Sterile Injectables: Opportunities Galore for Generics Manufacturers
Increasing use of biologics in healthcare industry, with the gaining prominence, the emergence of antibody-drug conjugates (ADCs) and monoclonal antibodies (MA) into the drug development and clinical pipeline, has spurred growth of the sterile injectable market worldwide. According to Piramal, the development and manufacturing of sterile injectables is highly complex and capital intensive. The operative cost for injectable is high as almost all injectables in present pharma market are toxic and infectious in natural, consequently, requiring a higher level of quality and significant care needs to be taken in order to ensure safe manufacture, packaging, storage, and distribution. Furthermore, strict regulations by Food and Drugs Administration on manufacturing facilities and equipment dissuades pharma players and potential new entrants from venturing into this lucrative sterile injectables market. Many sterile manufacturing facilities have closed down in the U.S. and many parts worldwide due to the alliance of in-house manufacturing capacities, which have led to an acute shortage of sterile injectables, adversely affecting the sterile injectables market. Earlier, there were individual companies developing injectables have now merged and acquired similar product profile companies in order to make up for operational cost required to develop the injectable. This in turn has adversely affected the sterile injectable market, leading to dearth of drugs.
The global sterile injectable market was valued at US$ 299.7 billion in 2015 and is expected to witness a CAGR of 6.9% during the forecast period (2016 – 2024).
Figure 1. Global Sterile Injectables Market Share, By Product Type (%)
Source: Coherent Market Insights Analysis (2017)
Contract Manufacturing Firms to gain importance in Sterile Injectables Market
Sterile injectables manufacturing requires major capital investment for the equipment and the production process. Many pharmaceutical companies due to lack of funding and investors are approaching contract manufacturing firms in the U.S. and Europe. Lonza, one of the top contract manufacturer of biologics and ADC, in Europe, have ample opportunity to be the top contract manufacturing firm globally in terms of revenue. Germany-based pharma company, Fresenius Kabi, plans to invest around US$ 250 million over the following decade to expand the company’s Melrose Park site, where it manufactures generic, sterile injectable pharmaceuticals.
Sterile Injectables Market Scenario: Indian companies are increasingly focusing on developing complex generics:
Some of the prominent pharma companies based in India have strived hard to achieve success by attaining approval for various novel biologics processes. The manufacturing facilities for development of biologics are GMP certified. There are many complex injectable drugs such as lyophilized products, high potency active pharmaceutical ingredients, long-acting suspensions, and liposomes which necessitate multifaceted manufacturing capabilities. For injectables, new drug, including drug delivery systems such as self-injection devices such as auto and pen injectors that improve patient compliance and enable differentiation is a strategy employed by various market players. Dr. Reddy’s has marked up its multifaceted injectables business since past 5 years to US$ 280 million in 2015, which is almost equal to 25% of its market value from North America. In order to enhance its geographical presence and venture into the injectables product segment, the company acquired a Netherland-based injectables manufacturer, to expand its injectables product portfolio. Lupin Limited acquired Naomi BV in 2014. Naomi BV has an injectable drug in the development pipeline and approximately total number of 38 products in the development pipeline targeting branded and generic injectables market.
The last decade has witnessed a major paradigm shift in the healthcare industry, with increasing inclination towards biologics over conventional drugs. Therapeutic areas such as Oncology, drugs are been overtaken by biologics as they are highly absorbable in the body with quick therapeutic response. Furthermore, the pharmaceutical industry too has been swept by winds of change, with strong biologics pipeline under their product portfolio. Novel drug delivery systems that deliver specific targeted therapies are gaining importance. These aspects, among others, have in turn led to a spike in growth of the sterile injectables market. Globally, around 2,400 injectables s are under development pipeline, which are potent and non-potent. This is a major factor directly fueling growth of the sterile injectables s market. The generic market is the largest target market for sterile injectables s. Major generics players such as Teva Pharmaceuticals, Hospira, Hikma, and Fresenius Kabi are also involved in development of sterile injectables s.
Accessibility of broader treatment therapy choice and growing prevalence of chronic illnesses prominently cancer globally is likely to fuel market demand for sterile injectables s over the forecast period. The high demand for sterile injectables is also driven by a large number of drug manufacturers/producers concentrating on developing drugs to treat cancer. Fast-track regulatory approvals of sterile injectables and minimization of approval timelines for innovative drug development to cure cancer is indirectly helping accelerate the drug supply and is significantly fueling growth of the global sterile injectables market. High operative costs and abrupt termination of injectables drugs for cancer treatment is expected to hamper revenue growth of the market across the globe. Manufacturing of sterile products necessitate the high end equipment for manufacturing and also the equipment needs regulatory certification and sterilization before production process. Hence, these activities lead to high operating costs and high debt levels. Furthermore, the FDA has stringent regulations pertaining to sterilization of drug and equipment, which further adds to the cost burden of the manufacturer as it entails maintaining a high degree of care in the manufacturing, packaging, storage, and distribution of sterile injectables drugs.
This report segments the sterile injectables market on the basis of molecule type, drug type, application, end user, and geography. On the basis of molecule type, the market is categorized into large molecules and small molecules. On the basis of drug type, the market is categorized into Monoclonal Antibodies (mAbs), Cytokines, Insulin, Peptide Hormones, Vaccines, Immunoglobulins, Blood Factors, Peptide Antibiotics, and Others. On the basis of application, the market is categorized into Cancer, Diabetes, Cardiovascular Diseases, Central Nervous Systems, Infectious Disorders, Musculoskeletal and Others. On the basis of end user, the market is categorized into Hospitals, Drug Stores, Pharmacies and online pharmacies. For comprehensive understanding of market dynamics, the global sterile injectables market is analyzed across key geographical regions namely North America, Europe, Asia Pacific, Latin America, Africa, and Middle East. Each of these regions is analyzed on basis of market findings across major countries in these regions for a macro-level understanding of the market.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.
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