Pharma industry predictions for 2021 l Manufacturing technologies l Supply Chain

                                 

Pharma industry predictions for 2021

Here’s a look at some of the top trends experts say will impact the industry in 2021 and predictions about how the COVID pandemic could permanently change life in pharma.

 Manufacturing technologies

Equipment will be more integrated

“2021 will continue the renewed focus on operational efficiency across equipment assets.  For tablet compression equipment, this can mean additional turrets to maximize output and streamline changeover — or the implementation of on-line tablet testing systems to permit a single operator to monitor the multiple machines. The tablet press control system will be increasingly integrated to the central plant system to facilitate domain login, central product recipe management, and central batch data storage.”

~Fredrick Murray, president, KORSCH America 

 COVID will trigger many other small — but critical — innovations

“COVID-19 vaccines have created a heightened focus on what will become the most widespread cold-chain inoculation effort in world history. This will inevitably lead to a cascading subset of obstacles that suppliers will need to address based on their own specific niches.

 For example, one of the 'micro-factors' that come into play with vaccines that have to be stored at ultra-cold temperatures is that adhesives — such as the glue that holds together many secondary packaging folding cartons — can't withstand that level of deep freeze; the glue crystalizes and expands, and the carton joint can pop apart. This has led to a situation where something as simple as paperboard has become a mission-critical packaging platform. And in this case, it has led to innovation in devising glue-free carton options.”

~Ward Smith, director of marketing and business development, Keystone Folding Box Company

 The ultra-low temperature (ULT) infrastructure rapidly put in place will help make precision medicine mainstream

“The infrastructure built now to protect the COVID-19 vaccine supply chain will have long-term benefit when it comes to the accessibility of precision medicine as more of these treatments are brought to market. As an added benefit, the range of temperature capability enabled by ULT infrastructure will shorten, if not eliminate, the need for stability testing of many kinds of drugs, which typically takes months. Dry ice will continue to play a role in larger-scale distribution where providers trained and equipped to handle this volatile substance carry product for a short time before handing off to the next. However, for last mile delivery and long-term storage in health facilities and pharmacies, ULT freezers will have greater long-term value and better manageability while skirting the liability and safety issues associated with dry ice.”

~Dusty Tenney, CEO, Stirling Ultracold

 Pharma companies will build a stronger quality culture

“COVID-19 had companies shifting to innovation mode to develop therapies, tests and vaccines to combat the pandemic. And they needed to move quickly.

On top of that now is the FDA’s announcement of a Quality Management Maturity (QMM) pilot program. The purpose of the program is to gain insight from third-party assessments of a manufacturer’s quality management system to inform a future development of an FDA rating system to characterize a manufacturer’s QMM. As stated in the announcement, ‘for manufacturers with a mature quality management system, the FDA can exercise a more flexible regulatory approach. Leading toward the goal of producing high-quality drug products without extensive regulatory oversight.’

While these are very different events, the common thread is digitally integrated quality and manufacturing processes, because that is what allows a manufacturer to deliver products quickly while maintaining the highest levels of quality.”

~Matt Lowe, president of Labs, MasterControl

For more information regarding Quality Management Maturity (QMM) Refer https://www.federalregister.gov/documents/2020/10/16/2020-22976/quality-management-maturity-for-finished-dosage-forms-pilot-program-for-domestic-drug-product

 

Supply Chain

The market will return to refrigerated temps for COVID-19 vaccines

“All else equal, it is likely the market will favor vaccines that require refrigerated temperatures of 2-8 degrees Celsius. This preference for refrigerated vaccines could push pharmaceutical companies with deep frozen vaccines to determine how to maintain efficacy of the vaccine at a refrigerated temperature. If this happens, we will gain knowledge that moves pharmaceuticals’ current storage and distribution temperature from minus 80 degrees Celsius to easier-to-distribute ranges of minus 50 or minus 20 degrees Celsius, or even refrigerated temperatures.”

~Dave Williams, president, Pelican BioThermal

 HPAPI capacity will grow

“An area of growth in the industry is the high-potency active pharmaceutical ingredient (HPAPI) space. The HPAPI market alone is set to grow to $33 billion by 2025, up from $16 billion in 2016. This is due to the growing importance of these ingredients in creating treatments that are not just more effective, but more patient-centric too, requiring fewer doses to achieve the same impact.

 With this in mind, we can expect more contract service providers to expand their aseptic and HPAPI manufacturing capacity in order to meet higher customer demand for both.”

~Tony O’Sullivan, chief commercial officer, ChargePoint

 New API competitors will emerge

“The cell and gene therapy landscape will continue to rapidly expand and competition for raw materials will increase as programs advance into late-stage clinical trials. As we learned during the pandemic, strengthening supply chains will continue to be important. Companies will also need to think strategically about how to implement secondary sourcing plans and carry significant inventory to minimize stockout risk. This will also likely lead to the emergence of several new competitors in the vector and API supplier space.”

~Bryan Gillis, vice president of manufacturing, Rubius Therapeutics and head of the Smithfield, RI site

 Novel raw materials will grow in importance

“Vaccine workflows such as mRNA and recombinant protein subunit production require novel raw materials in manufacturing and formulation steps alongside step change improvements in scale, documentation and characterization of impurities. At the same time, we must not forget that raw material inputs and single-use components for vaccine production are often shared with mAbs, where operational requirements are already significant and time sensitive.

 Balancing the increased production of vaccines with these other therapies will require innovative solutions in order to meet the needs of all patient populations.”

~Ger Brophy, executive vice president, Biopharma Production, Avantor

 Investments in reshoring will increase

“Pharma had recently been reversing the trend from having a global supply network to buying more and holding onto more emergency supply for resiliency. But that will simply create inventory problems. So pharma companies are now thinking about how they can bring manufacturing onshore in a tax-efficient fashion and then automate the process to lower costs.

EY recently surveyed 500 CEOs of $1B+ companies to understand post-election priorities; 64 percent said they would acquire or build more domestic production, given the anticipated onshoring incentives with continued ‘Buy American’ theme. The industry is not chasing low-cost labor arbitrage anymore, because then you are exposing yourself to black swan events like the pandemic. So reshoring is expected to get more traction.”

~Arda Ural, Americas Industry Markets leader for Health Sciences and Wellness, EY

 Pharmacy Benefit Management (PBM) companies will push against reshoring

“The U.S. is at a strategic disadvantage when it comes to drug supplies and they can be used as a weapon against the U.S. population. Viable strategies are needed to bring generic drug manufacturing home. The U.S. government has talked about this, but is inept to have a concrete plan. PBMs will make sure drug manufacturing does not come to the U.S. as their profitability will be lowered. This would not be acceptable as PBMs will have to raise generic drug prices to retain their profits.”

~Girish Malhotra, president, EPCOT International