Biologics Market Size, Share, Growth, Report 2025 to 2034

Biologics Market Size and Growth 2025 to 2034

The global biologics market size was estimated at USD 571.82 billion in 2024 and is expected to be worth around USD 1,157.58 billion by 2034, growing at a compound annual growth rate (CAGR) of 7.30% over the forecast period 2025 to 2034. The U.S. biologics market size was valued at USD 187.74 billion in 2024 and is expected to reach around USD 380.06 billion by 2034

Biologics represent the growing sector due to the surging cases of chronic diseases and the bourgeois demand for personalized medicines. The inclusion of biologics like monoclonal antibodies and gene therapy has become a significant part of management with respect to chronic medical conditions like cancer, autoimmunity, and one that might be genetic.  Developments in biomanufacturing technology and a favorable environment for relevant pharma regulatory affairs involve an important role in the resultant growth within the market. In addition, other factors taken in conjunction, like greater efficacy and target when well administered, will also witness a better adoption trend for biologics, thus acting as a driving factor for the growth of the market.

Biologics are medicines considered to be of living origin or derived from any of its components like proteins, cells, or tissues. These diverse products are used to treat various disorders that range from vaccines, monoclonal antibodies, cell-based therapies, or gene therapies. Biologics treat complex conditions, including but not limited to cancer, autoimmune diseases, and inherited genetic disorders. Compared with traditional chemical drugs, biologics are much more complex to manufacture and require more specialized processes. Some examples of biologics range from monoclonal antibodies and vaccines to gene therapies and cell-based therapies. The market for biologics is expanding rapidly because of their power to target specific mechanisms of diseases closely and the increasing interest in personalized medicine.

Report Highlights

• In 2024, the North America region is expected to dominate the market, holding a revenue share of 43.20%.
• Europe accounted for a revenue share of 30.10% in 2024.
• By product, the monoclonal antibodies segment has captured revenue share of 65.40% in 2024.
• By application, the oncology segment has generated revenue share of 29.10% in 2024.
• By source, the microbial segment has held revenue share of 58.20% in 2024.
• By manufacturing, the in-house segment has accounted revenue share of 84.57% in 2024.

Biologics Market Growth Factors

• An increase in chronic diseases: The new cases of chronic diseases are arising due to diabetes, cancer, and cardiovascular diseases, which require efficient biologic treatments. The growing adoption of biologics is the result of targeted treatments being developed for the efficient treatment of complicated diseases. As the age population increases all over the globe, so will chronic disease and create a necessity for advanced therapy and increase growth in the market.
• Increasing aging geriatric population globally: The biologics market is set to be driven by this aging population. Elderly people are more susceptible to chronic and degenerative diseases, which include arthritis, Alzheimer's, and cancer. For many of these conditions, biologic therapies, including particularly monoclonal antibodies and cell therapies, are often the only most effective treatments available. As such, the demand for biologics becomes critical because of the continued growth of the elderly population across the globe.
• Advancements in biologic manufacturing technology: Recent technological innovations in biologic production have enhanced the growth of the market through more efficient manufacturing methods on large scales and the stability of drugs. The drugs are now cost-effective and hence more accessible. Automation, innovative purification technologies, and innovative techniques of production facilitate faster development with reliable supply chains, hence allowing the growth of biologic therapies in developed as well as emerging markets.

Biologics Market Trends

• Development of combination therapies: The use of biologics as combination treatments along with other forms of therapies such as chemotherapy or immunotherapies has become common nowadays. Combination treatments have shown effective responses against diseases of a variety, and it ranges to cancers too. Therefore, combining several treatments that impact numerous pathways or reinforce the effect of a multitude of drugs enhances treatment effectiveness. This trend will continue to increase as research in synergistic treatment expands.
• Increased focus on immunotherapy and cancer treatments: Immunotherapy, especially checkpoint inhibitors and monoclonal antibodies, is quickly turning into the standard of care in cancer treatment. The biologics market is shifting towards immunotherapy because of its ability to enhance the body's immune system to fight cancer. This trend accelerates as increasing drugs are being approved and succeed in clinical trials. As such, immunotherapy has emerged to become one of the main areas for growth within the biologics market.
• Improved usage of AI and machine learning: The market for biologics is being transformed by dint of AI and machine learning. The faster the development, the shorter it makes the drug discovery process. Researchers get possible candidates for biologics much faster and with much accuracy using AI-based platforms, thus saving time and expense. The same technologies optimize personalized medicine, wherein biologics can be prepared according to individual patient's needs, which happens to be one of the trendy themes in today's healthcare.
• Increase in biologics production capacity: To fulfill the increasing demand for biologic therapies, manufacturing capacities are increased by manufacturers. Large-scale production plants are now built because the complexity of these drugs requires sophisticated facilities for manufacture. The production capacities are expected to grow as newer biologic drugs and biosimilars flood the market; it will ensure sufficient supply and growing patient demands and propel growth in the biologics sector.

