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The global biological drugs market size was valued at USD 285.5 billion in 2021 and is projected to reach around USD 720.0 billion in 2030 exhibiting a CAGR of 10.0% in the forecasted period. The several government efforts, higher share of biologics in the market, and increasing use of biopharmaceuticals over chemically produced molecules are boosting the market growth. Moreover, rising geriatric population and growing interest in preventive healthcare are anticipated to augment market growth over the forecast period.

Demand for biological drugs is anticipated to attain grip in the coming future due to the global increase in elderly population and higher prevalence of chronic diseases. Moreover, the global biological market is helping from numerous healthcare awareness initiatives taken by both public and private organizations. Similarly, revolution in biomedical technology and constant R&D programs are expected to highlight further possibility for market growth. On the other hand, problems associated to patent expiry of popular drugs and costly nature of such drugs are estimated to constrain the complete market growth. Similarly, further threats of severe side effects and related risks from injectable biological drugs may also adversely influence the growth of the market.

Due to incidence of populations with high risk to the COVID-19 pandemic, officials are more eagerly manufacturing micro molecule medications to remain than in the past. The healthcare sector is employing strong plans to touch the goal, which entails enduring biological drugs and medicines manufacturing, hence reinforcement of the biologics manufacturing industry. Consequently, COVID-19 pandemic has brought strong growth towards the biological drugs market.

Source Insights

On the basis of the source used for the manufacturing of these biopharmaceuticals, they are segmented into microbial, mammalian, with an addition of some other sources including transgenic models, insect, avian, and transgenic animals.

Microbial expression systems recorded the largest revenue generation due to a significant number of drugs produced by using these products. Microbial expression systems usually cover Escherichia Coli and yeast.

Products developed using these expression systems include granulocyte-macrophage colony-stimulating factor, platelet-derived growth factor, recombinant insulin, and recombinant interferon. Johnson & Johnson, Novartis, and Genentech are the players implementing the usage of microbial systems.

Product Insights

Monoclonal antibodies (MABs) lead the market with the maximum revenue share owing to higher usage of this group of drugs in several therapeutic areas. MABs permit targeting of unnatural cells without damaging the healthy cells.

Furthermore, these drugs are mostly useful in cancer management, treatment of autoimmune diseases, comprising rheumatoid arthritis. Vaccines are predicted to witness the fastest growth in the coming years due to usage as a preventive tool in infectious diseases.

The increase of a virus-based therapeutic vaccine is in the process of growth for melanoma treatment. This is a genetically-modified product for in tumour cells and expresses a gene for an immune-stimulating protein.

Manufacturing Insights

Manufacturing is a part of the major stages of biologics production and includes of a substantial share of the biological drugs market. Mode of manufacturing is an essential aspect to be considered, as it characterizes the outsourcing and in-house activities of the sector.

Companies are electing to manufacture than to purchase an entity or outsource the services. This has managed to the larger share of in-house manufacturing for biologics biopharmaceutical manufacturing capacity. But, the price of the outsourcing contracts is moderately lower than for the overall market and would be incapable to drive sector growth as it does in the pharmaceutical market.

Disease Insights

Oncology has the largest share as a significance of the increasing incidence of cancer along with the presence of various R&D projects. These projects contain gene therapies and antisense. Corporations are involved in investing on own bioprocessing abilities. There are investments done by the CMOs for growing the commercial therapies for cancer eradication.

Additionally, oncology is predicted to maintain its governance over the forecasted period. Factors for the anticipated growth include the increasing adoption of products to decrease the series of severe events related with the usage of cancer chemotherapy.

Region Insights

North America biological drugs market accounted for the largest share in 2021 due to the favourable reimbursement policies, presence of major companies, and high investment in R&D. Biological drugs accounts for about 38% of the total drug spending in the US. Approval of new biologic drugs is anticipated to further drive market growth during the forecasted period, for instance, in 2021, the U.S. FDA gave approval to 21 BLA’s. U.S market for biologics accounted for substantial share in 2021 due to increasing R&D spending for the biologic development combined with the presence of large number of FDA approved biologics in the nation.

The market in Europe, is predominantly driven by demand for biological drugs from the geriatric population of the region. As per the UN report, by 2025 geriatric population in Germany is anticipated to cover 33.2% of the total population in the nation.

In Asia, factors such as positive government initiatives and advanced funding for establishing new biotech companies, drug manufacturing facilities and life science organizations are predicted to stimulate the biological drugs market in the region. One of the important drivers responsible for the growth of the Chinese biological drugs market is continuous increase of biologic developing plants in the nation. For instance, in November 2021, WuXi Biologics launched the GMP operations at it drug production facility in China. The 12,000 m² plant will manufacture approximately 60 million vials for commercial drug annually.

Key Companies Insights

Key players are aiming on their technological partnerships, collaborations, and merger & acquisitions policies to gain a competitive edge and expand their product portfolio & business footmark. The ongoing COVID-19 pandemic hindered the healthcare systems worldwide and driven market players to update products for unexploited prospects. Some of the key players operating in the global biological drugs market include:

• Eli Lilly & Company
• Samsung Biologics
• F Hoffman La Roche
• Celltrion Addgene
• Bristol-Myers Squibb Company
• Amgen Inc.
• GlaxoSmithKline plc.
• Abbvie Inc.
• Baxter
• Sanofi
• Pfizer Inc.
• Merck & Co. Inc.
• Biocon Biologics
• Moderna Inc.
• Novo Nordisk A/S
• Other players

Some of the Recent Developments:

• In August 2021, Moderna Inc. completed the rolling application process to the FDA for full licensing of the Moderna COVID-19 vaccine for active vaccination to prevent COVID-19 in people aged 18 and higher.
• In August 2021, Pfizer Inc. and BioNTech SE have started a supplemental Biologics License Application with the FDA to get sanction for a booster dosage of COMIRNATY to prevent COVID-19 in patients aged 16 and up.
• Biocon Biologics is in discussions with ADQ, the Abu Dhabi government’s wealth fund, to improve the financing as India’s largest biosimilar maker increases its production to generate value for stakeholders ahead of a projected IPO.

Segments

By Source

• Microbial
• Mammalian
• Others

By Product

• Monoclonal Antibodies (MABs)
• Vaccines
• Hormones
• Therapeutic Enzymes
• Recombinant Proteins
• Antisense, RNAi & Molecular Therapy
• Blood Factors and Anticoagulants
• Allergenic extracts
• Human Cells and Tissues
• Proteins
• Gene Therapies
• Cellular Therapies
• Others

By Disease

• Oncology
• Immunological Disorders
• Cardiovascular Disorders
• Haematological Disorders
• Others

By Manufacturing

• Outsourced
• In-house

By Route of Administration

• Oral
• Others (IV and IP)

By Drug Classification

• Branded Drugs
• Generic Drugs

By Mode of Purchase

• Prescription Drugs
• Over-The-Counter (OTC) Drugs

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Geography

• North America
  • S.
  • Canada
  • Mexico
• Europe
  • K.
  • Germany
  • France
  • Italy
  • Spain
  • Russia
• Asia-Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • ASEAN
• Latin America
  • Brazil
  • Argentina
  • Colombia
• MEA
  • South Africa
  • Saudi Arabia
  • UAE
  • Egypt