The global sales of biologics is estimated to be worth USD 450.2 billion in 2025 and anticipated to reach a value of USD 1,077.2 billion by 2035. Sales are projected to rise at a CAGR of 9.1% over the forecast period between 2025 and 2035. The revenue generated by biologics in 2024 was USD 417.1 billion.
Biologics are the next-generation medicinal interventions produced by the biological processes of cells, tissues, or microorganisms. This new generation includes complex molecules-monoclonal antibodies, therapeutic proteins, vaccines, and gene therapies-formulated against very specific biological pathways.
Other than conventional small-molecule drugs, biologics give very precise and effective treatments for such complicated diseases as cancer, autoimmune disorders, and genetic conditions.
These biotechnical processes require state-of-the-art techniques of recombinant DNA technology and cell culture systems, making this modality of medication very specific and effective. The primary growth factor for the market of biologics is the increasing demand for personalizing medicine.
Biologics lie at the core of precision healthcare and could be tailored for the genetic profile of an individual patient, therefore improving outcomes while minimizing side effects.
Global Biologics Industry Assessment
| Attributes | Key Insights |
|---|---|
| Historical Size, 2024 | USD 417.1 billion |
| Estimated Size, 2025 | USD 450.2 billion |
| Projected Size, 2035 | USD 1,077.2 billion |
| CAGR (2025 to 2035) | 9.1% |
Cell and gene therapy is revolutionizing the treatment approaches to complex and untreatable diseases. These therapies use cellular and genetic mechanisms of the body to repair, replace, or modify dysfunctional cells or genes, offering a curative potential instead of symptomatic relief.
New innovations such as CAR-T therapy and the use of CRISPR-Cas9 genome editing are major focus nowadays. Indeed, CAR-T therapy has been so successful in treating certain types of blood cancer that in only a few years, its clinical use has become wide.
Meanwhile, therapies based on CRISPR are showing early promise to correct genetic mutations that underlie a variety of rare disorders, including sickle cell anemia and beta-thalassemia. The market is further driven by improvements in delivery mechanisms, increased manufacturing scalability, and reduction of production costs.
Regulatory bodies like the FDA and EMA are increasingly awarding designations of approval, further accelerating their adoption.
Further movement into diseases like hemophilia, muscular dystrophy, and retina disorders illustrates the widening circle of therapeutic versatility for gene therapies. As this innovation mature, substantial growth within the biologics market will continue to change the landscape of treatment options and unmet medical needs.
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The global biologics market's compound annual growth rate (CAGR) for the first half of 2024 and 2025 is compared in the table below. This analysis provides important insights into the performance of the industry by highlighting significant shifts and trends in revenue generation.
The first half (H1) is the period from January to June, and the second half (H2) is July to December. In the first half (H1) of the decade from 2024 to 2034, the business is predicted to surge at a CAGR of 10.3%, followed by a slightly lower growth rate of 9.8% in the second half (H2) of the same decade.
| Particular | Value CAGR |
|---|---|
| H1 | 10.3% (2024 to 2034) |
| H2 | 9.8% (2024 to 2034) |
| H1 | 9.1% (2025 to 2035) |
| H2 | 8.8% (2025 to 2035) |
Moving into the subsequent period, from H1 2025 to H2 2035, the CAGR is projected to decrease slightly to 9.1% in the first half and remain relatively moderate at 8.8% in the second half. In the first half (H1) the industry witnessed a decrease of 120 BPS while in the second half (H2), the industry witnessed a decrease of 100 BPS.
Rising prevalence of chronic diseases is driving the market growth
Chronic diseases, such as cancer, diabetes, and autoimmune disorders, require long-term management and are often related to complex biological pathways that traditional therapies cannot effectively manage. Biologics are targeted to act upon these specific molecules or pathways, thus providing a more precise and effective approach toward the treatment of these conditions.
For instance, according to the World Health Organization (WHO), Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, or nearly one in six deaths
Unlike traditional therapies, biologics are designed to interface with the body's normal processes to provide treatments complementary to the underlying causes of chronic diseases and are not just symptomatic. This targeted approach enhances therapeutic outcomes while reducing the likelihood of adverse effects and makes biologics a preferred choice among healthcare providers and patients.
Besides, increasing chronic diseases burdens have put a greater emphasis on treatment options through innovation. The solution has come to be biologics and provided a way to solve unmet medical needs.
Increasing awareness among physicians and patients regarding its benefits has increased demand for, and hence driving, the biologics market. This trend is indicative of the critical role biologics are playing to change how chronic diseases will be managed and in the future of healthcare.
