API Sector
API Sector
June 2021
Hello Readers,
The Global Outsourced API industry, valued at USD 75.1 Bn, forms an integral
part of the pharma value chain
Outsourced API Market 40% Share of Global API outsourced to third party
(USD 75.1 bn)
Indian API Market 15% Share of India in Global API Outsourced Market
(USD 11.3 bn)
North America dominates the global API market in terms of consumption, while Asia Pacific is the fastest growing market
China is the largest market for API production, with 40% market share globally
With USD 11.3 bn, Indian API is the fastest growing market; ranked third largest globally (after China and Italy)
India has the third highest no of USFDA plants (318) and highest no of US DMF filings (46%) worldwide
Source: Mordon Intelligence (2019), KPMG-CII report (Apr 2020) , Ministry of Commerce and Industry (2020), Pharma Bureau (Jul 2020)
The Indian API Industry of USD 11.3 Bn is expected to outpace the global
Industry, led by higher proportion of outsourcing and import substitution
Indian API Market, 2016-2024
Recent structural tailwinds have positively impacted the Indian API market
India ranks #1 in terms of DMF filings (2019) with 55% share India ranks #1 in terms of ANDA filings (2019) with 45% share
331 375
258
113
94
56 67 58 75
22
Indian Pharma players are perceived higher on quality and regulatory norms, given the large number of DMF and ANDA filings
Historically, China with a large capacity and economies of scale has dominated
the Global API industry, with India also being dependent on China…
India imports almost 67% of its API consumption from China… …because operating cost in China is 20-30% lower than India
70% 100 3
63% 63% 65% 65% 66% 67% 67%
61% 11 81.6 3
3.56 9 8
3.19 3.15 3.25 3.25 3.41 10 4
2.96 2.74 2.99 9
8 3
63
51
FY12 FY13 FY14 FY15 FY16 FY17 FY18 FY19 FY20 India China
Export
Low Limited 35-40% exported 45-50% exported
China benefits from shared utilities, large capacities and superior access to raw materials leading to low operating costs.
Hence, any disruption in supply chain from China can lead to significant shortages in the supply of essential drugs globally
Source: KPMG-CII report (Apr 2020), CRISIL research, Ministry of Commerce and Industry, Pharma Bureau
India’s high dependence of low cost Chinese imports has been recognized Environmental concerns in China has disrupted production of local API
as health security risks by Drug Controller General of India (DCGI) manufacturing units:
In early 2018, DCGI banned import of bulk drugs from 6 major Chinese — In 2018, China revamped its environmental protection law
firms citing quality concerns, and noting following observations: (proposed in 2016) to control pollution
— Inadequate process quality control checks — API manufacturers in China closed down/ suspended production of
API, in an effort to reduce air pollution and save compliance costs
— Inadequate re-validation of analytical procedure
— 80,000+ factories have been shut down by the Chinese government
— Registration requirements in contravention to GMP requirements
The enforcement of environmental standards has led to significant increase in compliance cost of Chinese API players
China’s API exports to US declined by 11% in CY19 Global players are focusing on de-risking their supply chain
46% 47%
Global Pharma players have adopted a “dual sourcing” strategy
28% 28% post the regulatory clampdown on Chinese manufacturers
15% 13%
9% 8%
3% 3% 1% 1%
India is expected to be the largest beneficiary due to better
Asia Europe North Latin Africa Oceania regulatory and quality norms and being a low-cost API manufacturer
America America
CY18 CY19
China’s export market is ~9x larger than India’s; even a small shift from China can significantly benefit the Indian API export market
PLI Scheme (financial outlay of INR 6,940 cr) Set up of 3 bulk drug parks (financial outlay of INR 3,000 cr)
53 KSM/ intermediates/ APIs has been covered, of which 26 are To set up 3 bulk drug parks for providing easy access to common R&D
