Biologics Coverage

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Biologics Industry Overview
The biologics market is expected to reach over $599.62 billion in 2027 at a CAGR of 9.5%!
The US Food and Drug Administration (FDA) has revised its regulations to eliminate outdated biologics requirements, thus allowing drug manufacturers to employ new manufacturing technologies and testing capabilities. Standard preparations (standard solutions containing a precisely known concentration of an element), which help to ensure safety, purity and potency of biologics can now be obtained from sources other than FDA’s Center for Biologics Evaluation and Research (CBER), or can be developed internally by the biologics license applicant. The FDA has also removed a rule (Section 610.21 of FDA code) which specifies minimal potency limits to be met for certain antibodies and antigens. In addition, FDA is also updating regulations (Section 610.53 of FDA code) regarding storage periods and storage conditions for biologics. These amendments in regulations are expected to increase regulatory flexibility by allowing the pharmaceutical industry and the FDA to incorporate current scientific technologies in the manufacture of licensed biological products.
Biologics Market Coverage
The biologics market consists of sales of biologics and related services by entities (organizations, sole traders and partnerships) that produce biologics or biosimilars to treat and prevent various microbial diseases and cancers. The biologics market comprises companies manufacturing biological products that are derived from genetically modified proteins and human genes. Biologics products include a wide range of recombinant therapeutic proteins, gene therapy tissues, somatic cells, vaccines, and allergenics.

The Business Research Company covers 337 markets overall in the biologics market providing global market numbers, market growth, market-specific drivers and restraints, trends, and other market specific information. The biologics market is segmented in the following manner:
  • 1. Therapeutic Proteins
    The therapeutic proteins market consists of sales of therapeutic proteins and related services by entities that produce therapeutic proteins products to treat various diseases. Therapeutic proteins provide important therapies for diseases, such as diabetes, cancer, infectious diseases, hemophilia, and anemia. Therapeutic proteins are proteins that are engineered in the laboratory for pharmaceutical use. Therapeutic proteins permit an individualized treatment approach by supporting a specifically targeted therapeutic process which compensates for the deficiency of an essential protein.

    The Therapeutic Proteins market is sub-segmented into –
    • 1.1 Metabolic Disorders Therapeutic Proteins
    • 1.2 Cancer Therapeutic Proteins
    • 1.3 Cardiovascular Therapeutic Proteins
    • 1.4 Immunological Therapeutic Proteins
    • 1.5 Other Therapeutic Proteins
  • 2. Monoclonal Antibodies ((MAbS)
    The monoclonal antibodies (MAbS) market consists of sales of monoclonal antibodies and related services by entities that produce monoclonal antibodies used to enhance and suppress immune response in various medical conditions and to treat various diseases such as cancer, cardiovascular and cerebrovascular diseases. Monoclonal antibodies are cells derived by cell division from a single ancestral cell. Monoclonal antibodies recognize and bind to antigens in order to discriminate between specific epitopes which provide protection against disease organisms.

    The Monoclonal Antibodies (MAbS) market is sub-segmented into –
    • 2.1 Anti-Cancer MAbs
    • 2.2 Immunological Mabs
    • 2.3 Anti-Infective Monoclonal Antibodies (Mabs)
    • 2.4 Cardiovascular And Cerebrovascular Mabs
    • 2.5 Neuropharmacological Mabs
    • 2.6 Other Monoclonal Antibodies
  • 3. Vaccines
    The vaccines market consists of sales of vaccines and related services by entities that produce vaccines to prevent infection and severe outcomes caused by influenza viruses. Vaccines are biological preparations that provide immunity from a disease. Vaccines can be administered orally, through injections or by aerosol. Vaccines for cancers include both prophylactic vaccines and therapeutic vaccines. Two types of cancer preventive vaccines (human papillomavirus vaccines and hepatitis B virus vaccines) are available (in the United States), and one treatment vaccine (for metastatic prostate cancer) is available.

