Biologics Market Development Strategies and key player analysis by 2026
The major Drivers for the Biologics Market include growing incidence of chronic diseases and their diagnoses, increased availability of advanced diagnostics, growing technological advancements in research and development across the globe.
Other factors increasing the demand for biologic drugs include rising regulatory convergence and better access to healthcare for all regions, the targeted therapies coupled with rising adoption of patient centric personalized medicine anticipated to fuel demand.
The development of human anti‐mouse antibodies was an important limiting factor for some of the early murine treatments due to higher usage of this category of drugs in different therapeutic areas.
Advances in technology have opened new perspectives for the selection and production of monoclonal antibodies. Also, Vaccines are expected to show significant growth during the forecast period due to the growing adoption of vaccines in the treatment of infectious diseases in the near future.
Monoclonal Antibodies allow targeting of unhealthy cells without harming the healthy cells. Also, these drugs are used in the management and treatment of diseases, including cancer and autoimmune disorder.
HTS Techniques to Target Compound Libraries and Pharmacokinetic Characteristics
The technology involved in miniaturization, automation and assay readouts required for HTS has developed rapidly and continues to do so.
The laboratory set-ups installed in HTS facilities are steadily broadening their capabilities beyond their primary function of identifying hits to applyHTS techniques to more diverse compound profiling assays relating not only to the target selectivity of compound libraries, but also to their pharmacokinetic characteristics.
Fusion of innovative bioengineering technologies for biopharmaceutical production to boost progress in pharmaceutical industry with fresh advances in automation including the selection process can be performed throug high throughput screening (HTS) system for selection of viable clones.
By gaining high-producing cell line through the high throughput screening (HTS) method that enables robust production of biopharmaceutical products, upstream and downstream processing would directly translate into there venue of larger level for the biologics market growth.
In addition to this, presence of several metabolic disorders that can be treated through the use of biologics is attributive to influence demand.
Biologic Therapies for Psoriasis, Atopic Dermatitis
As with psoriasis, there is a growing movement towards using targeted therapies to improve outcomes and minimize side effects in atopic dermatitis.
Janus kinase (JAK) inhibitors help address limitations of biologics, Several JAK inhibitors are in phase 2 and 3 clinical trials as oral therapies for moderate-to-severe atopic dermatitis or as topical treatments for mild-to-moderate disease.
In atopic dermatitis, there are multiple upregulation of cytokine familiesand JAK inhibitors can block a range of cytokines, growth factor or hormone receptor signalling the pathways which make them an important entrant treatment.
North America and Asia-Pacific to Dominate the Biologics Market Share Regionally
The North America is dominating the Biologics Market and is estimated to show a similar trend during the forecast period on account of the growth of biologics which is increasing incidences of chronic diseases, the presence of well-established pharmaceutical companies, and an increase in the number of biotech companies.
Furthermore, the presence of well-established firmsis making biologics more accessible in the United States. Also, government initiative for the awareness of biologics, is further expected to spur the growth of the biologics market in North America.
In 2018, FDA approved the Grifols product ErytraEflexis® which is a fully-automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 cards technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Compatibility Tests, and Direct Antiglobulin Tests
As a standalone analyzer or interfaced to the customer’s Laboratory Information System (LIS), ErytraEflexis® automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing.
Asia-Pacific is also expected to grow at a great pace owing to rise in the outsourcing of biologics contract manufacturing in emerging countries, less stringent regulatory environment for clinical trials of drugs and the growing awareness regarding the success of biologics for the treatment of chronic diseases.
In March 2019, Fujifilm acquired a Large-Scale Biologics Manufacturing Site from Biogen to accelerate Growth of its Bio CDMO Business. The facility allows for the support of high-volume production of biologics that requires large-scale culture tanks and is equipped with six 15,000-L bioreactors.
Key market entrants are strengthening the Biologics Market value
Prominent players operating in the biologics market include AbbVie Inc., AmgenInc., Eli Lilly and Company, Hoffmann-La Roche AG, GlaxoSmithKline PLC, Johnson & Johnson, Merck & Co., Novo Nordisk A/S, Pfizer Inc., Sanofi SA., GlaxoSmithKline PLC
In June 2019, GlaxoSmithKline announced that the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe, for patients or caregivers to administer once every four weeks, after a healthcare professional decides it is appropriate.
It is the first anti-IL5 biologic to be licensed in the US for at-home administration, and the first respiratory biologic to be approved for administration via an autoinjector.
The approval will give healthcare professionals and people living with severe eosinophilic asthma (SEA) or the rare disease eosinophilic granulomatosis with polyangiitis (EGPA) the option for Nucala to be administered outside of a clinical setting by a patient or caregiver after their healthcare professional agrees this approach is appropriate. The original lyophilised powder version remains available for administration by a healthcare professional.