In 2018, the global hard empty capsules (HEC) market was above 700 billion capsules (units). In 2020, the global growth for the capsule market is anticipated to be modest in value for pharma, and comprise approximately 70% of the capsule market globally. Within Pharma, demand has been driven by more complex drugs requiring specialized dosage forms to overcome bioavailability challenges, such as oncology and orphan drugs, as well as by volume growth in pharmerging markets driven by off-patent drugs. Moreover, the majority of new developments are in the generic space and more than half of NCE (New Chemical Entity) developments are currently in specialty polymers, underlining the current market trend in non-gelatine base alternative for capsules. From a geographic perspective, Pharma HEC sees increasing demand in the Asia-Pacific markets, as well as consolidated demand in developed markets. Asia is a key growth driver, especially in generic drugs and the traditional Chinese medicine segment in China.
1 Source: Internal Analysis
The pharma hard-capsule business continues to build on the Capsugel® brand and track record of ingenuity, credibility and flexibility to deliver a positive experience and drive added value creation for our customers. Our proprietary and patent-protected technologies, significant expertise in capsule polymer science and product and process design capabilities, all help our customers meet their target product profiles and commercial objectives. Business continuity for capsule supply to the biopharmaceutical industry is unmatched with eight production sites located in Europe, USA and Asia.
Leveraging this extensive experience in two-piece hard capsule design and manufacturing, we have also been able to deliver an unmatched value-added service portfolio. Following our commitment to deliver high-quality products, we have established standards and systems to oversee internal and external quality performance by establishing a global quality organization, with an integrated supply chain, technical and operational engineers, color lab support and global regulatory expertise.
Our acquisition of Capsugel, with its unique hard-capsule science and engineering, has allowed us to provide the broadest range of capsule polymers, sizes and designs in the global pharmaceutical industry. We also offer integrated product design, development, clinical supply and commercial manufacturing services to our customers around the world. The diversified customer base includes companies that make branded, generic and specialty pharmaceuticals, as well as biotech products and over-the-counter medicines.
Billion Capsules Produced1
1 Including Pharma and Nutritional Hard Capsules
Our Global Footprint
At our Greenwood, SC (USA), we provide hard capsule manufacturing, as well as the product development and manufacturing of liquid and multi-particulate filled hard capsules.
In Europe, our dedicated hard capsule manufacturing sites are in Bornem (BE) and Colmar (FR), with Colmar also offering finished product design and development and manufacturing of liquid and multi-particulate filled hard capsules. Both sites also serve as our R&D Centres of Excellence.
In Asia, our presence spans from Suzhou (CN), Jakarta (ID) and Haryana (IN) to Sagamihara (JP). Our Sagamihara facility provides capacity for hard capsule manufacturing, product development and manufacturing and multi-particulate filled hard capsules.
Highlights and Initiatives 2019
The pharma hard capsules business saw ongoing demand for specialty polymer and dry powder inhalation (DPI) offerings. The business was supported by new product launches but challenged by market conditions in the US and slower growth in developed markets. Several long-term agreements were signed.
In 2019, we launched Lonza EngineTM line for clinical and commercial scale processing equipment inclusive of specialized encapsulation technology which complement our capsule product line offering.
From early-stage development to commercial solutions, the hard-capsule business continues to offer the broadest portfolio of gelatin, hydroxypropylmethylcellulose (HPMC) and other specialized polymers for capsule production tailored to specific pharmaceutical applications. Supporting the fast growth of the HPMC lines, we re-launched Capsugel® Vcaps® Plus HPMC capsules globally. In addition, our specialized capsules for DPI applications were launched, branded as Zephyr® capsules, building on more than 20 years of experience in DPI encapsulation applications. Zephyr® capsules are supported by DPI and bioavailability enhancement formulation services to serve the growing number of pulmonary delivery route solutions.