    The Vaccines market is sub-segmented into –
    • 3.1 anti-infective vaccines
    • 3.2 autoimmunity vaccines
    • 3.3 other vaccines
How Can We Help?
The Business Research Company`s Biologics Market Research Practice provides marketing, planning and strategy departments with a wider range of market, business, customer and competitor intelligence services across different segments of the biologics industry. The biologics market research services and solutions The Business Research Company provides are as follows —
  • Biologics Market Sizing, Forecast and Trend Analysis
  • Biologics Market Competitor Analysis
  • Biologics Market Supply Chain Analysis
  • Biologics Market Customer Research
  • Biologics Market Partner or Distribution Research
  • Biologics Market Entry Strategy Research Study
  • Biologics Industry Analysis and Profiling
  • Biologics Market Regulations
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Vaccines Market 2023 – By Type (Anti-Infective Vaccines, Anti-Cancer Vaccines, Other Type), By Technology (Conjugate Vaccines, Inactivated And Subunit Vaccines, Live Attenuated Vaccines, Recombinant Vaccines, Toxoid Vaccines, Other Technologies), By Route Of Administration (Intramuscular (IM), Subcutaneous (SC), Oral, Other Route of Administration), By Valance (Monovalent, Multivalent), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Institutional Sales), And By Region, Opportunities And Strategies – Global Forecast To 2032
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Monoclonal Antibodies MAbS Global Market Report 2023 – By Source (Murine, Chimeric, Humanized, Human), By Application (Anti-Cancer, Immunological, Anti-Infective Monoclonal Antibodies (MAbs), Neuropharmacological, Cardiovascular And Cerebrovascular, Other Applications), By End Users (Hospitals, Private Clinics, Research Institute) – Market Size, Trends, And Global Forecast 2023-2032
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Therapeutic Proteins Global Market Report 2023 – By Product Type (Insulin, Fusion Protein, Erythropoietin, Interferon, Human Growth Hormone, Follicle Stimulating Hormone), By Application (Metabolic Disorders, Immunologic Disorders, Hematological Disorders, Cancer, Hormonal Disorders, Genetic Disorders, Other Applications), By Function (Enzymatic and Regulatory Activity, Special Targeting Activity, Vaccines, Protein Diagnostics) – Market Size, Trends, And Global Forecast 2023-2032
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Biosimilars Global Market Report 2023 – By Product (Recombinant Non-glycosylated Proteins, Recombinant Glycosylated Proteins), By Types (Human Growth Hormone, Erythropoietin, Monoclonal antibodies, Insulin, Interferon, Granulocyte-Colony Stimulating Factor, Other Types), By Application (Oncology, Chronic and Autoimmune Diseases, Growth Hormone Deficiency, Infectious Diseases, Other Applications) – Market Size, Trends, And Global Forecast 2023-2032
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Digestive Enzymes Global Market Report 2023 – By Enzyme Type (Carbohydrates, Protease, Lipase, Other Enzyme Types), By Origin (Animal, Fungi, Microbial, Plant), By Application (Indigestion, Chronic Pancreatitis, Irritable Bowel Syndrome, Other Applications),  By Distribution Channel (Retail Stores, Online Stores) – Market Size, Trends, And Global Forecast 2023-2032
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Oncology Biosimilars Global Market Report 2023 – By Drug Type (Monoclonal Antibody, Immunomodulators, Hematopoietic Agents, Granulocyte Colony-Stimulating Factor (g csf)), By Cancer Type (Breast Cancer, Colorectal Cancer, Blood Cancer, Neutropenia Cancer, Non-Small Cell Lung Cancer, Other Cancer Types), By Distribution Type (Hospital Pharmacy, Retail Pharmacy, Online Pharmacy) – Market Size, Trends, And Global Forecast 2023-2032
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Pediatric Vaccine Global Market Report 2023 – By Vaccine Type (Monovalent, Multivalent), By Technology (Live Attenuated, Inactivated, Toxoid, Conjugate, Other Technologies), By Application (Infectious Disease, Allergy, Cancer) – Market Size, Trends, And Global Forecast 2023-2032
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Interferons Global Market Report 2023 – By Type (Inteferon Alpha, Inteferon Beta, Inteferon Gamma), By Application (Hepatitis B, Hepatitis C, Melanoma, Leukemia, Multiple Sclerosis, Renal Cell Carcinoma), By Distribution Channel (Hospital Pharmacies, Online Pharmacies, Retail Pharmacies) – Market Size, Trends, And Global Forecast 2023-2032
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