Market Highlight: The Outsourcing of Pharmaceuticals

Patent expirations, growth of disease prevalence, and the greater availability of advanced diagnostic procedures have increased the discovery and development of new biopharmaceutical compounds at an exponential rate. Pharmaceutical outsourcing has become a massive industry and represents a key driver behind many of the drugs brought to market today.

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Why are pharmaceutical companies outsourcing?

When it comes to pharmaceutical research and development however, success is never guaranteed. The average cost of drug development can reach into the billions of dollars, and it takes an average of 10 years to bring a new drug to market. In addition, many drugs fail to be clinical effective and subsequently never see the light of day.

Due to these risks, pharmaceutical companies are not always eager to utilize their onsite resources for drug R&D. Certain cost-saving measures implemented in the pharmaceutical space have included outsourcing these activities, helping organizations reduce both their operational and manufacturing costs, thereby lowering financial risk.

Current outlook

An estimated $19.2 billion dollars were spent in 2016 for outsourcing the discovery of pharmaceutical drugs, which was primarily driven by a greater demand for contract research organizations (CROs) as well as advancements in scientific discovery and technology. Additionally, there is an expected growth of 46.7% from now until 2021 in the development of new biologic entities, translating into an overall expenditure of $72.7 billion.

Currently, the most common pharmaceutical products being outsourced for development include:

  • Vaccines (51%)
  • Blood factors (46%)
  • Hormones (44%)
  • Antibody drug conjugates (42%)

Specifically, drug discovery outsourcing is expected to rise to a $43.7 billion industry by the year 2026. The outsourcing sector is saturated with an enormous amount of capital, which continues to fuel pharmaceutical outsourcing. Since many pharmaceutical companies are small, have little capacity to perform research onsite, and lack appropriate equipment to perform R&D, outsourcing is essential.

As evident by its exponential growth, R&D outsourcing activities have become challenging to manage by pharmaceutical technical and R&D managers. Private contract research organizations (CROs) and other academic organizations represent the primary outsourcing locations for pharmaceutical companies, and many of these companies provide everything from drug discovery and structural analysis to phase 4 clinical trials.

Drug development

Pharmaceutical outsourcing is typically allocated to CROs, specifically in the testing phase. Prior to ultimate market approval, clinical trials are required to be carried out in controlled environments. This is where the CRO comes into play. In addition, pharmaceutical companies may wish to outsource their sales and marketing to external vendors as a means of improving efficiency and optimizing expenditures.

ThermoFisher Scientific, a leading biotechnology product development company who will be exhibiting their range of spectroscopy products at Pittcon 2018, is an example of a company that provides outsourcing drug development services to pharmaceutical clients across the globe.

While not a CRO, pharmaceutical companies can still utilize ThermoFisher’s services for identifying drug compounds via cell- and biochemical-based profiling, assaying compounds or formulations, and gaining assistance in cell engineering projects.

Pittcon 2018 exhibitor Bruker, also offers pharma-development services - including drug discovery and drug development programs, N and C terminal sequencing, structure determination via single crystal X-ray diffraction, cell culture media monitoring, and X-raying services.

In addition, Waters, a biotechnology instrument manufacturer, also assists companies in developing drug formulations, peptide and protein bioanalysis, and other manufacturing services for the biotech, pharma, and health sciences industries.

Pharmaceutical testing

One of the biggest challenges associated with pharmaceutical development is that of biopharmaceutical analysis. Onsite analyses are possible for large biopharmaceutical companies; however, the costs, time, and equipment associated with these tests can exert a substantial burden on the company’s resources.

ThermoFisher is specialized in the field of biopharmaceutical analyses as they offer a full suite of technological products that assist in rapid, high-quality analyses of minute pharmaceutical compounds. Many of their technologies aid protein characterization, assist in identifying three-dimensional structures, and facilitate protein aggregation.

Additionally, ThermoFisher provides pre-clinical and clinical drug testing, including drug metabolite characterization to facilitate new compound discovery and drug development. The organization relies on high-resolution mass spectrometry technologies for detecting, profiling, and quantifying metabolites.

Additionally, the company includes a quality assurance and quality control protocol which consists of multiple technologies, including mass spectrometry, to ensure consistency and to detect impurities in pharmaceutical samples.

Electron paramagnetic resonance (EPR) spectroscopy is an essential aspect of pharmaceutical testing, helping researchers gain insight into the drug’s degradation. By doing this, pharmaceutical companies understand the shelf life of a product, which ensures patient safety.

