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Biologics Market Size Envisioned at USD 845.78 Billion by 2033

Biologics is Poised for USD 845.78 Billion Market Size by 2033

Status: Published Category: Biotechnology Insight Code: 5108 Format: PDF / PPT / Excel

Report Highlights

  • The biologics market size ballooned to a staggering USD 419.07 billion in 2023.
  • It is anticipated to attain USD 845.78 billion by 2033.
  • It is expected to register 7.6% of CAGR by 2032.
  • Monoclonal antibodies led the market in 2023, capturing a commanding 66% market share.
  • Oncology takes center stage, with this application segment leading the pack at 36% share in 2023.
  • Asia Pacific is the rising star, predicted to be the fastest-growing region over the next decade.

Biologics Market Size 2023 - 2033

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The American Cancer Society estimates 1.92 million new cancer cases and 609,360 deaths in the U.S., contributing to a global toll of 9.6 million lives lost in 2022. Biologics, monoclonal antibodies, and immunotherapies revolutionize cancer care, boosting survival and minimizing side effects.

Biologics are therapeutic products derived from living organisms or their components, such as cells, proteins, or nucleic acids. Unlike traditional drugs, which are often chemically synthesized, biologics are typically large and complex molecules produced using advanced technologies like genetic engineering. This complexity allows them to closely mimic the natural substances in the human body, making them more targeted and specific in their actions. One significant aspect of biologics is their role in treating diseases at the molecular and cellular levels. They are designed to interact with specific biological pathways and mechanisms, making them highly effective in addressing the underlying causes of various diseases. This targeted approach can result in better treatment outcomes and, in many cases, fewer adverse effects than conventional drugs.

The application of biologics spans a wide range of therapeutic areas. One prominent example is their use in oncology. Monoclonal antibodies, a biologic, have revolutionized cancer treatment by selectively targeting cancer cells while sparing healthy cells. This targeted action helps minimize damage to surrounding tissues and reduces side effects commonly associated with traditional chemotherapy. In autoimmune disorders, where the immune system mistakenly attacks the body's tissues, biologics can modulate specific immune response components. This helps to restore the balance and alleviate symptoms without suppressing the entire immune system, as is often the case with conventional treatments.

The growth of the biologics market is fueled by ongoing advancements in biotechnology, such as improved techniques for protein engineering and manufacturing processes. These innovations enable the development of novel and more sophisticated biological therapies. It's important to note that biologics often come with higher production costs and can be more challenging to manufacture than small-molecule drugs. This can result in higher prices for biological treatments. Despite this, the demand for biologics continues to rise due to their ability to provide effective and often life-changing solutions for patients facing various health challenges.

Number of FDA Approved Biologics from 2015 to 2021

Additionally, the biologics market represents a transformative shift in medicine, offering targeted and personalized treatments that leverage the body's natural processes to address diseases at their roots. As research and development in biotechnology advance, we can expect further innovations and an expanding role for biologics in improving healthcare outcomes across diverse therapeutic areas.

Global Burden of Chronic Diseases

In 2023, the World Health Organization (WHO) revealed that globally, 41 million people die each year due to Noncommunicable Diseases (NCDs), accounting for 74% of worldwide deaths. The leading causes of NCD-related deaths include cardiovascular diseases (17.9 million annually), cancers (9.3 million), chronic respiratory diseases (4.1 million), and diabetes (2.0 million, which includes deaths from diabetes-induced kidney disease).  The escalating prevalence of chronic diseases, such as cancer, autoimmune disorders, and diabetes, has spurred a surge in demand for effective and innovative treatment solutions worldwide. These persistent health conditions necessitate ongoing and targeted medical interventions, propelling the growth of the biologics market. Biologics, crafted to interact with specific biological pathways within the body, exemplify their efficacy in managing the complexities of chronic diseases. In cancer treatment, they exhibit precision by targeting and inhibiting the growth of cancer cells. At the same time, in autoimmune disorders, they modulate the immune response to alleviate inflammation and prevent damage to healthy tissues. This targeted approach sets biologics apart from traditional drugs, offering precision and effectiveness that mitigates side effects often associated with broader-acting medications. As awareness of available treatment options grows, there is a rising patient demand for innovative therapies. Biologics' unique ability to address specific disease mechanisms aligns with these expectations, driving their adoption. Additionally, the long-term management requirements of chronic diseases find a fitting solution in biologics, as their targeted mechanisms of action make them well-suited for sustained use.

Biologics Drugs Used in Rare Diseases

Biologics Drugs Used in Rare Diseases

The economic and social impact of the increasing burden of chronic diseases on healthcare systems underscores the urgency to find effective treatments that not only improve patient outcomes but also alleviate the overall economic strain. This imperative has fueled substantial investments in research and development within the biopharmaceutical industry, with pharmaceutical companies actively exploring and developing new biologics to meet the unmet medical needs associated with chronic diseases. In essence, the pervasive prevalence of chronic diseases is a pivotal factor propelling the biologics market forward, driven by the pressing demand for advanced, effective, and targeted treatments to address the challenges posed by these persistent health conditions.

