Global Biologics Drug Development Industry Market Research 2030

"The biological products market includes entities (organizations, self-employed individuals, and associations) that produce biological or biological-similar products for the treatment and prevention of various microbial diseases and cancers that sell biological products and related services. The biologics market includes companies that produce biologics derived from genetically modified human genes and proteins. Biological products include a wide range of recombinant therapeutic proteins, gene therapy tissues, somatic cells, vaccines and allergens. 

Biological products are subject to various laws and regulations regarding patents, testing, safety, effectiveness, and marketing. Biological products are separated from natural sources such as humans, animals and microorganisms using biotechnological methods and other cutting-edge technologies. Compared with reference biological products, biosimilars should have similar safety and effectiveness. The biologics market includes oral, intravenous, and other routes of administration biologics and biosimilars for the treatment of chronic diseases.

 

Biologics market size: 

In 2021, the global biologics drug development market is estimated to be ~USD 300 billion. The market is anticipated to showcase decline over the forecast period. The main reasons for the decrease are the implementation of lockdown and social distancing regulations in several countries, as well as the economic slowdown in all countries due to the COVID-19 outbreak and containment measures. The market is expected to recover and grow at a compound annual growth rate of ~12% from 2021.. 

 

The historical growth is due to the aging of the population, government initiatives, high price capabilities, and greater demand for immunology. Factors that have had a negative impact on growth during the historical period are the price pressures of regulators and the lack of awareness of biosimilars by primary care doctors and experts. Oral biologics, the preference for pills rather than injections will promote growth. Factors that may hinder the growth of the biologics market in the future include the high stringency and low turnover rate of clinical trials, strict regulations related to biosimilar approval, long production and approval times, and naming challenges.

Biological agents market drivers: 

The main biologics market drivers include: Technological progress It is expected that technology will become a continuous driver of market growth during this period. A particular area of ​​development is likely to be physiological simulation modeling. Such markets will benefit from the higher efficiency brought about by the development of this field. For example, Eli Lilly and Pfizer have adopted Amazon’s Elastic Computing Cloud (EC2) platform to run simulation models in early drug discovery. These models can run within a few hours, while traditional models require data. Weeks to run the simulation. The Open Innovative Drug Discovery Program is another initiative of Lilly to improve the development of biologics.

 

 Biologics market restrictions : 

The main constraints on the biologics market include: Strict regulations related to the approval of biosimilars It is expected that strict regulations on the approval of biosimilars will hinder the growth of the biosimilar market during the forecast period. Governments in different regions have different regulations on the production and use of biological agents and biosimilars.

In addition, issues such as patent infringement or settlement issues restrict the sale of government: 
Approved biosimilars by manufacturers of biologics and biosimilars. The US Food and Drug Administration requires dual regulatory approvals for biosimilars, restricting the use of biosimilars as exchangeable drugs for biologics, while in Europe, the European Medicines Agency (EMA) approved biosimilars and interchangeable biologics. Change product. As of February 2019, out of 17 approved biosimilars, only 7 biosimilars (including 4 natural biologics) can enter the US commercial market. The government’s strong policy to approve these drugs has had a negative impact on manufacturers in the biologics market.

 

Biologics market trends

The main trends affecting the biologics market include: Strong R&D The biologics market is witnessing strong R&D activities. These R&;D activities have increased the success rate of clinical trials of biological products. The leaders in the biologics market conduct research and development as they continuously strive to advance the market in the form of new and effective biologics. For example, Biocon Limited is developing tregopil, an oral prandial insulin for the treatment of patients with type 2 diabetes, currently in phase II/III clinical trials. At present, trogopril insulin is in phase II/III clinical studies for patients with type 2 diabetes. 

 

In 2019, Jerusalem-based Oramed Pharmaceuticals developed an oral insulin drug, which is in a phase 2 trial, named ORMD-0801, for the treatment of type 2 diabetes. In September 2019, the Danish multinational pharmaceutical company Novo Nordisk was approved by the U.S. Food and Drug Administration and the Drug Administration launched its Rybelsus oral diabetes drug. The drug Rybelsus is an oral form of semaglutide used to treat patients with type 2 diabetes. 

