Biologics Market Share

Global Biologics Market Overview

The biologics market size was valued at USD 530.12 billion in 2023 and is projected to grow from USD 616.25 Billion in 2024 to USD 2105.11 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 16.60% during the forecast period (2024 - 2032). 

These goods result from cutting-edge research and help make the most recent scientific advancements possible. These discoveries can lead to cutting-edge medicines that give patients new treatment alternatives. Various targeted treatments are now possible thanks to a better knowledge of the disease's genetic and molecular causes. 

Recombinant proteins, for instance, help the immune system recognize and bind foreign molecules, thus driving the market growth of the biologics. These are just a few of the market drivers that are driving the market.

Drugs known as biologics are produced as genetically modified proteins obtained from human genes. Biologics can comprise carbohydrates, proteins, nucleic acids, complicated mixtures of these elements, and possibly live things like cells and tissues. Most biologics are complicated mixes that are difficult to describe or identify, are heat sensitive, and are vulnerable to microbial contamination. The biologic products come from various uncultivated sources, including people, animals, and microorganisms. Large, complex chemicals created in living; laboratory-grown cells are called "biologics".

Additionally, the market expansion is anticipated to be supported by the expanding technological improvements, global research, and development efforts in this field by major pharmaceutical companies to maintain competitiveness and the loss of patent protection for major brand-name pharmaceuticals. The size of biological medications can vary from 200 to 1,000 times that of a small molecule or chemical medication.

Biologics are primarily administered via parenteral routes due to their enormous molecular size and delicate molecular structure. Growth in the market is fueled by the increasing prevalence of autoimmune, genetic, and cancer disorders and the approval of various disease-modifying treatments for these conditions. The results may result in innovative drugs that provide patients with new therapeutic options. With a better understanding of the disease's hereditary and molecular basis, various tailored treatments are now feasible.

For instance, recombinant proteins support the immune system's ability to identify and bind foreign molecules, causing the biologics market to expand. A handful of the major drivers influencing the market are listed above. The rise of personalized medication and companion diagnostics further fuels the market's growth. Thanks to these developments, the availability of more tailored and efficient treatments raises the market for biological goods. 

The biologics sector is driven by the creation of disease-modifying treatments like monoclonal antibodies for these ailments. Novel products, including gene therapy, RNAi treatments, and mRNA-based vaccinations, have already been successfully launched in recent years. One major aspect limiting the biologics market is the approval of biosimilars.

The FDA approved 35 new drugs in the first quarter of 2023, thanks to a well-documented move toward freedom from regulation and a developing gene and cell therapy pipeline. The Center for Drug Evaluation and Research approved 26 innovative drugs in the first half of 2022, which is ten more than in the same period last year. But what truly sticks out is what the FDA's biologics division is doing.

Biologics Market Trends

• Rising investment in research and development of new drugs to propel market growth

The demand for sophisticated diagnostics and treatment drugs has increased along with the frequency and diagnosis of chronic diseases, propelling the market for Biologics. Biologics are medications that have undergone genetic modification to specifically target the inflammatory immune system. Governments in several nations are acting to strengthen the healthcare sector and secure the biologics supply in response to the rise of coronavirus illnesses. 

In addition, scientists and researchers are researching species and expression systems to increase the production of biological products. Also, several pharmaceutical firms are engaged in research and development to improve the effectiveness of oral arthritis drugs. Thus, this factor is driving the market CAGR.

Biologics are anticipated to expand significantly in the coming years due to the decline in small molecule drug research and development productivity. Pharmaceutical firms are developing a range of biological drugs to keep control of the market. More moderate patients are anticipated to switch to brand and novel therapy as oral treatments for Crohn's disease and rheumatoid arthritis become more successful. 

These substances also provide therapeutic choices for individuals who have previously not responded to conventional therapies, and they frequently exhibit higher efficacy and protection.

