Summary
The global radiotherapy market is valued at USD 5.9 billion in 2021 and is expected to reach USD 7.3 billion by 2026, at a CAGR of 4.2% during the forecast period [1]. And it is well known that cancer patients undergoing radiotherapy are exposed to excessive ionizing radiation on healthy body tissues. The problem of radiotherapy overexposure of healthy tissues affects about 60% of radiotherapy patients worldwide. At the present time, the primary goal of the research is to overcome the radioresistance of tumors, while protecting healthy tissues from the radiation effects remains a secondary goal. However, the consequence of overexposure of healthy tissues is the formation of non-healing ulcerative defects and dysfunction of healthy tissues. The main types of healthy tissue suffering from overexposure are bone marrow and gut tissues.
[1. Radiotherapy Market by Product (LINAC, CyberKnife, Gamma Knife, Tomotherapy, Particle Therapy, Cyclotron), Procedure (External (IMRT, IGRT, 3D-CRT) Internal (LDR, HDR)), Application (Prostate, Breast, Lung), End User (Hospitals) - Global Forecasts to 2026 https://www.marketsandmarkets.com/Market-Reports/radiotherapy-monitoring-devices-market-567.html?gclid=Cj0KCQjwnoqLBhD4ARIsAL5JedLSumbI3yHzN8pHMqNPAnpCyvk9gdfHryyqvY0AlI6uCwKAyLw9IXsaAqzOEALw_wcB ]
The aim of the project is to establish and develop a platform for human microbiota modification for the promotion of radioresistance of healthy gut tissues. Since the microbiota of healthy and tumor tissues differ in composition, targeted genetic engineering of the human microbiota can protect healthy tissues and have no effect on tumor tissues.
The total volume of investments of round A to develop the proof-of-concept is USD 24.55 mln. Planning horizon of 5 years is chosen in consideration of time frames when the company will reach the planned capacity and the investments will be returned. The criteria of the project’s economical efficiency are listed in table 1.
| Index Number Comparison | Index Number Comparison | Index Number Comparison |
| Total volume of investments | 24.55 | |
| NPV for 6 years, mln USD | 55.2 | >0 |
| Discounted Payback Period | 2.5 years | |
| Rwacc | 18% | Awarege on the Market |
| IRR | 19% | > Rwacc |
The project is considered as profitable.
Market
Market Overview
The global radiotherapy market is valued at USD 5.9 billion in 2021 and is expected to reach USD 7.3 billion by 2026, at a CAGR of 4.2% during the forecast period. Technological advancements in radiotherapy and the rising incidence of cancer are the major factors driving the growth of this market. Additionally, the growing adoption of radiotherapy procedures for cancer treatment, increasing the use of particle therapy for cancer treatment.
[2. Radiotherapy Market by Product (LINAC, CyberKnife, Gamma Knife, Tomotherapy, Particle Therapy, Cyclotron), Procedure (External (IMRT, IGRT, 3D-CRT) Internal (LDR, HDR)), Application (Prostate, Breast, Lung), End User (Hospitals) - Global Forecasts to 2026 https://www.marketsandmarkets.com/Market-Reports/radiotherapy-monitoring-devices-market-567.html?gclid=Cj0KCQjwnoqLBhD4ARIsAL5JedLSumbI3yHzN8pHMqNPAnpCyvk9gdfHryyqvY0AlI6uCwKAyLw9IXsaAqzOEALw_wcB ]
The value of the potential global market of innovative radioprotectors may be assessed as 1% of the global radiotherapy market, i.e. USD 73 mln by 2026 with the amount of procedures with requiration on radioprotection is 0.2 mln annually. That may be given a price for one dose of gene-engineered radioprotective probiotic is USD 350.
Additionally, a company with a first-in-class drug can count on 30% of the market (Figure 1), i.e. USD 22 mln by 2026.
Key Market Players
The dominant players in the global radiotherapy market are Varian Medical Systems, Inc. (US), Elekta (Sweden) Accuray Incorporated (US), Ion Beam Applications SA (Belgium), BD (US), Eckert & Ziegler (Germany), Hitachi Ltd. (Japan), ICAD, Inc. (US), IntraOp Medical, Inc. (US), IsoRay Medical, Inc. (US), Mevion Medical Systems, Inc. (US), Panacea Medical Technologies Pvt. Ltd. (India), P-cure Ltd. (Israel), ViewRay, Inc. (US), and ZEISS Group (Germany), among others. The listed companies can be considered as potential partners in the acquisition of the start-up company.
