Sterile Active Pharmaceutical Ingredients Market – Introduction
Sterile active pharmaceutical ingredients (API) or active ingredients are the biologically and chemically active component of drugs that produce the intended effects in the body. Active ingredients are used along with excipients which are chemically inactive substances that aid in the delivery of the medication system to the body.
Active ingredients are manufactured in a sterile environment in the absence of the presence of any contaminants as it could significantly impact the physiochemical nature of the compounds.
Partnerships with Contract Manufacturing Organizations to Emerge as a Pervasive Trend
Intensifying competition in the healthcare industry is prompting pharmaceutical companies to substantially reduce the time required for the production of sterile active pharmaceutical ingredients. Both leading and emerging companies are increasingly joining hands with contract development manufacturing organizations (CDMOs) to ramp up production of novel active pharmaceutical ingredients. The practice is gaining traction as it is providing pharmaceutical companies access to novel technology and aiding them in boosting manufacturing of drugs.
Furthermore, partnerships with CDMOs shields pharmaceutical companies from the potential risks in the market while paving a way for them to enter emerging markets. The array of benefits offered by the practice is making it increasingly popular in the healthcare industry and aiding in accelerating the production of active pharmaceutical ingredients. With the demand for specialty medication on the rise, an increasing number of pharmaceutical companies are leveraging partnerships with CDMOs for production of new and improved sterile active pharmaceutical ingredients. The trend is expected to fuel sterile active pharmaceutical ingredients market growth.
Patent Expirations Fuelling Production of Active Pharmaceutical Ingredients
The accelerating rate of patent expirations is estimated to cause intense competition in the healthcare industry which is expected to propel the growth of active pharmaceutical ingredients market. Leading players operating in the active pharmaceutical ingredients market are increasingly investing in the research and development of novel agents for use in medication to prevent a slump in their revenues. The factor is estimated to pave the way to lucrative opportunities in the sterile active pharmaceutical ingredients market. Additionally, infrastructure development supporting research and development is likely to uphold sterile active pharmaceutical ingredients growth.
Technological breakthroughs in the development of powdered dispensing systems which aid in accelerating clinical trials while substantially reducing the cost incurred during the process is one of the vital factors expected to propel sterile active pharmaceuticals growth.
Sustainability to Become a Key Focus in API Production
With large scale production of sterile active pharmaceutical ingredients on the rise, the sustainability of the manufacturing process is increasingly being scrutinized by both consumers and administrative authorities. API production generates substantial volumes of hazardous solvent which can enter the environment and negatively impact human health. Growing concerns surrounding management of this hazardous waste and growing pressure by governmental organizations to address the issue is prompting manufacturers in the sterile active pharmaceuticals market to streamline their production.
Manufacturers are focusing on the use of efficient catalyzers to accelerate production while keeping waste generation to a minimum. For instance, Pfizer re-engineered the manufacturing process of a nuerontin at its Singapore facility to achieve greater efficiency and reduce the adverse environmental impact of the process.
Stringent Regulations to Dampen Sterile Active Pharmaceutical Ingredients Market Growth
Regulatory authorities around the world are continuously issuing stringent guidelines on the production of sterile pharmaceutical ingredients. Intensifying inspections and strengthening collaborations between authorities around the world to keep a stringent check on sterile active pharmaceutical ingredients production through strategic alliances with CDMOs is expected to pose a daunting challenge for manufacturers. The US Food and Drug Administration issued new guidelines highlighting the good practices to be followed in active pharmaceutical production.
In addition, the authority set up a new guideline according to which manufacturers are required to take an approval before altering the drug production process in place. Similarly, the European Medicines Agency in association with other international partners released a detailed report titled “International API inspection programme report for 2011-2016” in 2018 enlisting the need to intensify inspections of active pharmaceutical ingredients production sites.
Sterile Active Pharmaceutical Ingredients – Competitive Landscape
- Banking on the burgeoning demand for generic drugs owing to the accelerating rate of patent expirations, Cambrex Corporation invested US$ 3 million to expand its facility in Milan for research and development of sterile active pharmaceutical ingredients for use in generic drugs.
- The pervasive trend of increasing collaboration between pharmaceutical companies received yet another boost after Lonza, a leading CDMO in the sterile active pharmaceuticals market, announced expanding its capacity for the development of highly potent API (HPAPI) to support antibody drug conjugate (ADC) manufacturing for an undisclosed biopharmaceutical company.
- GlaxoSmithKline inaugurated a new facility worth US$ 70 million for expanding the production of API for chronic obstructive pulmonary disease. The company plans to prevent a slump in the sales with this expansion after the patent for its blockbuster drug Advair expired.
- Intensifying development of assistive tools for enhancing and accelerating sterile active pharmaceutical production witnessed another development when BOC Sciences launched a cost-effective and novel technique for impurity synthesis in API. The company aims to help sterile active pharmaceutical ingredients producers in identifying impurities in early stages and streamline the drug discovery process.
Other leading players operating in the sterile active pharmaceutical ingredients market include Pfizer Inc., BASF SE, Dr. Reddy’s Laboratories Ltd., ALLERGAN, Boehringer Ingelheim International GmbH, and Teva Pharmaceutical Industries Ltd.
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