Report Scope

Biologics Market Dynamics

Drivers

• Increased use of monoclonal antibodies: Monoclonal antibodies are viewed as one of the most promising forms of biologic therapy, more so in the field of oncology. These drugs have demonstrated targeted action on cancer cells with high efficacy rates, and many have been introduced into the mainstream due to such effects. Cases like Rituxan and Herceptin have thus indicated the vast potential of monoclonal antibodies in cancer as well as for autoimmune diseases among others, rendering them rapidly adoptable in the clinical practice domain and thus boosting the market share.
• Advances in biologics production technologies: As the techniques of producing biologics advance, the cost of large volumes of such complex therapies has reduced. The availability of biosimilars, coupled with the development of better monoclonal antibodies and gene therapies, is making it easier for patients to get access to biologics. This migration in the methods of production is opening up the global market for entry and stimulating the growth of biologic treatments.
• The awareness and acceptance of biologic treatments among patients: Patients are more aware of the efficacy of biologic treatments, thereby boosting the demand in the market. The more patients get educated about the advanced therapies such as monoclonal antibodies, gene therapies, and biosimilars, the more they have accepted biologic treatments. This is furthered by patient advocacy groups, educational campaigns, and social media platforms for the benefits of biologics, which create greater trust and adoption in chronic and complex diseases.

Restraints

• Manufactured with complex techniques and supply chains: Biologics are notoriously produced with complexity and high expenditures because of specialized facilities and specific technologies. Hence, the elaboration process involves delays and excessive costs, some cases that make this difficult for others to market and sell their respective products. Not to mention in the biologics supply chains, which usually can be disordered, the market growth then turns out to have a limitation based on the restricted availability of that therapy to their patients.
• Limited availability of trained professionals: Biologic therapies need to be administered and monitored in specialized clinical settings. There is a lack of health professionals who are qualified to administer the biologics, and this further limits the availability of these therapies in emerging markets, especially where injections or complicated procedures are required. It is crucial to augment the workforce through training over and above increasing the number to overcome this problem and make biological therapy more widely available.
• Risk of adverse immune reactions: At times, biologics, particularly those of human and animal origin, might cause an immune reaction in patients, which leads to side effects such as allergic response or immune-related adverse events. Though these risks are low, they could become one of the most challenging factors for compliance with treatment and patient safety. Further monitoring and research into minimizing such immune reactions could help ensure the broader acceptance and success of biological therapies.

Opportunities

• Growth of the biosimilars segment: The advent of patent expiration on original biologic drugs opens space for cheaper alternatives: biosimilars represent a more affordable option for patients and healthcare systems, therefore increasing access to biologic therapies. The segment is anticipated to grow further with more refined regulatory regimes for biosimilars. Both new and established companies will have opportunities that will arise from the increasing demand for cost-effective biologic treatments.
• More emphasis on rare and orphan diseases: Recently, biologics have emerged as a new and promising treatment solution for some of the rare and orphan diseases and are being developed to treat a significant number of diseases that had not been effectively treated before. This appears to create tremendous scope for pharmaceutical innovation and portfolio build-up. As the regulatory environment opens up for rare treatments, the biologics market can expand further and fulfill unmet medical needs with new opportunities for companies that will develop new rare-disease-based therapies.
• Strategic alliances and partnerships: Collaboration among biopharma companies, research institutions, and healthcare organizations can thus open the way to even more innovative biologics. The essence of this partnership lies in knowledge, resource, and risk sharing-all of which are very important to partners in the special or expensive area of biologics. Accelerated drug development, expanded portfolios for the companies, and biologic therapies that came to market sooner, unlocking growth opportunities in many therapeutic areas.