Outsourcing pharmaceutical development organizations, like Bruker, offer this service in addition to their other development programs. Also, nuclear magnetic resonance imaging can work synergistically with EPR spectroscopy to assist in discovering insight into the structure of impurities, potency determination, and structure of biological drugs and biosimilars.

In addition to understanding a drug’s shelf life and potency, a drug stability test chamber is often used by pharmaceutical outsourcing organizations, like Hanon Instruments, to determine a structure’s strength under varying environmental conditions. Another organization, DynaLabs, provides stability indicating tests to determine the stability of pharmaceutical compounds.

Conclusion

Future innovation in pharmaceutical development relies on a more focused approach that moves away from competition and into areas where unmet needs exist. Additionally, pharmaceutical companies should realize the increasing rarity of blockbuster drugs and should focus on a strategy that pursues targeted therapies to diversify and increase portfolio value. In addition to outsourcing R&D activities, these actions will ensure greater cost-savings and higher returns on investment.

Outsourcing with experienced leaders in pharmaceutical development, such as ThermoFisher Scientific, Waters, Bruker, DynaLabs, and Hanon Instruments, will help ensure these goals are met now and in the future.

Check out the Pittcon 2018 guide to learn more about the companies’ services and their pharmaceutical outsourcing technologies they will be presenting at the event.

References:

  1. The Future of Pharmaceutical Innovation: Tackling the R&D Productivity Gap. https://www.accenture.com/t20150527T203922__w__/us-en/_acnmedia/Accenture/Conversion-Assets/Microsites/Documents/Accenture-The-Future-of-Pharmaceutical-Innovation-Tackling-the-RD-Productivity-Gap-Online.pdf. Accenture. Accessed February 4, 2018.
  2. Paul SM, Mytelka DS, Dunwiddie CT, et al. How to improve R&D productivity: the pharmaceutical industry's grand challenge. Nat Rev Drug Discov. 2010;9(3):203-214.
  3. Beyond Use Dating. http://www.dynalabs.us/what-we-do/hospital-pharmacy/hospital-pharmacies-stability-of-drug/. DynaLabs. Accessed February 4, 2018.
  4. Drug Stability Test Chamber. http://hanonlab.com/productshow.php?cid=140&id=179. Hanon Lab. Accessed February 4, 2018.
  5. Pharmaceutical Applications of NMR and EPR. https://www.bruker.com/products/mr/mr-in-pharma.html. Bruker. Accessed February 4, 2018.
  6. Pharmaceutical Applications of Electron Paramagnetic Resonance (EPR) Spectroscopy. https://www.bruker.com/se/service/education-training/webinars/epr-webinars/pharmaceutical-applications-of-electron-paramagnetic-resonance-epr-spectroscopy.html. Bruker. Accessed February 4, 2018.
  7. Pharmaceutical Quality Control Testing. https://www.thermofisher.com/us/en/home/industrial/pharma-biopharma/pharmaceutical-quality-control-testing.html. ThermoFisher Scientific. Accessed February 4, 2018.
  8. Pre-Clinical and Clinical Drug Testing. https://www.thermofisher.com/us/en/home/industrial/pharma-biopharma/pre-clinical-and-clinical-drug-testing.html. ThermoFisher Scientific. Accessed February 4, 2018.
  9. Biopharmaceutical Analytical Testing. https://www.thermofisher.com/us/en/home/industrial/pharma-biopharma/biopharmaceutical-analytical-testing.html. ThermoFisher Scientific. Accessed February 4, 2018.
  10. Pharmaceutical Development Solutions. http://www.waters.com/webassets/cms/library/docs/720002446en.pdf. Waters. Accessed February 4, 2018.
  11. Risk and reward to advance drug discovery, development and manufacture. https://www.bruker.com/applications/pharma-biopharma.html. Bruker. Accessed February 4, 2018.
  12. Pharma R&D Outsourcing Is On The Rise. https://www.biopharmatrend.com/post/30-pharma-rd-outsourcing-is-on-the-rise/. BiopharmaTrend. Accessed February 4, 2018.
  13. Laínez JM, Schaefer E, Reklaitis GV. Challenges and opportunities in enterprise-wide optimization in the pharmaceutical industry. Computers & Chemical Engineering. 2012;47:19-28.
  14. Paul SM, Mytelka DS, Dunwiddie CT, et al. How to improve R&D productivity: the pharmaceutical industry's grand challenge. Nat Rev Drug Discov. 2010;9(3):203-214.

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Last updated: Mar 16, 2018 at 12:16 PM

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