Advent of next-generation biologics is driving the industry growth
The scope and potential of the biologics market is widened with the advent of next-generation biologics. Indeed, newer treatments like antibody-drug conjugates, bispecific antibodies, and fusion proteins are already shifting the paradigms of treatment with much higher efficacy, precision, and diversity than their predecessors.
An example of this is antibody-drug conjugates or ADCs, which combine the specificity of monoclonal antibodies with the potent cytotoxicity of small molecule drugs, thus allowing for the targeted killing of cancer cells without destroying healthy tissues. So far, these treatments have proven highly effective in oncology, hence the investments in ADC development.
Bispecific antibodies, which can bind two different antigens simultaneously, open new mechanisms of action, including engaging immune cells to directly attack tumors. They are gaining ground in oncology and immunology as a way of addressing complex disease pathways.
Emerging options in conditions as diverse as hemophilia or immune-mediated disease benefit from newer possibilities in therapy derived from so-called fusion proteins where all the functionality from multiple biologics could potentially be addressed simultaneously.
As scalable and potentially economic, future success will only expand further driven by the strength gained from development work in variously improved bioprocessing techniques alongside engineering advancement to support more promising next-generation products.
Increased government incentives for rare disease therapies creates further growth opportunity
Government incentives for rare diseases' therapies are one good opportunity in the biologics market. Such policies as the USA orphan drug act, like others it has with other countries, were enacted to stimulate the development of treatments for rare and underserved conditions.
These incentives provided are tax credits in form of cost of clinical trials, grants for research as well as the waiver of application fees, and extended market exclusivity at approval.
The biologics sector, particularly addresses rare diseases because many diseases have genetic or molecular origins; monoclonal antibodies, gene therapies, and recombinant proteins have provided hope in the cure of conditions as diverse as Duchenne muscular dystrophy, cystic fibrosis, and rare cancers.
Globally, all markets outside of the United States such as the European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) had agreed on similar frameworks.
For biopharmaceutical companies, these incentives reduce financial risk and provide lucrative opportunities in niche markets, thereby fostering innovation and encouraging investment in biologics tailored for rare and orphan diseases. Increased rare diseases, with better diagnostic ability, are putting a greater demand on targeted biologic therapies.
High cost of biologics may restrict market growth
High cost of biologics is the major restricting factor in the global biologics market, which often prevents their accessibility and adoption-mainly in low-income and some middle-income countries. In contrast to the traditional small-molecule drugs, biologics require more complex biotechnological processes, skilled manufacturing facilities, and strict controls over their quality.
Consequently, it costs much to produce biologics and makes them many times costlier than the traditional therapy. Research and development (R&D) of biologics also comes at great expense, including considerable direct clinical trials and regulatory approval which add to the expenditure.
Biologics also require cold chain logistics, where the product remains stable during distribution, adding to their costs. These high costs make biologics unaffordable for patients and healthcare systems, especially in resource-poor settings where insurance coverage is either minimal or nonexistent. Even in high-income countries, the cost of biologics is a burden on healthcare budgets, which can result in restrictive reimbursement policies.
However, biosimilars are quite cheaper and hence not sufficient in filling the gap of access most parts of the world. Therefore, manufacturing innovations, government subsidies, or differential pricing strategies will be the keys to widening access to biologics and realizing their potential market.
The global biologics industry recorded a CAGR of 7.5% during the historical period between 2020 and 2024. The growth of biologics industry was positive as it reached a value of USD 1,077.2 billion in 2035 from USD 450.2 billion in 2025.
In the past, diseases were treated using small-molecule drugs and non-specific therapies like chemotherapy and steroids. Such treatments are very effective for most diseases but lack specificity and tend to target diseased and healthy cells alike, which results in serious side effects. For chronic and complex diseases, management of symptoms was the goal rather than a cure.
On the other hand, biologics are revolutionary; they provide targeted therapies that can be designed to react with specific molecular pathways. For instance, monoclonal antibodies can accurately inhibit inflammatory signals in autoimmune diseases or hit cancer cells without killing off normal tissues.
Gene and cell therapies can also provide personalized and curative treatment for genetic disorders. Specificity and efficacy are major advances of biologics, but with increased cost and production complexity compared to traditional therapies.
Advancements in bio-manufacturing technologies drive the biologics market by improving efficiency and scalability in production. Innovations such as single-use systems, continuous manufacturing, and advanced bioprocessing techniques reduce production costs and enhance product consistency.
The technologies help to streamline processes, minimize contamination risks, and accelerate production cycles in response to growing global demand for biologics.
