Parenteral drugs are types of medications that require non-oral administration, mostly through the direct injection of drugs into the body of the patient either in intravenous, intramuscular, and subcutaneous methods.

After oral administration, parenteral drug delivery is the most common way of getting drugs to patients. While more complex and costly to make than their oral counter-parts, parenteral drugs tout many advantages, such as greater bioavailability.

The market for injectables has been growing steadily over the last decade and projected growth is strong and being driven by the increasing number of drugs approved each year and the booming biologics space.

The emergence of orphan drug development to treat rare diseases is another area sparking growth, according to Marga Viñes, business development manager, contract manufacturing, Grifols International. “Recent successes in the development of orphan drugs coupled with productivity challenges in the classic pharma R&D model for indications with a higher prevalence have resulted in a number of major pharmaceutical companies establishing business units focused on rare diseases,” she said. “Investment by venture capital companies in early-stage biotechs with rare disease programs has also increased.”

Increasing complexity of formulations and associated clinical trial process complications have limited the entry of new players within the parenteral field, according to Ms. Viñes. With increasing outsourcing activities, contract manufacturing companies are likely to gain advantage compared to in-house manufacturing facilities in the coming years.

“The parenteral drug market continues to grow, but we’re seeing growth of the outsourced market surpassing the industry growth in general,” said Bert Barbosa, vice president, drug product, Ajinomoto Bio-Pharma Services. “There is an increasing number of emerging biopharmas that are developing products through late stage and thus requiring contract development and manufacturing organization (CDMO) support, as opposed to larger pharmas with internal manufacturing capabilities.”

Jeff Clement, president of business development, LSNE Contract Manufacturing, said the market continues to move towards fully integrated CDMOs for not only the GMP manufacturing of their product, but for supporting formulation development, analytical development, and quality control services. “Vendor management is a critical concern for many companies seeking to reduce costs and manage their clinical or commercial supply efficiently,” he said.

Growth drivers
Personalized medicine looks to be a large part of the future of drug development and an area where CDMOs can invest heavily to support patient needs. “CDMO support will be needed to help development companies navigate the difficult regulatory, time and quality hurdles that currently raise concerns,” said Mr. Barbosa, “but the companies that are early adopters of innovative solutions between customers and regulatory authorities will be poised for taking advantage of this growing sector.

Also, he said the number of oncology and potent drugs in development has dwarfed other therapeutic areas over the last decade, and that trend is likely to continue. “Within oncology there are HPAPI and ADC drugs that are poised for significant growth.”

Today’s CDMO needs to stay abreast of trends in new formulations or drug delivery technologies. To that end, strong CDMOs will have technologies to support liposomal formulations, emulsions, suspensions, as well as new drug products being formulated with a variety of cyclodextrins, according to Mr. Clement.

“Many companies have developed platform technologies, which are used for many products within the company’s pipeline,” he said. “LSNE has kept pace by developing programs which initiates a comprehensive lyophilization development program for the initial platform product and then performing an assessment of other APIs developed on our client’s platform technology. CDMOs working collaboratively with the developer on complex/aseptically processed projects are driving the business towards long term partnerships rather than one-off fills.”

At the same time, some companies seem to be moving toward more complex administration systems. These novel pre-filled devices are more user-friendly for the patient and can help the company distinguish themselves from their competition, Mr. Clement said. “However, the early clinical stage production costs may be very high so many companies delay the decision to move towards these novel delivery systems until they have completed successful clinical trials with more traditional methods of administration. We anticipate that companies will continue to explore novel prefill devices but there will be challenges with filling them aseptically and lyophilizing them, if required.” 

In recent years, Ms. Viñes reiterated that drug makers have shifted their focus from the development of blockbuster drugs to the development of therapies to treat rare diseases, also known as orphan drugs. “There have been 7000–8000 rare diseases identified to date—effective medicines have been developed for only a few hundred of these diseases,” she said.

Concerning biologics, Ms. Viñes said that as a result of positive development and success in treatment of a majority of chronic diseases, “a large number of companies have been investing in research and development for these products.”

The generics front offers other opportunities for growth. “Over the next 5 years, more than 30 drugs are likely to lose patent and go generic,” said Ms. Viñes. “With so many molecules converting to generics, there will be a lot of potential business for contract manufacturers focused on these types of drugs to capitalize on.”

Market challenges
By all accounts the market for the development and manufacture of injectable drugs is poised for tremendous growth. Despite the positive outlook, the CDMOs servicing the space face numerous challenges getting drugs to market.

An increase in cost bases and the demand for investments to support larger and more diverse service offerings is posing a significant obstacle, according to Mr. Barbosa. “Clinical customers who need flexible support services require cost effective means of working with a CDMO partner to deal with clinical issues that arise,” he said. “CDMOs then must have manufacturing and quality systems that can adapt to the customer’s needs.”

He continued, “Commercial customers face increasing pressure globally from regulators on costs of drugs and therefore need to partner with CDMOs to find mutually beneficial solutions to controlling costs and sharing savings over the life time of a drug. CDMO’s are in a tough position because they must try to accommodate the wide-ranging needs of clinical clients, but also have efficiencies in commercial manufacturing to cut costs down for partners and patients.”

As regulatory requirements continue to tighten, Mr. Clement says he expects to see a greater emphasis on isolators and automated equipment which will reduce human intervention. “Our clients are focused on their timelines and speed to market so continuing to provide them with timely service will be paramount,” he said. “There will likely be a focus on innovation and both existing and new CMOs will need to have growth plans and options in place to move quickly with an expanded customer base or new technology. Also, with many more novel, complex projects coming to the market there will be a trend towards partnerships between CMOs and their clients.”

Based on what he’s seen in the market over the last three years, Mr. Clement says he expects that the CMO industry will continue to grow, especially in the areas of fill/finish and lyophilization, to support parenteral drug product manufacturing. 

As noted earlier, the manufacture of sterile parenteral products is generally more complex than the production of oral dosage forms. Patients, healthcare providers, suppliers and regulators have an implicit requirement of injectable drugs about their safety and effectiveness, according to Ms. Viñes.

“A culture of quality and effective quality systems are essential for successful production of complex products such as sterile injectable,” she said. “It is imperative that all parenteral products be manufactured to the highest quality standards, regardless of whether they are branded drugs or generics. This demand includes the manufacture of injectable pharmaceuticals in compliance with uncompromising strict standards.”