Challenges

• High development costs: Highly sophisticated research, considerable clinical trials, and specialized production processes make it costly to produce biologic drugs. This translates to a hefty price tag in the market. Biologics are thus placed out of many patients' reaches and those of healthcare systems globally. Companies should therefore find better ways to trim costs without any compromise on treatment quality and effectiveness.
• Limited access to biologics in low-income regions: The cost of biologics is too high, and the infrastructure for the administration and storage of complex biologic drugs is lacking in low- and middle-income countries. This is a significant market gap. Companies will have to find ways such as tiered pricing or the introduction of lower-cost biosimilars to increase the availability of biologics in underserved regions, which would require significant investment and collaboration with local governments.
• Overcoming patient hesitancy and adverse public perceptions: In addition to the many benefits, however, biologics are plagued by patient apprehension, a factor that mainly stems from worries over safety and side effects or the perceived complicated nature of treatment. Public opinion may be altered by adverse reports in the press, high prices for treatment, or misunderstanding regarding the nature of biologics. Education and transparency will provide evidence of the long-term advantages and safety of biologic therapy in real-life practice.

Biologics Market Segmental Analysis

Product Analysis

Monoclonal Antibodies: Monoclonal antibodies, also known as mAbs, are manufactured laboratory-based molecules intended to act as replacement antibodies to enhance or replace the attack on diseased cells by the immune system. These drugs have applications in a range of treatments, including treating cancerous conditions, autoimmune disorders, and chronic conditions. As these treatments selectively bind monoclonal antibodies to antigens presented on the surfaces of diseased cells, they present a minimal area of tissue destruction. This describes the reason behind their increased utilization in immunotherapy.

Recombinant Proteins: Recombinant proteins refer to manufactured proteins from recombinant DNA. It involves insertion of a gene that encodes a protein whose necessity is located within a host cell, upon which they then manufacture enormous levels of the said proteins for atherapeutic treatment. Recombinant proteins are extensively used in the therapeutic use in diseases of genetic origin, hemophilia, and metabolic disorders. Its usage continues to expand according to the degree of accuracy they can substitute or supplement the missing or deficient proteins of the body.

Vaccines: Vaccines are biological preparations that can offer immunity against certain diseases by stimulating the body's immune response. There are four main types of biologic vaccines, including live pathogen, weakened pathogen, inactivated pathogen, and recombinant DNA. The vaccines play a vital role in preventing infectious diseases, such as flu, COVID-19, and hepatitis. Growth in this segment comes largely from the global vaccination campaign that is burgeoning new vaccines, especially for emerging infectious diseases.

Cell & Gene Therapy: Cell and gene therapy involve the implantation of genes or living cells for treatment of incurable diseases. Such therapies can be further classified as modification of patient genes for gene therapy and live cells for cell therapy for the repair of damaged tissue. Such advanced treatment could be an incredible tool in the cure of inherited genetic disorders, selected cancers, and cardiovascular diseases within the perspective of personalized medicine.

Application Analysis

Oncology: Oncology is the field of medicine dealing with cancer treatment. More and more, biologic therapies, including monoclonal antibodies, and gene therapies are applied in oncology to fight the cancer cells specifically, thus not damaging the normal tissue. It is applied to different types of cancers, such as breast, lung, and lymphoma, bringing forth new hope in cases where chemotherapy and radiation therapy alone are deemed insufficient. Immunotherapy is also a major part of the modern treatment for cancer.

Autoimmune & Immunological Disorders: Autoimmune and immunological diseases are a result of the immune system's wrong attack on the body's normal tissues. Biologic drugs include monoclonal antibodies, recombinant proteins, and cell therapies. Such therapies work to target particular parts of the immune system that would reduce inflammation and prevent more tissue damage; hence, there are more targeted and effective treatment options for patients with fewer side effects than those associated with other treatments.

Hematologic disorders: Biological disorders are such disorders that impact the blood and bone marrow directly, such as hemophilia, anemia, or leukemia. Biologic therapies are usually used to substitute either missing or defect proteins, clotting factors are used in replacement therapy for Hemophilia, but in leukemia; abnormal cells would be targeted to destroy them through biologic therapy. Monoclonal antibodies and recombinant proteins work significantly in diseases like these which improve the patient's quality of life and survivability, specifically with the innovation of precision medicines for blood-related cancer.