 

The demand for biological agents for the treatment of complex diseases:

 Biological agents are widely used to provide effective treatments for many complex diseases, such as arthritis, rheumatoid disease, psoriasis, and Crohn’s disease. Diseases with limited treatment options. The treatment of rheumatoid arthritis patients who have not responded to traditional anti-rheumatic drugs has been significantly improved. Key biological agents used to treat rheumatoid arthritis include Abatacept (Orencia), Adalimumab (Humira), Anakinra (Kineret), Infliximab (Remicade) and Rituximab (Rituxan). The key biological agents used to treat psoriasis include adalimumab (Humira), etanercept (Enbrel), infliximab (Remicade), and secukinumab (Cosentyx). Cimzia (certolizumab pegol), Humira (adalimumab), Remicade (infliximab), and Tysabri (natalizumab) are biological agents used to treat Crohns disease.Opportunities and recommendations in the biologics market: 

Opportunities: 

The main opportunities in the biologics market segmented by type will appear in the field of monoclonal antibodies, which will achieve global annual sales of USD ~70 billion by 2022. The best opportunity to subdivide the biologics market will appear in the hospital pharmacy field through distribution channels.  The main opportunities in the biologics market divided by route of administration will appear in other areas.

The main opportunity for the biologics market segmented by drug classification will appear in the brand-name drug field. he main opportunity of the market is that biologics, which are segmented according to the method of purchase, will appear in the field of prescription drugs.

Recommendation: 

Take the opportunity to follow the trend, and corporate research companies recommend biological companies to focus on R&D, use of macromolecules, and drug development. For complex diseases, expand into emerging markets, establish authorized distributors and sales representatives, use online pharmacies, target local pharmacies to spread knowledge, provide competitive prices in low-income countries to attract new users, price innovative drugs, and advertise for customers ( DTC), participation in trade shows and events, increased demand for R&D scientists.

 

Biological product market segmentation: 

 

The biological product market is segmented by type, distribution channel, route of administration, drug classification, purchase method, and region. 

By type: The biologics market is segmented by type. Monoclonal antibodies B. Therapeutic proteins C. Vaccines The monoclonal antibody market is the largest part of the biologics market by type, accounting for 42.6% of the total in 2019. Looking ahead, the therapeutic protein segment is expected to become the fastest-growing segment of the biological products market by type, with a compound annual growth rate of 14.9% in 2019-2023. 

 

Segmentation by type: The monoclonal antibody (MAbS) market is further segmented by ena type. MAbSb is anti-cancer. Immunization to MAbSc. Monoclonal anti-infective antibody (MAb) d. Cardiovascular and cerebrovascular MAbSe​​. Neuropharmacology MABS . Other-Monoclonal Antibodies (MAbs) Cancer MAbS market is the largest part of the monoclonal antibody market 

by type, accounting for 55% of the total in 2020. It is also expected to become the fastest growing part of the United States. For the market segmented by type, the compound annual growth rate for 2022-2030 would be ~14%. The therapeutic protein market is further subdivided into by type. Metabolic disorders Therapeutic protein b. Anti-cancer therapeutic protein C. Therapeutic cardiovascular protein d. Therapeutic immune protein. Others-Therapeutic protein metabolism disorder Therapeutic protein market is the largest segment of the therapeutic protein market by type, accounting for 33% of the total in 2020. It is also expected to become the fastest-growing part of the therapeutic protein market by type. The compound annual growth rate for 2022-2030 is 14%. The vaccine market is further subdivided into a by type. Anti-infective vaccines B. Vaccines against autoimmunity C. 

 

Other vaccines The anti-infective vaccine market is the largest part of the vaccine market by type, accounting for 40% of the total in 2020. It is also expected to be the fastest growing part of the vaccine market by type, with a compound annual growth rate of 13% in 2022-2030. By route of administration: the biologics market is subdivided into a by route of administration. Oral B. Others (IV or IP) Network function virtualization (NFV) is the largest part of the biologics market by network technology type, accounting for 55% of the total in 2020. 

Looking to the future, fog computing is expected to become the fastest. The growth part of the biologics market has a compound annual growth rate of 90% from 2022-2030. By drug classification: the biologics market is divided by drug classification into a. Branded drugs B. Generic drugs The branded drug market is divided by drug classification in the biologics market The largest segment of the market, accounting for 77% of the total in 2020.

