Manufacturing and supply trends
Looking back at 2011, what would you identify as the most significant issues shaping the direction of bio/pharmaceutical
manufacturing from a supply perspective, technical perspective, and/or regulatory perspective?
Issues shaping the direction of pharmaceutical manufacturing include: continuing to align capacity with future anticipated
demand, ensuring the security of the supply chain, and meeting shifting global market requirements.
The current drug-shortages issue in the United States is of increasing concern to patients, clinicians, and policymakers.
The issue is reflective of the challenges associated with complex sterile injectables and the supply chain; they were the
genesis of a recent report by the IMS Institute where we identified several new trends and found significant volatility in
the suppliers of drugs, but not always in the total volume of medicines. These issues will not get any easier as we approach
The most significant fact is that pharmaceutical manufacturers are operating in a time of continuous change. They are facing
an extraordinary range of challenges, from handling risk-management initiatives while maximizing their manufacturing, outsourcing,
and quality capabilities, to balancing the need for speed in technical problem resolution, all with the emphasis placed on
supply-chain security. They are facing these challenges while dealing with the intricacies associated with the development
of new products and their components, along with the responsibility to provide an uninterrupted supply of safe and secure
pharmaceuticals to the global patient population. In response to these challenges, cost management and operational excellence
projects abound, including the development of enhanced collaborations internally between R&D and manufacturing as well as
the use of external partnerships to meet strategic goals.
The direction of the industry is being shaped by the drive to meet tomorrow's manufacturing demands efficiently. Even as
single-use vessels, mixers, bioreactors, and manifolds have become reliable, GMP manufacturing standards, innovation, adoption,
and continuous improvement of disposable platforms are ongoing. Today, the focus is shifting from evaluation and integration
to other considerations, including assurance of supply-chain security, the evolution of single-use standards and continuous
technology, and efficiency improvement.
A look to 2012
: Looking ahead to 2012, what factors, conditions, or other developments do you think will play an important role in determining
the performance and direction of the pharmaceutical industry overall and manufacturing specifically?
Pharmaceutical manufacturers will need to ensure that their internal and external manufacturing capabilities are aligned
for the expected needs of the emerging new-product pipeline. They must have the strategic flexibility and agility to respond
to a more dynamic market environment and increasingly volatile product demand. In the emerging markets, manufacturers will
need to look to partnership relations as opportunities for capturing competitive advantage.
The performance of the drug pipeline, both in the approval of new entities and in the commercial success of those medicines,
will be critical for the long-term health of the sector and for the patients these medicines treat. For generic-drug makers,
an unprecedented bubble in new molecular opportunities comes also with an unprecedented race to the bottom and the margin
pressures that await.
Looking ahead to 2012 and onward, I see regulators adding new legislative powers to enable them to effectively control the
new global industry landscape and establish effective oversight process. As the Generic Drug User Fee Act (GDUFA) passes into law in the US, and the Falsified Medicines Directive into national laws in 27 EU member states, we should expect shock waves to the supply chains of APIs in the generic-drug industry.
We will witness a push toward higher standards and increased compliance. If there is increased demand from the few reliably
compliant sources, this may trigger shortages, which may lead to API price increases although this is unlikely to translate
into pharmacy-level price increases. The key dates are July 2013 for Europe and 2017 in the US, by which time, we shall have
parity between foreign and domestic inspections in two of the major global regions. Japan may be less in the news, but Japan's
Pharmaceuticals and Medical Devices Agency (PDMA) does expect the Japanese Drug Master File (J-DMF ) to mirror in detail the
reality of what goes on in the plant and for the inspectors to verify compliance in the field against the Japanese version
of the document; in fact, this is the only document they consider valid. Expect surprises.
The following challenges faced in 2011 within the pharmaceutical industry will continue as we move into 2012:
- The need for flexibility and adaptability within the manufacturing environment will continue, driven by the emphasis on cost
containment and efficiencies.
- The use of external resources and locally situated partnerships will grow as a means to enhance presence in global/emerging
- The ability to participate in these emerging markets will depend on the capability to have small, batch operations that can
cost-effectively produce finished products locally.
- There is a growing need for an ongoing comprehensive approach to resolving supply-chain security issues as they evolve around
- Uncertainty surrounding the sub-optimal performance of the global economy will continue to influence business decisions.
- Manufacturers will continue to contend with an environment of intense regulatory scrutiny, which will tighten on all aspects
of the very complex supply chain.
Our view of the biopharmaceutical industry is shaped by early development and ongoing growth in the single-use manufacturing
technology space. We are beyond trial and validation of these technologies. Once the question was: 'Will these tools work?'
Now, the expectation is to deliver on the efficiency and performance promises of lower operating costs, faster build of manufacturing
capacity, and product life-cycle flexibility. These expectations have hit stride in the recombinant protein and vaccine arenas
and are expanding into the fast-emerging stem-cell and cell-therapy markets. In 2012, the speed at which pharmaceutical and
biopharmaceutical organizations achieve strategic clinical milestones and maintain economically viable business models will
be differentiators. Suppliers of single-use technologies will be measured by their ability to excel in commercialization and
industrialization and their cycle of technology innovation, supply-chain security, and continued improvement of process efficiency.