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The biotech industry includes bio-pharma, bio-services, bio-agri, bio-industrials and bioinformatics. Biopharma is a rapidly growing segment that accounts for a dominant share in this sector. Advancements in biotechnology have enabled researchers to evaluate and identify target biomarkers/cell receptors to develop targeted and personalized therapies. Scientific research and technological advancements have resulted in the emergence of various personalized medicines that are undergoing research. According to research conducted by the 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.

The biotechnology 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 disease prevention.

Key Challenges

Biotech products have extensive application in oncology and autoimmune disease treatment. However, the cost of these drugs is 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 owing to growing concern for safety of the drug.

Also, there is lack of awareness about personalized medicine among most healthcare providers, which may hamper its adoption. Clinical adoption of biotechnology products is essential for its success. However, it significant scientific evidence and backing is required 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 a growth in their demand, Furthermore, consumers are willing to pay high prices for biopharmaceutical products compared to other conventional products. Biopharmaceutical brands have set new standards for blockbuster drugs by recording an annual average sale of over US$ 2bn. Drugs such as Humira have generated sales revenue of over US$ 10bn.

Governments in emerging economies are endorsing biosimilars as cost-effective alternatives to biotech products, which is expected to create significant growth opportunities for manufacturers of generic drugs. 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 on development of biosimilars and vaccines as preventive measures in addition to treatment. For instance, in 2015, Zarxio TM became the first biosimilar to be approved in the U.S. market. The EMA approved Mosquirix, a malaria vaccine, in the same year. Extensive research is currently underway to develop a dengue vaccine, which could be another breakthrough pharmaceutical product in the near future.


The increasing research in the biotechnology sector is expected to result in higher number of biopharmaceutical products seeking FDA approvals. Biopharmaceuticals are positioned to be promising treatment solutions that would improve patient outcomes and help with reduction of the cost of drug development.

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Biotechnology Published Insights

Coherent Market Insights

Pneumococcal Vaccines Market, by Vaccine Type (PCV10, PCV13, and PPSV23), by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies) - Size, Share, Outlook, and Opportunity Analysis, 2018 – 2026

Published Date : Nov 2018

Pneumococcal Vaccines Market Insights Pneumococcal vaccine is used to prevent infection caused by streptococcus pneumoniae bacteria. There are two types of pneumococcal vaccines: pneumococcal conjugate vaccin... Read more

Coherent Market Insights

Microneedle Flu Vaccine Market, by Product Type (Solid Microneedle, Hollow Microneedle , Coated Microneedle, Dissolving Microneedle), by Vaccine Type (Trivalent Flu Vaccine, Quadrivalent Flu Vaccine), by Flu Type (Influenza A( H1N1, H3N1), Influenza B) and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2020 - 2027

Published Date : Nov 2020

Micro-needles are new form of dose delivery systems, which can easily overcome various problems associated with the conventional formulations. Microneedle device consists of needles of micron size, which are arranged on a small dermal patch. The main principle of micr... Read more

Coherent Market Insights

Tissue Engineering Market, by Material Type (Synthetic, Biological and Others), by Application (Dermal, Orthopedic, Dental, Neurology, and Others), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Trends, and Forecast to 2026

Published Date : Oct 2018

Tissue Engineering Market – Insights Tissue engineering is an interdisciplinary field addressed to develop functional three-dimensional tissues combining cells, scaffolds, and bioactive molecules. This ... Read more

Coherent Market Insights

Plant-based Vaccines Market, by Vaccine Type (Bacterial Vaccines, Viral Vaccines, Parasite Vaccines, and Others), by Source (Tobacco Plant, Maize, Potato, and Others),  by Application (Influenza, Covid-19, Zika Virus, Ebola Virus, Poultry Disease, and Others) and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2021 - 2028

Published Date : May 2021

Plant serves as an important source to produce cost-effective vaccine derivatives. Plant-based production of vaccine helps to reduce economic burden of infectious disease in emerging economies, owing to its large-scale production and cost-efficiency. Various clinical ... Read more

Coherent Market Insights

Influenza Vaccines Market, by Vaccine Type (Trivalent Vaccines and Quadrivalent Vaccines), by Virus Type (Influenza Virus A and Influenza Virus B), by Age Group (Pediatrics and Adults) and by Region - Global Forecast to 2026

Published Date : May 2018

Influenza Vaccines Market Insights – To Stop the Flu Is All Up to You Influenza is a contagious respiratory infection caused due to influenza virus. Influenza is marked by fever, cough, muscles and joi... Read more

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Soft Tissue Repair Market, By Product Type (Synthetic, Allograft, Xenograft, Alloplast), By Application (Breast Reconstruction, Hernia, Dermatology, Orthopedics, Dental, Vaginal Sling, Others), By End User (Hospitals, Ambulatory Surgical Centers, Clinics), By Region (North America, Latin America, Europe, Asia Pacific, Middle East & Africa) - Size, Share, Outlook, and Opportunity Analysis, 2020 - 2027

Published Date : Sep 2020

Human body soft tissue comprises tendons, muscles, ligaments, skin, nervous tissue, cartilage, and synovial membrane. Tissue damage causes change in structure and biochemical composition. Soft tissue repair refers to replacement of the destroyed body tissue with livin... Read more

Coherent Market Insights

Wound Care Biologics Market - by Product Type (Biologic Skin Substitutes, Enzyme Based Formulations, and Growth Factors), by Application (Chronic Wounds and Acute Wounds), by End User (Hospitals, Clinics, Ambulatory Surgical Centers, and Home Care Settings), and by Region - Global Industry Insights, and Forecast to 2025

Published Date : Apr 2018

Wound Care Biologics Market – Experience the Power of Effective Healing Wound care biologics are bioengineered products used for non-healing wounds of the lower extremity.  Demand for wound care bi... Read more

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