The vaccines market consists of sales of vaccines and related services. This industry includes establishments that produce anti-infective vaccines, autoimmunity vaccines and vaccines for cancer and other diseases. Vaccines create antibody-antigen reaction that helps in attaining resistance to the disease causing organism. Vaccines include recombinant vaccines, conjugate vaccines, live attenuated vaccines, inactivated vaccines, toxoid vaccines and others.
The global vaccines market was valued at about $29.64 billion in 2018 and is expected to grow to $43.79 billion at a CAGR of 10.3% through 2022.
Rising awareness on immunization and vaccination benefits in emerging markets is consistently driving the global vaccines market growth. World Health Organization (WHO) is taking initiatives to increase awareness of immunization through global vaccine action plan (GVAP) and global Immunization vision and strategy (GIVS). They aim to strengthen routine immunization, control morbidity and mortality from vaccine preventable diseases and help countries to immunize more people with a greater range of vaccines. The Organization accomplishes this work through its biological programme, the WHO Collaborating Centers, and the WHO Expert Committee on Biological Standardization (ECBS). In 2017, according to WHO statistics,85% of the total infants across the globe, (116.2 million) received 3 doses of diphtheria-tetanus-pertussis vaccine in order to increase immunization and protect them against infectious diseases that can cause serious illness and disability. Furthermore, 123 countries reached 90% coverage of DTP3 vaccine in 2017.
The vaccines market growth is limited due to severe shortage of skilled healthcare professionals for developing biologics drugs which requires specialized skillsets. These skillsets are limited to some research organizations and medical equipment companies in the USA and Europe, this is expected to be a major restraint on the market. As of 2018, 40% of the biopharma industry was facing difficulties in hiring for process development staff due to shortage of talent. This shortage also led to rise in competition and salaries for the limited talent pool available for biologics talent, thereby further limiting growth of the market.
The vaccines market has been witnessing multiple strategic initiatives and mergers and acquisitions in the recent years. Top companies in the market are strategically acquiring start-ups and mid-sized companies to broaden products and services. For instance, in February 2019, Bharat Biotech acquired Chiron Behring Vaccines, a clinical biotechnology company, one of the leading manufacturers of rabies vaccines across the globe. Similarly, in 2017, Takeda Pharmaceutical acquired ARIAD Pharmaceuticals for approximately $5.2 billion, and Sanofi acquired Protein Sciences for $650 million. Companies in the industry are increasingly realigning their portfolios and pursuing profitable inorganic growth opportunities. Additionally, M&A interest is also being fueled by stronger corporate balance sheets, liquid debt markets, and continued favorable interest rates globally.
The Food and Drug Administration (FDA) is the National Regulatory Authority (NRA) in the United States responsible for assuring quality, safety, and effectiveness of all vaccines for human use. Center for Biologics Evaluation and Research (CBER) within the US FDA is responsible for regulating vaccines market. Governments across the world are encouraging the research and development of biologics in order to develop more targeted therapies and vaccines for various diseases. In May 2014, the US’s FDA announced a fast-track initiative to review its drugs and biologics policy to speed the availability of therapies to patients with serious conditions, orphan drugs for rare disease, while preserving the safety and efficacy standards. In 2016, FDA also removed a rule (Section 610.21 of the FDA code) which specified minimal potency limits for certain antibodies and antigens. . In addition, FDA is also updating regulations (Section 610.53 of FDA code) regarding storage periods and storage conditions for biologics.
In October 2018, Emergent BioSolutions, a multinational specialty biopharmaceutical company, acquired PaxVax for $270 million. This acquisition would strengthen and expand Emergent BioSolution's product portfolio with PaxVax's typhoid vaccine Vivotif, cholera vaccine Vaxchora and additional clinical-stage vaccine used in the prevention of typhoid fever, cholera, chikungunya and other emerging infectious diseases. PaxVax is a company focused on developing, manufacturing, and commercializing specialty vaccines that protect against existing and emerging infectious diseases. PaxVax was founded in 2006 and is headquartered in Cayman Islands, a British Overseas Territory.
Major players in the market are AstraZeneca, Emergent Biosolutions , Glaxosmithkline , Merck , Pfizer