With the increasing demand for generic medicines and biologics, the complex manufacturing requirements, and the capital-intensive nature of the business, many pharmaceutical companies have recognized the potential profitability in getting into agreement with a CMO for both clinical as well as commercial stage manufacturing. In addition, pharmaceutical companies have been directing their priorities toward the core areas of competency, and therefore, prefer not to dispense available resources, expertise, and technology on formulating the final dose of medicines.
Keeping at par with the paradigm shift in the biotechnology industry and the existing biopharmaceutical industry trends, CMOs have decided to shift from solely renting manufacturing units to a business model that offers extensive development and production support. CMOs and contract development and manufacturing organizations (CDMO) individually or together have begun to offer many specialized, value-added services for customers with early-stage development needs and for those who require support to generate a biologics license application enabling process validation data package.
CMOs have also started offering early development support to their customers, along with fully integrated services, which include specialized services like aseptic fill-finish. Though the concept of CDMO was introduced earlier, it has been fully realized over the last few years. It goes without saying that the costs invested in R&D are constantly increasing, and yet the useful results returned from these processes are becoming rarer. Many companies have realized that shifting this part of the business overseas and taking advantage of the still-emerging pharmaceutical markets is an effective method of cutting costs. Despite the existing proof of cost savings and competencies that can be accrued, many companies are reluctant to give up that control, going so far as to state that logistics are a core competency for the company. However, this scenario seems to be changing slowly.
The demand for API manufacturing has witnessed a sustained rise for some years, and it is expected to grow steadily and a subsequent increase in global generic production capacities. Most of the companies in the industry are overwhelmingly focusing on the development of biological APIs, which is driving the API market. The general prescription drug sub-segment occupies a major share in the API manufacturing segment, as compared to OTC drugs. Captive manufacturers are presently leading the API market, although they are expected to leave out their market share to contract manufacturers toward the end of the forecast period. This is entirely because of the complex and expensive in-house manufacturing of API and increasing competition from emerging players in the industry.
Our goal with this edition is to feature such companies who are at the forefront of revolutionizing the contract manufacturing organization space through their top-notch services. We hope this issue of the Pharma Tech Outlook helps you build the partnership you and your firm need to foster technologically-driven contract manufacturing organization services.
We present to you ‘Top 10 CMOs in APAC - 2020.’