Experts make pharma predictions for 2015: The good, the bad and the ugly

Experts from CPhI Worldwide have shared their pharma predictions for 2015, suggesting that Continuous Manufacturing and QbD will expand, with FDA becoming ‘industry tutor’. However, pharma concerns about supply chain persist.

Highlights from 2015’s Pharma Trends include:

The Good

• Big growth in use of QbD, continuous manufacturing and Quality Metrics with contract manufacturers and generic companies also starting to implement
• Shift in USFDA’s role from just being an “investigator” of products to an “enabler” of better quality processes and cultures within pharma manufacturing
• Breakthrough treatments for infectious diseases and growth across NCEs and biopharmaceuticals

The Bad

• Shortages of popular drugs in Western markets due to marginal pressures and reduced stockpiling
• Fears for pharma not ‘walking the talk’- QbD and continuous manufacturing and other quality changes are being implemented in finished dosage, but in API, not enough necessary manufacturing changes have occurred
• Challenging year for virtual drug developers as pharma exercises closer inspection of the robustness of CMC regulatory packages

The Ugly truth

• It’s crucial for pharma to take greater control over ingredients
• Outsourcing and related quality issues are unlikely to be reduced in the near future. Big Pharma may even, in some cases, repatriate key elements of the drug development chain
• Battle between IP protection and patient access set to hot up in 2015

The biggest talking point amongst the industry experts, and members of the panel, was how the consistent growth in big pharma’s implementation of continuous manufacturing and QbD over the next 12 months will unfold. For example, IFPAC (International Forum on Process Analytical Chemistry) are holding several sessions this year to encourage an increased use of generic PAT/QbD and a new Office of Pharmaceutical Quality, as launched by the FDA, will also encourage an increased QbD adoption throughout the industry. Beyond this, industry and the FDA will continue to emphasize Quality Metrics but nothing substantial is expected. Interestingly, Indian pharmaceutical companies are, according to Prabir Basu, also showing significant interest in implementing OPEX-which could be a significant cultural shift.

Dilip Shah predicts an evolution in the FDA’s role to become more of an “enabler” of better quality processes – rather than just an ‘investigator’ – helping the industry to adapt and implement new approaches. Emil W Ciurczak goes further and believes that in 2015 we will also see the CDMO market actively implementing QbD and PAT as a source of competitive edge. Vertex has already paved the way for future industry uptake by proving continuous manufacturing’s capability and incorporating it within the process part of their ANDA (abbreviated new drug application).  

Another positive advancement is anticipated across infectious disease treatments. Hendrik Baumann forecasts a major breakthrough for HIV, Hepatitis C or Malaria, and he also predicts solid growth for NCE’s (new chemical entities) and within the biopharmaceuticals market.  

Not all aspects of pharma supply are facing a positive outlook in 2015. Marginal pressures caused by a greater profit driven approach to sourcing and consequential reduced stockpiling by pharmaceutical producers and wholesalers will have a major effect on Western drug markets- with popular drugs in danger of falling short of demand warns Baumann. The production of popular medicines will be less appealing to companies who will decrease warehouse capacities and stockpiling to cope with increasing marginal pressures. 

Moreover, Girish Malhotra has called for action on QbD, continuous manufacturing and PAT to finally take hold across the pharmaceutical industry. One thing he did stress however is that whilst continuous processing is ideal for finished formulations, in API we need whole new solutions. This is where his concerns are greatest and despite a lot of talk about positive change, not enough progress will be implemented in 2015. Both Girish and Prabir Basu warn that outsourcing and quality related issues are not likely to reduce in the near future.

Declared as ‘the ugly truth’, it is now crucial for pharma to take greater control over ingredients and consistency of products should be ensured. Brian Carlin calls on the pharma industry to push for tighter controls. Pfizer, for example, has recently announced a “movable” process line to ensure product consistency, ensuring no variability of quality across products from different global locations.

Due to well-documented supply chain issues, Hedley Rees claims Big Pharma may repatriate some of the drug development chain in the coming months. Similarly, there is also the potential for a Big Pharma acquisition of a CDMO, which would give full control over the supply chain and reverse the huge outsourcing trend of recent years. Despite these concerns, Prabir is predicting that the progressive trend of outsourcing towards India and China will continue apace.

This year is set to be a challenging one for virtual drug developers, as pharma increases scrutiny of the robustness of CMC packages that are part of in-licensing agreements. Hedley Rees predicts a strain on the industry as developers are forced to meet their ever-increasing commitments to GMP/GDP. This will also lead to increased pressure to exceed expectations of potential pharma partners as they look to see a tighter grip on the supply chain.

According to Dilip Shah, another huge industry change will soon be unfolded by developed economies as we see an increasing battle between IP protection and patient access. Developed economies are looking to balance the interests between innovators and patients in the pharma industry, which would put increased pressure on patented products to become cheaper and more accessible.

Other significant trends forecast by the panel include “an increased Government influence over healthcare systems” and “a rise in generic API’s sold through ‘tender businesses’ which will reduce margins and may lead to a reduction in quality”. Hendrik also argues that continuous improvement of current processes combined with permanent technology investments and cGMP compliance will guarantee the existence of European API producers and hold key to their success. Finally, Dilip believes drug regulators will face societal pressures to facilitate entry of follow-on innovative drugs to promote competition in the patented segment.

“New technologies like continuous manufacturing, QbD and PAT continue to expand in importance within the pharma industry, yet age-old issues regarding the supply chain and working with the right partners are also seen as essential in 2015- demonstrating the integral role CPhI will continue to play. Strategic partnering has been a theme for some time in the industry and CPhI provides the necessary tools to establish more pharma contacts and make improved business decisions.” Chris Kilbee, Group Director Pharma at UBM.