Varian Medical Systems (US) is one of the leading players in the global radiotherapy market. Its broad portfolio of radiotherapy systems and brachytherapy products is the key factor accounting for its large share in this market. The company is focused on organic strategies such as product launches and introduced a number of new and advanced radiotherapy systems and received regulatory approvals for products in the past three years, such as the ProBeam 360 single-room proton therapy system, ProBeam 360 with multi-room configuration, Halcyon 2.0 system, and Calypso Anchored beam transponder system for LINACS, among others. It also adopted inorganic strategies such as agreements, partnerships, collaborations, and contracts to enhance its market presence.
[3,4. Radiotherapy Market by Product (LINAC, CyberKnife, Gamma Knife, Tomotherapy, Particle Therapy, Cyclotron), Procedure (External (IMRT, IGRT, 3D-CRT) Internal (LDR, HDR)), Application (Prostate, Breast, Lung), End User (Hospitals) - Global Forecasts to 2026 https://www.marketsandmarkets.com/Market-Reports/radiotherapy-monitoring-devices-market-567.html?gclid=Cj0KCQjwnoqLBhD4ARIsAL5JedLSumbI3yHzN8pHMqNPAnpCyvk9gdfHryyqvY0AlI6uCwKAyLw9IXsaAqzOEALw_wcB]
In November 2020, Elekta AB (Sweden) received CE mark for the Elekta Harmony linear accelerator, clearing the technology for commercial sales in Europe.
In April 2020, Elekta AB (Sweden) launched Geneva, the first universal gynecological applicator for brachytherapy. Geneva applicator is CE-marked and has received US FDA 510(k) clearance. It is used for cervical cancer up to stage IIB
In June 2020, Accuray Incorporated (US) launched the CyberKnife S7 System, an innovative device combining speed, advanced precision, and real-time AI-driven motion tracking and synchronization treatment delivery for all stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) treatments.
Although there are drugs on the market for radiosensitization of tumors (making tumor tissues more sensitive to ionizing radiation) [5], there are no commercial drugs for radioprotection.
[5. Poon, D. J. J., Tay, L. M., Ho, D., Chua, M. L. K., Chow, E. K. H., & Yeo, E. L. L. (2021). Improving the therapeutic ratio of radiotherapy against radioresistant cancers: Leveraging on novel artificial intelligence-based approaches for drug combination discovery. Cancer letters, 511, 56-67.]
Product
The goal of this project is to develop and to market the innovative radioprotector drug based on microbiological gene-engineered probiotics (Bacterial Radioprotector Probiotics) (Figure 2).
CAPEX (CAPital EXpenditures)
The capital expenditure on the project consists of R&D expenses, long-term contact production and primary marketing costs (Table 2). The preliminary costs were estimated by analogy with competitor companies in the field of synthetic microorganisms: Amyris and GinkGo Bioworks.
Table 2. Total CAPEX Expenditures
| Expenditures | Value, mln USD |
| R&D expenses | 12.0 |
| Long-term contact production on the plants in the EU and the US | 4.0 |
| Primary marketing costs | 2.75 |
| Registration procedures: FDA EMEA |
4.8 2.8 2.0 |
| Total | 24.55 |
OPEX (OPeration EXpenditures)
Operation Expenditure consists of annual contact production payment, logistics and marketing and management (Table 3).
Table 3. Annual OPEX Expenditures
| Expenditures | Value, mln USD |
| Annual contact production payment, per 1 million doses | 10.0 |
| Logistics, per 1 million doses | 5.0 |
| Marketing, per 1 million doses | 8.0 |
| Management | 0.8 |
CASH FLOW STATEMENT
Assisted market share for a company with a first-in-class drug as USD 22 mln by 2026 led to assisting the production value as 60.000 doses per USD 350, with annual revenue USD 21 mln.
CAPEX
- Total = 24.55 mln
OPEX
- Annual contact production payment = USD 600.000
- Logistics = USD 300.000
- Marketing = USD 480.000
- Management = USD 800 000
- Total = USD 2.18 mln (annually)