Biologics drugs are complex molecules that are manufactured from living organisms or components of living organisms. Biologics include a wide variety of products derived from human, animal, or microorganisms by using biotechnological processes. Many biologics are produced using recombinant DNA technology. They are sometimes referred to as biopharmaceuticals or biological drugs. Various types of biologic drugs include monoclonal antibody, recombinant proteins/hormones, vaccines, cell and gene therapy and others. These biologics may contain proteins that control the action of other proteins and cellular processes, genes that control production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system. Biologics are sometimes referred as referred to as biologic response modifiers, as they change the manner of operation of natural biologic intracellular and cellular actions.
The market for biologics is driven by increasing incidence of disease across the globe, increasing number of biologics approvals and emergence of next generation biologics such as cell and gene therapy. Strong pipelined products and huge number of ongoing clinical trials are providing market growth oppurtunity. Challenges associated with biologics production, high cost of the drug, increasing number of biologics going off patent and emergence of biosimilars are hampering market growth.
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Market Analysis: The “Global Biologics market” is estimated to witness a CAGR of 9.9% during the forecast period 2018–2024. The global market is analyzed based on three segments – Product, Application and regions.
Regional Analysis: The regions covered in the report are the North America, Europe, Asia Pacific, and Rest of the World (ROW). North America is the major shareholder in the global biologics market, followed by Europe. North America dominates the biologics market due to increasing product approvals, increasing demand for the product to treat various disease conditions, and presence of established players in this region. Asia-Pacific region is expected to have the fastest growth rate during the forecasted period due to increasing research activities, flexible regulatory environment for clinical trials, growing awareness about biopharmaceutical therapeutics, and rising healthcare expenditure.
Product Analysis: The market by product is segmented into monoclonal antibodies, recombinant proteins/hormones, vaccines, cell and gene therapy and others. Monoclonal antibodies occupied major market share of global biologics market in 2017 and cell and gene therapy is expected to grow at high CAGR during the forecasted period. Wide application of monoclonal antibodies in treatment of various diseases makes this segment, a major shareholder of biologics products market.
Application Analysis: The market by application is segmented into cancer, infectious disease, immunological disorders, hematological disorders, cardiovascular disease and others. Among various application, cancer occupied the largest share in 2017 and is expected to grow at fastest rate during the forecasted period. Growing elderly population, changing lifestyle, increasing disease prevalence makes cancer, the fastest growing application segment during the forecasted period.
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Key Players: F. Hoffmann-La Roche, Amgen, Inc., Sanofi S.A., Novo Nordisk A/S, Johnson and Johnson, AbbVie, Inc., Novartis AG, GlaxoSmithKline plc, Bristol-Myers Squibb, Merck & Co., Eli Lilly & Company Ltd., AstraZeneca PLC, Teva Pharmaceutical Industries Ltd., Takeda Pharmaceutical Company and other predominate and niche players.
Competitive Analysis: Currently cancer segment dominates the global biologics segment. Biologics are entering new therapeutic areas such as, asthma and allergy where they are not present historically. The key market players are taking the advantage of strategic deals and product approvals to increase their share in the market. For instance, in September 2017, GSK and AbCellera Biologics, Inc. entered an antibody discovery research collaboration, for the discovery of monoclonal antibodies against an undisclosed membrane protein target. In August 2017, Novartis received first FDA approval from FDA for CAR-T cell therapy, Kymriah to treat patients with B-cell precursor acute lymphoblastic leukemia (ALL) and in May 2018, Novartis received second FDA approval for Kymriah to treat patients with B-cell lymphoma.