SUBCUTANEOUS BIOLOGICS MARKET ANALYSIS

Biologic, also known as biopharmaceutical, is a complex medicinal product manufactured by a biological process. Examples of biologics include blood and plasma derived products, vaccines, somatic cells and body proteins. Biologics market refers to a multibillion dollar opportunity that is expanding globally at an impressive growth rate. Most biologic products are given intravenously. However, in the past few years, a number of biologics have been developed that are given subcutaneously. The subcutaneous route of administration offers significant advantages over intravenous administration such as ease of drug administration, does not require skilled personnel for drug administration, enables at-home drug delivery and thus reduces patient time at healthcare facilities, reduced medicine cost and increased therapy compliance. Owing to aforementioned factors, the subcutaneous route of administration has gained enormous traction in recent years. Subcutaneous route of drug administration are highly effective in administering biologics such as vaccines, proteins, peptides, antibodies and other large and complex molecules.

Subcutaneous Biologics Market Taxonomy

Humira (Adalimumab), MabThera/Rituxan (Rituximab), Zytux (Rituximab), Stelara (ustekinumab), Enbrel (Etanercept)., Neulasta (filgrastim), ORENCIA (abatacept), RoACTEMRA (tocilizumab) and Herceptin (Trastuzumab) are among the major commercially available biologics that are administered through subcutaneous route. F. Hoffmann-La Roche AG announced the European Commission (EU) approval of its subcutaneous formulation of RoACTEMRA (tocilizumab) in April 2014. Amgen launched Neulasta delivery kit in 2015 to automate the delivery of drug and preventing infection in cancer patients. The global market for subcutaneous biologics has been segmented by the aforementioned biologic brands. On the basis of subcutaneous drug delivery systems, the market is categorized as:

• Prefilled syringes
• Wearable injectors
• Auto-injectors
• Drug reconstitution delivery systems.

The subcutaneous biologics market is also analyzed based on the applications as follows:

• Crohn’s Disease
• Rheumatoid Arthritis
• Breast cancer
• Leukemia
• Lymphoma
• Psoriasis

Increase in Awareness and the number of Diagnosed cases will Drive Demand in Developing Regions

In terms of geography, the global market for subcutaneous biologics is segmented into four major regions, namely, North America, Europe, Asia-Pacific (APAC) and Rest of the World (RoW). There is huge healthcare spending in countries such as United States and Canada, and high prevalence of diseases such as rheumatoid arthritis and breast cancer. The Centers for Disease Control and Prevention (CDC) estimate that the current prevalence of rheumatoid arthritis (nearly 50 million Americans in 2012) will increase to 78 million by 2040. The disease also affects nearly 300,000 children in the U.S. according to RheumatoidArthritis.org. In the European region, EU-5 countries (Germany, France, United Kingdom, Italy and Spain) are the most potential market owing well established economy of these regions. Convenient drug delivery format is also in demand in developing regions such as Asia Pacific and Latin America where therapy compliance is a major issue. Large undiagnosed population, inadequate access to medicines and affordability issues hinder the market growth for subcutaneous biologics in developing regions.

The global market for subcutaneous biologics will be expanding under the influence of factors such as:

• Advantages over other routes of administration
• Increasing trend of self-medication
• Introduction of innovative drug delivery devices such as auto-injectors and prefilled syringes
• Growing incidence and prevalence of rheumatoid arthritis and breast cancer
• Growth in the biosimilars market

Some of the major companies operating in the global subcutaneous biologics market include Genentech Inc., Biogen Idec, F. Hoffmann-La Roche AG, Amgen, Inc., Eisai, Inc., AbbVie, Inc., Pfizer Ltd., Takeda Pharmaceutical Company Ltd. and Bristol-Myers Squibb.

Key Developments

1. Key players in the market are involved in various business strategies such as gaining biologics license from regulatory authorities. For instance, in July 2018, Halozyme Therapeutics, Inc. announced that the U.S. Food and Drugs Administration (FDA) accepted biologics license from ‘Genentech’, a member of the Roche Group, for subcutaneous formulation of trastuzumab (Herceptin), which is company’s FDA approved indication for breast cancer.
2. Major players in the market are focused on gaining approvals for products and treatment from regulatory authorities, in order to gain competitive edge in the market. For instance, in October 2018, Roche AG received the U.S. Food and Drugs Administration approval for Hemlibra, which is a routine treatment for adults and children suffering from bleeding episode. It consists haemophilia A without factor VIII inhibitors, which will reduce the frequency of bleeding episodes.
3. Major players in the market are focused on gaining approvals for products and treatment from regulatory authorities, in order to gain competitive edge in the market. For instance, in September 2018, AstraZenca and Amgen received the U.S. Food and Drug Administration ‘Breakthrough Therapy Designation’ for tezepelumab, which will be used for patients with severe asthma without an eosinophilic phenotype.