If there is one bright spot in new drug development it is probably in the exceptionally fast growth of the market for high potency drugs.
One of the main reasons for the incredible growth is due to the surge in oncology drugs. As oncology drugs are the fastest growing therapeutic area in the pharmaceutical industry and many of the drugs are classified as “high potency” it only follows logically that this market segment is on the fast track.
According to marketresearch.com the growth in oncology in the coming years, together with the increasing usage of high potency API in other therapies, is going to be major driver for the global market of high potency active pharmaceutical ingredients in the coming five years. According to their recently release report: The Future of High Potency Active Pharmaceutical Ingredients (HPAPIs), Market Forecasts and Growth Opportunities to 2015 – Growing Demand Drives Investment in Capacity the global high potency active pharmaceutical ingredients market is set to grow at a CAGR of 8.4% from 2009 to 2015.
Other findings of the report include:
• The branded sector holds a major share of the total high potency market.
• The generic sector has a small share, but it is set to grow as branded highly potent drugs will go off patent in the years to come.
• North America accounts for the majority of the global high potency market.
• This is followed by the European region. A large number of discoveries of new high potency compounds are being made in Europe.
• Healthcare standards in the Asia Pacific region are rising very fast as the economies in that region grow. As a result, the region shows the fastest growth rates in the high potency market. In 2009, the Asia Pacific region held a share of 9.3% in the global high potency active pharmaceutical ingredients market. This accounted for $0.7 billion in terms of market sales revenues. Japan holds a dominant share in the Asia Pacific high potency API market and is the fastest growing market. The Indian and Chinese markets are closely following Japan with high growth rates.
• The rest of the world held a 10.1% share of the global HPAPI market in 2009. Some countries in the rest of the world are also growing very fast as markets for high potency active pharmaceutical ingredients.1
As the market for these products expands it naturally follows that the need for equipment and technologies to process and manufacture these technologies is also expanding. To find out what some of the latest trends are in the area of containment technology design we spoke to several industry experts.
Cost Containment A Priority
Even though the market for high potency drugs is expanding, the industry is still in cost-containment mode. Many manufacturers want to develop these types of products but in many instances are not ready to make the large capital investments in new equipment. Many of our industry experts are getting requests for retrofit advice.
As Michelle Frisch from Powder Systems, Ltd. explains, “For containment (the recent trend) is retrofitting systems onto existing equipment. Simple solutions such as glovebags or hybrid containment systems, which is the acrylic, which is between the glove bag materials and stainless steel gives you better visibility and lighter weight than stainless steel.” She continues, “The other thing we are seeing is that clients now really want something that is multi-functional – the ability to do a multitude of tasks instead of a single thing. So let’s say a glovebox is being used as an API dispensary, people now want that to be used also as their cleaning or sampling station or even it being used as a type of wet bench-top. Flexibility is key, not only for different operations or procedures, but also for the future for different things that might be coming down the line. We’ve seen a lot of people want manifolds built into the sides of isolators so they can bring in utilities such as solutions, so they don’t have to use an airlock.”
Ray Ryan from Flow Sciences offers his opinion, “What we’ve noticed is that there are a lot of people looking to contain pieces of equipment that are basically older and were never designed to be contained. So, the challenges that we see are trying to understand how these pieces of equipment are being used so we can properly design the airflow that is required for the containment. The cost of isolators is becoming prohibitive in terms of being able to contain some of these pieces of equipment. So people are looking for alternative solutions.”
The growth of the high potency drug market has
spurred development of advanced containment technologies.
“We are doing some retrofitting,” says Giovanni Gianola, from F.P.S. Food and Pharma Systems Srl. “Due to the economic climate, there are some companies that are investigating retrofitting existing equipment and devices. This way they are trying to maintain a good technology level without investing in new machines that would take a longer time to develop and cost more money. We are always ready to evaluate a situation, but in some situations it can’t be done.”
A Regulatory Conundrum
The rapid expansion of high potency drugs has caused some consternation and even a bit of confusion amongst processors. Obviously, every manufacturer wants to abide by FDA regulations, but with containment technology advancing so quickly sometimes it’s hard to figure out what to do or what the FDA wants.
Frisch offers her thoughts, “A lot times a containment system becomes its own cleanroom. A lot of times it’s more cost-effective to put the process in an isolator that can be operated in a hallway rather than a cleanroom or classified area. The FDA has had some different ruling on that. Some questions include: do you have to have gowning/degowning areas when you are working in an isolator that has its own environment? I’ve had different comments on that. One was that yes, you can operate this if its proven that this “class” is inside the isolator. There are third-party service providers that can do this and if its proven you can put a processing line anywhere. But there is some ambiguity there with the regulations. Depending on how you read them they could go either way. It just states that the processing has to be done is a classified area. If you can prove that your isolator is Class 10 – there you go – you’ve met the regulation. I think that needs to be more clarified.”
“I think the FDA is keeping up with the technology,” she continues. “I think it all depends on who you talk to at the agency. I think they are pushing for this technology more than they used to. You are getting a more controlled environment with isolators. Isolators can be kept at a certain humidity, oxygen level, etc. In a clean room you can’t protect yourself from a dust explosion like you can in an isolator. From an OSHA point of view it’s a much safer environment to work in.”
Tim Russell, from TSI Inc. has this to say about the current regulatory environment. “Whenever you change your process, for example going from a more open to a closed aseptic process, you are going to be changing the process and thereby potentially introducing risk. On one side of the coin you are removing risk, for example contaminating the product. By bringing in RABS or isolators you are reducing that risk but then you are changing your process so the regulators want to make sure you have performed the appropriate risk analysis.”
Flow Sciences’ Ryan has a bit of a different view on the regulatory issue. “The regulatory scrutiny is coming from within the industry and its culture of safety and containment and that’s typically not an issue with the FDA. The FDA is worried about what happens when a drug is given to a patient. What happens is the pharma industry is very concerned with protecting its assets. And its assets include everything it owns. So they want to make sure they don’t have any liability down the road if someone was to acquire some kind of an affliction based on the materials they were working with. They want to prevent that from happening. So the incentive is to avoid litigation.”
Containment systems come in various configurations and can be in many cases,
adapted to fit current processing machinery.
He continues, “Biomanufacturing is where you are concerned about contamination of a product. That’s more of a regulatory issue with the FDA – but that’s always been the case. If you are working with a biological process you want to protect that from any kind of contaminaton. If you have contamination in you biological process you are going to be kissing away a lot of hard earned dollars.”
A Green Future
Returning to the subject of cost containment, many pharma companies are looking at all their options. One way is to reduce energy costs and containment technologies have not escaped the “go green” mantra.
“We are looking at more green systems,” says Frisch. “The reason why is because if we come up with a system that is more efficient with less maintenance, companies can get funding from the government for equipment that meets certain energy requirements. This is a completely different angle.”
Russell agrees, “I see an undercurrent of thinking regarding saving energy usage. If it’s possible to scale down your process to a small area that requires delivering clean air to it – I think that makes sense. Use of isolator technology can reduce the area that requires cleaning. The trend is toward energy saving, reducing risk and taking risk out of critical processes.