Market Challenges And Opportunities

Global Biotechnology Market - DriversIncreasing research and development activities in tissue culture and cell engineering

Increasing research and development in the field of cell and tissue engineering is expected to drive the global biotechnology market growth over the forecast period. For instance, on August 16, 2022, Bharat Biotech., an India-based vaccines & bio-therapeutics manufacturer, announced phase III clinical trial data for its intranasal COVID-19 vaccine. The vaccine was proved to be safe well tolerated and immunogenic in subjects in controlled clinical trials. Drug Controller Genaral of India (DCGI) has also granted permission to the firm to conduct a phase-3 clinical trial to compare the immunogenicity and safety of BBV-154 (intranasal) with Covaxin. This trial has been permitted to be conducted at nine sites in India.

Increasing launches of new products in biotechnology

Increasing launch of new products in biotechnology is expected to drive the global biotechnology market growth. For instance, on July 4, 2023, Niocon, India based biopharmaceutical company, launched a biosimilar version of AbbVie's top-selling biologic Humira (generically called adalimumab) in the U.S. market under the brand name HULIO. Adalimumab is used to treat certain inflammatory diseases like rheumatoid arthritis. The drug has been made available to patients in the United States after five years of experience in Europe and two years in Canada.

Global Biotechnology Market – Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe, and the World Health Organization declared it a public health emergency on January 30, 2020.

COVID-19 affected the economy in three main ways: by directly affecting the production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries, such as China, India, Saudi Arabia, the U.A.E., Egypt, and others faced problems regarding transportation of drugs from one place to another.

However, the COVID-19 pandemic had a positive impact on the global biotechnology market, due to increased demand for biotechnological products and vaccines for treatment. For instance, on November 9, 2020, Pfizer Inc., U.S. based multinational pharmaceutical and biotechnology corporation, announced a vaccine candidate against COVID-19. It is an mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 It has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted by external independent data monitoring committee. The protection against infection is achieved after 28 days of initiation of vaccination.

Restraints: Termination of clinical trials

The failure in obtaining expected results causes the termination of the clinical trial. Such failures can hamper the global biotechnology market growth. For instance, on July 7, 2022, Legend Biotech Corporation, U.S. based commercial-stage biotechnology company developing and manufacturing novel therapies, notified the U.S. Food and Drug Administration (FDA) that Legend Biotech has terminated its Phase 1 Clinical Trial under the Investigational New Drug (IND) application for LB1901, Legend Biotech's investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adults with relapsed or refractory T-cell lymphoma. The termination of the trial was based on a lack of clinical benefit from a similar Legend Biotech CAR-T product candidate expressing the same CAR protein as LB1901 which was the subject of an investigator-initiated study conducted in China.

To counterbalance this restraint, more research and development should be done that can avoid costly failures of clinical trials.

High cost of biotechnology therapies

In emerging economies, the lack of infrastructure facilities and the high cost of biotechnology therapies is expected to hamper the global biotechnology market growth. For instance, according to an article published in the Journal of managed care & Specialty Pharmacy in May 2021, average costs over a lifetime of treatment with antibodies for patients with factor VIII (FVIII) hemophilia A be between US$15 million and US$100 million, which is more than 3 times (and up to 20 times) the projected lifetime cost for a patient treated with alternative therapy.

To counterbalance this restrain, more funding by governments for reimbursement should be allocated.