The biotech industry comprises bio-pharma, bio-services, bio-agri, bio-industrials and bioinformatics. Biopharma is a rapidly growing segment that accounts for a dominant share of this sector. Advancements in biotechnology has enabled researchers to evaluate and identify target biomarkers/cell receptors to develop targeted and personalized therapies. Increasing scientific understanding, advanced tools and techniques has led to emergence of various personalized medicines that are now in research phase. According to a research conducted by Personalized Medicine Coalition, 42% of all compounds and 73% of oncology compounds in the pipeline possess the potential to be personalized medicine. Moreover, according to this study, it is expected that companies will increase their investment in R&D of personalized medicines by 1/3rd over the following five years. The study found that over 20% of drugs approved in 2014 were personalized medicines.

Biotech sector has witnessed some disruptive innovations such as gene and cell therapies, immunotherapy, and antibody drug conjugates. Advancement in stem cell therapy is resulting in effective treatment therapies for chronic conditions, organ growth and repair and also in disease prevention.

Key Challenges

Biotech products have extensive usage in oncology and autoimmune disease treatments. However, the costs of these drugs are exorbitantly high owing to extensive research and trials that need to be carried out for the same. Therefore, there is constant pressure to reduce price and increase accessibility, especially in emerging economies. In the U.S., companies are facing reimbursement issues with respect to biopharmaceutical products. Besides, there are regulatory and scientific challenges faced by the sector. Scientific research for new molecules and targeted therapies is capital intensive and challenging, with increased concern for safety of the drug.

Also, there is lack of awareness about personalized medicine among most healthcare providers, which hinders its adoption. Clinical adoption of the biotech products is essential for its success. However, it entails a lot of scientific evidences and explanation to the prescribers in order to ensure its safety.

“Translating genomic discoveries into personalized medicines entails overcoming substantial scientific, regulatory, and economic challenges, including identifying validated biomarkers, as well as developing personalized therapeutics and clinically relevant diagnostic tests.”

  • Tufts Center for the Study of Drug Development


The biopharmaceutical sector offers vast lucrative growth opportunities. High efficacy and safety of biopharmaceutical products has led to increased demand for the same, with consumers willing to pay high prices for these as compared to other conventional products. Moreover, biopharmaceutical brands have set new standards for blockbuster drugs by recording an annual average sales of over US$ 2 Bn. Certain drugs such as Humira have generated sales of over US$ 10 Bn. Thus, investing in biotech R&D has yielded better results than pharmaceutical drugs.

For generic players, biosimilars offers a very good growth opportunity, as governments in emerging economies are supporting such therapies as cost-effective alternatives to biotech products. Therefore, cost-effectiveness and high quality are prime parameters that need to be considered while developing biosimilars. Recent and upcoming biologic patent expirations include the following:

  • Erbitux (cetuximab) - February 2016
  • Rituxan (rituximab) - September 2016
  • Herceptin (trastuzumab) - June 2019
  • Avastin (bevacizumab) - July 2019
  • Aranesp (darbepoetin alfa) - May 2024
  • Enbrel (etanercept) - November 2028

Companies such as Teva Pharmaceuticals, Hospira, Sandoz and Amgen are focusing their resources ondevelopment of biosimilars. Also, vaccines are other major products in development to focus on prevention aspect rather than just treatment. For instance, 2015 marked the U.S. launch of Zarxio TM, the first biosimilar approved in this market and the EMA approval of Mosquirix, the malaria vaccine. Extensive research is currently underway to develop a dengue vaccine, which could be another breakthrough pharmaceutical product in the near future.


Increasing research in biotech sector, in turn would translate into higher number of biopharma products seeking FDA approvals in future. Biopharma is positioned to be a promising treatment solution that would improve treatment outcomes and serve to accelerate and help reduce cost of drug development.

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