Biologics are anticipated to have profitable expansion as small molecule medication R&D productivity declines in the upcoming years. Pharmaceutical companies are concentrating on developing several biological medicines to preserve their market position. It is projected that increasing oral product efficacy for Crohn's and rheumatoid arthritis would attract more moderate patients to the branded and new treatments.

Additionally, patients who have received treatment before have options thanks to the typically greater safety and efficacy of new compounds. Thus, it is anticipated that this aspect will accelerate Biologics market revenue globally.

Biologics Market Segment Insights

Biologics Product Insights

The market segmentation of Biologics, based on product includes, monoclonal antibody, interleukins, vaccines, growth factors, gene therapy, others. The monoclonal antibody segment held the majority share in 2022 in the Biologics Market data. Healthy cells can be targeted with MABs without suffering any negative effects. Also, these medications are particularly helpful in managing cancer and treating autoimmune illnesses, such as rheumatoid arthritis. 

Although it does not harm healthy cells, it helps to target sick bodily cells. Among the many uses for monoclonal antibodies include the treatment of cancer, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, cardiovascular disease, transplant rejection, Crohn's disease, psoriasis, and ulcerative colitis. The monoclonal antibody in these disorders disrupts a receptor's operations, which is in charge of causing the disorder being treated to develop.

Biologics Disease Indication Insights

The Biologics Market segmentation, based on disease indication, includes rheumatoid arthritis, psoriasis/psoriatic arthritis, cancer, diabetes, and others. The cancer segment dominated the market growth in 2022 and is projected to be the faster-growing segment during the forecast period, 2022-2030. The usage of biologics in the therapy of cancer must be used more frequently if the segment is to grow financially. Biologics support the immune system's ability to identify tumorous cells in the body, fight cancer, turn off cancerous cells' signals, and help cancer cells evade immune system cells, hence contributing in the market growth of the biologics. 

For instance, immunosuppressive drugs that target specific tumor cell chemical receptors stop tumor cells from signaling the immune system to be suppressed.

February 2022: The (FDA) has authorized the Janssen Pharmaceutical Companies of Johnson & Johnson to sell CARVYKTI (ciltacabtagene autoleucel; cilia-cel). This biologic medication is used to treat persons with relapsed or refractory multiple myeloma after four prior lines of therapy, such as proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody (RRMM). According to Biocon Biologics Ltd, a division of Biocon Ltd, Aflibercept biosimilar YESAFILI® has received a favorable opinion from the European Medicines Agency's Committee for medicinal products for Human Consumption. The ophthalmology product YESAFILI® is used to treat neovascular (wet AMD), and age-related macular degeneration, characterized by macular oedema brought on by retinal vein blockage. 

The European Commission will consider the CHMP's favorable conclusion. By the conclusion of September 2023, the European Commission is anticipated to decide on the approval.

Figure 2: Biologics Market, by Disease Indication, 2023 & 2032 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Biologics Regional Insights

By region, the study provides the market insights into North America, Europe, Asia-Pacific and Rest of the World. North America Biologics market accounted for USD 194.87 billion in 2022 with a share of around 45.80% and is expected to exhibit a significant CAGR growth during the study period. The prevalence of chronic diseases, the existence of reputable pharmaceutical firms, and an increase in the number of biotech firms are the main market-driving drivers. 

The American Cancer Society indicates that there will be approximately 1,918,030 new cancer cases and 609,360 cancer deaths in the US in 2022. Additionally, the National Cancer Institute projects that by 2030, there will be 22.2 million cancer survivors, up from 17 million in 2020.

 The most prevalent cancers in the country are skin, bladder, colorectal, breast, lung, and prostate. Thus, it is projected that increasing cancer prevalence will fuel the demand for cancer treatment, supporting the market's expansion. New product development, partnerships, partnerships, expansions, mergers, and acquisitions are the main strategies used by the organisations in the market.

Further, the major countries studied in the market report are: The U.S, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 3: BIOLOGICS MARKET SHARE BY REGION 2023 (%)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe Biologics market accounts for the second-largest market share. The dominance of this market in Europe is attributed to the presence of a sophisticated manufacturing industry, favorable reimbursement, the availability of numerous approved medications, and the target patient demographic. Moreover, UK market of biologics held the largest market share, and the Germany market of biologics was the fastest growing market in the region.

