Microbial Therapeutic Products Market by Product (Growth Factors, GCSF, Peg GCSF, Exenatide, Anti-cancer Agents, Immunosuppressants, Enzymes), Route of Administration (Single Use Pre-Filled Injection/Injector Pen, Multi-use Injectors), Source, Application, End User & Region - Forecast to 2020-2030

About the Report

There is a growing body of evidence that establishes the link between microbial imbalance and the risk of developing certain diseases. As focus on developing therapeutic products that treat and effectively mitigate development of such diseases has gained traction, the commercial prospects have also increased. In this new study, Future Market Insights (FMI) offers a comprehensive analysis on how microbial therapeutic products market is likely to gain traction over the forecast period 2020-2030. In addition to analysing market forces, the report also outlines the impact regulatory climate can have on future microbial therapeutic product development.

Introduction

The global microbial therapeutic products market is poised to expand robustly at a value CAGR worth 7% across the 2020-2030 assessment period. Rising prevalence of lifestyle induced chronic disorders as well as antimicrobial resistance are primarily driving the market’s growth. Resistance to penicillin, for instance, ranges from 0 to 51%, and 8 to 65% for anti-E.coli drugs.

Market players, therefore, are scrambling to develop novel approaches to treat various immunological disorders and other body ailments, thereby uplifting scope of the market in the forthcoming decade.

Rising Prevalence of Chronic Disorders

According to the World Health Organization, chronic disease prevalence is slated to augment 57% by 2020-end. As the global geriatric population increases, prevalence of conditions such as diabetes, cardiovascular problems, cancers and asthma are bound to rise. Against this backdrop, pharmaceutical companies are accelerating their research to develop effective treatments.

Over the years, acknowledgement of microbial role in human health and disease has been heightening. A recently published study has laid bare the possibilities of developing live biotherapeutics consisting of engineered microbes to address specific disease mechanisms by incorporating non-pathogenic bacteria.

Emerging markets are likely to emerge as potential opportunity hubs, given the high incidence of global population combined with the emergence of various lifestyle diseases. India, for instance, represents significant growth opportunities, with over 60% of the population suffering from asthma, CVDs, high cholesterol or diabetes. 

Advanced Technologies in Disease Diagnostics

As the global healthcare industry undergoes paradigm shifts, disease diagnostics is experiencing a sea-change. Demand for faster turnaround time, multiplexing of reaction and specificity are prompting healthcare institutions to invest in technologically advanced testing and diagnostic mechanisms.

For instance, the Mass Spec Pen developed by researchers at the University of Texas is capable of identifying and isolating cancerous tissue with a 96% accuracy rate. It analyses tissue metabolites, enabling surgeons to distinguish between healthy tissue and tumours without the need for specific labelling.

Until now, the Mass Spec Pen has been tested on over 800 human tissues through an ex-vivo approach for detecting breast, ovarian, thyroid, lung and pancreatic cancers respectively. Ongoing clinical studies are concentrating on developing in-vivo approaches along with other minimally invasive procedures to enhance patient comfort.  

Increased Biological Drug Development Funding

Over the years, governments have proactively pushed for enhanced budgetary allocation to further research on biosimilar drug development. The U.S FDA, for instance, has granted approval to nearly 300 biologics products in the recent past, with 87% of them being imports.

Out of the US$ 5.9 billion budgetary allocation for FY 2020, one-third of the total proportion has been dedicated to human drug development. This is expected to generate white spaces for future microbial therapeutic product development.

On a similar plane, Europe also offers favourable reimbursement policies for drug development. A coalition of medical researchers published an exhaustive study on the reimbursement and pricing scenarios of select CEE countries in 2017, which revealed that the reimbursement rate was 100%, especially for filgrastim, epoetin and somatropin.

Based on these aforementioned trends, the future of microbial therapeutic products indeed looks bright, with prominent manufacturers scrambling to acquire a consolidated presence across prominent markets in the upcoming forecast period.

Key Challenges

A major hurdle faced by microbial therapeutic specialists is the dearth of accurate data availability. According to Microbiotica, a prominent microbiome specialist, the mapping of different bacteria sources is imprecise, rendering most approaches redundant. While identification is possible, there is uncertainty about effects of multiple strains on human health.

Moreover, many functions of the specific bacteria can be shared with unrelated species. Thus, amongst a combination of around 10 bacteria linked to any disease, there may probably be just one equivalent strain. This poses a challenge as to what formulations must be deployed to ensure the drug’s effectiveness.

Although multiple treatment approaches have emerged, there is no common consensus about the most appropriate one. Live bacterial therapeutics is one such approach, which, although widely implemented, still remains quite ambiguous in terms of effectiveness. Many studies have failed to prove how live bacteria engraft and remain in the gut post-ingestion.