Infectious Diseases: A pathogen such as bacteria, viruses, fungi, and parasites has usually been given etiology of infectious diseases. The latest additions have been biologics, comprising vaccines and monoclonal antibodies, increasingly being used for prevention and treatment of infectious diseases. Vaccines are here to stay, and vaccination continues to play an important role in preventing the next outbreak, just like influenza or COVID-19. Monoclonal antibodies will be useful in treating a viral infection, for example Ebola or COVID-19, immediately. Their application continues to evolve with the emerging pathogens and global health challenges.

Biologics Market Regional Analysis

The biologics market is segmented into several key regions: North America, Europe, Asia-Pacific, and LAMEA (Latin America, Middle East, and Africa). Here's an in-depth look at each region

Why North America holds the largest share in the biologics market?

The North America biologics market size was estimated at USD 247.03 billion in 2024 and is expected to reach around USD 500.07 billion by 2034. North America holds the largest market share, primarily contributed by the United States and Canada.  A technologically advanced healthcare system, stronger research and development structure, and several leading biopharmaceutical companies are contributing factors that have made it the leader in the biologics market. An example is in Tenvie which was released by using acquired assets in January 2025 under a focus area targeting neurological and metabolic diseases, thereby raising the firm USD 200 million in finance towards its work. This was part of strategic progression, driving this venture to greater accomplishments in combating illnesses such as Alzheimer's disease, and Parkinson's, and putting into action aggressive steps in expanding its scope and development across biopharma. Significant strength by strong reimbursement, efficient manufacturing space, and huge spending on health aids this venture.

Why is Europe hit sustainable growth in the biologics market?

The Europe biologics market size was valued at USD 172.12 billion in 2024 and is projected to hit around USD 348.43 billion by 2034. The largest share in the biologics market is held by Europe and dominated by Germany, the United Kingdom, France, Italy, and Spain. This region has a proper strong regulatory system under the EMA to protect and promote safe and effective biologics. Strong government support towards R&D in the healthcare sector, combined with the continually rising aging population and increased incidence of chronic diseases, fuels the growth in this market. In December 2024, EMA and the Heads of Medicines Agencies published new guidelines related to commercially confidential information and personal data in the marketing authorization dossiers. The new rules would make most of the data releasable by default, increase transparency, and bring them into line with current practice. The guidelines also relate to the protection of personal data in response to all the regulations that the EU has set in this regard, continuously striving toward data security and transparency. An increase in biosimilars has been seen in Europe as patents for biologic drugs expired, lowering their costs and making them more accessible to patients across this continent.

Why is Asia-Pacific fast-emerging for biologics market?

The Asia-Pacific biologics market size was accounted for USD 116.65 billion in 2024 and is forecasted to grow around USD 236.15 billion by 2034. Asia-Pacific (APAC) is a fast-emerging market for biologics. Key countries of the region are China, Japan, India, South Korea, and Australia. Particularly, China and India are on the list, given their significant population, increase in access to healthcare, and booming economies. The region sees considerable investment in biotechnology research and manufacturing. Japan, due to its very advanced healthcare structure, is considered one of the markets with the largest potential for the sale of biologics. For example, as of January 2025, the pharmaceutical companies are keener to pursue deals in China. It is attracted to improved data transparency and a more favorable regulatory environment. Owing to geopolitical tensions, it still manages to develop some massive partnerships in oncology and metabolic diseases. Analysts are now of the view that the global pharma industry will increasingly come under the influence of China. Its focus would be on next-generation assets and international standards for clinical trials.

LAMEA Biologics Market Trends

The LAMEA biologics market was valued at USD 36.02 billion in 2024 and is anticipated to reach around USD 72.93 billion by 2034. In the LAMEA region, slow growth is being noticed by countries such as Brazil, Mexico, South Africa, Saudi Arabia, and the United Arab Emirates. Latin America is gaining increased attention from developing economies concerning improvement in healthcare infrastructure that is driving the demand for biologic therapies. Healthcare investments are starting to grow in the Middle East region led by the UAE and Saudi Arabia. The adoption of advanced treatments there is currently accelerating. In Africa, despite the fact that the market is still in its nascent stages, growing awareness and need for biologics in dealing with infectious diseases, cancer, and chronic conditions exists but challenges remain in terms of accessibility and cost toward good health.