The introduction of automation, artificial intelligence, and digital monitoring systems for the production of biologics further optimized control and regulatory compliances. Advances such as those above are vital to complex biologics products like monoclonal antibodies and cell therapies.
The integration of technologies over the manufacturing challenges and bottlenecks allows for enhanced access to the products, propels innovation speed, and consequently fosters further market growth.
Tier 1 companies are the industry leaders with 45.2% of the global industry. These companies stand out for having a large product portfolio and a high production capacity.
These industry leaders also stand out for having a wide geographic reach, a strong customer base, and substantial experience in manufacturing and having enough financial resources, which enables them to enhance their research and development efforts and expand into new industries.
The companies within tier 1 have a good reputation and high brand value. These companies frequently get involved in strategies such as acquisition and product launches. Prominent companies within tier 1 include Amgen, Inc., Eli Lilly and Company, GlaxoSmithKline PLC and AbbVie Inc.
Tier 2 companies are relatively smaller as compared with tier 1 players. The tier 2 companies hold a market share of 29.1% worldwide. These firms may not have cutting-edge technology or a broad global reach, but they do ensure regulatory compliance and have good technology.
The players are more competitive when it comes to pricing and target niche markets. Key Companies under this category include F. Hoffmann-La Roche Ltd, Novartis AG, Pfizer Inc. and AstraZeneca.
Compared to Tiers 1 and 2, Tier 3 companies offer biologics, but with smaller revenue spouts and less influence. These companies mostly operate in one or two countries and have limited customer base. The companies such as Bayer AG, and others falls under tier 3 category. They specialize in specific products and cater to niche markets, adding diversity to the industry.
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The market analysis for biologics in various nations is covered in the section below. An analysis of important nations in North America, Latin America, Western Europe, Eastern Europe, East Asia, South Asia & Pacific, and Middle East & Africa of the world has been mentioned below.
It is projected that the United States will maintain its leading position in North America through 2035, holding a value share of 88.9%. By 2035, China is expected to experience a CAGR of 9.0% in the Asia-Pacific region.
| Countries | Value CAGR (2025 to 2035) |
|---|---|
| United States | 3.7% |
| Germany | 3.8% |
| France | 4.7% |
| UK | 4.1% |
| China | 9.0% |
| India | 9.5% |
| South Korea | 8.7% |
Germany’s biologics market is poised to exhibit a CAGR of 3.8% between 2025 and 2035. The Germany holds highest market share in European market.
AI in biologic development is a significant growth factor in the German biologics market. Artificial intelligence technologies are changing the ways of identification, development, and optimization of biologics while accelerating R&D.
In Germany, where much focus lies on innovative and state-of-the-art technologies in the pharmaceutical industry, AI is increasingly being used to identify novel therapeutic targets, predict protein structures, and streamline drug design.
AI-powered tools grant the opportunity for more effective analysis of big biological data, which may lead to biomarker identification, optimization of clinical trial designs, and personalized treatments. This would decrease the overall time and expenses spent on new biologic development and enhance the capability of the market to meet the growing demand by the use of innovative therapies.
Coupled with AI, Germany has a strong biotechnology ecosystem that positions it as an international leader in the development of biologics. AI accelerates the discovery of new biologic therapies, enhances treatment efficiency and effectiveness, thereby driving growth within Germany's biologics market.
United States is anticipated to show a CAGR of 3.7% between 2025 and 2035.
Favorable regulatory approvals are one of the major growth drivers for the biologics market in the United States. The USA FDA offers expedited approval pathways, which include the breakthrough therapy designation, accelerated approval, and priority review programs, to expedite promising biologic therapies.
These programs are implemented with an aim of speeding up the development and approval of drugs in respect of significant potential in the treatment of serious conditions, especially where there are limited or no existing treatments.
For biologics, it means sooner speed to the market for therapies targeted to diseases like cancer, autoimmune disorders, and rare genetic conditions. The flexible regulatory framework that the FDA offers encourages innovation and investment because companies can bring life-saving treatments to patients more rapidly.
Moreover, biotech companies engage closely with the FDA to assure that scientific achievements in biologics, gene and cell therapy, are adapted efficiently into health care. All these factors foster a favorable environment for the regulations, which expedites penetration into the markets and fuels further growth in the USA market.
China is anticipated to show a CAGR of 9.0% between 2025 and 2035.
The increasing adoption of cell and gene therapies acts as a major growth factor in the biologics market of China. Innovations in the use of breakthrough gene-editing technologies like CRISPR, together with new developments around CAR-T-cell therapies, present an ever-changing treatment paradigm-very significantly within oncology and for conditions considered genetic in nature.