 

 Looking ahead, the generic drug segment is expected to become the fastest growing segment of the biologics market segmented by drug classification, with a compound annual growth rate of 14% during 2022-2030. a. Prescription drugs B. OTC drugs The prescription drug market is the largest market segment in the biologics market by purchase method, accounting for 75% of the total in 2020. In the future, the OTC drug segment is expected to become the fastest-growing market segment for biological products. 

 

The compound annual growth rate for 2019-2023 is 13%. By distribution channel: The biological product market is divided into a. Hospital pharmacy B. Retail pharmacies C. Online pharmacies The hospital pharmacy market is the largest part of the biologics market divided by distribution channels, accounting for 51% of the total in 2020. Looking ahead, the online pharmacy segment is expected to become the fastest growing biologics market segment by distribution. Channel, the compound annual growth rate for 2022-2030 is 20%

 

Competitors: 

• Pfizer Inc. • F. Hoffmann-La Roche AG • AbbVie Inc. • Merck & Co., Inc. • Johnson & Johnson Otros Competidores incluyen: • Bristol Myers Squibb Company • GlaxoSmithKline Plc. • Amgen Inc. • Sanofi SA • Eli Lilly y compañía • Wockhardt • Zydus Cadilla • Asahi Glass Co. Ltd • China Bioproducts Holding Company • China Regenerative Medicine International • ABLbio • Adimmune • Henlius • Biológicos innovadores • Bio-Thera • Hisun Pharmaceuticals 3SBio • Beijing Shuanglu Pharmaceuticals • Qilu Pharmaceuticals • Shanghai Fosun Pharmaceuticals • Biocon • Dr. Reddy's • Mylan • Kyowa Hakko Kirin • Takeda • Tanabe Mitsubishi • AGC Biologics • Tonghua Toho Pharmaceuticals • Biogen Idec • Novartis • BiosanaPharma • Teva UK Limited • AstraZeneca • Abbott Laboratories • Vectura Group • Roche • Lonza • Seqens • Piramal Pharma Solutions • Corden Pharma • Procos SpA • BSP Pharmaceuticals • Microgen • Geropharm • Valenta • NovaMedica • SynBio • Rani Therapeutics • Emisphere Technologies, Inc. • Enteris BioPharma • Allena Pharmaceuticals • Biogen Inc. • Apotex • Gilead Sciences • Hypermarcas • Aché • Eurofa rma • Teuto Brasileiro • BioMarin Pharmaceutical • BIONOVIS BRASIL • Ecopharm • Julphar • SPIMACO ADDWAEIH Hikma Pharmaceuticals • BBI Solutions Ltd • Aspen Pharmacare • Amoun Pharmaceutical 54gene • Baxter International • Altis Biologics
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Geography Analysis:

The report further discusses the market opportunity, compound annual growth rate (CAGR) growth rate, competition, new technology innovations, market players analysis, government guidelines, export and import (EXIM) analysis, historical revenues, future forecasts etc. in the following regions and/or countries:

• North America (U.S. & Canada) Market Size, Y-O-Y Growth, Market Players Analysis & Opportunity Outlook
• Latin America (Brazil, Mexico, Argentina, Rest of Latin America) Market Size, Y-O-Y Growth & Market Players Analysis & Opportunity Outlook
• Europe (U.K., Germany, France, Italy, Spain, Hungary, Belgium, Netherlands & Luxembourg, NORDIC(Finland, Sweden, Norway, Denmark), Ireland, Switzerland, Austria, Poland, Turkey, Russia, Rest of Europe), Poland, Turkey, Russia, Rest of Europe) Market Size, Y-O-Y Growth Market Players Analys  & Opportunity Outlook
• Asia-Pacific (China, India, Japan, South Korea, Singapore, Indonesia, Malaysia, Australia, New Zealand, Rest of Asia-Pacific) Market Size, Y-O-Y Growth & Market Players Analysis & Opportunity Outlook
• Middle East and Africa  (Israel, GCC (Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman), North Africa, South Africa, Rest of Middle East and Africa) Market Size, Y-O-Y Growth Market Players Analysis & Opportunity Outlook

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