Microbial Therapeutics Market- Region-wise Analysis

North America Microbial Therapeutics Market

North America will remain the leading market for global microbial therapeutics, with global volume sales set to grow at over 7%. Increasing frequency of regulatory approvals to biosimilar candidates is the primary growth catalyst.

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According to the National Cancer Institute, cancer incidence amounted to 442.4 per 100,000 men and women between 2013 and 2017, with death rates measuring 158.3 per 100,000 individuals. As of January 2019, there were nearly 17 million cancer survivors across the United States, with the number projected to increase to 22.2 million in 2030.

Spurred by this, pharmaceutical companies are leveraging microbial therapeutics, mostly bacteria-derived, to regress certain forms of cancer and other ailments, leading experts to develop multiple modified bacterial strains.

For instance, in 2016, Seres Therapeutics collaborated with Nestle Health Sciences to develop microbiome-based clostridium difficile and inflammatory bowel disease therapies, which also includes ulcerative colitis and Crohn’s disease.

Europe Microbial Therapeutic Products Market

According to the National Centre for Biotechnology Information, cancer emerged as a major public health concern in Europe since the dawn of the 21^st century, with a prevalence rate of nearly 3% and increasing to 15% during old age. A burgeoning geriatric population pool is the key reason.

Furthermore, W.H.O estimates the impact of non-communicable diseases such as diabetes, chronic respiratory diseases, mental disorders and CVDs to an estimated 86% of fatalities and 77% of disease burden throughout the region. This is largely in response to the prevalence of sedentary lifestyles.

Besides, the burden of infectious diseases is also inclining along with antibiotic resistance as bacterium strains mutate. For instance, E. coli represents nearly 60% resistance level. Thus, pharmaceutical companies are racing to develop various microbial therapeutic products.

East Asia Microbial Therapeutic Products Market

The East Asian market is expected to register a staggering CAGR of nearly 9% through 2030. Growth is largely attributed to a growing presence of pharmaceutical giants who are introducing novel drug combinations to address the growing burden of infectious and chronic disorders.

In November 2019, regulatory authorities in China approved Shanghai Green Valley Pharmaceutical’s oligomannate infused drug to improve cognitive functioning of patients suffering from Alzheimer’s disease. The approval signals entry of the first new treatment since the past 17 years.

 In 2017, the Kitasato Institute entered into a joint drug discovery research agreement with Sumimoto Dainippon Pharma to assess infections caused by bacteria with antimicrobial resistance across Japan.

Category-wise Insights

Opportunities abound across Anti-cancer Agents

Rising global cancer burden is nurturing prolific advancements in oncology, thereby paving the way for enhanced anti-cancer agents’ sales across prominent markets. By 2020-end, the segment is expected to register over 4 billion volume sales. Numerous precision-based medicine candidates are being explored for numerous cancers, a key growth stimulant.

At the same time, demand for anti-microbial growth factors is experiencing noteworthy growth. Heightened potential for enhanced tissue regeneration among patients is prompting healthcare and pharmaceutical behemoths to leverage this approach in their drug formulations. The segment is likely to expand at nearly 8% CAGR through 2030.

Injector Pens to Remain Frequently Administration Approach

By route of administration, single use pre-filled injections shall be the most frequently deployed method of infusing microbial therapeutic products. Concerns over infection transmissions from multiple-use injections is accelerating single use injection pens usage.

The others segment is expected to hold maximum sway, expected to generate greater than 40% revenue throughout the forecast period. Approaches such as ecotherapeutics and faecal microbiome transplants are acquiring popularity, especially with regard to altering the intestinal microbiome.

Bacteria-Sourced Therapeutic Products Most Preferred

Bacterium-sourced microbial therapeutic products are likely to retain lucrativeness, attributed to abundant availability across different sources. Moreover, bacteria has been the baseline for developing and manufacturing various therapeutic drugs such as antibiotics and vitamins.

Over the years, intestinal microbiota has emerged as an attractive bacteria culturing source, attributed to their benign nature. Intestinal bacteria have proven highly useful in addressing digestive diseases and food-borne illnesses. Hence, genetic engineering mechanisms to enable their extraction have multiplied in recent years.

Oncology to be Key Application Area

In spite of several advancements in cancer treatment, new therapeutic platforms are still being investigated, with the objective of providing top quality care to cancer patients. This heightened search is expected to generate credible growth opportunities in the oncology segment.

Research indicates that bacetriocins antibiotics, enzymes and peptides offer tremendous potential for developing anti-cancer drugs. Out of these, bacetriocins offer the most promising prospects for future drug development.

COVID-19’s Impact on Microbial Therapeutic Products

The COVID-19 pandemic has opened new frontiers for the microbial therapeutic products market. Presently, key therapeutic approaches for the virus include supportive care and complication prevention. Currently, it is acknowledged that developing a potential drug candidate is bound to take several years.

