“Governments should make global set of specifications that can be followed”
Bio-Techne Corporation is a leading developer and manufacturer of high quality purified proteins––notably cytokines and growth factors, antibodies, immunoassays, as well as biologically active small molecule compounds --which are sold to biomedical researchers and clinical research laboratories; these operations constitute the core Biotechnology Division, headquartered in Minneapolis, Minnesota. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately $563 million in net sales in fiscal 2017 and has approximately 1,800 employees worldwide. In an interaction with BioSpectrum Charles (Chuck) Kummeth, President & CEO, Bio-Techne Corporation shared his views on opportunities and challenges before the bio suppliers market. Excerpts of the interview.
What are the trends in bio suppliers market with respect to life sciences and healthcare industry?
The healthcare industry, in particular the pharmaceutical industry, is certainly experiencing a certain level of consolidation. India has benefitted with roughly 8% of the global market for generics. It’s a very high percentage of generics compared to the real size of the market here in India; so that is probably going to dictate the trend of what’s going to happen here in India.
I think in life sciences the trend in India is very similar to the trend across Asia, which is different in the US and in Europe which is found in biosimilars.
So the big trend in Asia is to get away from traditional biosimilar development of large and small molecule and go after generics with the chemical based version of a drug.
I think it’s difficult to understand the trends and how much regulation there will be, how detailed they need to be plus it should be cheaper and more economical which is why I think people come to India for generics at first place.
I think, the major trend will be biosimilars related and heavily dictated by still forming regulations that will be required to be in a market with a biosimilar drug.
We see a consolidation of the various suppliers in this industry in an attempt to provide more complete workflow solutions to customers. The idea is that onestop-shopping would make it easier for a customer to find most of their needs.
How do you see the opportunity for bio supplier in the same domain?
Biosimilars are the next generation. There are around 800 biotech companies in India and I am sure many are developing biosimilars. Reasons like less cost and less capital makes it a very entrepreneurial like and that’s why China and Korea are also chasing India. Japan is more into regenerative medicine and is really not focussed on biosimilars but they are the leaders when it comes to stem cells and IPS cells.
The pharma world has gone from a pure chemistry based approach in finding new drugs to now adopting many biologicals as new drugs. In doing so there is greater interest in learning more about the function of each molecule, its receptors and mechanics to block or enhance the action through the use of a biological. This has re-energized the life science industry.
A lot is going to come down to tools and reagents and specifications of how to actually make a good product. This in turn is going to come down to quality in general and for our company too since we are mostly a research tools company, comprised of reagents and instruments. For us it is really about the quality of the pieces that go into the workflow that will create biosimilars. What is GMP and PDMA? What will the regulations be? This is going to be very very critical and people are going to stretch the truth and some people are going to claim to be GMP certified even if they are not.
Our company has always been a very leading
company putting quality first, with a very gold standard brand like R&D Systems, so, we are very careful about making GMP and quality claims. Each of our protein products carry bioassays claims that ensure the bioactivity of these products. Very few in our industry do this. I think many of these quality issues will ultimately determine who will succeed and who will not in the supply chain of biosimilars. We are hoping success because we think our brand and quality reputation will provide confidence to those who rely on our products.
What are the opportunities that can be generated in biosimilar domain?
The opportunity for Bio-Techne Corporation is having so many products that lend themselves to the development of biosimilars. We are not really involved with pharma on small and large molecules or doing research with the products. I think in terms of biosimilars we can do much more in the workflow and get more share of that supply chain. We engage in many custom developments of antibodies for companies right now. We have about 40,000 products. We manufacture in house, in terms of antibodies, assays and proteins and we’ve been doing this for over 40 years. Nobody has more cloned proteins and related reagents than we do. Such a large collection of biologically active molecules can be very appealing to any company trying to develop the next successful biosimilars.
We are very well known for high level of purity and quality of antibodies. We don’t expect to be in the drug business but we do expect to be licensing more and more of our intellectual property to companies who want to develop new drugs. Pharma will do the clinical trials which will require significant capital to support these activities. But in the end they will make good returns on their investment. Again, our company having roughly $600 million in revenues, can be satisfied with a growth of 10 per cent per year, but for a large pharmaceutical company this can be too small.
We launch in the market almost 1500 new products each year among antibodies, proteins and immunoassays. Also, we are the world leaders in Luminex-based immunoassays. Through our 10 acquisitions in the last four years we are participating more and more in our customers’ whole workflow by having instruments, products in addition to reagents. We think this is one way to scale our company and go beyond just research because many of these technologies that use our reagents can also become companion diagnostics for the pharma industry.
What are major challenges before industry and what are your suggestions to overcome these issues?
Some of the challenges in the biosupplier space is that the barrier to entry is low and it’s easy to launch products, have a low price structure and with a website everyone can look reputable. However the quality in these products can be questionable and customers are challenged in knowing whether the product they are buying at a low price has maximal bioactivity or purity. These issues can set back a long term experiment or confound the interpretation of experimental data.
Concerning rules and regulations, what’s going to happen in India will be different in Japan and different in China. We are looking for governments to make a global set of specifications that can be followed. Since its different everywhere, it’s challenging.
SOME OF THE CHALLENGES IN THE BIOSUPPLIER SPACE INCLUDE THE BARRIER TO ENTRY IS LOW, IT’S EASY TO LAUNCH PRODUCTS,
WHICH HAVE A LOW PRICE STRUCTURE AND WITH A WEBSITE EVERYONE CAN LOOK REPUTABLE. HOWEVER THE QUALITY OF THESE PRODUCTS CAN BE QUESTIONABLE.
Charles (Chuck) Kummeth President & CEO, Bio-Techne Corporation
Charles (Chuck) Kummeth President & CEO, Bio-Techne Corporation