fermentation products Infrastructure and testing facilities, with assured land
Selection criteria will be based on capacity of the proposed plant 3 States to be selected through challenge method, with selection
(35% weightage) and Sale price of API (65% weightage) based on objective evaluation criteria
Incentive is linked to a threshold investment and incremental sales Expected to help pharma companies reduce the initial plant set-up
over base year costs and achieve economies of scale
Fermentation based Chemical synthesis based Steps taken by few State Governments to set up bulk drug parks
Parameter KSM/ KSM/ API/ KSM/ KSM/ \API/
Intermediate Intermediate Intermediate Intermediate
Few state governments like Telangana are also promoting pharma
Max incentive INR 3,600 cr INR 1,000 cr INR 960 cr INR 1,380 cr parks by initiating work on a pharma park in Hyderabad
Number of The decision is based on the assessment that several pharma suppliers
8 20 16 92
manufacturers could shift out of China post-COVID-19
Min. threshold
INR 400 cr INR 50 cr INR 50 cr INR 20 cr The project will feature common facilities including ZLD based
investment
Common Effluent Treatment Plant, an integrated solid waste
% incentive FY24-FY27: 20%, management facility, logistic parks, testing labs & other facilities
FY23-FY28: 10%
(for 6 years) FY28: 15%, FY29: 10%
Structural tailwinds have heightened PE deal activity in API space during the
pandemic, larger than the sum of all API deals witnessed over the last decade
PE deal activity in API space in India
PE funds
API players
M&A Deal in Focus: Merger of Aurore Life Sciences into Solara Active Pharma
Merged
(Apr-21) Founded in 2017 at Hyderabad, Aurore is a pure-play API
manufacturer with a diverse portfolio serving to generic
players globally
India based pure-play $279 Mn Leading pure-play API Houses an R&D and two manufacturing facilities in
API manufacturer manufacturer in India and Hyderabad with a combined capacity of 600 KL
CRAMS in regulated market The facility has approvals from USFDA, EDQM, WHO
Geneva, COFEPRIS, KFDA
Merger of Solara and Aurore has created second largest pure play API Company
in India, with a combined revenue of USD 292 mn Transaction structure
The combined entity houses eight manufacturing facilities, three R&D centers
and increases the customer footprint to over 75 countries Aurore, Empyrean Lifesciences (100% subsidiary of Aurore)
and Hydra Active Pharma Sciences (common promoter in
The merger is expected to generate significant synergies in terms of operations Aurore) shall be merged into Solara
and cost savings through economies of scale
The shareholders of Aurore will own 27% stake in the
The merger also increases the capability to offer a wider portfolio of products merged entity
with a diversified resource base and deeper client relationships
Apr 21 279 Manufactures diverse portfolio of API, serving to generic players globally
May-20 367 Manufactures API and intermediates as well as provides CDMO services
Dec-19 30 Manufactures naturally sourced APIs for Pharma and Nutra industry
Multiple investors 775 Biotech firm that develops a cell programming platform
Multiple investors 200 Biotech firm that develops small molecule oncology medicines
Biotech Firm that develops drug candidates across multiple indications for
Multiple investors 155
the treatment of cancer
Alembic Pharma 1,92,652 1,95,031 53,931 27% 22% 3.6x 13.3x 16.4x 3.5x 13.7x 19.7x
Glenmark Pharma 1,80,291 2,11,475 1,09,439 19% 9% 1.9x 10.1x 18.6x 1.7x 9.2x 16.8x
Ajanta Pharma 1,67,854 1,64,450 28,897 34% 23% 5.7x 16.6x 25.7x 5.0x 15.7x 23.6x
J. B. Chemicals 1,19,467 1,12,838 21,549 27% 22% 5.5x 20.1x 26.7x 4.9x 18.8x 26.8x
Eris Lifesciences 94,924 93,627 11,926 36% 30% 7.9x 21.7x 26.7x 6.9x 19.9x 23.5x
Strides Pharma 68,799 87,694 33,159 19% 8% 2.6x 14.0x 25.6x 2.3x 11.8x 19.7x
FDC 59,944 54,523 13,332 25% 23% 4.1x 16.3x 19.9x 3.4x 12.5x 16.7x
Indoco Remedies 37,021 38,983 12,415 18% 7% 3.1x 17.4x 39.8x 2.5x 14.7x 24.9x
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