October 26, 2018 PAP-Q4-18-CL-005
International relationships are undergoing significant change, and the following issues have particularly affected the pharmaceutical industry:
The growth of the global pharmaceutical market has been driven largely by the rise of emerging markets, including Brazil, Russia, India, China and South Africa (BRICS) and Mexico, Indonesia, South Korea and Turkey (MIST). These countries combined now account for approximately 20% of global pharmaceutical sales, with drug sales expanding enough to double in just five years.4
Access to these new markets is essential to ensuring consistent future growth. Many of these countries recognize the potential value they represent to drug manufacturers and wish to also benefit. To do so, they are requiring some level of local manufacturing.5 In some cases, countries are offering incentives for localization, such as higher reimbursement rates or favored status in the tender process. In others, only locally produced drugs will receive public reimbursement. The latter is the case in Russia (with its Pharma 2020 plan) where only drugs on the Vital and Essential Drugs List that are produced in the country receive government reimbursement.5
Requirements can be related to all aspects of the value chain, including research and development, clinical trials and commercial production activities (drug product manufacturing and packaging). Some have requirements on the portfolio level (if a production process is localized for one product, then all products can be sold in Indonesia and China, for instance), while others apply on the product level (Brazil requires local production for any product sold in the country, even if this rule seems to be softened a bit lately).6
Rising complexity is not limited to changes in international trade and global manufacturing challenges. Drug substances are becoming more complex, requiring a broader range of specialized chemistry and bioprocessing capabilities. Biologic drugs, from monoclonal antibodies to next-generation cell and gene therapies, are beginning to dominate the pharma pipeline. The limited solubility and bioavailability of many new small-molecule APIs require more advanced drug delivery solutions. All new drug products must assure convenience and ease of administration to support improved medication adherence (while also deterring abuse and preventing the introduction of fraudulent products). These issues must be addressed at a time when pressure to reduce costs and accelerate new drug development are mounting.
Quality expectations are also increasing. Many pharmaceutical manufacturers in emerging markets7 — as well as some in the United States and Europe (particularly facilities producing injectable products) — have received warning letters from various regulatory agencies due to quality and cGMP compliance issues. The U.S. Food and Drug Administration is also shifting from a focus on compliance to an emphasis on quality culture. The agency has introduced new voluntary quality metrics programs and encourages the use of tools and technologies (design-of-experiment [DoE], quality-by-design [QbD], continuous manufacturing, etc.) for quality to be designed into processes from the start.
Access to basic raw materials is also being affected. For instance, in an effort to reduce pollution and improve the country’s manufacturing base (Blue Sky Initiative), the Chinese government has shuttered approximately 4000 facilities in the last 12 months alone.8 As a result, supplies of some basic materials have become increasingly limited, which will impact pharmaceutical intermediate and API producers that do not have comprehensive sourcing strategies in place.
Relying on outsourcing partners may seem to be a risky proposition. However, collaborating over the long term with an embedded organization with decades of experience in the pharmaceutical industry — and an integrated, global network of facilities covering all aspects of the drug development life cycle — can help guarantee quality and facilitate access to growing markets.
Servier offers contract development and manufacturing services for drug substances and drug products across 11 sites throughout France, Spain, Italy, Ireland, China, Russia, Poland, Egypt, Morocco and Brazil. In areas where we do not have our own facilities, we have established relationships with reliable partners. This global network is embedded within the Servier Group, a global pharmaceutical company with more than 60 years of experience and a presence in 148 countries. All of our CDMO services leverage the Servier Group’s knowledge, quality culture and support functions (regulatory, supply chain, finance, etc.).
Servier’s services include clinical and commercial manufacture from lab to pilot through scale-up to marketed product manufacturing. Our global quality systems management (QSM) infrastructure proactively assures the implementation of quality assurance/quality control (QA/QC) best practices at all of our facilities, resulting in the implementation of the same quality and management systems and advanced technologies, including assay and validation techniques and systems, across the entire network.
Servier is committed to continuous improvement, from quality to operational excellence to advancing capabilities. Between 2016 and 2018, Servier invested €250 million in its global services network. Some of our latest advances are as follows:
Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.