Asia Pacific Biologics Market is expected to grow at the fastest CAGR from 2024 to 2032. In the forthcoming years, it is projected that further efforts by regulators, policymakers, and the pharmaceutical industry to address the availability and affordability of biologics, particularly mAbs, will increase the market size for biologics. The country's ongoing proliferation of biologic-creating plants is one of the main factors influencing the market's expansion. 

For instance, WuXi Biologics stated in November 2021 that GMP operations had begun successfully at its Chinese medication production facility. Further, the China market of biologics held the largest market share, and the India market of biologics was the fastest-growing market in the region.

Biologics Key Market Players & Competitive Insights

Major market players are spending a lot of money on R&D to increase their product lines, which will help the market growth of biologics. Market participants are also taking a range of strategic initiatives to grow their worldwide footprint, with key market developments such as new product launches, mergers and acquisitions, contractual agreements, increased investments, and collaboration with other organizations. Competitors in the Biologics industry must offer cost-effective items to expand and survive in an increasingly competitive and rising market environment.

One of the primary business strategies adopted by manufacturers in the global Biologics industry to benefit clients and expand the market sector is to manufacture locally to reduce operating costs. In recent years, Biologics industry has provided medicine with some of the most significant benefits. The Biologics market major player such as Sanofi, Eli Lilly and Company, GlaxoSmithKline Plc, Celltrion Inc., Samsung Biologics Co. Ltd., G. Chem Ltd.

Cadila Pharmaceuticals is a worldwide pharmaceutical corporation located in Ahmedabad, Gujarat, India. The company's main areas of interest are manufacturing products such as finished formulations, over-the-counter food supplements, biotechnology products, and pharmaceutical machinery. The teriparatide biologic NuPTH and the auto-immune medication adalimumab-related biologic Cadalimab were introduced by Cadila Pharmaceuticals (Cadila) in October 2021.

An international biopharmaceutical firm with its main office in Thousand Oaks, California, is called Amgen Inc. Amgen, one of the biggest independent biotechnology firms in the world, was founded in 1980 in Thousand Oaks, California. Tezepelumab, a potential first-in-class treatment for severe asthma, was the subject of a Biologics License Application (BLA) submitted to the US Food and Drug Administration (FDA) by Amgen's partner AstraZeneca in May 2021.

Key Companies in the Biologics market includes

• 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.

Biologics Industry Developments

February 2022: CARVYKTI has been approved by the US Food and Drug Administration (FDA) for sale by the Janssen Pharmaceutical Companies of Johnson & Johnson (ciltacabtagene autoleucel; cilia-cel). After four prior lines of therapy, such as proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, this biologic drug is used to treat people with relapsed or refractory multiple myeloma (RRMM).

June 2022: Administrators rejected the company's biologic pegzilarginase, and Aeglea BioTherapuetics declared that it could not get a biologics licensing application (BLA) from the FDA.

December 2021: Sanofi will pay an upfront payment of around $1 billion and up to USD 225 million if future development milestones are completed, per the settlement's conditions. The acquisition supports Sanofi's goals to accelerate and expand its contributions to cutting-edge cancer treatments by adding to the approximately 20 molecules currently under development.

Biologics Market Segmentation

Biologics Product Service Outlook (USD Billion, 2018-2032)

• Monoclonal Antibody


• Interleukins


• Vaccines


• Growth Factors


• Gene Therapy


• Others

Biologics Disease Indication Outlook (USD Billion, 2018-2032)

• Rheumatoid Arthritis


• Psoriasis/Psoriatic Arthritis


• Cancer


• Diabetes


• Others

Biologics Regional Outlook (USD Billion, 2018-2032)

• 
  

  North America

  
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• 
  

  Europe

  
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• 
  

  Asia-Pacific

  
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• 
  

  Rest of the World

  
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America