The growing patient demand for innovative treatments, particularly in chronic health conditions, is a multifaceted trend shaped by several key factors. As individuals become more informed about available treatment options, they increasingly seek therapies that offer effectiveness, innovation, and personalization.

Growing Patient Demand for Innovative Treatments

Advances in technology and increased access to healthcare information have empowered patients to be more proactive in understanding their health conditions. With the rise of online resources, patients are becoming better informed about various treatment options, including the benefits and limitations of traditional drugs versus innovative biologics.

The concept of personalized medicine, personalized treatments to an individual's unique genetic and molecular profile, has gained prominence. Biologics fit well into this paradigm, as they can be customized to target specific disease mechanisms in a way that traditional drugs may not. Patients are drawn to treatments tailored to their unique needs and characteristics. Biologics often have fewer side effects than conventional drugs, as their targeted nature minimizes the impact on healthy tissues. Patients, particularly those managing chronic conditions that require long-term treatment, are inclined towards therapies that offer effective results with a lower likelihood of adverse effects. The healthcare landscape is evolving, and patients are increasingly expecting innovative solutions. Biologics represent a frontier in medical innovation, offering novel approaches to treating diseases that may have been challenging to manage with traditional methods. This aspect aligns with the desires of patients actively seeking innovative and forward-thinking therapies.

Recent Update:

  • The U.S. Food and Drug Administration has approved recent vaccine updates for emergency use. These vaccines, developed by ModernaTX Inc. and Pfizer Inc. in 2023-2024, have been modified to target current COVID-19 variants better and offer improved protection against severe outcomes like hospitalization and death.

Monoclonal Antibodies Set Remarkable Treatment for Cancer

In 2022, the latest data from the International Agency for Research on Cancer's Global Cancer Observatory indicates that ten specific types of cancer collectively represented approximately two-thirds of both new cases and fatalities worldwide. Covering 185 countries and 36 different types of cancer, the rising demand for biologics, including monoclonal antibodies and immunotherapies, has surged due to the increasing incidence of cancer. These innovative treatments are revolutionizing cancer care by enhancing survival rates and minimizing adverse effects.

Estimated Cancer Survivors in the U.S., By Age 2022

Recently Approved Cancer Treatment Drugs by Food and Drug Administration
Sr. No. Drug Name Indication Approved Date
1. Elranatamab T-cell engager for multiple myeloma 14 August 2023
2. Epcoritamab T-cell engager for lymphoma 29 June 2023
3. Truqap PARP inhibitor for breast cancer 2 December 2023
4. Ryzneuta Used in conjunction with myelosuppressive anti-cancer drugs 25 July 2023
5. Augtyro ROS1-positive non-small cell lung cancer 5 August 2023


Patients dealing with chronic health conditions often prioritize not only the efficacy of treatments but also the impact on their overall quality of life. Biologics, with their ability to provide targeted and often more tolerable therapies, appeal to individuals who want to manage their conditions effectively without compromising their daily activities and well-being. The growing patient demand for innovative treatments, including biologics, results from increased effective and personalized solutions and an expectation for medical innovation. As patients take a more active role in their healthcare journeys, the appeal of therapies that offer targeted, low-risk, and forward-thinking approaches becomes increasingly significant, shaping the landscape of modern healthcare.

The Challenge Posed by Biosimilar Products

The advent of biosimilars has introduced a significant challenge to the established biologics market. Biosimilars, while similar in function to existing biologics, are different, and their entry into the market poses a threat to the market share and profitability of originator biologic manufacturers. Often entering the market at lower prices, biosimilars create pricing pressures that force original biologic manufacturers to reconsider their pricing strategies.

This intensified competition can result in a shift in consumer preferences and market dynamics as biosimilars gain acceptance. To navigate this challenge, biologic manufacturers must strategically adapt their approaches, potentially exploring innovations and new formulations or emphasizing superior efficacy and safety. Furthermore, educating healthcare professionals and patients about the unique benefits and proven track record of original biologics becomes crucial to maintaining trust and market presence. Legal considerations, such as protecting intellectual property and managing patent challenges, add another layer of complexity to the competitive landscape. Overall, the biosimilar challenge compels biologic manufacturers to engage in strategic initiatives to preserve their market position, emphasizing the need for adaptability and differentiation in the evolving pharmaceutical landscape.

Geographical Landscape

Several factors contribute to the growth of the biologics market in North America. One key reason is the high number of people dealing with long-term health issues. North America has many top biopharmaceutical companies, and the reimbursement policies for these advanced therapies are favorable. The use of biological prescriptions is increasing, and a lot of money is invested in developing targeted drugs, which is helping the market grow. Additionally, the approval of new and innovative biological drugs, like gene therapy and RNAi therapeutics, is expected to push the market further. In the North American map, places like Boston, San Francisco, and San Diego stand out as central hubs for these advancements, with numerous biotech companies, research centers and clinical trial sites contributing to the region's prominence in the biologics landscape.

