Cancer Segment, by Application to Account Larger Share in Biologics Market during 2023-2031
According to our new research study on "Biologics Market Forecast to 2031 - Global Analysis - by Product, Application, Source, Manufacturing, and Geography," the market was valued at US$ 469.2 billion in 2023 and is projected to reach US$ 1,793.9 billion by 2031; it is expected to register a CAGR of 18.2% during 2023-2031. The market growth is attributed to the increasing cases of chronic diseases and the preference for outsourcing manufacturing operations. However, the stringent regulations and high drug development costs hinder the growth of the market.
Biologics manufacturing is a complex process whose success depends on the proper execution and monitoring of all operations. The manufacturing facilities need trained personnel with the technical knowledge of bioprocessing and process engineering. Managing the attempts to reach the first clinical trial using a manual and open manufacturing method and then building a more commercially suitable process can be tricky for an experienced team. Thus, manufacturers choose to work with contract development and manufacturing organizations (CDMOs) to accelerate their clinical studies and commercialization operations. CDMOs provide product development, clinical trial support, manufacturing, and commercialization services to biologics companies on a contract basis. Partnering with a CDMO enables scalability and access to technical expertise without overhead costs, along with higher speed to market and greater cost efficiencies for biologics manufacturers. In April 2022, ThermoGenesis established its own CDMO facility in California, US, to provide CDMO services to cell and gene therapy manufacturers. Using its expertise, the company focuses on manufacturing chimeric antigen receptor-T cell (CAR-T cell), T-cell receptor (TCR), tumor-infiltrating leukocyte (TIL), natural killer cell (NK), iPSC, and mesenchymal stem cell (MSC). Outsourcing biologics manufacturing to CDMOs proves cost-effective for manufacturers. Additionally, they gain access to the technologically advanced infrastructure and expertise of CDMOs. CDMOs employ proper, mapped processes for manufacturing biologics. Thus, the surging preference for outsourcing biologics manufacturing operations to CDMOs fuels the biologics market growth.
Based on product, the biologics market is divided into monoclonal antibodies, vaccines, recombinant hormones/proteins, cell and gene therapy, and others. The monoclonal antibodies segment held the largest market share in 2023, and it is further likely to register the highest CAGR during 2023-2031.
By application, the market is segmented into cancer, infectious diseases, autoimmune diseases, and others. The cancer segment held the largest share of the market in 2023, and it is anticipated to register the highest CAGR during 2023-2031. As per the World Health Organization (WHO), the count of new cancer cases reached ~20 million in the world while ~9.7 million people succumbed to death due to the disease in 2022; the new diagnoses included 9.3 million men and 8.8 million women. Additionally, breast and lung cancers were the most common cancer types, accounting for 12.5% and 12.2% of the total diagnoses, respectively. Therefore, oncology, an area with high unmet medical needs, has received massive attention for the need for new treatment options. Over 1,500 ongoing clinical trials for cell and gene therapies have been registered with ClinicalTrials.gov, and approximately 60% of these are for cancer treatment. Moreover, 90% of all total clinical trials are the Phase 1 and 2 trials. In May 2024, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive-stage small-cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
In terms of manufacturing, the market is bifurcated into outsourced and in-house. The outsourced segment held a larger share of the market in 2023; it is estimated to register a higher CAGR during 2023-2031.
In terms of source, the biologics market is segmented into mammalian and microbial. The microbial segment held a larger market share in 2023. The mammalian is estimated to record a faster CAGR during 2023-2031. In production, cultured mammalian cells have become the predominant expression systems due to their ability to complete the posttranslational modifications that are necessary for drug safety and efficacy. The mammalian cell culture production processes have evolved dramatically due to improvements in both volumetric and specific outcomes. Over the past decade, cells derived from animals, especially rodents, have become primary vectors for producing biologics. Mammalian cell culture is employed for the synthesis of vaccines and various other proteins for their clinical applications, including the treatment of cancer, genetic diseases, and other ailments. The production of vaccines and therapeutic proteins through mammalian cells requires viral infection and genetic engineering stages for the transfer of the gene of interest in the expression systems.
AbbVie Inc.; Pfizer Inc.; Samsung Biologics; ADMA Biologics, Inc.; WuXi Biologics; Catalent, Inc; AGC Biologics; AstraZeneca; Amgen Inc.; Nitto Avecia; and Quality Assistance SA are among the leading companies operating in the global biologics market.
Companies operating in the biologics market adopt various organic and inorganic strategies. Organic strategies mainly include product launches and product approvals. Acquisitions, collaborations, and partnerships are among the inorganic growth strategies witnessed in the biologics market. These growth strategies allow the market players to expand their businesses and enhance their geographic presence, thereby contributing to the overall biologics market growth. Further, acquisition and partnership strategies help them strengthen their customer base and expand their product portfolios.
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