Biologics Market Definition
The biologics industry comprises companies manufacturing biological products. Biological products include a wide range of products such as vaccines, allergenics, somatic cells, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. These products are isolated from natural sources such as human, animal, and microorganisms by biotechnological methods and other cutting-edge technologies. Specifically, most biologic medicines are developed using recombinant DNA (rDNA) technology.
In contrast to most chemical drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized. Biological products differ from conventional drugs in that they tend to be heat-sensitive and susceptible to microbial contamination. This requires sterile processes to be applied from initial manufacturing steps for Biological drugs.
Like drugs, biological products are used to either:
- • Treat or Cure Diseases and Medical Conditions,
- • Prevent Diseases, or
- • Diagnose Diseases
Biologics Market Size
The global biologics market was worth $221 billion in 2017, having grown at a compound annual growth rate (CAGR) of more than 5.4% since 2013.
Growth in the biologics market in the historic period resulted from aging population, government initiatives, ability to command high prices, increased mergers and acquisitions, and increased share of biologics in the pipeline. Factors that negatively affected growth in the historic period were difficulty in manufacturing biologics, and pricing pressures from regulators. Going forward, technological advances increase in healthcare access, and reimbursement of biologics will drive growth. Factors that could hinder the growth of this market in the future include rise of biosimilars, and higher supervision during clinical.
Biologics Market Drivers
The Key drivers of the biologics market include:
Ability To Command High Prices - Biologics are used in the treatment of chronic disease conditions and unlike small molecules, the number of biosimilars (generic version of biologics) are less. This gives the monopoly to biologics and the manufacturers to state high price in the market. For instance, a biologic drug costs an average of US$ 22 per day compared to a small molecule drug that costs an average of US$1 per day. This in turn drives the biologics market.
Biologics Market Restraints
The key restraints on the biologics market include:
Difficulty In Manufacturing Biologics - Biological drugs are highly sensitive and dependent on the conditions in which they are manufactured and handled. They tend to aggregate during the production and purification process and quality control plays an important part in the manufacture of these drugs. Even minor differences in the production process can generate variations in the resulting protein, potentially leading to catastrophic results. Thus, biopharmaceutical companies manufacturing these biologicals have to put in extra care and resources, thus raising the cost and price of biologics.
Biologics Market Trends
Major trends influencing the biologics market include:
Demand For Biologics In The Treatment Of Complex Diseases - Biologics are being widely used to provide effective treatment for many complex diseases such as rheumatoid arthritis, psoriasis, Crohn’s disease that have limited treatment options. There has been a significant advance in the treatment of rheumatoid arthritis patients who do not respond to traditional disease-modifying anti-rheumatic drugs. The key biologics used for the treatment of rheumatoid arthritis include Abatacept (Orencia), Adalimumab (Humira), Anakinra (Kineret), Infliximab (Remicade), and Rituximab (Rituxan). Key biologics used to treat psoriasis include Adalimumab (Humira), Etanercept (Enbrel), Infliximab (Remicade), Secukinumab (Cosentyx). Cimzia (certolizumab pegol), Humira (adalimumab), and Remicade (infliximab), Tysabri (natalizumab) are biologics that are used to treat Crohn’s disease.
Development And Increasing Demand For Next Generation Biologics - Antibody drug conjugates (ADCs) are being used to treat diseases such as inflammatory, oncology and respiratory diseases. ADCs are monoclonal antibodies that have the ability to discriminate between healthy and diseased tissues and kill the diseased tissues when detected. ADCs are also being used in cancer treatment by attaching them to cancer-killing drugs that kill cancerous cells, leaving healthy tissues unaffected.
Companies in the biologics market are investing in technologies to develop next generation biologics such as ADCs, bispecifics, fusion proteins, cell and gene therapy that will be more effective. These next generation biologics are expected to have better potency against the target disease as well as have the ability to treat more than one aspect of the disease. They are being manufactured with the help of technology, along with drug delivery systems. Some of the next generation biologics brands include Kadcyla, Tresiba, Alprolix, Adcetris, Eloctate, Plegridy, Afrezza. Companies such as Roche, Bristol-Myers Squibb and Novartis are investing heavily in the development of next generation biologics. The scope of market growth seems to be very high as the technology giant Samsung, through its subsidiary Samsung BioLogics Co., is investing around $740 million for the production of next-gen biologics.
Biologics Market Segmentation
The Biologics market is segmented by type, and by geography.
By Type -
The biologics market can be segmented by type into
Vaccines had the highest growth rate of nearly 5.86% during the historic period. The fastest growth in the historic period can be attributed to the increasing government and non-government initiatives for vaccine R&D activities and prevention of various infectious diseases. Various bivalent and pentavalent vaccines that can prevent an individual from more than one disease have also been developed and are being administered in many countries across the world.
- a) Monoclonal Antibodies (mAbs)
- b) Therapeutic Proteins
- c) Vaccines
By Geography - The biologics market is segmented into
North America is the largest market for biologics, accounting for 39.5% of the global market. It was followed by Western Europe, Asia-Pacific and then the other regions. Going forward, North America and Asia-Pacific will be the fastest growing regions in this market.
- o North America
- o Western Europe
- o Asia Pacific
- o Eastern Europe
- o South America
- o Middle East
- o Africa
Biologics Competitive Landscape
Major Competitors are:
Other Competitors Include:
- • Johnson & Johnson
- • F. Hoffmann-La Roche Ltd.
- • Bristol-Myers Squibb Company
- • GlaxoSmithKline Plc.
- • AbbVie
- • Amgen
- • Sanofi S.A.
- • Eli Lilly and Company
- • Merck & Co.
- • Pfizer