Healthcare Insights

Biologics Market Size to Grow USD 1,369.40 Billion by 2033

Healthcare Insights

The biologics market is driven by the increasing number of chronic illnesses impacting millions of individuals globally and placing a heavy strain on healthcare systems. Biologics provide a more focused and efficient therapy alternative for many diseases, boosting demand and propelling market expansion.

Medications classified as biologics are made from living things or their byproducts. This indicates that they differ from conventional medicines, generally created using lab-synthesized tiny molecules. Proteins, nucleic acids, cells, tissues, and other components can all be used to develop biologics, which are frequently more extensive and complicated. Although biologics functions in many different ways, they frequently target particular chemicals or bodily cells. Because of this, they may be more effective than conventional medications, which frequently have broader effects. Biologics, however, could have effects and cost more money. The field of biologics is expanding quickly in medicine, and new kinds of biologics are created regularly.

Biologics Market Highlights:

Biologics Market Dynamics

Driver: Emergence of precision medicine and personalized treatment options

Due to developments in genetic and molecular testing, healthcare practitioners are becoming more adept at identifying patients with specific genetic abnormalities or biomarkers that increase their susceptibility to particular diseases or increase their likelihood of responding to specific therapies. As a result, targeted biologics which target these characteristics have been developed. These treatments have the potential to be less hazardous and more successful than conventional, one-size-fits-all pharmaceuticals.

Restraint: High cost of production and development

Biologics are complex compounds that are frequently produced from live cells. Examples of these include genetically modified proteins and antibodies. Because of this, producing them is more expensive and complicated than producing conventional synthetic medications. It takes capital to set up and maintain facilities and equipment for biomanufacturing, which calls for specialized knowledge and technology. Finding and characterizing the particular cell lines or organisms required for biologic production can also be expensive and time-consuming. Finally, downstream processing and clinical trials add to the expense of development. This high-cost barrier may restrict a patient’s access to these life-saving treatments, especially in underdeveloped nations. Additionally, it poses difficulties for smaller biopharmaceutical businesses and may impede industry innovation.

Opportunity: Development of personalized biologics for cancer treatment

Conventional cancer therapies, such as radiation therapy and chemotherapy, can have significant adverse effects and are frequently ineffective. Personalized biologics, on the other hand, are made to specifically target the genetic abnormalities that are causing a patient’s cancer. Therefore, they are far less harmful and more effective than conventional therapies. The invention of new technologies for providing biologics to cancer cells, the growing awareness of the advantages of personalized medicine, and the increasing affordability of genomic testing, which may determine the genetic mutations leading to a patient’s cancer, are some of the factors propelling the growth of this market.

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Regional Snapshot

In 2023, North America commanded the largest revenue share at 45%. This dominant position is attributed to several factors, including a high prevalence of chronic diseases, the presence of major biopharmaceutical companies, favorable reimbursement policies, and substantial investments in research and development. In the U.S., biologics accounted for 37% of total drug expenditure, driven by a rise in biologic prescriptions and ongoing investments in targeted drug development, which are fueling market expansion.

Looking ahead, the Asia Pacific region is expected to experience a robust growth rate, with a projected compound annual growth rate (CAGR) of 11.03% throughout the forecast period. This growth is being propelled by increasing rates of cancer, diabetes, and cardiovascular diseases, as well as an aging population. To address this growing demand, market leaders are focusing on advanced biologic products. Additionally, the rise of biosimilars is significantly contributing to market growth by improving the accessibility and affordability of biologic therapies in the region.

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Disease Category Outlook

In 2023, oncology emerged as the leading segment in the biologics market, capturing 29% of the total market share. According to the American Cancer Society, the U.S. alone reported approximately 1.92 million new cancer cases and about 609,360 cancer-related deaths that year. Globally, cancer ranked as the second leading cause of death, with an estimated 9.6 million fatalities in 2020. Biologic treatments, especially monoclonal antibodies and immunotherapies, have significantly advanced cancer care by improving survival rates and reducing side effects. A notable example is Herceptin, which has made substantial strides in breast cancer treatment. The global biologics market is projected to surpass $100 billion by 2023, underscoring the growing importance of biologics in oncology.

The hematological disorders segment is expected to see the fastest growth, with a compound annual growth rate (CAGR) of 11.73% during the forecast period. This rapid expansion is largely due to innovations in gene therapies for rare blood disorders, such as hemophilia. For instance, CSL Behring’s Hemgenix for hemophilia B received FDA approval in November 2023, while BioMarin’s ROCTAVIAN for hemophilia A was approved in Europe in August 2023. Additionally, Pfizer’s PF-07055480 and PF-06838435 are in phase 3 trials for hemophilia A and B, respectively, signaling continued advancements in this field.

Source Outlook

In 2023, the microbial segment led the biologics market, holding a 59% share. The majority of approved biologics are produced using microbial systems, including well-known products like platelet-derived growth factor, recombinant insulin, granulocyte-macrophage colony-stimulating factor, and recombinant interferons.

The mammalian expression systems segment is anticipated to experience significant growth during the forecast period. These systems are pivotal in developing recombinant proteins and viral-vector vaccines. Common mammalian cell lines used include CHO (Chinese Hamster Ovary) and HEK (Human Embryonic Kidney). Noteworthy products manufactured using mammalian systems include Perjeta (Pertuzumab), Adcetris (Brentuximab-Vedotin), Shingrix (zoster vaccine), Kadycla (Trastuzumab emtansine), and Aimovig (erenumab).

Manufacturing Outlook

In-house manufacturing dominated the market in 2023, with an 85% share. The production of biologic drugs is complex, involving live microorganism cultures and stringent regulatory standards. In-house manufacturing allows for greater control and more effective management of the drug production process.

Conversely, the outsourcing segment is projected to grow at a CAGR of 10.73% during the forecast period. Many Contract Development and Manufacturing Organizations (CDMOs), such as WuXi Biologics, Lonza, and Samsung Biologics, have cutting-edge biologic manufacturing facilities. Collaborations with these CDMOs provide access to advanced manufacturing expertise and technologies. For example, WuXi Biologics opened its integrated biologics center in Shanghai in November 2023, offering comprehensive facilities for product development, quality control, and manufacturing.

Product Outlook

Monoclonal antibodies (MABs) dominated the market with a 67% share in 2023, thanks to their widespread application across various therapeutic areas. MABs specifically target diseased cells while sparing healthy ones, making them a leading category of biologic drugs. The U.S. FDA approved its 100th monoclonal antibody product in 2021, a notable achievement achieved just six years after its 50th approval. Humanized monoclonal antibodies are particularly prominent in the market due to their reduced risk of inducing immune responses compared to murine or chimeric antibodies.

The antisense and RNAi therapeutics segment is expected to grow at a remarkable CAGR of 20.63% during the forecast period. These therapies allow for precise gene silencing, facilitating the development of treatments for genetic disorders. A notable example is Alnylam Pharmaceuticals’ RNAi therapeutic AMVUTTRA, which received FDA approval in June 2023 for treating hereditary transthyretin-mediated amyloidosis.

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Top Manufactures in Biologics Market

Biologics Market Segmentation:

By Source

By Product

By Disease Category

By Manufacturing

By Region

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