Biologics Market Top Companies

• AbbVie Inc.
• Pfizer Inc.
• Novartis AG
• Hoffman-La Roche AG
• Bayer AG
• Amgen
• Sanofi
• Eli Lilly and Company
• GlaxoSmithKline Plc
• Celltrion Inc.
• AstraZeneca
• Samsung Biologics Co. Ltd.
• G. Chem Ltd. 

CEO Statements

Rob Michael, CEO of AbbVie Inc.

• "At AbbVie, we are committed to leading the charge in the biologics market, leveraging cutting-edge technologies and deep expertise to address the most complex and unmet medical needs. Our portfolio of biologic therapies, including immunotherapies and monoclonal antibodies, continues to improve patient outcomes globally, driving both innovation and access to high-quality treatments for chronic diseases and cancer."

Albert Bourla , CEO of Pfizer Inc.

• "At Pfizer, we are focused on advancing innovative biologic therapies that address some of the world’s most pressing health challenges. Through cutting-edge research, collaboration, and leveraging our deep scientific expertise, we aim to transform patient outcomes. Our biologics portfolio, including vaccines and immunotherapies, is a critical part of our commitment to improving global health and ensuring that people everywhere have access to the life-saving treatments they need."

Vasant Narasimhan, CEO of Novartis AG

• "At Novartis, we are dedicated to pioneering the future of healthcare with innovative biologic therapies. Our portfolio of cutting-edge treatments, including advanced gene therapies and monoclonal antibodies, is designed to address some of the most complex diseases of our time. We remain committed to improving patient outcomes globally through transformative science and making these life-saving therapies accessible to as many people as possible."

Recent Developments

• In October 2023, Amgen closed acquisition deal with Horizon Therapeutics PLC that had an approximate value of USD 27.8 billion. Because the company aimed to strengthen its pipelines with innovative drugs whose point of focus is rare diseases, the core business of Horizon Therapeutics PLC was constituted by TEPEZZA and KRYSTEXXA. The acquisition was likely to fuel Amgen's drive towards creating first-in-class medicines as it drived the improvement in health amongst patients afflicted with serious conditions. The strength of Horizon in filling the unmet needs of rare and autoimmune diseases supplemented the already existing Amgen's strength in biotechnology and therapeutics development.
• In February 2024, Novartis said it agreed to buy MorphoSys AG in an all-cash deal worth about USD 2.76 billion, paying USD 69.6 a share. Aside from that, the transaction should facilitate the company in populating its oncology pipeline with drugs for myelofibrosis, an early-stage dual inhibitor for solid tumors and lymphomas. That would be subject to receipt of all necessary regulatory clearances and passing a minimum acceptance threshold of 65% in MorphoSys shares tendered. It would close in the first half of 2024.
• In October 2023, Celltrion Group reported that subsidiaries, Celltrion, Inc. and Celltrion Healthcare Co., Ltd. received approval for their merger from respective shareholders. Thus, extraordinary general meetings were held on 23 October 2023. In the merger, Celltrion shares would be issued to the shareholders of Celltrion Healthcare at a ratio of 0.4492620 for every share. The board also resolved that its treasury shares above 2.3 million be retired and it acquired approximately 2.4 million shares of both companies to boost shareholder value. The merger seeks to strengthen Celltrion as the global leader in biopharmaceutical and operate in a streamlined form for growth into the future.

Market Segmentation

By Product

• Monoclonal Antibodies
  
  • MABs by Application
    
    • Diagnostic
      
      • Biochemical Analysis
      • Diagnostic Imaging
    • Therapeutic
      
      • Direct MAB Agents
      • Targeting MAB Agents
    • Protein Purification
    • Others
• MABs by Type
  
  • Murine
  • Chimeric
  • Humanized
  • Human
  • Others
• Recombinant Proteins
• Vaccines
• Cell & Gene Therapy
• Others

By Application

• Oncology
• Autoimmune & Immunological Disorders
• Hematological Disorders
• Infectious Diseases
• Others

By Source

• Microbial
• Mammalian
• Others

By Manufacturing

• Outsourced
• In-house

By Region

• North America
• APAC
• Europe
• LAMEA