These revolutionary treatments have begun to speedily take shape and gain swift acceptance with advances in China's healthcare structure and government-friendly policies.
All this has created a very good environment for both domestic and international companies to develop and bring innovative biologics to the market. Besides, China's huge patient population and the high incidence of diseases such as cancer and genetic disorders create a huge demand for personalized treatments.
As cell and gene therapies continue to evolve, the increasing usage of biologics in clinical practice within China propels the market forward. The ability to offer curative options for previously untreatable diseases will further accelerate this growth, making China a vital part of the development of biologics worldwide.
The section contains information about the leading segments in the industry. Based on drug class, the monoclonal antibody segment is expected to account for 31.5% of the global share in 2023.
| By Drug Class | Monoclonal Antibody |
|---|---|
| Value Share (2025) | 31.5% |
The monoclonal antibody segment is projected to be a dominating segment in terms of revenue, accounting for almost 31.5% of the market share in 2025.
The monoclonal antibodies segment will dominate the biologics market owing to their wide field of therapeutic applications and high efficacy in treating several diseases. These mAbs have applications in the treatment of cancer, autoimmune disorders, infectious diseases, and more by offering targeted therapies with fewer side effects compared to conventional treatments.
They interact with specific antigens with high affinity, making them potent against disease-causing cells, particularly in oncology, where combination therapies are becoming a leading trend.
Moreover, improvements in engineering have enabled mAbs to become functional with the development of bispecific antibodies and ADCs. This has also been one of the main reasons for their high demand, strong clinical data, and deep pipeline developments, which secure mAbs' leadership in biologics for years to come.
| By Source | Bacterial cells |
|---|---|
| Value Share (2025) | 44.5% |
The bacterial cells segment will dominate the industry in terms of revenue, accounting for almost 44.5% of the market share in 2025.
Among source types, the bacterial cells segment is expected to dominate the biologics market owing to cost-effectiveness and scalability in production. Bacterial cells, especially E. coli, are widely used in the manufacturing of recombinant proteins, vaccines, and other biologic therapies. Their ability to grow rapidly in controlled environments makes them ideal for large-scale manufacturing.
Besides, bacterial expression systems are simpler and less costly in development compared to mammalian cell cultures that need very complex conditions. Features that make bacterial cells one of the favorite options for choice in producing biosimilars and therapeutic proteins: with rising demand for biologics, efficiency, cost-effectiveness, and well-established use will be the driving factors to keep bacterial cell systems at the top in the biologics market.
The biologics industry is highly competitive, with numerous companies actively conducting clinical trials across various therapeutic areas. Manufacturers are focused on continuous innovation and expanding their product portfolios to stay ahead in the market.
Leading biologics producers are also prioritizing international growth to enhance their revenue streams and expand their market footprint in developing regions.To achieve this, many companies are pursuing the acquisition of regional players, enabling them to tap into local markets and strengthen their global presence.
Additionally, manufacturers are leveraging key strategies such as new product launches, strategic collaborations, research sponsorships, and agreements to boost product sales and reinforce their market position. These efforts are driving competition and fostering rapid advancements in the biologics sector.
Recent Industry Developments in Biologics Market
In terms of drug class, the industry is divided into monoclonal antibodies, recombinant hormones/proteins, vaccines, cellular based biologics, gene-based biologics, therapeutic enzymes and others.
In terms of application, the industry is segregated into infectious diseases, cancer, autoimmune diseases, rare diseases, and others
In terms of manufacturing type, the industry is divided into contract manufacturing and in-house manufacturing.
In drug classification, the industry is segregated into branded drugs and generic drugs
In terms of mode of purchase, the industry is divided into prescription drugs and over-the-counter (OTC) drugs.
In terms of source, the industry is segregated into bacterial cells, yeast cells, plant cells, animal cells and others source
In terms of distribution channel, the industry is divided into hospital pharmacies, retail pharmacies and online pharmacies.
Key countries of North America, Latin America, East Asia, South Asia & Pacific, Western Europe, Eastern Europe and Middle East and Africa (MEA) have been covered in the report.
The global biologics industry is projected to witness CAGR of 9.1% between 2025 and 2035.
The global biologics industry stood at USD 417.1 billion in 2024.
The global biologics industry is anticipated to reach USD 1,077.2 billion by 2035 end.
China is expected to show a CAGR of 9.0% in the assessment period.
The key players operating in the global biologics industry Amgen, Inc., Eli Lilly and Company, GlaxoSmithKline PLC, AbbVie Inc., F. Hoffmann- La Roche AG, Novartis AG, Pfizer Inc, AstraZeneca, Bayer AG, Merck & Co. Inc., Others.
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