In spite of this hindrance, healthcare providers are accelerating efforts to discover a potential cure as soon as possible. A breakthrough has already been achieved, with Pfizer Inc. successfully testing and distributing anti-COVID-19 vaccines across the United Kingdom. Global availability of the vaccine is projected to occur from 2021.

Presently, Ribavarin, a broad spectrum antiviral drug, is being administered in-vitro to patients afflicted by the novel coronavirus. However, several contesting claims have limited its uptake across healthcare settings, thus prompting experts to investigate new drug formulations.

Against this backdrop, several golden opportunities are in store for the global microbial therapeutic products in the upcoming decade. With proactive government support and adequate funding for COVID-19 drug research, the market is expected to remain positive in the long-run. 

Microbial Therapeutic Products Market- Competition Analysis

Future Market Insights’ microbial therapeutic study has profiled the following prominent pharmaceutical companies*:

• Mylan N.V.
• F. Hoffmann La-Roche Ltd.
• Novartis AG
• Amgen Inc.
• Merck & Co. Inc.
• Biocon
• Pfizer Inc.
• Dr. Reddy’s Laboratories Ltd.
• Intas Pharmaceuticals Ltd.
• Novo Nordisk A/S
• Eli Lilly and Company
• Sanofi S.A.
• Boehringer Ingelheim
• Bristol-Myers Squibb Company
• Abbot Laboratories

*This list is indicative- full details about prominent microbial therapeutic products vendors is available upon request.

Out of these, Pfizer Inc., Sanofi S.A., Merck & Co. Amgen Inc. and Novartis AG constitute the bulk of overall revenue share. Primary emphasis is laid on collaborative license agreements with partners to commercialize and market their products. Moreover, remaining players focus on acquisitions and launching biosimilars.

For instance, Pfizer Inc. is actively collaborating with Merck & Co. to foster research and development in the oncology domain. The partnership was initiated with the objective of furthering the latter’s investigational anti PD-1 therapy drug candidate with two Pfizer oncology assets since many years.

Companies are also seeking enhanced regulatory approvals to penetrate lucrative markets. In November 2020, for example, Sanofi S.A’s Dupixent^® (dipilumab) was approved by the European Commission, making it the first and only biologic medicine for children aged 6 to 11 years suffering from atopic dermatitis.

More recently, in December 2020, Amgen Inc.’s AMG 510 investigation sotorasib KRAS^G12C Inhibitor has been granted Breakthrough Therapy designation for metastatic non-small lung cancer (NSCLC) by the U.S. Food & Drug Administration. The approval is expected to reduce clinical trial durations and deliver quicker outcomes.

Microbial Therapeutic Products Market- Report Scope

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• Is the microbial therapeutic products research conducted by Future Market Insights?

  Yes, the microbial therapeutic products report has been compiled by expert analysts of Future Market Insights through a combination of primary and secondary research. To know more about how the research was conducted, you can speak to the research analyst.

• What research methodology is followed by FMI?

  FMI follows a methodology that encompasses the demand side assessment of the market, and triangulates the same through a supply side analysis. This methodology is based on use of standard market structure, methods and definitions.

• Who are the respondents for primary research?

  FMI speaks to stakeholders across the spectrum, including C-level executives, distributors, product manufacturers, industry experts. For a full list of primary respondents, please reach out to us.

• What are the sources of secondary research?

  FMI conducts extensive secondary research through proprietary databases, paid databases, and information available in the public domain. We refer to industry associations, company press releases, annual reports, investor presentations, and research papers. More information about desk research is available upon request. 

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Key Segments

Product

• Growth Factors
• GCSF
• Peg GCSF
• Exenatide
• Anti-cancer Agents
• Immunosuppressants
• Enzymes
• Others

Route of Administration

• Single Use Pre-Filled Injection/Injector Pen
• Multi-use Injectors
• Others

Source

• Bacteria
• Fungi

Application

• Metabolic Disorders
• Haematological Disorders
• Oncology
• Immunological Disorders
• Infectious Diseases
• Allergic Diseases
• Others

End User

• Hospitals
• Pharmaceuticals & Biopharmaceutical Companies
• Research & Academic Institutions

Region

• North America (US & Canada)
• Latin America (Brazil, Mexico, Argentina & Rest of Latin America)
• Europe (Germany, Italy, France, U.K, Spain, BENELUX, Russia & Rest of Europe)
• East Asia (China, Japan & South Korea)
• South Asia (India, Thailand, Indonesia, Malaysia & Rest of South Asia)
• Oceania (Australia & New Zealand)
• Middle East & Africa (GCC, South Africa & Rest of MEA)