rapidly evolving industries.
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