The geographical landscape of the biologics market in the Asia-Pacific (APAC) region has been dynamic and characterized by growth. Japan's well-established pharmaceutical industry has been a critical player in the APAC biologics market. The country has a robust regulatory framework and has seen the development and approval of various biologic drugs. India has a strong presence in the generic pharmaceutical market, and the biologics sector has been gaining traction. The country's biotech industry has been expanding, focusing on biosimilars. The COVID-19 pandemic has influenced biologics, with increased attention to biopharmaceutical research and vaccine and treatment development.

Competitive Landscape

The presence of established pharmaceutical companies and emerging biotechnology firms characterize the competitive landscape of the biologics market. The landscape is dynamic, with ongoing research and development, collaborations, mergers, and acquisitions shaping the industry. Companies often engage in collaborations and partnerships to enhance their biologics pipelines. Collaborations between big pharmaceutical and smaller biotech firms are typical for developing novel therapies. Mergers and acquisitions are prevalent in the biologics sector, allowing companies to expand their portfolios and strengthen their positions. The competitive landscape is influenced by product innovation, clinical trial success, regulatory approvals, and market expansion strategies.

Recent Developments

  • In 2020, WuXi Biologics bought Bayer's drug manufacturing facility in Germany, marking its first facility in Europe. This move aimed to boost WuXi Biologics' ability to produce medications commercially.
  • In October 2020, Cadila Pharmaceuticals introduced two similar biologic drugs, NuPTH and Cadalimab, in the Indian market. This step was taken to expand the company's presence in different regions.

Market Players

  • Amgen
  • Merck & Co.
  • F. Hoffmann-La Roche Ltd.
  • Bristol-Myers Squibb
  • Sanofi
  • Bayer AG
  • AstraZeneca
  • GlaxoSmithKline Plc.
  • Novartis AG
  • Eli Lilly and Company

Market Segments

By Product

  • Monoclonal Antibodies
  • Recombinant Hormones/Proteins
  • Vaccines
  • Cellular Based Biologics
  • Gene-Based Biologics
  • Therapeutic Enzymes
  • Others

By Application

  • Oncology
  • Immunology
  • Infectious Diseases
  • Other Therapeutic Areas

By Drug Classification

  • Branded Drugs
  • Generic Drugs

By Mode of Purchase

  • Prescription Drugs
  • Over-the-counter (OTC) Drugs

By Distribution Channel

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

By Geography

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa

About The Author

Namrata Bukshet is not just a market researcher; she is a detective, a storyteller, and a champion for healthier lives. Her journey began with a Bachelor of Pharmacy degree and a thirst for knowledge that led her to pursue a Post Graduate Diploma in Pharmaceutical Management. Her curiosity for consumer behaviour and market trends burned bright. She delved deep into the world of lifestyle disorders, conducting extensive research that sheds light on the intricate dance between personal choices and societal pressures. This exploration culminated in a groundbreaking paper on E-Biz: Indias 1st G2B Online Portal, presented at an international conference, where her insights resonated with a global audience. But Namrata has impact extends far beyond a single paper. Her expertise has shaped the very landscape of market research and pharmaceuticals. Her keen eye for detail and unwavering commitment to understanding the why behind consumer behaviour have made her a sought-after professional in the industry. She is the decoder ring that unlocks the secrets hidden within data, the translator who turns complex trends into actionable insights. As she continues to unravel the mysteries of consumer behaviour, she paves the way for a future where healthcare is not just about treatment but about understanding the why and building a bridge to a healthier world, one insightful discovery at a time.

FAQ's

Biosimilar products are biological medicines highly similar to already approved biologic drugs, known as reference or originator biologics. These biosimilars are developed to have efficacy, safety and quality comparable to the original biologic, but different manufacturers produce them. Unlike generic versions of small-molecule drugs, which are identical to the original chemical compounds, biosimilars are not exact copies due to the complexity of biologics.

The monoclonal antibodies (mAbs) segment significantly drives growth in the biologics market. Monoclonal antibodies are biological therapy that has seen substantial innovation and success in various therapeutic areas, including oncology, autoimmune diseases and infectious diseases.

Biologics development involves complex and costly processes, including extensive research, clinical trials, and manufacturing. The high upfront costs can be a barrier for smaller companies and may impact the overall affordability of biologic therapies. While biosimilars present opportunities for cost savings and increased market competition, their adoption can be hindered by factors such as physician and patient preferences, concerns about efficacy and safety, and marketing strategies of originator biologic manufacturers.

Food and Drug Administration, World Health Organization, American Cancer Society, ASCO.gov., National Institute of Biologics, CDSCO.